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Authentication:

Basic (Bearer token with base64-encoded string username:password)

Response Data:

totalcount is the total number of labels retrieved for the given filter criteria.
\n
skip is used to skip the given number of labels from the result, default 0.
\n
limit is the number of labels retrieved in the result, default 100.
\n
data contains generic name wise list of label details and current MedDRA version.
\n
GenericName is the generic name of the label.
\n
MeddraVersion shows the current MedDRA version.
\n
Labels contains the list of label details including id(s), ndccode, updated date, country, version and label's annotation details.
\n
The Id property uniquely identifies the label.
\n
- For US it is the combination of Country and FileId \n (FileId uniquely identifies the label version).
- For UK, CA, and EU Id is the combination of Country, ProductId, and Version.
- e.g. UK19887-2: UK label with productid 19887 and version 2.
\n
NDCCode is the label NDC Code, available for US only.
\n
UpdatedDate is the date on which the label is imported.
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LabelSource contains the label id, label version and country of label.
\n
Country displays the region of the label.
\n
ProductId is populated by the SetId for US labels and the ProductId for UK/CA/EU labels.
\n
FileId is a unique value for US for each version of the label, while other regions only have ProductId for all the versions of the label. So FileId will be the actual value of the FileId field for the US region, for other regions it will be the combination of ProductId and Version.
\n
- e.g. EUEMEA_H_C_000088-31: productid is EUEMEA_H_C_000088 and version is 31 \n (EU label)
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Version shows the latest version of the label.
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AdverseEventTerms contains the list of adverse terms, their MedDRA code and details about sections in which the term was found.
\n
Term is the preferred term found in MedDRA dictionary for the given label.
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MEDDRACode is a unique eight-digit number assigned to a term by MedDRA.
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Overdose describes whether the term found in the Overdose section or not.
\n
Warnings describes whether the term found in the Warnings section or not.
\n
BoxedWarning describes whether the term found in the Boxed Warning section or not.
\n
AdverseReactions describes whether the term found in the Adverse Reactions section or not.
\n
Contraindications describes whether the term found in the Contraindications section or not.
\n
DrugInteractions describes whether the term found in the Drug Interactions section or not.
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UseInSpecificPopulations contains all the sub-sections of Use In Specific Populations section and describes whether the term found in those sections or not.
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AnySection describes whether the term found in any of the sub-sections of Use In Specific Populations section or not.
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Pregnancy describes whether the term found in the Pregnancy section or not.
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NursingMothers describes whether the term found in the Nursing Mothers section or not.
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Lactation describes whether the term found in the Lactation section or not.
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PediatricUse describes whether the term found in the Pediatric Use section or not.
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GeriatricUse describes whether the term found in the Geriatric Use section or not.
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Other describes whether the term found in sections other than Overdose, Warnings & Precautions, Boxed Warning, Adverse Drug Reactions, Contraindications, Drug Interactions and Use in specific populations or not.
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Blacklisted describes whether the term found is blacklisted or not.
\n
Annotations contains the list of all VerbatimTerms, Probability and SemanticContext for the given term.
\n
- VerbatimTerm is the raw original term (aka verbatim term).
  \n
- Probability is a number between 0 and 1 that represents the confidence of the machine learning model that the term is an Adverse Event (1 being highest and 0 lowest confidence).
  \n
- SemanticContext is a snippet of the context from which the verbatim term was extracted, usually the sentence.
  \n
\n
IndicationTerms contains the list of terms found in indication section with their MedDRA code.
\n
The response data is sorted by SetId for US labels and by ProductId for UK/CA/EU labels.
\n

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Value for Number of records to skip (integer). Defaults to 0

\n","type":"text"},{"key":"limit","value":"10","description":"

Value for number of records to fetch (integer). Defaults to 100

\n","type":"text"},{"key":"country","value":"all","description":"

Options are \"us\", \"uk\", \"ca\", \"eu\", \"all\" (string). Defaults to \"us\"

\n","type":"text"}]},"url":"https://labelapi.doctorevidence.com/services/api/annotation/label","description":"

Bulk import of all label annotation in database.
To be used with skip and limit params.

e.g. To fetch all records, start with skip=0 and limit=100 (100 is max)\n and then every subsequent query will skip in multiples of 100 \n (value of limit)

NOTE: DO NOT USE THIS FOR DAILY MONITORING. THIS IS ONLY TO FETCH DATA FOR INITIAL DATA SET.

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Content-Range"},{"key":"Access-Control-Allow-Credentials","value":"true"},{"key":"Access-Control-Expose-Headers","value":"Content-Range"},{"key":"X-AspNet-Version","value":"4.0.30319"},{"key":"Set-Cookie","value":"ss-id=Rpvt9qqgaXXxDWQwX6Av; path=/; HttpOnly"},{"key":"Set-Cookie","value":"ss-pid=zqALYxDH51ODEqS2JGcP; expires=Fri, 26-Jul-2041 04:51:19 GMT; path=/; HttpOnly"},{"key":"Set-Cookie","value":"ss-opt=temp; expires=Fri, 26-Jul-2041 04:51:19 GMT; path=/; HttpOnly"},{"key":"strict-transport-security","value":"max-age=31536000; includeSubdomains"},{"key":"Date","value":"Mon, 26 Jul 2021 04:51:23 GMT"},{"key":"Content-Length","value":"2048728"}],"cookie":[],"responseTime":null,"body":"{\n \"totalcount\": 26669,\n \"skip\": 0,\n \"limit\": 10,\n \"data\": [\n {\n \"GenericName\": \"tramadol hydrochloride\",\n \"MeddraVersion\": \"24.0\",\n \"Labels\": [\n {\n \"Id\": \"UScffa4953-1dcd-4abd-a589-68d667292ed2\",\n \"NDCCode\": \"47335-859\",\n \"UpdatedDate\": \"Jul 02, 2021\",\n \"LabelSource\": {\n \"Country\": \"us\",\n \"ProductId\": \"004de5a4-80f8-4040-a6ea-be5e99352a36\",\n \"FileId\": \"cffa4953-1dcd-4abd-a589-68d667292ed2\",\n \"Version\": \"16\"\n },\n \"AdverseEventTerms\": [\n {\n \"Term\": \"Disease progression\",\n \"MEDDRACode\": \"10061818\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"disease progression\",\n \"Probability\": \"0.0017059743\",\n \"SemanticContext\": \"Tolerance is the need for increasing doses of opioids to maintain a defined effect such as analgesia in the absence of disease progression or other external factors .\"\n }\n ]\n },\n {\n \"Term\": \"Cough\",\n \"MEDDRACode\": \"10011224\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"cough\",\n \"Probability\": \"0.9995154142\",\n \"SemanticContext\": \"Eye disorders: vision blurred Gastrointestinal disorders: abdominal pain upper, dyspepsia, abdominal pain, sore throat General disorders: weakness, pain, feeling hot, influenza like illness, fall, rigors, lethargy, pyrexia, chest pain Infections and infestations: nasopharyngitis, upper respiratory tract infection, sinusitis, influenza, gastroenteritis viral, urinary tract infection, bronchitis Investigations: blood creatine phosphokinase increased, weight decreased Metabolism and nutrition disorders: appetite decreased Musculoskeletal, connective tissue and bone disorders: arthralgia, back pain, pain in limb, neck pain Nervous system disorders: tremor, paresthesia, hypoesthesia Psychiatric disorders: nervousness, anxiety, depression, restlessness Respiratory, thoracic and mediastinal disorders: sneezing, cough, rhinorrhea, nasal congestion, dyspnea, sinus congestion Skin and subcutaneous tissue disorders: sweating increased, dermatitis Vascular disorders: hot flushes, vasodilatation Adverse Reactions With Incidence Rates of 0.5% to \\n<1.0% and Serious Adverse Reactions Reported in at Least 2 patients During Clinical Trials Cardiac disorders: palpitations, myocardial infarction Ear and labyrinth disorders: tinnitus, vertigo Gastrointestinal disorders: flatulence, toothache, constipation aggravated, appendicitis, pancreatitis General disorders: feeling jittery, edema lower limb, shivering, joint swelling, malaise, drug withdrawal syndrome, peripheral swelling Hepato-biliary disorders: cholelithiasis, cholecystitis Infections and infestations: cellulitis, ear infection, gastroenteritis, pneumonia, viral infection Injury and poisoning: joint sprain, muscle injury Investigations: alanine aminotransferase increased, blood pressure increased, aspartate aminotransferase increased, heart rate increased, blood glucose increased, liver function tests abnormal Musculoskeletal, connective tissue and bone disorders: muscle cramps, muscle spasms, joint stiffness, muscle twitching, myalgia, osteoarthritis aggravated Nervous system disorders: migraine, sedation, syncope, disturbance in attention, dizziness aggravated Psychiatric disorders: euphoric mood, irritability, libido decreased, sleep disorder, agitation, disorientation, abnormal dreams Renal and urinary disorders: difficulty in micturition, urinary frequency, hematuria, dysuria, urinary retention Respiratory, thoracic and mediastinal disorders: yawning Skin and subcutaneous tissue disorders: contusion, piloerection, clamminess, night sweats, urticaria Vascular disorders: hypertension aggravated, hypertension, peripheral ischemia 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of tramadol.\"\n }\n ]\n },\n {\n \"Term\": \"Disorientation\",\n \"MEDDRACode\": \"10013395\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"disorientation\",\n \"Probability\": \"0.0015870929\",\n \"SemanticContext\": \"Monitor for signs and symptoms of hyponatremia e.g., confusion, disorientation , during treatment with tramadol hydrochloride extended-release tablets, especially during initiation of therapy.\"\n }\n ]\n },\n {\n \"Term\": \"Appendicitis\",\n \"MEDDRACode\": \"10003011\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"appendicitis\",\n \"Probability\": \"0.9978792667\",\n \"SemanticContext\": \"Eye disorders: vision blurred Gastrointestinal disorders: abdominal pain upper, dyspepsia, abdominal pain, sore throat General disorders: weakness, pain, feeling hot, influenza like illness, fall, rigors, lethargy, pyrexia, chest pain Infections and infestations: nasopharyngitis, upper respiratory tract infection, sinusitis, influenza, gastroenteritis viral, urinary tract infection, bronchitis Investigations: blood creatine phosphokinase increased, weight decreased Metabolism and nutrition disorders: appetite decreased Musculoskeletal, connective tissue and bone disorders: arthralgia, back pain, pain in limb, neck pain Nervous system disorders: tremor, paresthesia, hypoesthesia Psychiatric disorders: nervousness, anxiety, depression, restlessness Respiratory, thoracic and mediastinal disorders: sneezing, cough, rhinorrhea, nasal congestion, dyspnea, sinus congestion Skin and subcutaneous tissue disorders: sweating increased, dermatitis Vascular disorders: hot flushes, vasodilatation Adverse Reactions With Incidence Rates of 0.5% to \\n <1.0% and Serious Adverse Reactions Reported in at Least 2 patients During Clinical Trials Cardiac disorders: palpitations, myocardial infarction Ear and labyrinth disorders: tinnitus, vertigo Gastrointestinal disorders: flatulence, toothache, constipation aggravated, appendicitis, pancreatitis General disorders: feeling jittery, edema lower limb, shivering, joint swelling, malaise, drug withdrawal syndrome, peripheral swelling Hepato-biliary disorders: cholelithiasis, cholecystitis Infections and infestations: cellulitis, ear infection, gastroenteritis, pneumonia, viral infection Injury and poisoning: joint sprain, muscle injury Investigations: alanine aminotransferase increased, blood pressure increased, aspartate aminotransferase increased, heart rate increased, blood glucose increased, liver function tests abnormal Musculoskeletal, connective tissue and bone disorders: muscle cramps, muscle spasms, joint stiffness, muscle twitching, myalgia, osteoarthritis aggravated Nervous system disorders: migraine, sedation, syncope, disturbance in attention, dizziness aggravated Psychiatric disorders: euphoric mood, irritability, libido decreased, sleep disorder, agitation, disorientation, abnormal dreams Renal and urinary disorders: difficulty in micturition, urinary frequency, hematuria, dysuria, urinary retention Respiratory, thoracic and mediastinal disorders: yawning Skin and subcutaneous tissue disorders: contusion, piloerection, clamminess, night sweats, urticaria Vascular disorders: hypertension aggravated, hypertension, peripheral ischemia 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of tramadol.\"\n }\n ]\n },\n {\n \"Term\": \"Chills\",\n \"MEDDRACode\": \"10008531\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"chills\",\n \"Probability\": \"0.9951411486\",\n \"SemanticContext\": \"Common withdrawal symptoms include restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia, and mydriasis.\"\n }\n ]\n },\n {\n \"Term\": \"Drug abuse\",\n \"MEDDRACode\": \"10013654\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"opioid abuse\",\n \"Probability\": \"8.17716E-05\",\n \"SemanticContext\": \"Screen patients for risk of substance use disorders, including opioid abuse and misuse, and warn them of the risk for overdose and death associated with the use of additional CNS depressants including alcohol and illicit drugs [see Drug Interactions 7 , Patient Counseling Information 17 ] .\"\n }\n ]\n },\n {\n \"Term\": \"Bone disorder\",\n \"MEDDRACode\": \"10005956\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"bone disorders\",\n \"Probability\": \"0.0209535658\",\n \"SemanticContext\": \"Eye disorders: vision blurred Gastrointestinal disorders: abdominal pain upper, dyspepsia, abdominal pain, sore throat General disorders: weakness, pain, feeling hot, influenza like illness, fall, rigors, lethargy, pyrexia, chest pain Infections and infestations: nasopharyngitis, upper respiratory tract infection, sinusitis, influenza, gastroenteritis viral, urinary tract infection, bronchitis Investigations: blood creatine phosphokinase increased, weight decreased Metabolism and nutrition disorders: appetite decreased Musculoskeletal, connective tissue and bone disorders: arthralgia, back pain, pain in limb, neck pain Nervous system disorders: tremor, paresthesia, hypoesthesia Psychiatric disorders: nervousness, anxiety, depression, restlessness Respiratory, thoracic and mediastinal disorders: sneezing, cough, rhinorrhea, nasal congestion, dyspnea, sinus congestion Skin and subcutaneous tissue disorders: sweating increased, dermatitis Vascular disorders: hot flushes, vasodilatation Adverse Reactions With Incidence Rates of 0.5% to \\n <1.0% and Serious Adverse Reactions Reported in at Least 2 patients During Clinical Trials Cardiac disorders: palpitations, myocardial infarction Ear and labyrinth disorders: tinnitus, vertigo Gastrointestinal disorders: flatulence, toothache, constipation aggravated, appendicitis, pancreatitis General disorders: feeling jittery, edema lower limb, shivering, joint swelling, malaise, drug withdrawal syndrome, peripheral swelling Hepato-biliary disorders: cholelithiasis, cholecystitis Infections and infestations: cellulitis, ear infection, gastroenteritis, pneumonia, viral infection Injury and poisoning: joint sprain, muscle injury Investigations: alanine aminotransferase increased, blood pressure increased, aspartate aminotransferase increased, heart rate increased, blood glucose increased, liver function tests abnormal Musculoskeletal, connective tissue and bone disorders: muscle cramps, muscle spasms, joint stiffness, muscle twitching, myalgia, osteoarthritis aggravated Nervous system disorders: migraine, sedation, syncope, disturbance in attention, dizziness aggravated Psychiatric disorders: euphoric mood, irritability, libido decreased, sleep disorder, agitation, disorientation, abnormal dreams Renal and urinary disorders: difficulty in micturition, urinary frequency, hematuria, dysuria, urinary retention Respiratory, thoracic and mediastinal disorders: yawning Skin and subcutaneous tissue disorders: contusion, piloerection, clamminess, night sweats, urticaria Vascular disorders: hypertension aggravated, hypertension, peripheral ischemia 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of tramadol.\"\n }\n ]\n },\n {\n \"Term\": \"Cellulitis\",\n \"MEDDRACode\": \"10007882\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"cellulitis\",\n \"Probability\": \"0.9578021765\",\n \"SemanticContext\": \"Eye disorders: vision blurred Gastrointestinal disorders: abdominal pain upper, dyspepsia, abdominal pain, sore throat General disorders: weakness, pain, feeling hot, influenza like illness, fall, rigors, lethargy, pyrexia, chest pain Infections and infestations: nasopharyngitis, upper respiratory tract infection, sinusitis, influenza, gastroenteritis viral, urinary tract infection, bronchitis Investigations: blood creatine phosphokinase increased, weight decreased Metabolism and nutrition disorders: appetite decreased Musculoskeletal, connective tissue and bone disorders: arthralgia, back pain, pain in limb, neck pain Nervous system disorders: tremor, paresthesia, hypoesthesia Psychiatric disorders: nervousness, anxiety, depression, restlessness Respiratory, thoracic and mediastinal disorders: sneezing, cough, rhinorrhea, nasal congestion, dyspnea, sinus congestion Skin and subcutaneous tissue disorders: sweating increased, dermatitis Vascular disorders: hot flushes, vasodilatation Adverse Reactions With Incidence Rates of 0.5% to \\n <1.0% and Serious Adverse Reactions Reported in at Least 2 patients During Clinical Trials Cardiac disorders: palpitations, myocardial infarction Ear and labyrinth disorders: tinnitus, vertigo Gastrointestinal disorders: flatulence, toothache, constipation aggravated, appendicitis, pancreatitis General disorders: feeling jittery, edema lower limb, shivering, joint swelling, malaise, drug withdrawal syndrome, peripheral swelling Hepato-biliary disorders: cholelithiasis, cholecystitis Infections and infestations: cellulitis, ear infection, gastroenteritis, pneumonia, viral infection Injury and poisoning: joint sprain, muscle injury Investigations: alanine aminotransferase increased, blood pressure increased, aspartate aminotransferase increased, heart rate increased, blood glucose increased, liver function tests abnormal Musculoskeletal, connective tissue and bone disorders: muscle cramps, muscle spasms, joint stiffness, muscle twitching, myalgia, osteoarthritis aggravated Nervous system disorders: migraine, sedation, syncope, disturbance in attention, dizziness aggravated Psychiatric disorders: euphoric mood, irritability, libido decreased, sleep disorder, agitation, disorientation, abnormal dreams Renal and urinary disorders: difficulty in micturition, urinary frequency, hematuria, dysuria, urinary retention Respiratory, thoracic and mediastinal disorders: yawning Skin and subcutaneous tissue disorders: contusion, piloerection, clamminess, night sweats, urticaria Vascular disorders: hypertension aggravated, hypertension, peripheral ischemia 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of tramadol.\"\n }\n ]\n },\n {\n \"Term\": \"Emotional distress\",\n \"MEDDRACode\": \"10049119\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"suffering\",\n \"Probability\": \"0.0002831221\",\n \"SemanticContext\": \"“Doctor shopping” visiting multiple prescribers to obtain additional prescriptions is common among drug abusers and people suffering from untreated addiction.\"\n },\n {\n \"VerbatimTerm\": \"suffering\",\n \"Probability\": \"0.0002831221\",\n \"SemanticContext\": \"“Doctor shopping” visiting multiple prescribers to obtain additional prescriptions is common among drug abusers and people suffering from untreated addiction.\"\n }\n ]\n },\n {\n \"Term\": \"Infection\",\n \"MEDDRACode\": \"10021789\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"infection\",\n \"Probability\": \"0.1436038911\",\n \"SemanticContext\": \"With intravenous abuse the inactive ingredients in tramadol hydrochloride extended-release tablets can result in local tissue necrosis, infection, pulmonary granulomas, embolism and death, and increased risk of endocarditis and valvular heart injury.\"\n },\n {\n \"VerbatimTerm\": \"infection\",\n \"Probability\": \"0.1436038911\",\n \"SemanticContext\": \"With intravenous abuse the inactive ingredients in tramadol hydrochloride extended-release tablets can result in local tissue necrosis, infection, pulmonary granulomas, embolism and death, and increased risk of endocarditis and valvular heart injury.\"\n },\n {\n \"VerbatimTerm\": \"Infections\",\n \"Probability\": \"0.5551630259\",\n \"SemanticContext\": \"Eye disorders: vision blurred Gastrointestinal disorders: abdominal pain upper, dyspepsia, abdominal pain, sore throat General disorders: weakness, pain, feeling hot, influenza like illness, fall, rigors, lethargy, pyrexia, chest pain Infections and infestations: nasopharyngitis, upper respiratory tract infection, sinusitis, influenza, gastroenteritis viral, urinary tract infection, bronchitis Investigations: blood creatine phosphokinase increased, weight decreased Metabolism and nutrition disorders: appetite decreased Musculoskeletal, connective tissue and bone disorders: arthralgia, back pain, pain in limb, neck pain Nervous system disorders: tremor, paresthesia, hypoesthesia Psychiatric disorders: nervousness, anxiety, depression, restlessness Respiratory, thoracic and mediastinal disorders: sneezing, cough, rhinorrhea, nasal congestion, dyspnea, sinus congestion Skin and subcutaneous tissue disorders: sweating increased, dermatitis Vascular disorders: hot flushes, vasodilatation Adverse Reactions With Incidence Rates of 0.5% to \\n <1.0% and Serious Adverse Reactions Reported in at Least 2 patients During Clinical Trials Cardiac disorders: palpitations, myocardial infarction Ear and labyrinth disorders: tinnitus, vertigo Gastrointestinal disorders: flatulence, toothache, constipation aggravated, appendicitis, pancreatitis General disorders: feeling jittery, edema lower limb, shivering, joint swelling, malaise, drug withdrawal syndrome, peripheral swelling Hepato-biliary disorders: cholelithiasis, cholecystitis Infections and infestations: cellulitis, ear infection, gastroenteritis, pneumonia, viral infection Injury and poisoning: joint sprain, muscle injury Investigations: alanine aminotransferase increased, blood pressure increased, aspartate aminotransferase increased, heart rate increased, blood glucose increased, liver function tests abnormal Musculoskeletal, connective tissue and bone disorders: muscle cramps, muscle spasms, joint stiffness, muscle twitching, myalgia, osteoarthritis aggravated Nervous system disorders: migraine, sedation, syncope, disturbance in attention, dizziness aggravated Psychiatric disorders: euphoric mood, irritability, libido decreased, sleep disorder, agitation, disorientation, abnormal dreams Renal and urinary disorders: difficulty in micturition, urinary frequency, hematuria, dysuria, urinary retention Respiratory, thoracic and mediastinal disorders: yawning Skin and subcutaneous tissue disorders: contusion, piloerection, clamminess, night sweats, urticaria Vascular disorders: hypertension aggravated, hypertension, peripheral ischemia 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of tramadol.\"\n },\n {\n \"VerbatimTerm\": \"Infections\",\n \"Probability\": \"0.9895673394\",\n \"SemanticContext\": \"Eye disorders: vision blurred Gastrointestinal disorders: abdominal pain upper, dyspepsia, abdominal pain, sore throat General disorders: weakness, pain, feeling hot, influenza like illness, fall, rigors, lethargy, pyrexia, chest pain Infections and infestations: nasopharyngitis, upper respiratory tract infection, sinusitis, influenza, gastroenteritis viral, urinary tract infection, bronchitis Investigations: blood creatine phosphokinase increased, weight decreased Metabolism and nutrition disorders: appetite decreased Musculoskeletal, connective tissue and bone disorders: arthralgia, back pain, pain in limb, neck pain Nervous system disorders: tremor, paresthesia, hypoesthesia Psychiatric disorders: nervousness, anxiety, depression, restlessness Respiratory, thoracic and mediastinal disorders: sneezing, cough, rhinorrhea, nasal congestion, dyspnea, sinus congestion Skin and subcutaneous tissue disorders: sweating increased, dermatitis Vascular disorders: hot flushes, vasodilatation Adverse Reactions With Incidence Rates of 0.5% to \\n <1.0% and Serious Adverse Reactions Reported in at Least 2 patients During Clinical Trials Cardiac disorders: palpitations, myocardial infarction Ear and labyrinth disorders: tinnitus, vertigo Gastrointestinal disorders: flatulence, toothache, constipation aggravated, appendicitis, pancreatitis General disorders: feeling jittery, edema lower limb, shivering, joint swelling, malaise, drug withdrawal syndrome, peripheral swelling Hepato-biliary disorders: cholelithiasis, cholecystitis Infections and infestations: cellulitis, ear infection, gastroenteritis, pneumonia, viral infection Injury and poisoning: joint sprain, muscle injury Investigations: alanine aminotransferase increased, blood pressure increased, aspartate aminotransferase increased, heart rate increased, blood glucose increased, liver function tests abnormal Musculoskeletal, connective tissue and bone disorders: muscle cramps, muscle spasms, joint stiffness, muscle twitching, myalgia, osteoarthritis aggravated Nervous system disorders: migraine, sedation, syncope, disturbance in attention, dizziness aggravated Psychiatric disorders: euphoric mood, irritability, libido decreased, sleep disorder, agitation, disorientation, abnormal dreams Renal and urinary disorders: difficulty in micturition, urinary frequency, hematuria, dysuria, urinary retention Respiratory, thoracic and mediastinal disorders: yawning Skin and subcutaneous tissue disorders: contusion, piloerection, clamminess, night sweats, urticaria Vascular disorders: hypertension aggravated, hypertension, peripheral ischemia 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of tramadol.\"\n },\n {\n \"VerbatimTerm\": \"infections\",\n \"Probability\": \"0.0759860575\",\n \"SemanticContext\": \"Risk of seizures may also increase in patients with epilepsy, those with a history of seizures, or in patients with a recognized risk for seizure such as head trauma, metabolic disorders, alcohol and drug withdrawal, CNS infections .\"\n }\n ]\n },\n {\n \"Term\": \"Dermatitis\",\n \"MEDDRACode\": \"10012431\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"dermatitis\",\n \"Probability\": \"0.9881383777\",\n \"SemanticContext\": \"Eye disorders: vision blurred Gastrointestinal disorders: abdominal pain upper, dyspepsia, abdominal pain, sore throat General disorders: weakness, pain, feeling hot, influenza like illness, fall, rigors, lethargy, pyrexia, chest pain Infections and infestations: nasopharyngitis, upper respiratory tract infection, sinusitis, influenza, gastroenteritis viral, urinary tract infection, bronchitis Investigations: blood creatine phosphokinase increased, weight decreased Metabolism and nutrition disorders: appetite decreased Musculoskeletal, connective tissue and bone disorders: arthralgia, back pain, pain in limb, neck pain Nervous system disorders: tremor, paresthesia, hypoesthesia Psychiatric disorders: nervousness, anxiety, depression, restlessness Respiratory, thoracic and mediastinal disorders: sneezing, cough, rhinorrhea, nasal congestion, dyspnea, sinus congestion Skin and subcutaneous tissue disorders: sweating increased, dermatitis Vascular disorders: hot flushes, vasodilatation Adverse Reactions With Incidence Rates of 0.5% to \\n <1.0% and Serious Adverse Reactions Reported in at Least 2 patients During Clinical Trials Cardiac disorders: palpitations, myocardial infarction Ear and labyrinth disorders: tinnitus, vertigo Gastrointestinal disorders: flatulence, toothache, constipation aggravated, appendicitis, pancreatitis General disorders: feeling jittery, edema lower limb, shivering, joint swelling, malaise, drug withdrawal syndrome, peripheral swelling Hepato-biliary disorders: cholelithiasis, cholecystitis Infections and infestations: cellulitis, ear infection, gastroenteritis, pneumonia, viral infection Injury and poisoning: joint sprain, muscle injury Investigations: alanine aminotransferase increased, blood pressure increased, aspartate aminotransferase increased, heart rate increased, blood glucose increased, liver function tests abnormal Musculoskeletal, connective tissue and bone disorders: muscle cramps, muscle spasms, joint stiffness, muscle twitching, myalgia, osteoarthritis aggravated Nervous system disorders: migraine, sedation, syncope, disturbance in attention, dizziness aggravated Psychiatric disorders: euphoric mood, irritability, libido decreased, sleep disorder, agitation, disorientation, abnormal dreams Renal and urinary disorders: difficulty in micturition, urinary frequency, hematuria, dysuria, urinary retention Respiratory, thoracic and mediastinal disorders: yawning Skin and subcutaneous tissue disorders: contusion, piloerection, clamminess, night sweats, urticaria Vascular disorders: hypertension aggravated, hypertension, peripheral ischemia 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of tramadol.\"\n }\n ]\n },\n {\n \"Term\": \"Embolism\",\n \"MEDDRACode\": \"10061169\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"embolism\",\n \"Probability\": \"0.0355734229\",\n \"SemanticContext\": \"With intravenous abuse the inactive ingredients in tramadol hydrochloride extended-release tablets can result in local tissue necrosis, infection, pulmonary granulomas, embolism and death, and increased risk of endocarditis and valvular heart injury.\"\n },\n {\n \"VerbatimTerm\": \"embolism\",\n \"Probability\": \"0.0355734229\",\n \"SemanticContext\": \"With intravenous abuse the inactive ingredients in tramadol hydrochloride extended-release tablets can result in local tissue necrosis, infection, pulmonary granulomas, embolism and death, and increased risk of endocarditis and valvular heart injury.\"\n }\n ]\n },\n {\n \"Term\": \"Decreased appetite\",\n \"MEDDRACode\": \"10061428\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"anorectics\",\n \"Probability\": \"0.0046367049\",\n \"SemanticContext\": \"Risk is increased with higher than recommended doses and concomitant use of SSRIs, SNRIs, anorectics, tricyclic antidepressants and other tricyclic compounds, other opioids, MAOIs, neuroleptics, other drugs that reduce seizure threshold, in patients with epilepsy or at risk for seizures.\"\n },\n {\n \"VerbatimTerm\": \"anorectics\",\n \"Probability\": \"0.0137173235\",\n \"SemanticContext\": \"Selective serotonin re-uptake inhibitors SSRIs and Serotonin-norepinephrine re-uptake inhibitors SNRIs antidepressants or anorectics, Tricyclic antidepressants TCAs , and other tricyclic compounds e.g., cyclobenzaprine, promethazine, etc. , Other opioids, MAO inhibitors [see Warnings and Precautions 5.8 , Drug Interactions 7 ] Neuroleptics, or Other drugs that reduce the seizure threshold.\"\n }\n ]\n },\n {\n \"Term\": \"Substance use disorder\",\n \"MEDDRACode\": \"10079384\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"substance use disorders\",\n \"Probability\": \"0.0010553598\",\n \"SemanticContext\": \"“Drug-seeking” behavior is very common in persons with substance use disorders.\"\n },\n {\n \"VerbatimTerm\": \"substance use disorders\",\n \"Probability\": \"0.0010553598\",\n \"SemanticContext\": \"“Drug-seeking” behavior is very common in persons with substance use disorders.\"\n },\n {\n \"VerbatimTerm\": \"substance use disorders\",\n \"Probability\": \"0.0006661117\",\n \"SemanticContext\": \"Complex patients with co-morbid pain and substance use disorders may benefit from referral to a specialist.\"\n },\n {\n \"VerbatimTerm\": \"substance use disorders\",\n \"Probability\": \"0.0002229214\",\n \"SemanticContext\": \"Screen patients for risk of substance use disorders, including opioid abuse and misuse, and warn them of the risk for overdose and death associated with the use of additional CNS depressants including alcohol and illicit drugs [see Drug Interactions 7 , Patient Counseling Information 17 ] .\"\n },\n {\n \"VerbatimTerm\": \"substance use disorder\",\n \"Probability\": \"0.0002623796\",\n \"SemanticContext\": \"When opioid analgesics are being discontinued due to a suspected substance use disorder, evaluate and treat the patient, or refer for evaluation and treatment of the substance use disorder.\"\n },\n {\n \"VerbatimTerm\": \"substance use disorder\",\n \"Probability\": \"0.0002126098\",\n \"SemanticContext\": \"When opioid analgesics are being discontinued due to a suspected substance use disorder, evaluate and treat the patient, or refer for evaluation and treatment of the substance use disorder.\"\n }\n ]\n },\n {\n \"Term\": \"Ear infection\",\n \"MEDDRACode\": \"10014011\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"ear infection\",\n \"Probability\": \"0.8806265593\",\n \"SemanticContext\": \"Eye disorders: vision blurred Gastrointestinal disorders: abdominal pain upper, dyspepsia, abdominal pain, sore throat General disorders: weakness, pain, feeling hot, influenza like illness, fall, rigors, lethargy, pyrexia, chest pain Infections and infestations: nasopharyngitis, upper respiratory tract infection, sinusitis, influenza, gastroenteritis viral, urinary tract infection, bronchitis Investigations: blood creatine phosphokinase increased, weight decreased Metabolism and nutrition disorders: appetite decreased Musculoskeletal, connective tissue and bone disorders: arthralgia, back pain, pain in limb, neck pain Nervous system disorders: tremor, paresthesia, hypoesthesia Psychiatric disorders: nervousness, anxiety, depression, restlessness Respiratory, thoracic and mediastinal disorders: sneezing, cough, rhinorrhea, nasal congestion, dyspnea, sinus congestion Skin and subcutaneous tissue disorders: sweating increased, dermatitis Vascular disorders: hot flushes, vasodilatation Adverse Reactions With Incidence Rates of 0.5% to \\n <1.0% and Serious Adverse Reactions Reported in at Least 2 patients During Clinical Trials Cardiac disorders: palpitations, myocardial infarction Ear and labyrinth disorders: tinnitus, vertigo Gastrointestinal disorders: flatulence, toothache, constipation aggravated, appendicitis, pancreatitis General disorders: feeling jittery, edema lower limb, shivering, joint swelling, malaise, drug withdrawal syndrome, peripheral swelling Hepato-biliary disorders: cholelithiasis, cholecystitis Infections and infestations: cellulitis, ear infection, gastroenteritis, pneumonia, viral infection Injury and poisoning: joint sprain, muscle injury Investigations: alanine aminotransferase increased, blood pressure increased, aspartate aminotransferase increased, heart rate increased, blood glucose increased, liver function tests abnormal Musculoskeletal, connective tissue and bone disorders: muscle cramps, muscle spasms, joint stiffness, muscle twitching, myalgia, osteoarthritis aggravated Nervous system disorders: migraine, sedation, syncope, disturbance in attention, dizziness aggravated Psychiatric disorders: euphoric mood, irritability, libido decreased, sleep disorder, agitation, disorientation, abnormal dreams Renal and urinary disorders: difficulty in micturition, urinary frequency, hematuria, dysuria, urinary retention Respiratory, thoracic and mediastinal disorders: yawning Skin and subcutaneous tissue disorders: contusion, piloerection, clamminess, night sweats, urticaria Vascular disorders: hypertension aggravated, hypertension, peripheral ischemia 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of tramadol.\"\n }\n ]\n },\n {\n \"Term\": \"Confusional state\",\n \"MEDDRACode\": \"10010305\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"confusion\",\n \"Probability\": \"0.0001953244\",\n \"SemanticContext\": \"Even at labeled dosage regimens, individuals who are ultra-rapid metabolizers may have life-threatening or fatal respiratory depression or experience signs of overdose such as extreme sleepiness, confusion, or shallow breathing [see Overdosage 10 ] .\"\n },\n {\n \"VerbatimTerm\": \"confusion\",\n \"Probability\": \"0.0007885695\",\n \"SemanticContext\": \"Monitor for signs and symptoms of hyponatremia e.g., confusion, disorientation , during treatment with tramadol hydrochloride extended-release tablets, especially during initiation of therapy.\"\n },\n {\n \"VerbatimTerm\": \"confusion\",\n \"Probability\": \"0.0057374537\",\n \"SemanticContext\": \"Get emergency medical help or call 911 right away, if you have: trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue, or throat, extreme drowsiness, light-headedness when changing positions, feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion.\"\n }\n ]\n },\n {\n \"Term\": \"Cholecystitis\",\n \"MEDDRACode\": \"10008612\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"cholecystitis\",\n \"Probability\": \"0.9678144455\",\n \"SemanticContext\": \"Eye disorders: vision blurred Gastrointestinal disorders: abdominal pain upper, dyspepsia, abdominal pain, sore throat General disorders: weakness, pain, feeling hot, influenza like illness, fall, rigors, lethargy, pyrexia, chest pain Infections and infestations: nasopharyngitis, upper respiratory tract infection, sinusitis, influenza, gastroenteritis viral, urinary tract infection, bronchitis Investigations: blood creatine phosphokinase increased, weight decreased Metabolism and nutrition disorders: appetite decreased Musculoskeletal, connective tissue and bone disorders: arthralgia, back pain, pain in limb, neck pain Nervous system disorders: tremor, paresthesia, hypoesthesia Psychiatric disorders: nervousness, anxiety, depression, restlessness Respiratory, thoracic and mediastinal disorders: sneezing, cough, rhinorrhea, nasal congestion, dyspnea, sinus congestion Skin and subcutaneous tissue disorders: sweating increased, dermatitis Vascular disorders: hot flushes, vasodilatation Adverse Reactions With Incidence Rates of 0.5% to \\n <1.0% and Serious Adverse Reactions Reported in at Least 2 patients During Clinical Trials Cardiac disorders: palpitations, myocardial infarction Ear and labyrinth disorders: tinnitus, vertigo Gastrointestinal disorders: flatulence, toothache, constipation aggravated, appendicitis, pancreatitis General disorders: feeling jittery, edema lower limb, shivering, joint swelling, malaise, drug withdrawal syndrome, peripheral swelling Hepato-biliary disorders: cholelithiasis, cholecystitis Infections and infestations: cellulitis, ear infection, gastroenteritis, pneumonia, viral infection Injury and poisoning: joint sprain, muscle injury Investigations: alanine aminotransferase increased, blood pressure increased, aspartate aminotransferase increased, heart rate increased, blood glucose increased, liver function tests abnormal Musculoskeletal, connective tissue and bone disorders: muscle cramps, muscle spasms, joint stiffness, muscle twitching, myalgia, osteoarthritis aggravated Nervous system disorders: migraine, sedation, syncope, disturbance in attention, dizziness aggravated Psychiatric disorders: euphoric mood, irritability, libido decreased, sleep disorder, agitation, disorientation, abnormal dreams Renal and urinary disorders: difficulty in micturition, urinary frequency, hematuria, dysuria, urinary retention Respiratory, thoracic and mediastinal disorders: yawning Skin and subcutaneous tissue disorders: contusion, piloerection, clamminess, night sweats, urticaria Vascular disorders: hypertension aggravated, hypertension, peripheral ischemia 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of tramadol.\"\n }\n ]\n },\n {\n \"Term\": \"Mediastinal disorder\",\n \"MEDDRACode\": \"10061280\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"mediastinal disorders\",\n \"Probability\": \"0.052249521\",\n \"SemanticContext\": \"Eye disorders: vision blurred Gastrointestinal disorders: abdominal pain upper, dyspepsia, abdominal pain, sore throat General disorders: weakness, pain, feeling hot, influenza like illness, fall, rigors, lethargy, pyrexia, chest pain Infections and infestations: nasopharyngitis, upper respiratory tract infection, sinusitis, influenza, gastroenteritis viral, urinary tract infection, bronchitis Investigations: blood creatine phosphokinase increased, weight decreased Metabolism and nutrition disorders: appetite decreased Musculoskeletal, connective tissue and bone disorders: arthralgia, back pain, pain in limb, neck pain Nervous system disorders: tremor, paresthesia, hypoesthesia Psychiatric disorders: nervousness, anxiety, depression, restlessness Respiratory, thoracic and mediastinal disorders: sneezing, cough, rhinorrhea, nasal congestion, dyspnea, sinus congestion Skin and subcutaneous tissue disorders: sweating increased, dermatitis Vascular disorders: hot flushes, vasodilatation Adverse Reactions With Incidence Rates of 0.5% to \\n <1.0% and Serious Adverse Reactions Reported in at Least 2 patients During Clinical Trials Cardiac disorders: palpitations, myocardial infarction Ear and labyrinth disorders: tinnitus, vertigo Gastrointestinal disorders: flatulence, toothache, constipation aggravated, appendicitis, pancreatitis General disorders: feeling jittery, edema lower limb, shivering, joint swelling, malaise, drug withdrawal syndrome, peripheral swelling Hepato-biliary disorders: cholelithiasis, cholecystitis Infections and infestations: cellulitis, ear infection, gastroenteritis, pneumonia, viral infection Injury and poisoning: joint sprain, muscle injury Investigations: alanine aminotransferase increased, blood pressure increased, aspartate aminotransferase increased, heart rate increased, blood glucose increased, liver function tests abnormal Musculoskeletal, connective tissue and bone disorders: muscle cramps, muscle spasms, joint stiffness, muscle twitching, myalgia, osteoarthritis aggravated Nervous system disorders: migraine, sedation, syncope, disturbance in attention, dizziness aggravated Psychiatric disorders: euphoric mood, irritability, libido decreased, sleep disorder, agitation, disorientation, abnormal dreams Renal and urinary disorders: difficulty in micturition, urinary frequency, hematuria, dysuria, urinary retention Respiratory, thoracic and mediastinal disorders: yawning Skin and subcutaneous tissue disorders: contusion, piloerection, clamminess, night sweats, urticaria Vascular disorders: hypertension aggravated, hypertension, peripheral ischemia 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of tramadol.\"\n }\n ]\n },\n {\n \"Term\": \"Drug abuser\",\n \"MEDDRACode\": \"10061111\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"drug abusers\",\n \"Probability\": \"1.25338E-05\",\n \"SemanticContext\": \"“Doctor shopping” visiting multiple prescribers to obtain additional prescriptions is common among drug abusers and people suffering from untreated addiction.\"\n },\n {\n \"VerbatimTerm\": \"drug abusers\",\n \"Probability\": \"1.25338E-05\",\n \"SemanticContext\": \"“Doctor shopping” visiting multiple prescribers to obtain additional prescriptions is common among drug abusers and people suffering from untreated addiction.\"\n },\n {\n \"VerbatimTerm\": \"drug abusers\",\n \"Probability\": \"0.0001175\",\n \"SemanticContext\": \"Opioids are sought by drug abusers and people with addiction disorders and are subject to criminal diversion.\"\n }\n ]\n },\n {\n \"Term\": \"Drug dependence\",\n \"MEDDRACode\": \"10013663\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Drug addiction\",\n \"Probability\": \"0.0015924275\",\n \"SemanticContext\": \"Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that develop after repeated substance use and includes: a strong desire to take the drug, difficulties in controlling its use, persisting in its use despite harmful consequences, a higher priority given to drug use than to other activities and obligations, increased tolerance, and sometimes a physical withdrawal.\"\n },\n {\n \"VerbatimTerm\": \"Drug addiction\",\n \"Probability\": \"0.0015924275\",\n \"SemanticContext\": \"Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that develop after repeated substance use and includes: a strong desire to take the drug, difficulties in controlling its use, persisting in its use despite harmful consequences, a higher priority given to drug use than to other activities and obligations, increased tolerance, and sometimes a physical withdrawal.\"\n }\n ]\n },\n {\n \"Term\": \"Analgesic therapy\",\n \"MEDDRACode\": \"10053469\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"pain relief\",\n \"Probability\": \"0.0034392178\",\n \"SemanticContext\": \"HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use children who developed life-threatening respiratory depression or died after taking tramadol for pain relief TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively.\"\n },\n {\n \"VerbatimTerm\": \"pain relief\",\n \"Probability\": \"4.13166E-05\",\n \"SemanticContext\": \"Preoccupation with achieving adequate pain relief can be appropriate behavior in a patient with poor pain control.\"\n },\n {\n \"VerbatimTerm\": \"pain relief\",\n \"Probability\": \"4.13166E-05\",\n \"SemanticContext\": \"Preoccupation with achieving adequate pain relief can be appropriate behavior in a patient with poor pain control.\"\n }\n ]\n },\n {\n \"Term\": \"Angiopathy\",\n \"MEDDRACode\": \"10059245\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Vascular disorders\",\n \"Probability\": \"0.1467842758\",\n \"SemanticContext\": \"Eye disorders: vision blurred Gastrointestinal disorders: abdominal pain upper, dyspepsia, abdominal pain, sore throat General disorders: weakness, pain, feeling hot, influenza like illness, fall, rigors, lethargy, pyrexia, chest pain Infections and infestations: nasopharyngitis, upper respiratory tract infection, sinusitis, influenza, gastroenteritis viral, urinary tract infection, bronchitis Investigations: blood creatine phosphokinase increased, weight decreased Metabolism and nutrition disorders: appetite decreased Musculoskeletal, connective tissue and bone disorders: arthralgia, back pain, pain in limb, neck pain Nervous system disorders: tremor, paresthesia, hypoesthesia Psychiatric disorders: nervousness, anxiety, depression, restlessness Respiratory, thoracic and mediastinal disorders: sneezing, cough, rhinorrhea, nasal congestion, dyspnea, sinus congestion Skin and subcutaneous tissue disorders: sweating increased, dermatitis Vascular disorders: hot flushes, vasodilatation Adverse Reactions With Incidence Rates of 0.5% to \\n <1.0% and Serious Adverse Reactions Reported in at Least 2 patients During Clinical Trials Cardiac disorders: palpitations, myocardial infarction Ear and labyrinth disorders: tinnitus, vertigo Gastrointestinal disorders: flatulence, toothache, constipation aggravated, appendicitis, pancreatitis General disorders: feeling jittery, edema lower limb, shivering, joint swelling, malaise, drug withdrawal syndrome, peripheral swelling Hepato-biliary disorders: cholelithiasis, cholecystitis Infections and infestations: cellulitis, ear infection, gastroenteritis, pneumonia, viral infection Injury and poisoning: joint sprain, muscle injury Investigations: alanine aminotransferase increased, blood pressure increased, aspartate aminotransferase increased, heart rate increased, blood glucose increased, liver function tests abnormal Musculoskeletal, connective tissue and bone disorders: muscle cramps, muscle spasms, joint stiffness, muscle twitching, myalgia, osteoarthritis aggravated Nervous system disorders: migraine, sedation, syncope, disturbance in attention, dizziness aggravated Psychiatric disorders: euphoric mood, irritability, libido decreased, sleep disorder, agitation, disorientation, abnormal dreams Renal and urinary disorders: difficulty in micturition, urinary frequency, hematuria, dysuria, urinary retention Respiratory, thoracic and mediastinal disorders: yawning Skin and subcutaneous tissue disorders: contusion, piloerection, clamminess, night sweats, urticaria Vascular disorders: hypertension aggravated, hypertension, peripheral ischemia 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of tramadol.\"\n }\n ]\n },\n {\n \"Term\": \"Hot flush\",\n \"MEDDRACode\": \"10060800\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hot flushes\",\n \"Probability\": \"0.9963228703\",\n \"SemanticContext\": \"Eye disorders: vision blurred Gastrointestinal disorders: abdominal pain upper, dyspepsia, abdominal pain, sore throat General disorders: weakness, pain, feeling hot, influenza like illness, fall, rigors, lethargy, pyrexia, chest pain Infections and infestations: nasopharyngitis, upper respiratory tract infection, sinusitis, influenza, gastroenteritis viral, urinary tract infection, bronchitis Investigations: blood creatine phosphokinase increased, weight decreased Metabolism and nutrition disorders: appetite decreased Musculoskeletal, connective tissue and bone disorders: arthralgia, back pain, pain in limb, neck pain Nervous system disorders: tremor, paresthesia, hypoesthesia Psychiatric disorders: nervousness, anxiety, depression, restlessness Respiratory, thoracic and mediastinal disorders: sneezing, cough, rhinorrhea, nasal congestion, dyspnea, sinus congestion Skin and subcutaneous tissue disorders: sweating increased, dermatitis Vascular disorders: hot flushes, vasodilatation Adverse Reactions With Incidence Rates of 0.5% to \\n <1.0% and Serious Adverse Reactions Reported in at Least 2 patients During Clinical Trials Cardiac disorders: palpitations, myocardial infarction Ear and labyrinth disorders: tinnitus, vertigo Gastrointestinal disorders: flatulence, toothache, constipation aggravated, appendicitis, pancreatitis General disorders: feeling jittery, edema lower limb, shivering, joint swelling, malaise, drug withdrawal syndrome, peripheral swelling Hepato-biliary disorders: cholelithiasis, cholecystitis Infections and infestations: cellulitis, ear infection, gastroenteritis, pneumonia, viral infection Injury and poisoning: joint sprain, muscle injury Investigations: alanine aminotransferase increased, blood pressure increased, aspartate aminotransferase increased, heart rate increased, blood glucose increased, liver function tests abnormal Musculoskeletal, connective tissue and bone disorders: muscle cramps, muscle spasms, joint stiffness, muscle twitching, myalgia, osteoarthritis aggravated Nervous system disorders: migraine, sedation, syncope, disturbance in attention, dizziness aggravated Psychiatric disorders: euphoric mood, irritability, libido decreased, sleep disorder, agitation, disorientation, abnormal dreams Renal and urinary disorders: difficulty in micturition, urinary frequency, hematuria, dysuria, urinary retention Respiratory, thoracic and mediastinal disorders: yawning Skin and subcutaneous tissue disorders: contusion, piloerection, clamminess, night sweats, urticaria Vascular disorders: hypertension aggravated, hypertension, peripheral ischemia 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of tramadol.\"\n }\n ]\n },\n {\n \"Term\": \"Hypoaesthesia\",\n \"MEDDRACode\": \"10020937\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hypoesthesia\",\n \"Probability\": \"0.9819977283\",\n \"SemanticContext\": \"Eye disorders: vision blurred Gastrointestinal disorders: abdominal pain upper, dyspepsia, abdominal pain, sore throat General disorders: weakness, pain, feeling hot, influenza like illness, fall, rigors, lethargy, pyrexia, chest pain Infections and infestations: nasopharyngitis, upper respiratory tract infection, sinusitis, influenza, gastroenteritis viral, urinary tract infection, bronchitis Investigations: blood creatine phosphokinase increased, weight decreased Metabolism and nutrition disorders: appetite decreased Musculoskeletal, connective tissue and bone disorders: arthralgia, back pain, pain in limb, neck pain Nervous system disorders: tremor, paresthesia, hypoesthesia Psychiatric disorders: nervousness, anxiety, depression, restlessness Respiratory, thoracic and mediastinal disorders: sneezing, cough, rhinorrhea, nasal congestion, dyspnea, sinus congestion Skin and subcutaneous tissue disorders: sweating increased, dermatitis Vascular disorders: hot flushes, vasodilatation Adverse Reactions With Incidence Rates of 0.5% to \\n <1.0% and Serious Adverse Reactions Reported in at Least 2 patients During Clinical Trials Cardiac disorders: palpitations, myocardial infarction Ear and labyrinth disorders: tinnitus, vertigo Gastrointestinal disorders: flatulence, toothache, constipation aggravated, appendicitis, pancreatitis General disorders: feeling jittery, edema lower limb, shivering, joint swelling, malaise, drug withdrawal syndrome, peripheral swelling Hepato-biliary disorders: cholelithiasis, cholecystitis Infections and infestations: cellulitis, ear infection, gastroenteritis, pneumonia, viral infection Injury and poisoning: joint sprain, muscle injury Investigations: alanine aminotransferase increased, blood pressure increased, aspartate aminotransferase increased, heart rate increased, blood glucose increased, liver function tests abnormal Musculoskeletal, connective tissue and bone disorders: muscle cramps, muscle spasms, joint stiffness, muscle twitching, myalgia, osteoarthritis aggravated Nervous system disorders: migraine, sedation, syncope, disturbance in attention, dizziness aggravated Psychiatric disorders: euphoric mood, irritability, libido decreased, sleep disorder, agitation, disorientation, abnormal dreams Renal and urinary disorders: difficulty in micturition, urinary frequency, hematuria, dysuria, urinary retention Respiratory, thoracic and mediastinal disorders: yawning Skin and subcutaneous tissue disorders: contusion, piloerection, clamminess, night sweats, urticaria Vascular disorders: hypertension aggravated, hypertension, peripheral ischemia 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of tramadol.\"\n }\n ]\n },\n {\n \"Term\": \"Eye disorder\",\n \"MEDDRACode\": \"10015916\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Eye disorders\",\n \"Probability\": \"0.273907572\",\n \"SemanticContext\": \"Eye disorders: vision blurred Gastrointestinal disorders: abdominal pain upper, dyspepsia, abdominal pain, sore throat General disorders: weakness, pain, feeling hot, influenza like illness, fall, rigors, lethargy, pyrexia, chest pain Infections and infestations: nasopharyngitis, upper respiratory tract infection, sinusitis, influenza, gastroenteritis viral, urinary tract infection, bronchitis Investigations: blood creatine phosphokinase increased, weight decreased Metabolism and nutrition disorders: appetite decreased Musculoskeletal, connective tissue and bone disorders: arthralgia, back pain, pain in limb, neck pain Nervous system disorders: tremor, paresthesia, hypoesthesia Psychiatric disorders: nervousness, anxiety, depression, restlessness Respiratory, thoracic and mediastinal disorders: sneezing, cough, rhinorrhea, nasal congestion, dyspnea, sinus congestion Skin and subcutaneous tissue disorders: sweating increased, dermatitis Vascular disorders: hot flushes, vasodilatation Adverse Reactions With Incidence Rates of 0.5% to \\n <1.0% and Serious Adverse Reactions Reported in at Least 2 patients During Clinical Trials Cardiac disorders: palpitations, myocardial infarction Ear and labyrinth disorders: tinnitus, vertigo Gastrointestinal disorders: flatulence, toothache, constipation aggravated, appendicitis, pancreatitis General disorders: feeling jittery, edema lower limb, shivering, joint swelling, malaise, drug withdrawal syndrome, peripheral swelling Hepato-biliary disorders: cholelithiasis, cholecystitis Infections and infestations: cellulitis, ear infection, gastroenteritis, pneumonia, viral infection Injury and poisoning: joint sprain, muscle injury Investigations: alanine aminotransferase increased, blood pressure increased, aspartate aminotransferase increased, heart rate increased, blood glucose increased, liver function tests abnormal Musculoskeletal, connective tissue and bone disorders: muscle cramps, muscle spasms, joint stiffness, muscle twitching, myalgia, osteoarthritis aggravated Nervous system disorders: migraine, sedation, syncope, disturbance in attention, dizziness aggravated Psychiatric disorders: euphoric mood, irritability, libido decreased, sleep disorder, agitation, disorientation, abnormal dreams Renal and urinary disorders: difficulty in micturition, urinary frequency, hematuria, dysuria, urinary retention Respiratory, thoracic and mediastinal disorders: yawning Skin and subcutaneous tissue disorders: contusion, piloerection, clamminess, night sweats, urticaria Vascular disorders: hypertension aggravated, hypertension, peripheral ischemia 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of tramadol.\"\n }\n ]\n },\n {\n \"Term\": \"Fall\",\n \"MEDDRACode\": \"10016173\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"fall\",\n \"Probability\": \"0.9724941254\",\n \"SemanticContext\": \"Eye disorders: vision blurred Gastrointestinal disorders: abdominal pain upper, dyspepsia, abdominal pain, sore throat General disorders: weakness, pain, feeling hot, influenza like illness, fall, rigors, lethargy, pyrexia, chest pain Infections and infestations: nasopharyngitis, upper respiratory tract infection, sinusitis, influenza, gastroenteritis viral, urinary tract infection, bronchitis Investigations: blood creatine phosphokinase increased, weight decreased Metabolism and nutrition disorders: appetite decreased Musculoskeletal, connective tissue and bone disorders: arthralgia, back pain, pain in limb, neck pain Nervous system disorders: tremor, paresthesia, hypoesthesia Psychiatric disorders: nervousness, anxiety, depression, restlessness Respiratory, thoracic and mediastinal disorders: sneezing, cough, rhinorrhea, nasal congestion, dyspnea, sinus congestion Skin and subcutaneous tissue disorders: sweating increased, dermatitis Vascular disorders: hot flushes, vasodilatation Adverse Reactions With Incidence Rates of 0.5% to \\n <1.0% and Serious Adverse Reactions Reported in at Least 2 patients During Clinical Trials Cardiac disorders: palpitations, myocardial infarction Ear and labyrinth disorders: tinnitus, vertigo Gastrointestinal disorders: flatulence, toothache, constipation aggravated, appendicitis, pancreatitis General disorders: feeling jittery, edema lower limb, shivering, joint swelling, malaise, drug withdrawal syndrome, peripheral swelling Hepato-biliary disorders: cholelithiasis, cholecystitis Infections and infestations: cellulitis, ear infection, gastroenteritis, pneumonia, viral infection Injury and poisoning: joint sprain, muscle injury Investigations: alanine aminotransferase increased, blood pressure increased, aspartate aminotransferase increased, heart rate increased, blood glucose increased, liver function tests abnormal Musculoskeletal, connective tissue and bone disorders: muscle cramps, muscle spasms, joint stiffness, muscle twitching, myalgia, osteoarthritis aggravated Nervous system disorders: migraine, sedation, syncope, disturbance in attention, dizziness aggravated Psychiatric disorders: euphoric mood, irritability, libido decreased, sleep disorder, agitation, disorientation, abnormal dreams Renal and urinary disorders: difficulty in micturition, urinary frequency, hematuria, dysuria, urinary retention Respiratory, thoracic and mediastinal disorders: yawning Skin and subcutaneous tissue disorders: contusion, piloerection, clamminess, night sweats, urticaria Vascular disorders: hypertension aggravated, hypertension, peripheral ischemia 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of tramadol.\"\n }\n ]\n },\n {\n \"Term\": \"Nasal congestion\",\n \"MEDDRACode\": \"10028735\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"nasal congestion\",\n \"Probability\": \"0.998272419\",\n \"SemanticContext\": \"Eye disorders: vision blurred Gastrointestinal disorders: abdominal pain upper, dyspepsia, abdominal pain, sore throat General disorders: weakness, pain, feeling hot, influenza like illness, fall, rigors, lethargy, pyrexia, chest pain Infections and infestations: nasopharyngitis, upper respiratory tract infection, sinusitis, influenza, gastroenteritis viral, urinary tract infection, bronchitis Investigations: blood creatine phosphokinase increased, weight decreased Metabolism and nutrition disorders: appetite decreased Musculoskeletal, connective tissue and bone disorders: arthralgia, back pain, pain in limb, neck pain Nervous system disorders: tremor, paresthesia, hypoesthesia Psychiatric disorders: nervousness, anxiety, depression, restlessness Respiratory, thoracic and mediastinal disorders: sneezing, cough, rhinorrhea, nasal congestion, dyspnea, sinus congestion Skin and subcutaneous tissue disorders: sweating increased, dermatitis Vascular disorders: hot flushes, vasodilatation Adverse Reactions With Incidence Rates of 0.5% to \\n <1.0% and Serious Adverse Reactions Reported in at Least 2 patients During Clinical Trials Cardiac disorders: palpitations, myocardial infarction Ear and labyrinth disorders: tinnitus, vertigo Gastrointestinal disorders: flatulence, toothache, constipation aggravated, appendicitis, pancreatitis General disorders: feeling jittery, edema lower limb, shivering, joint swelling, malaise, drug withdrawal syndrome, peripheral swelling Hepato-biliary disorders: cholelithiasis, cholecystitis Infections and infestations: cellulitis, ear infection, gastroenteritis, pneumonia, viral infection Injury and poisoning: joint sprain, muscle injury Investigations: alanine aminotransferase increased, blood pressure increased, aspartate aminotransferase increased, heart rate increased, blood glucose increased, liver function tests abnormal Musculoskeletal, connective tissue and bone disorders: muscle cramps, muscle spasms, joint stiffness, muscle twitching, myalgia, osteoarthritis aggravated Nervous system disorders: migraine, sedation, syncope, disturbance in attention, dizziness aggravated Psychiatric disorders: euphoric mood, irritability, libido decreased, sleep disorder, agitation, disorientation, abnormal dreams Renal and urinary disorders: difficulty in micturition, urinary frequency, hematuria, dysuria, urinary retention Respiratory, thoracic and mediastinal disorders: yawning Skin and subcutaneous tissue disorders: contusion, piloerection, clamminess, night sweats, urticaria Vascular disorders: hypertension aggravated, hypertension, peripheral ischemia 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of tramadol.\"\n }\n ]\n },\n {\n \"Term\": \"Toothache\",\n \"MEDDRACode\": \"10044055\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"toothache\",\n \"Probability\": \"0.9979377985\",\n \"SemanticContext\": \"Eye disorders: vision blurred Gastrointestinal disorders: abdominal pain upper, dyspepsia, abdominal pain, sore throat General disorders: weakness, pain, feeling hot, influenza like illness, fall, rigors, lethargy, pyrexia, chest pain Infections and infestations: nasopharyngitis, upper respiratory tract infection, sinusitis, influenza, gastroenteritis viral, urinary tract infection, bronchitis Investigations: blood creatine phosphokinase increased, weight decreased Metabolism and nutrition disorders: appetite decreased Musculoskeletal, connective tissue and bone disorders: arthralgia, back pain, pain in limb, neck pain Nervous system disorders: tremor, paresthesia, hypoesthesia Psychiatric disorders: nervousness, anxiety, depression, restlessness Respiratory, thoracic and mediastinal disorders: sneezing, cough, rhinorrhea, nasal congestion, dyspnea, sinus congestion Skin and subcutaneous tissue disorders: sweating increased, dermatitis Vascular disorders: hot flushes, vasodilatation Adverse Reactions With Incidence Rates of 0.5% to \\n <1.0% and Serious Adverse Reactions Reported in at Least 2 patients During Clinical Trials Cardiac disorders: palpitations, myocardial infarction Ear and labyrinth disorders: tinnitus, vertigo Gastrointestinal disorders: flatulence, toothache, constipation aggravated, appendicitis, pancreatitis General disorders: feeling jittery, edema lower limb, shivering, joint swelling, malaise, drug withdrawal syndrome, peripheral swelling Hepato-biliary disorders: cholelithiasis, cholecystitis Infections and infestations: cellulitis, ear infection, gastroenteritis, pneumonia, viral infection Injury and poisoning: joint sprain, muscle injury Investigations: alanine aminotransferase increased, blood pressure increased, aspartate aminotransferase increased, heart rate increased, blood glucose increased, liver function tests abnormal Musculoskeletal, connective tissue and bone disorders: muscle cramps, muscle spasms, joint stiffness, muscle twitching, myalgia, osteoarthritis aggravated Nervous system disorders: migraine, sedation, syncope, disturbance in attention, dizziness aggravated Psychiatric disorders: euphoric mood, irritability, libido decreased, sleep disorder, agitation, disorientation, abnormal dreams Renal and urinary disorders: difficulty in micturition, urinary frequency, hematuria, dysuria, urinary retention Respiratory, thoracic and mediastinal disorders: yawning Skin and subcutaneous tissue disorders: contusion, piloerection, clamminess, night sweats, urticaria Vascular disorders: hypertension aggravated, hypertension, peripheral ischemia 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of tramadol.\"\n }\n ]\n },\n {\n \"Term\": \"Abdominal pain upper\",\n \"MEDDRACode\": \"10000087\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"abdominal pain upper\",\n \"Probability\": \"0.9971837401\",\n \"SemanticContext\": \"Eye disorders: vision blurred Gastrointestinal disorders: abdominal pain upper, dyspepsia, abdominal pain, sore throat General disorders: weakness, pain, feeling hot, influenza like illness, fall, rigors, lethargy, pyrexia, chest pain Infections and infestations: nasopharyngitis, upper respiratory tract infection, sinusitis, influenza, gastroenteritis viral, urinary tract infection, bronchitis Investigations: blood creatine phosphokinase increased, weight decreased Metabolism and nutrition disorders: appetite decreased Musculoskeletal, connective tissue and bone disorders: arthralgia, back pain, pain in limb, neck pain Nervous system disorders: tremor, paresthesia, hypoesthesia Psychiatric disorders: nervousness, anxiety, depression, restlessness Respiratory, thoracic and mediastinal disorders: sneezing, cough, rhinorrhea, nasal congestion, dyspnea, sinus congestion Skin and subcutaneous tissue disorders: sweating increased, dermatitis Vascular disorders: hot flushes, vasodilatation Adverse Reactions With Incidence Rates of 0.5% to \\n <1.0% and Serious Adverse Reactions Reported in at Least 2 patients During Clinical Trials Cardiac disorders: palpitations, myocardial infarction Ear and labyrinth disorders: tinnitus, vertigo Gastrointestinal disorders: flatulence, toothache, constipation aggravated, appendicitis, pancreatitis General disorders: feeling jittery, edema lower limb, shivering, joint swelling, malaise, drug withdrawal syndrome, peripheral swelling Hepato-biliary disorders: cholelithiasis, cholecystitis Infections and infestations: cellulitis, ear infection, gastroenteritis, pneumonia, viral infection Injury and poisoning: joint sprain, muscle injury Investigations: alanine aminotransferase increased, blood pressure increased, aspartate aminotransferase increased, heart rate increased, blood glucose increased, liver function tests abnormal Musculoskeletal, connective tissue and bone disorders: muscle cramps, muscle spasms, joint stiffness, muscle twitching, myalgia, osteoarthritis aggravated Nervous system disorders: migraine, sedation, syncope, disturbance in attention, dizziness aggravated Psychiatric disorders: euphoric mood, irritability, libido decreased, sleep disorder, agitation, disorientation, abnormal dreams Renal and urinary disorders: difficulty in micturition, urinary frequency, hematuria, dysuria, urinary retention Respiratory, thoracic and mediastinal disorders: yawning Skin and subcutaneous tissue disorders: contusion, piloerection, clamminess, night sweats, urticaria Vascular disorders: hypertension aggravated, hypertension, peripheral ischemia 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of tramadol.\"\n }\n ]\n },\n {\n \"Term\": \"Cardiac disorder\",\n \"MEDDRACode\": \"10061024\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Cardiac disorders\",\n \"Probability\": \"0.0368194878\",\n \"SemanticContext\": \"Eye disorders: vision blurred Gastrointestinal disorders: abdominal pain upper, dyspepsia, abdominal pain, sore throat General disorders: weakness, pain, feeling hot, influenza like illness, fall, rigors, lethargy, pyrexia, chest pain Infections and infestations: nasopharyngitis, upper respiratory tract infection, sinusitis, influenza, gastroenteritis viral, urinary tract infection, bronchitis Investigations: blood creatine phosphokinase increased, weight decreased Metabolism and nutrition disorders: appetite decreased Musculoskeletal, connective tissue and bone disorders: arthralgia, back pain, pain in limb, neck pain Nervous system disorders: tremor, paresthesia, hypoesthesia Psychiatric disorders: nervousness, anxiety, depression, restlessness Respiratory, thoracic and mediastinal disorders: sneezing, cough, rhinorrhea, nasal congestion, dyspnea, sinus congestion Skin and subcutaneous tissue disorders: sweating increased, dermatitis Vascular disorders: hot flushes, vasodilatation Adverse Reactions With Incidence Rates of 0.5% to \\n <1.0% and Serious Adverse Reactions Reported in at Least 2 patients During Clinical Trials Cardiac disorders: palpitations, myocardial infarction Ear and labyrinth disorders: tinnitus, vertigo Gastrointestinal disorders: flatulence, toothache, constipation aggravated, appendicitis, pancreatitis General disorders: feeling jittery, edema lower limb, shivering, joint swelling, malaise, drug withdrawal syndrome, peripheral swelling Hepato-biliary disorders: cholelithiasis, cholecystitis Infections and infestations: cellulitis, ear infection, gastroenteritis, pneumonia, viral infection Injury and poisoning: joint sprain, muscle injury Investigations: alanine aminotransferase increased, blood pressure increased, aspartate aminotransferase increased, heart rate increased, blood glucose increased, liver function tests abnormal Musculoskeletal, connective tissue and bone disorders: muscle cramps, muscle spasms, joint stiffness, muscle twitching, myalgia, osteoarthritis aggravated Nervous system disorders: migraine, sedation, syncope, disturbance in attention, dizziness aggravated Psychiatric disorders: euphoric mood, irritability, libido decreased, sleep disorder, agitation, disorientation, abnormal dreams Renal and urinary disorders: difficulty in micturition, urinary frequency, hematuria, dysuria, urinary retention Respiratory, thoracic and mediastinal disorders: yawning Skin and subcutaneous tissue disorders: contusion, piloerection, clamminess, night sweats, urticaria Vascular disorders: hypertension aggravated, hypertension, peripheral ischemia 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of tramadol.\"\n }\n ]\n },\n {\n \"Term\": \"Crime\",\n \"MEDDRACode\": \"10068954\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"criminal\",\n \"Probability\": \"0.0006331503\",\n \"SemanticContext\": \"Tramadol hydrochloride extended-release tablets can be abused and is subject to misuse, addiction, and criminal diversion [see Warnings and Precautions 5.1 ].\"\n },\n {\n \"VerbatimTerm\": \"criminal\",\n \"Probability\": \"0.0006331503\",\n \"SemanticContext\": \"Tramadol hydrochloride extended-release tablets can be abused and is subject to misuse, addiction, and criminal diversion [see Warnings and Precautions 5.1 ].\"\n },\n {\n \"VerbatimTerm\": \"criminal\",\n \"Probability\": \"0.0001113465\",\n \"SemanticContext\": \"Opioids are sought by drug abusers and people with addiction disorders and are subject to criminal diversion.\"\n }\n ]\n },\n {\n \"Term\": \"Blood creatine phosphokinase increased\",\n \"MEDDRACode\": \"10005470\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"blood creatine phosphokinase increased\",\n \"Probability\": \"0.9375294447\",\n \"SemanticContext\": \"Eye disorders: vision blurred Gastrointestinal disorders: abdominal pain upper, dyspepsia, abdominal pain, sore throat General disorders: weakness, pain, feeling hot, influenza like illness, fall, rigors, lethargy, pyrexia, chest pain Infections and infestations: nasopharyngitis, upper respiratory tract infection, sinusitis, influenza, gastroenteritis viral, urinary tract infection, bronchitis Investigations: blood creatine phosphokinase increased, weight decreased Metabolism and nutrition disorders: appetite decreased Musculoskeletal, connective tissue and bone disorders: arthralgia, back pain, pain in limb, neck pain Nervous system disorders: tremor, paresthesia, hypoesthesia Psychiatric disorders: nervousness, anxiety, depression, restlessness Respiratory, thoracic and mediastinal disorders: sneezing, cough, rhinorrhea, nasal congestion, dyspnea, sinus congestion Skin and subcutaneous tissue disorders: sweating increased, dermatitis Vascular disorders: hot flushes, vasodilatation Adverse Reactions With Incidence Rates of 0.5% to \\n <1.0% and Serious Adverse Reactions Reported in at Least 2 patients During Clinical Trials Cardiac disorders: palpitations, myocardial infarction Ear and labyrinth disorders: tinnitus, vertigo Gastrointestinal disorders: flatulence, toothache, constipation aggravated, appendicitis, pancreatitis General disorders: feeling jittery, edema lower limb, shivering, joint swelling, malaise, drug withdrawal syndrome, peripheral swelling Hepato-biliary disorders: cholelithiasis, cholecystitis Infections and infestations: cellulitis, ear infection, gastroenteritis, pneumonia, viral infection Injury and poisoning: joint sprain, muscle injury Investigations: alanine aminotransferase increased, blood pressure increased, aspartate aminotransferase increased, heart rate increased, blood glucose increased, liver function tests abnormal Musculoskeletal, connective tissue and bone disorders: muscle cramps, muscle spasms, joint stiffness, muscle twitching, myalgia, osteoarthritis aggravated Nervous system disorders: migraine, sedation, syncope, disturbance in attention, dizziness aggravated Psychiatric disorders: euphoric mood, irritability, libido decreased, sleep disorder, agitation, disorientation, abnormal dreams Renal and urinary disorders: difficulty in micturition, urinary frequency, hematuria, dysuria, urinary retention Respiratory, thoracic and mediastinal disorders: yawning Skin and subcutaneous tissue disorders: contusion, piloerection, clamminess, night sweats, urticaria Vascular disorders: hypertension aggravated, hypertension, peripheral ischemia 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of tramadol.\"\n }\n ]\n },\n {\n \"Term\": \"Heart injury\",\n \"MEDDRACode\": \"10061200\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"heart injury\",\n \"Probability\": \"0.1114349961\",\n \"SemanticContext\": \"With intravenous abuse the inactive ingredients in tramadol hydrochloride extended-release tablets can result in local tissue necrosis, infection, pulmonary granulomas, embolism and death, and increased risk of endocarditis and valvular heart injury.\"\n },\n {\n \"VerbatimTerm\": \"heart injury\",\n \"Probability\": \"0.1114349961\",\n \"SemanticContext\": \"With intravenous abuse the inactive ingredients in tramadol hydrochloride extended-release tablets can result in local tissue necrosis, infection, pulmonary granulomas, embolism and death, and increased risk of endocarditis and valvular heart injury.\"\n }\n ]\n },\n {\n \"Term\": \"Euphoric mood\",\n \"MEDDRACode\": \"10015535\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": true\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"higher\",\n \"Probability\": \"0.0003928542\",\n \"SemanticContext\": \"Risk is increased with higher than recommended doses and concomitant use of SSRIs, SNRIs, anorectics, tricyclic antidepressants and other tricyclic compounds, other opioids, MAOIs, neuroleptics, other drugs that reduce seizure threshold, in patients with epilepsy or at risk for seizures.\"\n },\n {\n \"VerbatimTerm\": \"higher\",\n \"Probability\": \"3.52188E-05\",\n \"SemanticContext\": \"Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that develop after repeated substance use and includes: a strong desire to take the drug, difficulties in controlling its use, persisting in its use despite harmful consequences, a higher priority given to drug use than to other activities and obligations, increased tolerance, and sometimes a physical withdrawal.\"\n },\n {\n \"VerbatimTerm\": \"higher\",\n \"Probability\": \"3.52188E-05\",\n \"SemanticContext\": \"Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that develop after repeated substance use and includes: a strong desire to take the drug, difficulties in controlling its use, persisting in its use despite harmful consequences, a higher priority given to drug use than to other activities and obligations, increased tolerance, and sometimes a physical withdrawal.\"\n },\n {\n \"VerbatimTerm\": \"higher\",\n \"Probability\": \"0.0004740059\",\n \"SemanticContext\": \"Opioid activity of tramadol is due to both low affinity binding of the parent compound and higher affinity binding of the O-desmethyl metabolite M1 to µ-opioid receptors.\"\n },\n {\n \"VerbatimTerm\": \"higher\",\n \"Probability\": \"0.002061367\",\n \"SemanticContext\": \"The observed tramadol AUC values for the 400 mg dose were 26% higher than predicted based on the AUC values for the 200 mg dose.\"\n },\n {\n \"VerbatimTerm\": \"higher\",\n \"Probability\": \"0.001522094\",\n \"SemanticContext\": \"Sex Based on pooled multiple-dose pharmacokinetics studies for tramadol hydrochloride extended-release tablets in 166 healthy subjects 111 males and 55 females , the dose-normalized AUC values for tramadol were somewhat higher in females than in males.\"\n },\n {\n \"VerbatimTerm\": \"higher\",\n \"Probability\": \"0.0005705953\",\n \"SemanticContext\": \"Tramadol does not appear to induce its own metabolism in humans, since observed maximal plasma concentrations after multiple oral doses are higher than expected based on single-dose data.\"\n },\n {\n \"VerbatimTerm\": \"higher\",\n \"Probability\": \"0.0100977719\",\n \"SemanticContext\": \"Based on a population PK analysis of Phase 1 studies with IR tablets in healthy subjects, concentrations of tramadol were approximately 20% higher in \\\"poor metabolizers\\\" versus \\\"extensive metabolizers,\\\" while M1 concentrations were 40% lower.\"\n },\n {\n \"VerbatimTerm\": \"higher\",\n \"Probability\": \"0.0016953945\",\n \"SemanticContext\": \"This rapid conversion results in higher than expected serum M1 levels.\"\n },\n {\n \"VerbatimTerm\": \"higher\",\n \"Probability\": \"0.001919955\",\n \"SemanticContext\": \"In general, higher incidence rates of adverse events were observed for patients older than 65 years of age compared with patients 65 years and younger, particularly for the following adverse events: constipation, fatigue, weakness, postural hypotension and dyspepsia.\"\n },\n {\n \"VerbatimTerm\": \"high\",\n \"Probability\": \"8.83416E-05\",\n \"SemanticContext\": \"9.2 Abuse Tramadol hydrochloride extended-release tablet contains tramadol, a substance with a high potential for abuse similar to other opioids.\"\n },\n {\n \"VerbatimTerm\": \"high\",\n \"Probability\": \"0.0016107559\",\n \"SemanticContext\": \"The high drug content in extended-release formulations adds to the risk of adverse outcomes from abuse and misuse.\"\n },\n {\n \"VerbatimTerm\": \"high\",\n \"Probability\": \"8.83416E-05\",\n \"SemanticContext\": \"9.2 Abuse Tramadol hydrochloride extended-release tablet contains tramadol, a substance with a high potential for abuse similar to other opioids.\"\n },\n {\n \"VerbatimTerm\": \"high\",\n \"Probability\": \"0.0016107559\",\n \"SemanticContext\": \"The high drug content in extended-release formulations adds to the risk of adverse outcomes from abuse and misuse.\"\n },\n {\n \"VerbatimTerm\": \"high\",\n \"Probability\": \"3.09081E-05\",\n \"SemanticContext\": \"In patients taking opioids for a long duration at high doses, ensure that a multimodal approach to pain management, including mental health support if needed , is in place prior to initiating an opioid analgesic taper [See Dosage and Administration 2.5 , Warnings and Precautions 5.17 ].\"\n },\n {\n \"VerbatimTerm\": \"high\",\n \"Probability\": \"8.73319E-05\",\n \"SemanticContext\": \"Food Effects After a single dose administration of 200 mg tramadol hydrochloride extended-release tablet with a high fat meal, the C max and AUC 0-8 of tramadol decreased 28% and 16%, respectively, compared to fasting conditions.\"\n },\n {\n \"VerbatimTerm\": \"high\",\n \"Probability\": \"3.30397E-05\",\n \"SemanticContext\": \"When managing patients taking opioid analgesics, particularly those who have been treated for a long duration and/or with high doses for chronic pain, ensure that a multimodal approach to pain management, including mental health support if needed , is in place prior to initiating an opioid analgesic taper.\"\n },\n {\n \"VerbatimTerm\": \"high\",\n \"Probability\": \"0.0022313595\",\n \"SemanticContext\": \"At least one death was reported in a nursing infant who was exposed to high levels of morphine in breast milk because the mother was an ultra-rapid metabolizer of codeine.\"\n },\n {\n \"VerbatimTerm\": \"high\",\n \"Probability\": \"0.0002051294\",\n \"SemanticContext\": \"A baby nursing from an ultra-rapid metabolizer mother taking Tramadol hydrochloride extended-release tablets could potentially be exposed to high levels of M1, and experience life-threatening respiratory depression.\"\n },\n {\n \"VerbatimTerm\": \"high\",\n \"Probability\": \"8.7811E-05\",\n \"SemanticContext\": \"Get emergency medical help or call 911 right away, if you have: trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue, or throat, extreme drowsiness, light-headedness when changing positions, feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion.\"\n }\n ]\n },\n {\n \"Term\": \"Paraesthesia\",\n \"MEDDRACode\": \"10033775\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"paresthesia\",\n \"Probability\": \"0.9980505705\",\n \"SemanticContext\": \"Eye disorders: vision blurred Gastrointestinal disorders: abdominal pain upper, dyspepsia, abdominal pain, sore throat General disorders: weakness, pain, feeling hot, influenza like illness, fall, rigors, lethargy, pyrexia, chest pain Infections and infestations: nasopharyngitis, upper respiratory tract infection, sinusitis, influenza, gastroenteritis viral, urinary tract infection, bronchitis Investigations: blood creatine phosphokinase increased, weight decreased Metabolism and nutrition disorders: appetite decreased Musculoskeletal, connective tissue and bone disorders: arthralgia, back pain, pain in limb, neck pain Nervous system disorders: tremor, paresthesia, hypoesthesia Psychiatric disorders: nervousness, anxiety, depression, restlessness Respiratory, thoracic and mediastinal disorders: sneezing, cough, rhinorrhea, nasal congestion, dyspnea, sinus congestion Skin and subcutaneous tissue disorders: sweating increased, dermatitis Vascular disorders: hot flushes, vasodilatation Adverse Reactions With Incidence Rates of 0.5% to \\n <1.0% and Serious Adverse Reactions Reported in at Least 2 patients During Clinical Trials Cardiac disorders: palpitations, myocardial infarction Ear and labyrinth disorders: tinnitus, vertigo Gastrointestinal disorders: flatulence, toothache, constipation aggravated, appendicitis, pancreatitis General disorders: feeling jittery, edema lower limb, shivering, joint swelling, malaise, drug withdrawal syndrome, peripheral swelling Hepato-biliary disorders: cholelithiasis, cholecystitis Infections and infestations: cellulitis, ear infection, gastroenteritis, pneumonia, viral infection Injury and poisoning: joint sprain, muscle injury Investigations: alanine aminotransferase increased, blood pressure increased, aspartate aminotransferase increased, heart rate increased, blood glucose increased, liver function tests abnormal Musculoskeletal, connective tissue and bone disorders: muscle cramps, muscle spasms, joint stiffness, muscle twitching, myalgia, osteoarthritis aggravated Nervous system disorders: migraine, sedation, syncope, disturbance in attention, dizziness aggravated Psychiatric disorders: euphoric mood, irritability, libido decreased, sleep disorder, agitation, disorientation, abnormal dreams Renal and urinary disorders: difficulty in micturition, urinary frequency, hematuria, dysuria, urinary retention Respiratory, thoracic and mediastinal disorders: yawning Skin and subcutaneous tissue disorders: contusion, piloerection, clamminess, night sweats, urticaria Vascular disorders: hypertension aggravated, hypertension, peripheral ischemia 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of tramadol.\"\n }\n ]\n },\n {\n \"Term\": \"Neck pain\",\n \"MEDDRACode\": \"10028836\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"neck pain\",\n \"Probability\": \"0.9550468326\",\n \"SemanticContext\": \"Eye disorders: vision blurred Gastrointestinal disorders: abdominal pain upper, dyspepsia, abdominal pain, sore throat General disorders: weakness, pain, feeling hot, influenza like illness, fall, rigors, lethargy, pyrexia, chest pain Infections and infestations: nasopharyngitis, upper respiratory tract infection, sinusitis, influenza, gastroenteritis viral, urinary tract infection, bronchitis Investigations: blood creatine phosphokinase increased, weight decreased Metabolism and nutrition disorders: appetite decreased Musculoskeletal, connective tissue and bone disorders: arthralgia, back pain, pain in limb, neck pain Nervous system disorders: tremor, paresthesia, hypoesthesia Psychiatric disorders: nervousness, anxiety, depression, restlessness Respiratory, thoracic and mediastinal disorders: sneezing, cough, rhinorrhea, nasal congestion, dyspnea, sinus congestion Skin and subcutaneous tissue disorders: sweating increased, dermatitis Vascular disorders: hot flushes, vasodilatation Adverse Reactions With Incidence Rates of 0.5% to \\n <1.0% and Serious Adverse Reactions Reported in at Least 2 patients During Clinical Trials Cardiac disorders: palpitations, myocardial infarction Ear and labyrinth disorders: tinnitus, vertigo Gastrointestinal disorders: flatulence, toothache, constipation aggravated, appendicitis, pancreatitis General disorders: feeling jittery, edema lower limb, shivering, joint swelling, malaise, drug withdrawal syndrome, peripheral swelling Hepato-biliary disorders: cholelithiasis, cholecystitis Infections and infestations: cellulitis, ear infection, gastroenteritis, pneumonia, viral infection Injury and poisoning: joint sprain, muscle injury Investigations: alanine aminotransferase increased, blood pressure increased, aspartate aminotransferase increased, heart rate increased, blood glucose increased, liver function tests abnormal Musculoskeletal, connective tissue and bone disorders: muscle cramps, muscle spasms, joint stiffness, muscle twitching, myalgia, osteoarthritis aggravated Nervous system disorders: migraine, sedation, syncope, disturbance in attention, dizziness aggravated Psychiatric disorders: euphoric mood, irritability, libido decreased, sleep disorder, agitation, disorientation, abnormal dreams Renal and urinary disorders: difficulty in micturition, urinary frequency, hematuria, dysuria, urinary retention Respiratory, thoracic and mediastinal disorders: yawning Skin and subcutaneous tissue disorders: contusion, piloerection, clamminess, night sweats, urticaria Vascular disorders: hypertension aggravated, hypertension, peripheral ischemia 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of tramadol.\"\n }\n ]\n },\n {\n \"Term\": \"Oedema peripheral\",\n \"MEDDRACode\": \"10030124\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"edema lower limb\",\n \"Probability\": \"0.9926609397\",\n \"SemanticContext\": \"Eye disorders: vision blurred Gastrointestinal disorders: abdominal pain upper, dyspepsia, abdominal pain, sore throat General disorders: weakness, pain, feeling hot, influenza like illness, fall, rigors, lethargy, pyrexia, chest pain Infections and infestations: nasopharyngitis, upper respiratory tract infection, sinusitis, influenza, gastroenteritis viral, urinary tract infection, bronchitis Investigations: blood creatine phosphokinase increased, weight decreased Metabolism and nutrition disorders: appetite decreased Musculoskeletal, connective tissue and bone disorders: arthralgia, back pain, pain in limb, neck pain Nervous system disorders: tremor, paresthesia, hypoesthesia Psychiatric disorders: nervousness, anxiety, depression, restlessness Respiratory, thoracic and mediastinal disorders: sneezing, cough, rhinorrhea, nasal congestion, dyspnea, sinus congestion Skin and subcutaneous tissue disorders: sweating increased, dermatitis Vascular disorders: hot flushes, vasodilatation Adverse Reactions With Incidence Rates of 0.5% to \\n <1.0% and Serious Adverse Reactions Reported in at Least 2 patients During Clinical Trials Cardiac disorders: palpitations, myocardial infarction Ear and labyrinth disorders: tinnitus, vertigo Gastrointestinal disorders: flatulence, toothache, constipation aggravated, appendicitis, pancreatitis General disorders: feeling jittery, edema lower limb, shivering, joint swelling, malaise, drug withdrawal syndrome, peripheral swelling Hepato-biliary disorders: cholelithiasis, cholecystitis Infections and infestations: cellulitis, ear infection, gastroenteritis, pneumonia, viral infection Injury and poisoning: joint sprain, muscle injury Investigations: alanine aminotransferase increased, blood pressure increased, aspartate aminotransferase increased, heart rate increased, blood glucose increased, liver function tests abnormal Musculoskeletal, connective tissue and bone disorders: muscle cramps, muscle spasms, joint stiffness, muscle twitching, myalgia, osteoarthritis aggravated Nervous system disorders: migraine, sedation, syncope, disturbance in attention, dizziness aggravated Psychiatric disorders: euphoric mood, irritability, libido decreased, sleep disorder, agitation, disorientation, abnormal dreams Renal and urinary disorders: difficulty in micturition, urinary frequency, hematuria, dysuria, urinary retention Respiratory, thoracic and mediastinal disorders: yawning Skin and subcutaneous tissue disorders: contusion, piloerection, clamminess, night sweats, urticaria Vascular disorders: hypertension aggravated, hypertension, peripheral ischemia 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of tramadol.\"\n }\n ]\n },\n {\n \"Term\": \"Gastroenteritis viral\",\n \"MEDDRACode\": \"10017918\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"gastroenteritis viral\",\n \"Probability\": \"0.9987550378\",\n \"SemanticContext\": \"Eye disorders: vision blurred Gastrointestinal disorders: abdominal pain upper, dyspepsia, abdominal pain, sore throat General disorders: weakness, pain, feeling hot, influenza like illness, fall, rigors, lethargy, pyrexia, chest pain Infections and infestations: nasopharyngitis, upper respiratory tract infection, sinusitis, influenza, gastroenteritis viral, urinary tract infection, bronchitis Investigations: blood creatine phosphokinase increased, weight decreased Metabolism and nutrition disorders: appetite decreased Musculoskeletal, connective tissue and bone disorders: arthralgia, back pain, pain in limb, neck pain Nervous system disorders: tremor, paresthesia, hypoesthesia Psychiatric disorders: nervousness, anxiety, depression, restlessness Respiratory, thoracic and mediastinal disorders: sneezing, cough, rhinorrhea, nasal congestion, dyspnea, sinus congestion Skin and subcutaneous tissue disorders: sweating increased, dermatitis Vascular disorders: hot flushes, vasodilatation Adverse Reactions With Incidence Rates of 0.5% to \\n <1.0% and Serious Adverse Reactions Reported in at Least 2 patients During Clinical Trials Cardiac disorders: palpitations, myocardial infarction Ear and labyrinth disorders: tinnitus, vertigo Gastrointestinal disorders: flatulence, toothache, constipation aggravated, appendicitis, pancreatitis General disorders: feeling jittery, edema lower limb, shivering, joint swelling, malaise, drug withdrawal syndrome, peripheral swelling Hepato-biliary disorders: cholelithiasis, cholecystitis Infections and infestations: cellulitis, ear infection, gastroenteritis, pneumonia, viral infection Injury and poisoning: joint sprain, muscle injury Investigations: alanine aminotransferase increased, blood pressure increased, aspartate aminotransferase increased, heart rate increased, blood glucose increased, liver function tests abnormal Musculoskeletal, connective tissue and bone disorders: muscle cramps, muscle spasms, joint stiffness, muscle twitching, myalgia, osteoarthritis aggravated Nervous system disorders: migraine, sedation, syncope, disturbance in attention, dizziness aggravated Psychiatric disorders: euphoric mood, irritability, libido decreased, sleep disorder, agitation, disorientation, abnormal dreams Renal and urinary disorders: difficulty in micturition, urinary frequency, hematuria, dysuria, urinary retention Respiratory, thoracic and mediastinal disorders: yawning Skin and subcutaneous tissue disorders: contusion, piloerection, clamminess, night sweats, urticaria Vascular disorders: hypertension aggravated, hypertension, peripheral ischemia 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of tramadol.\"\n }\n ]\n },\n {\n \"Term\": \"Asthenia\",\n \"MEDDRACode\": \"10003549\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"weakness\",\n \"Probability\": \"0.9976981878\",\n \"SemanticContext\": \"Eye disorders: vision blurred Gastrointestinal disorders: abdominal pain upper, dyspepsia, abdominal pain, sore throat General disorders: weakness, pain, feeling hot, influenza like illness, fall, rigors, lethargy, pyrexia, chest pain Infections and infestations: nasopharyngitis, upper respiratory tract infection, sinusitis, influenza, gastroenteritis viral, urinary tract infection, bronchitis Investigations: blood creatine phosphokinase increased, weight decreased Metabolism and nutrition disorders: appetite decreased Musculoskeletal, connective tissue and bone disorders: arthralgia, back pain, pain in limb, neck pain Nervous system disorders: tremor, paresthesia, hypoesthesia Psychiatric disorders: nervousness, anxiety, depression, restlessness Respiratory, thoracic and mediastinal disorders: sneezing, cough, rhinorrhea, nasal congestion, dyspnea, sinus congestion Skin and subcutaneous tissue disorders: sweating increased, dermatitis Vascular disorders: hot flushes, vasodilatation Adverse Reactions With Incidence Rates of 0.5% to \\n <1.0% and Serious Adverse Reactions Reported in at Least 2 patients During Clinical Trials Cardiac disorders: palpitations, myocardial infarction Ear and labyrinth disorders: tinnitus, vertigo Gastrointestinal disorders: flatulence, toothache, constipation aggravated, appendicitis, pancreatitis General disorders: feeling jittery, edema lower limb, shivering, joint swelling, malaise, drug withdrawal syndrome, peripheral swelling Hepato-biliary disorders: cholelithiasis, cholecystitis Infections and infestations: cellulitis, ear infection, gastroenteritis, pneumonia, viral infection Injury and poisoning: joint sprain, muscle injury Investigations: alanine aminotransferase increased, blood pressure increased, aspartate aminotransferase increased, heart rate increased, blood glucose increased, liver function tests abnormal Musculoskeletal, connective tissue and bone disorders: muscle cramps, muscle spasms, joint stiffness, muscle twitching, myalgia, osteoarthritis aggravated Nervous system disorders: migraine, sedation, syncope, disturbance in attention, dizziness aggravated Psychiatric disorders: euphoric mood, irritability, libido decreased, sleep disorder, agitation, disorientation, abnormal dreams Renal and urinary disorders: difficulty in micturition, urinary frequency, hematuria, dysuria, urinary retention Respiratory, thoracic and mediastinal disorders: yawning Skin and subcutaneous tissue disorders: contusion, piloerection, clamminess, night sweats, urticaria Vascular disorders: hypertension aggravated, hypertension, peripheral ischemia 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of tramadol.\"\n },\n {\n \"VerbatimTerm\": \"weakness\",\n \"Probability\": \"0.6617373824\",\n \"SemanticContext\": \"Other signs and symptoms also may develop, including irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate.\"\n },\n {\n \"VerbatimTerm\": \"weakness\",\n \"Probability\": \"0.9640351534\",\n \"SemanticContext\": \"Adrenal insufficiency may present with non-specific symptoms and signs such as nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure.\"\n },\n {\n \"VerbatimTerm\": \"weakness\",\n \"Probability\": \"0.8961240053\",\n \"SemanticContext\": \"Presentation of adrenal insufficiency may include non-specific symptoms and signs including nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure.\"\n },\n {\n \"VerbatimTerm\": \"weakness\",\n \"Probability\": \"0.9991335273\",\n \"SemanticContext\": \"In general, higher incidence rates of adverse events were observed for patients older than 65 years of age compared with patients 65 years and younger, particularly for the following adverse events: constipation, fatigue, weakness, postural hypotension and dyspepsia.\"\n }\n ]\n },\n {\n \"Term\": \"Bronchitis\",\n \"MEDDRACode\": \"10006451\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"bronchitis\",\n \"Probability\": \"0.9989563227\",\n \"SemanticContext\": \"Eye disorders: vision blurred Gastrointestinal disorders: abdominal pain upper, dyspepsia, abdominal pain, sore throat General disorders: weakness, pain, feeling hot, influenza like illness, fall, rigors, lethargy, pyrexia, chest pain Infections and infestations: nasopharyngitis, upper respiratory tract infection, sinusitis, influenza, gastroenteritis viral, urinary tract infection, bronchitis Investigations: blood creatine phosphokinase increased, weight decreased Metabolism and nutrition disorders: appetite decreased Musculoskeletal, connective tissue and bone disorders: arthralgia, back pain, pain in limb, neck pain Nervous system disorders: tremor, paresthesia, hypoesthesia Psychiatric disorders: nervousness, anxiety, depression, restlessness Respiratory, thoracic and mediastinal disorders: sneezing, cough, rhinorrhea, nasal congestion, dyspnea, sinus congestion Skin and subcutaneous tissue disorders: sweating increased, dermatitis Vascular disorders: hot flushes, vasodilatation Adverse Reactions With Incidence Rates of 0.5% to \\n <1.0% and Serious Adverse Reactions Reported in at Least 2 patients During Clinical Trials Cardiac disorders: palpitations, myocardial infarction Ear and labyrinth disorders: tinnitus, vertigo Gastrointestinal disorders: flatulence, toothache, constipation aggravated, appendicitis, pancreatitis General disorders: feeling jittery, edema lower limb, shivering, joint swelling, malaise, drug withdrawal syndrome, peripheral swelling Hepato-biliary disorders: cholelithiasis, cholecystitis Infections and infestations: cellulitis, ear infection, gastroenteritis, pneumonia, viral infection Injury and poisoning: joint sprain, muscle injury Investigations: alanine aminotransferase increased, blood pressure increased, aspartate aminotransferase increased, heart rate increased, blood glucose increased, liver function tests abnormal Musculoskeletal, connective tissue and bone disorders: muscle cramps, muscle spasms, joint stiffness, muscle twitching, myalgia, osteoarthritis aggravated Nervous system disorders: migraine, sedation, syncope, disturbance in attention, dizziness aggravated Psychiatric disorders: euphoric mood, irritability, libido decreased, sleep disorder, agitation, disorientation, abnormal dreams Renal and urinary disorders: difficulty in micturition, urinary frequency, hematuria, dysuria, urinary retention Respiratory, thoracic and mediastinal disorders: yawning Skin and subcutaneous tissue disorders: contusion, piloerection, clamminess, night sweats, urticaria Vascular disorders: hypertension aggravated, hypertension, peripheral ischemia 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of tramadol.\"\n }\n ]\n },\n {\n \"Term\": \"Feeling hot\",\n \"MEDDRACode\": \"10016334\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"feeling hot\",\n \"Probability\": \"0.9788745642\",\n \"SemanticContext\": \"Eye disorders: vision blurred Gastrointestinal disorders: abdominal pain upper, dyspepsia, abdominal pain, sore throat General disorders: weakness, pain, feeling hot, influenza like illness, fall, rigors, lethargy, pyrexia, chest pain Infections and infestations: nasopharyngitis, upper respiratory tract infection, sinusitis, influenza, gastroenteritis viral, urinary tract infection, bronchitis Investigations: blood creatine phosphokinase increased, weight decreased Metabolism and nutrition disorders: appetite decreased Musculoskeletal, connective tissue and bone disorders: arthralgia, back pain, pain in limb, neck pain Nervous system disorders: tremor, paresthesia, hypoesthesia Psychiatric disorders: nervousness, anxiety, depression, restlessness Respiratory, thoracic and mediastinal disorders: sneezing, cough, rhinorrhea, nasal congestion, dyspnea, sinus congestion Skin and subcutaneous tissue disorders: sweating increased, dermatitis Vascular disorders: hot flushes, vasodilatation Adverse Reactions With Incidence Rates of 0.5% to \\n <1.0% and Serious Adverse Reactions Reported in at Least 2 patients During Clinical Trials Cardiac disorders: palpitations, myocardial infarction Ear and labyrinth disorders: tinnitus, vertigo Gastrointestinal disorders: flatulence, toothache, constipation aggravated, appendicitis, pancreatitis General disorders: feeling jittery, edema lower limb, shivering, joint swelling, malaise, drug withdrawal syndrome, peripheral swelling Hepato-biliary disorders: cholelithiasis, cholecystitis Infections and infestations: cellulitis, ear infection, gastroenteritis, pneumonia, viral infection Injury and poisoning: joint sprain, muscle injury Investigations: alanine aminotransferase increased, blood pressure increased, aspartate aminotransferase increased, heart rate increased, blood glucose increased, liver function tests abnormal Musculoskeletal, connective tissue and bone disorders: muscle cramps, muscle spasms, joint stiffness, muscle twitching, myalgia, osteoarthritis aggravated Nervous system disorders: migraine, sedation, syncope, disturbance in attention, dizziness aggravated Psychiatric disorders: euphoric mood, irritability, libido decreased, sleep disorder, agitation, disorientation, abnormal dreams Renal and urinary disorders: difficulty in micturition, urinary frequency, hematuria, dysuria, urinary retention Respiratory, thoracic and mediastinal disorders: yawning Skin and subcutaneous tissue disorders: contusion, piloerection, clamminess, night sweats, urticaria Vascular disorders: hypertension aggravated, hypertension, peripheral ischemia 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of tramadol.\"\n }\n ]\n },\n {\n \"Term\": \"Gastrointestinal disorder\",\n \"MEDDRACode\": \"10017944\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Gastrointestinal disorders\",\n \"Probability\": \"0.2308742702\",\n \"SemanticContext\": \"Eye disorders: vision blurred Gastrointestinal disorders: abdominal pain upper, dyspepsia, abdominal pain, sore throat General disorders: weakness, pain, feeling hot, influenza like illness, fall, rigors, lethargy, pyrexia, chest pain Infections and infestations: nasopharyngitis, upper respiratory tract infection, sinusitis, influenza, gastroenteritis viral, urinary tract infection, bronchitis Investigations: blood creatine phosphokinase increased, weight decreased Metabolism and nutrition disorders: appetite decreased Musculoskeletal, connective tissue and bone disorders: arthralgia, back pain, pain in limb, neck pain Nervous system disorders: tremor, paresthesia, hypoesthesia Psychiatric disorders: nervousness, anxiety, depression, restlessness Respiratory, thoracic and mediastinal disorders: sneezing, cough, rhinorrhea, nasal congestion, dyspnea, sinus congestion Skin and subcutaneous tissue disorders: sweating increased, dermatitis Vascular disorders: hot flushes, vasodilatation Adverse Reactions With Incidence Rates of 0.5% to \\n <1.0% and Serious Adverse Reactions Reported in at Least 2 patients During Clinical Trials Cardiac disorders: palpitations, myocardial infarction Ear and labyrinth disorders: tinnitus, vertigo Gastrointestinal disorders: flatulence, toothache, constipation aggravated, appendicitis, pancreatitis General disorders: feeling jittery, edema lower limb, shivering, joint swelling, malaise, drug withdrawal syndrome, peripheral swelling Hepato-biliary disorders: cholelithiasis, cholecystitis Infections and infestations: cellulitis, ear infection, gastroenteritis, pneumonia, viral infection Injury and poisoning: joint sprain, muscle injury Investigations: alanine aminotransferase increased, blood pressure increased, aspartate aminotransferase increased, heart rate increased, blood glucose increased, liver function tests abnormal Musculoskeletal, connective tissue and bone disorders: muscle cramps, muscle spasms, joint stiffness, muscle twitching, myalgia, osteoarthritis aggravated Nervous system disorders: migraine, sedation, syncope, disturbance in attention, dizziness aggravated Psychiatric disorders: euphoric mood, irritability, libido decreased, sleep disorder, agitation, disorientation, abnormal dreams Renal and urinary disorders: difficulty in micturition, urinary frequency, hematuria, dysuria, urinary retention Respiratory, thoracic and mediastinal disorders: yawning Skin and subcutaneous tissue disorders: contusion, piloerection, clamminess, night sweats, urticaria Vascular disorders: hypertension aggravated, hypertension, peripheral ischemia 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of tramadol.\"\n },\n {\n \"VerbatimTerm\": \"Gastrointestinal disorders\",\n \"Probability\": \"0.6248656511\",\n \"SemanticContext\": \"Eye disorders: vision blurred Gastrointestinal disorders: abdominal pain upper, dyspepsia, abdominal pain, sore throat General disorders: weakness, pain, feeling hot, influenza like illness, fall, rigors, lethargy, pyrexia, chest pain Infections and infestations: nasopharyngitis, upper respiratory tract infection, sinusitis, influenza, gastroenteritis viral, urinary tract infection, bronchitis Investigations: blood creatine phosphokinase increased, weight decreased Metabolism and nutrition disorders: appetite decreased Musculoskeletal, connective tissue and bone disorders: arthralgia, back pain, pain in limb, neck pain Nervous system disorders: tremor, paresthesia, hypoesthesia Psychiatric disorders: nervousness, anxiety, depression, restlessness Respiratory, thoracic and mediastinal disorders: sneezing, cough, rhinorrhea, nasal congestion, dyspnea, sinus congestion Skin and subcutaneous tissue disorders: sweating increased, dermatitis Vascular disorders: hot flushes, vasodilatation Adverse Reactions With Incidence Rates of 0.5% to \\n <1.0% and Serious Adverse Reactions Reported in at Least 2 patients During Clinical Trials Cardiac disorders: palpitations, myocardial infarction Ear and labyrinth disorders: tinnitus, vertigo Gastrointestinal disorders: flatulence, toothache, constipation aggravated, appendicitis, pancreatitis General disorders: feeling jittery, edema lower limb, shivering, joint swelling, malaise, drug withdrawal syndrome, peripheral swelling Hepato-biliary disorders: cholelithiasis, cholecystitis Infections and infestations: cellulitis, ear infection, gastroenteritis, pneumonia, viral infection Injury and poisoning: joint sprain, muscle injury Investigations: alanine aminotransferase increased, blood pressure increased, aspartate aminotransferase increased, heart rate increased, blood glucose increased, liver function tests abnormal Musculoskeletal, connective tissue and bone disorders: muscle cramps, muscle spasms, joint stiffness, muscle twitching, myalgia, osteoarthritis aggravated Nervous system disorders: migraine, sedation, syncope, disturbance in attention, dizziness aggravated Psychiatric disorders: euphoric mood, irritability, libido decreased, sleep disorder, agitation, disorientation, abnormal dreams Renal and urinary disorders: difficulty in micturition, urinary frequency, hematuria, dysuria, urinary retention Respiratory, thoracic and mediastinal disorders: yawning Skin and subcutaneous tissue disorders: contusion, piloerection, clamminess, night sweats, urticaria Vascular disorders: hypertension aggravated, hypertension, peripheral ischemia 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of tramadol.\"\n }\n ]\n },\n {\n \"Term\": \"Constipation\",\n \"MEDDRACode\": \"10010774\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"constipation\",\n \"Probability\": \"0.999835968\",\n \"SemanticContext\": \"ADVERSE REACTIONS Most common adverse reactions =10% and =2 x placebo rate : Dizziness, constipation, nausea, headache, somnolence, flushing, pruritus, vomiting, insomnia, dry mouth.\"\n },\n {\n \"VerbatimTerm\": \"constipation\",\n \"Probability\": \"0.9992898107\",\n \"SemanticContext\": \"The most common adverse reactions from Table 1 occurring in =10% and =2 x placebo rate of the patients treated with tramadol hydrochloride extended-release tablets are dizziness not vertigo , nausea, constipation, headache, somnolence, flushing, pruritus, vomiting, insomnia, and dry mouth.\"\n },\n {\n \"VerbatimTerm\": \"constipation\",\n \"Probability\": \"0.2892974913\",\n \"SemanticContext\": \"Apart from analgesia, tramadol administration may produce a constellation of symptoms including dizziness, somnolence, nausea, constipation, sweating and pruritus similar to that of other opioids.\"\n },\n {\n \"VerbatimTerm\": \"constipation\",\n \"Probability\": \"0.7571685314\",\n \"SemanticContext\": \"Propulsive peristaltic waves in the colon are decreased, while tone may be increased to the point of spasm, resulting in constipation.\"\n },\n {\n \"VerbatimTerm\": \"constipation\",\n \"Probability\": \"0.5909851789\",\n \"SemanticContext\": \"Anticholinergic Drugs Clinical Impact: The concomitant use of anticholinergic drugs may increase risk of urinary retention and/or severe constipation, which may lead to paralytic ileus.\"\n },\n {\n \"VerbatimTerm\": \"constipation\",\n \"Probability\": \"0.0017177165\",\n \"SemanticContext\": \"Constipation Advise patients of the potential for severe constipation, including management instructions and when to seek medical attention [see Adverse Reactions 6 , Clinical Pharmacology 12.1 ].\"\n },\n {\n \"VerbatimTerm\": \"constipation\",\n \"Probability\": \"0.9942947626\",\n \"SemanticContext\": \"The possible side effects of tramadol hydrochloride extended-release tablets: constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain, seizure.\"\n },\n {\n \"VerbatimTerm\": \"constipation\",\n \"Probability\": \"0.9995458126\",\n \"SemanticContext\": \"In general, higher incidence rates of adverse events were observed for patients older than 65 years of age compared with patients 65 years and younger, particularly for the following adverse events: constipation, fatigue, weakness, postural hypotension and dyspepsia.\"\n },\n {\n \"VerbatimTerm\": \"Constipation\",\n \"Probability\": \"0.9994293451\",\n \"SemanticContext\": \"MedDRA Preferred Term Tramadol Hydrochloride Extended-Release Tablets Placebo 100 mg N=403 n % 200 mg N=400 n % 300 mg N=400 n % 400 mg N=202 n % N=406 n % Dizziness not vertigo 64 16 81 20 90 23 57 28 28 7 Nausea 61 15 90 23 102 26 53 26 32 8 Constipation 49 12 68 17 85 21 60 30 17 4 Headache 49 12 62 16 46 12 32 16 43 11 Somnolence 33 8 45 11 29 7 41 20 7 2 Flushing 31 8 40 10 35 9 32 16 18 4 Pruritus 25 6 34 9 30 8 24 12 4 1 Vomiting 20 5 29 7 34 9 19 9 11 3 Insomnia 26 7 32 8 36 9 22 11 13 3 Dry Mouth 20 5 29 7 39 10 18 9 6 2 Diarrhea 15 4 27 7 37 9 10 5 17 4 Asthenia 14 4 24 6 26 7 13 6 7 2 Postural hypotension 7 2 17 4 8 2 11 5 9 2 Sweating increased 6 2 8 2 15 4 13 6 1 0 Anorexia 3 1 7 2 21 5 12 6 1 0 .\"\n },\n {\n \"VerbatimTerm\": \"Constipation\",\n \"Probability\": \"0.6398057938\",\n \"SemanticContext\": \"Constipation Advise patients of the potential for severe constipation, including management instructions and when to seek medical attention [see Adverse Reactions 6 , Clinical Pharmacology 12.1 ].\"\n }\n ]\n },\n {\n \"Term\": \"Substance use\",\n \"MEDDRACode\": \"10070964\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"substance use\",\n \"Probability\": \"0.000410527\",\n \"SemanticContext\": \"Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that develop after repeated substance use and includes: a strong desire to take the drug, difficulties in controlling its use, persisting in its use despite harmful consequences, a higher priority given to drug use than to other activities and obligations, increased tolerance, and sometimes a physical withdrawal.\"\n },\n {\n \"VerbatimTerm\": \"substance use\",\n \"Probability\": \"0.000410527\",\n \"SemanticContext\": \"Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that develop after repeated substance use and includes: a strong desire to take the drug, difficulties in controlling its use, persisting in its use despite harmful consequences, a higher priority given to drug use than to other activities and obligations, increased tolerance, and sometimes a physical withdrawal.\"\n }\n ]\n },\n {\n \"Term\": \"Feeling jittery\",\n \"MEDDRACode\": \"10016338\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"feeling jittery\",\n \"Probability\": \"0.9901491404\",\n \"SemanticContext\": \"Eye disorders: vision blurred Gastrointestinal disorders: abdominal pain upper, dyspepsia, abdominal pain, sore throat General disorders: weakness, pain, feeling hot, influenza like illness, fall, rigors, lethargy, pyrexia, chest pain Infections and infestations: nasopharyngitis, upper respiratory tract infection, sinusitis, influenza, gastroenteritis viral, urinary tract infection, bronchitis Investigations: blood creatine phosphokinase increased, weight decreased Metabolism and nutrition disorders: appetite decreased Musculoskeletal, connective tissue and bone disorders: arthralgia, back pain, pain in limb, neck pain Nervous system disorders: tremor, paresthesia, hypoesthesia Psychiatric disorders: nervousness, anxiety, depression, restlessness Respiratory, thoracic and mediastinal disorders: sneezing, cough, rhinorrhea, nasal congestion, dyspnea, sinus congestion Skin and subcutaneous tissue disorders: sweating increased, dermatitis Vascular disorders: hot flushes, vasodilatation Adverse Reactions With Incidence Rates of 0.5% to \\n <1.0% and Serious Adverse Reactions Reported in at Least 2 patients During Clinical Trials Cardiac disorders: palpitations, myocardial infarction Ear and labyrinth disorders: tinnitus, vertigo Gastrointestinal disorders: flatulence, toothache, constipation aggravated, appendicitis, pancreatitis General disorders: feeling jittery, edema lower limb, shivering, joint swelling, malaise, drug withdrawal syndrome, peripheral swelling Hepato-biliary disorders: cholelithiasis, cholecystitis Infections and infestations: cellulitis, ear infection, gastroenteritis, pneumonia, viral infection Injury and poisoning: joint sprain, muscle injury Investigations: alanine aminotransferase increased, blood pressure increased, aspartate aminotransferase increased, heart rate increased, blood glucose increased, liver function tests abnormal Musculoskeletal, connective tissue and bone disorders: muscle cramps, muscle spasms, joint stiffness, muscle twitching, myalgia, osteoarthritis aggravated Nervous system disorders: migraine, sedation, syncope, disturbance in attention, dizziness aggravated Psychiatric disorders: euphoric mood, irritability, libido decreased, sleep disorder, agitation, disorientation, abnormal dreams Renal and urinary disorders: difficulty in micturition, urinary frequency, hematuria, dysuria, urinary retention Respiratory, thoracic and mediastinal disorders: yawning Skin and subcutaneous tissue disorders: contusion, piloerection, clamminess, night sweats, urticaria Vascular disorders: hypertension aggravated, hypertension, peripheral ischemia 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of tramadol.\"\n }\n ]\n },\n {\n \"Term\": \"Endocarditis\",\n \"MEDDRACode\": \"10014665\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"endocarditis\",\n \"Probability\": \"0.1799874604\",\n \"SemanticContext\": \"With intravenous abuse the inactive ingredients in tramadol hydrochloride extended-release tablets can result in local tissue necrosis, infection, pulmonary granulomas, embolism and death, and increased risk of endocarditis and valvular heart injury.\"\n },\n {\n \"VerbatimTerm\": \"endocarditis\",\n \"Probability\": \"0.1799874604\",\n \"SemanticContext\": \"With intravenous abuse the inactive ingredients in tramadol hydrochloride extended-release tablets can result in local tissue necrosis, infection, pulmonary granulomas, embolism and death, and increased risk of endocarditis and valvular heart injury.\"\n }\n ]\n },\n {\n \"Term\": \"Pulmonary granuloma\",\n \"MEDDRACode\": \"10037391\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"pulmonary granulomas\",\n \"Probability\": \"0.1970857978\",\n \"SemanticContext\": \"With intravenous abuse the inactive ingredients in tramadol hydrochloride extended-release tablets can result in local tissue necrosis, infection, pulmonary granulomas, embolism and death, and increased risk of endocarditis and valvular heart injury.\"\n },\n {\n \"VerbatimTerm\": \"pulmonary granulomas\",\n \"Probability\": \"0.1970857978\",\n \"SemanticContext\": \"With intravenous abuse the inactive ingredients in tramadol hydrochloride extended-release tablets can result in local tissue necrosis, infection, pulmonary granulomas, embolism and death, and increased risk of endocarditis and valvular heart injury.\"\n }\n ]\n },\n {\n \"Term\": \"Pain management\",\n \"MEDDRACode\": \"10056350\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"pain management\",\n \"Probability\": \"0.000708431\",\n \"SemanticContext\": \"In patients taking opioids for a long duration at high doses, ensure that a multimodal approach to pain management, including mental health support if needed , is in place prior to initiating an opioid analgesic taper [See Dosage and Administration 2.5 , Warnings and Precautions 5.17 ].\"\n },\n {\n \"VerbatimTerm\": \"pain management\",\n \"Probability\": \"0.0007398427\",\n \"SemanticContext\": \"When managing patients taking opioid analgesics, particularly those who have been treated for a long duration and/or with high doses for chronic pain, ensure that a multimodal approach to pain management, including mental health support if needed , is in place prior to initiating an opioid analgesic taper.\"\n },\n {\n \"VerbatimTerm\": \"pain management\",\n \"Probability\": \"0.0422249138\",\n \"SemanticContext\": \"A multimodal approach to pain management may optimize the treatment of chronic pain, as well as assist with the successful tapering of the opioid analgesic [see Warnings and Precautions 5.17 , Drug Abuse and Dependence 9.3 ].\"\n }\n ]\n },\n {\n \"Term\": \"Infant\",\n \"MEDDRACode\": \"10021731\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"newborn\",\n \"Probability\": \"0.0144145489\",\n \"SemanticContext\": \"The onset, duration, and severity of neonatal opioid withdrawal syndrome vary based on the specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination of the drug by the newborn.\"\n },\n {\n \"VerbatimTerm\": \"newborn\",\n \"Probability\": \"3.75825E-05\",\n \"SemanticContext\": \"Prolonged use of tramadol hydrochloride extended-release tablets during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.\"\n },\n {\n \"VerbatimTerm\": \"newborns\",\n \"Probability\": \"0.0019807518\",\n \"SemanticContext\": \"Observe newborns for symptoms and signs of neonatal opioid withdrawal syndrome and manage accordingly [see Warnings and Precautions 5.5 ] .\"\n },\n {\n \"VerbatimTerm\": \"newborns\",\n \"Probability\": \"0.0004071891\",\n \"SemanticContext\": \"Observe newborns for signs of neonatal opioid withdrawal syndrome and manage accordingly.\"\n }\n ]\n },\n {\n \"Term\": \"Hepatitis\",\n \"MEDDRACode\": \"10019717\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hepatitis\",\n \"Probability\": \"0.3712218404\",\n \"SemanticContext\": \"Parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and HIV.\"\n },\n {\n \"VerbatimTerm\": \"hepatitis\",\n \"Probability\": \"0.1984451413\",\n \"SemanticContext\": \"Parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and HIV.\"\n }\n ]\n },\n {\n \"Term\": \"Necrosis\",\n \"MEDDRACode\": \"10028851\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"necrosis\",\n \"Probability\": \"0.0124768317\",\n \"SemanticContext\": \"With intravenous abuse the inactive ingredients in tramadol hydrochloride extended-release tablets can result in local tissue necrosis, infection, pulmonary granulomas, embolism and death, and increased risk of endocarditis and valvular heart injury.\"\n },\n {\n \"VerbatimTerm\": \"necrosis\",\n \"Probability\": \"0.0124768317\",\n \"SemanticContext\": \"With intravenous abuse the inactive ingredients in tramadol hydrochloride extended-release tablets can result in local tissue necrosis, infection, pulmonary granulomas, embolism and death, and increased risk of endocarditis and valvular heart injury.\"\n }\n ]\n },\n {\n \"Term\": \"Vision blurred\",\n \"MEDDRACode\": \"10047513\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"vision blurred\",\n \"Probability\": \"0.9276163578\",\n \"SemanticContext\": \"Eye disorders: vision blurred Gastrointestinal disorders: abdominal pain upper, dyspepsia, abdominal pain, sore throat General disorders: weakness, pain, feeling hot, influenza like illness, fall, rigors, lethargy, pyrexia, chest pain Infections and infestations: nasopharyngitis, upper respiratory tract infection, sinusitis, influenza, gastroenteritis viral, urinary tract infection, bronchitis Investigations: blood creatine phosphokinase increased, weight decreased Metabolism and nutrition disorders: appetite decreased Musculoskeletal, connective tissue and bone disorders: arthralgia, back pain, pain in limb, neck pain Nervous system disorders: tremor, paresthesia, hypoesthesia Psychiatric disorders: nervousness, anxiety, depression, restlessness Respiratory, thoracic and mediastinal disorders: sneezing, cough, rhinorrhea, nasal congestion, dyspnea, sinus congestion Skin and subcutaneous tissue disorders: sweating increased, dermatitis Vascular disorders: hot flushes, vasodilatation Adverse Reactions With Incidence Rates of 0.5% to \\n <1.0% and Serious Adverse Reactions Reported in at Least 2 patients During Clinical Trials Cardiac disorders: palpitations, myocardial infarction Ear and labyrinth disorders: tinnitus, vertigo Gastrointestinal disorders: flatulence, toothache, constipation aggravated, appendicitis, pancreatitis General disorders: feeling jittery, edema lower limb, shivering, joint swelling, malaise, drug withdrawal syndrome, peripheral swelling Hepato-biliary disorders: cholelithiasis, cholecystitis Infections and infestations: cellulitis, ear infection, gastroenteritis, pneumonia, viral infection Injury and poisoning: joint sprain, muscle injury Investigations: alanine aminotransferase increased, blood pressure increased, aspartate aminotransferase increased, heart rate increased, blood glucose increased, liver function tests abnormal Musculoskeletal, connective tissue and bone disorders: muscle cramps, muscle spasms, joint stiffness, muscle twitching, myalgia, osteoarthritis aggravated Nervous system disorders: migraine, sedation, syncope, disturbance in attention, dizziness aggravated Psychiatric disorders: euphoric mood, irritability, libido decreased, sleep disorder, agitation, disorientation, abnormal dreams Renal and urinary disorders: difficulty in micturition, urinary frequency, hematuria, dysuria, urinary retention Respiratory, thoracic and mediastinal disorders: yawning Skin and subcutaneous tissue disorders: contusion, piloerection, clamminess, night sweats, urticaria Vascular disorders: hypertension aggravated, hypertension, peripheral ischemia 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of tramadol.\"\n }\n ]\n },\n {\n \"Term\": \"Diarrhoea\",\n \"MEDDRACode\": \"10012735\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Diarrhea\",\n \"Probability\": \"0.9993629456\",\n \"SemanticContext\": \"MedDRA Preferred Term Tramadol Hydrochloride Extended-Release Tablets Placebo 100 mg N=403 n % 200 mg N=400 n % 300 mg N=400 n % 400 mg N=202 n % N=406 n % Dizziness not vertigo 64 16 81 20 90 23 57 28 28 7 Nausea 61 15 90 23 102 26 53 26 32 8 Constipation 49 12 68 17 85 21 60 30 17 4 Headache 49 12 62 16 46 12 32 16 43 11 Somnolence 33 8 45 11 29 7 41 20 7 2 Flushing 31 8 40 10 35 9 32 16 18 4 Pruritus 25 6 34 9 30 8 24 12 4 1 Vomiting 20 5 29 7 34 9 19 9 11 3 Insomnia 26 7 32 8 36 9 22 11 13 3 Dry Mouth 20 5 29 7 39 10 18 9 6 2 Diarrhea 15 4 27 7 37 9 10 5 17 4 Asthenia 14 4 24 6 26 7 13 6 7 2 Postural hypotension 7 2 17 4 8 2 11 5 9 2 Sweating increased 6 2 8 2 15 4 13 6 1 0 Anorexia 3 1 7 2 21 5 12 6 1 0 .\"\n },\n {\n \"VerbatimTerm\": \"diarrhea\",\n \"Probability\": \"0.5573646426\",\n \"SemanticContext\": \"Other signs and symptoms also may develop, including irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate.\"\n },\n {\n \"VerbatimTerm\": \"diarrhea\",\n \"Probability\": \"0.9804904461\",\n \"SemanticContext\": \"Neonatal opioid withdrawal syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea, and failure to gain weight.\"\n },\n {\n \"VerbatimTerm\": \"diarrhea\",\n \"Probability\": \"0.9760729671\",\n \"SemanticContext\": \"Serotonin syndrome symptoms may include mental status changes e.g., agitation, hallucinations, coma , autonomic instability e.g., tachycardia, labile blood pressure, hyperthermia , neuromuscular aberrations e.g., hyperreflexia, incoordination, rigidity , and/or gastrointestinal symptoms e.g., nausea, vomiting, diarrhea .\"\n }\n ]\n },\n {\n \"Term\": \"Chest pain\",\n \"MEDDRACode\": \"10008479\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"chest pain\",\n \"Probability\": \"0.7824928761\",\n \"SemanticContext\": \"Eye disorders: vision blurred Gastrointestinal disorders: abdominal pain upper, dyspepsia, abdominal pain, sore throat General disorders: weakness, pain, feeling hot, influenza like illness, fall, rigors, lethargy, pyrexia, chest pain Infections and infestations: nasopharyngitis, upper respiratory tract infection, sinusitis, influenza, gastroenteritis viral, urinary tract infection, bronchitis Investigations: blood creatine phosphokinase increased, weight decreased Metabolism and nutrition disorders: appetite decreased Musculoskeletal, connective tissue and bone disorders: arthralgia, back pain, pain in limb, neck pain Nervous system disorders: tremor, paresthesia, hypoesthesia Psychiatric disorders: nervousness, anxiety, depression, restlessness Respiratory, thoracic and mediastinal disorders: sneezing, cough, rhinorrhea, nasal congestion, dyspnea, sinus congestion Skin and subcutaneous tissue disorders: sweating increased, dermatitis Vascular disorders: hot flushes, vasodilatation Adverse Reactions With Incidence Rates of 0.5% to \\n <1.0% and Serious Adverse Reactions Reported in at Least 2 patients During Clinical Trials Cardiac disorders: palpitations, myocardial infarction Ear and labyrinth disorders: tinnitus, vertigo Gastrointestinal disorders: flatulence, toothache, constipation aggravated, appendicitis, pancreatitis General disorders: feeling jittery, edema lower limb, shivering, joint swelling, malaise, drug withdrawal syndrome, peripheral swelling Hepato-biliary disorders: cholelithiasis, cholecystitis Infections and infestations: cellulitis, ear infection, gastroenteritis, pneumonia, viral infection Injury and poisoning: joint sprain, muscle injury Investigations: alanine aminotransferase increased, blood pressure increased, aspartate aminotransferase increased, heart rate increased, blood glucose increased, liver function tests abnormal Musculoskeletal, connective tissue and bone disorders: muscle cramps, muscle spasms, joint stiffness, muscle twitching, myalgia, osteoarthritis aggravated Nervous system disorders: migraine, sedation, syncope, disturbance in attention, dizziness aggravated Psychiatric disorders: euphoric mood, irritability, libido decreased, sleep disorder, agitation, disorientation, abnormal dreams Renal and urinary disorders: difficulty in micturition, urinary frequency, hematuria, dysuria, urinary retention Respiratory, thoracic and mediastinal disorders: yawning Skin and subcutaneous tissue disorders: contusion, piloerection, clamminess, night sweats, urticaria Vascular disorders: hypertension aggravated, hypertension, peripheral ischemia 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of tramadol.\"\n },\n {\n \"VerbatimTerm\": \"chest pain\",\n \"Probability\": \"0.0001679361\",\n \"SemanticContext\": \"Get emergency medical help or call 911 right away, if you have: trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue, or throat, extreme drowsiness, light-headedness when changing positions, feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion.\"\n }\n ]\n },\n {\n \"Term\": \"Urinary tract infection\",\n \"MEDDRACode\": \"10046571\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"urinary tract infection\",\n \"Probability\": \"0.9910638332\",\n \"SemanticContext\": \"Eye disorders: vision blurred Gastrointestinal disorders: abdominal pain upper, dyspepsia, abdominal pain, sore throat General disorders: weakness, pain, feeling hot, influenza like illness, fall, rigors, lethargy, pyrexia, chest pain Infections and infestations: nasopharyngitis, upper respiratory tract infection, sinusitis, influenza, gastroenteritis viral, urinary tract infection, bronchitis Investigations: blood creatine phosphokinase increased, weight decreased Metabolism and nutrition disorders: appetite decreased Musculoskeletal, connective tissue and bone disorders: arthralgia, back pain, pain in limb, neck pain Nervous system disorders: tremor, paresthesia, hypoesthesia Psychiatric disorders: nervousness, anxiety, depression, restlessness Respiratory, thoracic and mediastinal disorders: sneezing, cough, rhinorrhea, nasal congestion, dyspnea, sinus congestion Skin and subcutaneous tissue disorders: sweating increased, dermatitis Vascular disorders: hot flushes, vasodilatation Adverse Reactions With Incidence Rates of 0.5% to \\n <1.0% and Serious Adverse Reactions Reported in at Least 2 patients During Clinical Trials Cardiac disorders: palpitations, myocardial infarction Ear and labyrinth disorders: tinnitus, vertigo Gastrointestinal disorders: flatulence, toothache, constipation aggravated, appendicitis, pancreatitis General disorders: feeling jittery, edema lower limb, shivering, joint swelling, malaise, drug withdrawal syndrome, peripheral swelling Hepato-biliary disorders: cholelithiasis, cholecystitis Infections and infestations: cellulitis, ear infection, gastroenteritis, pneumonia, viral infection Injury and poisoning: joint sprain, muscle injury Investigations: alanine aminotransferase increased, blood pressure increased, aspartate aminotransferase increased, heart rate increased, blood glucose increased, liver function tests abnormal Musculoskeletal, connective tissue and bone disorders: muscle cramps, muscle spasms, joint stiffness, muscle twitching, myalgia, osteoarthritis aggravated Nervous system disorders: migraine, sedation, syncope, disturbance in attention, dizziness aggravated Psychiatric disorders: euphoric mood, irritability, libido decreased, sleep disorder, agitation, disorientation, abnormal dreams Renal and urinary disorders: difficulty in micturition, urinary frequency, hematuria, dysuria, urinary retention Respiratory, thoracic and mediastinal disorders: yawning Skin and subcutaneous tissue disorders: contusion, piloerection, clamminess, night sweats, urticaria Vascular disorders: hypertension aggravated, hypertension, peripheral ischemia 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of tramadol.\"\n }\n ]\n },\n {\n \"Term\": \"Hypoglycaemia\",\n \"MEDDRACode\": \"10020993\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Hypoglycemia\",\n \"Probability\": \"0.6134980321\",\n \"SemanticContext\": \"Hypoglycemia: Cases of hypoglycemia have been reported in patients taking tramadol.\"\n },\n {\n \"VerbatimTerm\": \"Hypoglycemia\",\n \"Probability\": \"0.67170012\",\n \"SemanticContext\": \"5.20 Hypoglycemia Cases of tramadol-associated hypoglycemia have been reported, some resulting in hospitalization.\"\n },\n {\n \"VerbatimTerm\": \"hypoglycemia\",\n \"Probability\": \"0.9356529713\",\n \"SemanticContext\": \"Hypoglycemia: Cases of hypoglycemia have been reported in patients taking tramadol.\"\n },\n {\n \"VerbatimTerm\": \"hypoglycemia\",\n \"Probability\": \"0.965051055\",\n \"SemanticContext\": \"5.20 Hypoglycemia Cases of tramadol-associated hypoglycemia have been reported, some resulting in hospitalization.\"\n },\n {\n \"VerbatimTerm\": \"hypoglycemia\",\n \"Probability\": \"0.0255595148\",\n \"SemanticContext\": \"If hypoglycemia is suspected, monitor blood glucose levels and consider drug discontinuation as appropriate [see Dosage and Administration: Safe Reduction or Discontinuation of Tram\"\n }\n ]\n },\n {\n \"Term\": \"Blood antidiuretic hormone\",\n \"MEDDRACode\": \"10005331\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"antidiuretic hormone\",\n \"Probability\": \"0.0263155699\",\n \"SemanticContext\": \"Due to the risk of respiratory depression with concomitant use of skeletal muscle relaxants and opioids, consider prescribing naloxone for the emergency treatment of opioid overdose [see Dosage and Administration 2.2 , Warnings and Precautions 5.3, 5.7 ] Diuretics Clinical Impact: Opioids can reduce the efficacy of diuretics by inducing the release of antidiuretic hormone.\"\n }\n ]\n },\n {\n \"Term\": \"Blood growth hormone\",\n \"MEDDRACode\": \"10005571\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"growth hormone\",\n \"Probability\": \"0.0034219325\",\n \"SemanticContext\": \"They also stimulate prolactin, growth hormone GH secretion, and pancreatic secretion of insulin and glucagon.\"\n }\n ]\n },\n {\n \"Term\": \"Nasopharyngitis\",\n \"MEDDRACode\": \"10028810\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"nasopharyngitis\",\n \"Probability\": \"0.9998581409\",\n \"SemanticContext\": \"Eye disorders: vision blurred Gastrointestinal disorders: abdominal pain upper, dyspepsia, abdominal pain, sore throat General disorders: weakness, pain, feeling hot, influenza like illness, fall, rigors, lethargy, pyrexia, chest pain Infections and infestations: nasopharyngitis, upper respiratory tract infection, sinusitis, influenza, gastroenteritis viral, urinary tract infection, bronchitis Investigations: blood creatine phosphokinase increased, weight decreased Metabolism and nutrition disorders: appetite decreased Musculoskeletal, connective tissue and bone disorders: arthralgia, back pain, pain in limb, neck pain Nervous system disorders: tremor, paresthesia, hypoesthesia Psychiatric disorders: nervousness, anxiety, depression, restlessness Respiratory, thoracic and mediastinal disorders: sneezing, cough, rhinorrhea, nasal congestion, dyspnea, sinus congestion Skin and subcutaneous tissue disorders: sweating increased, dermatitis Vascular disorders: hot flushes, vasodilatation Adverse Reactions With Incidence Rates of 0.5% to \\n <1.0% and Serious Adverse Reactions Reported in at Least 2 patients During Clinical Trials Cardiac disorders: palpitations, myocardial infarction Ear and labyrinth disorders: tinnitus, vertigo Gastrointestinal disorders: flatulence, toothache, constipation aggravated, appendicitis, pancreatitis General disorders: feeling jittery, edema lower limb, shivering, joint swelling, malaise, drug withdrawal syndrome, peripheral swelling Hepato-biliary disorders: cholelithiasis, cholecystitis Infections and infestations: cellulitis, ear infection, gastroenteritis, pneumonia, viral infection Injury and poisoning: joint sprain, muscle injury Investigations: alanine aminotransferase increased, blood pressure increased, aspartate aminotransferase increased, heart rate increased, blood glucose increased, liver function tests abnormal Musculoskeletal, connective tissue and bone disorders: muscle cramps, muscle spasms, joint stiffness, muscle twitching, myalgia, osteoarthritis aggravated Nervous system disorders: migraine, sedation, syncope, disturbance in attention, dizziness aggravated Psychiatric disorders: euphoric mood, irritability, libido decreased, sleep disorder, agitation, disorientation, abnormal dreams Renal and urinary disorders: difficulty in micturition, urinary frequency, hematuria, dysuria, urinary retention Respiratory, thoracic and mediastinal disorders: yawning Skin and subcutaneous tissue disorders: contusion, piloerection, clamminess, night sweats, urticaria Vascular disorders: hypertension aggravated, hypertension, peripheral ischemia 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of tramadol.\"\n }\n ]\n },\n {\n \"Term\": \"Sneezing\",\n \"MEDDRACode\": \"10041232\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"sneezing\",\n \"Probability\": \"0.9989341497\",\n \"SemanticContext\": \"Eye disorders: vision blurred Gastrointestinal disorders: abdominal pain upper, dyspepsia, abdominal pain, sore throat General disorders: weakness, pain, feeling hot, influenza like illness, fall, rigors, lethargy, pyrexia, chest pain Infections and infestations: nasopharyngitis, upper respiratory tract infection, sinusitis, influenza, gastroenteritis viral, urinary tract infection, bronchitis Investigations: blood creatine phosphokinase increased, weight decreased Metabolism and nutrition disorders: appetite decreased Musculoskeletal, connective tissue and bone disorders: arthralgia, back pain, pain in limb, neck pain Nervous system disorders: tremor, paresthesia, hypoesthesia Psychiatric disorders: nervousness, anxiety, depression, restlessness Respiratory, thoracic and mediastinal disorders: sneezing, cough, rhinorrhea, nasal congestion, dyspnea, sinus congestion Skin and subcutaneous tissue disorders: sweating increased, dermatitis Vascular disorders: hot flushes, vasodilatation Adverse Reactions With Incidence Rates of 0.5% to \\n <1.0% and Serious Adverse Reactions Reported in at Least 2 patients During Clinical Trials Cardiac disorders: palpitations, myocardial infarction Ear and labyrinth disorders: tinnitus, vertigo Gastrointestinal disorders: flatulence, toothache, constipation aggravated, appendicitis, pancreatitis General disorders: feeling jittery, edema lower limb, shivering, joint swelling, malaise, drug withdrawal syndrome, peripheral swelling Hepato-biliary disorders: cholelithiasis, cholecystitis Infections and infestations: cellulitis, ear infection, gastroenteritis, pneumonia, viral infection Injury and poisoning: joint sprain, muscle injury Investigations: alanine aminotransferase increased, blood pressure increased, aspartate aminotransferase increased, heart rate increased, blood glucose increased, liver function tests abnormal Musculoskeletal, connective tissue and bone disorders: muscle cramps, muscle spasms, joint stiffness, muscle twitching, myalgia, osteoarthritis aggravated Nervous system disorders: migraine, sedation, syncope, disturbance in attention, dizziness aggravated Psychiatric disorders: euphoric mood, irritability, libido decreased, sleep disorder, agitation, disorientation, abnormal dreams Renal and urinary disorders: difficulty in micturition, urinary frequency, hematuria, dysuria, urinary retention Respiratory, thoracic and mediastinal disorders: yawning Skin and subcutaneous tissue disorders: contusion, piloerection, clamminess, night sweats, urticaria Vascular disorders: hypertension aggravated, hypertension, peripheral ischemia 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of tramadol.\"\n }\n ]\n },\n {\n \"Term\": \"Hyperhidrosis\",\n \"MEDDRACode\": \"10020642\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"sweating\",\n \"Probability\": \"0.1556983888\",\n \"SemanticContext\": \"Apart from analgesia, tramadol administration may produce a constellation of symptoms including dizziness, somnolence, nausea, constipation, sweating and pruritus similar to that of other opioids.\"\n },\n {\n \"VerbatimTerm\": \"sweating\",\n \"Probability\": \"0.6945566535\",\n \"SemanticContext\": \"Manifestations of histamine release and/or peripheral vasodilation may include pruritus, flushing, red eyes, sweating, and/or orthostatic hypotension.\"\n }\n ]\n },\n {\n \"Term\": \"Hypokalaemia\",\n \"MEDDRACode\": \"10021015\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hypokalemia\",\n \"Probability\": \"0.100443095\",\n \"SemanticContext\": \"Many of these cases were reported in patients taking another drug labeled for QT prolongation, in patients with a risk factor for QT prolongation e.g., hypokalemia , or in overdose setting.\"\n }\n ]\n },\n {\n \"Term\": \"Diabetes mellitus\",\n \"MEDDRACode\": \"10012601\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"diabetes\",\n \"Probability\": \"0.2356590927\",\n \"SemanticContext\": \"Most reports were in patients with predisposing risk factors, including diabetes or renal insufficiency, or in elderly patients [see Warnings and Precautions 5.20 ] .\"\n },\n {\n \"VerbatimTerm\": \"diabetes\",\n \"Probability\": \"0.0752805471\",\n \"SemanticContext\": \"In most cases, patients had predisposing risk factors e.g. diabetes .\"\n }\n ]\n },\n {\n \"Term\": \"Drug tolerance increased\",\n \"MEDDRACode\": \"10052806\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"increased tolerance\",\n \"Probability\": \"0.0927634835\",\n \"SemanticContext\": \"Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that develop after repeated substance use and includes: a strong desire to take the drug, difficulties in controlling its use, persisting in its use despite harmful consequences, a higher priority given to drug use than to other activities and obligations, increased tolerance, and sometimes a physical withdrawal.\"\n },\n {\n \"VerbatimTerm\": \"increased tolerance\",\n \"Probability\": \"0.0927634835\",\n \"SemanticContext\": \"Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that develop after repeated substance use and includes: a strong desire to take the drug, difficulties in controlling its use, persisting in its use despite harmful consequences, a higher priority given to drug use than to other activities and obligations, increased tolerance, and sometimes a physical withdrawal.\"\n }\n ]\n },\n {\n \"Term\": \"Gastroenteritis\",\n \"MEDDRACode\": \"10017888\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"gastroenteritis\",\n \"Probability\": \"0.8872926831\",\n \"SemanticContext\": \"Eye disorders: vision blurred Gastrointestinal disorders: abdominal pain upper, dyspepsia, abdominal pain, sore throat General disorders: weakness, pain, feeling hot, influenza like illness, fall, rigors, lethargy, pyrexia, chest pain Infections and infestations: nasopharyngitis, upper respiratory tract infection, sinusitis, influenza, gastroenteritis viral, urinary tract infection, bronchitis Investigations: blood creatine phosphokinase increased, weight decreased Metabolism and nutrition disorders: appetite decreased Musculoskeletal, connective tissue and bone disorders: arthralgia, back pain, pain in limb, neck pain Nervous system disorders: tremor, paresthesia, hypoesthesia Psychiatric disorders: nervousness, anxiety, depression, restlessness Respiratory, thoracic and mediastinal disorders: sneezing, cough, rhinorrhea, nasal congestion, dyspnea, sinus congestion Skin and subcutaneous tissue disorders: sweating increased, dermatitis Vascular disorders: hot flushes, vasodilatation Adverse Reactions With Incidence Rates of 0.5% to \\n <1.0% and Serious Adverse Reactions Reported in at Least 2 patients During Clinical Trials Cardiac disorders: palpitations, myocardial infarction Ear and labyrinth disorders: tinnitus, vertigo Gastrointestinal disorders: flatulence, toothache, constipation aggravated, appendicitis, pancreatitis General disorders: feeling jittery, edema lower limb, shivering, joint swelling, malaise, drug withdrawal syndrome, peripheral swelling Hepato-biliary disorders: cholelithiasis, cholecystitis Infections and infestations: cellulitis, ear infection, gastroenteritis, pneumonia, viral infection Injury and poisoning: joint sprain, muscle injury Investigations: alanine aminotransferase increased, blood pressure increased, aspartate aminotransferase increased, heart rate increased, blood glucose increased, liver function tests abnormal Musculoskeletal, connective tissue and bone disorders: muscle cramps, muscle spasms, joint stiffness, muscle twitching, myalgia, osteoarthritis aggravated Nervous system disorders: migraine, sedation, syncope, disturbance in attention, dizziness aggravated Psychiatric disorders: euphoric mood, irritability, libido decreased, sleep disorder, agitation, disorientation, abnormal dreams Renal and urinary disorders: difficulty in micturition, urinary frequency, hematuria, dysuria, urinary retention Respiratory, thoracic and mediastinal disorders: yawning Skin and subcutaneous tissue disorders: contusion, piloerection, clamminess, night sweats, urticaria Vascular disorders: hypertension aggravated, hypertension, peripheral ischemia 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of tramadol.\"\n }\n ]\n },\n {\n \"Term\": \"Vertigo\",\n \"MEDDRACode\": \"10047340\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"vertigo\",\n \"Probability\": \"0.9982892275\",\n \"SemanticContext\": \"The most common adverse reactions from Table 1 occurring in =10% and =2 x placebo rate of the patients treated with tramadol hydrochloride extended-release tablets are dizziness not vertigo , nausea, constipation, headache, somnolence, flushing, pruritus, vomiting, insomnia, and dry mouth.\"\n },\n {\n \"VerbatimTerm\": \"vertigo\",\n \"Probability\": \"0.9986659288\",\n \"SemanticContext\": \"MedDRA Preferred Term Tramadol Hydrochloride Extended-Release Tablets Placebo 100 mg N=403 n % 200 mg N=400 n % 300 mg N=400 n % 400 mg N=202 n % N=406 n % Dizziness not vertigo 64 16 81 20 90 23 57 28 28 7 Nausea 61 15 90 23 102 26 53 26 32 8 Constipation 49 12 68 17 85 21 60 30 17 4 Headache 49 12 62 16 46 12 32 16 43 11 Somnolence 33 8 45 11 29 7 41 20 7 2 Flushing 31 8 40 10 35 9 32 16 18 4 Pruritus 25 6 34 9 30 8 24 12 4 1 Vomiting 20 5 29 7 34 9 19 9 11 3 Insomnia 26 7 32 8 36 9 22 11 13 3 Dry Mouth 20 5 29 7 39 10 18 9 6 2 Diarrhea 15 4 27 7 37 9 10 5 17 4 Asthenia 14 4 24 6 26 7 13 6 7 2 Postural hypotension 7 2 17 4 8 2 11 5 9 2 Sweating increased 6 2 8 2 15 4 13 6 1 0 Anorexia 3 1 7 2 21 5 12 6 1 0 .\"\n },\n {\n \"VerbatimTerm\": \"vertigo\",\n \"Probability\": \"0.9931923151\",\n \"SemanticContext\": \"Eye disorders: vision blurred Gastrointestinal disorders: abdominal pain upper, dyspepsia, abdominal pain, sore throat General disorders: weakness, pain, feeling hot, influenza like illness, fall, rigors, lethargy, pyrexia, chest pain Infections and infestations: nasopharyngitis, upper respiratory tract infection, sinusitis, influenza, gastroenteritis viral, urinary tract infection, bronchitis Investigations: blood creatine phosphokinase increased, weight decreased Metabolism and nutrition disorders: appetite decreased Musculoskeletal, connective tissue and bone disorders: arthralgia, back pain, pain in limb, neck pain Nervous system disorders: tremor, paresthesia, hypoesthesia Psychiatric disorders: nervousness, anxiety, depression, restlessness Respiratory, thoracic and mediastinal disorders: sneezing, cough, rhinorrhea, nasal congestion, dyspnea, sinus congestion Skin and subcutaneous tissue disorders: sweating increased, dermatitis Vascular disorders: hot flushes, vasodilatation Adverse Reactions With Incidence Rates of 0.5% to \\n <1.0% and Serious Adverse Reactions Reported in at Least 2 patients During Clinical Trials Cardiac disorders: palpitations, myocardial infarction Ear and labyrinth disorders: tinnitus, vertigo Gastrointestinal disorders: flatulence, toothache, constipation aggravated, appendicitis, pancreatitis General disorders: feeling jittery, edema lower limb, shivering, joint swelling, malaise, drug withdrawal syndrome, peripheral swelling Hepato-biliary disorders: cholelithiasis, cholecystitis Infections and infestations: cellulitis, ear infection, gastroenteritis, pneumonia, viral infection Injury and poisoning: joint sprain, muscle injury Investigations: alanine aminotransferase increased, blood pressure increased, aspartate aminotransferase increased, heart rate increased, blood glucose increased, liver function tests abnormal Musculoskeletal, connective tissue and bone disorders: muscle cramps, muscle spasms, joint stiffness, muscle twitching, myalgia, osteoarthritis aggravated Nervous system disorders: migraine, sedation, syncope, disturbance in attention, dizziness aggravated Psychiatric disorders: euphoric mood, irritability, libido decreased, sleep disorder, agitation, disorientation, abnormal dreams Renal and urinary disorders: difficulty in micturition, urinary frequency, hematuria, dysuria, urinary retention Respiratory, thoracic and mediastinal disorders: yawning Skin and subcutaneous tissue disorders: contusion, piloerection, clamminess, night sweats, urticaria Vascular disorders: hypertension aggravated, hypertension, peripheral ischemia 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of tramadol.\"\n }\n ]\n },\n {\n \"Term\": \"Orthostatic hypotension\",\n \"MEDDRACode\": \"10031127\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": true\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Orthostatic hypotension\",\n \"Probability\": \"0.7812080383\",\n \"SemanticContext\": \"Orthostatic hypotension has been observed.\"\n },\n {\n \"VerbatimTerm\": \"orthostatic hypotension\",\n \"Probability\": \"0.9730084538\",\n \"SemanticContext\": \"Effects on the Cardiovascular System Tramadol produces peripheral vasodilation, which may result in orthostatic hypotension or syncope.\"\n },\n {\n \"VerbatimTerm\": \"orthostatic hypotension\",\n \"Probability\": \"0.5586087704\",\n \"SemanticContext\": \"Manifestations of histamine release and/or peripheral vasodilation may include pruritus, flushing, red eyes, sweating, and/or orthostatic hypotension.\"\n },\n {\n \"VerbatimTerm\": \"orthostatic hypotension\",\n \"Probability\": \"0.8150483966\",\n \"SemanticContext\": \"Hypotension Inform patients that tramadol hydrochloride extended-release tablets may cause orthostatic hypotension and syncope.\"\n },\n {\n \"VerbatimTerm\": \"orthostatic hypotension\",\n \"Probability\": \"0.9930921197\",\n \"SemanticContext\": \"5.13 Severe Hypotension Tramadol hydrochloride extended-release tablets may cause severe hypotension including orthostatic hypotension and syncope in ambulatory patients.\"\n }\n ]\n },\n {\n \"Term\": \"Arthralgia\",\n \"MEDDRACode\": \"10003239\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"joint pain\",\n \"Probability\": \"0.7846921682\",\n \"SemanticContext\": \"Other signs and symptoms also may develop, including irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate.\"\n }\n ]\n },\n {\n \"Term\": \"Abdominal pain\",\n \"MEDDRACode\": \"10000081\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"abdominal cramps\",\n \"Probability\": \"0.4466865361\",\n \"SemanticContext\": \"Other signs and symptoms also may develop, including irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate.\"\n }\n ]\n },\n {\n \"Term\": \"Ocular hyperaemia\",\n \"MEDDRACode\": \"10030041\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"red eyes\",\n \"Probability\": \"0.5497479439\",\n \"SemanticContext\": \"Manifestations of histamine release and/or peripheral vasodilation may include pruritus, flushing, red eyes, sweating, and/or orthostatic hypotension.\"\n }\n ]\n },\n {\n \"Term\": \"Renal impairment\",\n \"MEDDRACode\": \"10062237\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": true\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Renal Impairment\",\n \"Probability\": \"0.2109543085\",\n \"SemanticContext\": \"Severe Hepatic or Renal Impairment: Use not recommended.\"\n },\n {\n \"VerbatimTerm\": \"Renal Impairment\",\n \"Probability\": \"0.1587170362\",\n \"SemanticContext\": \"Renal Impairment Impaired renal function results in a decreased rate and extent of excretion of tramadol and its active metabolite, M1.\"\n },\n {\n \"VerbatimTerm\": \"renal impairment\",\n \"Probability\": \"4.57479E-05\",\n \"SemanticContext\": \"The pharmacokinetics of tramadol were studied in patients with mild or moderate renal impairment after receiving multiple doses of tramadol hydrochloride extended-release tablets 100 mg.\"\n },\n {\n \"VerbatimTerm\": \"renal impairment\",\n \"Probability\": \"0.0350230336\",\n \"SemanticContext\": \"There is no consistent trend observed for tramadol exposure related to renal function in patients with mild CL cr : 50 to 80 mL/min or moderate CL cr : 30 to 50 mL/min renal impairment in comparison to patients with normal renal function.\"\n },\n {\n \"VerbatimTerm\": \"renal impairment\",\n \"Probability\": \"0.5460555553\",\n \"SemanticContext\": \"However, exposure of M1 increased 20 to 40% with increased severity of the renal impairment from normal to mild and moderate .\"\n },\n {\n \"VerbatimTerm\": \"renal impairment\",\n \"Probability\": \"9.90959E-05\",\n \"SemanticContext\": \"Tramadol hydrochloride extended-release tablets have not been studied in patients with severe renal impairment CL cr < 30 mL/min .\"\n }\n ]\n },\n {\n \"Term\": \"Upper respiratory tract infection\",\n \"MEDDRACode\": \"10046306\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"upper respiratory tract infection\",\n \"Probability\": \"0.9984213114\",\n \"SemanticContext\": \"Eye disorders: vision blurred Gastrointestinal disorders: abdominal pain upper, dyspepsia, abdominal pain, sore throat General disorders: weakness, pain, feeling hot, influenza like illness, fall, rigors, lethargy, pyrexia, chest pain Infections and infestations: nasopharyngitis, upper respiratory tract infection, sinusitis, influenza, gastroenteritis viral, urinary tract infection, bronchitis Investigations: blood creatine phosphokinase increased, weight decreased Metabolism and nutrition disorders: appetite decreased Musculoskeletal, connective tissue and bone disorders: arthralgia, back pain, pain in limb, neck pain Nervous system disorders: tremor, paresthesia, hypoesthesia Psychiatric disorders: nervousness, anxiety, depression, restlessness Respiratory, thoracic and mediastinal disorders: sneezing, cough, rhinorrhea, nasal congestion, dyspnea, sinus congestion Skin and subcutaneous tissue disorders: sweating increased, dermatitis Vascular disorders: hot flushes, vasodilatation Adverse Reactions With Incidence Rates of 0.5% to \\n <1.0% and Serious Adverse Reactions Reported in at Least 2 patients During Clinical Trials Cardiac disorders: palpitations, myocardial infarction Ear and labyrinth disorders: tinnitus, vertigo Gastrointestinal disorders: flatulence, toothache, constipation aggravated, appendicitis, pancreatitis General disorders: feeling jittery, edema lower limb, shivering, joint swelling, malaise, drug withdrawal syndrome, peripheral swelling Hepato-biliary disorders: cholelithiasis, cholecystitis Infections and infestations: cellulitis, ear infection, gastroenteritis, pneumonia, viral infection Injury and poisoning: joint sprain, muscle injury Investigations: alanine aminotransferase increased, blood pressure increased, aspartate aminotransferase increased, heart rate increased, blood glucose increased, liver function tests abnormal Musculoskeletal, connective tissue and bone disorders: muscle cramps, muscle spasms, joint stiffness, muscle twitching, myalgia, osteoarthritis aggravated Nervous system disorders: migraine, sedation, syncope, disturbance in attention, dizziness aggravated Psychiatric disorders: euphoric mood, irritability, libido decreased, sleep disorder, agitation, disorientation, abnormal dreams Renal and urinary disorders: difficulty in micturition, urinary frequency, hematuria, dysuria, urinary retention Respiratory, thoracic and mediastinal disorders: yawning Skin and subcutaneous tissue disorders: contusion, piloerection, clamminess, night sweats, urticaria Vascular disorders: hypertension aggravated, hypertension, peripheral ischemia 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of tramadol.\"\n }\n ]\n },\n {\n \"Term\": \"Miosis\",\n \"MEDDRACode\": \"10027646\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Pinpoint pupils\",\n \"Probability\": \"0.0175435543\",\n \"SemanticContext\": \"Pinpoint pupils are a sign of opioid overdose but are not pathognomonic e.g., pontine lesions of hemorrhagic or ischemic origins may produce similar findings .\"\n }\n ]\n },\n {\n \"Term\": \"Muscle spasms\",\n \"MEDDRACode\": \"10028334\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"spasm\",\n \"Probability\": \"0.9758866429\",\n \"SemanticContext\": \"Propulsive peristaltic waves in the colon are decreased, while tone may be increased to the point of spasm, resulting in constipation.\"\n },\n {\n \"VerbatimTerm\": \"spasm\",\n \"Probability\": \"0.2483043075\",\n \"SemanticContext\": \"The tramadol in tramadol hydrochloride extended-release tablets may cause spasm of the sphincter of Oddi.\"\n }\n ]\n },\n {\n \"Term\": \"Breakthrough pain\",\n \"MEDDRACode\": \"10064556\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"breakthrough pain\",\n \"Probability\": \"0.004686147\",\n \"SemanticContext\": \"Patients who experience breakthrough pain may require a dosage adjustment of tramadol hydrochloride extended-release tablets, or may need rescue medication with an appropriate dose of an immediate-release analgesic.\"\n }\n ]\n },\n {\n \"Term\": \"Lacrimation increased\",\n \"MEDDRACode\": \"10023644\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"lacrimation\",\n \"Probability\": \"0.9935921431\",\n \"SemanticContext\": \"Common withdrawal symptoms include restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia, and mydriasis.\"\n }\n ]\n },\n {\n \"Term\": \"Weight decreased\",\n \"MEDDRACode\": \"10047895\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"weight decreased\",\n \"Probability\": \"0.9834747314\",\n \"SemanticContext\": \"Eye disorders: vision blurred Gastrointestinal disorders: abdominal pain upper, dyspepsia, abdominal pain, sore throat General disorders: weakness, pain, feeling hot, influenza like illness, fall, rigors, lethargy, pyrexia, chest pain Infections and infestations: nasopharyngitis, upper respiratory tract infection, sinusitis, influenza, gastroenteritis viral, urinary tract infection, bronchitis Investigations: blood creatine phosphokinase increased, weight decreased Metabolism and nutrition disorders: appetite decreased Musculoskeletal, connective tissue and bone disorders: arthralgia, back pain, pain in limb, neck pain Nervous system disorders: tremor, paresthesia, hypoesthesia Psychiatric disorders: nervousness, anxiety, depression, restlessness Respiratory, thoracic and mediastinal disorders: sneezing, cough, rhinorrhea, nasal congestion, dyspnea, sinus congestion Skin and subcutaneous tissue disorders: sweating increased, dermatitis Vascular disorders: hot flushes, vasodilatation Adverse Reactions With Incidence Rates of 0.5% to \\n <1.0% and Serious Adverse Reactions Reported in at Least 2 patients During Clinical Trials Cardiac disorders: palpitations, myocardial infarction Ear and labyrinth disorders: tinnitus, vertigo Gastrointestinal disorders: flatulence, toothache, constipation aggravated, appendicitis, pancreatitis General disorders: feeling jittery, edema lower limb, shivering, joint swelling, malaise, drug withdrawal syndrome, peripheral swelling Hepato-biliary disorders: cholelithiasis, cholecystitis Infections and infestations: cellulitis, ear infection, gastroenteritis, pneumonia, viral infection Injury and poisoning: joint sprain, muscle injury Investigations: alanine aminotransferase increased, blood pressure increased, aspartate aminotransferase increased, heart rate increased, blood glucose increased, liver function tests abnormal Musculoskeletal, connective tissue and bone disorders: muscle cramps, muscle spasms, joint stiffness, muscle twitching, myalgia, osteoarthritis aggravated Nervous system disorders: migraine, sedation, syncope, disturbance in attention, dizziness aggravated Psychiatric disorders: euphoric mood, irritability, libido decreased, sleep disorder, agitation, disorientation, abnormal dreams Renal and urinary disorders: difficulty in micturition, urinary frequency, hematuria, dysuria, urinary retention Respiratory, thoracic and mediastinal disorders: yawning Skin and subcutaneous tissue disorders: contusion, piloerection, clamminess, night sweats, urticaria Vascular disorders: hypertension aggravated, hypertension, peripheral ischemia 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of tramadol.\"\n },\n {\n \"VerbatimTerm\": \"decreased weights\",\n \"Probability\": \"0.0550216436\",\n \"SemanticContext\": \"Progeny of dams receiving oral gavage dose levels of 50 mg/kg 1.6 times the MRHD or greater had decreased weights, and pup survival was decreased early in lactation at 80 mg/kg 2.6 times the MRHD .\"\n }\n ]\n },\n {\n \"Term\": \"Joint swelling\",\n \"MEDDRACode\": \"10023232\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"joint swelling\",\n \"Probability\": \"0.988222003\",\n \"SemanticContext\": \"Eye disorders: vision blurred Gastrointestinal disorders: abdominal pain upper, dyspepsia, abdominal pain, sore throat General disorders: weakness, pain, feeling hot, influenza like illness, fall, rigors, lethargy, pyrexia, chest pain Infections and infestations: nasopharyngitis, upper respiratory tract infection, sinusitis, influenza, gastroenteritis viral, urinary tract infection, bronchitis Investigations: blood creatine phosphokinase increased, weight decreased Metabolism and nutrition disorders: appetite decreased Musculoskeletal, connective tissue and bone disorders: arthralgia, back pain, pain in limb, neck pain Nervous system disorders: tremor, paresthesia, hypoesthesia Psychiatric disorders: nervousness, anxiety, depression, restlessness Respiratory, thoracic and mediastinal disorders: sneezing, cough, rhinorrhea, nasal congestion, dyspnea, sinus congestion Skin and subcutaneous tissue disorders: sweating increased, dermatitis Vascular disorders: hot flushes, vasodilatation Adverse Reactions With Incidence Rates of 0.5% to \\n <1.0% and Serious Adverse Reactions Reported in at Least 2 patients During Clinical Trials Cardiac disorders: palpitations, myocardial infarction Ear and labyrinth disorders: tinnitus, vertigo Gastrointestinal disorders: flatulence, toothache, constipation aggravated, appendicitis, pancreatitis General disorders: feeling jittery, edema lower limb, shivering, joint swelling, malaise, drug withdrawal syndrome, peripheral swelling Hepato-biliary disorders: cholelithiasis, cholecystitis Infections and infestations: cellulitis, ear infection, gastroenteritis, pneumonia, viral infection Injury and poisoning: joint sprain, muscle injury Investigations: alanine aminotransferase increased, blood pressure increased, aspartate aminotransferase increased, heart rate increased, blood glucose increased, liver function tests abnormal Musculoskeletal, connective tissue and bone disorders: muscle cramps, muscle spasms, joint stiffness, muscle twitching, myalgia, osteoarthritis aggravated Nervous system disorders: migraine, sedation, syncope, disturbance in attention, dizziness aggravated Psychiatric disorders: euphoric mood, irritability, libido decreased, sleep disorder, agitation, disorientation, abnormal dreams Renal and urinary disorders: difficulty in micturition, urinary frequency, hematuria, dysuria, urinary retention Respiratory, thoracic and mediastinal disorders: yawning Skin and subcutaneous tissue disorders: contusion, piloerection, clamminess, night sweats, urticaria Vascular disorders: hypertension aggravated, hypertension, peripheral ischemia 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of tramadol.\"\n }\n ]\n },\n {\n \"Term\": \"Weight\",\n \"MEDDRACode\": \"10047890\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"weight\",\n \"Probability\": \"0.0008178353\",\n \"SemanticContext\": \"Its structural formula is: The molecular weight of tramadol hydrochloride is 299.84.\"\n },\n {\n \"VerbatimTerm\": \"weight\",\n \"Probability\": \"0.0120092332\",\n \"SemanticContext\": \"Tramadol decreased pup body weight and increased pup mortality at 1.2 and 1.9 times the MRHD [see Data].\"\n },\n {\n \"VerbatimTerm\": \"weights\",\n \"Probability\": \"0.0003040135\",\n \"SemanticContext\": \"In animal reproduction studies, tramadol administration during organogenesis decreased fetal weights and reduced ossification in mice, rats, and rabbits at 1.4, 0.6, and 3.6 times the maximum recommended human daily dosage MRHD .\"\n },\n {\n \"VerbatimTerm\": \"weights\",\n \"Probability\": \"0.0655753911\",\n \"SemanticContext\": \"Embryo and fetal toxicity consisted primarily of decreased fetal weights, decreased skeletal ossification, and increased supernumerary ribs at maternally toxic dose levels.\"\n }\n ]\n },\n {\n \"Term\": \"Hepatic function abnormal\",\n \"MEDDRACode\": \"10019670\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Hepatic Impairment\",\n \"Probability\": \"0.0407406986\",\n \"SemanticContext\": \"Special Populations Hepatic Impairment Pharmacokinetics of tramadol was studied in patients with mild or moderate hepatic impairment after receiving multiple doses of tramadol hydrochloride extended-release tablets 100 mg.\"\n },\n {\n \"VerbatimTerm\": \"hepatic impairment\",\n \"Probability\": \"0.0014401078\",\n \"SemanticContext\": \"Special Populations Hepatic Impairment Pharmacokinetics of tramadol was studied in patients with mild or moderate hepatic impairment after receiving multiple doses of tramadol hydrochloride extended-release tablets 100 mg.\"\n },\n {\n \"VerbatimTerm\": \"hepatic impairment\",\n \"Probability\": \"0.1714379787\",\n \"SemanticContext\": \"The exposure of + - and - -tramadol was similar in mild and moderate hepatic impairment patients in comparison to patients with normal hepatic function.\"\n },\n {\n \"VerbatimTerm\": \"hepatic impairment\",\n \"Probability\": \"0.7743471265\",\n \"SemanticContext\": \"However, exposure of active metabolite + - and - -M1 decreased ~50% with increased severity of the hepatic impairment from normal to mild and moderate .\"\n },\n {\n \"VerbatimTerm\": \"hepatic impairment\",\n \"Probability\": \"0.0011584461\",\n \"SemanticContext\": \"The pharmacokinetics of tramadol after the administration of tramadol hydrochloride extended-release tablets has not been studied in patients with severe hepatic impairment Child-Pugh Class C .\"\n }\n ]\n },\n {\n \"Term\": \"Pneumonia\",\n \"MEDDRACode\": \"10035664\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"pneumonia\",\n \"Probability\": \"0.9520287514\",\n \"SemanticContext\": \"Eye disorders: vision blurred Gastrointestinal disorders: abdominal pain upper, dyspepsia, abdominal pain, sore throat General disorders: weakness, pain, feeling hot, influenza like illness, fall, rigors, lethargy, pyrexia, chest pain Infections and infestations: nasopharyngitis, upper respiratory tract infection, sinusitis, influenza, gastroenteritis viral, urinary tract infection, bronchitis Investigations: blood creatine phosphokinase increased, weight decreased Metabolism and nutrition disorders: appetite decreased Musculoskeletal, connective tissue and bone disorders: arthralgia, back pain, pain in limb, neck pain Nervous system disorders: tremor, paresthesia, hypoesthesia Psychiatric disorders: nervousness, anxiety, depression, restlessness Respiratory, thoracic and mediastinal disorders: sneezing, cough, rhinorrhea, nasal congestion, dyspnea, sinus congestion Skin and subcutaneous tissue disorders: sweating increased, dermatitis Vascular disorders: hot flushes, vasodilatation Adverse Reactions With Incidence Rates of 0.5% to \\n <1.0% and Serious Adverse Reactions Reported in at Least 2 patients During Clinical Trials Cardiac disorders: palpitations, myocardial infarction Ear and labyrinth disorders: tinnitus, vertigo Gastrointestinal disorders: flatulence, toothache, constipation aggravated, appendicitis, pancreatitis General disorders: feeling jittery, edema lower limb, shivering, joint swelling, malaise, drug withdrawal syndrome, peripheral swelling Hepato-biliary disorders: cholelithiasis, cholecystitis Infections and infestations: cellulitis, ear infection, gastroenteritis, pneumonia, viral infection Injury and poisoning: joint sprain, muscle injury Investigations: alanine aminotransferase increased, blood pressure increased, aspartate aminotransferase increased, heart rate increased, blood glucose increased, liver function tests abnormal Musculoskeletal, connective tissue and bone disorders: muscle cramps, muscle spasms, joint stiffness, muscle twitching, myalgia, osteoarthritis aggravated Nervous system disorders: migraine, sedation, syncope, disturbance in attention, dizziness aggravated Psychiatric disorders: euphoric mood, irritability, libido decreased, sleep disorder, agitation, disorientation, abnormal dreams Renal and urinary disorders: difficulty in micturition, urinary frequency, hematuria, dysuria, urinary retention Respiratory, thoracic and mediastinal disorders: yawning Skin and subcutaneous tissue disorders: contusion, piloerection, clamminess, night sweats, urticaria Vascular disorders: hypertension aggravated, hypertension, peripheral ischemia 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of tramadol.\"\n }\n ]\n },\n {\n \"Term\": \"Viral infection\",\n \"MEDDRACode\": \"10047461\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"viral infection\",\n \"Probability\": \"0.8025641441\",\n \"SemanticContext\": \"Eye disorders: vision blurred Gastrointestinal disorders: abdominal pain upper, dyspepsia, abdominal pain, sore throat General disorders: weakness, pain, feeling hot, influenza like illness, fall, rigors, lethargy, pyrexia, chest pain Infections and infestations: nasopharyngitis, upper respiratory tract infection, sinusitis, influenza, gastroenteritis viral, urinary tract infection, bronchitis Investigations: blood creatine phosphokinase increased, weight decreased Metabolism and nutrition disorders: appetite decreased Musculoskeletal, connective tissue and bone disorders: arthralgia, back pain, pain in limb, neck pain Nervous system disorders: tremor, paresthesia, hypoesthesia Psychiatric disorders: nervousness, anxiety, depression, restlessness Respiratory, thoracic and mediastinal disorders: sneezing, cough, rhinorrhea, nasal congestion, dyspnea, sinus congestion Skin and subcutaneous tissue disorders: sweating increased, dermatitis Vascular disorders: hot flushes, vasodilatation Adverse Reactions With Incidence Rates of 0.5% to \\n <1.0% and Serious Adverse Reactions Reported in at Least 2 patients During Clinical Trials Cardiac disorders: palpitations, myocardial infarction Ear and labyrinth disorders: tinnitus, vertigo Gastrointestinal disorders: flatulence, toothache, constipation aggravated, appendicitis, pancreatitis General disorders: feeling jittery, edema lower limb, shivering, joint swelling, malaise, drug withdrawal syndrome, peripheral swelling Hepato-biliary disorders: cholelithiasis, cholecystitis Infections and infestations: cellulitis, ear infection, gastroenteritis, pneumonia, viral infection Injury and poisoning: joint sprain, muscle injury Investigations: alanine aminotransferase increased, blood pressure increased, aspartate aminotransferase increased, heart rate increased, blood glucose increased, liver function tests abnormal Musculoskeletal, connective tissue and bone disorders: muscle cramps, muscle spasms, joint stiffness, muscle twitching, myalgia, osteoarthritis aggravated Nervous system disorders: migraine, sedation, syncope, disturbance in attention, dizziness aggravated Psychiatric disorders: euphoric mood, irritability, libido decreased, sleep disorder, agitation, disorientation, abnormal dreams Renal and urinary disorders: difficulty in micturition, urinary frequency, hematuria, dysuria, urinary retention Respiratory, thoracic and mediastinal disorders: yawning Skin and subcutaneous tissue disorders: contusion, piloerection, clamminess, night sweats, urticaria Vascular disorders: hypertension aggravated, hypertension, peripheral ischemia 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of tramadol.\"\n }\n ]\n },\n {\n \"Term\": \"Osteoarthritis\",\n \"MEDDRACode\": \"10031161\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"osteoarthritis\",\n \"Probability\": \"0.0019125342\",\n \"SemanticContext\": \"These included four double-blind studies in patients with osteoarthritis and/or chronic low back pain and one open-label study in patients with chronic non-malignant pain.\"\n },\n {\n \"VerbatimTerm\": \"osteoarthritis\",\n \"Probability\": \"0.0233204961\",\n \"SemanticContext\": \"tramadol-figure1 tramadol-figure2 14 CLINICAL STUDIES Clinical Trial Experience Tramadol hydrochloride extended-release tablets were studied in patients with chronic, moderate to moderately severe pain due to osteoarthritis and/or low back pain in four 12-week, randomized, double-blind, placebo-controlled trials.\"\n },\n {\n \"VerbatimTerm\": \"osteoarthritis\",\n \"Probability\": \"0.0284595191\",\n \"SemanticContext\": \"Adequate evidence of efficacy was demonstrated in the following two studies: Study 1 : Osteoarthritis of the Knee and/or Hip In one 12-week randomized, double-blind, placebo-controlled study, patients with moderate to moderately severe pain due to osteoarthritis of the knee and/or hip were administered doses from 100 mg to 400 mg daily.\"\n },\n {\n \"VerbatimTerm\": \"osteoarthritis\",\n \"Probability\": \"0.0004374087\",\n \"SemanticContext\": \"Study 2: Osteoarthritis of the Knee In one 12-week randomized, double-blind, placebo-controlled flexible-dosing trial of tramadol hydrochloride extended-release tablets in patients with osteoarthritis of the knee, patients titrated to an average daily tramadol hydrochloride extended-release tablets dose of approximately 270 mg/day.\"\n },\n {\n \"VerbatimTerm\": \"Osteoarthritis\",\n \"Probability\": \"0.0004459918\",\n \"SemanticContext\": \"Adequate evidence of efficacy was demonstrated in the following two studies: Study 1 : Osteoarthritis of the Knee and/or Hip In one 12-week randomized, double-blind, placebo-controlled study, patients with moderate to moderately severe pain due to osteoarthritis of the knee and/or hip were administered doses from 100 mg to 400 mg daily.\"\n },\n {\n \"VerbatimTerm\": \"Osteoarthritis\",\n \"Probability\": \"0.0005913079\",\n \"SemanticContext\": \"Study 2: Osteoarthritis of the Knee In one 12-week randomized, double-blind, placebo-controlled flexible-dosing trial of tramadol hydrochloride extended-release tablets in patients with osteoarthritis of the knee, patients titrated to an average daily tramadol hydrochloride extended-release tablets dose of approximately 270 mg/day.\"\n }\n ]\n },\n {\n \"Term\": \"Visual analogue scale\",\n \"MEDDRACode\": \"10075166\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"visual analog scale\",\n \"Probability\": \"0.0567851067\",\n \"SemanticContext\": \"To qualify for inclusion into these studies, patients were required to have moderate to moderately severe pain as defined by a pain intensity score of =40 mm, off previous medications, on a 0 to 100 mm visual analog scale VAS .\"\n },\n {\n \"VerbatimTerm\": \"VAS\",\n \"Probability\": \"0.1318226159\",\n \"SemanticContext\": \"To qualify for inclusion into these studies, patients were required to have moderate to moderately severe pain as defined by a pain intensity score of =40 mm, off previous medications, on a 0 to 100 mm visual analog scale VAS .\"\n },\n {\n \"VerbatimTerm\": \"VAS\",\n \"Probability\": \"0.1423755288\",\n \"SemanticContext\": \"The tramadol hydrochloride extended-release tablets group demonstrated a statistically significant decrease in the mean VAS score, and a statistically significant difference in the responder rate, based on the percent change from baseline in the VAS score, measured at 1, 2, 4, 8, and 12 weeks, between patients receiving tramadol hydrochloride extended-release tablets and placebo see Figure 3 .\"\n },\n {\n \"VerbatimTerm\": \"VAS\",\n \"Probability\": \"0.1446301639\",\n \"SemanticContext\": \"The tramadol hydrochloride extended-release tablets group demonstrated a statistically significant decrease in the mean VAS score, and a statistically significant difference in the responder rate, based on the percent change from baseline in the VAS score, measured at 1, 2, 4, 8, and 12 weeks, between patients receiving tramadol hydrochloride extended-release tablets and placebo see Figure 3 .\"\n }\n ]\n },\n {\n \"Term\": \"Lethargy\",\n \"MEDDRACode\": \"10024264\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"lethargy\",\n \"Probability\": \"0.990794301\",\n \"SemanticContext\": \"Eye disorders: vision blurred Gastrointestinal disorders: abdominal pain upper, dyspepsia, abdominal pain, sore throat General disorders: weakness, pain, feeling hot, influenza like illness, fall, rigors, lethargy, pyrexia, chest pain Infections and infestations: nasopharyngitis, upper respiratory tract infection, sinusitis, influenza, gastroenteritis viral, urinary tract infection, bronchitis Investigations: blood creatine phosphokinase increased, weight decreased Metabolism and nutrition disorders: appetite decreased Musculoskeletal, connective tissue and bone disorders: arthralgia, back pain, pain in limb, neck pain Nervous system disorders: tremor, paresthesia, hypoesthesia Psychiatric disorders: nervousness, anxiety, depression, restlessness Respiratory, thoracic and mediastinal disorders: sneezing, cough, rhinorrhea, nasal congestion, dyspnea, sinus congestion Skin and subcutaneous tissue disorders: sweating increased, dermatitis Vascular disorders: hot flushes, vasodilatation Adverse Reactions With Incidence Rates of 0.5% to \\n <1.0% and Serious Adverse Reactions Reported in at Least 2 patients During Clinical Trials Cardiac disorders: palpitations, myocardial infarction Ear and labyrinth disorders: tinnitus, vertigo Gastrointestinal disorders: flatulence, toothache, constipation aggravated, appendicitis, pancreatitis General disorders: feeling jittery, edema lower limb, shivering, joint swelling, malaise, drug withdrawal syndrome, peripheral swelling Hepato-biliary disorders: cholelithiasis, cholecystitis Infections and infestations: cellulitis, ear infection, gastroenteritis, pneumonia, viral infection Injury and poisoning: joint sprain, muscle injury Investigations: alanine aminotransferase increased, blood pressure increased, aspartate aminotransferase increased, heart rate increased, blood glucose increased, liver function tests abnormal Musculoskeletal, connective tissue and bone disorders: muscle cramps, muscle spasms, joint stiffness, muscle twitching, myalgia, osteoarthritis aggravated Nervous system disorders: migraine, sedation, syncope, disturbance in attention, dizziness aggravated Psychiatric disorders: euphoric mood, irritability, libido decreased, sleep disorder, agitation, disorientation, abnormal dreams Renal and urinary disorders: difficulty in micturition, urinary frequency, hematuria, dysuria, urinary retention Respiratory, thoracic and mediastinal disorders: yawning Skin and subcutaneous tissue disorders: contusion, piloerection, clamminess, night sweats, urticaria Vascular disorders: hypertension aggravated, hypertension, peripheral ischemia 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of tramadol.\"\n }\n ]\n },\n {\n \"Term\": \"Pain in extremity\",\n \"MEDDRACode\": \"10033425\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"pain in limb\",\n \"Probability\": \"0.9914773703\",\n \"SemanticContext\": \"Eye disorders: vision blurred Gastrointestinal disorders: abdominal pain upper, dyspepsia, abdominal pain, sore throat General disorders: weakness, pain, feeling hot, influenza like illness, fall, rigors, lethargy, pyrexia, chest pain Infections and infestations: nasopharyngitis, upper respiratory tract infection, sinusitis, influenza, gastroenteritis viral, urinary tract infection, bronchitis Investigations: blood creatine phosphokinase increased, weight decreased Metabolism and nutrition disorders: appetite decreased Musculoskeletal, connective tissue and bone disorders: arthralgia, back pain, pain in limb, neck pain Nervous system disorders: tremor, paresthesia, hypoesthesia Psychiatric disorders: nervousness, anxiety, depression, restlessness Respiratory, thoracic and mediastinal disorders: sneezing, cough, rhinorrhea, nasal congestion, dyspnea, sinus congestion Skin and subcutaneous tissue disorders: sweating increased, dermatitis Vascular disorders: hot flushes, vasodilatation Adverse Reactions With Incidence Rates of 0.5% to \\n <1.0% and Serious Adverse Reactions Reported in at Least 2 patients During Clinical Trials Cardiac disorders: palpitations, myocardial infarction Ear and labyrinth disorders: tinnitus, vertigo Gastrointestinal disorders: flatulence, toothache, constipation aggravated, appendicitis, pancreatitis General disorders: feeling jittery, edema lower limb, shivering, joint swelling, malaise, drug withdrawal syndrome, peripheral swelling Hepato-biliary disorders: cholelithiasis, cholecystitis Infections and infestations: cellulitis, ear infection, gastroenteritis, pneumonia, viral infection Injury and poisoning: joint sprain, muscle injury Investigations: alanine aminotransferase increased, blood pressure increased, aspartate aminotransferase increased, heart rate increased, blood glucose increased, liver function tests abnormal Musculoskeletal, connective tissue and bone disorders: muscle cramps, muscle spasms, joint stiffness, muscle twitching, myalgia, osteoarthritis aggravated Nervous system disorders: migraine, sedation, syncope, disturbance in attention, dizziness aggravated Psychiatric disorders: euphoric mood, irritability, libido decreased, sleep disorder, agitation, disorientation, abnormal dreams Renal and urinary disorders: difficulty in micturition, urinary frequency, hematuria, dysuria, urinary retention Respiratory, thoracic and mediastinal disorders: yawning Skin and subcutaneous tissue disorders: contusion, piloerection, clamminess, night sweats, urticaria Vascular disorders: hypertension aggravated, hypertension, peripheral ischemia 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of tramadol.\"\n }\n ]\n },\n {\n \"Term\": \"Back pain\",\n \"MEDDRACode\": \"10003988\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"back pain\",\n \"Probability\": \"0.9961071014\",\n \"SemanticContext\": \"Eye disorders: vision blurred Gastrointestinal disorders: abdominal pain upper, dyspepsia, abdominal pain, sore throat General disorders: weakness, pain, feeling hot, influenza like illness, fall, rigors, lethargy, pyrexia, chest pain Infections and infestations: nasopharyngitis, upper respiratory tract infection, sinusitis, influenza, gastroenteritis viral, urinary tract infection, bronchitis Investigations: blood creatine phosphokinase increased, weight decreased Metabolism and nutrition disorders: appetite decreased Musculoskeletal, connective tissue and bone disorders: arthralgia, back pain, pain in limb, neck pain Nervous system disorders: tremor, paresthesia, hypoesthesia Psychiatric disorders: nervousness, anxiety, depression, restlessness Respiratory, thoracic and mediastinal disorders: sneezing, cough, rhinorrhea, nasal congestion, dyspnea, sinus congestion Skin and subcutaneous tissue disorders: sweating increased, dermatitis Vascular disorders: hot flushes, vasodilatation Adverse Reactions With Incidence Rates of 0.5% to \\n <1.0% and Serious Adverse Reactions Reported in at Least 2 patients During Clinical Trials Cardiac disorders: palpitations, myocardial infarction Ear and labyrinth disorders: tinnitus, vertigo Gastrointestinal disorders: flatulence, toothache, constipation aggravated, appendicitis, pancreatitis General disorders: feeling jittery, edema lower limb, shivering, joint swelling, malaise, drug withdrawal syndrome, peripheral swelling Hepato-biliary disorders: cholelithiasis, cholecystitis Infections and infestations: cellulitis, ear infection, gastroenteritis, pneumonia, viral infection Injury and poisoning: joint sprain, muscle injury Investigations: alanine aminotransferase increased, blood pressure increased, aspartate aminotransferase increased, heart rate increased, blood glucose increased, liver function tests abnormal Musculoskeletal, connective tissue and bone disorders: muscle cramps, muscle spasms, joint stiffness, muscle twitching, myalgia, osteoarthritis aggravated Nervous system disorders: migraine, sedation, syncope, disturbance in attention, dizziness aggravated Psychiatric disorders: euphoric mood, irritability, libido decreased, sleep disorder, agitation, disorientation, abnormal dreams Renal and urinary disorders: difficulty in micturition, urinary frequency, hematuria, dysuria, urinary retention Respiratory, thoracic and mediastinal disorders: yawning Skin and subcutaneous tissue disorders: contusion, piloerection, clamminess, night sweats, urticaria Vascular disorders: hypertension aggravated, hypertension, peripheral ischemia 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of tramadol.\"\n }\n ]\n },\n {\n \"Term\": \"Hypotension\",\n \"MEDDRACode\": \"10021097\",\n \"Overdose\": true,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"low blood pressure\",\n \"Probability\": \"0.9551359415\",\n \"SemanticContext\": \"Adrenal insufficiency may present with non-specific symptoms and signs such as nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure.\"\n },\n {\n \"VerbatimTerm\": \"low blood pressure\",\n \"Probability\": \"0.0004095137\",\n \"SemanticContext\": \"Instruct patients how to recognize symptoms of low blood pressure and how to reduce the risk of serious consequences should hypotension occur e.g., sit or lie down, carefully rise from a sitting or lying position [see Warnings and Precautions 5.13 ] .\"\n },\n {\n \"VerbatimTerm\": \"low blood pressure\",\n \"Probability\": \"0.9014049172\",\n \"SemanticContext\": \"Presentation of adrenal insufficiency may include non-specific symptoms and signs including nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure.\"\n }\n ]\n },\n {\n \"Term\": \"Peripheral swelling\",\n \"MEDDRACode\": \"10048959\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"peripheral swelling\",\n \"Probability\": \"0.9784090519\",\n \"SemanticContext\": \"Eye disorders: vision blurred Gastrointestinal disorders: abdominal pain upper, dyspepsia, abdominal pain, sore throat General disorders: weakness, pain, feeling hot, influenza like illness, fall, rigors, lethargy, pyrexia, chest pain Infections and infestations: nasopharyngitis, upper respiratory tract infection, sinusitis, influenza, gastroenteritis viral, urinary tract infection, bronchitis Investigations: blood creatine phosphokinase increased, weight decreased Metabolism and nutrition disorders: appetite decreased Musculoskeletal, connective tissue and bone disorders: arthralgia, back pain, pain in limb, neck pain Nervous system disorders: tremor, paresthesia, hypoesthesia Psychiatric disorders: nervousness, anxiety, depression, restlessness Respiratory, thoracic and mediastinal disorders: sneezing, cough, rhinorrhea, nasal congestion, dyspnea, sinus congestion Skin and subcutaneous tissue disorders: sweating increased, dermatitis Vascular disorders: hot flushes, vasodilatation Adverse Reactions With Incidence Rates of 0.5% to \\n <1.0% and Serious Adverse Reactions Reported in at Least 2 patients During Clinical Trials Cardiac disorders: palpitations, myocardial infarction Ear and labyrinth disorders: tinnitus, vertigo Gastrointestinal disorders: flatulence, toothache, constipation aggravated, appendicitis, pancreatitis General disorders: feeling jittery, edema lower limb, shivering, joint swelling, malaise, drug withdrawal syndrome, peripheral swelling Hepato-biliary disorders: cholelithiasis, cholecystitis Infections and infestations: cellulitis, ear infection, gastroenteritis, pneumonia, viral infection Injury and poisoning: joint sprain, muscle injury Investigations: alanine aminotransferase increased, blood pressure increased, aspartate aminotransferase increased, heart rate increased, blood glucose increased, liver function tests abnormal Musculoskeletal, connective tissue and bone disorders: muscle cramps, muscle spasms, joint stiffness, muscle twitching, myalgia, osteoarthritis aggravated Nervous system disorders: migraine, sedation, syncope, disturbance in attention, dizziness aggravated Psychiatric disorders: euphoric mood, irritability, libido decreased, sleep disorder, agitation, disorientation, abnormal dreams Renal and urinary disorders: difficulty in micturition, urinary frequency, hematuria, dysuria, urinary retention Respiratory, thoracic and mediastinal disorders: yawning Skin and subcutaneous tissue disorders: contusion, piloerection, clamminess, night sweats, urticaria Vascular disorders: hypertension aggravated, hypertension, peripheral ischemia 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of tramadol.\"\n }\n ]\n },\n {\n \"Term\": \"Blood cortisol\",\n \"MEDDRACode\": \"10005455\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"cortisol\",\n \"Probability\": \"0.0010856986\",\n \"SemanticContext\": \"Effects on the Endocrine System Opioids inhibit the secretion of adrenocorticotropic hormone ACTH , cortisol, and luteinizing hormone LH in humans [see Adverse Reactions 6.2 ] .\"\n }\n ]\n },\n {\n \"Term\": \"Blood ketone body\",\n \"MEDDRACode\": \"10057593\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"acetone\",\n \"Probability\": \"0.0001245737\",\n \"SemanticContext\": \"It is a white, crystalline powder that is freely soluble in water and methanol, very slightly soluble in acetone and has a pKa of 9.41.\"\n }\n ]\n },\n {\n \"Term\": \"Rhinorrhoea\",\n \"MEDDRACode\": \"10039101\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"rhinorrhea\",\n \"Probability\": \"0.998108685\",\n \"SemanticContext\": \"Eye disorders: vision blurred Gastrointestinal disorders: abdominal pain upper, dyspepsia, abdominal pain, sore throat General disorders: weakness, pain, feeling hot, influenza like illness, fall, rigors, lethargy, pyrexia, chest pain Infections and infestations: nasopharyngitis, upper respiratory tract infection, sinusitis, influenza, gastroenteritis viral, urinary tract infection, bronchitis Investigations: blood creatine phosphokinase increased, weight decreased Metabolism and nutrition disorders: appetite decreased Musculoskeletal, connective tissue and bone disorders: arthralgia, back pain, pain in limb, neck pain Nervous system disorders: tremor, paresthesia, hypoesthesia Psychiatric disorders: nervousness, anxiety, depression, restlessness Respiratory, thoracic and mediastinal disorders: sneezing, cough, rhinorrhea, nasal congestion, dyspnea, sinus congestion Skin and subcutaneous tissue disorders: sweating increased, dermatitis Vascular disorders: hot flushes, vasodilatation Adverse Reactions With Incidence Rates of 0.5% to \\n <1.0% and Serious Adverse Reactions Reported in at Least 2 patients During Clinical Trials Cardiac disorders: palpitations, myocardial infarction Ear and labyrinth disorders: tinnitus, vertigo Gastrointestinal disorders: flatulence, toothache, constipation aggravated, appendicitis, pancreatitis General disorders: feeling jittery, edema lower limb, shivering, joint swelling, malaise, drug withdrawal syndrome, peripheral swelling Hepato-biliary disorders: cholelithiasis, cholecystitis Infections and infestations: cellulitis, ear infection, gastroenteritis, pneumonia, viral infection Injury and poisoning: joint sprain, muscle injury Investigations: alanine aminotransferase increased, blood pressure increased, aspartate aminotransferase increased, heart rate increased, blood glucose increased, liver function tests abnormal Musculoskeletal, connective tissue and bone disorders: muscle cramps, muscle spasms, joint stiffness, muscle twitching, myalgia, osteoarthritis aggravated Nervous system disorders: migraine, sedation, syncope, disturbance in attention, dizziness aggravated Psychiatric disorders: euphoric mood, irritability, libido decreased, sleep disorder, agitation, disorientation, abnormal dreams Renal and urinary disorders: difficulty in micturition, urinary frequency, hematuria, dysuria, urinary retention Respiratory, thoracic and mediastinal disorders: yawning Skin and subcutaneous tissue disorders: contusion, piloerection, clamminess, night sweats, urticaria Vascular disorders: hypertension aggravated, hypertension, peripheral ischemia 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of tramadol.\"\n },\n {\n \"VerbatimTerm\": \"rhinorrhea\",\n \"Probability\": \"0.9830816388\",\n \"SemanticContext\": \"Common withdrawal symptoms include restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia, and mydriasis.\"\n }\n ]\n },\n {\n \"Term\": \"Flatulence\",\n \"MEDDRACode\": \"10016766\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"flatulence\",\n \"Probability\": \"0.9908992052\",\n \"SemanticContext\": \"Eye disorders: vision blurred Gastrointestinal disorders: abdominal pain upper, dyspepsia, abdominal pain, sore throat General disorders: weakness, pain, feeling hot, influenza like illness, fall, rigors, lethargy, pyrexia, chest pain Infections and infestations: nasopharyngitis, upper respiratory tract infection, sinusitis, influenza, gastroenteritis viral, urinary tract infection, bronchitis Investigations: blood creatine phosphokinase increased, weight decreased Metabolism and nutrition disorders: appetite decreased Musculoskeletal, connective tissue and bone disorders: arthralgia, back pain, pain in limb, neck pain Nervous system disorders: tremor, paresthesia, hypoesthesia Psychiatric disorders: nervousness, anxiety, depression, restlessness Respiratory, thoracic and mediastinal disorders: sneezing, cough, rhinorrhea, nasal congestion, dyspnea, sinus congestion Skin and subcutaneous tissue disorders: sweating increased, dermatitis Vascular disorders: hot flushes, vasodilatation Adverse Reactions With Incidence Rates of 0.5% to \\n <1.0% and Serious Adverse Reactions Reported in at Least 2 patients During Clinical Trials Cardiac disorders: palpitations, myocardial infarction Ear and labyrinth disorders: tinnitus, vertigo Gastrointestinal disorders: flatulence, toothache, constipation aggravated, appendicitis, pancreatitis General disorders: feeling jittery, edema lower limb, shivering, joint swelling, malaise, drug withdrawal syndrome, peripheral swelling Hepato-biliary disorders: cholelithiasis, cholecystitis Infections and infestations: cellulitis, ear infection, gastroenteritis, pneumonia, viral infection Injury and poisoning: joint sprain, muscle injury Investigations: alanine aminotransferase increased, blood pressure increased, aspartate aminotransferase increased, heart rate increased, blood glucose increased, liver function tests abnormal Musculoskeletal, connective tissue and bone disorders: muscle cramps, muscle spasms, joint stiffness, muscle twitching, myalgia, osteoarthritis aggravated Nervous system disorders: migraine, sedation, syncope, disturbance in attention, dizziness aggravated Psychiatric disorders: euphoric mood, irritability, libido decreased, sleep disorder, agitation, disorientation, abnormal dreams Renal and urinary disorders: difficulty in micturition, urinary frequency, hematuria, dysuria, urinary retention Respiratory, thoracic and mediastinal disorders: yawning Skin and subcutaneous tissue disorders: contusion, piloerection, clamminess, night sweats, urticaria Vascular disorders: hypertension aggravated, hypertension, peripheral ischemia 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of tramadol.\"\n }\n ]\n },\n {\n \"Term\": \"Nervous system disorder\",\n \"MEDDRACode\": \"10029202\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Nervous system disorders\",\n \"Probability\": \"0.063361913\",\n \"SemanticContext\": \"Eye disorders: vision blurred Gastrointestinal disorders: abdominal pain upper, dyspepsia, abdominal pain, sore throat General disorders: weakness, pain, feeling hot, influenza like illness, fall, rigors, lethargy, pyrexia, chest pain Infections and infestations: nasopharyngitis, upper respiratory tract infection, sinusitis, influenza, gastroenteritis viral, urinary tract infection, bronchitis Investigations: blood creatine phosphokinase increased, weight decreased Metabolism and nutrition disorders: appetite decreased Musculoskeletal, connective tissue and bone disorders: arthralgia, back pain, pain in limb, neck pain Nervous system disorders: tremor, paresthesia, hypoesthesia Psychiatric disorders: nervousness, anxiety, depression, restlessness Respiratory, thoracic and mediastinal disorders: sneezing, cough, rhinorrhea, nasal congestion, dyspnea, sinus congestion Skin and subcutaneous tissue disorders: sweating increased, dermatitis Vascular disorders: hot flushes, vasodilatation Adverse Reactions With Incidence Rates of 0.5% to \\n <1.0% and Serious Adverse Reactions Reported in at Least 2 patients During Clinical Trials Cardiac disorders: palpitations, myocardial infarction Ear and labyrinth disorders: tinnitus, vertigo Gastrointestinal disorders: flatulence, toothache, constipation aggravated, appendicitis, pancreatitis General disorders: feeling jittery, edema lower limb, shivering, joint swelling, malaise, drug withdrawal syndrome, peripheral swelling Hepato-biliary disorders: cholelithiasis, cholecystitis Infections and infestations: cellulitis, ear infection, gastroenteritis, pneumonia, viral infection Injury and poisoning: joint sprain, muscle injury Investigations: alanine aminotransferase increased, blood pressure increased, aspartate aminotransferase increased, heart rate increased, blood glucose increased, liver function tests abnormal Musculoskeletal, connective tissue and bone disorders: muscle cramps, muscle spasms, joint stiffness, muscle twitching, myalgia, osteoarthritis aggravated Nervous system disorders: migraine, sedation, syncope, disturbance in attention, dizziness aggravated Psychiatric disorders: euphoric mood, irritability, libido decreased, sleep disorder, agitation, disorientation, abnormal dreams Renal and urinary disorders: difficulty in micturition, urinary frequency, hematuria, dysuria, urinary retention Respiratory, thoracic and mediastinal disorders: yawning Skin and subcutaneous tissue disorders: contusion, piloerection, clamminess, night sweats, urticaria Vascular disorders: hypertension aggravated, hypertension, peripheral ischemia 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of tramadol.\"\n }\n ]\n },\n {\n \"Term\": \"Amenorrhoea\",\n \"MEDDRACode\": \"10001928\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"amenorrhea\",\n \"Probability\": \"0.544023633\",\n \"SemanticContext\": \"Chronic use of opioids may influence the hypothalamic-pituitary-gonadal axis, leading to androgen deficiency that may manifest as low libido, impotence, erectile dysfunction, amenorrhea, or infertility.\"\n }\n ]\n },\n {\n \"Term\": \"Cardiac index\",\n \"MEDDRACode\": \"10007575\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"cardiac index\",\n \"Probability\": \"0.0083353519\",\n \"SemanticContext\": \"At therapeutic doses, tramadol has no effect on heart rate, left-ventricular function, or cardiac index.\"\n }\n ]\n },\n {\n \"Term\": \"Sinus congestion\",\n \"MEDDRACode\": \"10040742\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"sinus congestion\",\n \"Probability\": \"0.9986970425\",\n \"SemanticContext\": \"Eye disorders: vision blurred Gastrointestinal disorders: abdominal pain upper, dyspepsia, abdominal pain, sore throat General disorders: weakness, pain, feeling hot, influenza like illness, fall, rigors, lethargy, pyrexia, chest pain Infections and infestations: nasopharyngitis, upper respiratory tract infection, sinusitis, influenza, gastroenteritis viral, urinary tract infection, bronchitis Investigations: blood creatine phosphokinase increased, weight decreased Metabolism and nutrition disorders: appetite decreased Musculoskeletal, connective tissue and bone disorders: arthralgia, back pain, pain in limb, neck pain Nervous system disorders: tremor, paresthesia, hypoesthesia Psychiatric disorders: nervousness, anxiety, depression, restlessness Respiratory, thoracic and mediastinal disorders: sneezing, cough, rhinorrhea, nasal congestion, dyspnea, sinus congestion Skin and subcutaneous tissue disorders: sweating increased, dermatitis Vascular disorders: hot flushes, vasodilatation Adverse Reactions With Incidence Rates of 0.5% to \\n <1.0% and Serious Adverse Reactions Reported in at Least 2 patients During Clinical Trials Cardiac disorders: palpitations, myocardial infarction Ear and labyrinth disorders: tinnitus, vertigo Gastrointestinal disorders: flatulence, toothache, constipation aggravated, appendicitis, pancreatitis General disorders: feeling jittery, edema lower limb, shivering, joint swelling, malaise, drug withdrawal syndrome, peripheral swelling Hepato-biliary disorders: cholelithiasis, cholecystitis Infections and infestations: cellulitis, ear infection, gastroenteritis, pneumonia, viral infection Injury and poisoning: joint sprain, muscle injury Investigations: alanine aminotransferase increased, blood pressure increased, aspartate aminotransferase increased, heart rate increased, blood glucose increased, liver function tests abnormal Musculoskeletal, connective tissue and bone disorders: muscle cramps, muscle spasms, joint stiffness, muscle twitching, myalgia, osteoarthritis aggravated Nervous system disorders: migraine, sedation, syncope, disturbance in attention, dizziness aggravated Psychiatric disorders: euphoric mood, irritability, libido decreased, sleep disorder, agitation, disorientation, abnormal dreams Renal and urinary disorders: difficulty in micturition, urinary frequency, hematuria, dysuria, urinary retention Respiratory, thoracic and mediastinal disorders: yawning Skin and subcutaneous tissue disorders: contusion, piloerection, clamminess, night sweats, urticaria Vascular disorders: hypertension aggravated, hypertension, peripheral ischemia 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of tramadol.\"\n }\n ]\n },\n {\n \"Term\": \"Tinnitus\",\n \"MEDDRACode\": \"10043882\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"tinnitus\",\n \"Probability\": \"0.9981485009\",\n \"SemanticContext\": \"Eye disorders: vision blurred Gastrointestinal disorders: abdominal pain upper, dyspepsia, abdominal pain, sore throat General disorders: weakness, pain, feeling hot, influenza like illness, fall, rigors, lethargy, pyrexia, chest pain Infections and infestations: nasopharyngitis, upper respiratory tract infection, sinusitis, influenza, gastroenteritis viral, urinary tract infection, bronchitis Investigations: blood creatine phosphokinase increased, weight decreased Metabolism and nutrition disorders: appetite decreased Musculoskeletal, connective tissue and bone disorders: arthralgia, back pain, pain in limb, neck pain Nervous system disorders: tremor, paresthesia, hypoesthesia Psychiatric disorders: nervousness, anxiety, depression, restlessness Respiratory, thoracic and mediastinal disorders: sneezing, cough, rhinorrhea, nasal congestion, dyspnea, sinus congestion Skin and subcutaneous tissue disorders: sweating increased, dermatitis Vascular disorders: hot flushes, vasodilatation Adverse Reactions With Incidence Rates of 0.5% to \\n <1.0% and Serious Adverse Reactions Reported in at Least 2 patients During Clinical Trials Cardiac disorders: palpitations, myocardial infarction Ear and labyrinth disorders: tinnitus, vertigo Gastrointestinal disorders: flatulence, toothache, constipation aggravated, appendicitis, pancreatitis General disorders: feeling jittery, edema lower limb, shivering, joint swelling, malaise, drug withdrawal syndrome, peripheral swelling Hepato-biliary disorders: cholelithiasis, cholecystitis Infections and infestations: cellulitis, ear infection, gastroenteritis, pneumonia, viral infection Injury and poisoning: joint sprain, muscle injury Investigations: alanine aminotransferase increased, blood pressure increased, aspartate aminotransferase increased, heart rate increased, blood glucose increased, liver function tests abnormal Musculoskeletal, connective tissue and bone disorders: muscle cramps, muscle spasms, joint stiffness, muscle twitching, myalgia, osteoarthritis aggravated Nervous system disorders: migraine, sedation, syncope, disturbance in attention, dizziness aggravated Psychiatric disorders: euphoric mood, irritability, libido decreased, sleep disorder, agitation, disorientation, abnormal dreams Renal and urinary disorders: difficulty in micturition, urinary frequency, hematuria, dysuria, urinary retention Respiratory, thoracic and mediastinal disorders: yawning Skin and subcutaneous tissue disorders: contusion, piloerection, clamminess, night sweats, urticaria Vascular disorders: hypertension aggravated, hypertension, peripheral ischemia 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of tramadol.\"\n }\n ]\n },\n {\n \"Term\": \"Anaphylactic reaction\",\n \"MEDDRACode\": \"10002198\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": true,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Anaphylaxis\",\n \"Probability\": \"0.8874599934\",\n \"SemanticContext\": \"Anaphylaxis: Anaphylaxis has been reported with ingredients contained in tramadol hydrochloride extended-release tablets.\"\n },\n {\n \"VerbatimTerm\": \"Anaphylaxis\",\n \"Probability\": \"0.9769564867\",\n \"SemanticContext\": \"Anaphylaxis: Anaphylaxis has been reported with ingredients contained in tramadol hydrochloride extended-release tablets.\"\n },\n {\n \"VerbatimTerm\": \"Anaphylaxis\",\n \"Probability\": \"0.7107470036\",\n \"SemanticContext\": \"Anaphylaxis Inform patients that anaphylaxis has been reported with ingredients contained in tramadol hydrochloride extended-release tablets.\"\n },\n {\n \"VerbatimTerm\": \"Anaphylaxis\",\n \"Probability\": \"0.9811096787\",\n \"SemanticContext\": \"5.16 Anaphylaxis and Other Hypersensitivity Reactions Serious and rarely fatal hypersensitive reactions have been reported in patients receiving therapy with tramadol.\"\n },\n {\n \"VerbatimTerm\": \"anaphylaxis\",\n \"Probability\": \"0.9507756233\",\n \"SemanticContext\": \"Tramadol hydrochloride extended-release tablets are also contraindicated in patients with: Significant respiratory depression [ see Warnings and Precautions 5.3 ] Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [ see Warnings and Precautions 5.12 ] Known or suspected gastrointestinal obstruction, including paralytic ileus [ see Warnings and Precautions 5.15 ] Hypersensitivity to tramadol e.g., anaphylaxis [ see Warnings and Precautions 5.16 , Adverse Reactions 6.2 ] Concurrent use of monoamine oxidase inhibitors MAOIs or use within the last 14 days [see Drug Interactions 7 ] .\"\n },\n {\n \"VerbatimTerm\": \"anaphylaxis\",\n \"Probability\": \"0.1046380699\",\n \"SemanticContext\": \"Anaphylaxis Inform patients that anaphylaxis has been reported with ingredients contained in tramadol hydrochloride extended-release tablets.\"\n },\n {\n \"VerbatimTerm\": \"anaphylaxis\",\n \"Probability\": \"0.003818959\",\n \"SemanticContext\": \"If anaphylaxis or other hypersensitivity occurs, stop administration of tramadol hydrochloride extended-release tablets immediately, discontinue tramadol hydrochloride extended-release tablets permanently, and do not rechallenge with any formulation of tramadol.\"\n }\n ]\n },\n {\n \"Term\": \"Torsade de pointes\",\n \"MEDDRACode\": \"10044066\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"torsade de pointes\",\n \"Probability\": \"0.1115028858\",\n \"SemanticContext\": \"QT prolongation/torsade de pointes: Cases of QT prolongation and/or torsade de pointes have been reported with tramadol use.\"\n },\n {\n \"VerbatimTerm\": \"torsade de pointes\",\n \"Probability\": \"0.1092066765\",\n \"SemanticContext\": \"QT prolongation/torsade de pointes: Cases of QT prolongation and/or torsade de pointes have been reported with tramadol use.\"\n }\n ]\n },\n {\n \"Term\": \"Heart rate\",\n \"MEDDRACode\": \"10019299\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"heart rate\",\n \"Probability\": \"0.0006766617\",\n \"SemanticContext\": \"At therapeutic doses, tramadol has no effect on heart rate, left-ventricular function, or cardiac index.\"\n },\n {\n \"VerbatimTerm\": \"heart rate\",\n \"Probability\": \"0.2281419337\",\n \"SemanticContext\": \"Other signs and symptoms also may develop, including irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate.\"\n }\n ]\n },\n {\n \"Term\": \"Amylase\",\n \"MEDDRACode\": \"10002013\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"serum amylase\",\n \"Probability\": \"0.0035156012\",\n \"SemanticContext\": \"Other opioid-induced effects may include a reduction in biliary and pancreatic secretions, spasm of sphincter of Oddi, and transient elevations in serum amylase.\"\n }\n ]\n },\n {\n \"Term\": \"Irritability\",\n \"MEDDRACode\": \"10022998\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"irritability\",\n \"Probability\": \"0.6123974323\",\n \"SemanticContext\": \"Other signs and symptoms also may develop, including irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate.\"\n },\n {\n \"VerbatimTerm\": \"irritability\",\n \"Probability\": \"0.931430459\",\n \"SemanticContext\": \"Neonatal opioid withdrawal syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea, and failure to gain weight.\"\n }\n ]\n },\n {\n \"Term\": \"Swelling\",\n \"MEDDRACode\": \"10042674\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"swelling\",\n \"Probability\": \"4.64443E-05\",\n \"SemanticContext\": \"Get emergency medical help or call 911 right away, if you have: trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue, or throat, extreme drowsiness, light-headedness when changing positions, feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion.\"\n }\n ]\n },\n {\n \"Term\": \"Chronic obstructive pulmonary disease\",\n \"MEDDRACode\": \"10009033\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"chronic obstructive pulmonary disease\",\n \"Probability\": \"0.0048431158\",\n \"SemanticContext\": \"Patients with Chronic Pulmonary Disease: Tramadol hydrochloride extended-release tablets-treated patients with significant chronic obstructive pulmonary disease or cor pulmonale, and those with a substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression are at increased risk of decreased respiratory drive including apnea, even at recommended dosages of tramadol hydrochloride extended-release tablets [see Warnings and Precautions 5.3 ].\"\n }\n ]\n },\n {\n \"Term\": \"Fasting\",\n \"MEDDRACode\": \"10068315\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"fasting\",\n \"Probability\": \"0.0001158175\",\n \"SemanticContext\": \"Food Effects After a single dose administration of 200 mg tramadol hydrochloride extended-release tablet with a high fat meal, the C max and AUC 0-8 of tramadol decreased 28% and 16%, respectively, compared to fasting conditions.\"\n },\n {\n \"VerbatimTerm\": \"fasting\",\n \"Probability\": \"1.80559E-05\",\n \"SemanticContext\": \"Mean T max was increased by 3 hr from 14 hr under fasting conditions to 17 hr under fed conditions .\"\n },\n {\n \"VerbatimTerm\": \"fast\",\n \"Probability\": \"1.39112E-05\",\n \"SemanticContext\": \"Get emergency medical help or call 911 right away, if you have: trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue, or throat, extreme drowsiness, light-headedness when changing positions, feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion.\"\n }\n ]\n },\n {\n \"Term\": \"Neuromuscular blockade\",\n \"MEDDRACode\": \"10029315\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"neuromuscular blocking\",\n \"Probability\": \"0.011639446\",\n \"SemanticContext\": \"Examples: butorphanol, nalbuphine, pentazocine, buprenorphine Muscle Relaxants Clinical Impact: Tramadol may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression.\"\n }\n ]\n },\n {\n \"Term\": \"Protein total\",\n \"MEDDRACode\": \"10050537\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"plasma proteins\",\n \"Probability\": \"0.0025456846\",\n \"SemanticContext\": \"The binding of tramadol to human plasma proteins is approximately 20% and binding also appears to be independent of concentration up to 10 mcg/mL.\"\n },\n {\n \"VerbatimTerm\": \"plasma protein\",\n \"Probability\": \"0.0002915263\",\n \"SemanticContext\": \"Saturation of plasma protein binding occurs only at concentrations outside the clinically relevant range.\"\n }\n ]\n },\n {\n \"Term\": \"Dry mouth\",\n \"MEDDRACode\": \"10013781\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"dry mouth\",\n \"Probability\": \"0.9962306023\",\n \"SemanticContext\": \"ADVERSE REACTIONS Most common adverse reactions =10% and =2 x placebo rate : Dizziness, constipation, nausea, headache, somnolence, flushing, pruritus, vomiting, insomnia, dry mouth.\"\n },\n {\n \"VerbatimTerm\": \"dry mouth\",\n \"Probability\": \"0.9773581624\",\n \"SemanticContext\": \"The most common adverse reactions from Table 1 occurring in =10% and =2 x placebo rate of the patients treated with tramadol hydrochloride extended-release tablets are dizziness not vertigo , nausea, constipation, headache, somnolence, flushing, pruritus, vomiting, insomnia, and dry mouth.\"\n },\n {\n \"VerbatimTerm\": \"Dry Mouth\",\n \"Probability\": \"0.9992938042\",\n \"SemanticContext\": \"MedDRA Preferred Term Tramadol Hydrochloride Extended-Release Tablets Placebo 100 mg N=403 n % 200 mg N=400 n % 300 mg N=400 n % 400 mg N=202 n % N=406 n % Dizziness not vertigo 64 16 81 20 90 23 57 28 28 7 Nausea 61 15 90 23 102 26 53 26 32 8 Constipation 49 12 68 17 85 21 60 30 17 4 Headache 49 12 62 16 46 12 32 16 43 11 Somnolence 33 8 45 11 29 7 41 20 7 2 Flushing 31 8 40 10 35 9 32 16 18 4 Pruritus 25 6 34 9 30 8 24 12 4 1 Vomiting 20 5 29 7 34 9 19 9 11 3 Insomnia 26 7 32 8 36 9 22 11 13 3 Dry Mouth 20 5 29 7 39 10 18 9 6 2 Diarrhea 15 4 27 7 37 9 10 5 17 4 Asthenia 14 4 24 6 26 7 13 6 7 2 Postural hypotension 7 2 17 4 8 2 11 5 9 2 Sweating increased 6 2 8 2 15 4 13 6 1 0 Anorexia 3 1 7 2 21 5 12 6 1 0 .\"\n }\n ]\n },\n {\n \"Term\": \"Influenza like illness\",\n \"MEDDRACode\": \"10022004\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"influenza like illness\",\n \"Probability\": \"0.9591107368\",\n \"SemanticContext\": \"Eye disorders: vision blurred Gastrointestinal disorders: abdominal pain upper, dyspepsia, abdominal pain, sore throat General disorders: weakness, pain, feeling hot, influenza like illness, fall, rigors, lethargy, pyrexia, chest pain Infections and infestations: nasopharyngitis, upper respiratory tract infection, sinusitis, influenza, gastroenteritis viral, urinary tract infection, bronchitis Investigations: blood creatine phosphokinase increased, weight decreased Metabolism and nutrition disorders: appetite decreased Musculoskeletal, connective tissue and bone disorders: arthralgia, back pain, pain in limb, neck pain Nervous system disorders: tremor, paresthesia, hypoesthesia Psychiatric disorders: nervousness, anxiety, depression, restlessness Respiratory, thoracic and mediastinal disorders: sneezing, cough, rhinorrhea, nasal congestion, dyspnea, sinus congestion Skin and subcutaneous tissue disorders: sweating increased, dermatitis Vascular disorders: hot flushes, vasodilatation Adverse Reactions With Incidence Rates of 0.5% to \\n <1.0% and Serious Adverse Reactions Reported in at Least 2 patients During Clinical Trials Cardiac disorders: palpitations, myocardial infarction Ear and labyrinth disorders: tinnitus, vertigo Gastrointestinal disorders: flatulence, toothache, constipation aggravated, appendicitis, pancreatitis General disorders: feeling jittery, edema lower limb, shivering, joint swelling, malaise, drug withdrawal syndrome, peripheral swelling Hepato-biliary disorders: cholelithiasis, cholecystitis Infections and infestations: cellulitis, ear infection, gastroenteritis, pneumonia, viral infection Injury and poisoning: joint sprain, muscle injury Investigations: alanine aminotransferase increased, blood pressure increased, aspartate aminotransferase increased, heart rate increased, blood glucose increased, liver function tests abnormal Musculoskeletal, connective tissue and bone disorders: muscle cramps, muscle spasms, joint stiffness, muscle twitching, myalgia, osteoarthritis aggravated Nervous system disorders: migraine, sedation, syncope, disturbance in attention, dizziness aggravated Psychiatric disorders: euphoric mood, irritability, libido decreased, sleep disorder, agitation, disorientation, abnormal dreams Renal and urinary disorders: difficulty in micturition, urinary frequency, hematuria, dysuria, urinary retention Respiratory, thoracic and mediastinal disorders: yawning Skin and subcutaneous tissue disorders: contusion, piloerection, clamminess, night sweats, urticaria Vascular disorders: hypertension aggravated, hypertension, peripheral ischemia 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of tramadol.\"\n }\n ]\n },\n {\n \"Term\": \"Oropharyngeal pain\",\n \"MEDDRACode\": \"10068319\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"sore throat\",\n \"Probability\": \"0.9832577705\",\n \"SemanticContext\": \"Eye disorders: vision blurred Gastrointestinal disorders: abdominal pain upper, dyspepsia, abdominal pain, sore throat General disorders: weakness, pain, feeling hot, influenza like illness, fall, rigors, lethargy, pyrexia, chest pain Infections and infestations: nasopharyngitis, upper respiratory tract infection, sinusitis, influenza, gastroenteritis viral, urinary tract infection, bronchitis Investigations: blood creatine phosphokinase increased, weight decreased Metabolism and nutrition disorders: appetite decreased Musculoskeletal, connective tissue and bone disorders: arthralgia, back pain, pain in limb, neck pain Nervous system disorders: tremor, paresthesia, hypoesthesia Psychiatric disorders: nervousness, anxiety, depression, restlessness Respiratory, thoracic and mediastinal disorders: sneezing, cough, rhinorrhea, nasal congestion, dyspnea, sinus congestion Skin and subcutaneous tissue disorders: sweating increased, dermatitis Vascular disorders: hot flushes, vasodilatation Adverse Reactions With Incidence Rates of 0.5% to \\n <1.0% and Serious Adverse Reactions Reported in at Least 2 patients During Clinical Trials Cardiac disorders: palpitations, myocardial infarction Ear and labyrinth disorders: tinnitus, vertigo Gastrointestinal disorders: flatulence, toothache, constipation aggravated, appendicitis, pancreatitis General disorders: feeling jittery, edema lower limb, shivering, joint swelling, malaise, drug withdrawal syndrome, peripheral swelling Hepato-biliary disorders: cholelithiasis, cholecystitis Infections and infestations: cellulitis, ear infection, gastroenteritis, pneumonia, viral infection Injury and poisoning: joint sprain, muscle injury Investigations: alanine aminotransferase increased, blood pressure increased, aspartate aminotransferase increased, heart rate increased, blood glucose increased, liver function tests abnormal Musculoskeletal, connective tissue and bone disorders: muscle cramps, muscle spasms, joint stiffness, muscle twitching, myalgia, osteoarthritis aggravated Nervous system disorders: migraine, sedation, syncope, disturbance in attention, dizziness aggravated Psychiatric disorders: euphoric mood, irritability, libido decreased, sleep disorder, agitation, disorientation, abnormal dreams Renal and urinary disorders: difficulty in micturition, urinary frequency, hematuria, dysuria, urinary retention Respiratory, thoracic and mediastinal disorders: yawning Skin and subcutaneous tissue disorders: contusion, piloerection, clamminess, night sweats, urticaria Vascular disorders: hypertension aggravated, hypertension, peripheral ischemia 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of tramadol.\"\n }\n ]\n },\n {\n \"Term\": \"Polyuria\",\n \"MEDDRACode\": \"10036142\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"diuresis\",\n \"Probability\": \"0.0009921491\",\n \"SemanticContext\": \"Intervention: Monitor patients for signs of diminished diuresis and/or effects on blood pressure and increase the dosage of the diuretic as needed.\"\n }\n ]\n },\n {\n \"Term\": \"Urinary retention\",\n \"MEDDRACode\": \"10046555\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"urinary retention\",\n \"Probability\": \"0.6274046302\",\n \"SemanticContext\": \"Anticholinergic Drugs Clinical Impact: The concomitant use of anticholinergic drugs may increase risk of urinary retention and/or severe constipation, which may lead to paralytic ileus.\"\n },\n {\n \"VerbatimTerm\": \"urinary retention\",\n \"Probability\": \"0.001331389\",\n \"SemanticContext\": \"Intervention: Monitor patients for signs of urinary retention or reduced gastric motility when tramadol hydrochloride extended-release tablets are used concomitantly with anticholinergic drugs.\"\n }\n ]\n },\n {\n \"Term\": \"Substance abuse\",\n \"MEDDRACode\": \"10066169\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"substance abuse\",\n \"Probability\": \"7.04502E-05\",\n \"SemanticContext\": \"Risks are increased in patients with a personal or family history of substance abuse including drug or alcohol abuse or addiction or mental illness e.g., major depression .\"\n }\n ]\n },\n {\n \"Term\": \"Toxicity to various agents\",\n \"MEDDRACode\": \"10070863\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"digoxin toxicity\",\n \"Probability\": \"0.0180174708\",\n \"SemanticContext\": \"Digoxin Clinical Impact: Post-marketing surveillance of tramadol has revealed rare reports of digoxin toxicity.\"\n },\n {\n \"VerbatimTerm\": \"digoxin toxicity\",\n \"Probability\": \"0.0005612373\",\n \"SemanticContext\": \"Intervention: Follow patients for signs of digoxin toxicity and adjust the dosage of digoxin as needed.\"\n }\n ]\n },\n {\n \"Term\": \"Flushing\",\n \"MEDDRACode\": \"10016825\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"flushing\",\n \"Probability\": \"0.9995667338\",\n \"SemanticContext\": \"ADVERSE REACTIONS Most common adverse reactions =10% and =2 x placebo rate : Dizziness, constipation, nausea, headache, somnolence, flushing, pruritus, vomiting, insomnia, dry mouth.\"\n },\n {\n \"VerbatimTerm\": \"flushing\",\n \"Probability\": \"0.9994796515\",\n \"SemanticContext\": \"The most common adverse reactions from Table 1 occurring in =10% and =2 x placebo rate of the patients treated with tramadol hydrochloride extended-release tablets are dizziness not vertigo , nausea, constipation, headache, somnolence, flushing, pruritus, vomiting, insomnia, and dry mouth.\"\n },\n {\n \"VerbatimTerm\": \"flushing\",\n \"Probability\": \"0.8477581739\",\n \"SemanticContext\": \"Manifestations of histamine release and/or peripheral vasodilation may include pruritus, flushing, red eyes, sweating, and/or orthostatic hypotension.\"\n },\n {\n \"VerbatimTerm\": \"Flushing\",\n \"Probability\": \"0.9989757538\",\n \"SemanticContext\": \"MedDRA Preferred Term Tramadol Hydrochloride Extended-Release Tablets Placebo 100 mg N=403 n % 200 mg N=400 n % 300 mg N=400 n % 400 mg N=202 n % N=406 n % Dizziness not vertigo 64 16 81 20 90 23 57 28 28 7 Nausea 61 15 90 23 102 26 53 26 32 8 Constipation 49 12 68 17 85 21 60 30 17 4 Headache 49 12 62 16 46 12 32 16 43 11 Somnolence 33 8 45 11 29 7 41 20 7 2 Flushing 31 8 40 10 35 9 32 16 18 4 Pruritus 25 6 34 9 30 8 24 12 4 1 Vomiting 20 5 29 7 34 9 19 9 11 3 Insomnia 26 7 32 8 36 9 22 11 13 3 Dry Mouth 20 5 29 7 39 10 18 9 6 2 Diarrhea 15 4 27 7 37 9 10 5 17 4 Asthenia 14 4 24 6 26 7 13 6 7 2 Postural hypotension 7 2 17 4 8 2 11 5 9 2 Sweating increased 6 2 8 2 15 4 13 6 1 0 Anorexia 3 1 7 2 21 5 12 6 1 0 .\"\n }\n ]\n },\n {\n \"Term\": \"Illness\",\n \"MEDDRACode\": \"10080284\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"illness\",\n \"Probability\": \"0.0003690124\",\n \"SemanticContext\": \"Risks are increased in patients with a personal or family history of substance abuse including drug or alcohol abuse or addiction or mental illness e.g., major depression .\"\n }\n ]\n },\n {\n \"Term\": \"Hypersensitivity\",\n \"MEDDRACode\": \"10020751\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": true,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Hypersensitivity Reactions\",\n \"Probability\": \"0.9219652414\",\n \"SemanticContext\": \"6 ADVERSE REACTIONS The following serious adverse reactions are described in greater detail, in other sections: Addiction, Abuse, and Misuse [see Warnings and Precautions 5.1 ] Life-Threatening Respiratory Depression [see Warnings and Precautions 5.3 ] Ultra-Rapid Metabolism of Tramadol and Other Risk Factors for Life-Threatening Respiratory Depression in Children [see Warnings and Precautions 5.4 ] Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions 5.5 ] Interactions with Benzodiazepines and Other CNS Depressants [see Warnings and Precautions 5.7 ] Serotonin Syndrome [see Warnings and Precautions 5.8 ] Seizures [see Warnings and Precautions 5.9 ] Suicide [see Warnings and Precautions 5.10 ] Adrenal Insufficiency [see Warnings and Precautions 5.11 ] Severe Hypotension [see Warnings and Precautions 5.13 ] Gastrointestinal Adverse Reactions [see Warnings and Precautions 5.15 ] Hypersensitivity Reactions [see Warnings and Precautions 5.16 ] Withdrawal [see Warnings and Precautions 5.17 ] 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.\"\n },\n {\n \"VerbatimTerm\": \"Hypersensitivity Reactions\",\n \"Probability\": \"0.8650612831\",\n \"SemanticContext\": \"5.16 Anaphylaxis and Other Hypersensitivity Reactions Serious and rarely fatal hypersensitive reactions have been reported in patients receiving therapy with tramadol.\"\n },\n {\n \"VerbatimTerm\": \"hypersensitivity reactions\",\n \"Probability\": \"0.9612672329\",\n \"SemanticContext\": \"Other reported hypersensitivity reactions include pruritus, hives, bronchospasm, angioedema, toxic epidermal necrolysis and Stevens-Johnson syndrome.\"\n },\n {\n \"VerbatimTerm\": \"hypersensitivity reactions\",\n \"Probability\": \"0.001409173\",\n \"SemanticContext\": \"Patients with a history of hypersensitivity reactions to tramadol and other opioids may be at increased risk and therefore should not receive tramadol hydrochloride extended-release tablets.\"\n },\n {\n \"VerbatimTerm\": \"hypersensitivity reaction\",\n \"Probability\": \"0.0001275539\",\n \"SemanticContext\": \"Advise patients to seek immediate medical attention if they experience any symptoms of a hypersensitivity reaction [see Patient Counseling Information 17 ] .\"\n }\n ]\n },\n {\n \"Term\": \"Adrenal insufficiency\",\n \"MEDDRACode\": \"10001367\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Adrenal Insufficiency\",\n \"Probability\": \"0.115994513\",\n \"SemanticContext\": \"Adrenal Insufficiency : If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid.\"\n },\n {\n \"VerbatimTerm\": \"Adrenal Insufficiency\",\n \"Probability\": \"0.9852702618\",\n \"SemanticContext\": \"6 ADVERSE REACTIONS The following serious adverse reactions are described in greater detail, in other sections: Addiction, Abuse, and Misuse [see Warnings and Precautions 5.1 ] Life-Threatening Respiratory Depression [see Warnings and Precautions 5.3 ] Ultra-Rapid Metabolism of Tramadol and Other Risk Factors for Life-Threatening Respiratory Depression in Children [see Warnings and Precautions 5.4 ] Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions 5.5 ] Interactions with Benzodiazepines and Other CNS Depressants [see Warnings and Precautions 5.7 ] Serotonin Syndrome [see Warnings and Precautions 5.8 ] Seizures [see Warnings and Precautions 5.9 ] Suicide [see Warnings and Precautions 5.10 ] Adrenal Insufficiency [see Warnings and Precautions 5.11 ] Severe Hypotension [see Warnings and Precautions 5.13 ] Gastrointestinal Adverse Reactions [see Warnings and Precautions 5.15 ] Hypersensitivity Reactions [see Warnings and Precautions 5.16 ] Withdrawal [see Warnings and Precautions 5.17 ] 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.\"\n },\n {\n \"VerbatimTerm\": \"Adrenal Insufficiency\",\n \"Probability\": \"0.5873386264\",\n \"SemanticContext\": \"Adrenal Insufficiency Inform patients that opioids could cause adrenal insufficiency, a potentially life-threatening condition.\"\n },\n {\n \"VerbatimTerm\": \"Adrenal Insufficiency\",\n \"Probability\": \"0.7984864116\",\n \"SemanticContext\": \"5.11 Adrenal Insufficiency Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use.\"\n },\n {\n \"VerbatimTerm\": \"Adrenal insufficiency\",\n \"Probability\": \"0.8249887228\",\n \"SemanticContext\": \"Adrenal insufficiency: Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use.\"\n },\n {\n \"VerbatimTerm\": \"Adrenal insufficiency\",\n \"Probability\": \"0.6691302061\",\n \"SemanticContext\": \"Adrenal insufficiency may present with non-specific symptoms and signs such as nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure.\"\n },\n {\n \"VerbatimTerm\": \"adrenal insufficiency\",\n \"Probability\": \"0.9510415792\",\n \"SemanticContext\": \"Adrenal insufficiency: Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use.\"\n },\n {\n \"VerbatimTerm\": \"adrenal insufficiency\",\n \"Probability\": \"0.8092061877\",\n \"SemanticContext\": \"Adrenal Insufficiency Inform patients that opioids could cause adrenal insufficiency, a potentially life-threatening condition.\"\n },\n {\n \"VerbatimTerm\": \"adrenal insufficiency\",\n \"Probability\": \"0.965976119\",\n \"SemanticContext\": \"5.11 Adrenal Insufficiency Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use.\"\n },\n {\n \"VerbatimTerm\": \"adrenal insufficiency\",\n \"Probability\": \"0.5977256298\",\n \"SemanticContext\": \"Presentation of adrenal insufficiency may include non-specific symptoms and signs including nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure.\"\n },\n {\n \"VerbatimTerm\": \"adrenal insufficiency\",\n \"Probability\": \"0.0003885627\",\n \"SemanticContext\": \"If adrenal insufficiency is suspected, confirm the diagnosis with diagnostic testing as soon as possible.\"\n },\n {\n \"VerbatimTerm\": \"adrenal insufficiency\",\n \"Probability\": \"0.000217706\",\n \"SemanticContext\": \"If adrenal insufficiency is diagnosed, treat with physiologic replacement doses of corticosteroids.\"\n },\n {\n \"VerbatimTerm\": \"adrenal insufficiency\",\n \"Probability\": \"0.2265610099\",\n \"SemanticContext\": \"Other opioids may be tried as some cases reported use of a different opioid without recurrence of adrenal insufficiency.\"\n },\n {\n \"VerbatimTerm\": \"adrenal insufficiency\",\n \"Probability\": \"0.0704641938\",\n \"SemanticContext\": \"The information available does not identify any particular opioids as being more likely to be associated with adrenal insufficiency.\"\n }\n ]\n },\n {\n \"Term\": \"Hyperreflexia\",\n \"MEDDRACode\": \"10020745\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hyperreflexia\",\n \"Probability\": \"0.8675523996\",\n \"SemanticContext\": \"Serotonin syndrome symptoms may include mental status changes e.g., agitation, hallucinations, coma , autonomic instability e.g., tachycardia, labile blood pressure, hyperthermia , neuromuscular aberrations e.g., hyperreflexia, incoordination, rigidity , and/or gastrointestinal symptoms e.g., nausea, vomiting, diarrhea .\"\n }\n ]\n },\n {\n \"Term\": \"Hypopnoea\",\n \"MEDDRACode\": \"10021079\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"shallow breathing\",\n \"Probability\": \"0.0348971784\",\n \"SemanticContext\": \"Even at labeled dosage regimens, individuals who are ultra-rapid metabolizers may have life-threatening or fatal respiratory depression or experience signs of overdose such as extreme sleepiness, confusion, or shallow breathing [see Overdosage 10 ] .\"\n }\n ]\n },\n {\n \"Term\": \"Mental status changes\",\n \"MEDDRACode\": \"10048294\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"mental status changes\",\n \"Probability\": \"0.3649662137\",\n \"SemanticContext\": \"Serotonin syndrome symptoms may include mental status changes e.g., agitation, hallucinations, coma , autonomic instability e.g., tachycardia, labile blood pressure, hyperthermia , neuromuscular aberrations e.g., hyperreflexia, incoordination, rigidity , and/or gastrointestinal symptoms e.g., nausea, vomiting, diarrhea .\"\n }\n ]\n },\n {\n \"Term\": \"Toxic epidermal necrolysis\",\n \"MEDDRACode\": \"10044223\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"toxic epidermal necrolysis\",\n \"Probability\": \"0.9554685354\",\n \"SemanticContext\": \"Other reported hypersensitivity reactions include pruritus, hives, bronchospasm, angioedema, toxic epidermal necrolysis and Stevens-Johnson syndrome.\"\n }\n ]\n },\n {\n \"Term\": \"Withdrawal syndrome\",\n \"MEDDRACode\": \"10048010\",\n \"Overdose\": true,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"withdrawal symptoms\",\n \"Probability\": \"0.0127127171\",\n \"SemanticContext\": \"DRUG INTERACTIONS Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics: Avoid use with tramadol hydrochloride extended-release tablets because they may reduce analgesic effect of tramadol hydrochloride extended-release tablets or precipitate withdrawal symptoms.\"\n },\n {\n \"VerbatimTerm\": \"withdrawal symptoms\",\n \"Probability\": \"0.0767877102\",\n \"SemanticContext\": \"Physical dependence is a physiological state in which the body adapts to the drug after a period of regular exposure, resulting in withdrawal symptoms after abrupt discontinuation or a significant dosage reduction of a drug.\"\n },\n {\n \"VerbatimTerm\": \"withdrawal symptoms\",\n \"Probability\": \"0.2953691483\",\n \"SemanticContext\": \"Rapid tapering of tramadol hydrochloride extended-release tablets in a patient physically dependent on opioids may lead to serious withdrawal symptoms, uncontrolled pain, and suicide.\"\n },\n {\n \"VerbatimTerm\": \"withdrawal symptoms\",\n \"Probability\": \"0.0051228404\",\n \"SemanticContext\": \"To improve the likelihood of a successful taper and minimize withdrawal symptoms, it is important that the opioid tapering schedule is agreed upon by the patient.\"\n },\n {\n \"VerbatimTerm\": \"withdrawal symptoms\",\n \"Probability\": \"0.1311777234\",\n \"SemanticContext\": \"Examples: phenelzine, tranylcypromine, linezolid Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics Clinical Impact: May reduce the analgesic effect of tramadol hydrochloride extended-release tablets and/or precipitate withdrawal symptoms.\"\n },\n {\n \"VerbatimTerm\": \"withdrawal symptoms\",\n \"Probability\": \"0.0758216381\",\n \"SemanticContext\": \"Rapid discontinuation of opioid analgesics in patients who are physically dependent on opioids has resulted in serious withdrawal symptoms, uncontrolled pain, and suicide.\"\n },\n {\n \"VerbatimTerm\": \"withdrawal symptoms\",\n \"Probability\": \"0.0065332949\",\n \"SemanticContext\": \"Patients may also attempt to treat their pain or withdrawal symptoms with illicit opioids, such as heroin, and other substances.\"\n },\n {\n \"VerbatimTerm\": \"withdrawal symptoms\",\n \"Probability\": \"0.0315282047\",\n \"SemanticContext\": \"For patients on tramadol hydrochloride extended-release tablets who are physically opioid-dependent, initiate the taper by a small enough increment e.g., no greater than 10% to 25% of the total daily dose to avoid withdrawal symptoms, and proceed with dose-lowering at an interval of every 2 to 4 weeks.\"\n },\n {\n \"VerbatimTerm\": \"withdrawal symptoms\",\n \"Probability\": \"0.0026292205\",\n \"SemanticContext\": \"Reassess the patient frequently to manage pain and withdrawal symptoms, should they emerge.\"\n },\n {\n \"VerbatimTerm\": \"withdrawal symptoms\",\n \"Probability\": \"0.9717495441\",\n \"SemanticContext\": \"Common withdrawal symptoms include restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia, and mydriasis.\"\n },\n {\n \"VerbatimTerm\": \"withdrawal symptoms\",\n \"Probability\": \"0.0037903786\",\n \"SemanticContext\": \"If withdrawal symptoms arise, it may be necessary to pause the taper for a period of time or raise the dose of the opioid analgesic to the previous dose, and then proceed with a slower taper.\"\n },\n {\n \"VerbatimTerm\": \"withdrawal symptoms\",\n \"Probability\": \"0.0001616776\",\n \"SemanticContext\": \"Important Discontinuation Instructions In order to avoid developing withdrawal symptoms, instruct patients not to discontinue tramadol hydrochloride extended-release tablets without first discussing a tapering plan with the prescriber [see Dosage and Administration 2.5 ].\"\n },\n {\n \"VerbatimTerm\": \"withdrawal symptoms\",\n \"Probability\": \"0.183683455\",\n \"SemanticContext\": \"The severity of the withdrawal symptoms experienced will depend on the degree of physical dependence and the dose of the antagonist administered.\"\n },\n {\n \"VerbatimTerm\": \"withdrawal symptoms\",\n \"Probability\": \"0.0160230398\",\n \"SemanticContext\": \"In these patients, mixed agonist/antagonist and partial agonist analgesics may reduce the analgesic effect and/or precipitate withdrawal symptoms [see Drug Interactions 7 ].\"\n },\n {\n \"VerbatimTerm\": \"withdrawal symptoms\",\n \"Probability\": \"0.014850646300000001\",\n \"SemanticContext\": \"Prolonged use of tramadol hydrochloride extended-release tablets during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.\"\n }\n ]\n },\n {\n \"Term\": \"Drug interaction\",\n \"MEDDRACode\": \"10013710\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": true,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"INTERACTIONS\",\n \"Probability\": \"0.0019847453\",\n \"SemanticContext\": \"TRAMADOL HYDROCHLORIDE extended-release tablets for oral use, C IV Initial U.S. Approval: 1995 WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY REMS ; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; ULTRA-RAPID METABOLISM OF TRAMADOL AND OTHER RISK FACTORS FOR LIFE-THREATENING RESPIRATORY DEPRESSION IN CHILDREN; NEONATAL OPIOID WITHDRAWAL SYNDROME; INTERACTIONS WITH DRUGS AFFECTING CYTOCHROME P450 ISOENZYMES; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS See full prescribing information for complete boxed warning .\"\n },\n {\n \"VerbatimTerm\": \"Interactions\",\n \"Probability\": \"0.0162598491\",\n \"SemanticContext\": \"6 ADVERSE REACTIONS The following serious adverse reactions are described in greater detail, in other sections: Addiction, Abuse, and Misuse [see Warnings and Precautions 5.1 ] Life-Threatening Respiratory Depression [see Warnings and Precautions 5.3 ] Ultra-Rapid Metabolism of Tramadol and Other Risk Factors for Life-Threatening Respiratory Depression in Children [see Warnings and Precautions 5.4 ] Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions 5.5 ] Interactions with Benzodiazepines and Other CNS Depressants [see Warnings and Precautions 5.7 ] Serotonin Syndrome [see Warnings and Precautions 5.8 ] Seizures [see Warnings and Precautions 5.9 ] Suicide [see Warnings and Precautions 5.10 ] Adrenal Insufficiency [see Warnings and Precautions 5.11 ] Severe Hypotension [see Warnings and Precautions 5.13 ] Gastrointestinal Adverse Reactions [see Warnings and Precautions 5.15 ] Hypersensitivity Reactions [see Warnings and Precautions 5.16 ] Withdrawal [see Warnings and Precautions 5.17 ] 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.\"\n },\n {\n \"VerbatimTerm\": \"Interactions\",\n \"Probability\": \"0.0023202002\",\n \"SemanticContext\": \"Interactions with Benzodiazepines and Other CNS Depressants Inform patients and caregivers that potentially fatal additive effects may occur if tramadol hydrochloride extended-release tablets are used with benzodiazepines or other CNS depressants, including alcohol, and not to use these concomitantly unless supervised by a healthcare provider [see Warnings and Precautions 5.7 , Drug Interactions 7 ].\"\n },\n {\n \"VerbatimTerm\": \"Interactions\",\n \"Probability\": \"5.98581E-05\",\n \"SemanticContext\": \"5.6 Risks of Interactions with Drugs Affecting Cytochrome P450 Isoenzymes The effects of concomitant use or discontinuation of cytochrome P450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors on levels of tramadol and M1 from tramadol hydrochloride extended-release tablets are complex.\"\n },\n {\n \"VerbatimTerm\": \"Interaction\",\n \"Probability\": \"0.0001303852\",\n \"SemanticContext\": \"MAOI Interaction Inform patients not to take tramadol hydrochloride extended-release tablets while using any drugs that inhibit monoamine oxidase.\"\n },\n {\n \"VerbatimTerm\": \"Interaction\",\n \"Probability\": \"0.000148356\",\n \"SemanticContext\": \"Cytochrome P450 3A4 Interaction The concomitant use of tramadol hydrochloride extended-release tablets with cytochrome P450 3A4 inhibitors, such as macrolide antibiotics e.g., erythromycin , azole-antifungal agents e.g., ketoconazole , and protease inhibitors e.g., ritonavir or discontinuation of a cytochrome P450 3A4 inducer such as rifampin, carbamazepine, and phenytoin, may result in an increase in tramadol plasma concentrations, which could increase or prolong adverse reactions, increase the risk for serious adverse events including seizures and serotonin syndrome, and may cause potentially fatal respiratory depression.\"\n },\n {\n \"VerbatimTerm\": \"interaction\",\n \"Probability\": \"1.80725E-05\",\n \"SemanticContext\": \"Intervention: Monitor the prothrombin time of patients on warfarin for signs of an interaction and adjust the dosage of warfarin as needed.\"\n },\n {\n \"VerbatimTerm\": \"interactions\",\n \"Probability\": \"7.25535E-05\",\n \"SemanticContext\": \"Monoamine Oxidase Inhibitors MAOIs Clinical Impact: MAOI interactions with opioids may manifest as serotonin syndrome [see Warnings and Precautions 5.8 ] or opioid toxicity e.g., respiratory depression, coma [see Warnings and Precautions 5.3 ].\"\n }\n ]\n },\n {\n \"Term\": \"Yawning\",\n \"MEDDRACode\": \"10048232\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"yawning\",\n \"Probability\": \"0.9766795039\",\n \"SemanticContext\": \"Common withdrawal symptoms include restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia, and mydriasis.\"\n }\n ]\n },\n {\n \"Term\": \"Drug tolerance\",\n \"MEDDRACode\": \"10052804\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"tolerance\",\n \"Probability\": \"0.0003131926\",\n \"SemanticContext\": \"For opioid-naïve and opioid non-tolerant patients, initiate tramadol hydrochloride extended-release tablets at a dose of 100 mg once daily, then titrate up by 100 mg increments every 5 days according to need and tolerance.\"\n },\n {\n \"VerbatimTerm\": \"tolerance\",\n \"Probability\": \"0.0001841784\",\n \"SemanticContext\": \"For patients currently on tramadol IR, calculate total 24-hr IR dose, and initiate tramadol hydrochloride extended-release tablets at a dose rounded down to next lower 100 mg increment; then adjust dose according to need and tolerance.\"\n },\n {\n \"VerbatimTerm\": \"tolerance\",\n \"Probability\": \"0.0002457201\",\n \"SemanticContext\": \"Abuse and addiction are separate and distinct from physical dependence and tolerance.\"\n },\n {\n \"VerbatimTerm\": \"tolerance\",\n \"Probability\": \"9.5772E-06\",\n \"SemanticContext\": \"Healthcare providers should be aware that addiction may not be accompanied by concurrent tolerance and symptoms of physical dependence in all addicts.\"\n },\n {\n \"VerbatimTerm\": \"tolerance\",\n \"Probability\": \"0.0002457201\",\n \"SemanticContext\": \"Abuse and addiction are separate and distinct from physical dependence and tolerance.\"\n },\n {\n \"VerbatimTerm\": \"tolerance\",\n \"Probability\": \"9.5772E-06\",\n \"SemanticContext\": \"Healthcare providers should be aware that addiction may not be accompanied by concurrent tolerance and symptoms of physical dependence in all addicts.\"\n },\n {\n \"VerbatimTerm\": \"tolerance\",\n \"Probability\": \"0.0001599193\",\n \"SemanticContext\": \"9.3 Dependence Both tolerance and physical dependence can develop during chronic opioid therapy.\"\n },\n {\n \"VerbatimTerm\": \"tolerance\",\n \"Probability\": \"8.71391E-05\",\n \"SemanticContext\": \"The minimum effective analgesic concentration of tramadol for any individual patient may increase over time due to an increase in pain, the development of a new pain syndrome, and/or the development of analgesic tolerance [see Dosage and Administration 2.1 ] .\"\n },\n {\n \"VerbatimTerm\": \"tolerance\",\n \"Probability\": \"0.0008040965\",\n \"SemanticContext\": \"In opioid-tolerant patients, the situation may be altered by the development of tolerance to opioid-related adverse reactions [ see Dosage and Administration 2.1 , 2.3 ].\"\n },\n {\n \"VerbatimTerm\": \"Tolerance\",\n \"Probability\": \"0.0002866089\",\n \"SemanticContext\": \"Tolerance is the need for increasing doses of opioids to maintain a defined effect such as analgesia in the absence of disease progression or other external factors .\"\n },\n {\n \"VerbatimTerm\": \"Tolerance\",\n \"Probability\": \"0.0035586357\",\n \"SemanticContext\": \"Tolerance may occur to both the desired and undesired effects of drugs, and may develop at different rates for different effects.\"\n }\n ]\n },\n {\n \"Term\": \"Blood pressure increased\",\n \"MEDDRACode\": \"10005750\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"increased blood pressure\",\n \"Probability\": \"0.6428662539\",\n \"SemanticContext\": \"Other signs and symptoms also may develop, including irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate.\"\n }\n ]\n },\n {\n \"Term\": \"Dyspepsia\",\n \"MEDDRACode\": \"10013946\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": true\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"dyspepsia\",\n \"Probability\": \"0.9962597489\",\n \"SemanticContext\": \"Eye disorders: vision blurred Gastrointestinal disorders: abdominal pain upper, dyspepsia, abdominal pain, sore throat General disorders: weakness, pain, feeling hot, influenza like illness, fall, rigors, lethargy, pyrexia, chest pain Infections and infestations: nasopharyngitis, upper respiratory tract infection, sinusitis, influenza, gastroenteritis viral, urinary tract infection, bronchitis Investigations: blood creatine phosphokinase increased, weight decreased Metabolism and nutrition disorders: appetite decreased Musculoskeletal, connective tissue and bone disorders: arthralgia, back pain, pain in limb, neck pain Nervous system disorders: tremor, paresthesia, hypoesthesia Psychiatric disorders: nervousness, anxiety, depression, restlessness Respiratory, thoracic and mediastinal disorders: sneezing, cough, rhinorrhea, nasal congestion, dyspnea, sinus congestion Skin and subcutaneous tissue disorders: sweating increased, dermatitis Vascular disorders: hot flushes, vasodilatation Adverse Reactions With Incidence Rates of 0.5% to \\n <1.0% and Serious Adverse Reactions Reported in at Least 2 patients During Clinical Trials Cardiac disorders: palpitations, myocardial infarction Ear and labyrinth disorders: tinnitus, vertigo Gastrointestinal disorders: flatulence, toothache, constipation aggravated, appendicitis, pancreatitis General disorders: feeling jittery, edema lower limb, shivering, joint swelling, malaise, drug withdrawal syndrome, peripheral swelling Hepato-biliary disorders: cholelithiasis, cholecystitis Infections and infestations: cellulitis, ear infection, gastroenteritis, pneumonia, viral infection Injury and poisoning: joint sprain, muscle injury Investigations: alanine aminotransferase increased, blood pressure increased, aspartate aminotransferase increased, heart rate increased, blood glucose increased, liver function tests abnormal Musculoskeletal, connective tissue and bone disorders: muscle cramps, muscle spasms, joint stiffness, muscle twitching, myalgia, osteoarthritis aggravated Nervous system disorders: migraine, sedation, syncope, disturbance in attention, dizziness aggravated Psychiatric disorders: euphoric mood, irritability, libido decreased, sleep disorder, agitation, disorientation, abnormal dreams Renal and urinary disorders: difficulty in micturition, urinary frequency, hematuria, dysuria, urinary retention Respiratory, thoracic and mediastinal disorders: yawning Skin and subcutaneous tissue disorders: contusion, piloerection, clamminess, night sweats, urticaria Vascular disorders: hypertension aggravated, hypertension, peripheral ischemia 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of tramadol.\"\n },\n {\n \"VerbatimTerm\": \"dyspepsia\",\n \"Probability\": \"0.9910011292\",\n \"SemanticContext\": \"In general, higher incidence rates of adverse events were observed for patients older than 65 years of age compared with patients 65 years and younger, particularly for the following adverse events: constipation, fatigue, weakness, postural hypotension and dyspepsia.\"\n }\n ]\n },\n {\n \"Term\": \"Palpitations\",\n \"MEDDRACode\": \"10033557\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"palpitations\",\n \"Probability\": \"0.9943681955\",\n \"SemanticContext\": \"Eye disorders: vision blurred Gastrointestinal disorders: abdominal pain upper, dyspepsia, abdominal pain, sore throat General disorders: weakness, pain, feeling hot, influenza like illness, fall, rigors, lethargy, pyrexia, chest pain Infections and infestations: nasopharyngitis, upper respiratory tract infection, sinusitis, influenza, gastroenteritis viral, urinary tract infection, bronchitis Investigations: blood creatine phosphokinase increased, weight decreased Metabolism and nutrition disorders: appetite decreased Musculoskeletal, connective tissue and bone disorders: arthralgia, back pain, pain in limb, neck pain Nervous system disorders: tremor, paresthesia, hypoesthesia Psychiatric disorders: nervousness, anxiety, depression, restlessness Respiratory, thoracic and mediastinal disorders: sneezing, cough, rhinorrhea, nasal congestion, dyspnea, sinus congestion Skin and subcutaneous tissue disorders: sweating increased, dermatitis Vascular disorders: hot flushes, vasodilatation Adverse Reactions With Incidence Rates of 0.5% to \\n <1.0% and Serious Adverse Reactions Reported in at Least 2 patients During Clinical Trials Cardiac disorders: palpitations, myocardial infarction Ear and labyrinth disorders: tinnitus, vertigo Gastrointestinal disorders: flatulence, toothache, constipation aggravated, appendicitis, pancreatitis General disorders: feeling jittery, edema lower limb, shivering, joint swelling, malaise, drug withdrawal syndrome, peripheral swelling Hepato-biliary disorders: cholelithiasis, cholecystitis Infections and infestations: cellulitis, ear infection, gastroenteritis, pneumonia, viral infection Injury and poisoning: joint sprain, muscle injury Investigations: alanine aminotransferase increased, blood pressure increased, aspartate aminotransferase increased, heart rate increased, blood glucose increased, liver function tests abnormal Musculoskeletal, connective tissue and bone disorders: muscle cramps, muscle spasms, joint stiffness, muscle twitching, myalgia, osteoarthritis aggravated Nervous system disorders: migraine, sedation, syncope, disturbance in attention, dizziness aggravated Psychiatric disorders: euphoric mood, irritability, libido decreased, sleep disorder, agitation, disorientation, abnormal dreams Renal and urinary disorders: difficulty in micturition, urinary frequency, hematuria, dysuria, urinary retention Respiratory, thoracic and mediastinal disorders: yawning Skin and subcutaneous tissue disorders: contusion, piloerection, clamminess, night sweats, urticaria Vascular disorders: hypertension aggravated, hypertension, peripheral ischemia 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of tramadol.\"\n }\n ]\n },\n {\n \"Term\": \"Investigation\",\n \"MEDDRACode\": \"10062026\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Investigations\",\n \"Probability\": \"0.9721921682\",\n \"SemanticContext\": \"Eye disorders: vision blurred Gastrointestinal disorders: abdominal pain upper, dyspepsia, abdominal pain, sore throat General disorders: weakness, pain, feeling hot, influenza like illness, fall, rigors, lethargy, pyrexia, chest pain Infections and infestations: nasopharyngitis, upper respiratory tract infection, sinusitis, influenza, gastroenteritis viral, urinary tract infection, bronchitis Investigations: blood creatine phosphokinase increased, weight decreased Metabolism and nutrition disorders: appetite decreased Musculoskeletal, connective tissue and bone disorders: arthralgia, back pain, pain in limb, neck pain Nervous system disorders: tremor, paresthesia, hypoesthesia Psychiatric disorders: nervousness, anxiety, depression, restlessness Respiratory, thoracic and mediastinal disorders: sneezing, cough, rhinorrhea, nasal congestion, dyspnea, sinus congestion Skin and subcutaneous tissue disorders: sweating increased, dermatitis Vascular disorders: hot flushes, vasodilatation Adverse Reactions With Incidence Rates of 0.5% to \\n <1.0% and Serious Adverse Reactions Reported in at Least 2 patients During Clinical Trials Cardiac disorders: palpitations, myocardial infarction Ear and labyrinth disorders: tinnitus, vertigo Gastrointestinal disorders: flatulence, toothache, constipation aggravated, appendicitis, pancreatitis General disorders: feeling jittery, edema lower limb, shivering, joint swelling, malaise, drug withdrawal syndrome, peripheral swelling Hepato-biliary disorders: cholelithiasis, cholecystitis Infections and infestations: cellulitis, ear infection, gastroenteritis, pneumonia, viral infection Injury and poisoning: joint sprain, muscle injury Investigations: alanine aminotransferase increased, blood pressure increased, aspartate aminotransferase increased, heart rate increased, blood glucose increased, liver function tests abnormal Musculoskeletal, connective tissue and bone disorders: muscle cramps, muscle spasms, joint stiffness, muscle twitching, myalgia, osteoarthritis aggravated Nervous system disorders: migraine, sedation, syncope, disturbance in attention, dizziness aggravated Psychiatric disorders: euphoric mood, irritability, libido decreased, sleep disorder, agitation, disorientation, abnormal dreams Renal and urinary disorders: difficulty in micturition, urinary frequency, hematuria, dysuria, urinary retention Respiratory, thoracic and mediastinal disorders: yawning Skin and subcutaneous tissue disorders: contusion, piloerection, clamminess, night sweats, urticaria Vascular disorders: hypertension aggravated, hypertension, peripheral ischemia 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of tramadol.\"\n }\n ]\n },\n {\n \"Term\": \"Anxiety\",\n \"MEDDRACode\": \"10002855\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"anxiety\",\n \"Probability\": \"0.9821605682\",\n \"SemanticContext\": \"Eye disorders: vision blurred Gastrointestinal disorders: abdominal pain upper, dyspepsia, abdominal pain, sore throat General disorders: weakness, pain, feeling hot, influenza like illness, fall, rigors, lethargy, pyrexia, chest pain Infections and infestations: nasopharyngitis, upper respiratory tract infection, sinusitis, influenza, gastroenteritis viral, urinary tract infection, bronchitis Investigations: blood creatine phosphokinase increased, weight decreased Metabolism and nutrition disorders: appetite decreased Musculoskeletal, connective tissue and bone disorders: arthralgia, back pain, pain in limb, neck pain Nervous system disorders: tremor, paresthesia, hypoesthesia Psychiatric disorders: nervousness, anxiety, depression, restlessness Respiratory, thoracic and mediastinal disorders: sneezing, cough, rhinorrhea, nasal congestion, dyspnea, sinus congestion Skin and subcutaneous tissue disorders: sweating increased, dermatitis Vascular disorders: hot flushes, vasodilatation Adverse Reactions With Incidence Rates of 0.5% to \\n <1.0% and Serious Adverse Reactions Reported in at Least 2 patients During Clinical Trials Cardiac disorders: palpitations, myocardial infarction Ear and labyrinth disorders: tinnitus, vertigo Gastrointestinal disorders: flatulence, toothache, constipation aggravated, appendicitis, pancreatitis General disorders: feeling jittery, edema lower limb, shivering, joint swelling, malaise, drug withdrawal syndrome, peripheral swelling Hepato-biliary disorders: cholelithiasis, cholecystitis Infections and infestations: cellulitis, ear infection, gastroenteritis, pneumonia, viral infection Injury and poisoning: joint sprain, muscle injury Investigations: alanine aminotransferase increased, blood pressure increased, aspartate aminotransferase increased, heart rate increased, blood glucose increased, liver function tests abnormal Musculoskeletal, connective tissue and bone disorders: muscle cramps, muscle spasms, joint stiffness, muscle twitching, myalgia, osteoarthritis aggravated Nervous system disorders: migraine, sedation, syncope, disturbance in attention, dizziness aggravated Psychiatric disorders: euphoric mood, irritability, libido decreased, sleep disorder, agitation, disorientation, abnormal dreams Renal and urinary disorders: difficulty in micturition, urinary frequency, hematuria, dysuria, urinary retention Respiratory, thoracic and mediastinal disorders: yawning Skin and subcutaneous tissue disorders: contusion, piloerection, clamminess, night sweats, urticaria Vascular disorders: hypertension aggravated, hypertension, peripheral ischemia 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of tramadol.\"\n },\n {\n \"VerbatimTerm\": \"anxiety\",\n \"Probability\": \"0.326883316\",\n \"SemanticContext\": \"Other signs and symptoms also may develop, including irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate.\"\n }\n ]\n },\n {\n \"Term\": \"Vasodilatation\",\n \"MEDDRACode\": \"10047141\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"vasodilatation\",\n \"Probability\": \"0.8944745064\",\n \"SemanticContext\": \"Eye disorders: vision blurred Gastrointestinal disorders: abdominal pain upper, dyspepsia, abdominal pain, sore throat General disorders: weakness, pain, feeling hot, influenza like illness, fall, rigors, lethargy, pyrexia, chest pain Infections and infestations: nasopharyngitis, upper respiratory tract infection, sinusitis, influenza, gastroenteritis viral, urinary tract infection, bronchitis Investigations: blood creatine phosphokinase increased, weight decreased Metabolism and nutrition disorders: appetite decreased Musculoskeletal, connective tissue and bone disorders: arthralgia, back pain, pain in limb, neck pain Nervous system disorders: tremor, paresthesia, hypoesthesia Psychiatric disorders: nervousness, anxiety, depression, restlessness Respiratory, thoracic and mediastinal disorders: sneezing, cough, rhinorrhea, nasal congestion, dyspnea, sinus congestion Skin and subcutaneous tissue disorders: sweating increased, dermatitis Vascular disorders: hot flushes, vasodilatation Adverse Reactions With Incidence Rates of 0.5% to \\n <1.0% and Serious Adverse Reactions Reported in at Least 2 patients During Clinical Trials Cardiac disorders: palpitations, myocardial infarction Ear and labyrinth disorders: tinnitus, vertigo Gastrointestinal disorders: flatulence, toothache, constipation aggravated, appendicitis, pancreatitis General disorders: feeling jittery, edema lower limb, shivering, joint swelling, malaise, drug withdrawal syndrome, peripheral swelling Hepato-biliary disorders: cholelithiasis, cholecystitis Infections and infestations: cellulitis, ear infection, gastroenteritis, pneumonia, viral infection Injury and poisoning: joint sprain, muscle injury Investigations: alanine aminotransferase increased, blood pressure increased, aspartate aminotransferase increased, heart rate increased, blood glucose increased, liver function tests abnormal Musculoskeletal, connective tissue and bone disorders: muscle cramps, muscle spasms, joint stiffness, muscle twitching, myalgia, osteoarthritis aggravated Nervous system disorders: migraine, sedation, syncope, disturbance in attention, dizziness aggravated Psychiatric disorders: euphoric mood, irritability, libido decreased, sleep disorder, agitation, disorientation, abnormal dreams Renal and urinary disorders: difficulty in micturition, urinary frequency, hematuria, dysuria, urinary retention Respiratory, thoracic and mediastinal disorders: yawning Skin and subcutaneous tissue disorders: contusion, piloerection, clamminess, night sweats, urticaria Vascular disorders: hypertension aggravated, hypertension, peripheral ischemia 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of tramadol.\"\n }\n ]\n },\n {\n \"Term\": \"Vomiting\",\n \"MEDDRACode\": \"10047700\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"vomiting\",\n \"Probability\": \"0.9955341816\",\n \"SemanticContext\": \"ADVERSE REACTIONS Most common adverse reactions =10% and =2 x placebo rate : Dizziness, constipation, nausea, headache, somnolence, flushing, pruritus, vomiting, insomnia, dry mouth.\"\n },\n {\n \"VerbatimTerm\": \"vomiting\",\n \"Probability\": \"0.9918984175\",\n \"SemanticContext\": \"The most common adverse reactions from Table 1 occurring in =10% and =2 x placebo rate of the patients treated with tramadol hydrochloride extended-release tablets are dizziness not vertigo , nausea, constipation, headache, somnolence, flushing, pruritus, vomiting, insomnia, and dry mouth.\"\n },\n {\n \"VerbatimTerm\": \"vomiting\",\n \"Probability\": \"0.907764554\",\n \"SemanticContext\": \"Concentration--Adverse Reaction Relationships There is a relationship between increasing tramadol plasma concentration and increasing frequency of dose-related opioid adverse reactions such as nausea, vomiting, CNS effects, and respiratory depression.\"\n },\n {\n \"VerbatimTerm\": \"vomiting\",\n \"Probability\": \"0.6137365103\",\n \"SemanticContext\": \"Other signs and symptoms also may develop, including irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate.\"\n },\n {\n \"VerbatimTerm\": \"vomiting\",\n \"Probability\": \"0.9684486389\",\n \"SemanticContext\": \"Adrenal insufficiency may present with non-specific symptoms and signs such as nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure.\"\n },\n {\n \"VerbatimTerm\": \"vomiting\",\n \"Probability\": \"0.979385376\",\n \"SemanticContext\": \"Neonatal opioid withdrawal syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea, and failure to gain weight.\"\n },\n {\n \"VerbatimTerm\": \"vomiting\",\n \"Probability\": \"0.9317337275\",\n \"SemanticContext\": \"Serotonin syndrome symptoms may include mental status changes e.g., agitation, hallucinations, coma , autonomic instability e.g., tachycardia, labile blood pressure, hyperthermia , neuromuscular aberrations e.g., hyperreflexia, incoordination, rigidity , and/or gastrointestinal symptoms e.g., nausea, vomiting, diarrhea .\"\n },\n {\n \"VerbatimTerm\": \"vomiting\",\n \"Probability\": \"0.9162968397\",\n \"SemanticContext\": \"Presentation of adrenal insufficiency may include non-specific symptoms and signs including nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure.\"\n },\n {\n \"VerbatimTerm\": \"vomiting\",\n \"Probability\": \"0.9607931972\",\n \"SemanticContext\": \"The possible side effects of tramadol hydrochloride extended-release tablets: constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain, seizure.\"\n },\n {\n \"VerbatimTerm\": \"Vomiting\",\n \"Probability\": \"0.9990336895\",\n \"SemanticContext\": \"MedDRA Preferred Term Tramadol Hydrochloride Extended-Release Tablets Placebo 100 mg N=403 n % 200 mg N=400 n % 300 mg N=400 n % 400 mg N=202 n % N=406 n % Dizziness not vertigo 64 16 81 20 90 23 57 28 28 7 Nausea 61 15 90 23 102 26 53 26 32 8 Constipation 49 12 68 17 85 21 60 30 17 4 Headache 49 12 62 16 46 12 32 16 43 11 Somnolence 33 8 45 11 29 7 41 20 7 2 Flushing 31 8 40 10 35 9 32 16 18 4 Pruritus 25 6 34 9 30 8 24 12 4 1 Vomiting 20 5 29 7 34 9 19 9 11 3 Insomnia 26 7 32 8 36 9 22 11 13 3 Dry Mouth 20 5 29 7 39 10 18 9 6 2 Diarrhea 15 4 27 7 37 9 10 5 17 4 Asthenia 14 4 24 6 26 7 13 6 7 2 Postural hypotension 7 2 17 4 8 2 11 5 9 2 Sweating increased 6 2 8 2 15 4 13 6 1 0 Anorexia 3 1 7 2 21 5 12 6 1 0 .\"\n }\n ]\n },\n {\n \"Term\": \"Myocardial infarction\",\n \"MEDDRACode\": \"10028596\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"myocardial infarction\",\n \"Probability\": \"0.9744311571\",\n \"SemanticContext\": \"Eye disorders: vision blurred Gastrointestinal disorders: abdominal pain upper, dyspepsia, abdominal pain, sore throat General disorders: weakness, pain, feeling hot, influenza like illness, fall, rigors, lethargy, pyrexia, chest pain Infections and infestations: nasopharyngitis, upper respiratory tract infection, sinusitis, influenza, gastroenteritis viral, urinary tract infection, bronchitis Investigations: blood creatine phosphokinase increased, weight decreased Metabolism and nutrition disorders: appetite decreased Musculoskeletal, connective tissue and bone disorders: arthralgia, back pain, pain in limb, neck pain Nervous system disorders: tremor, paresthesia, hypoesthesia Psychiatric disorders: nervousness, anxiety, depression, restlessness Respiratory, thoracic and mediastinal disorders: sneezing, cough, rhinorrhea, nasal congestion, dyspnea, sinus congestion Skin and subcutaneous tissue disorders: sweating increased, dermatitis Vascular disorders: hot flushes, vasodilatation Adverse Reactions With Incidence Rates of 0.5% to \\n <1.0% and Serious Adverse Reactions Reported in at Least 2 patients During Clinical Trials Cardiac disorders: palpitations, myocardial infarction Ear and labyrinth disorders: tinnitus, vertigo Gastrointestinal disorders: flatulence, toothache, constipation aggravated, appendicitis, pancreatitis General disorders: feeling jittery, edema lower limb, shivering, joint swelling, malaise, drug withdrawal syndrome, peripheral swelling Hepato-biliary disorders: cholelithiasis, cholecystitis Infections and infestations: cellulitis, ear infection, gastroenteritis, pneumonia, viral infection Injury and poisoning: joint sprain, muscle injury Investigations: alanine aminotransferase increased, blood pressure increased, aspartate aminotransferase increased, heart rate increased, blood glucose increased, liver function tests abnormal Musculoskeletal, connective tissue and bone disorders: muscle cramps, muscle spasms, joint stiffness, muscle twitching, myalgia, osteoarthritis aggravated Nervous system disorders: migraine, sedation, syncope, disturbance in attention, dizziness aggravated Psychiatric disorders: euphoric mood, irritability, libido decreased, sleep disorder, agitation, disorientation, abnormal dreams Renal and urinary disorders: difficulty in micturition, urinary frequency, hematuria, dysuria, urinary retention Respiratory, thoracic and mediastinal disorders: yawning Skin and subcutaneous tissue disorders: contusion, piloerection, clamminess, night sweats, urticaria Vascular disorders: hypertension aggravated, hypertension, peripheral ischemia 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of tramadol.\"\n }\n ]\n },\n {\n \"Term\": \"Nervousness\",\n \"MEDDRACode\": \"10029216\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"nervous\",\n \"Probability\": \"0.0001741052\",\n \"SemanticContext\": \"Concomitant use of opioids with benzodiazepines or other central nervous system CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.\"\n },\n {\n \"VerbatimTerm\": \"nervous\",\n \"Probability\": \"0.0005558431\",\n \"SemanticContext\": \"The risk is increased with concurrent use of tramadol hydrochloride extended-release tablets with alcohol and other central nervous system depressants.\"\n },\n {\n \"VerbatimTerm\": \"nervous\",\n \"Probability\": \"0.0005558431\",\n \"SemanticContext\": \"The risk is increased with concurrent use of tramadol hydrochloride extended-release tablets with alcohol and other central nervous system depressants.\"\n },\n {\n \"VerbatimTerm\": \"nervous\",\n \"Probability\": \"0.000169754\",\n \"SemanticContext\": \"Taking tramadol hydrochloride extended-release tablets with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants including street drugs can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.\"\n },\n {\n \"VerbatimTerm\": \"nervous\",\n \"Probability\": \"0.0004346967\",\n \"SemanticContext\": \"Titrate the dosage of tramadol hydrochloride extended-release tablets slowly in geriatric patients and monitor closely for signs of central nervous system and respiratory depression [see Warnings and Precautions 5.12 ] .\"\n },\n {\n \"VerbatimTerm\": \"Nervous\",\n \"Probability\": \"0.0201847553\",\n \"SemanticContext\": \"12.2 Pharmacodynamics Effects on the Central Nervous System Tramadol produces respiratory depression by direct action on brain stem respiratory centers.\"\n },\n {\n \"VerbatimTerm\": \"Nervous\",\n \"Probability\": \"0.0096356869\",\n \"SemanticContext\": \"Examples: Rifampin, carbamazepine, phenytoin Benzodiazepines and Other Central Nervous System CNS Depressants Clinical Impact: Due to additive pharmacologic effect, the concomitant use of benzodiazepines or other CNS depressants, including alcohol, can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death.\"\n }\n ]\n },\n {\n \"Term\": \"Pruritus\",\n \"MEDDRACode\": \"10037087\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"pruritus\",\n \"Probability\": \"0.9975259304\",\n \"SemanticContext\": \"ADVERSE REACTIONS Most common adverse reactions =10% and =2 x placebo rate : Dizziness, constipation, nausea, headache, somnolence, flushing, pruritus, vomiting, insomnia, dry mouth.\"\n },\n {\n \"VerbatimTerm\": \"pruritus\",\n \"Probability\": \"0.997333765\",\n \"SemanticContext\": \"The most common adverse reactions from Table 1 occurring in =10% and =2 x placebo rate of the patients treated with tramadol hydrochloride extended-release tablets are dizziness not vertigo , nausea, constipation, headache, somnolence, flushing, pruritus, vomiting, insomnia, and dry mouth.\"\n },\n {\n \"VerbatimTerm\": \"pruritus\",\n \"Probability\": \"0.0714193285\",\n \"SemanticContext\": \"Apart from analgesia, tramadol administration may produce a constellation of symptoms including dizziness, somnolence, nausea, constipation, sweating and pruritus similar to that of other opioids.\"\n },\n {\n \"VerbatimTerm\": \"pruritus\",\n \"Probability\": \"0.8529739976\",\n \"SemanticContext\": \"Manifestations of histamine release and/or peripheral vasodilation may include pruritus, flushing, red eyes, sweating, and/or orthostatic hypotension.\"\n },\n {\n \"VerbatimTerm\": \"pruritus\",\n \"Probability\": \"0.9946123362\",\n \"SemanticContext\": \"Other reported hypersensitivity reactions include pruritus, hives, bronchospasm, angioedema, toxic epidermal necrolysis and Stevens-Johnson syndrome.\"\n },\n {\n \"VerbatimTerm\": \"Pruritus\",\n \"Probability\": \"0.9979618788\",\n \"SemanticContext\": \"MedDRA Preferred Term Tramadol Hydrochloride Extended-Release Tablets Placebo 100 mg N=403 n % 200 mg N=400 n % 300 mg N=400 n % 400 mg N=202 n % N=406 n % Dizziness not vertigo 64 16 81 20 90 23 57 28 28 7 Nausea 61 15 90 23 102 26 53 26 32 8 Constipation 49 12 68 17 85 21 60 30 17 4 Headache 49 12 62 16 46 12 32 16 43 11 Somnolence 33 8 45 11 29 7 41 20 7 2 Flushing 31 8 40 10 35 9 32 16 18 4 Pruritus 25 6 34 9 30 8 24 12 4 1 Vomiting 20 5 29 7 34 9 19 9 11 3 Insomnia 26 7 32 8 36 9 22 11 13 3 Dry Mouth 20 5 29 7 39 10 18 9 6 2 Diarrhea 15 4 27 7 37 9 10 5 17 4 Asthenia 14 4 24 6 26 7 13 6 7 2 Postural hypotension 7 2 17 4 8 2 11 5 9 2 Sweating increased 6 2 8 2 15 4 13 6 1 0 Anorexia 3 1 7 2 21 5 12 6 1 0 .\"\n }\n ]\n },\n {\n \"Term\": \"Somnolence\",\n \"MEDDRACode\": \"10041349\",\n \"Overdose\": true,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"sleepy\",\n \"Probability\": \"0.0008162558\",\n \"SemanticContext\": \"Tramadol hydrochloride extended-release tablets can make you sleepy, dizzy, or lightheaded.\"\n }\n ]\n },\n {\n \"Term\": \"Cholelithiasis\",\n \"MEDDRACode\": \"10008629\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"cholelithiasis\",\n \"Probability\": \"0.9839526415\",\n \"SemanticContext\": \"Eye disorders: vision blurred Gastrointestinal disorders: abdominal pain upper, dyspepsia, abdominal pain, sore throat General disorders: weakness, pain, feeling hot, influenza like illness, fall, rigors, lethargy, pyrexia, chest pain Infections and infestations: nasopharyngitis, upper respiratory tract infection, sinusitis, influenza, gastroenteritis viral, urinary tract infection, bronchitis Investigations: blood creatine phosphokinase increased, weight decreased Metabolism and nutrition disorders: appetite decreased Musculoskeletal, connective tissue and bone disorders: arthralgia, back pain, pain in limb, neck pain Nervous system disorders: tremor, paresthesia, hypoesthesia Psychiatric disorders: nervousness, anxiety, depression, restlessness Respiratory, thoracic and mediastinal disorders: sneezing, cough, rhinorrhea, nasal congestion, dyspnea, sinus congestion Skin and subcutaneous tissue disorders: sweating increased, dermatitis Vascular disorders: hot flushes, vasodilatation Adverse Reactions With Incidence Rates of 0.5% to \\n <1.0% and Serious Adverse Reactions Reported in at Least 2 patients During Clinical Trials Cardiac disorders: palpitations, myocardial infarction Ear and labyrinth disorders: tinnitus, vertigo Gastrointestinal disorders: flatulence, toothache, constipation aggravated, appendicitis, pancreatitis General disorders: feeling jittery, edema lower limb, shivering, joint swelling, malaise, drug withdrawal syndrome, peripheral swelling Hepato-biliary disorders: cholelithiasis, cholecystitis Infections and infestations: cellulitis, ear infection, gastroenteritis, pneumonia, viral infection Injury and poisoning: joint sprain, muscle injury Investigations: alanine aminotransferase increased, blood pressure increased, aspartate aminotransferase increased, heart rate increased, blood glucose increased, liver function tests abnormal Musculoskeletal, connective tissue and bone disorders: muscle cramps, muscle spasms, joint stiffness, muscle twitching, myalgia, osteoarthritis aggravated Nervous system disorders: migraine, sedation, syncope, disturbance in attention, dizziness aggravated Psychiatric disorders: euphoric mood, irritability, libido decreased, sleep disorder, agitation, disorientation, abnormal dreams Renal and urinary disorders: difficulty in micturition, urinary frequency, hematuria, dysuria, urinary retention Respiratory, thoracic and mediastinal disorders: yawning Skin and subcutaneous tissue disorders: contusion, piloerection, clamminess, night sweats, urticaria Vascular disorders: hypertension aggravated, hypertension, peripheral ischemia 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of tramadol.\"\n }\n ]\n },\n {\n \"Term\": \"Infestation\",\n \"MEDDRACode\": \"10061217\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"infestations\",\n \"Probability\": \"0.5037198663\",\n \"SemanticContext\": \"Eye disorders: vision blurred Gastrointestinal disorders: abdominal pain upper, dyspepsia, abdominal pain, sore throat General disorders: weakness, pain, feeling hot, influenza like illness, fall, rigors, lethargy, pyrexia, chest pain Infections and infestations: nasopharyngitis, upper respiratory tract infection, sinusitis, influenza, gastroenteritis viral, urinary tract infection, bronchitis Investigations: blood creatine phosphokinase increased, weight decreased Metabolism and nutrition disorders: appetite decreased Musculoskeletal, connective tissue and bone disorders: arthralgia, back pain, pain in limb, neck pain Nervous system disorders: tremor, paresthesia, hypoesthesia Psychiatric disorders: nervousness, anxiety, depression, restlessness Respiratory, thoracic and mediastinal disorders: sneezing, cough, rhinorrhea, nasal congestion, dyspnea, sinus congestion Skin and subcutaneous tissue disorders: sweating increased, dermatitis Vascular disorders: hot flushes, vasodilatation Adverse Reactions With Incidence Rates of 0.5% to \\n <1.0% and Serious Adverse Reactions Reported in at Least 2 patients During Clinical Trials Cardiac disorders: palpitations, myocardial infarction Ear and labyrinth disorders: tinnitus, vertigo Gastrointestinal disorders: flatulence, toothache, constipation aggravated, appendicitis, pancreatitis General disorders: feeling jittery, edema lower limb, shivering, joint swelling, malaise, drug withdrawal syndrome, peripheral swelling Hepato-biliary disorders: cholelithiasis, cholecystitis Infections and infestations: cellulitis, ear infection, gastroenteritis, pneumonia, viral infection Injury and poisoning: joint sprain, muscle injury Investigations: alanine aminotransferase increased, blood pressure increased, aspartate aminotransferase increased, heart rate increased, blood glucose increased, liver function tests abnormal Musculoskeletal, connective tissue and bone disorders: muscle cramps, muscle spasms, joint stiffness, muscle twitching, myalgia, osteoarthritis aggravated Nervous system disorders: migraine, sedation, syncope, disturbance in attention, dizziness aggravated Psychiatric disorders: euphoric mood, irritability, libido decreased, sleep disorder, agitation, disorientation, abnormal dreams Renal and urinary disorders: difficulty in micturition, urinary frequency, hematuria, dysuria, urinary retention Respiratory, thoracic and mediastinal disorders: yawning Skin and subcutaneous tissue disorders: contusion, piloerection, clamminess, night sweats, urticaria Vascular disorders: hypertension aggravated, hypertension, peripheral ischemia 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of tramadol.\"\n },\n {\n \"VerbatimTerm\": \"infestations\",\n \"Probability\": \"0.2927306294\",\n \"SemanticContext\": \"Eye disorders: vision blurred Gastrointestinal disorders: abdominal pain upper, dyspepsia, abdominal pain, sore throat General disorders: weakness, pain, feeling hot, influenza like illness, fall, rigors, lethargy, pyrexia, chest pain Infections and infestations: nasopharyngitis, upper respiratory tract infection, sinusitis, influenza, gastroenteritis viral, urinary tract infection, bronchitis Investigations: blood creatine phosphokinase increased, weight decreased Metabolism and nutrition disorders: appetite decreased Musculoskeletal, connective tissue and bone disorders: arthralgia, back pain, pain in limb, neck pain Nervous system disorders: tremor, paresthesia, hypoesthesia Psychiatric disorders: nervousness, anxiety, depression, restlessness Respiratory, thoracic and mediastinal disorders: sneezing, cough, rhinorrhea, nasal congestion, dyspnea, sinus congestion Skin and subcutaneous tissue disorders: sweating increased, dermatitis Vascular disorders: hot flushes, vasodilatation Adverse Reactions With Incidence Rates of 0.5% to \\n <1.0% and Serious Adverse Reactions Reported in at Least 2 patients During Clinical Trials Cardiac disorders: palpitations, myocardial infarction Ear and labyrinth disorders: tinnitus, vertigo Gastrointestinal disorders: flatulence, toothache, constipation aggravated, appendicitis, pancreatitis General disorders: feeling jittery, edema lower limb, shivering, joint swelling, malaise, drug withdrawal syndrome, peripheral swelling Hepato-biliary disorders: cholelithiasis, cholecystitis Infections and infestations: cellulitis, ear infection, gastroenteritis, pneumonia, viral infection Injury and poisoning: joint sprain, muscle injury Investigations: alanine aminotransferase increased, blood pressure increased, aspartate aminotransferase increased, heart rate increased, blood glucose increased, liver function tests abnormal Musculoskeletal, connective tissue and bone disorders: muscle cramps, muscle spasms, joint stiffness, muscle twitching, myalgia, osteoarthritis aggravated Nervous system disorders: migraine, sedation, syncope, disturbance in attention, dizziness aggravated Psychiatric disorders: euphoric mood, irritability, libido decreased, sleep disorder, agitation, disorientation, abnormal dreams Renal and urinary disorders: difficulty in micturition, urinary frequency, hematuria, dysuria, urinary retention Respiratory, thoracic and mediastinal disorders: yawning Skin and subcutaneous tissue disorders: contusion, piloerection, clamminess, night sweats, urticaria Vascular disorders: hypertension aggravated, hypertension, peripheral ischemia 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of tramadol.\"\n }\n ]\n },\n {\n \"Term\": \"Congenital nephrotic syndrome\",\n \"MEDDRACode\": \"10060737\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"CNS\",\n \"Probability\": \"0.2406264842\",\n \"SemanticContext\": \"TRAMADOL HYDROCHLORIDE extended-release tablets for oral use, C IV Initial U.S. Approval: 1995 WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY REMS ; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; ULTRA-RAPID METABOLISM OF TRAMADOL AND OTHER RISK FACTORS FOR LIFE-THREATENING RESPIRATORY DEPRESSION IN CHILDREN; NEONATAL OPIOID WITHDRAWAL SYNDROME; INTERACTIONS WITH DRUGS AFFECTING CYTOCHROME P450 ISOENZYMES; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS See full prescribing information for complete boxed warning .\"\n },\n {\n \"VerbatimTerm\": \"CNS\",\n \"Probability\": \"0.0005870759\",\n \"SemanticContext\": \"Concomitant use of opioids with benzodiazepines or other central nervous system CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.\"\n },\n {\n \"VerbatimTerm\": \"CNS\",\n \"Probability\": \"0.2476581037\",\n \"SemanticContext\": \"6 ADVERSE REACTIONS The following serious adverse reactions are described in greater detail, in other sections: Addiction, Abuse, and Misuse [see Warnings and Precautions 5.1 ] Life-Threatening Respiratory Depression [see Warnings and Precautions 5.3 ] Ultra-Rapid Metabolism of Tramadol and Other Risk Factors for Life-Threatening Respiratory Depression in Children [see Warnings and Precautions 5.4 ] Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions 5.5 ] Interactions with Benzodiazepines and Other CNS Depressants [see Warnings and Precautions 5.7 ] Serotonin Syndrome [see Warnings and Precautions 5.8 ] Seizures [see Warnings and Precautions 5.9 ] Suicide [see Warnings and Precautions 5.10 ] Adrenal Insufficiency [see Warnings and Precautions 5.11 ] Severe Hypotension [see Warnings and Precautions 5.13 ] Gastrointestinal Adverse Reactions [see Warnings and Precautions 5.15 ] Hypersensitivity Reactions [see Warnings and Precautions 5.16 ] Withdrawal [see Warnings and Precautions 5.17 ] 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.\"\n },\n {\n \"VerbatimTerm\": \"CNS\",\n \"Probability\": \"0.486502409\",\n \"SemanticContext\": \"Concentration--Adverse Reaction Relationships There is a relationship between increasing tramadol plasma concentration and increasing frequency of dose-related opioid adverse reactions such as nausea, vomiting, CNS effects, and respiratory depression.\"\n },\n {\n \"VerbatimTerm\": \"CNS\",\n \"Probability\": \"0.0174636841\",\n \"SemanticContext\": \"Examples: Rifampin, carbamazepine, phenytoin Benzodiazepines and Other Central Nervous System CNS Depressants Clinical Impact: Due to additive pharmacologic effect, the concomitant use of benzodiazepines or other CNS depressants, including alcohol, can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death.\"\n },\n {\n \"VerbatimTerm\": \"CNS\",\n \"Probability\": \"0.0061528683\",\n \"SemanticContext\": \"Examples: Rifampin, carbamazepine, phenytoin Benzodiazepines and Other Central Nervous System CNS Depressants Clinical Impact: Due to additive pharmacologic effect, the concomitant use of benzodiazepines or other CNS depressants, including alcohol, can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death.\"\n },\n {\n \"VerbatimTerm\": \"CNS\",\n \"Probability\": \"0.0001793206\",\n \"SemanticContext\": \"Consider prescribing naloxone, based on the patient’s risk factors for overdose, such as concomitant use of CNS depressants, a history of opioid use disorder, or prior opioid overdose.\"\n },\n {\n \"VerbatimTerm\": \"CNS\",\n \"Probability\": \"0.039839983\",\n \"SemanticContext\": \"Interactions with Benzodiazepines and Other CNS Depressants Inform patients and caregivers that potentially fatal additive effects may occur if tramadol hydrochloride extended-release tablets are used with benzodiazepines or other CNS depressants, including alcohol, and not to use these concomitantly unless supervised by a healthcare provider [see Warnings and Precautions 5.7 , Drug Interactions 7 ].\"\n },\n {\n \"VerbatimTerm\": \"CNS\",\n \"Probability\": \"0.0004059374\",\n \"SemanticContext\": \"Interactions with Benzodiazepines and Other CNS Depressants Inform patients and caregivers that potentially fatal additive effects may occur if tramadol hydrochloride extended-release tablets are used with benzodiazepines or other CNS depressants, including alcohol, and not to use these concomitantly unless supervised by a healthcare provider [see Warnings and Precautions 5.7 , Drug Interactions 7 ].\"\n },\n {\n \"VerbatimTerm\": \"CNS\",\n \"Probability\": \"0.0001793206\",\n \"SemanticContext\": \"Consider prescribing naloxone, based on the patient’s risk factors for overdose, such as concomitant use of CNS depressants, a history of opioid use disorder, or prior opioid overdose.\"\n },\n {\n \"VerbatimTerm\": \"CNS\",\n \"Probability\": \"0.0017902255\",\n \"SemanticContext\": \"5.7 Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants Profound sedation, respiratory depression, coma, and death may result from the concomitant use of tramadol hydrochloride extended-release tablets with benzodiazepines or other CNS depressants e.g., non-benzodiazepine sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, other opioids, alcohol .\"\n },\n {\n \"VerbatimTerm\": \"CNS\",\n \"Probability\": \"0.0005233586\",\n \"SemanticContext\": \"5.7 Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants Profound sedation, respiratory depression, coma, and death may result from the concomitant use of tramadol hydrochloride extended-release tablets with benzodiazepines or other CNS depressants e.g., non-benzodiazepine sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, other opioids, alcohol .\"\n },\n {\n \"VerbatimTerm\": \"CNS\",\n \"Probability\": \"0.0063717365\",\n \"SemanticContext\": \"Because of similar pharmacological properties, it is reasonable to expect similar risk with the concomitant use of other CNS depressant drugs with opioid analgesics [see Drug Interactions 7 ] .\"\n },\n {\n \"VerbatimTerm\": \"CNS\",\n \"Probability\": \"4.33908E-05\",\n \"SemanticContext\": \"If the decision is made to prescribe a benzodiazepine or other CNS depressant concomitantly with an opioid analgesic, prescribe the lowest effective dosages and minimum durations of concomitant use.\"\n },\n {\n \"VerbatimTerm\": \"CNS\",\n \"Probability\": \"0.0001268685\",\n \"SemanticContext\": \"In patients already receiving an opioid analgesic, prescribe a lower initial dose of the benzodiazepine or other CNS depressant than indicated in the absence of an opioid, and titrate based on clinical response.\"\n },\n {\n \"VerbatimTerm\": \"CNS\",\n \"Probability\": \"3.48102E-05\",\n \"SemanticContext\": \"If an opioid analgesic is initiated in a patient already taking a benzodiazepine or other CNS depressant, prescribe a lower initial dose of the opioid analgesic, and titrate based on clinical response.\"\n },\n {\n \"VerbatimTerm\": \"CNS\",\n \"Probability\": \"0.0001205102\",\n \"SemanticContext\": \"Advise both patients and caregivers about the risks of respiratory depression and sedation when tramadol hydrochloride extended-release tablets are used with benzodiazepines or other CNS depressants including alcohol and illicit drugs .\"\n },\n {\n \"VerbatimTerm\": \"CNS\",\n \"Probability\": \"6.27933E-05\",\n \"SemanticContext\": \"Advise patients not to drive or operate heavy machinery until the effects of concomitant use of the benzodiazepine or other CNS depressant have been determined.\"\n },\n {\n \"VerbatimTerm\": \"CNS\",\n \"Probability\": \"0.0101629794\",\n \"SemanticContext\": \"Screen patients for risk of substance use disorders, including opioid abuse and misuse, and warn them of the risk for overdose and death associated with the use of additional CNS depressants including alcohol and illicit drugs [see Drug Interactions 7 , Patient Counseling Information 17 ] .\"\n },\n {\n \"VerbatimTerm\": \"CNS\",\n \"Probability\": \"0.0189942718\",\n \"SemanticContext\": \"Risk of seizures may also increase in patients with epilepsy, those with a history of seizures, or in patients with a recognized risk for seizure such as head trauma, metabolic disorders, alcohol and drug withdrawal, CNS infections .\"\n },\n {\n \"VerbatimTerm\": \"CNS\",\n \"Probability\": \"7.0586E-06\",\n \"SemanticContext\": \"[ see Drug Abuse and Dependence 9.2 ] Prescribe tramadol hydrochloride extended-release tablets with caution for patients with a history of misuse and/or are currently taking CNS-active drugs including tranquilizers, or antidepressant drugs, or alcohol in excess, and patients who suffer from emotional disturbance or depression [ see Drug Interactions 7 ].\"\n },\n {\n \"VerbatimTerm\": \"CNS\",\n \"Probability\": \"0.0004235208\",\n \"SemanticContext\": \"There is increased risk in patients whose ability to maintain blood pressure has already been compromised by a reduced blood volume or concurrent administration of certain CNS depressant drugs e.g., phenothiazines or general anesthetics [see Drug Interactions 7 ].\"\n }\n ]\n },\n {\n \"Term\": \"Sedation\",\n \"MEDDRACode\": \"10039897\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"sedation\",\n \"Probability\": \"0.1089715362\",\n \"SemanticContext\": \"Concomitant use of opioids with benzodiazepines or other central nervous system CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.\"\n },\n {\n \"VerbatimTerm\": \"sedation\",\n \"Probability\": \"0.0024932325\",\n \"SemanticContext\": \"Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate; limit dosages and durations to the minimum required; and follow patients for signs and symptoms of respiratory depression and sedation.\"\n },\n {\n \"VerbatimTerm\": \"sedation\",\n \"Probability\": \"0.1483992338\",\n \"SemanticContext\": \"Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness: Monitor for sedation and respiratory depression.\"\n },\n {\n \"VerbatimTerm\": \"sedation\",\n \"Probability\": \"0.0415492952\",\n \"SemanticContext\": \"Follow patients closely for adverse events including respiratory depression and sedation.\"\n },\n {\n \"VerbatimTerm\": \"sedation\",\n \"Probability\": \"0.0459794998\",\n \"SemanticContext\": \"Follow patients closely for seizures and serotonin syndrome, and signs of respiratory depression and sedation at frequent intervals.\"\n },\n {\n \"VerbatimTerm\": \"sedation\",\n \"Probability\": \"0.0105074942\",\n \"SemanticContext\": \"If a CYP3A4 inducer is discontinued, consider tramadol hydrochloride extended-release tablets dosage reduction and monitor for seizures and serotonin syndrome, and signs of sedation and respiratory depression.\"\n },\n {\n \"VerbatimTerm\": \"sedation\",\n \"Probability\": \"0.1826572716\",\n \"SemanticContext\": \"Examples: Rifampin, carbamazepine, phenytoin Benzodiazepines and Other Central Nervous System CNS Depressants Clinical Impact: Due to additive pharmacologic effect, the concomitant use of benzodiazepines or other CNS depressants, including alcohol, can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death.\"\n },\n {\n \"VerbatimTerm\": \"sedation\",\n \"Probability\": \"0.0006047785\",\n \"SemanticContext\": \"Follow patients closely for signs of respiratory depression and sedation [see Warnings and Precautions 5.7 ] .\"\n },\n {\n \"VerbatimTerm\": \"sedation\",\n \"Probability\": \"0.0011909902\",\n \"SemanticContext\": \"Monitor neonates exposed to opioid analgesics during labor for signs of excess sedation and respiratory depression.\"\n },\n {\n \"VerbatimTerm\": \"sedation\",\n \"Probability\": \"0.0441307127\",\n \"SemanticContext\": \"5.7 Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants Profound sedation, respiratory depression, coma, and death may result from the concomitant use of tramadol hydrochloride extended-release tablets with benzodiazepines or other CNS depressants e.g., non-benzodiazepine sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, other opioids, alcohol .\"\n },\n {\n \"VerbatimTerm\": \"sedation\",\n \"Probability\": \"0.0027060807\",\n \"SemanticContext\": \"Follow patients closely for signs and symptoms of respiratory depression and sedation.\"\n },\n {\n \"VerbatimTerm\": \"sedation\",\n \"Probability\": \"0.0001475215\",\n \"SemanticContext\": \"Advise both patients and caregivers about the risks of respiratory depression and sedation when tramadol hydrochloride extended-release tablets are used with benzodiazepines or other CNS depressants including alcohol and illicit drugs .\"\n },\n {\n \"VerbatimTerm\": \"sedation\",\n \"Probability\": \"0.0021467805\",\n \"SemanticContext\": \"Monitor such patients for signs of sedation and respiratory depression, particularly when initiating therapy with tramadol hydrochloride extended-release tablets.\"\n }\n ]\n },\n {\n \"Term\": \"Sinusitis\",\n \"MEDDRACode\": \"10040753\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"sinusitis\",\n \"Probability\": \"0.9995769262\",\n \"SemanticContext\": \"Eye disorders: vision blurred Gastrointestinal disorders: abdominal pain upper, dyspepsia, abdominal pain, sore throat General disorders: weakness, pain, feeling hot, influenza like illness, fall, rigors, lethargy, pyrexia, chest pain Infections and infestations: nasopharyngitis, upper respiratory tract infection, sinusitis, influenza, gastroenteritis viral, urinary tract infection, bronchitis Investigations: blood creatine phosphokinase increased, weight decreased Metabolism and nutrition disorders: appetite decreased Musculoskeletal, connective tissue and bone disorders: arthralgia, back pain, pain in limb, neck pain Nervous system disorders: tremor, paresthesia, hypoesthesia Psychiatric disorders: nervousness, anxiety, depression, restlessness Respiratory, thoracic and mediastinal disorders: sneezing, cough, rhinorrhea, nasal congestion, dyspnea, sinus congestion Skin and subcutaneous tissue disorders: sweating increased, dermatitis Vascular disorders: hot flushes, vasodilatation Adverse Reactions With Incidence Rates of 0.5% to \\n <1.0% and Serious Adverse Reactions Reported in at Least 2 patients During Clinical Trials Cardiac disorders: palpitations, myocardial infarction Ear and labyrinth disorders: tinnitus, vertigo Gastrointestinal disorders: flatulence, toothache, constipation aggravated, appendicitis, pancreatitis General disorders: feeling jittery, edema lower limb, shivering, joint swelling, malaise, drug withdrawal syndrome, peripheral swelling Hepato-biliary disorders: cholelithiasis, cholecystitis Infections and infestations: cellulitis, ear infection, gastroenteritis, pneumonia, viral infection Injury and poisoning: joint sprain, muscle injury Investigations: alanine aminotransferase increased, blood pressure increased, aspartate aminotransferase increased, heart rate increased, blood glucose increased, liver function tests abnormal Musculoskeletal, connective tissue and bone disorders: muscle cramps, muscle spasms, joint stiffness, muscle twitching, myalgia, osteoarthritis aggravated Nervous system disorders: migraine, sedation, syncope, disturbance in attention, dizziness aggravated Psychiatric disorders: euphoric mood, irritability, libido decreased, sleep disorder, agitation, disorientation, abnormal dreams Renal and urinary disorders: difficulty in micturition, urinary frequency, hematuria, dysuria, urinary retention Respiratory, thoracic and mediastinal disorders: yawning Skin and subcutaneous tissue disorders: contusion, piloerection, clamminess, night sweats, urticaria Vascular disorders: hypertension aggravated, hypertension, peripheral ischemia 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of tramadol.\"\n }\n ]\n },\n {\n \"Term\": \"Blood iron\",\n \"MEDDRACode\": \"10005616\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"iron\",\n \"Probability\": \"0.0140954852\",\n \"SemanticContext\": \"Imprinting ink contains, shellac glaze, iron oxide black, N-butyl alcohol, ammonium hydroxide and propylene glycol.\"\n }\n ]\n },\n {\n \"Term\": \"Blood magnesium\",\n \"MEDDRACode\": \"10005651\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"magnesium\",\n \"Probability\": \"0.0008087754\",\n \"SemanticContext\": \"The tablets are white in color and contain the inactive ingredients pregelatinized maize starch, hypromellose, mannitol, magnesium stearate, cellulose acetate and polyethylene glycol.\"\n }\n ]\n },\n {\n \"Term\": \"Drug withdrawal syndrome\",\n \"MEDDRACode\": \"10013754\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"drug withdrawal syndrome\",\n \"Probability\": \"0.8817064166\",\n \"SemanticContext\": \"Eye disorders: vision blurred Gastrointestinal disorders: abdominal pain upper, dyspepsia, abdominal pain, sore throat General disorders: weakness, pain, feeling hot, influenza like illness, fall, rigors, lethargy, pyrexia, chest pain Infections and infestations: nasopharyngitis, upper respiratory tract infection, sinusitis, influenza, gastroenteritis viral, urinary tract infection, bronchitis Investigations: blood creatine phosphokinase increased, weight decreased Metabolism and nutrition disorders: appetite decreased Musculoskeletal, connective tissue and bone disorders: arthralgia, back pain, pain in limb, neck pain Nervous system disorders: tremor, paresthesia, hypoesthesia Psychiatric disorders: nervousness, anxiety, depression, restlessness Respiratory, thoracic and mediastinal disorders: sneezing, cough, rhinorrhea, nasal congestion, dyspnea, sinus congestion Skin and subcutaneous tissue disorders: sweating increased, dermatitis Vascular disorders: hot flushes, vasodilatation Adverse Reactions With Incidence Rates of 0.5% to \\n <1.0% and Serious Adverse Reactions Reported in at Least 2 patients During Clinical Trials Cardiac disorders: palpitations, myocardial infarction Ear and labyrinth disorders: tinnitus, vertigo Gastrointestinal disorders: flatulence, toothache, constipation aggravated, appendicitis, pancreatitis General disorders: feeling jittery, edema lower limb, shivering, joint swelling, malaise, drug withdrawal syndrome, peripheral swelling Hepato-biliary disorders: cholelithiasis, cholecystitis Infections and infestations: cellulitis, ear infection, gastroenteritis, pneumonia, viral infection Injury and poisoning: joint sprain, muscle injury Investigations: alanine aminotransferase increased, blood pressure increased, aspartate aminotransferase increased, heart rate increased, blood glucose increased, liver function tests abnormal Musculoskeletal, connective tissue and bone disorders: muscle cramps, muscle spasms, joint stiffness, muscle twitching, myalgia, osteoarthritis aggravated Nervous system disorders: migraine, sedation, syncope, disturbance in attention, dizziness aggravated Psychiatric disorders: euphoric mood, irritability, libido decreased, sleep disorder, agitation, disorientation, abnormal dreams Renal and urinary disorders: difficulty in micturition, urinary frequency, hematuria, dysuria, urinary retention Respiratory, thoracic and mediastinal disorders: yawning Skin and subcutaneous tissue disorders: contusion, piloerection, clamminess, night sweats, urticaria Vascular disorders: hypertension aggravated, hypertension, peripheral ischemia 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of tramadol.\"\n }\n ]\n },\n {\n \"Term\": \"Hyponatraemia\",\n \"MEDDRACode\": \"10021036\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Hyponatremia\",\n \"Probability\": \"0.7810349464\",\n \"SemanticContext\": \"Metabolism and nutrition disorders Hyponatremia: cases of severe hyponatremia and/or SIADH have been reported in patients taking tramadol, most often in females over the age of 65, and within the first week of therapy [see Warnings and Precautions 5.19 ].\"\n },\n {\n \"VerbatimTerm\": \"Hyponatremia\",\n \"Probability\": \"0.0967376232\",\n \"SemanticContext\": \"5.19 Hyponatremia Hyponatremia serum sodium < 135 mmol/L has been reported with the use of tramadol, and many cases are severe sodium level < 120 mmol/L .\"\n },\n {\n \"VerbatimTerm\": \"Hyponatremia\",\n \"Probability\": \"0.2312732041\",\n \"SemanticContext\": \"5.19 Hyponatremia Hyponatremia serum sodium < 135 mmol/L has been reported with the use of tramadol, and many cases are severe sodium level < 120 mmol/L .\"\n },\n {\n \"VerbatimTerm\": \"hyponatremia\",\n \"Probability\": \"0.9493225813\",\n \"SemanticContext\": \"Metabolism and nutrition disorders Hyponatremia: cases of severe hyponatremia and/or SIADH have been reported in patients taking tramadol, most often in females over the age of 65, and within the first week of therapy [see Warnings and Precautions 5.19 ].\"\n },\n {\n \"VerbatimTerm\": \"hyponatremia\",\n \"Probability\": \"0.9784311056\",\n \"SemanticContext\": \"Most cases of hyponatremia occurred in females over the age of 65 and within the first week of therapy.\"\n },\n {\n \"VerbatimTerm\": \"hyponatremia\",\n \"Probability\": \"0.9954584241\",\n \"SemanticContext\": \"In some reports, hyponatremia resulted from the syndrome of inappropriate antidiuretic hormone secretion SIADH .\"\n },\n {\n \"VerbatimTerm\": \"hyponatremia\",\n \"Probability\": \"0.0122089088\",\n \"SemanticContext\": \"Monitor for signs and symptoms of hyponatremia e.g., confusion, disorientation , during treatment with tramadol hydrochloride extended-release tablets, especially during initiation of therapy.\"\n },\n {\n \"VerbatimTerm\": \"hyponatremia\",\n \"Probability\": \"0.0004660785\",\n \"SemanticContext\": \"If signs and symptoms of hyponatremia are present, initiate appropriate treatment e.g., fluid restriction and discontinue tramadol hydrochloride extended-release tablets [see Dosage and Administration: Safe Reduction or Discontinuation of Tramadol Hydrochloride Extended-Release Tablets 2.5 ].\"\n }\n ]\n },\n {\n \"Term\": \"Respiratory depression\",\n \"MEDDRACode\": \"10038678\",\n \"Overdose\": true,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": true,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": true\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"respiratory depression\",\n \"Probability\": \"0.1922824979\",\n \"SemanticContext\": \"HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use children who developed life-threatening respiratory depression or died after taking tramadol for pain relief TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively.\"\n },\n {\n \"VerbatimTerm\": \"respiratory depression\",\n \"Probability\": \"0.9476833344\",\n \"SemanticContext\": \"Serious, life-threatening, or fatal respiratory depression may occur.\"\n },\n {\n \"VerbatimTerm\": \"respiratory depression\",\n \"Probability\": \"0.6092455387\",\n \"SemanticContext\": \"Life-threatening respiratory depression and death have occurred in children who received tramadol.\"\n },\n {\n \"VerbatimTerm\": \"respiratory depression\",\n \"Probability\": \"0.3301602602\",\n \"SemanticContext\": \"Concomitant use of opioids with benzodiazepines or other central nervous system CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.\"\n },\n {\n \"VerbatimTerm\": \"respiratory depression\",\n \"Probability\": \"0.0117007494\",\n \"SemanticContext\": \"Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate; limit dosages and durations to the minimum required; and follow patients for signs and symptoms of respiratory depression and sedation.\"\n },\n {\n \"VerbatimTerm\": \"respiratory depression\",\n \"Probability\": \"0.5823684335\",\n \"SemanticContext\": \"Significant respiratory depression 4 .\"\n },\n {\n \"VerbatimTerm\": \"respiratory depression\",\n \"Probability\": \"0.341137588\",\n \"SemanticContext\": \"Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness: Monitor for sedation and respiratory depression.\"\n },\n {\n \"VerbatimTerm\": \"respiratory depression\",\n \"Probability\": \"0.9240041971\",\n \"SemanticContext\": \"12.2 Pharmacodynamics Effects on the Central Nervous System Tramadol produces respiratory depression by direct action on brain stem respiratory centers.\"\n },\n {\n \"VerbatimTerm\": \"respiratory depression\",\n \"Probability\": \"0.9195978642\",\n \"SemanticContext\": \"The respiratory depression involves a reduction in the responsiveness of the brain stem respiratory centers to both increases in carbon dioxide tension and electrical stimulation.\"\n },\n {\n \"VerbatimTerm\": \"respiratory depression\",\n \"Probability\": \"0.8465958834\",\n \"SemanticContext\": \"Concentration--Adverse Reaction Relationships There is a relationship between increasing tramadol plasma concentration and increasing frequency of dose-related opioid adverse reactions such as nausea, vomiting, CNS effects, and respiratory depression.\"\n },\n {\n \"VerbatimTerm\": \"respiratory depression\",\n \"Probability\": \"0.0080823004\",\n \"SemanticContext\": \"Tramadol hydrochloride extended-release tablets are also contraindicated in patients with: Significant respiratory depression [ see Warnings and Precautions 5.3 ] Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [ see Warnings and Precautions 5.12 ] Known or suspected gastrointestinal obstruction, including paralytic ileus [ see Warnings and Precautions 5.15 ] Hypersensitivity to tramadol e.g., anaphylaxis [ see Warnings and Precautions 5.16 , Adverse Reactions 6.2 ] Concurrent use of monoamine oxidase inhibitors MAOIs or use within the last 14 days [see Drug Interactions 7 ] .\"\n },\n {\n \"VerbatimTerm\": \"respiratory depression\",\n \"Probability\": \"0.8887597322\",\n \"SemanticContext\": \"After stopping a CYP2D6 inhibitor, as the effects of the inhibitor decline, the tramadol plasma concentration will decrease and the M1 plasma concentration will increase which could increase or prolong therapeutic effects but also increase adverse reactions related to opioid toxicity, and may cause potentially fatal respiratory depression [see Clinical Pharmacology 12.3 ] .\"\n },\n {\n \"VerbatimTerm\": \"respiratory depression\",\n \"Probability\": \"0.140283972\",\n \"SemanticContext\": \"Follow patients closely for adverse events including respiratory depression and sedation.\"\n },\n {\n \"VerbatimTerm\": \"respiratory depression\",\n \"Probability\": \"0.7170354724\",\n \"SemanticContext\": \"Follow patients closely for increased risk of serious adverse events including seizures and serotonin syndrome, and adverse reactions related to opioid toxicity including potentially fatal respiratory depression, particularly when an inhibitor is added after a stable dose of tramadol hydrochloride extended-release tablets is achieved.\"\n },\n {\n \"VerbatimTerm\": \"respiratory depression\",\n \"Probability\": \"0.4224621058\",\n \"SemanticContext\": \"Follow patients closely for seizures and serotonin syndrome, and signs of respiratory depression and sedation at frequent intervals.\"\n },\n {\n \"VerbatimTerm\": \"respiratory depression\",\n \"Probability\": \"0.9613766074\",\n \"SemanticContext\": \"After stopping a CYP3A4 inducer, as the effects of the inducer decline, the tramadol plasma concentration will increase [see Clinical Pharmacology 12.3 ] , which could increase or prolong both the therapeutic effects and adverse reactions, and may cause seizures and serotonin syndrome, and potentially fatal respiratory depression.\"\n },\n {\n \"VerbatimTerm\": \"respiratory depression\",\n \"Probability\": \"0.0217495263\",\n \"SemanticContext\": \"If a CYP3A4 inducer is discontinued, consider tramadol hydrochloride extended-release tablets dosage reduction and monitor for seizures and serotonin syndrome, and signs of sedation and respiratory depression.\"\n },\n {\n \"VerbatimTerm\": \"respiratory depression\",\n \"Probability\": \"0.5200172067\",\n \"SemanticContext\": \"Examples: Rifampin, carbamazepine, phenytoin Benzodiazepines and Other Central Nervous System CNS Depressants Clinical Impact: Due to additive pharmacologic effect, the concomitant use of benzodiazepines or other CNS depressants, including alcohol, can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death.\"\n },\n {\n \"VerbatimTerm\": \"respiratory depression\",\n \"Probability\": \"0.0050921738\",\n \"SemanticContext\": \"Follow patients closely for signs of respiratory depression and sedation [see Warnings and Precautions 5.7 ] .\"\n },\n {\n \"VerbatimTerm\": \"respiratory depression\",\n \"Probability\": \"0.5352143049\",\n \"SemanticContext\": \"Monoamine Oxidase Inhibitors MAOIs Clinical Impact: MAOI interactions with opioids may manifest as serotonin syndrome [see Warnings and Precautions 5.8 ] or opioid toxicity e.g., respiratory depression, coma [see Warnings and Precautions 5.3 ].\"\n },\n {\n \"VerbatimTerm\": \"respiratory depression\",\n \"Probability\": \"0.3175444305\",\n \"SemanticContext\": \"Examples: butorphanol, nalbuphine, pentazocine, buprenorphine Muscle Relaxants Clinical Impact: Tramadol may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression.\"\n },\n {\n \"VerbatimTerm\": \"respiratory depression\",\n \"Probability\": \"0.0024019182\",\n \"SemanticContext\": \"Intervention: Monitor patients for signs of respiratory depression that may be greater than otherwise expected and decrease the dosage of tramadol hydrochloride extended-release tablets and/or the muscle relaxant as necessary.\"\n },\n {\n \"VerbatimTerm\": \"respiratory depression\",\n \"Probability\": \"0.2666012943\",\n \"SemanticContext\": \"Due to the risk of respiratory depression with concomitant use of skeletal muscle relaxants and opioids, consider prescribing naloxone for the emergency treatment of opioid overdose [see Dosage and Administration 2.2 , Warnings and Precautions 5.3, 5.7 ] Diuretics Clinical Impact: Opioids can reduce the efficacy of diuretics by inducing the release of antidiuretic hormone.\"\n },\n {\n \"VerbatimTerm\": \"respiratory depression\",\n \"Probability\": \"0.0172142982\",\n \"SemanticContext\": \"Initiate the dosing regimen for each patient individually, taking into account the patient's severity of pain, patient response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse [ see Warnings and Precautions 5.1 ] Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy and following dosage increases with tramadol hydrochloride extended-release tablets and adjust the dosage accordingly [ see Warnings and Precautions 5.3 ].\"\n },\n {\n \"VerbatimTerm\": \"respiratory depression\",\n \"Probability\": \"0.1314492524\",\n \"SemanticContext\": \"Life-Threatening Respiratory Depression Inform patients of the risk of life-threatening respiratory depression, including information that the risk is greatest when starting tramadol hydrochloride extended-release tablets or when the dosage is increased, and that it can occur even at recommended dosages.\"\n },\n {\n \"VerbatimTerm\": \"respiratory depression\",\n \"Probability\": \"0.0036390126\",\n \"SemanticContext\": \"Educate patients and caregivers on how to recognize respiratory depression and emphasize the importance of calling 911 or getting emergency medical help right away in the event of a known or suspected overdose [see Warnings and Precautions 5.3 ] .\"\n },\n {\n \"VerbatimTerm\": \"respiratory depression\",\n \"Probability\": \"0.0357355177\",\n \"SemanticContext\": \"Accidental Ingestion Inform patients that accidental ingestion, especially by children, may result in respiratory depression or death [see Warnings and Precautions 5.3 ] .\"\n },\n {\n \"VerbatimTerm\": \"respiratory depression\",\n \"Probability\": \"0.0118088126\",\n \"SemanticContext\": \"Advise caregivers of children 12 to 18 years of age receiving tramadol hydrochloride extended-release tablets to monitor for signs of respiratory depression [see Warnings and Precautions 5.4 ] .\"\n },\n {\n \"VerbatimTerm\": \"respiratory depression\",\n \"Probability\": \"0.5961142182\",\n \"SemanticContext\": \"Advise patients not to exceed the single-dose and 24-hour dose limit and the time interval between doses, since exceeding these recommendations can result in respiratory depression, seizures, hepatic toxicity, and death.\"\n },\n {\n \"VerbatimTerm\": \"respiratory depression\",\n \"Probability\": \"0.9938031435\",\n \"SemanticContext\": \"10 OVERDOSAGE Clinical Presentation Acute overdosage with tramadol hydrochloride extended-release tablets can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and, in some cases, pulmonary edema, bradycardia, QT prolongation, hypotension, partial or complete airway obstruction, atypical snoring, and death.\"\n },\n {\n \"VerbatimTerm\": \"respiratory depression\",\n \"Probability\": \"0.5681241751\",\n \"SemanticContext\": \"Opioid antagonists, such as naloxone, are specific antidotes to respiratory depression resulting from opioid overdose.\"\n },\n {\n \"VerbatimTerm\": \"respiratory depression\",\n \"Probability\": \"8.00426E-05\",\n \"SemanticContext\": \"If a decision is made to treat serious respiratory depression in the physically dependent patient, administration of the antagonist should be initiated with care and by titration with smaller than usual doses of the antagonist.\"\n },\n {\n \"VerbatimTerm\": \"respiratory depression\",\n \"Probability\": \"0.254804194\",\n \"SemanticContext\": \"Labor or Delivery Opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates.\"\n },\n {\n \"VerbatimTerm\": \"respiratory depression\",\n \"Probability\": \"0.0078192055\",\n \"SemanticContext\": \"An opioid antagonist, such as naloxone, must be available for reversal of opioid-induced respiratory depression in the neonate.\"\n },\n {\n \"VerbatimTerm\": \"respiratory depression\",\n \"Probability\": \"0.0050756335\",\n \"SemanticContext\": \"Monitor neonates exposed to opioid analgesics during labor for signs of excess sedation and respiratory depression.\"\n },\n {\n \"VerbatimTerm\": \"respiratory depression\",\n \"Probability\": \"0.6157881618\",\n \"SemanticContext\": \"5.3 Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression has been reported with the use of opioids, even when used as recommended.\"\n },\n {\n \"VerbatimTerm\": \"respiratory depression\",\n \"Probability\": \"0.0968835354\",\n \"SemanticContext\": \"Management of respiratory depression may include close observation, supportive measures, and use of opioid antagonists, depending on the patient’s clinical status [see Overdosage 10 ] .\"\n },\n {\n \"VerbatimTerm\": \"respiratory depression\",\n \"Probability\": \"0.0457291603\",\n \"SemanticContext\": \"Carbon dioxide CO 2 retention from opioid- induced respiratory depression can exacerbate the sedating effects of opioids.\"\n },\n {\n \"VerbatimTerm\": \"respiratory depression\",\n \"Probability\": \"0.5783853531\",\n \"SemanticContext\": \"While serious, life-threatening, or fatal respiratory depression can occur at any time during the use of tramadol hydrochloride extended-release tablets, the risk is greatest during the initiation of therapy or following a dosage increase.\"\n },\n {\n \"VerbatimTerm\": \"respiratory depression\",\n \"Probability\": \"0.026624769\",\n \"SemanticContext\": \"Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy with and following dosage increases of tramadol hydrochloride extended-release tablets.\"\n },\n {\n \"VerbatimTerm\": \"respiratory depression\",\n \"Probability\": \"0.0499376953\",\n \"SemanticContext\": \"To reduce the risk of respiratory depression, proper dosing and titration of tramadol hydrochloride extended-release tablets are essential [see Dosage and Administration 2 ] .\"\n },\n {\n \"VerbatimTerm\": \"respiratory depression\",\n \"Probability\": \"0.0539630949\",\n \"SemanticContext\": \"Accidental ingestion of even one dose of tramadol hydrochloride extended-release tablet, especially by children, can result in respiratory depression and death due to an overdose of tramadol.\"\n },\n {\n \"VerbatimTerm\": \"respiratory depression\",\n \"Probability\": \"0.0044176877\",\n \"SemanticContext\": \"Educate patients and caregivers on how to recognize respiratory depression and emphasize the importance of calling 911 or getting emergency medical help right away in the event of a known or suspected overdose [see Patient Counseling Information 17 ].\"\n },\n {\n \"VerbatimTerm\": \"respiratory depression\",\n \"Probability\": \"0.0031771362\",\n \"SemanticContext\": \"Educate patients and caregivers on how to recognize respiratory depression and emphasize the importance of calling 911 or getting emergency medical help, even if naloxone is administered [see Patient Counseling Information 17 ].\"\n },\n {\n \"VerbatimTerm\": \"respiratory depression\",\n \"Probability\": \"0.6221625805\",\n \"SemanticContext\": \"5.4 Ultra-Rapid Metabolism of Tramadol and Other Risk Factors for Life-threatening Respiratory Depression in Children Life-threatening respiratory depression and death have occurred in children who received tramadol.\"\n },\n {\n \"VerbatimTerm\": \"respiratory depression\",\n \"Probability\": \"0.4138276577\",\n \"SemanticContext\": \"Because of the risk of life-threatening respiratory depression and death: Tramadol hydrochloride extended-release tablets are contraindicated for all children younger than 12 years of age [ see Contraindications 4 ].\"\n },\n {\n \"VerbatimTerm\": \"respiratory depression\",\n \"Probability\": \"0.0868705809\",\n \"SemanticContext\": \"Risk factors include conditions associated with hypoventilation, such as postoperative status, obstructive sleep apnea, obesity, severe pulmonary disease, neuromuscular disease, and concomitant use of other medications that cause respiratory depression.\"\n },\n {\n \"VerbatimTerm\": \"respiratory depression\",\n \"Probability\": \"0.5048621297\",\n \"SemanticContext\": \"A baby nursing from an ultra-rapid metabolizer mother taking Tramadol hydrochloride extended-release tablets could potentially be exposed to high levels of M1, and experience life-threatening respiratory depression.\"\n },\n {\n \"VerbatimTerm\": \"respiratory depression\",\n \"Probability\": \"0.0307398736\",\n \"SemanticContext\": \"Even at labeled dosage regimens, individuals who are ultra-rapid metabolizers may have life-threatening or fatal respiratory depression or experience signs of overdose such as extreme sleepiness, confusion, or shallow breathing [see Overdosage 10 ] .\"\n },\n {\n \"VerbatimTerm\": \"respiratory depression\",\n \"Probability\": \"0.9442644119\",\n \"SemanticContext\": \"Discontinuation of a concomitantly used cytochrome P450 2D6 inhibitor may result in a decrease in tramadol plasma levels and an increase in active metabolite M1 levels, which could increase or prolong adverse reactions related to opioid toxicity and may cause potentially fatal respiratory depression.\"\n },\n {\n \"VerbatimTerm\": \"respiratory depression\",\n \"Probability\": \"0.9693653584\",\n \"SemanticContext\": \"Cytochrome P450 3A4 Interaction The concomitant use of tramadol hydrochloride extended-release tablets with cytochrome P450 3A4 inhibitors, such as macrolide antibiotics e.g., erythromycin , azole-antifungal agents e.g., ketoconazole , and protease inhibitors e.g., ritonavir or discontinuation of a cytochrome P450 3A4 inducer such as rifampin, carbamazepine, and phenytoin, may result in an increase in tramadol plasma concentrations, which could increase or prolong adverse reactions, increase the risk for serious adverse events including seizures and serotonin syndrome, and may cause potentially fatal respiratory depression.\"\n },\n {\n \"VerbatimTerm\": \"respiratory depression\",\n \"Probability\": \"0.3336649537\",\n \"SemanticContext\": \"5.7 Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants Profound sedation, respiratory depression, coma, and death may result from the concomitant use of tramadol hydrochloride extended-release tablets with benzodiazepines or other CNS depressants e.g., non-benzodiazepine sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, other opioids, alcohol .\"\n },\n {\n \"VerbatimTerm\": \"respiratory depression\",\n \"Probability\": \"0.011167556\",\n \"SemanticContext\": \"Follow patients closely for signs and symptoms of respiratory depression and sedation.\"\n },\n {\n \"VerbatimTerm\": \"respiratory depression\",\n \"Probability\": \"0.0002138317\",\n \"SemanticContext\": \"Advise both patients and caregivers about the risks of respiratory depression and sedation when tramadol hydrochloride extended-release tablets are used with benzodiazepines or other CNS depressants including alcohol and illicit drugs .\"\n },\n {\n \"VerbatimTerm\": \"respiratory depression\",\n \"Probability\": \"0.0365904868\",\n \"SemanticContext\": \"Patients with Chronic Pulmonary Disease: Tramadol hydrochloride extended-release tablets-treated patients with significant chronic obstructive pulmonary disease or cor pulmonale, and those with a substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression are at increased risk of decreased respiratory drive including apnea, even at recommended dosages of tramadol hydrochloride extended-release tablets [see Warnings and Precautions 5.3 ].\"\n },\n {\n \"VerbatimTerm\": \"respiratory depression\",\n \"Probability\": \"0.064629823\",\n \"SemanticContext\": \"Elderly, Cachectic, or Debilitated Patients: Life-threatening respiratory depression is more likely to occur in elderly, cachectic, or debilitated patients because they may have altered pharmacokinetics or altered clearance compared to younger, healthier patients [see Warnings and Precautions 5.3 ].\"\n },\n {\n \"VerbatimTerm\": \"respiratory depression\",\n \"Probability\": \"0.0052529871\",\n \"SemanticContext\": \"Monitor such patients for signs of sedation and respiratory depression, particularly when initiating therapy with tramadol hydrochloride extended-release tablets.\"\n },\n {\n \"VerbatimTerm\": \"respiratory depression\",\n \"Probability\": \"0.9230279326\",\n \"SemanticContext\": \"Life-threatening respiratory depression and death have occurred in children who received tramadol [see Warnings and Precautions 5.4 ] .\"\n },\n {\n \"VerbatimTerm\": \"respiratory depression\",\n \"Probability\": \"0.4050910473\",\n \"SemanticContext\": \"Because of the risk of life-threatening respiratory depression and death: Tramadol hydrochloride extended-release tablets are contraindicated for all children younger than age 12 years of age [ see Contraindications 4 ].\"\n },\n {\n \"VerbatimTerm\": \"respiratory depression\",\n \"Probability\": \"0.0868705809\",\n \"SemanticContext\": \"Risk factors include conditions associated with hypoventilation, such as postoperative status, obstructive sleep apnea, obesity, severe pulmonary disease, neuromuscular disease, and concomitant use of other medications that cause respiratory depression.\"\n },\n {\n \"VerbatimTerm\": \"respiratory depression\",\n \"Probability\": \"0.0102591515\",\n \"SemanticContext\": \"Titrate the dosage of tramadol hydrochloride extended-release tablets slowly in geriatric patients and monitor closely for signs of central nervous system and respiratory depression [see Warnings and Precautions 5.12 ] .\"\n },\n {\n \"VerbatimTerm\": \"RESPIRATORY DEPRESSION\",\n \"Probability\": \"0.9960480928\",\n \"SemanticContext\": \"TRAMADOL HYDROCHLORIDE extended-release tablets for oral use, C IV Initial U.S. Approval: 1995 WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY REMS ; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; ULTRA-RAPID METABOLISM OF TRAMADOL AND OTHER RISK FACTORS FOR LIFE-THREATENING RESPIRATORY DEPRESSION IN CHILDREN; NEONATAL OPIOID WITHDRAWAL SYNDROME; INTERACTIONS WITH DRUGS AFFECTING CYTOCHROME P450 ISOENZYMES; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS See full prescribing information for complete boxed warning .\"\n },\n {\n \"VerbatimTerm\": \"RESPIRATORY DEPRESSION\",\n \"Probability\": \"0.9398782253\",\n \"SemanticContext\": \"TRAMADOL HYDROCHLORIDE extended-release tablets for oral use, C IV Initial U.S. Approval: 1995 WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY REMS ; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; ULTRA-RAPID METABOLISM OF TRAMADOL AND OTHER RISK FACTORS FOR LIFE-THREATENING RESPIRATORY DEPRESSION IN CHILDREN; NEONATAL OPIOID WITHDRAWAL SYNDROME; INTERACTIONS WITH DRUGS AFFECTING CYTOCHROME P450 ISOENZYMES; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS See full prescribing information for complete boxed warning .\"\n },\n {\n \"VerbatimTerm\": \"Respiratory Depression\",\n \"Probability\": \"0.0456462502\",\n \"SemanticContext\": \"Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients: Monitor closely, particularly during initiation and titration.\"\n },\n {\n \"VerbatimTerm\": \"Respiratory Depression\",\n \"Probability\": \"0.9175163507\",\n \"SemanticContext\": \"6 ADVERSE REACTIONS The following serious adverse reactions are described in greater detail, in other sections: Addiction, Abuse, and Misuse [see Warnings and Precautions 5.1 ] Life-Threatening Respiratory Depression [see Warnings and Precautions 5.3 ] Ultra-Rapid Metabolism of Tramadol and Other Risk Factors for Life-Threatening Respiratory Depression in Children [see Warnings and Precautions 5.4 ] Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions 5.5 ] Interactions with Benzodiazepines and Other CNS Depressants [see Warnings and Precautions 5.7 ] Serotonin Syndrome [see Warnings and Precautions 5.8 ] Seizures [see Warnings and Precautions 5.9 ] Suicide [see Warnings and Precautions 5.10 ] Adrenal Insufficiency [see Warnings and Precautions 5.11 ] Severe Hypotension [see Warnings and Precautions 5.13 ] Gastrointestinal Adverse Reactions [see Warnings and Precautions 5.15 ] Hypersensitivity Reactions [see Warnings and Precautions 5.16 ] Withdrawal [see Warnings and Precautions 5.17 ] 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.\"\n },\n {\n \"VerbatimTerm\": \"Respiratory Depression\",\n \"Probability\": \"0.1204552948\",\n \"SemanticContext\": \"6 ADVERSE REACTIONS The following serious adverse reactions are described in greater detail, in other sections: Addiction, Abuse, and Misuse [see Warnings and Precautions 5.1 ] Life-Threatening Respiratory Depression [see Warnings and Precautions 5.3 ] Ultra-Rapid Metabolism of Tramadol and Other Risk Factors for Life-Threatening Respiratory Depression in Children [see Warnings and Precautions 5.4 ] Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions 5.5 ] Interactions with Benzodiazepines and Other CNS Depressants [see Warnings and Precautions 5.7 ] Serotonin Syndrome [see Warnings and Precautions 5.8 ] Seizures [see Warnings and Precautions 5.9 ] Suicide [see Warnings and Precautions 5.10 ] Adrenal Insufficiency [see Warnings and Precautions 5.11 ] Severe Hypotension [see Warnings and Precautions 5.13 ] Gastrointestinal Adverse Reactions [see Warnings and Precautions 5.15 ] Hypersensitivity Reactions [see Warnings and Precautions 5.16 ] Withdrawal [see Warnings and Precautions 5.17 ] 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.\"\n },\n {\n \"VerbatimTerm\": \"Respiratory Depression\",\n \"Probability\": \"0.6513592005\",\n \"SemanticContext\": \"Life-Threatening Respiratory Depression Inform patients of the risk of life-threatening respiratory depression, including information that the risk is greatest when starting tramadol hydrochloride extended-release tablets or when the dosage is increased, and that it can occur even at recommended dosages.\"\n },\n {\n \"VerbatimTerm\": \"Respiratory Depression\",\n \"Probability\": \"0.0219693184\",\n \"SemanticContext\": \"Ultra-Rapid Metabolism of Tramadol and Other Risk Factors for Life-threatening Respiratory Depression in Children Advise caregivers that tramadol hydrochloride extended-release tablets are contraindicated in children younger than 12 years of age and in children younger than 18 years of age following tonsillectomy and/or adenoidectomy.\"\n },\n {\n \"VerbatimTerm\": \"Respiratory Depression\",\n \"Probability\": \"0.6355376244\",\n \"SemanticContext\": \"5.3 Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression has been reported with the use of opioids, even when used as recommended.\"\n },\n {\n \"VerbatimTerm\": \"Respiratory Depression\",\n \"Probability\": \"0.354414165\",\n \"SemanticContext\": \"5.4 Ultra-Rapid Metabolism of Tramadol and Other Risk Factors for Life-threatening Respiratory Depression in Children Life-threatening respiratory depression and death have occurred in children who received tramadol.\"\n },\n {\n \"VerbatimTerm\": \"Respiratory Depression\",\n \"Probability\": \"0.0545828938\",\n \"SemanticContext\": \"5.12 Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients The use of tramadol hydrochloride extended-release tablets in patients with acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment is contraindicated.\"\n },\n {\n \"VerbatimTerm\": \"Respiratory depression\",\n \"Probability\": \"0.8516961932\",\n \"SemanticContext\": \"Respiratory depression, if not immediately recognized and treated, may lead to respiratory arrest and death.\"\n },\n {\n \"VerbatimTerm\": \"Respiratory depression\",\n \"Probability\": \"0.6082434654\",\n \"SemanticContext\": \"Respiratory depression is the chief risk for elderly patients treated with opioids, and has occurred after large initial doses were administered to patients who were not opioidtolerant or when opioids were co-administered with other agents that depress respiration.\"\n }\n ]\n },\n {\n \"Term\": \"Carbon dioxide\",\n \"MEDDRACode\": \"10007220\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Carbon dioxide\",\n \"Probability\": \"0.0026080012\",\n \"SemanticContext\": \"Carbon dioxide CO 2 retention from opioid- induced respiratory depression can exacerbate the sedating effects of opioids.\"\n }\n ]\n },\n {\n \"Term\": \"Inappropriate antidiuretic hormone secretion\",\n \"MEDDRACode\": \"10053198\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"SIADH\",\n \"Probability\": \"0.6932223439\",\n \"SemanticContext\": \"Metabolism and nutrition disorders Hyponatremia: cases of severe hyponatremia and/or SIADH have been reported in patients taking tramadol, most often in females over the age of 65, and within the first week of therapy [see Warnings and Precautions 5.19 ].\"\n },\n {\n \"VerbatimTerm\": \"SIADH\",\n \"Probability\": \"0.3098105192\",\n \"SemanticContext\": \"In some reports, hyponatremia resulted from the syndrome of inappropriate antidiuretic hormone secretion SIADH .\"\n }\n ]\n },\n {\n \"Term\": \"Nausea\",\n \"MEDDRACode\": \"10028813\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"nausea\",\n \"Probability\": \"0.9997763634\",\n \"SemanticContext\": \"ADVERSE REACTIONS Most common adverse reactions =10% and =2 x placebo rate : Dizziness, constipation, nausea, headache, somnolence, flushing, pruritus, vomiting, insomnia, dry mouth.\"\n },\n {\n \"VerbatimTerm\": \"nausea\",\n \"Probability\": \"0.9991760254\",\n \"SemanticContext\": \"The most common adverse reactions from Table 1 occurring in =10% and =2 x placebo rate of the patients treated with tramadol hydrochloride extended-release tablets are dizziness not vertigo , nausea, constipation, headache, somnolence, flushing, pruritus, vomiting, insomnia, and dry mouth.\"\n },\n {\n \"VerbatimTerm\": \"nausea\",\n \"Probability\": \"0.571375668\",\n \"SemanticContext\": \"Apart from analgesia, tramadol administration may produce a constellation of symptoms including dizziness, somnolence, nausea, constipation, sweating and pruritus similar to that of other opioids.\"\n },\n {\n \"VerbatimTerm\": \"nausea\",\n \"Probability\": \"0.9150570035\",\n \"SemanticContext\": \"Concentration--Adverse Reaction Relationships There is a relationship between increasing tramadol plasma concentration and increasing frequency of dose-related opioid adverse reactions such as nausea, vomiting, CNS effects, and respiratory depression.\"\n },\n {\n \"VerbatimTerm\": \"nausea\",\n \"Probability\": \"0.2578266859\",\n \"SemanticContext\": \"Other signs and symptoms also may develop, including irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate.\"\n },\n {\n \"VerbatimTerm\": \"nausea\",\n \"Probability\": \"0.9493057728\",\n \"SemanticContext\": \"Adrenal insufficiency may present with non-specific symptoms and signs such as nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure.\"\n },\n {\n \"VerbatimTerm\": \"nausea\",\n \"Probability\": \"0.9080708623\",\n \"SemanticContext\": \"Serotonin syndrome symptoms may include mental status changes e.g., agitation, hallucinations, coma , autonomic instability e.g., tachycardia, labile blood pressure, hyperthermia , neuromuscular aberrations e.g., hyperreflexia, incoordination, rigidity , and/or gastrointestinal symptoms e.g., nausea, vomiting, diarrhea .\"\n },\n {\n \"VerbatimTerm\": \"nausea\",\n \"Probability\": \"0.9219824672\",\n \"SemanticContext\": \"Presentation of adrenal insufficiency may include non-specific symptoms and signs including nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure.\"\n },\n {\n \"VerbatimTerm\": \"nausea\",\n \"Probability\": \"0.9894989729\",\n \"SemanticContext\": \"The possible side effects of tramadol hydrochloride extended-release tablets: constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain, seizure.\"\n },\n {\n \"VerbatimTerm\": \"Nausea\",\n \"Probability\": \"0.9993904829\",\n \"SemanticContext\": \"MedDRA Preferred Term Tramadol Hydrochloride Extended-Release Tablets Placebo 100 mg N=403 n % 200 mg N=400 n % 300 mg N=400 n % 400 mg N=202 n % N=406 n % Dizziness not vertigo 64 16 81 20 90 23 57 28 28 7 Nausea 61 15 90 23 102 26 53 26 32 8 Constipation 49 12 68 17 85 21 60 30 17 4 Headache 49 12 62 16 46 12 32 16 43 11 Somnolence 33 8 45 11 29 7 41 20 7 2 Flushing 31 8 40 10 35 9 32 16 18 4 Pruritus 25 6 34 9 30 8 24 12 4 1 Vomiting 20 5 29 7 34 9 19 9 11 3 Insomnia 26 7 32 8 36 9 22 11 13 3 Dry Mouth 20 5 29 7 39 10 18 9 6 2 Diarrhea 15 4 27 7 37 9 10 5 17 4 Asthenia 14 4 24 6 26 7 13 6 7 2 Postural hypotension 7 2 17 4 8 2 11 5 9 2 Sweating increased 6 2 8 2 15 4 13 6 1 0 Anorexia 3 1 7 2 21 5 12 6 1 0 .\"\n }\n ]\n },\n {\n \"Term\": \"Dyspnoea\",\n \"MEDDRACode\": \"10013968\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"dyspnea\",\n \"Probability\": \"0.9987846017\",\n \"SemanticContext\": \"Eye disorders: vision blurred Gastrointestinal disorders: abdominal pain upper, dyspepsia, abdominal pain, sore throat General disorders: weakness, pain, feeling hot, influenza like illness, fall, rigors, lethargy, pyrexia, chest pain Infections and infestations: nasopharyngitis, upper respiratory tract infection, sinusitis, influenza, gastroenteritis viral, urinary tract infection, bronchitis Investigations: blood creatine phosphokinase increased, weight decreased Metabolism and nutrition disorders: appetite decreased Musculoskeletal, connective tissue and bone disorders: arthralgia, back pain, pain in limb, neck pain Nervous system disorders: tremor, paresthesia, hypoesthesia Psychiatric disorders: nervousness, anxiety, depression, restlessness Respiratory, thoracic and mediastinal disorders: sneezing, cough, rhinorrhea, nasal congestion, dyspnea, sinus congestion Skin and subcutaneous tissue disorders: sweating increased, dermatitis Vascular disorders: hot flushes, vasodilatation Adverse Reactions With Incidence Rates of 0.5% to \\n <1.0% and Serious Adverse Reactions Reported in at Least 2 patients During Clinical Trials Cardiac disorders: palpitations, myocardial infarction Ear and labyrinth disorders: tinnitus, vertigo Gastrointestinal disorders: flatulence, toothache, constipation aggravated, appendicitis, pancreatitis General disorders: feeling jittery, edema lower limb, shivering, joint swelling, malaise, drug withdrawal syndrome, peripheral swelling Hepato-biliary disorders: cholelithiasis, cholecystitis Infections and infestations: cellulitis, ear infection, gastroenteritis, pneumonia, viral infection Injury and poisoning: joint sprain, muscle injury Investigations: alanine aminotransferase increased, blood pressure increased, aspartate aminotransferase increased, heart rate increased, blood glucose increased, liver function tests abnormal Musculoskeletal, connective tissue and bone disorders: muscle cramps, muscle spasms, joint stiffness, muscle twitching, myalgia, osteoarthritis aggravated Nervous system disorders: migraine, sedation, syncope, disturbance in attention, dizziness aggravated Psychiatric disorders: euphoric mood, irritability, libido decreased, sleep disorder, agitation, disorientation, abnormal dreams Renal and urinary disorders: difficulty in micturition, urinary frequency, hematuria, dysuria, urinary retention Respiratory, thoracic and mediastinal disorders: yawning Skin and subcutaneous tissue disorders: contusion, piloerection, clamminess, night sweats, urticaria Vascular disorders: hypertension aggravated, hypertension, peripheral ischemia 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of tramadol.\"\n }\n ]\n },\n {\n \"Term\": \"Blood corticotrophin\",\n \"MEDDRACode\": \"10005450\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"ACTH\",\n \"Probability\": \"0.0031433702\",\n \"SemanticContext\": \"Effects on the Endocrine System Opioids inhibit the secretion of adrenocorticotropic hormone ACTH , cortisol, and luteinizing hormone LH in humans [see Adverse Reactions 6.2 ] .\"\n }\n ]\n },\n {\n \"Term\": \"Blood glucagon\",\n \"MEDDRACode\": \"10005547\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"glucagon\",\n \"Probability\": \"1.79828E-05\",\n \"SemanticContext\": \"They also stimulate prolactin, growth hormone GH secretion, and pancreatic secretion of insulin and glucagon.\"\n }\n ]\n },\n {\n \"Term\": \"Gait disturbance\",\n \"MEDDRACode\": \"10017577\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"steps\",\n \"Probability\": \"0.0727284551\",\n \"SemanticContext\": \"If no take back programs or DEA-registered collectors are available, instruct patients to dispose of tramadol hydrochloride extended-release tablets by following these four steps: Mix tramadol hydrochloride extended-release tablets do not crush with an unpalatable substance such as dirt, cat litter, or used coffee grounds; Place the mixture in a container such as a sealed plastic bag; Throw the container in the household trash; Delete all personal information on the prescription label of the empty bottle Inform patients that they can visit www.fda.gov/drugdisposa l for additional information on disposal of unused medicines.\"\n },\n {\n \"VerbatimTerm\": \"steps\",\n \"Probability\": \"0.0010811985\",\n \"SemanticContext\": \"Instruct patients not to share tramadol hydrochloride extended-release tablets with others and to take steps to protect tramadol hydrochloride extended-release tablets from theft or misuse.\"\n }\n ]\n },\n {\n \"Term\": \"Pain\",\n \"MEDDRACode\": \"10033371\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"chronic pain\",\n \"Probability\": \"0.0006233752\",\n \"SemanticContext\": \"DOSAGE AND ADMINISTRATION To be prescribed only by healthcare providers knowledgeable in use of potent opioids for management of chronic pain.\"\n },\n {\n \"VerbatimTerm\": \"chronic pain\",\n \"Probability\": \"0.0508572757\",\n \"SemanticContext\": \"Table 1: Incidence % of patients with adverse reaction rates = 5% from two 12-week placebo-controlled studies in patients with moderate to moderately severe chronic pain by dose N=1811 .\"\n },\n {\n \"VerbatimTerm\": \"chronic pain\",\n \"Probability\": \"0.3961720765\",\n \"SemanticContext\": \"Adverse reactions With Incidence Rates of 1.0% to \\n <5.0% During Clinical Trials The following adverse reactions were reported from all the chronic pain studies N=3108 .\"\n },\n {\n \"VerbatimTerm\": \"chronic pain\",\n \"Probability\": \"0.0006764829\",\n \"SemanticContext\": \"2 DOSAGE AND ADMINISTRATION 2.1 Important Dosage and Administration Instructions Tramadol hydrochloride extended-release tablets should be prescribed only by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain.\"\n },\n {\n \"VerbatimTerm\": \"chronic pain\",\n \"Probability\": \"0.012986213\",\n \"SemanticContext\": \"When managing patients taking opioid analgesics, particularly those who have been treated for a long duration and/or with high doses for chronic pain, ensure that a multimodal approach to pain management, including mental health support if needed , is in place prior to initiating an opioid analgesic taper.\"\n },\n {\n \"VerbatimTerm\": \"chronic pain\",\n \"Probability\": \"0.0146743357\",\n \"SemanticContext\": \"A multimodal approach to pain management may optimize the treatment of chronic pain, as well as assist with the successful tapering of the opioid analgesic [see Warnings and Precautions 5.17 , Drug Abuse and Dependence 9.3 ].\"\n }\n ]\n },\n {\n \"Term\": \"Drug ineffective\",\n \"MEDDRACode\": \"10013709\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"lack of efficacy\",\n \"Probability\": \"0.0755881369\",\n \"SemanticContext\": \"Thirty-seven percent of the placebo-treated patients discontinued the study due to lack of efficacy compared to 15% of tramadol hydrochloride extended-release tablets-treated patients.\"\n }\n ]\n },\n {\n \"Term\": \"Hypogonadism\",\n \"MEDDRACode\": \"10058359\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hypogonadism\",\n \"Probability\": \"0.0024128258\",\n \"SemanticContext\": \"The causal role of opioids in the clinical syndrome of hypogonadism is unknown because the various medical, physical, lifestyle, and psychological stressors that may influence gonadal hormone levels have not been adequately controlled for in studies conducted to date [see Adverse Reactions 6.2 ] .\"\n }\n ]\n },\n {\n \"Term\": \"Vasodilation procedure\",\n \"MEDDRACode\": \"10058794\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"vasodilation\",\n \"Probability\": \"0.4648489952\",\n \"SemanticContext\": \"Effects on the Cardiovascular System Tramadol produces peripheral vasodilation, which may result in orthostatic hypotension or syncope.\"\n },\n {\n \"VerbatimTerm\": \"vasodilation\",\n \"Probability\": \"0.0375151336\",\n \"SemanticContext\": \"Manifestations of histamine release and/or peripheral vasodilation may include pruritus, flushing, red eyes, sweating, and/or orthostatic hypotension.\"\n },\n {\n \"VerbatimTerm\": \"vasodilation\",\n \"Probability\": \"0.0064065158\",\n \"SemanticContext\": \"In patients with circulatory shock, tramadol hydrochloride extended-release tablets may cause vasodilation that can further reduce cardiac output and blood pressure.\"\n }\n ]\n },\n {\n \"Term\": \"Norepinephrine\",\n \"MEDDRACode\": \"10050925\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"norepinephrine\",\n \"Probability\": \"0.0170013011\",\n \"SemanticContext\": \"tramadol-structure 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Tramadol hydrochloride extended-release tablets contain tramadol, an opioid agonist and an inhibitor of reuptake of norepinephrine and serotonin.\"\n },\n {\n \"VerbatimTerm\": \"norepinephrine\",\n \"Probability\": \"0.0158469975\",\n \"SemanticContext\": \"Although the mode of action of tramadol is not completely understood, the analgesic effect of tramadol is believed to be due to both binding to µ-opioid receptors and weak inhibition of reuptake of norepinephrine and serotonin.\"\n },\n {\n \"VerbatimTerm\": \"norepinephrine\",\n \"Probability\": \"0.0071795881\",\n \"SemanticContext\": \"Tramadol has been shown to inhibit reuptake of norepinephrine and serotonin in vitro , as have some other opioid analgesics.\"\n },\n {\n \"VerbatimTerm\": \"norepinephrine\",\n \"Probability\": \"0.0332776904\",\n \"SemanticContext\": \"Examples: Selective serotonin reuptake inhibitors SSRIs , serotonin and norepinephrine reuptake inhibitors SNRIs , tricyclic antidepressants TCAs , triptans, 5-HT3 receptor antagonists, drugs that affect the serotonin neurotransmitter system e.g., mirtazapine, trazodone, tramadol , certain muscle relaxants i.e., cyclobenzaprine, metaxalone , monoamine oxidase MAO inhibitors those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue .\"\n },\n {\n \"VerbatimTerm\": \"norepinephrine\",\n \"Probability\": \"0.00050053\",\n \"SemanticContext\": \"Use of cytochrome P450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with tramadol hydrochloride extended-release tablets requires careful consideration of the effects on the parent drug, tramadol which is a weak serotonin and norepinephrine reuptake inhibitor and µ-opioid agonist, and the active metabolite, M1, which is more potent than tramadol in µ-opioid receptor binding [see Drug Interactions 7 ] .\"\n },\n {\n \"VerbatimTerm\": \"norepinephrine\",\n \"Probability\": \"0.0439791381\",\n \"SemanticContext\": \"Serotonergic drugs include selective serotonin reuptake inhibitors SSRIs , serotonin and norepinephrine reuptake inhibitors SNRIs , tricyclic antidepressants TCAs , triptans, 5-HT3 receptor antagonists, drugs that affect the serotonergic neurotransmitter system e.g., mirtazapine, trazodone, tramadol , certain muscle relaxants i.e., cyclobenzaprine, metaxalone , and drugs that impair metabolism of serotonin including MAO inhibitors, both those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue [see Drug Interactions 7 ] .\"\n },\n {\n \"VerbatimTerm\": \"norepinephrine\",\n \"Probability\": \"0.0016352832\",\n \"SemanticContext\": \"Selective serotonin re-uptake inhibitors SSRIs and Serotonin-norepinephrine re-uptake inhibitors SNRIs antidepressants or anorectics, Tricyclic antidepressants TCAs , and other tricyclic compounds e.g., cyclobenzaprine, promethazine, etc. , Other opioids, MAO inhibitors [see Warnings and Precautions 5.8 , Drug Interactions 7 ] Neuroleptics, or Other drugs that reduce the seizure threshold.\"\n }\n ]\n },\n {\n \"Term\": \"Influenza\",\n \"MEDDRACode\": \"10022000\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"influenza\",\n \"Probability\": \"0.999460578\",\n \"SemanticContext\": \"Eye disorders: vision blurred Gastrointestinal disorders: abdominal pain upper, dyspepsia, abdominal pain, sore throat General disorders: weakness, pain, feeling hot, influenza like illness, fall, rigors, lethargy, pyrexia, chest pain Infections and infestations: nasopharyngitis, upper respiratory tract infection, sinusitis, influenza, gastroenteritis viral, urinary tract infection, bronchitis Investigations: blood creatine phosphokinase increased, weight decreased Metabolism and nutrition disorders: appetite decreased Musculoskeletal, connective tissue and bone disorders: arthralgia, back pain, pain in limb, neck pain Nervous system disorders: tremor, paresthesia, hypoesthesia Psychiatric disorders: nervousness, anxiety, depression, restlessness Respiratory, thoracic and mediastinal disorders: sneezing, cough, rhinorrhea, nasal congestion, dyspnea, sinus congestion Skin and subcutaneous tissue disorders: sweating increased, dermatitis Vascular disorders: hot flushes, vasodilatation Adverse Reactions With Incidence Rates of 0.5% to \\n <1.0% and Serious Adverse Reactions Reported in at Least 2 patients During Clinical Trials Cardiac disorders: palpitations, myocardial infarction Ear and labyrinth disorders: tinnitus, vertigo Gastrointestinal disorders: flatulence, toothache, constipation aggravated, appendicitis, pancreatitis General disorders: feeling jittery, edema lower limb, shivering, joint swelling, malaise, drug withdrawal syndrome, peripheral swelling Hepato-biliary disorders: cholelithiasis, cholecystitis Infections and infestations: cellulitis, ear infection, gastroenteritis, pneumonia, viral infection Injury and poisoning: joint sprain, muscle injury Investigations: alanine aminotransferase increased, blood pressure increased, aspartate aminotransferase increased, heart rate increased, blood glucose increased, liver function tests abnormal Musculoskeletal, connective tissue and bone disorders: muscle cramps, muscle spasms, joint stiffness, muscle twitching, myalgia, osteoarthritis aggravated Nervous system disorders: migraine, sedation, syncope, disturbance in attention, dizziness aggravated Psychiatric disorders: euphoric mood, irritability, libido decreased, sleep disorder, agitation, disorientation, abnormal dreams Renal and urinary disorders: difficulty in micturition, urinary frequency, hematuria, dysuria, urinary retention Respiratory, thoracic and mediastinal disorders: yawning Skin and subcutaneous tissue disorders: contusion, piloerection, clamminess, night sweats, urticaria Vascular disorders: hypertension aggravated, hypertension, peripheral ischemia 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of tramadol.\"\n }\n ]\n },\n {\n \"Term\": \"Malaise\",\n \"MEDDRACode\": \"10025482\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"malaise\",\n \"Probability\": \"0.9890885353\",\n \"SemanticContext\": \"Eye disorders: vision blurred Gastrointestinal disorders: abdominal pain upper, dyspepsia, abdominal pain, sore throat General disorders: weakness, pain, feeling hot, influenza like illness, fall, rigors, lethargy, pyrexia, chest pain Infections and infestations: nasopharyngitis, upper respiratory tract infection, sinusitis, influenza, gastroenteritis viral, urinary tract infection, bronchitis Investigations: blood creatine phosphokinase increased, weight decreased Metabolism and nutrition disorders: appetite decreased Musculoskeletal, connective tissue and bone disorders: arthralgia, back pain, pain in limb, neck pain Nervous system disorders: tremor, paresthesia, hypoesthesia Psychiatric disorders: nervousness, anxiety, depression, restlessness Respiratory, thoracic and mediastinal disorders: sneezing, cough, rhinorrhea, nasal congestion, dyspnea, sinus congestion Skin and subcutaneous tissue disorders: sweating increased, dermatitis Vascular disorders: hot flushes, vasodilatation Adverse Reactions With Incidence Rates of 0.5% to \\n <1.0% and Serious Adverse Reactions Reported in at Least 2 patients During Clinical Trials Cardiac disorders: palpitations, myocardial infarction Ear and labyrinth disorders: tinnitus, vertigo Gastrointestinal disorders: flatulence, toothache, constipation aggravated, appendicitis, pancreatitis General disorders: feeling jittery, edema lower limb, shivering, joint swelling, malaise, drug withdrawal syndrome, peripheral swelling Hepato-biliary disorders: cholelithiasis, cholecystitis Infections and infestations: cellulitis, ear infection, gastroenteritis, pneumonia, viral infection Injury and poisoning: joint sprain, muscle injury Investigations: alanine aminotransferase increased, blood pressure increased, aspartate aminotransferase increased, heart rate increased, blood glucose increased, liver function tests abnormal Musculoskeletal, connective tissue and bone disorders: muscle cramps, muscle spasms, joint stiffness, muscle twitching, myalgia, osteoarthritis aggravated Nervous system disorders: migraine, sedation, syncope, disturbance in attention, dizziness aggravated Psychiatric disorders: euphoric mood, irritability, libido decreased, sleep disorder, agitation, disorientation, abnormal dreams Renal and urinary disorders: difficulty in micturition, urinary frequency, hematuria, dysuria, urinary retention Respiratory, thoracic and mediastinal disorders: yawning Skin and subcutaneous tissue disorders: contusion, piloerection, clamminess, night sweats, urticaria Vascular disorders: hypertension aggravated, hypertension, peripheral ischemia 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of tramadol.\"\n }\n ]\n },\n {\n \"Term\": \"Dizziness\",\n \"MEDDRACode\": \"10013573\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Dizziness\",\n \"Probability\": \"0.9997872114\",\n \"SemanticContext\": \"ADVERSE REACTIONS Most common adverse reactions =10% and =2 x placebo rate : Dizziness, constipation, nausea, headache, somnolence, flushing, pruritus, vomiting, insomnia, dry mouth.\"\n },\n {\n \"VerbatimTerm\": \"Dizziness\",\n \"Probability\": \"0.9821653366\",\n \"SemanticContext\": \"MedDRA Preferred Term Tramadol Hydrochloride Extended-Release Tablets Placebo 100 mg N=403 n % 200 mg N=400 n % 300 mg N=400 n % 400 mg N=202 n % N=406 n % Dizziness not vertigo 64 16 81 20 90 23 57 28 28 7 Nausea 61 15 90 23 102 26 53 26 32 8 Constipation 49 12 68 17 85 21 60 30 17 4 Headache 49 12 62 16 46 12 32 16 43 11 Somnolence 33 8 45 11 29 7 41 20 7 2 Flushing 31 8 40 10 35 9 32 16 18 4 Pruritus 25 6 34 9 30 8 24 12 4 1 Vomiting 20 5 29 7 34 9 19 9 11 3 Insomnia 26 7 32 8 36 9 22 11 13 3 Dry Mouth 20 5 29 7 39 10 18 9 6 2 Diarrhea 15 4 27 7 37 9 10 5 17 4 Asthenia 14 4 24 6 26 7 13 6 7 2 Postural hypotension 7 2 17 4 8 2 11 5 9 2 Sweating increased 6 2 8 2 15 4 13 6 1 0 Anorexia 3 1 7 2 21 5 12 6 1 0 .\"\n },\n {\n \"VerbatimTerm\": \"dizziness\",\n \"Probability\": \"0.9996874332\",\n \"SemanticContext\": \"The most common adverse reactions from Table 1 occurring in =10% and =2 x placebo rate of the patients treated with tramadol hydrochloride extended-release tablets are dizziness not vertigo , nausea, constipation, headache, somnolence, flushing, pruritus, vomiting, insomnia, and dry mouth.\"\n },\n {\n \"VerbatimTerm\": \"dizziness\",\n \"Probability\": \"0.9522627592\",\n \"SemanticContext\": \"Apart from analgesia, tramadol administration may produce a constellation of symptoms including dizziness, somnolence, nausea, constipation, sweating and pruritus similar to that of other opioids.\"\n },\n {\n \"VerbatimTerm\": \"dizziness\",\n \"Probability\": \"0.9578182697\",\n \"SemanticContext\": \"Adrenal insufficiency may present with non-specific symptoms and signs such as nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure.\"\n },\n {\n \"VerbatimTerm\": \"dizziness\",\n \"Probability\": \"0.8804808855\",\n \"SemanticContext\": \"Presentation of adrenal insufficiency may include non-specific symptoms and signs including nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure.\"\n },\n {\n \"VerbatimTerm\": \"dizziness\",\n \"Probability\": \"0.9644421935\",\n \"SemanticContext\": \"The possible side effects of tramadol hydrochloride extended-release tablets: constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain, seizure.\"\n }\n ]\n },\n {\n \"Term\": \"Carcinogenicity\",\n \"MEDDRACode\": \"10007269\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Carcinogenicity\",\n \"Probability\": \"0.0003749728\",\n \"SemanticContext\": \"13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Carcinogenicity assessment has been conducted in mice, rats and p53 +/- heterozygous mice.\"\n },\n {\n \"VerbatimTerm\": \"carcinogenicity\",\n \"Probability\": \"0.0001712143\",\n \"SemanticContext\": \"A slight but statistically significant increase in two common murine tumors, pulmonary and hepatic, was observed in an NMRI mouse carcinogenicity study, particularly in aged mice.\"\n },\n {\n \"VerbatimTerm\": \"carcinogenicity\",\n \"Probability\": \"0.0027191937\",\n \"SemanticContext\": \"No evidence of carcinogenicity was noted in a rat 2-year carcinogenicity study testing oral doses of up to 30 mg/kg in the drinking water 1 times the MRHD .\"\n },\n {\n \"VerbatimTerm\": \"carcinogenicity\",\n \"Probability\": \"2.23113E-05\",\n \"SemanticContext\": \"No evidence of carcinogenicity was noted in a rat 2-year carcinogenicity study testing oral doses of up to 30 mg/kg in the drinking water 1 times the MRHD .\"\n },\n {\n \"VerbatimTerm\": \"carcinogenicity\",\n \"Probability\": \"0.0023177564\",\n \"SemanticContext\": \"In a second rat study, no evidence of carcinogenicity was noted in rats at oral doses up to 75 mg/kg/day for males and 100 mg/kg/day for females approximately 2-fold the maximum recommended human daily dose MRHD for two years.\"\n }\n ]\n },\n {\n \"Term\": \"Intracranial pressure increased\",\n \"MEDDRACode\": \"10022773\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Increased Intracranial Pressure\",\n \"Probability\": \"0.0251664817\",\n \"SemanticContext\": \"Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness: Monitor for sedation and respiratory depression.\"\n },\n {\n \"VerbatimTerm\": \"Increased Intracranial Pressure\",\n \"Probability\": \"0.0164189041\",\n \"SemanticContext\": \"5.14 Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness In patients who may be susceptible to the intracranial effects of CO 2 retention e.g., those with evidence of increased intracranial pressure or brain tumors , tramadol hydrochloride extended-release tablets may reduce respiratory drive, and the resultant CO 2 retention can further increase intracranial pressure.\"\n },\n {\n \"VerbatimTerm\": \"increased intracranial pressure\",\n \"Probability\": \"0.2525470853\",\n \"SemanticContext\": \"5.14 Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness In patients who may be susceptible to the intracranial effects of CO 2 retention e.g., those with evidence of increased intracranial pressure or brain tumors , tramadol hydrochloride extended-release tablets may reduce respiratory drive, and the resultant CO 2 retention can further increase intracranial pressure.\"\n },\n {\n \"VerbatimTerm\": \"increase intracranial pressure\",\n \"Probability\": \"0.903285265\",\n \"SemanticContext\": \"5.14 Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness In patients who may be susceptible to the intracranial effects of CO 2 retention e.g., those with evidence of increased intracranial pressure or brain tumors , tramadol hydrochloride extended-release tablets may reduce respiratory drive, and the resultant CO 2 retention can further increase intracranial pressure.\"\n }\n ]\n },\n {\n \"Term\": \"Accidental exposure to product\",\n \"MEDDRACode\": \"10073317\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"ACCIDENTAL INGESTION\",\n \"Probability\": \"0.0520499945\",\n \"SemanticContext\": \"TRAMADOL HYDROCHLORIDE extended-release tablets for oral use, C IV Initial U.S. Approval: 1995 WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY REMS ; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; ULTRA-RAPID METABOLISM OF TRAMADOL AND OTHER RISK FACTORS FOR LIFE-THREATENING RESPIRATORY DEPRESSION IN CHILDREN; NEONATAL OPIOID WITHDRAWAL SYNDROME; INTERACTIONS WITH DRUGS AFFECTING CYTOCHROME P450 ISOENZYMES; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS See full prescribing information for complete boxed warning .\"\n },\n {\n \"VerbatimTerm\": \"Accidental ingestion\",\n \"Probability\": \"0.0052469373\",\n \"SemanticContext\": \"Accidental ingestion of tramadol hydrochloride extended-release tablets, especially by children, can result in a fatal overdose of tramadol.\"\n },\n {\n \"VerbatimTerm\": \"Accidental ingestion\",\n \"Probability\": \"0.0013768673\",\n \"SemanticContext\": \"Accidental ingestion of even one dose of tramadol hydrochloride extended-release tablet, especially by children, can result in respiratory depression and death due to an overdose of tramadol.\"\n },\n {\n \"VerbatimTerm\": \"accidental ingestion\",\n \"Probability\": \"0.0002267659\",\n \"SemanticContext\": \"Consider prescribing naloxone if the patient has household members including children or other close contacts at risk for accidental ingestion or overdose.\"\n },\n {\n \"VerbatimTerm\": \"accidental ingestion\",\n \"Probability\": \"1.43617E-05\",\n \"SemanticContext\": \"Storage and Disposal Because of the risks associated with accidental ingestion, misuse, and abuse, advise patients to store tramadol hydrochloride extended-release tablets securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home [see Warnings and Precautions 5.1 , Drug Abuse And Dependence 9.3 ] .\"\n },\n {\n \"VerbatimTerm\": \"accidental ingestion\",\n \"Probability\": \"0.0001425743\",\n \"SemanticContext\": \"Accidental Ingestion Inform patients that accidental ingestion, especially by children, may result in respiratory depression or death [see Warnings and Precautions 5.3 ] .\"\n },\n {\n \"VerbatimTerm\": \"accidental ingestion\",\n \"Probability\": \"0.0002314448\",\n \"SemanticContext\": \"Also consider prescribing naloxone if the patient has household members including children or other close contacts at risk for accidental ingestion or overdose.\"\n },\n {\n \"VerbatimTerm\": \"Accidental Ingestion\",\n \"Probability\": \"0.0170716941\",\n \"SemanticContext\": \"Accidental Ingestion Inform patients that accidental ingestion, especially by children, may result in respiratory depression or death [see Warnings and Precautions 5.3 ] .\"\n }\n ]\n },\n {\n \"Term\": \"Coma\",\n \"MEDDRACode\": \"10010071\",\n \"Overdose\": true,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"coma\",\n \"Probability\": \"0.3209856153\",\n \"SemanticContext\": \"Concomitant use of opioids with benzodiazepines or other central nervous system CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.\"\n },\n {\n \"VerbatimTerm\": \"coma\",\n \"Probability\": \"0.0665064156\",\n \"SemanticContext\": \"Avoid use of tramadol hydrochloride extended-release tablets in patients with impaired consciousness or coma.\"\n },\n {\n \"VerbatimTerm\": \"coma\",\n \"Probability\": \"0.1829692423\",\n \"SemanticContext\": \"Examples: Rifampin, carbamazepine, phenytoin Benzodiazepines and Other Central Nervous System CNS Depressants Clinical Impact: Due to additive pharmacologic effect, the concomitant use of benzodiazepines or other CNS depressants, including alcohol, can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death.\"\n },\n {\n \"VerbatimTerm\": \"coma\",\n \"Probability\": \"0.3565955162\",\n \"SemanticContext\": \"Monoamine Oxidase Inhibitors MAOIs Clinical Impact: MAOI interactions with opioids may manifest as serotonin syndrome [see Warnings and Precautions 5.8 ] or opioid toxicity e.g., respiratory depression, coma [see Warnings and Precautions 5.3 ].\"\n },\n {\n \"VerbatimTerm\": \"coma\",\n \"Probability\": \"0.7856088877\",\n \"SemanticContext\": \"10 OVERDOSAGE Clinical Presentation Acute overdosage with tramadol hydrochloride extended-release tablets can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and, in some cases, pulmonary edema, bradycardia, QT prolongation, hypotension, partial or complete airway obstruction, atypical snoring, and death.\"\n },\n {\n \"VerbatimTerm\": \"coma\",\n \"Probability\": \"0.4339153767\",\n \"SemanticContext\": \"5.7 Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants Profound sedation, respiratory depression, coma, and death may result from the concomitant use of tramadol hydrochloride extended-release tablets with benzodiazepines or other CNS depressants e.g., non-benzodiazepine sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, other opioids, alcohol .\"\n },\n {\n \"VerbatimTerm\": \"coma\",\n \"Probability\": \"0.9853959084\",\n \"SemanticContext\": \"Serotonin syndrome symptoms may include mental status changes e.g., agitation, hallucinations, coma , autonomic instability e.g., tachycardia, labile blood pressure, hyperthermia , neuromuscular aberrations e.g., hyperreflexia, incoordination, rigidity , and/or gastrointestinal symptoms e.g., nausea, vomiting, diarrhea .\"\n },\n {\n \"VerbatimTerm\": \"coma\",\n \"Probability\": \"0.0087015629\",\n \"SemanticContext\": \"Avoid the use of tramadol hydrochloride extended-release tablets in patients with impaired consciousness or coma.\"\n },\n {\n \"VerbatimTerm\": \"coma\",\n \"Probability\": \"0.0575398803\",\n \"SemanticContext\": \"Taking tramadol hydrochloride extended-release tablets with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants including street drugs can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.\"\n }\n ]\n },\n {\n \"Term\": \"Biliary tract disorder\",\n \"MEDDRACode\": \"10061008\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"biliary tract disease\",\n \"Probability\": \"0.0364189148\",\n \"SemanticContext\": \"Monitor patients with biliary tract disease, including acute pancreatitis, for worsening symptoms.\"\n }\n ]\n },\n {\n \"Term\": \"Sphincter of Oddi dysfunction\",\n \"MEDDRACode\": \"10066424\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"spasm of sphincter of Oddi\",\n \"Probability\": \"0.1655838192\",\n \"SemanticContext\": \"Other opioid-induced effects may include a reduction in biliary and pancreatic secretions, spasm of sphincter of Oddi, and transient elevations in serum amylase.\"\n }\n ]\n },\n {\n \"Term\": \"Mydriasis\",\n \"MEDDRACode\": \"10028521\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"mydriasis\",\n \"Probability\": \"0.2382217646\",\n \"SemanticContext\": \"Marked mydriasis rather than miosis may be seen due to hypoxia in overdose situations.\"\n },\n {\n \"VerbatimTerm\": \"mydriasis\",\n \"Probability\": \"0.973081708\",\n \"SemanticContext\": \"Common withdrawal symptoms include restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia, and mydriasis.\"\n },\n {\n \"VerbatimTerm\": \"mydriasis\",\n \"Probability\": \"0.1430811286\",\n \"SemanticContext\": \"Marked mydriasis rather than miosis may be seen with hypoxia in overdose situations [see Clinical Pharmacology 12.2 ] .\"\n }\n ]\n },\n {\n \"Term\": \"Dialysis\",\n \"MEDDRACode\": \"10061105\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"dialysis\",\n \"Probability\": \"4.79675E-05\",\n \"SemanticContext\": \"The total amount of tramadol and M1 removed during a 4-hour dialysis period is less than 7% of the administered dose [see Use in Specific Populations 8.7 ] .\"\n },\n {\n \"VerbatimTerm\": \"dialysis\",\n \"Probability\": \"3.42941E-05\",\n \"SemanticContext\": \"Hemodialysis is not expected to be helpful in an overdose because it removes less than 7% of the administered dose in a 4-hour dialysis period.\"\n }\n ]\n },\n {\n \"Term\": \"Drug use disorder\",\n \"MEDDRACode\": \"10079381\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"opioid use disorder\",\n \"Probability\": \"3.06203E-05\",\n \"SemanticContext\": \"Consider prescribing naloxone, based on the patient’s risk factors for overdose, such as concomitant use of CNS depressants, a history of opioid use disorder, or prior opioid overdose.\"\n },\n {\n \"VerbatimTerm\": \"opioid use disorder\",\n \"Probability\": \"0.0005704761\",\n \"SemanticContext\": \"Treatment should include evidence-based approaches, such as medication assisted treatment of opioid use disorder.\"\n },\n {\n \"VerbatimTerm\": \"opioid use disorder\",\n \"Probability\": \"3.06203E-05\",\n \"SemanticContext\": \"Consider prescribing naloxone, based on the patient’s risk factors for overdose, such as concomitant use of CNS depressants, a history of opioid use disorder, or prior opioid overdose.\"\n }\n ]\n },\n {\n \"Term\": \"Renal failure\",\n \"MEDDRACode\": \"10038435\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"renal insufficiency\",\n \"Probability\": \"0.6061968207\",\n \"SemanticContext\": \"Most reports were in patients with predisposing risk factors, including diabetes or renal insufficiency, or in elderly patients [see Warnings and Precautions 5.20 ] .\"\n }\n ]\n },\n {\n \"Term\": \"Fatigue\",\n \"MEDDRACode\": \"10016256\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"fatigue\",\n \"Probability\": \"0.9584726095\",\n \"SemanticContext\": \"Adrenal insufficiency may present with non-specific symptoms and signs such as nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure.\"\n },\n {\n \"VerbatimTerm\": \"fatigue\",\n \"Probability\": \"0.8798103333\",\n \"SemanticContext\": \"Presentation of adrenal insufficiency may include non-specific symptoms and signs including nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure.\"\n },\n {\n \"VerbatimTerm\": \"fatigue\",\n \"Probability\": \"0.9990112782\",\n \"SemanticContext\": \"In general, higher incidence rates of adverse events were observed for patients older than 65 years of age compared with patients 65 years and younger, particularly for the following adverse events: constipation, fatigue, weakness, postural hypotension and dyspepsia.\"\n }\n ]\n },\n {\n \"Term\": \"Pulmonary oedema\",\n \"MEDDRACode\": \"10037423\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"pulmonary edema\",\n \"Probability\": \"0.3398272991\",\n \"SemanticContext\": \"10 OVERDOSAGE Clinical Presentation Acute overdosage with tramadol hydrochloride extended-release tablets can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and, in some cases, pulmonary edema, bradycardia, QT prolongation, hypotension, partial or complete airway obstruction, atypical snoring, and death.\"\n },\n {\n \"VerbatimTerm\": \"pulmonary edema\",\n \"Probability\": \"0.0606105626\",\n \"SemanticContext\": \"Employ other supportive measures including oxygen and vasopressors in the management of circulatory shock and pulmonary edema as indicated.\"\n }\n ]\n },\n {\n \"Term\": \"Body surface area\",\n \"MEDDRACode\": \"10050311\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"body surface area\",\n \"Probability\": \"0.0002937019\",\n \"SemanticContext\": \"These dosages are 1.2 and 1.8 times the maximum recommended human daily dose based on body surface area, respectively.\"\n }\n ]\n },\n {\n \"Term\": \"Salmonellosis\",\n \"MEDDRACode\": \"10039447\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Salmonella\",\n \"Probability\": \"0.0015630424\",\n \"SemanticContext\": \"Tramadol was not mutagenic in the in vitro bacterial reverse mutation assay using Salmonella and E. coli Ames , the mouse lymphoma assay in the absence of metabolic activation, the in vitro chromosomal aberration assay, or the in vivo micronucleus assay in bone marrow.\"\n }\n ]\n },\n {\n \"Term\": \"High-pitched crying\",\n \"MEDDRACode\": \"10052286\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"high pitched cry\",\n \"Probability\": \"0.9768663645\",\n \"SemanticContext\": \"Neonatal opioid withdrawal syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea, and failure to gain weight.\"\n }\n ]\n },\n {\n \"Term\": \"Androgen deficiency\",\n \"MEDDRACode\": \"10002261\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Androgen deficiency\",\n \"Probability\": \"0.216678828\",\n \"SemanticContext\": \"Androgen deficiency: Cases of androgen deficiency have occurred with chronic use of opioids [ see Clinical Pharmacology 12.2 ].\"\n },\n {\n \"VerbatimTerm\": \"androgen deficiency\",\n \"Probability\": \"0.5815461278\",\n \"SemanticContext\": \"Androgen deficiency: Cases of androgen deficiency have occurred with chronic use of opioids [ see Clinical Pharmacology 12.2 ].\"\n },\n {\n \"VerbatimTerm\": \"androgen deficiency\",\n \"Probability\": \"0.8782791495\",\n \"SemanticContext\": \"Chronic use of opioids may influence the hypothalamic-pituitary-gonadal axis, leading to androgen deficiency that may manifest as low libido, impotence, erectile dysfunction, amenorrhea, or infertility.\"\n }\n ]\n },\n {\n \"Term\": \"Restlessness\",\n \"MEDDRACode\": \"10038743\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"restlessness\",\n \"Probability\": \"0.9476048946\",\n \"SemanticContext\": \"Eye disorders: vision blurred Gastrointestinal disorders: abdominal pain upper, dyspepsia, abdominal pain, sore throat General disorders: weakness, pain, feeling hot, influenza like illness, fall, rigors, lethargy, pyrexia, chest pain Infections and infestations: nasopharyngitis, upper respiratory tract infection, sinusitis, influenza, gastroenteritis viral, urinary tract infection, bronchitis Investigations: blood creatine phosphokinase increased, weight decreased Metabolism and nutrition disorders: appetite decreased Musculoskeletal, connective tissue and bone disorders: arthralgia, back pain, pain in limb, neck pain Nervous system disorders: tremor, paresthesia, hypoesthesia Psychiatric disorders: nervousness, anxiety, depression, restlessness Respiratory, thoracic and mediastinal disorders: sneezing, cough, rhinorrhea, nasal congestion, dyspnea, sinus congestion Skin and subcutaneous tissue disorders: sweating increased, dermatitis Vascular disorders: hot flushes, vasodilatation Adverse Reactions With Incidence Rates of 0.5% to \\n <1.0% and Serious Adverse Reactions Reported in at Least 2 patients During Clinical Trials Cardiac disorders: palpitations, myocardial infarction Ear and labyrinth disorders: tinnitus, vertigo Gastrointestinal disorders: flatulence, toothache, constipation aggravated, appendicitis, pancreatitis General disorders: feeling jittery, edema lower limb, shivering, joint swelling, malaise, drug withdrawal syndrome, peripheral swelling Hepato-biliary disorders: cholelithiasis, cholecystitis Infections and infestations: cellulitis, ear infection, gastroenteritis, pneumonia, viral infection Injury and poisoning: joint sprain, muscle injury Investigations: alanine aminotransferase increased, blood pressure increased, aspartate aminotransferase increased, heart rate increased, blood glucose increased, liver function tests abnormal Musculoskeletal, connective tissue and bone disorders: muscle cramps, muscle spasms, joint stiffness, muscle twitching, myalgia, osteoarthritis aggravated Nervous system disorders: migraine, sedation, syncope, disturbance in attention, dizziness aggravated Psychiatric disorders: euphoric mood, irritability, libido decreased, sleep disorder, agitation, disorientation, abnormal dreams Renal and urinary disorders: difficulty in micturition, urinary frequency, hematuria, dysuria, urinary retention Respiratory, thoracic and mediastinal disorders: yawning Skin and subcutaneous tissue disorders: contusion, piloerection, clamminess, night sweats, urticaria Vascular disorders: hypertension aggravated, hypertension, peripheral ischemia 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of tramadol.\"\n },\n {\n \"VerbatimTerm\": \"restlessness\",\n \"Probability\": \"0.8591858149\",\n \"SemanticContext\": \"Common withdrawal symptoms include restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia, and mydriasis.\"\n }\n ]\n },\n {\n \"Term\": \"Muscle rigidity\",\n \"MEDDRACode\": \"10028330\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"rigidity\",\n \"Probability\": \"0.8902742863\",\n \"SemanticContext\": \"Serotonin syndrome symptoms may include mental status changes e.g., agitation, hallucinations, coma , autonomic instability e.g., tachycardia, labile blood pressure, hyperthermia , neuromuscular aberrations e.g., hyperreflexia, incoordination, rigidity , and/or gastrointestinal symptoms e.g., nausea, vomiting, diarrhea .\"\n }\n ]\n },\n {\n \"Term\": \"Pancreatitis acute\",\n \"MEDDRACode\": \"10033647\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"acute pancreatitis\",\n \"Probability\": \"0.0999776721\",\n \"SemanticContext\": \"Monitor patients with biliary tract disease, including acute pancreatitis, for worsening symptoms.\"\n }\n ]\n },\n {\n \"Term\": \"Major depression\",\n \"MEDDRACode\": \"10057840\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"major depression\",\n \"Probability\": \"0.0009146929\",\n \"SemanticContext\": \"Risks are increased in patients with a personal or family history of substance abuse including drug or alcohol abuse or addiction or mental illness e.g., major depression .\"\n }\n ]\n },\n {\n \"Term\": \"Pyrexia\",\n \"MEDDRACode\": \"10037660\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"pyrexia\",\n \"Probability\": \"0.9956879616\",\n \"SemanticContext\": \"Eye disorders: vision blurred Gastrointestinal disorders: abdominal pain upper, dyspepsia, abdominal pain, sore throat General disorders: weakness, pain, feeling hot, influenza like illness, fall, rigors, lethargy, pyrexia, chest pain Infections and infestations: nasopharyngitis, upper respiratory tract infection, sinusitis, influenza, gastroenteritis viral, urinary tract infection, bronchitis Investigations: blood creatine phosphokinase increased, weight decreased Metabolism and nutrition disorders: appetite decreased Musculoskeletal, connective tissue and bone disorders: arthralgia, back pain, pain in limb, neck pain Nervous system disorders: tremor, paresthesia, hypoesthesia Psychiatric disorders: nervousness, anxiety, depression, restlessness Respiratory, thoracic and mediastinal disorders: sneezing, cough, rhinorrhea, nasal congestion, dyspnea, sinus congestion Skin and subcutaneous tissue disorders: sweating increased, dermatitis Vascular disorders: hot flushes, vasodilatation Adverse Reactions With Incidence Rates of 0.5% to \\n <1.0% and Serious Adverse Reactions Reported in at Least 2 patients During Clinical Trials Cardiac disorders: palpitations, myocardial infarction Ear and labyrinth disorders: tinnitus, vertigo Gastrointestinal disorders: flatulence, toothache, constipation aggravated, appendicitis, pancreatitis General disorders: feeling jittery, edema lower limb, shivering, joint swelling, malaise, drug withdrawal syndrome, peripheral swelling Hepato-biliary disorders: cholelithiasis, cholecystitis Infections and infestations: cellulitis, ear infection, gastroenteritis, pneumonia, viral infection Injury and poisoning: joint sprain, muscle injury Investigations: alanine aminotransferase increased, blood pressure increased, aspartate aminotransferase increased, heart rate increased, blood glucose increased, liver function tests abnormal Musculoskeletal, connective tissue and bone disorders: muscle cramps, muscle spasms, joint stiffness, muscle twitching, myalgia, osteoarthritis aggravated Nervous system disorders: migraine, sedation, syncope, disturbance in attention, dizziness aggravated Psychiatric disorders: euphoric mood, irritability, libido decreased, sleep disorder, agitation, disorientation, abnormal dreams Renal and urinary disorders: difficulty in micturition, urinary frequency, hematuria, dysuria, urinary retention Respiratory, thoracic and mediastinal disorders: yawning Skin and subcutaneous tissue disorders: contusion, piloerection, clamminess, night sweats, urticaria Vascular disorders: hypertension aggravated, hypertension, peripheral ischemia 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of tramadol.\"\n }\n ]\n },\n {\n \"Term\": \"Pancreatitis\",\n \"MEDDRACode\": \"10033645\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"pancreatitis\",\n \"Probability\": \"0.9962222576\",\n \"SemanticContext\": \"Eye disorders: vision blurred Gastrointestinal disorders: abdominal pain upper, dyspepsia, abdominal pain, sore throat General disorders: weakness, pain, feeling hot, influenza like illness, fall, rigors, lethargy, pyrexia, chest pain Infections and infestations: nasopharyngitis, upper respiratory tract infection, sinusitis, influenza, gastroenteritis viral, urinary tract infection, bronchitis Investigations: blood creatine phosphokinase increased, weight decreased Metabolism and nutrition disorders: appetite decreased Musculoskeletal, connective tissue and bone disorders: arthralgia, back pain, pain in limb, neck pain Nervous system disorders: tremor, paresthesia, hypoesthesia Psychiatric disorders: nervousness, anxiety, depression, restlessness Respiratory, thoracic and mediastinal disorders: sneezing, cough, rhinorrhea, nasal congestion, dyspnea, sinus congestion Skin and subcutaneous tissue disorders: sweating increased, dermatitis Vascular disorders: hot flushes, vasodilatation Adverse Reactions With Incidence Rates of 0.5% to \\n <1.0% and Serious Adverse Reactions Reported in at Least 2 patients During Clinical Trials Cardiac disorders: palpitations, myocardial infarction Ear and labyrinth disorders: tinnitus, vertigo Gastrointestinal disorders: flatulence, toothache, constipation aggravated, appendicitis, pancreatitis General disorders: feeling jittery, edema lower limb, shivering, joint swelling, malaise, drug withdrawal syndrome, peripheral swelling Hepato-biliary disorders: cholelithiasis, cholecystitis Infections and infestations: cellulitis, ear infection, gastroenteritis, pneumonia, viral infection Injury and poisoning: joint sprain, muscle injury Investigations: alanine aminotransferase increased, blood pressure increased, aspartate aminotransferase increased, heart rate increased, blood glucose increased, liver function tests abnormal Musculoskeletal, connective tissue and bone disorders: muscle cramps, muscle spasms, joint stiffness, muscle twitching, myalgia, osteoarthritis aggravated Nervous system disorders: migraine, sedation, syncope, disturbance in attention, dizziness aggravated Psychiatric disorders: euphoric mood, irritability, libido decreased, sleep disorder, agitation, disorientation, abnormal dreams Renal and urinary disorders: difficulty in micturition, urinary frequency, hematuria, dysuria, urinary retention Respiratory, thoracic and mediastinal disorders: yawning Skin and subcutaneous tissue disorders: contusion, piloerection, clamminess, night sweats, urticaria Vascular disorders: hypertension aggravated, hypertension, peripheral ischemia 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of tramadol.\"\n }\n ]\n },\n {\n \"Term\": \"Blood methanol\",\n \"MEDDRACode\": \"10005663\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"methanol\",\n \"Probability\": \"4.57523E-05\",\n \"SemanticContext\": \"It is a white, crystalline powder that is freely soluble in water and methanol, very slightly soluble in acetone and has a pKa of 9.41.\"\n }\n ]\n },\n {\n \"Term\": \"Erectile dysfunction\",\n \"MEDDRACode\": \"10061461\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"erectile dysfunction\",\n \"Probability\": \"0.9269838333\",\n \"SemanticContext\": \"Chronic use of opioids may influence the hypothalamic-pituitary-gonadal axis, leading to androgen deficiency that may manifest as low libido, impotence, erectile dysfunction, amenorrhea, or infertility.\"\n }\n ]\n },\n {\n \"Term\": \"Volume blood\",\n \"MEDDRACode\": \"10060917\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"blood volume\",\n \"Probability\": \"2.5019E-06\",\n \"SemanticContext\": \"There is increased risk in patients whose ability to maintain blood pressure has already been compromised by a reduced blood volume or concurrent administration of certain CNS depressant drugs e.g., phenothiazines or general anesthetics [see Drug Interactions 7 ].\"\n }\n ]\n },\n {\n \"Term\": \"Respiratory rate\",\n \"MEDDRACode\": \"10038709\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"respiratory rate\",\n \"Probability\": \"0.1354759037\",\n \"SemanticContext\": \"Other signs and symptoms also may develop, including irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate.\"\n }\n ]\n },\n {\n \"Term\": \"Prothrombin time\",\n \"MEDDRACode\": \"10037056\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"prothrombin times\",\n \"Probability\": \"0.0031123757\",\n \"SemanticContext\": \"Warfarin Clinical Impact: Post-marketing surveillance of tramadol has revealed rare reports of alteration of warfarin effect, including elevation of prothrombin times.\"\n },\n {\n \"VerbatimTerm\": \"prothrombin time\",\n \"Probability\": \"3.9689E-05\",\n \"SemanticContext\": \"Intervention: Monitor the prothrombin time of patients on warfarin for signs of an interaction and adjust the dosage of warfarin as needed.\"\n }\n ]\n },\n {\n \"Term\": \"Muscle relaxant therapy\",\n \"MEDDRACode\": \"10058909\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"muscle relaxants\",\n \"Probability\": \"0.0004397035\",\n \"SemanticContext\": \"Examples: Benzodiazepines and other sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, other opioids, alcohol.\"\n },\n {\n \"VerbatimTerm\": \"muscle relaxants\",\n \"Probability\": \"0.0003102422\",\n \"SemanticContext\": \"Examples: Selective serotonin reuptake inhibitors SSRIs , serotonin and norepinephrine reuptake inhibitors SNRIs , tricyclic antidepressants TCAs , triptans, 5-HT3 receptor antagonists, drugs that affect the serotonin neurotransmitter system e.g., mirtazapine, trazodone, tramadol , certain muscle relaxants i.e., cyclobenzaprine, metaxalone , monoamine oxidase MAO inhibitors those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue .\"\n },\n {\n \"VerbatimTerm\": \"muscle relaxants\",\n \"Probability\": \"0.0036576986\",\n \"SemanticContext\": \"Examples: butorphanol, nalbuphine, pentazocine, buprenorphine Muscle Relaxants Clinical Impact: Tramadol may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression.\"\n },\n {\n \"VerbatimTerm\": \"muscle relaxants\",\n \"Probability\": \"0.0001734793\",\n \"SemanticContext\": \"Due to the risk of respiratory depression with concomitant use of skeletal muscle relaxants and opioids, consider prescribing naloxone for the emergency treatment of opioid overdose [see Dosage and Administration 2.2 , Warnings and Precautions 5.3, 5.7 ] Diuretics Clinical Impact: Opioids can reduce the efficacy of diuretics by inducing the release of antidiuretic hormone.\"\n },\n {\n \"VerbatimTerm\": \"muscle relaxants\",\n \"Probability\": \"7.0093E-06\",\n \"SemanticContext\": \"5.7 Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants Profound sedation, respiratory depression, coma, and death may result from the concomitant use of tramadol hydrochloride extended-release tablets with benzodiazepines or other CNS depressants e.g., non-benzodiazepine sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, other opioids, alcohol .\"\n },\n {\n \"VerbatimTerm\": \"muscle relaxants\",\n \"Probability\": \"0.0002638698\",\n \"SemanticContext\": \"Serotonergic drugs include selective serotonin reuptake inhibitors SSRIs , serotonin and norepinephrine reuptake inhibitors SNRIs , tricyclic antidepressants TCAs , triptans, 5-HT3 receptor antagonists, drugs that affect the serotonergic neurotransmitter system e.g., mirtazapine, trazodone, tramadol , certain muscle relaxants i.e., cyclobenzaprine, metaxalone , and drugs that impair metabolism of serotonin including MAO inhibitors, both those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue [see Drug Interactions 7 ] .\"\n },\n {\n \"VerbatimTerm\": \"Muscle Relaxants\",\n \"Probability\": \"0.0020636022\",\n \"SemanticContext\": \"Examples: butorphanol, nalbuphine, pentazocine, buprenorphine Muscle Relaxants Clinical Impact: Tramadol may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression.\"\n },\n {\n \"VerbatimTerm\": \"muscle relaxant\",\n \"Probability\": \"9.23886E-05\",\n \"SemanticContext\": \"Intervention: Monitor patients for signs of respiratory depression that may be greater than otherwise expected and decrease the dosage of tramadol hydrochloride extended-release tablets and/or the muscle relaxant as necessary.\"\n }\n ]\n },\n {\n \"Term\": \"Myalgia\",\n \"MEDDRACode\": \"10028411\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"myalgia\",\n \"Probability\": \"0.9896271229\",\n \"SemanticContext\": \"Common withdrawal symptoms include restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia, and mydriasis.\"\n }\n ]\n },\n {\n \"Term\": \"Dependence\",\n \"MEDDRACode\": \"10012335\",\n \"Overdose\": true,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"dependence\",\n \"Probability\": \"0.0004838407\",\n \"SemanticContext\": \"Abuse and addiction are separate and distinct from physical dependence and tolerance.\"\n },\n {\n \"VerbatimTerm\": \"dependence\",\n \"Probability\": \"7.49032E-05\",\n \"SemanticContext\": \"Healthcare providers should be aware that addiction may not be accompanied by concurrent tolerance and symptoms of physical dependence in all addicts.\"\n },\n {\n \"VerbatimTerm\": \"dependence\",\n \"Probability\": \"0.0004838407\",\n \"SemanticContext\": \"Abuse and addiction are separate and distinct from physical dependence and tolerance.\"\n },\n {\n \"VerbatimTerm\": \"dependence\",\n \"Probability\": \"7.49032E-05\",\n \"SemanticContext\": \"Healthcare providers should be aware that addiction may not be accompanied by concurrent tolerance and symptoms of physical dependence in all addicts.\"\n },\n {\n \"VerbatimTerm\": \"dependence\",\n \"Probability\": \"0.0012704432\",\n \"SemanticContext\": \"9.3 Dependence Both tolerance and physical dependence can develop during chronic opioid therapy.\"\n },\n {\n \"VerbatimTerm\": \"dependence\",\n \"Probability\": \"0.0005607605\",\n \"SemanticContext\": \"Physical dependence is a physiological state in which the body adapts to the drug after a period of regular exposure, resulting in withdrawal symptoms after abrupt discontinuation or a significant dosage reduction of a drug.\"\n },\n {\n \"VerbatimTerm\": \"dependence\",\n \"Probability\": \"0.0063131154\",\n \"SemanticContext\": \"Physical dependence may not occur to a clinically significant degree until after several days to weeks of continued opioid usage.\"\n },\n {\n \"VerbatimTerm\": \"dependence\",\n \"Probability\": \"6.48603E-05\",\n \"SemanticContext\": \"Since M1 is a more potent µ-opioid agonist, decreased M1 exposure could result in decreased therapeutic effects, and may result in signs and symptoms of opioid withdrawal in patients who had developed physical dependence to tramadol.\"\n },\n {\n \"VerbatimTerm\": \"dependence\",\n \"Probability\": \"0.0002217591\",\n \"SemanticContext\": \"After stopping a CYP3A4 inhibitor, as the effects of the inhibitor decline, the tramadol plasma concentration will decrease [see Clinical Pharmacology 12.3 ] , resulting in decreased opioid efficacy and possibly signs and symptoms of opioid withdrawal in patients who had developed physical dependence to tramadol.\"\n },\n {\n \"VerbatimTerm\": \"dependence\",\n \"Probability\": \"0.0007760823\",\n \"SemanticContext\": \"Examples Macrolide antibiotics e.g., erythromycin , azole-antifungal agents e.g. ketoconazole , protease inhibitors e.g., ritonavir CYP3A4 Inducers Clinical Impact: The concomitant use of tramadol hydrochloride extended-release tablets and CYP3A4 inducers can decrease the plasma concentration of tramadol [see Clinical Pharmacology 12.3 ] , resulting in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical dependence to tramadol, [see Warnings and Precautions 5.6 ] .\"\n },\n {\n \"VerbatimTerm\": \"dependence\",\n \"Probability\": \"7.98173E-05\",\n \"SemanticContext\": \"The severity of the withdrawal symptoms experienced will depend on the degree of physical dependence and the dose of the antagonist administered.\"\n },\n {\n \"VerbatimTerm\": \"dependence\",\n \"Probability\": \"0.0026449561\",\n \"SemanticContext\": \"Clinical Considerations Fetal/Neonatal Adverse Reactions Prolonged use of opioid analgesics during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth.\"\n },\n {\n \"VerbatimTerm\": \"dependence\",\n \"Probability\": \"0.0002874136\",\n \"SemanticContext\": \"A decrease in M1 exposure in patients who have developed physical dependence to tramadol, may result in signs and symptoms of opioid withdrawal and reduced efficacy.\"\n },\n {\n \"VerbatimTerm\": \"DEPENDENCE\",\n \"Probability\": \"0.1016250253\",\n \"SemanticContext\": \"9 DRUG ABUSE AND DEPENDENCE 9.1 Controlled Substance Tramadol hydrochloride extended-release tablet contains tramadol, a scheduled IV controlled substance.\"\n },\n {\n \"VerbatimTerm\": \"Dependence\",\n \"Probability\": \"0.0009608269\",\n \"SemanticContext\": \"9.3 Dependence Both tolerance and physical dependence can develop during chronic opioid therapy.\"\n },\n {\n \"VerbatimTerm\": \"Dependence\",\n \"Probability\": \"0.0049241483\",\n \"SemanticContext\": \"A multimodal approach to pain management may optimize the treatment of chronic pain, as well as assist with the successful tapering of the opioid analgesic [see Warnings and Precautions 5.17 , Drug Abuse and Dependence 9.3 ].\"\n },\n {\n \"VerbatimTerm\": \"Dependence\",\n \"Probability\": \"0.0019048452\",\n \"SemanticContext\": \"Storage and Disposal Because of the risks associated with accidental ingestion, misuse, and abuse, advise patients to store tramadol hydrochloride extended-release tablets securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home [see Warnings and Precautions 5.1 , Drug Abuse And Dependence 9.3 ] .\"\n },\n {\n \"VerbatimTerm\": \"Dependence\",\n \"Probability\": \"0.0006778538\",\n \"SemanticContext\": \"Because extended-release products such as tramadol hydrochloride extended-release tablets deliver the opioid over an extended period of time, there is a greater risk for overdose and death due to the larger amount of tramadol present [see Drug Abuse and Dependence 9 ].\"\n },\n {\n \"VerbatimTerm\": \"Dependence\",\n \"Probability\": \"0.0023342073\",\n \"SemanticContext\": \"[ see Drug Abuse and Dependence 9.2 ] Prescribe tramadol hydrochloride extended-release tablets with caution for patients with a history of misuse and/or are currently taking CNS-active drugs including tranquilizers, or antidepressant drugs, or alcohol in excess, and patients who suffer from emotional disturbance or depression [ see Drug Interactions 7 ].\"\n },\n {\n \"VerbatimTerm\": \"Dependence\",\n \"Probability\": \"0.0006866753\",\n \"SemanticContext\": \"Rapid tapering of tramadol hydrochloride extended-release tablets in a patient physically dependent on opioids may lead to a withdrawal syndrome and return of pain [see Dosage and Administration 2.5 , Drug Abuse and Dependence 9 ].\"\n }\n ]\n },\n {\n \"Term\": \"Ileus paralytic\",\n \"MEDDRACode\": \"10021333\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": true,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"paralytic ileus\",\n \"Probability\": \"0.0061845481\",\n \"SemanticContext\": \"Known or suspected gastrointestinal obstruction, including paralytic ileus 4 .\"\n },\n {\n \"VerbatimTerm\": \"paralytic ileus\",\n \"Probability\": \"0.0454797447\",\n \"SemanticContext\": \"Tramadol hydrochloride extended-release tablets are also contraindicated in patients with: Significant respiratory depression [ see Warnings and Precautions 5.3 ] Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [ see Warnings and Precautions 5.12 ] Known or suspected gastrointestinal obstruction, including paralytic ileus [ see Warnings and Precautions 5.15 ] Hypersensitivity to tramadol e.g., anaphylaxis [ see Warnings and Precautions 5.16 , Adverse Reactions 6.2 ] Concurrent use of monoamine oxidase inhibitors MAOIs or use within the last 14 days [see Drug Interactions 7 ] .\"\n },\n {\n \"VerbatimTerm\": \"paralytic ileus\",\n \"Probability\": \"0.1840053499\",\n \"SemanticContext\": \"Anticholinergic Drugs Clinical Impact: The concomitant use of anticholinergic drugs may increase risk of urinary retention and/or severe constipation, which may lead to paralytic ileus.\"\n },\n {\n \"VerbatimTerm\": \"paralytic ileus\",\n \"Probability\": \"0.0429908335\",\n \"SemanticContext\": \"5.15 Risks of Use in Patients with Gastrointestinal Conditions Tramadol hydrochloride extended-release tablets are contraindicated in patients with known or suspected gastrointestinal obstruction, including paralytic ileus.\"\n }\n ]\n },\n {\n \"Term\": \"Seizure\",\n \"MEDDRACode\": \"10039906\",\n \"Overdose\": true,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"convulsions\",\n \"Probability\": \"0.0315510929\",\n \"SemanticContext\": \"In animals, convulsions following the administration of toxic doses of tramadol hydrochloride extended-release tablets could be suppressed with barbiturates or benzodiazepines but were increased with naloxone.\"\n }\n ]\n },\n {\n \"Term\": \"Serotonin syndrome\",\n \"MEDDRACode\": \"10040108\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Serotonin Syndrome\",\n \"Probability\": \"0.9101626873\",\n \"SemanticContext\": \"WARNINGS AND PRECAUTIONS Serotonin Syndrome: Potentially life-threatening condition could result from concomitant serotonergic drug administration.\"\n },\n {\n \"VerbatimTerm\": \"Serotonin Syndrome\",\n \"Probability\": \"0.9174646735\",\n \"SemanticContext\": \"6 ADVERSE REACTIONS The following serious adverse reactions are described in greater detail, in other sections: Addiction, Abuse, and Misuse [see Warnings and Precautions 5.1 ] Life-Threatening Respiratory Depression [see Warnings and Precautions 5.3 ] Ultra-Rapid Metabolism of Tramadol and Other Risk Factors for Life-Threatening Respiratory Depression in Children [see Warnings and Precautions 5.4 ] Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions 5.5 ] Interactions with Benzodiazepines and Other CNS Depressants [see Warnings and Precautions 5.7 ] Serotonin Syndrome [see Warnings and Precautions 5.8 ] Seizures [see Warnings and Precautions 5.9 ] Suicide [see Warnings and Precautions 5.10 ] Adrenal Insufficiency [see Warnings and Precautions 5.11 ] Severe Hypotension [see Warnings and Precautions 5.13 ] Gastrointestinal Adverse Reactions [see Warnings and Precautions 5.15 ] Hypersensitivity Reactions [see Warnings and Precautions 5.16 ] Withdrawal [see Warnings and Precautions 5.17 ] 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.\"\n },\n {\n \"VerbatimTerm\": \"Serotonin Syndrome\",\n \"Probability\": \"0.8794002533\",\n \"SemanticContext\": \"Serotonin Syndrome Inform patients that tramadol could cause a rare but potentially life-threatening condition, particularly during concomitant use with serotonergic drugs.\"\n },\n {\n \"VerbatimTerm\": \"Serotonin Syndrome\",\n \"Probability\": \"0.2099452913\",\n \"SemanticContext\": \"5.8 Serotonin Syndrome with Concomitant Use of Serotonergic Drugs Cases of serotonin syndrome, a potentially life-threatening condition, have been reported with the use of tramadol, including tramadol hydrochloride extended-release tablets, particularly during concomitant use with serotonergic drugs.\"\n },\n {\n \"VerbatimTerm\": \"serotonin syndrome\",\n \"Probability\": \"0.0064933896\",\n \"SemanticContext\": \"Discontinue tramadol hydrochloride extended-release tablets if serotonin syndrome is suspected.\"\n },\n {\n \"VerbatimTerm\": \"serotonin syndrome\",\n \"Probability\": \"0.8454880118\",\n \"SemanticContext\": \"Serotonin syndrome: Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs.\"\n },\n {\n \"VerbatimTerm\": \"serotonin syndrome\",\n \"Probability\": \"0.5441736579\",\n \"SemanticContext\": \"Increased tramadol exposure can result in increased or prolonged therapeutic effects and increased risk for serious adverse events including seizures and serotonin syndrome.\"\n },\n {\n \"VerbatimTerm\": \"serotonin syndrome\",\n \"Probability\": \"0.0745917559\",\n \"SemanticContext\": \"Intervention: If concomitant use of a CYP2D6 inhibitor is necessary, follow patients closely for adverse reactions including opioid withdrawal, seizures, and serotonin syndrome.\"\n },\n {\n \"VerbatimTerm\": \"serotonin syndrome\",\n \"Probability\": \"0.5746407509\",\n \"SemanticContext\": \"Follow patients closely for increased risk of serious adverse events including seizures and serotonin syndrome, and adverse reactions related to opioid toxicity including potentially fatal respiratory depression, particularly when an inhibitor is added after a stable dose of tramadol hydrochloride extended-release tablets is achieved.\"\n },\n {\n \"VerbatimTerm\": \"serotonin syndrome\",\n \"Probability\": \"0.4045512676\",\n \"SemanticContext\": \"Follow patients closely for seizures and serotonin syndrome, and signs of respiratory depression and sedation at frequent intervals.\"\n },\n {\n \"VerbatimTerm\": \"serotonin syndrome\",\n \"Probability\": \"0.9842547774\",\n \"SemanticContext\": \"After stopping a CYP3A4 inducer, as the effects of the inducer decline, the tramadol plasma concentration will increase [see Clinical Pharmacology 12.3 ] , which could increase or prolong both the therapeutic effects and adverse reactions, and may cause seizures and serotonin syndrome, and potentially fatal respiratory depression.\"\n },\n {\n \"VerbatimTerm\": \"serotonin syndrome\",\n \"Probability\": \"0.0039645731\",\n \"SemanticContext\": \"If a CYP3A4 inducer is discontinued, consider tramadol hydrochloride extended-release tablets dosage reduction and monitor for seizures and serotonin syndrome, and signs of sedation and respiratory depression.\"\n },\n {\n \"VerbatimTerm\": \"serotonin syndrome\",\n \"Probability\": \"0.5230820179\",\n \"SemanticContext\": \"Serotonergic Drugs Clinical Impact: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome .\"\n },\n {\n \"VerbatimTerm\": \"serotonin syndrome\",\n \"Probability\": \"0.0189042985\",\n \"SemanticContext\": \"Discontinue tramadol hydrochloride extended-release tablets if serotonin syndrome is suspected.\"\n },\n {\n \"VerbatimTerm\": \"serotonin syndrome\",\n \"Probability\": \"0.0233778954\",\n \"SemanticContext\": \"Monoamine Oxidase Inhibitors MAOIs Clinical Impact: MAOI interactions with opioids may manifest as serotonin syndrome [see Warnings and Precautions 5.8 ] or opioid toxicity e.g., respiratory depression, coma [see Warnings and Precautions 5.3 ].\"\n },\n {\n \"VerbatimTerm\": \"serotonin syndrome\",\n \"Probability\": \"0.0091623068\",\n \"SemanticContext\": \"Warn patients of the symptoms of serotonin syndrome and to seek medical attention right away if symptoms develop.\"\n },\n {\n \"VerbatimTerm\": \"serotonin syndrome\",\n \"Probability\": \"0.5728973746\",\n \"SemanticContext\": \"The effect of increased tramadol levels may be an increased risk for serious adverse events including seizures and serotonin syndrome.\"\n },\n {\n \"VerbatimTerm\": \"serotonin syndrome\",\n \"Probability\": \"0.0391566157\",\n \"SemanticContext\": \"Follow patients receiving tramadol hydrochloride extended-release tablets and any CYP2D6 inhibitor for the risk of serious adverse events including seizures and serotonin syndrome, signs and symptoms that may reflect opioid toxicity, and opioid withdrawal when tramadol hydrochloride extended-release tablets are used in conjunction with inhibitors of CYP2D6 [see Drug Interactions 7 ] .\"\n },\n {\n \"VerbatimTerm\": \"serotonin syndrome\",\n \"Probability\": \"0.9849107265\",\n \"SemanticContext\": \"Cytochrome P450 3A4 Interaction The concomitant use of tramadol hydrochloride extended-release tablets with cytochrome P450 3A4 inhibitors, such as macrolide antibiotics e.g., erythromycin , azole-antifungal agents e.g., ketoconazole , and protease inhibitors e.g., ritonavir or discontinuation of a cytochrome P450 3A4 inducer such as rifampin, carbamazepine, and phenytoin, may result in an increase in tramadol plasma concentrations, which could increase or prolong adverse reactions, increase the risk for serious adverse events including seizures and serotonin syndrome, and may cause potentially fatal respiratory depression.\"\n },\n {\n \"VerbatimTerm\": \"serotonin syndrome\",\n \"Probability\": \"0.0214293003\",\n \"SemanticContext\": \"Follow patients receiving tramadol hydrochloride extended-release tablets and any CYP3A4 inhibitor or inducer for the risk for serious adverse events including seizures and serotonin syndrome, signs and symptoms that may reflect opioid toxicity and opioid withdrawal when tramadol hydrochloride extended-release tablets are used in conjunction with inhibitors and inducers of CYP3A4 [see Drug Interactions 7 ] .\"\n },\n {\n \"VerbatimTerm\": \"serotonin syndrome\",\n \"Probability\": \"0.5114994049\",\n \"SemanticContext\": \"5.8 Serotonin Syndrome with Concomitant Use of Serotonergic Drugs Cases of serotonin syndrome, a potentially life-threatening condition, have been reported with the use of tramadol, including tramadol hydrochloride extended-release tablets, particularly during concomitant use with serotonergic drugs.\"\n },\n {\n \"VerbatimTerm\": \"serotonin syndrome\",\n \"Probability\": \"0.0094581544\",\n \"SemanticContext\": \"Discontinue tramadol hydrochloride extended-release tablets if serotonin syndrome is suspected.\"\n },\n {\n \"VerbatimTerm\": \"Serotonin syndrome\",\n \"Probability\": \"0.6397670507\",\n \"SemanticContext\": \"Serotonin syndrome: Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs.\"\n },\n {\n \"VerbatimTerm\": \"Serotonin syndrome\",\n \"Probability\": \"0.9055794477\",\n \"SemanticContext\": \"Serotonin syndrome symptoms may include mental status changes e.g., agitation, hallucinations, coma , autonomic instability e.g., tachycardia, labile blood pressure, hyperthermia , neuromuscular aberrations e.g., hyperreflexia, incoordination, rigidity , and/or gastrointestinal symptoms e.g., nausea, vomiting, diarrhea .\"\n }\n ]\n },\n {\n \"Term\": \"CYP2D6 polymorphism\",\n \"MEDDRACode\": \"10071601\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"CYP2D6 polymorphism\",\n \"Probability\": \"0.0138364434\",\n \"SemanticContext\": \"Some of the reported cases followed tonsillectomy and/or adenoidectomy; in at least one case, the child had evidence of being an ultra-rapid metabolizer of tramadol due to a CYP2D6 polymorphism 5.4 .\"\n }\n ]\n },\n {\n \"Term\": \"Therapy naive\",\n \"MEDDRACode\": \"10051259\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"opioid-naïve\",\n \"Probability\": \"0.0003350377\",\n \"SemanticContext\": \"For opioid-naïve and opioid non-tolerant patients, initiate tramadol hydrochloride extended-release tablets at a dose of 100 mg once daily, then titrate up by 100 mg increments every 5 days according to need and tolerance.\"\n }\n ]\n },\n {\n \"Term\": \"Crigler-Najjar syndrome\",\n \"MEDDRACode\": \"10011386\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"CNS\",\n \"Probability\": \"0.2406264842\",\n \"SemanticContext\": \"TRAMADOL HYDROCHLORIDE extended-release tablets for oral use, C IV Initial U.S. Approval: 1995 WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY REMS ; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; ULTRA-RAPID METABOLISM OF TRAMADOL AND OTHER RISK FACTORS FOR LIFE-THREATENING RESPIRATORY DEPRESSION IN CHILDREN; NEONATAL OPIOID WITHDRAWAL SYNDROME; INTERACTIONS WITH DRUGS AFFECTING CYTOCHROME P450 ISOENZYMES; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS See full prescribing information for complete boxed warning .\"\n },\n {\n \"VerbatimTerm\": \"CNS\",\n \"Probability\": \"0.0005870759\",\n \"SemanticContext\": \"Concomitant use of opioids with benzodiazepines or other central nervous system CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.\"\n },\n {\n \"VerbatimTerm\": \"CNS\",\n \"Probability\": \"0.2476581037\",\n \"SemanticContext\": \"6 ADVERSE REACTIONS The following serious adverse reactions are described in greater detail, in other sections: Addiction, Abuse, and Misuse [see Warnings and Precautions 5.1 ] Life-Threatening Respiratory Depression [see Warnings and Precautions 5.3 ] Ultra-Rapid Metabolism of Tramadol and Other Risk Factors for Life-Threatening Respiratory Depression in Children [see Warnings and Precautions 5.4 ] Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions 5.5 ] Interactions with Benzodiazepines and Other CNS Depressants [see Warnings and Precautions 5.7 ] Serotonin Syndrome [see Warnings and Precautions 5.8 ] Seizures [see Warnings and Precautions 5.9 ] Suicide [see Warnings and Precautions 5.10 ] Adrenal Insufficiency [see Warnings and Precautions 5.11 ] Severe Hypotension [see Warnings and Precautions 5.13 ] Gastrointestinal Adverse Reactions [see Warnings and Precautions 5.15 ] Hypersensitivity Reactions [see Warnings and Precautions 5.16 ] Withdrawal [see Warnings and Precautions 5.17 ] 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.\"\n },\n {\n \"VerbatimTerm\": \"CNS\",\n \"Probability\": \"0.486502409\",\n \"SemanticContext\": \"Concentration--Adverse Reaction Relationships There is a relationship between increasing tramadol plasma concentration and increasing frequency of dose-related opioid adverse reactions such as nausea, vomiting, CNS effects, and respiratory depression.\"\n },\n {\n \"VerbatimTerm\": \"CNS\",\n \"Probability\": \"0.0174636841\",\n \"SemanticContext\": \"Examples: Rifampin, carbamazepine, phenytoin Benzodiazepines and Other Central Nervous System CNS Depressants Clinical Impact: Due to additive pharmacologic effect, the concomitant use of benzodiazepines or other CNS depressants, including alcohol, can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death.\"\n },\n {\n \"VerbatimTerm\": \"CNS\",\n \"Probability\": \"0.0061528683\",\n \"SemanticContext\": \"Examples: Rifampin, carbamazepine, phenytoin Benzodiazepines and Other Central Nervous System CNS Depressants Clinical Impact: Due to additive pharmacologic effect, the concomitant use of benzodiazepines or other CNS depressants, including alcohol, can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death.\"\n },\n {\n \"VerbatimTerm\": \"CNS\",\n \"Probability\": \"0.0001793206\",\n \"SemanticContext\": \"Consider prescribing naloxone, based on the patient’s risk factors for overdose, such as concomitant use of CNS depressants, a history of opioid use disorder, or prior opioid overdose.\"\n },\n {\n \"VerbatimTerm\": \"CNS\",\n \"Probability\": \"0.039839983\",\n \"SemanticContext\": \"Interactions with Benzodiazepines and Other CNS Depressants Inform patients and caregivers that potentially fatal additive effects may occur if tramadol hydrochloride extended-release tablets are used with benzodiazepines or other CNS depressants, including alcohol, and not to use these concomitantly unless supervised by a healthcare provider [see Warnings and Precautions 5.7 , Drug Interactions 7 ].\"\n },\n {\n \"VerbatimTerm\": \"CNS\",\n \"Probability\": \"0.0004059374\",\n \"SemanticContext\": \"Interactions with Benzodiazepines and Other CNS Depressants Inform patients and caregivers that potentially fatal additive effects may occur if tramadol hydrochloride extended-release tablets are used with benzodiazepines or other CNS depressants, including alcohol, and not to use these concomitantly unless supervised by a healthcare provider [see Warnings and Precautions 5.7 , Drug Interactions 7 ].\"\n },\n {\n \"VerbatimTerm\": \"CNS\",\n \"Probability\": \"0.0001793206\",\n \"SemanticContext\": \"Consider prescribing naloxone, based on the patient’s risk factors for overdose, such as concomitant use of CNS depressants, a history of opioid use disorder, or prior opioid overdose.\"\n },\n {\n \"VerbatimTerm\": \"CNS\",\n \"Probability\": \"0.0017902255\",\n \"SemanticContext\": \"5.7 Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants Profound sedation, respiratory depression, coma, and death may result from the concomitant use of tramadol hydrochloride extended-release tablets with benzodiazepines or other CNS depressants e.g., non-benzodiazepine sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, other opioids, alcohol .\"\n },\n {\n \"VerbatimTerm\": \"CNS\",\n \"Probability\": \"0.0005233586\",\n \"SemanticContext\": \"5.7 Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants Profound sedation, respiratory depression, coma, and death may result from the concomitant use of tramadol hydrochloride extended-release tablets with benzodiazepines or other CNS depressants e.g., non-benzodiazepine sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, other opioids, alcohol .\"\n },\n {\n \"VerbatimTerm\": \"CNS\",\n \"Probability\": \"0.0063717365\",\n \"SemanticContext\": \"Because of similar pharmacological properties, it is reasonable to expect similar risk with the concomitant use of other CNS depressant drugs with opioid analgesics [see Drug Interactions 7 ] .\"\n },\n {\n \"VerbatimTerm\": \"CNS\",\n \"Probability\": \"4.33908E-05\",\n \"SemanticContext\": \"If the decision is made to prescribe a benzodiazepine or other CNS depressant concomitantly with an opioid analgesic, prescribe the lowest effective dosages and minimum durations of concomitant use.\"\n },\n {\n \"VerbatimTerm\": \"CNS\",\n \"Probability\": \"0.0001268685\",\n \"SemanticContext\": \"In patients already receiving an opioid analgesic, prescribe a lower initial dose of the benzodiazepine or other CNS depressant than indicated in the absence of an opioid, and titrate based on clinical response.\"\n },\n {\n \"VerbatimTerm\": \"CNS\",\n \"Probability\": \"3.48102E-05\",\n \"SemanticContext\": \"If an opioid analgesic is initiated in a patient already taking a benzodiazepine or other CNS depressant, prescribe a lower initial dose of the opioid analgesic, and titrate based on clinical response.\"\n },\n {\n \"VerbatimTerm\": \"CNS\",\n \"Probability\": \"0.0001205102\",\n \"SemanticContext\": \"Advise both patients and caregivers about the risks of respiratory depression and sedation when tramadol hydrochloride extended-release tablets are used with benzodiazepines or other CNS depressants including alcohol and illicit drugs .\"\n },\n {\n \"VerbatimTerm\": \"CNS\",\n \"Probability\": \"6.27933E-05\",\n \"SemanticContext\": \"Advise patients not to drive or operate heavy machinery until the effects of concomitant use of the benzodiazepine or other CNS depressant have been determined.\"\n },\n {\n \"VerbatimTerm\": \"CNS\",\n \"Probability\": \"0.0101629794\",\n \"SemanticContext\": \"Screen patients for risk of substance use disorders, including opioid abuse and misuse, and warn them of the risk for overdose and death associated with the use of additional CNS depressants including alcohol and illicit drugs [see Drug Interactions 7 , Patient Counseling Information 17 ] .\"\n },\n {\n \"VerbatimTerm\": \"CNS\",\n \"Probability\": \"0.0189942718\",\n \"SemanticContext\": \"Risk of seizures may also increase in patients with epilepsy, those with a history of seizures, or in patients with a recognized risk for seizure such as head trauma, metabolic disorders, alcohol and drug withdrawal, CNS infections .\"\n },\n {\n \"VerbatimTerm\": \"CNS\",\n \"Probability\": \"7.0586E-06\",\n \"SemanticContext\": \"[ see Drug Abuse and Dependence 9.2 ] Prescribe tramadol hydrochloride extended-release tablets with caution for patients with a history of misuse and/or are currently taking CNS-active drugs including tranquilizers, or antidepressant drugs, or alcohol in excess, and patients who suffer from emotional disturbance or depression [ see Drug Interactions 7 ].\"\n },\n {\n \"VerbatimTerm\": \"CNS\",\n \"Probability\": \"0.0004235208\",\n \"SemanticContext\": \"There is increased risk in patients whose ability to maintain blood pressure has already been compromised by a reduced blood volume or concurrent administration of certain CNS depressant drugs e.g., phenothiazines or general anesthetics [see Drug Interactions 7 ].\"\n }\n ]\n },\n {\n \"Term\": \"Congenital anomaly\",\n \"MEDDRACode\": \"10010356\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"birth defects\",\n \"Probability\": \"0.1438693404\",\n \"SemanticContext\": \"Available data with tramadol hydrochloride extended-release tablets in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage.\"\n },\n {\n \"VerbatimTerm\": \"birth defects\",\n \"Probability\": \"0.0899811387\",\n \"SemanticContext\": \"The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.\"\n },\n {\n \"VerbatimTerm\": \"birth defects\",\n \"Probability\": \"0.0714996159\",\n \"SemanticContext\": \"In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.\"\n },\n {\n \"VerbatimTerm\": \"birth defect\",\n \"Probability\": \"0.080376178\",\n \"SemanticContext\": \"All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.\"\n }\n ]\n },\n {\n \"Term\": \"Pregnancy\",\n \"MEDDRACode\": \"10036556\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"pregnant\",\n \"Probability\": \"7.6943E-06\",\n \"SemanticContext\": \"If prolonged opioid use is required in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.\"\n },\n {\n \"VerbatimTerm\": \"pregnant\",\n \"Probability\": \"0.0033317208\",\n \"SemanticContext\": \"Available data with tramadol hydrochloride extended-release tablets in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage.\"\n },\n {\n \"VerbatimTerm\": \"pregnant\",\n \"Probability\": \"5.6488E-06\",\n \"SemanticContext\": \"Based on animal data, advise pregnant women of the potential risk to a fetus.\"\n },\n {\n \"VerbatimTerm\": \"pregnant\",\n \"Probability\": \"6.3166E-06\",\n \"SemanticContext\": \"Tramadol hydrochloride extended-release tablets are not recommended for use in pregnant women during or immediately prior to labor, when use of shorter-acting analgesics or other analgesic techniques are more appropriate.\"\n },\n {\n \"VerbatimTerm\": \"pregnant\",\n \"Probability\": \"0.0006903112\",\n \"SemanticContext\": \"Advise pregnant women using opioids for a prolonged period of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [see Use in Specific Populations 8.1 , Patient Counseling Information 17 ] .\"\n },\n {\n \"VerbatimTerm\": \"pregnant\",\n \"Probability\": \"5.96E-07\",\n \"SemanticContext\": \"Tell your healthcare provider if you are: pregnant or planning to become pregnant.\"\n }\n ]\n },\n {\n \"Term\": \"Head injury\",\n \"MEDDRACode\": \"10019196\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Head Injury\",\n \"Probability\": \"0.0543237031\",\n \"SemanticContext\": \"Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness: Monitor for sedation and respiratory depression.\"\n },\n {\n \"VerbatimTerm\": \"Head Injury\",\n \"Probability\": \"0.0195042193\",\n \"SemanticContext\": \"5.14 Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness In patients who may be susceptible to the intracranial effects of CO 2 retention e.g., those with evidence of increased intracranial pressure or brain tumors , tramadol hydrochloride extended-release tablets may reduce respiratory drive, and the resultant CO 2 retention can further increase intracranial pressure.\"\n },\n {\n \"VerbatimTerm\": \"head injury\",\n \"Probability\": \"0.0013278425\",\n \"SemanticContext\": \"Opioids may also obscure the clinical course in a patient with a head injury.\"\n },\n {\n \"VerbatimTerm\": \"head injury\",\n \"Probability\": \"2.81783E-05\",\n \"SemanticContext\": \"Before taking tramadol hydrochloride extended-release tablets, tell your healthcare provider if you have a history of: head injury, seizures ?\"\n }\n ]\n },\n {\n \"Term\": \"Neoplasm\",\n \"MEDDRACode\": \"10028980\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"tumors\",\n \"Probability\": \"0.0690262616\",\n \"SemanticContext\": \"A slight but statistically significant increase in two common murine tumors, pulmonary and hepatic, was observed in an NMRI mouse carcinogenicity study, particularly in aged mice.\"\n }\n ]\n },\n {\n \"Term\": \"Elderly\",\n \"MEDDRACode\": \"10014348\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": true,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": true\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Elderly\",\n \"Probability\": \"0.0001805127\",\n \"SemanticContext\": \"Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients: Monitor closely, particularly during initiation and titration.\"\n },\n {\n \"VerbatimTerm\": \"Elderly\",\n \"Probability\": \"0.0001185265\",\n \"SemanticContext\": \"5.12 Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients The use of tramadol hydrochloride extended-release tablets in patients with acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment is contraindicated.\"\n },\n {\n \"VerbatimTerm\": \"Elderly\",\n \"Probability\": \"0.0005015731\",\n \"SemanticContext\": \"Elderly, Cachectic, or Debilitated Patients: Life-threatening respiratory depression is more likely to occur in elderly, cachectic, or debilitated patients because they may have altered pharmacokinetics or altered clearance compared to younger, healthier patients [see Warnings and Precautions 5.3 ].\"\n },\n {\n \"VerbatimTerm\": \"elderly\",\n \"Probability\": \"0.0017936826\",\n \"SemanticContext\": \"Most reports were in patients with predisposing risk factors, including diabetes or renal insufficiency, or in elderly patients [see Warnings and Precautions 5.20 ] .\"\n },\n {\n \"VerbatimTerm\": \"elderly\",\n \"Probability\": \"6.7041E-05\",\n \"SemanticContext\": \"Healthy elderly subjects aged 65 to 75 years administered an immediate-release formulation of tramadol, have plasma concentrations and elimination half-lives comparable to those observed in healthy subjects younger than 65 years of age.\"\n },\n {\n \"VerbatimTerm\": \"elderly\",\n \"Probability\": \"0.0121361613\",\n \"SemanticContext\": \"Elderly, Cachectic, or Debilitated Patients: Life-threatening respiratory depression is more likely to occur in elderly, cachectic, or debilitated patients because they may have altered pharmacokinetics or altered clearance compared to younger, healthier patients [see Warnings and Precautions 5.3 ].\"\n },\n {\n \"VerbatimTerm\": \"elderly\",\n \"Probability\": \"0.0004112422\",\n \"SemanticContext\": \"8.5 Geriatric Use Nine-hundred-one elderly 65 years of age or older subjects were exposed to tramadol hydrochloride extended-release tablets in clinical trials.\"\n },\n {\n \"VerbatimTerm\": \"elderly\",\n \"Probability\": \"0.0014536977\",\n \"SemanticContext\": \"Respiratory depression is the chief risk for elderly patients treated with opioids, and has occurred after large initial doses were administered to patients who were not opioidtolerant or when opioids were co-administered with other agents that depress respiration.\"\n },\n {\n \"VerbatimTerm\": \"elderly\",\n \"Probability\": \"8.72738E-05\",\n \"SemanticContext\": \"Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.\"\n }\n ]\n },\n {\n \"Term\": \"Prolonged labour\",\n \"MEDDRACode\": \"10036872\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"prolong labor\",\n \"Probability\": \"0.2836594582\",\n \"SemanticContext\": \"Opioid analgesics, including tramadol hydrochloride extended-release tablets, can prolong labor through actions which temporarily reduce the strength, duration, and frequency of uterine contractions.\"\n }\n ]\n },\n {\n \"Term\": \"Angioedema\",\n \"MEDDRACode\": \"10002424\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"angioedema\",\n \"Probability\": \"0.9791195393\",\n \"SemanticContext\": \"Other reported hypersensitivity reactions include pruritus, hives, bronchospasm, angioedema, toxic epidermal necrolysis and Stevens-Johnson syndrome.\"\n }\n ]\n },\n {\n \"Term\": \"Breathing-related sleep disorder\",\n \"MEDDRACode\": \"10006344\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"sleep-related breathing disorders\",\n \"Probability\": \"0.0064644814\",\n \"SemanticContext\": \"Opioids can cause sleep-related breathing disorders including central sleep apnea CSA and sleep-related hypoxemia.\"\n }\n ]\n },\n {\n \"Term\": \"Depression\",\n \"MEDDRACode\": \"10012378\",\n \"Overdose\": true,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": true,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": true\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"depression\",\n \"Probability\": \"0.9889639616\",\n \"SemanticContext\": \"Eye disorders: vision blurred Gastrointestinal disorders: abdominal pain upper, dyspepsia, abdominal pain, sore throat General disorders: weakness, pain, feeling hot, influenza like illness, fall, rigors, lethargy, pyrexia, chest pain Infections and infestations: nasopharyngitis, upper respiratory tract infection, sinusitis, influenza, gastroenteritis viral, urinary tract infection, bronchitis Investigations: blood creatine phosphokinase increased, weight decreased Metabolism and nutrition disorders: appetite decreased Musculoskeletal, connective tissue and bone disorders: arthralgia, back pain, pain in limb, neck pain Nervous system disorders: tremor, paresthesia, hypoesthesia Psychiatric disorders: nervousness, anxiety, depression, restlessness Respiratory, thoracic and mediastinal disorders: sneezing, cough, rhinorrhea, nasal congestion, dyspnea, sinus congestion Skin and subcutaneous tissue disorders: sweating increased, dermatitis Vascular disorders: hot flushes, vasodilatation Adverse Reactions With Incidence Rates of 0.5% to \\n <1.0% and Serious Adverse Reactions Reported in at Least 2 patients During Clinical Trials Cardiac disorders: palpitations, myocardial infarction Ear and labyrinth disorders: tinnitus, vertigo Gastrointestinal disorders: flatulence, toothache, constipation aggravated, appendicitis, pancreatitis General disorders: feeling jittery, edema lower limb, shivering, joint swelling, malaise, drug withdrawal syndrome, peripheral swelling Hepato-biliary disorders: cholelithiasis, cholecystitis Infections and infestations: cellulitis, ear infection, gastroenteritis, pneumonia, viral infection Injury and poisoning: joint sprain, muscle injury Investigations: alanine aminotransferase increased, blood pressure increased, aspartate aminotransferase increased, heart rate increased, blood glucose increased, liver function tests abnormal Musculoskeletal, connective tissue and bone disorders: muscle cramps, muscle spasms, joint stiffness, muscle twitching, myalgia, osteoarthritis aggravated Nervous system disorders: migraine, sedation, syncope, disturbance in attention, dizziness aggravated Psychiatric disorders: euphoric mood, irritability, libido decreased, sleep disorder, agitation, disorientation, abnormal dreams Renal and urinary disorders: difficulty in micturition, urinary frequency, hematuria, dysuria, urinary retention Respiratory, thoracic and mediastinal disorders: yawning Skin and subcutaneous tissue disorders: contusion, piloerection, clamminess, night sweats, urticaria Vascular disorders: hypertension aggravated, hypertension, peripheral ischemia 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of tramadol.\"\n },\n {\n \"VerbatimTerm\": \"depression\",\n \"Probability\": \"0.0212188959\",\n \"SemanticContext\": \"[ see Drug Abuse and Dependence 9.2 ] Prescribe tramadol hydrochloride extended-release tablets with caution for patients with a history of misuse and/or are currently taking CNS-active drugs including tranquilizers, or antidepressant drugs, or alcohol in excess, and patients who suffer from emotional disturbance or depression [ see Drug Interactions 7 ].\"\n }\n ]\n },\n {\n \"Term\": \"Asthma\",\n \"MEDDRACode\": \"10003553\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": true,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"asthma\",\n \"Probability\": \"5.54775E-05\",\n \"SemanticContext\": \"Do not take tramadol hydrochloride extended-release tablets if you have: severe asthma, trouble breathing, or other lung problems.\"\n }\n ]\n },\n {\n \"Term\": \"Blindness\",\n \"MEDDRACode\": \"10005169\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"blind\",\n \"Probability\": \"0.0932188034\",\n \"SemanticContext\": \"These included four double-blind studies in patients with osteoarthritis and/or chronic low back pain and one open-label study in patients with chronic non-malignant pain.\"\n },\n {\n \"VerbatimTerm\": \"blind\",\n \"Probability\": \"0.0038627684\",\n \"SemanticContext\": \"The frequency of adverse reactions generally increased with doses from 100 mg to 400 mg in the two pooled, twelve-week, randomized, double-blind, placebo-controlled studies in patients with chronic non-malignant pain see Table 1 .\"\n },\n {\n \"VerbatimTerm\": \"blind\",\n \"Probability\": \"0.0003345311\",\n \"SemanticContext\": \"The effect of oral tramadol on the QTcF interval was evaluated in a double-blind, randomized, four-way crossover, placebo-and positive- moxifloxacin controlled study in 68 adult male and female healthy subjects.\"\n },\n {\n \"VerbatimTerm\": \"blind\",\n \"Probability\": \"0.0002960861\",\n \"SemanticContext\": \"tramadol-figure1 tramadol-figure2 14 CLINICAL STUDIES Clinical Trial Experience Tramadol hydrochloride extended-release tablets were studied in patients with chronic, moderate to moderately severe pain due to osteoarthritis and/or low back pain in four 12-week, randomized, double-blind, placebo-controlled trials.\"\n },\n {\n \"VerbatimTerm\": \"blind\",\n \"Probability\": \"0.0023614168\",\n \"SemanticContext\": \"Adequate evidence of efficacy was demonstrated in the following two studies: Study 1 : Osteoarthritis of the Knee and/or Hip In one 12-week randomized, double-blind, placebo-controlled study, patients with moderate to moderately severe pain due to osteoarthritis of the knee and/or hip were administered doses from 100 mg to 400 mg daily.\"\n },\n {\n \"VerbatimTerm\": \"blind\",\n \"Probability\": \"0.0022854209\",\n \"SemanticContext\": \"Study 2: Osteoarthritis of the Knee In one 12-week randomized, double-blind, placebo-controlled flexible-dosing trial of tramadol hydrochloride extended-release tablets in patients with osteoarthritis of the knee, patients titrated to an average daily tramadol hydrochloride extended-release tablets dose of approximately 270 mg/day.\"\n }\n ]\n },\n {\n \"Term\": \"Blood insulin\",\n \"MEDDRACode\": \"10005605\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"insulin\",\n \"Probability\": \"0.0001018593\",\n \"SemanticContext\": \"They also stimulate prolactin, growth hormone GH secretion, and pancreatic secretion of insulin and glucagon.\"\n }\n ]\n },\n {\n \"Term\": \"Blood prolactin\",\n \"MEDDRACode\": \"10005777\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"prolactin\",\n \"Probability\": \"0.0025370717\",\n \"SemanticContext\": \"They also stimulate prolactin, growth hormone GH secretion, and pancreatic secretion of insulin and glucagon.\"\n }\n ]\n },\n {\n \"Term\": \"Barbiturates\",\n \"MEDDRACode\": \"10063229\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"barbiturates\",\n \"Probability\": \"0.0017106235\",\n \"SemanticContext\": \"In animals, convulsions following the administration of toxic doses of tramadol hydrochloride extended-release tablets could be suppressed with barbiturates or benzodiazepines but were increased with naloxone.\"\n }\n ]\n },\n {\n \"Term\": \"Alcoholism\",\n \"MEDDRACode\": \"10001639\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"alcohol addiction\",\n \"Probability\": \"0.0034687221\",\n \"SemanticContext\": \"pancreas or gallbladder problems abuse of street or prescription drugs, alcohol addiction, opioid overdose, or mental health problems.\"\n }\n ]\n },\n {\n \"Term\": \"Phytotherapy\",\n \"MEDDRACode\": \"10063339\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"herbal supplements\",\n \"Probability\": \"7.5289E-06\",\n \"SemanticContext\": \"living in a household where there are small children or someone who has abused street or prescription drugs taking prescription or over-the-counter medicines, vitamins, or herbal supplements.\"\n }\n ]\n },\n {\n \"Term\": \"Overdose\",\n \"MEDDRACode\": \"10033295\",\n \"Overdose\": true,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"overdose\",\n \"Probability\": \"0.0111010373\",\n \"SemanticContext\": \"Tramadol hydrochloride extended-release tablets expose users to risks of addiction, abuse, and misuse, which can lead to overdose and death.\"\n },\n {\n \"VerbatimTerm\": \"overdose\",\n \"Probability\": \"0.1075200737\",\n \"SemanticContext\": \"Accidental ingestion of tramadol hydrochloride extended-release tablets, especially by children, can result in a fatal overdose of tramadol.\"\n },\n {\n \"VerbatimTerm\": \"overdose\",\n \"Probability\": \"0.0018526316\",\n \"SemanticContext\": \"Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve tramadol hydrochloride extended-release tablets for use in patients for whom alternative treatment options e.g., non-opioid analgesics or immediate-release opioids are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.\"\n },\n {\n \"VerbatimTerm\": \"overdose\",\n \"Probability\": \"0.0387978554\",\n \"SemanticContext\": \"Consider prescribing naloxone based on the patient’s risk factors for overdose 2.2 , 5.1 , 5.3 , 5.7 .\"\n },\n {\n \"VerbatimTerm\": \"overdose\",\n \"Probability\": \"0.1011111438\",\n \"SemanticContext\": \"The abuse of tramadol hydrochloride extended-release tablets poses a risk of overdose and death.\"\n },\n {\n \"VerbatimTerm\": \"overdose\",\n \"Probability\": \"0.1011111438\",\n \"SemanticContext\": \"The abuse of tramadol hydrochloride extended-release tablets poses a risk of overdose and death.\"\n },\n {\n \"VerbatimTerm\": \"overdose\",\n \"Probability\": \"0.0258967578\",\n \"SemanticContext\": \"Many of these cases were reported in patients taking another drug labeled for QT prolongation, in patients with a risk factor for QT prolongation e.g., hypokalemia , or in overdose setting.\"\n },\n {\n \"VerbatimTerm\": \"overdose\",\n \"Probability\": \"0.0016646683\",\n \"SemanticContext\": \"Pinpoint pupils are a sign of opioid overdose but are not pathognomonic e.g., pontine lesions of hemorrhagic or ischemic origins may produce similar findings .\"\n },\n {\n \"VerbatimTerm\": \"overdose\",\n \"Probability\": \"0.1628444195\",\n \"SemanticContext\": \"Marked mydriasis rather than miosis may be seen due to hypoxia in overdose situations.\"\n },\n {\n \"VerbatimTerm\": \"overdose\",\n \"Probability\": \"0.0003590584\",\n \"SemanticContext\": \"If concomitant use is warranted, consider prescribing naloxone for the emergency treatment of opioid overdose [see Dosage and Administration 2.2 , Warnings and Precautions 5.1, 5.3, 5.7 ].\"\n },\n {\n \"VerbatimTerm\": \"overdose\",\n \"Probability\": \"0.0002604127\",\n \"SemanticContext\": \"Due to the risk of respiratory depression with concomitant use of skeletal muscle relaxants and opioids, consider prescribing naloxone for the emergency treatment of opioid overdose [see Dosage and Administration 2.2 , Warnings and Precautions 5.3, 5.7 ] Diuretics Clinical Impact: Opioids can reduce the efficacy of diuretics by inducing the release of antidiuretic hormone.\"\n },\n {\n \"VerbatimTerm\": \"overdose\",\n \"Probability\": \"0.0289117098\",\n \"SemanticContext\": \"Crushing, chewing, splitting, or dissolving tramadol hydrochloride extended-release tablets will result in uncontrolled delivery of tramadol and can lead to overdose or death [ see Warnings and Precautions 5.1 ].\"\n },\n {\n \"VerbatimTerm\": \"overdose\",\n \"Probability\": \"0.0092558265\",\n \"SemanticContext\": \"2.2 Patient Access to Naloxone for the Emergency Treatment of Opioid Overdose Discuss the availability of naloxone for the emergency treatment of opioid overdose with the patient and caregiver and assess the potential need for access to naloxone, both when initiating and renewing treatment with tramadol hydrochloride extended-release tablets [see Warnings and Precautions 5.3 , Patient Counseling Information 17 ].\"\n },\n {\n \"VerbatimTerm\": \"overdose\",\n \"Probability\": \"0.0029552281\",\n \"SemanticContext\": \"Consider prescribing naloxone, based on the patient’s risk factors for overdose, such as concomitant use of CNS depressants, a history of opioid use disorder, or prior opioid overdose.\"\n },\n {\n \"VerbatimTerm\": \"overdose\",\n \"Probability\": \"0.0005274117\",\n \"SemanticContext\": \"Consider prescribing naloxone, based on the patient’s risk factors for overdose, such as concomitant use of CNS depressants, a history of opioid use disorder, or prior opioid overdose.\"\n },\n {\n \"VerbatimTerm\": \"overdose\",\n \"Probability\": \"0.2776871324\",\n \"SemanticContext\": \"The presence of risk factors for overdose should not prevent the proper management of pain in any given patient [see Warnings and Precautions 5.1, 5.3, 5.7 ].\"\n },\n {\n \"VerbatimTerm\": \"overdose\",\n \"Probability\": \"0.0062602162\",\n \"SemanticContext\": \"Consider prescribing naloxone if the patient has household members including children or other close contacts at risk for accidental ingestion or overdose.\"\n },\n {\n \"VerbatimTerm\": \"overdose\",\n \"Probability\": \"0.0057391226\",\n \"SemanticContext\": \"Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations [ see Warnings and Precautions 5.1 ], reserve tramadol hydrochloride extended-release tablets for use in patients for whom alternative treatment options e.g., non-opioid analgesics or immediate-release opioids are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.\"\n },\n {\n \"VerbatimTerm\": \"overdose\",\n \"Probability\": \"0.0295683146\",\n \"SemanticContext\": \"Addiction, Abuse, and Misuse Inform patients that the use of tramadol hydrochloride extended-release tablets, even when taken as recommended, can result in addiction, abuse, and misuse, which can lead to overdose and death [see Warnings and Precautions 5.1 ].\"\n },\n {\n \"VerbatimTerm\": \"overdose\",\n \"Probability\": \"0.0059044361\",\n \"SemanticContext\": \"Educate patients and caregivers on how to recognize respiratory depression and emphasize the importance of calling 911 or getting emergency medical help right away in the event of a known or suspected overdose [see Warnings and Precautions 5.3 ] .\"\n },\n {\n \"VerbatimTerm\": \"overdose\",\n \"Probability\": \"0.0005107522\",\n \"SemanticContext\": \"Patient Access to Naloxone for the Emergency Treatment of Opioid Overdose Discuss with the patient and caregiver the availability of naloxone for the emergency treatment of opioid overdose, both when initiating and renewing treatment with tramadol hydrochloride extended-release tablets.\"\n },\n {\n \"VerbatimTerm\": \"overdose\",\n \"Probability\": \"0.0076821148\",\n \"SemanticContext\": \"Educate patients and caregivers on how to recognize the signs and symptoms of an overdose.\"\n },\n {\n \"VerbatimTerm\": \"overdose\",\n \"Probability\": \"0.000274688\",\n \"SemanticContext\": \"Explain to patients and caregivers that naloxone’s effects are temporary, and that they must call 911 or get emergency medical help right away in all cases of known or suspected opioid overdose, even if naloxone is administered [ see Overdosage 10 ].\"\n },\n {\n \"VerbatimTerm\": \"overdose\",\n \"Probability\": \"0.0005418956\",\n \"SemanticContext\": \"If naloxone is prescribed, also advise patients and caregivers: How to treat with naloxone in the event of an opioid overdose To tell family and friends about their naloxone and to keep it in a place where family and friends can access it in an emergency To read the Patient Information or other educational material that will come with their naloxone.\"\n },\n {\n \"VerbatimTerm\": \"overdose\",\n \"Probability\": \"0.3273505569\",\n \"SemanticContext\": \"Taking cut, broken, chewed, crushed, or dissolved tramadol hydrochloride extended-release tablets can result in a fatal overdose [see Dosage and Administration 2.1 ].\"\n },\n {\n \"VerbatimTerm\": \"overdose\",\n \"Probability\": \"0.0714708865\",\n \"SemanticContext\": \"Marked mydriasis rather than miosis may be seen with hypoxia in overdose situations [see Clinical Pharmacology 12.2 ] .\"\n },\n {\n \"VerbatimTerm\": \"overdose\",\n \"Probability\": \"0.0553041995\",\n \"SemanticContext\": \"Treatment of Overdose In case of overdose, priorities are the reestablishment of a patent and protected airway and institution of assisted or controlled ventilation, if needed.\"\n },\n {\n \"VerbatimTerm\": \"overdose\",\n \"Probability\": \"0.0322738588\",\n \"SemanticContext\": \"Opioid antagonists, such as naloxone, are specific antidotes to respiratory depression resulting from opioid overdose.\"\n },\n {\n \"VerbatimTerm\": \"overdose\",\n \"Probability\": \"0.000629425\",\n \"SemanticContext\": \"For clinically significant respiratory or circulatory depression secondary to tramadol overdose, administer an opioid antagonist.\"\n },\n {\n \"VerbatimTerm\": \"overdose\",\n \"Probability\": \"0.0151299536\",\n \"SemanticContext\": \"Naloxone administration did not change the lethality of an overdose in mice.\"\n },\n {\n \"VerbatimTerm\": \"overdose\",\n \"Probability\": \"0.0230125487\",\n \"SemanticContext\": \"Hemodialysis is not expected to be helpful in an overdose because it removes less than 7% of the administered dose in a 4-hour dialysis period.\"\n },\n {\n \"VerbatimTerm\": \"overdose\",\n \"Probability\": \"0.031462729\",\n \"SemanticContext\": \"Because extended-release products such as tramadol hydrochloride extended-release tablets deliver the opioid over an extended period of time, there is a greater risk for overdose and death due to the larger amount of tramadol present [see Drug Abuse and Dependence 9 ].\"\n },\n {\n \"VerbatimTerm\": \"overdose\",\n \"Probability\": \"0.0005276799\",\n \"SemanticContext\": \"Consider prescribing naloxone for the emergency treatment of opioid overdose [see Dosage and Administration 2.2 , Warnings and Precautions 5.3 ].\"\n },\n {\n \"VerbatimTerm\": \"overdose\",\n \"Probability\": \"0.0139390826\",\n \"SemanticContext\": \"Abuse or misuse of tramadol hydrochloride extended-release tablets by cutting, breaking, chewing, crushing, snorting, or injecting the dissolved product will result in the uncontrolled delivery of tramadol and can result in overdose and death [see Overdosage 10 ].\"\n },\n {\n \"VerbatimTerm\": \"overdose\",\n \"Probability\": \"0.0198417306\",\n \"SemanticContext\": \"Overestimating the tramadol hydrochloride extended-release tablets dosage when converting patients from another opioid product can result in a fatal overdose with the first dose.\"\n },\n {\n \"VerbatimTerm\": \"overdose\",\n \"Probability\": \"0.1003206968\",\n \"SemanticContext\": \"Accidental ingestion of even one dose of tramadol hydrochloride extended-release tablet, especially by children, can result in respiratory depression and death due to an overdose of tramadol.\"\n },\n {\n \"VerbatimTerm\": \"overdose\",\n \"Probability\": \"0.005045563\",\n \"SemanticContext\": \"Educate patients and caregivers on how to recognize respiratory depression and emphasize the importance of calling 911 or getting emergency medical help right away in the event of a known or suspected overdose [see Patient Counseling Information 17 ].\"\n },\n {\n \"VerbatimTerm\": \"overdose\",\n \"Probability\": \"0.0012175143\",\n \"SemanticContext\": \"Patient Access to Naloxone for the Emergency Treatment of Opioid Overdose Discuss the availability of naloxone for the emergency treatment of opioid overdose with the patient and caregiver and assess the potential need for access to naloxone, both when initiating and renewing treatment with tramadol hydrochloride extended-release tablet.\"\n },\n {\n \"VerbatimTerm\": \"overdose\",\n \"Probability\": \"0.0029552281\",\n \"SemanticContext\": \"Consider prescribing naloxone, based on the patient’s risk factors for overdose, such as concomitant use of CNS depressants, a history of opioid use disorder, or prior opioid overdose.\"\n },\n {\n \"VerbatimTerm\": \"overdose\",\n \"Probability\": \"0.0005274117\",\n \"SemanticContext\": \"Consider prescribing naloxone, based on the patient’s risk factors for overdose, such as concomitant use of CNS depressants, a history of opioid use disorder, or prior opioid overdose.\"\n },\n {\n \"VerbatimTerm\": \"overdose\",\n \"Probability\": \"0.2093174458\",\n \"SemanticContext\": \"The presence of risk factors for overdose should not prevent the proper management of pain in any given patient.\"\n },\n {\n \"VerbatimTerm\": \"overdose\",\n \"Probability\": \"0.0063729286\",\n \"SemanticContext\": \"Also consider prescribing naloxone if the patient has household members including children or other close contacts at risk for accidental ingestion or overdose.\"\n },\n {\n \"VerbatimTerm\": \"overdose\",\n \"Probability\": \"0.0006169379\",\n \"SemanticContext\": \"As with adults, when prescribing opioids for adolescents, healthcare providers should choose the lowest effective dose for the shortest period of time and inform patients and caregivers about these risks and the signs of opioid overdose [ see Use in Specific Populations 8.4 , Overdosage 10 ].\"\n },\n {\n \"VerbatimTerm\": \"overdose\",\n \"Probability\": \"0.0182758868\",\n \"SemanticContext\": \"Even at labeled dosage regimens, individuals who are ultra-rapid metabolizers may have life-threatening or fatal respiratory depression or experience signs of overdose such as extreme sleepiness, confusion, or shallow breathing [see Overdosage 10 ] .\"\n },\n {\n \"VerbatimTerm\": \"overdose\",\n \"Probability\": \"0.0004037023\",\n \"SemanticContext\": \"If concomitant use is warranted, consider prescribing naloxone for the emergency treatment of opioid overdose [see Dosage and Administration 2.2 , Warnings and Precautions 5.3 ].\"\n },\n {\n \"VerbatimTerm\": \"overdose\",\n \"Probability\": \"0.0049318373\",\n \"SemanticContext\": \"Screen patients for risk of substance use disorders, including opioid abuse and misuse, and warn them of the risk for overdose and death associated with the use of additional CNS depressants including alcohol and illicit drugs [see Drug Interactions 7 , Patient Counseling Information 17 ] .\"\n },\n {\n \"VerbatimTerm\": \"overdose\",\n \"Probability\": \"0.0477697253\",\n \"SemanticContext\": \"In tramadol overdose, naloxone administration may increase the risk of seizure.\"\n },\n {\n \"VerbatimTerm\": \"overdose\",\n \"Probability\": \"0.0031919181\",\n \"SemanticContext\": \"A long-acting extended-release opioid pain medicine that can put you at risk for overdose and death.\"\n },\n {\n \"VerbatimTerm\": \"overdose\",\n \"Probability\": \"0.0023896694\",\n \"SemanticContext\": \"Important information about tramadol hydrochloride extended-release tablets: Get emergency help or call 911 right away if you take too much tramadol hydrochloride extended-release tablets overdose .\"\n },\n {\n \"VerbatimTerm\": \"overdose\",\n \"Probability\": \"0.0007846653\",\n \"SemanticContext\": \"When you first start taking tramadol hydrochloride extended-release tablets, when your dose is changed, or if you take too much overdose , serious or life-threatening breathing problems that can lead to death may occur.\"\n },\n {\n \"VerbatimTerm\": \"overdose\",\n \"Probability\": \"0.0002962351\",\n \"SemanticContext\": \"Talk to your healthcare provider about naloxone, a medicine for the emergency treatment of an opioid overdose.\"\n },\n {\n \"VerbatimTerm\": \"overdose\",\n \"Probability\": \"0.0018415153\",\n \"SemanticContext\": \"pancreas or gallbladder problems abuse of street or prescription drugs, alcohol addiction, opioid overdose, or mental health problems.\"\n },\n {\n \"VerbatimTerm\": \"overdose\",\n \"Probability\": \"0.0015048981\",\n \"SemanticContext\": \"Do not cut, break, chew, crush, dissolve, snort, or inject tramadol hydrochloride extended-release tablet because this may cause you to overdose and die.\"\n },\n {\n \"VerbatimTerm\": \"overdose\",\n \"Probability\": \"0.0094014704\",\n \"SemanticContext\": \"Using products containing alcohol during treatment with tramadol hydrochloride extended-release tablets may cause you to overdose and die.\"\n },\n {\n \"VerbatimTerm\": \"Overdose\",\n \"Probability\": \"0.0259677768\",\n \"SemanticContext\": \"2.2 Patient Access to Naloxone for the Emergency Treatment of Opioid Overdose Discuss the availability of naloxone for the emergency treatment of opioid overdose with the patient and caregiver and assess the potential need for access to naloxone, both when initiating and renewing treatment with tramadol hydrochloride extended-release tablets [see Warnings and Precautions 5.3 , Patient Counseling Information 17 ].\"\n },\n {\n \"VerbatimTerm\": \"Overdose\",\n \"Probability\": \"0.0104232728\",\n \"SemanticContext\": \"Patient Access to Naloxone for the Emergency Treatment of Opioid Overdose Discuss with the patient and caregiver the availability of naloxone for the emergency treatment of opioid overdose, both when initiating and renewing treatment with tramadol hydrochloride extended-release tablets.\"\n },\n {\n \"VerbatimTerm\": \"Overdose\",\n \"Probability\": \"0.2109907269\",\n \"SemanticContext\": \"Treatment of Overdose In case of overdose, priorities are the reestablishment of a patent and protected airway and institution of assisted or controlled ventilation, if needed.\"\n },\n {\n \"VerbatimTerm\": \"Overdose\",\n \"Probability\": \"0.011844933\",\n \"SemanticContext\": \"Patient Access to Naloxone for the Emergency Treatment of Opioid Overdose Discuss the availability of naloxone for the emergency treatment of opioid overdose with the patient and caregiver and assess the potential need for access to naloxone, both when initiating and renewing treatment with tramadol hydrochloride extended-release tablet.\"\n }\n ]\n },\n {\n \"Term\": \"Haemodialysis\",\n \"MEDDRACode\": \"10018875\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Hemodialysis\",\n \"Probability\": \"0.0026456714\",\n \"SemanticContext\": \"Hemodialysis is not expected to be helpful in an overdose because it removes less than 7% of the administered dose in a 4-hour dialysis period.\"\n }\n ]\n },\n {\n \"Term\": \"Surgery\",\n \"MEDDRACode\": \"10042609\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"surgery\",\n \"Probability\": \"1.3935E-06\",\n \"SemanticContext\": \"Do not give tramadol hydrochloride extended-release tablets to a child younger than 18 years of age after surgery to remove the tonsils and/or adenoids.\"\n }\n ]\n },\n {\n \"Term\": \"Adenoidectomy\",\n \"MEDDRACode\": \"10001230\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": true,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"adenoidectomy\",\n \"Probability\": \"0.0015025735\",\n \"SemanticContext\": \"Some of the reported cases followed tonsillectomy and/or adenoidectomy; in at least one case, the child had evidence of being an ultra-rapid metabolizer of tramadol due to a CYP2D6 polymorphism 5.4 .\"\n },\n {\n \"VerbatimTerm\": \"adenoidectomy\",\n \"Probability\": \"0.0003342927\",\n \"SemanticContext\": \"T ramadol hydrochloride extended-release tablets are contraindicated in children younger than 12 years of age and in children younger than 18 years of age following tonsillectomy and/or adenoidectomy 4 .\"\n },\n {\n \"VerbatimTerm\": \"adenoidectomy\",\n \"Probability\": \"0.012707442\",\n \"SemanticContext\": \"Postoperative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy.\"\n },\n {\n \"VerbatimTerm\": \"adenoidectomy\",\n \"Probability\": \"0.0030440092\",\n \"SemanticContext\": \"4 CONTRAINDICATIONS Tramadol hydrochloride extended-release tablets are contraindicated for: all children younger than 12 years of age [ see Warnings and Precautions 5.4 ] post-operative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy [ see Warnings and Precautions 5.4 ].\"\n },\n {\n \"VerbatimTerm\": \"adenoidectomy\",\n \"Probability\": \"0.0001097984\",\n \"SemanticContext\": \"Ultra-Rapid Metabolism of Tramadol and Other Risk Factors for Life-threatening Respiratory Depression in Children Advise caregivers that tramadol hydrochloride extended-release tablets are contraindicated in children younger than 12 years of age and in children younger than 18 years of age following tonsillectomy and/or adenoidectomy.\"\n },\n {\n \"VerbatimTerm\": \"adenoidectomy\",\n \"Probability\": \"3.01621E-05\",\n \"SemanticContext\": \"Furthermore, children with obstructive sleep apnea who are treated with opioids for post-tonsillectomy and/or adenoidectomy pain may be particularly sensitive to their respiratory depressant effect.\"\n },\n {\n \"VerbatimTerm\": \"adenoidectomy\",\n \"Probability\": \"1.82924E-05\",\n \"SemanticContext\": \"Tramadol hydrochloride extended-release tablets are contraindicated for post-operative management in pediatric patients younger than 18 years of age following tonsillectomy and/or adenoidectomy [ see Contraindications 4 ].\"\n },\n {\n \"VerbatimTerm\": \"adenoidectomy\",\n \"Probability\": \"0.0018435419\",\n \"SemanticContext\": \"In some of the reported cases, these events followed tonsillectomy and/or adenoidectomy, and one of the children had evidence of being an ultra-rapid metabolizer of tramadol i.e., multiple copies of the gene for cytochrome P450 isoenzyme 2D6 .\"\n },\n {\n \"VerbatimTerm\": \"adenoidectomy\",\n \"Probability\": \"1.82924E-05\",\n \"SemanticContext\": \"Tramadol hydrochloride extended-release tablets are contraindicated for post-operative management in pediatric patients younger than 18 years of age following tonsillectomy and/or adenoidectomy [ see Contraindications 4 ].\"\n }\n ]\n },\n {\n \"Term\": \"Blood sodium\",\n \"MEDDRACode\": \"10005799\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"serum sodium\",\n \"Probability\": \"0.0018510222\",\n \"SemanticContext\": \"5.19 Hyponatremia Hyponatremia serum sodium < 135 mmol/L has been reported with the use of tramadol, and many cases are severe sodium level < 120 mmol/L .\"\n }\n ]\n },\n {\n \"Term\": \"Hallucination\",\n \"MEDDRACode\": \"10019063\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hallucinations\",\n \"Probability\": \"0.9668416381\",\n \"SemanticContext\": \"Serotonin syndrome symptoms may include mental status changes e.g., agitation, hallucinations, coma , autonomic instability e.g., tachycardia, labile blood pressure, hyperthermia , neuromuscular aberrations e.g., hyperreflexia, incoordination, rigidity , and/or gastrointestinal symptoms e.g., nausea, vomiting, diarrhea .\"\n }\n ]\n },\n {\n \"Term\": \"Hypoxia\",\n \"MEDDRACode\": \"10021143\",\n \"Overdose\": true,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hypoxemia\",\n \"Probability\": \"0.0089636743\",\n \"SemanticContext\": \"Opioids can cause sleep-related breathing disorders including central sleep apnea CSA and sleep-related hypoxemia.\"\n }\n ]\n },\n {\n \"Term\": \"Labile blood pressure\",\n \"MEDDRACode\": \"10023533\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"labile blood pressure\",\n \"Probability\": \"0.8617646694\",\n \"SemanticContext\": \"Serotonin syndrome symptoms may include mental status changes e.g., agitation, hallucinations, coma , autonomic instability e.g., tachycardia, labile blood pressure, hyperthermia , neuromuscular aberrations e.g., hyperreflexia, incoordination, rigidity , and/or gastrointestinal symptoms e.g., nausea, vomiting, diarrhea .\"\n }\n ]\n },\n {\n \"Term\": \"Foetal death\",\n \"MEDDRACode\": \"10055690\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"fetal death\",\n \"Probability\": \"0.8687831163\",\n \"SemanticContext\": \"Neonatal seizures, neonatal withdrawal syndrome, fetal death and stillbirth have been reported with tramadol during post-approval use of tramadol immediate-release products.\"\n }\n ]\n },\n {\n \"Term\": \"Supernumerary rib\",\n \"MEDDRACode\": \"10084170\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"supernumerary ribs\",\n \"Probability\": \"0.0062604845\",\n \"SemanticContext\": \"Embryo and fetal toxicity consisted primarily of decreased fetal weights, decreased skeletal ossification, and increased supernumerary ribs at maternally toxic dose levels.\"\n }\n ]\n },\n {\n \"Term\": \"Blood glucose\",\n \"MEDDRACode\": \"10005553\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"blood glucose\",\n \"Probability\": \"9.4334E-06\",\n \"SemanticContext\": \"If hypoglycemia is suspected, monitor blood glucose levels and consider drug discontinuation as appropriate [see Dosage and Administration: Safe Reduction or Discontinuation of Tram\"\n }\n ]\n },\n {\n \"Term\": \"Blood pressure decreased\",\n \"MEDDRACode\": \"10005734\",\n \"Overdose\": true,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"low blood pressure\",\n \"Probability\": \"0.9551359415\",\n \"SemanticContext\": \"Adrenal insufficiency may present with non-specific symptoms and signs such as nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure.\"\n },\n {\n \"VerbatimTerm\": \"low blood pressure\",\n \"Probability\": \"0.0004095137\",\n \"SemanticContext\": \"Instruct patients how to recognize symptoms of low blood pressure and how to reduce the risk of serious consequences should hypotension occur e.g., sit or lie down, carefully rise from a sitting or lying position [see Warnings and Precautions 5.13 ] .\"\n },\n {\n \"VerbatimTerm\": \"low blood pressure\",\n \"Probability\": \"0.9014049172\",\n \"SemanticContext\": \"Presentation of adrenal insufficiency may include non-specific symptoms and signs including nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure.\"\n }\n ]\n },\n {\n \"Term\": \"Arrhythmia\",\n \"MEDDRACode\": \"10003119\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"arrhythmias\",\n \"Probability\": \"0.0019932389\",\n \"SemanticContext\": \"Cardiac arrest or arrhythmias will require advanced life-support techniques.\"\n }\n ]\n },\n {\n \"Term\": \"Bronchospasm\",\n \"MEDDRACode\": \"10006482\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"bronchospasm\",\n \"Probability\": \"0.9455502629\",\n \"SemanticContext\": \"Other reported hypersensitivity reactions include pruritus, hives, bronchospasm, angioedema, toxic epidermal necrolysis and Stevens-Johnson syndrome.\"\n }\n ]\n },\n {\n \"Term\": \"Syncope\",\n \"MEDDRACode\": \"10042772\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"syncope\",\n \"Probability\": \"0.9150594473\",\n \"SemanticContext\": \"Effects on the Cardiovascular System Tramadol produces peripheral vasodilation, which may result in orthostatic hypotension or syncope.\"\n },\n {\n \"VerbatimTerm\": \"syncope\",\n \"Probability\": \"0.3243943155\",\n \"SemanticContext\": \"Hypotension Inform patients that tramadol hydrochloride extended-release tablets may cause orthostatic hypotension and syncope.\"\n },\n {\n \"VerbatimTerm\": \"syncope\",\n \"Probability\": \"0.9346322417\",\n \"SemanticContext\": \"5.13 Severe Hypotension Tramadol hydrochloride extended-release tablets may cause severe hypotension including orthostatic hypotension and syncope in ambulatory patients.\"\n }\n ]\n },\n {\n \"Term\": \"Respiratory arrest\",\n \"MEDDRACode\": \"10038669\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"respiratory arrest\",\n \"Probability\": \"0.3734912276\",\n \"SemanticContext\": \"Respiratory depression, if not immediately recognized and treated, may lead to respiratory arrest and death.\"\n }\n ]\n },\n {\n \"Term\": \"Sleep apnoea syndrome\",\n \"MEDDRACode\": \"10040979\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"sleep apnea\",\n \"Probability\": \"0.0594769716\",\n \"SemanticContext\": \"Opioids can cause sleep-related breathing disorders including central sleep apnea CSA and sleep-related hypoxemia.\"\n },\n {\n \"VerbatimTerm\": \"sleep apnea\",\n \"Probability\": \"0.0012479126\",\n \"SemanticContext\": \"Furthermore, children with obstructive sleep apnea who are treated with opioids for post-tonsillectomy and/or adenoidectomy pain may be particularly sensitive to their respiratory depressant effect.\"\n },\n {\n \"VerbatimTerm\": \"sleep apnea\",\n \"Probability\": \"0.1055368483\",\n \"SemanticContext\": \"Risk factors include conditions associated with hypoventilation, such as postoperative status, obstructive sleep apnea, obesity, severe pulmonary disease, neuromuscular disease, and concomitant use of other medications that cause respiratory depression.\"\n },\n {\n \"VerbatimTerm\": \"sleep apnea\",\n \"Probability\": \"0.052354455\",\n \"SemanticContext\": \"Avoid giving tramadol hydrochloride extended-release tablets to children between 12 to 18 years of age who have risk factors for breathing problems such as obstructive sleep apnea, obesity, or underlying lung problems.\"\n },\n {\n \"VerbatimTerm\": \"sleep apnea\",\n \"Probability\": \"0.0431864858\",\n \"SemanticContext\": \"Children with sleep apnea may be particularly sensitive to the respiratory depressant effects of tramadol.\"\n },\n {\n \"VerbatimTerm\": \"sleep apnea\",\n \"Probability\": \"0.1055368483\",\n \"SemanticContext\": \"Risk factors include conditions associated with hypoventilation, such as postoperative status, obstructive sleep apnea, obesity, severe pulmonary disease, neuromuscular disease, and concomitant use of other medications that cause respiratory depression.\"\n }\n ]\n },\n {\n \"Term\": \"Ultrasound scan\",\n \"MEDDRACode\": \"10045434\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"U.S.\",\n \"Probability\": \"0.0001225926\",\n \"SemanticContext\": \"TRAMADOL HYDROCHLORIDE extended-release tablets for oral use, C IV Initial U.S. Approval: 1995 WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY REMS ; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; ULTRA-RAPID METABOLISM OF TRAMADOL AND OTHER RISK FACTORS FOR LIFE-THREATENING RESPIRATORY DEPRESSION IN CHILDREN; NEONATAL OPIOID WITHDRAWAL SYNDROME; INTERACTIONS WITH DRUGS AFFECTING CYTOCHROME P450 ISOENZYMES; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS See full prescribing information for complete boxed warning .\"\n },\n {\n \"VerbatimTerm\": \"U.S.\",\n \"Probability\": \"0.0001934171\",\n \"SemanticContext\": \"In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.\"\n },\n {\n \"VerbatimTerm\": \"U.S.\",\n \"Probability\": \"0.0001976788\",\n \"SemanticContext\": \"This Medication Guide has been approved by the U.S. Food and Drug Administration.\"\n }\n ]\n },\n {\n \"Term\": \"Alcohol abuse\",\n \"MEDDRACode\": \"10001584\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"abuse alcohol\",\n \"Probability\": \"1.2542E-05\",\n \"SemanticContext\": \"Use with caution in those taking tranquilizers, antidepressants or abuse alcohol.\"\n },\n {\n \"VerbatimTerm\": \"alcohol abuse\",\n \"Probability\": \"0.0001989007\",\n \"SemanticContext\": \"Risks are increased in patients with a personal or family history of substance abuse including drug or alcohol abuse or addiction or mental illness e.g., major depression .\"\n }\n ]\n },\n {\n \"Term\": \"Injury\",\n \"MEDDRACode\": \"10022116\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"trauma\",\n \"Probability\": \"0.0390564799\",\n \"SemanticContext\": \"Risk of seizures may also increase in patients with epilepsy, those with a history of seizures, or in patients with a recognized risk for seizure such as head trauma, metabolic disorders, alcohol and drug withdrawal, CNS infections .\"\n }\n ]\n },\n {\n \"Term\": \"Planning to become pregnant\",\n \"MEDDRACode\": \"10076056\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"planning to become pregnant\",\n \"Probability\": \"1.0932E-06\",\n \"SemanticContext\": \"Tell your healthcare provider if you are: pregnant or planning to become pregnant.\"\n }\n ]\n },\n {\n \"Term\": \"Bradycardia\",\n \"MEDDRACode\": \"10006093\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"bradycardia\",\n \"Probability\": \"0.4401573837\",\n \"SemanticContext\": \"10 OVERDOSAGE Clinical Presentation Acute overdosage with tramadol hydrochloride extended-release tablets can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and, in some cases, pulmonary edema, bradycardia, QT prolongation, hypotension, partial or complete airway obstruction, atypical snoring, and death.\"\n }\n ]\n },\n {\n \"Term\": \"Life support\",\n \"MEDDRACode\": \"10024447\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"life-support\",\n \"Probability\": \"2.0005E-06\",\n \"SemanticContext\": \"Cardiac arrest or arrhythmias will require advanced life-support techniques.\"\n }\n ]\n },\n {\n \"Term\": \"Stupor\",\n \"MEDDRACode\": \"10042264\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"stupor\",\n \"Probability\": \"0.8776342869\",\n \"SemanticContext\": \"10 OVERDOSAGE Clinical Presentation Acute overdosage with tramadol hydrochloride extended-release tablets can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and, in some cases, pulmonary edema, bradycardia, QT prolongation, hypotension, partial or complete airway obstruction, atypical snoring, and death.\"\n }\n ]\n },\n {\n \"Term\": \"Short stature\",\n \"MEDDRACode\": \"10040600\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"ISS\",\n \"Probability\": \"0.006842941\",\n \"SemanticContext\": \"ISS: 06/2021 5221235\"\n }\n ]\n },\n {\n \"Term\": \"Cardiovascular insufficiency\",\n \"MEDDRACode\": \"10065929\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"circulatory depression\",\n \"Probability\": \"0.0008039176\",\n \"SemanticContext\": \"For clinically significant respiratory or circulatory depression secondary to tramadol overdose, administer an opioid antagonist.\"\n }\n ]\n },\n {\n \"Term\": \"Blood lead\",\n \"MEDDRACode\": \"10005639\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"leading\",\n \"Probability\": \"0.0119742453\",\n \"SemanticContext\": \"Chronic use of opioids may influence the hypothalamic-pituitary-gonadal axis, leading to androgen deficiency that may manifest as low libido, impotence, erectile dysfunction, amenorrhea, or infertility.\"\n },\n {\n \"VerbatimTerm\": \"leading\",\n \"Probability\": \"4.9732E-05\",\n \"SemanticContext\": \"CYP3A4 Inhibitors and Inducers Since tramadol is also metabolized by CYP3A4, administration of CYP3A4 inhibitors, such as ketoconazole and erythromycin, or CYP3A4 inducers, such as rifampin and St. John’s Wort, with tramadol hydrochloride extended-release tablets may affect the metabolism of tramadol leading to altered tramadol exposure [see Warnings and Precautions 5.6 , Drug Interactions 7 ].\"\n }\n ]\n },\n {\n \"Term\": \"Enteral nutrition\",\n \"MEDDRACode\": \"10052591\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"gavage\",\n \"Probability\": \"3.863E-07\",\n \"SemanticContext\": \"Progeny of dams receiving oral gavage dose levels of 50 mg/kg 1.6 times the MRHD or greater had decreased weights, and pup survival was decreased early in lactation at 80 mg/kg 2.6 times the MRHD .\"\n }\n ]\n },\n {\n \"Term\": \"Hypoventilation\",\n \"MEDDRACode\": \"10021133\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hypoventilation\",\n \"Probability\": \"0.1136113107\",\n \"SemanticContext\": \"Risk factors include conditions associated with hypoventilation, such as postoperative status, obstructive sleep apnea, obesity, severe pulmonary disease, neuromuscular disease, and concomitant use of other medications that cause respiratory depression.\"\n },\n {\n \"VerbatimTerm\": \"hypoventilation\",\n \"Probability\": \"0.1136113107\",\n \"SemanticContext\": \"Risk factors include conditions associated with hypoventilation, such as postoperative status, obstructive sleep apnea, obesity, severe pulmonary disease, neuromuscular disease, and concomitant use of other medications that cause respiratory depression.\"\n }\n ]\n },\n {\n \"Term\": \"Autonomic nervous system imbalance\",\n \"MEDDRACode\": \"10003840\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"autonomic instability\",\n \"Probability\": \"0.8906466961\",\n \"SemanticContext\": \"Serotonin syndrome symptoms may include mental status changes e.g., agitation, hallucinations, coma , autonomic instability e.g., tachycardia, labile blood pressure, hyperthermia , neuromuscular aberrations e.g., hyperreflexia, incoordination, rigidity , and/or gastrointestinal symptoms e.g., nausea, vomiting, diarrhea .\"\n }\n ]\n },\n {\n \"Term\": \"Cystoid macular oedema\",\n \"MEDDRACode\": \"10058202\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"CME\",\n \"Probability\": \"0.0005894899\",\n \"SemanticContext\": \"To obtain further information on the opioid analgesic REMS and for a list of accredited REMS CME/CE, call 800-503-0784, or log on to www.opioidanalgesicrems.com .\"\n }\n ]\n },\n {\n \"Term\": \"Shock\",\n \"MEDDRACode\": \"10040560\",\n \"Overdose\": true,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"circulatory shock\",\n \"Probability\": \"0.0933890045\",\n \"SemanticContext\": \"Avoid use of tramadol hydrochloride extended-release tablets in patients with circulatory shock.\"\n },\n {\n \"VerbatimTerm\": \"circulatory shock\",\n \"Probability\": \"0.1884361506\",\n \"SemanticContext\": \"Employ other supportive measures including oxygen and vasopressors in the management of circulatory shock and pulmonary edema as indicated.\"\n },\n {\n \"VerbatimTerm\": \"circulatory shock\",\n \"Probability\": \"0.0892641246\",\n \"SemanticContext\": \"In patients with circulatory shock, tramadol hydrochloride extended-release tablets may cause vasodilation that can further reduce cardiac output and blood pressure.\"\n },\n {\n \"VerbatimTerm\": \"circulatory shock\",\n \"Probability\": \"0.1539903283\",\n \"SemanticContext\": \"Avoid the use of tramadol hydrochloride extended-release tablets in patients with circulatory shock.\"\n }\n ]\n },\n {\n \"Term\": \"Headache\",\n \"MEDDRACode\": \"10019211\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"headache\",\n \"Probability\": \"0.999769628\",\n \"SemanticContext\": \"ADVERSE REACTIONS Most common adverse reactions =10% and =2 x placebo rate : Dizziness, constipation, nausea, headache, somnolence, flushing, pruritus, vomiting, insomnia, dry mouth.\"\n },\n {\n \"VerbatimTerm\": \"headache\",\n \"Probability\": \"0.9994366169\",\n \"SemanticContext\": \"The most common adverse reactions from Table 1 occurring in =10% and =2 x placebo rate of the patients treated with tramadol hydrochloride extended-release tablets are dizziness not vertigo , nausea, constipation, headache, somnolence, flushing, pruritus, vomiting, insomnia, and dry mouth.\"\n },\n {\n \"VerbatimTerm\": \"headache\",\n \"Probability\": \"0.9784380198\",\n \"SemanticContext\": \"The possible side effects of tramadol hydrochloride extended-release tablets: constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain, seizure.\"\n },\n {\n \"VerbatimTerm\": \"Headache\",\n \"Probability\": \"0.9989091158\",\n \"SemanticContext\": \"MedDRA Preferred Term Tramadol Hydrochloride Extended-Release Tablets Placebo 100 mg N=403 n % 200 mg N=400 n % 300 mg N=400 n % 400 mg N=202 n % N=406 n % Dizziness not vertigo 64 16 81 20 90 23 57 28 28 7 Nausea 61 15 90 23 102 26 53 26 32 8 Constipation 49 12 68 17 85 21 60 30 17 4 Headache 49 12 62 16 46 12 32 16 43 11 Somnolence 33 8 45 11 29 7 41 20 7 2 Flushing 31 8 40 10 35 9 32 16 18 4 Pruritus 25 6 34 9 30 8 24 12 4 1 Vomiting 20 5 29 7 34 9 19 9 11 3 Insomnia 26 7 32 8 36 9 22 11 13 3 Dry Mouth 20 5 29 7 39 10 18 9 6 2 Diarrhea 15 4 27 7 37 9 10 5 17 4 Asthenia 14 4 24 6 26 7 13 6 7 2 Postural hypotension 7 2 17 4 8 2 11 5 9 2 Sweating increased 6 2 8 2 15 4 13 6 1 0 Anorexia 3 1 7 2 21 5 12 6 1 0 .\"\n }\n ]\n },\n {\n \"Term\": \"Agitation\",\n \"MEDDRACode\": \"10001497\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"agitation\",\n \"Probability\": \"0.9741472006\",\n \"SemanticContext\": \"Serotonin syndrome symptoms may include mental status changes e.g., agitation, hallucinations, coma , autonomic instability e.g., tachycardia, labile blood pressure, hyperthermia , neuromuscular aberrations e.g., hyperreflexia, incoordination, rigidity , and/or gastrointestinal symptoms e.g., nausea, vomiting, diarrhea .\"\n },\n {\n \"VerbatimTerm\": \"agitation\",\n \"Probability\": \"0.0004918575\",\n \"SemanticContext\": \"Get emergency medical help or call 911 right away, if you have: trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue, or throat, extreme drowsiness, light-headedness when changing positions, feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion.\"\n }\n ]\n },\n {\n \"Term\": \"Tension\",\n \"MEDDRACode\": \"10043268\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"tension\",\n \"Probability\": \"0.0039684772\",\n \"SemanticContext\": \"The respiratory depression involves a reduction in the responsiveness of the brain stem respiratory centers to both increases in carbon dioxide tension and electrical stimulation.\"\n }\n ]\n },\n {\n \"Term\": \"Obstructive airways disorder\",\n \"MEDDRACode\": \"10061877\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"airway obstruction\",\n \"Probability\": \"0.0750405192\",\n \"SemanticContext\": \"10 OVERDOSAGE Clinical Presentation Acute overdosage with tramadol hydrochloride extended-release tablets can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and, in some cases, pulmonary edema, bradycardia, QT prolongation, hypotension, partial or complete airway obstruction, atypical snoring, and death.\"\n }\n ]\n },\n {\n \"Term\": \"Neonatal seizure\",\n \"MEDDRACode\": \"10082067\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Neonatal seizures\",\n \"Probability\": \"0.7607560158\",\n \"SemanticContext\": \"Neonatal seizures, neonatal withdrawal syndrome, fetal death and stillbirth have been reported with tramadol during post-approval use of tramadol immediate-release products.\"\n }\n ]\n },\n {\n \"Term\": \"Hyperthermia\",\n \"MEDDRACode\": \"10020843\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hyperthermia\",\n \"Probability\": \"0.8213771582\",\n \"SemanticContext\": \"Serotonin syndrome symptoms may include mental status changes e.g., agitation, hallucinations, coma , autonomic instability e.g., tachycardia, labile blood pressure, hyperthermia , neuromuscular aberrations e.g., hyperreflexia, incoordination, rigidity , and/or gastrointestinal symptoms e.g., nausea, vomiting, diarrhea .\"\n }\n ]\n },\n {\n \"Term\": \"Tachycardia\",\n \"MEDDRACode\": \"10043071\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"tachycardia\",\n \"Probability\": \"0.9941282868\",\n \"SemanticContext\": \"Serotonin syndrome symptoms may include mental status changes e.g., agitation, hallucinations, coma , autonomic instability e.g., tachycardia, labile blood pressure, hyperthermia , neuromuscular aberrations e.g., hyperreflexia, incoordination, rigidity , and/or gastrointestinal symptoms e.g., nausea, vomiting, diarrhea .\"\n }\n ]\n },\n {\n \"Term\": \"Blood pressure measurement\",\n \"MEDDRACode\": \"10076581\",\n \"Overdose\": true,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"blood pressure\",\n \"Probability\": \"3.7741E-06\",\n \"SemanticContext\": \"Intervention: Monitor patients for signs of diminished diuresis and/or effects on blood pressure and increase the dosage of the diuretic as needed.\"\n },\n {\n \"VerbatimTerm\": \"blood pressure\",\n \"Probability\": \"0.0001085592\",\n \"SemanticContext\": \"There is increased risk in patients whose ability to maintain blood pressure has already been compromised by a reduced blood volume or concurrent administration of certain CNS depressant drugs e.g., phenothiazines or general anesthetics [see Drug Interactions 7 ].\"\n },\n {\n \"VerbatimTerm\": \"blood pressure\",\n \"Probability\": \"0.0003328919\",\n \"SemanticContext\": \"In patients with circulatory shock, tramadol hydrochloride extended-release tablets may cause vasodilation that can further reduce cardiac output and blood pressure.\"\n }\n ]\n },\n {\n \"Term\": \"Insomnia\",\n \"MEDDRACode\": \"10022437\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"insomnia\",\n \"Probability\": \"0.9824098349\",\n \"SemanticContext\": \"ADVERSE REACTIONS Most common adverse reactions =10% and =2 x placebo rate : Dizziness, constipation, nausea, headache, somnolence, flushing, pruritus, vomiting, insomnia, dry mouth.\"\n },\n {\n \"VerbatimTerm\": \"insomnia\",\n \"Probability\": \"0.9143223763\",\n \"SemanticContext\": \"The most common adverse reactions from Table 1 occurring in =10% and =2 x placebo rate of the patients treated with tramadol hydrochloride extended-release tablets are dizziness not vertigo , nausea, constipation, headache, somnolence, flushing, pruritus, vomiting, insomnia, and dry mouth.\"\n },\n {\n \"VerbatimTerm\": \"insomnia\",\n \"Probability\": \"0.0620782077\",\n \"SemanticContext\": \"Other signs and symptoms also may develop, including irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate.\"\n },\n {\n \"VerbatimTerm\": \"Insomnia\",\n \"Probability\": \"0.8866719007\",\n \"SemanticContext\": \"MedDRA Preferred Term Tramadol Hydrochloride Extended-Release Tablets Placebo 100 mg N=403 n % 200 mg N=400 n % 300 mg N=400 n % 400 mg N=202 n % N=406 n % Dizziness not vertigo 64 16 81 20 90 23 57 28 28 7 Nausea 61 15 90 23 102 26 53 26 32 8 Constipation 49 12 68 17 85 21 60 30 17 4 Headache 49 12 62 16 46 12 32 16 43 11 Somnolence 33 8 45 11 29 7 41 20 7 2 Flushing 31 8 40 10 35 9 32 16 18 4 Pruritus 25 6 34 9 30 8 24 12 4 1 Vomiting 20 5 29 7 34 9 19 9 11 3 Insomnia 26 7 32 8 36 9 22 11 13 3 Dry Mouth 20 5 29 7 39 10 18 9 6 2 Diarrhea 15 4 27 7 37 9 10 5 17 4 Asthenia 14 4 24 6 26 7 13 6 7 2 Postural hypotension 7 2 17 4 8 2 11 5 9 2 Sweating increased 6 2 8 2 15 4 13 6 1 0 Anorexia 3 1 7 2 21 5 12 6 1 0 .\"\n }\n ]\n },\n {\n \"Term\": \"Urticaria\",\n \"MEDDRACode\": \"10046735\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hives\",\n \"Probability\": \"0.9823913574\",\n \"SemanticContext\": \"Other reported hypersensitivity reactions include pruritus, hives, bronchospasm, angioedema, toxic epidermal necrolysis and Stevens-Johnson syndrome.\"\n }\n ]\n },\n {\n \"Term\": \"Tonsillectomy\",\n \"MEDDRACode\": \"10044006\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": true,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"tonsillectomy\",\n \"Probability\": \"0.0060372055\",\n \"SemanticContext\": \"Some of the reported cases followed tonsillectomy and/or adenoidectomy; in at least one case, the child had evidence of being an ultra-rapid metabolizer of tramadol due to a CYP2D6 polymorphism 5.4 .\"\n },\n {\n \"VerbatimTerm\": \"tonsillectomy\",\n \"Probability\": \"7.16783E-05\",\n \"SemanticContext\": \"T ramadol hydrochloride extended-release tablets are contraindicated in children younger than 12 years of age and in children younger than 18 years of age following tonsillectomy and/or adenoidectomy 4 .\"\n },\n {\n \"VerbatimTerm\": \"tonsillectomy\",\n \"Probability\": \"0.0014172792\",\n \"SemanticContext\": \"Postoperative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy.\"\n },\n {\n \"VerbatimTerm\": \"tonsillectomy\",\n \"Probability\": \"0.0010649264\",\n \"SemanticContext\": \"4 CONTRAINDICATIONS Tramadol hydrochloride extended-release tablets are contraindicated for: all children younger than 12 years of age [ see Warnings and Precautions 5.4 ] post-operative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy [ see Warnings and Precautions 5.4 ].\"\n },\n {\n \"VerbatimTerm\": \"tonsillectomy\",\n \"Probability\": \"0.0001203541\",\n \"SemanticContext\": \"Ultra-Rapid Metabolism of Tramadol and Other Risk Factors for Life-threatening Respiratory Depression in Children Advise caregivers that tramadol hydrochloride extended-release tablets are contraindicated in children younger than 12 years of age and in children younger than 18 years of age following tonsillectomy and/or adenoidectomy.\"\n },\n {\n \"VerbatimTerm\": \"tonsillectomy\",\n \"Probability\": \"4.8323E-06\",\n \"SemanticContext\": \"Furthermore, children with obstructive sleep apnea who are treated with opioids for post-tonsillectomy and/or adenoidectomy pain may be particularly sensitive to their respiratory depressant effect.\"\n },\n {\n \"VerbatimTerm\": \"tonsillectomy\",\n \"Probability\": \"1.22192E-05\",\n \"SemanticContext\": \"Tramadol hydrochloride extended-release tablets are contraindicated for post-operative management in pediatric patients younger than 18 years of age following tonsillectomy and/or adenoidectomy [ see Contraindications 4 ].\"\n },\n {\n \"VerbatimTerm\": \"tonsillectomy\",\n \"Probability\": \"0.0060463846\",\n \"SemanticContext\": \"In some of the reported cases, these events followed tonsillectomy and/or adenoidectomy, and one of the children had evidence of being an ultra-rapid metabolizer of tramadol i.e., multiple copies of the gene for cytochrome P450 isoenzyme 2D6 .\"\n },\n {\n \"VerbatimTerm\": \"tonsillectomy\",\n \"Probability\": \"1.22192E-05\",\n \"SemanticContext\": \"Tramadol hydrochloride extended-release tablets are contraindicated for post-operative management in pediatric patients younger than 18 years of age following tonsillectomy and/or adenoidectomy [ see Contraindications 4 ].\"\n }\n ]\n },\n {\n \"Term\": \"Cardiac output\",\n \"MEDDRACode\": \"10007594\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"cardiac output\",\n \"Probability\": \"0.0325995684\",\n \"SemanticContext\": \"In patients with circulatory shock, tramadol hydrochloride extended-release tablets may cause vasodilation that can further reduce cardiac output and blood pressure.\"\n }\n ]\n },\n {\n \"Term\": \"Coordination abnormal\",\n \"MEDDRACode\": \"10010947\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"incoordination\",\n \"Probability\": \"0.9029893875\",\n \"SemanticContext\": \"Serotonin syndrome symptoms may include mental status changes e.g., agitation, hallucinations, coma , autonomic instability e.g., tachycardia, labile blood pressure, hyperthermia , neuromuscular aberrations e.g., hyperreflexia, incoordination, rigidity , and/or gastrointestinal symptoms e.g., nausea, vomiting, diarrhea .\"\n }\n ]\n },\n {\n \"Term\": \"Cor pulmonale\",\n \"MEDDRACode\": \"10010968\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"cor pulmonale\",\n \"Probability\": \"0.0209417343\",\n \"SemanticContext\": \"Patients with Chronic Pulmonary Disease: Tramadol hydrochloride extended-release tablets-treated patients with significant chronic obstructive pulmonary disease or cor pulmonale, and those with a substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression are at increased risk of decreased respiratory drive including apnea, even at recommended dosages of tramadol hydrochloride extended-release tablets [see Warnings and Precautions 5.3 ].\"\n }\n ]\n },\n {\n \"Term\": \"Theft\",\n \"MEDDRACode\": \"10043405\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"theft\",\n \"Probability\": \"0.0004523695\",\n \"SemanticContext\": \"Instruct patients not to share tramadol hydrochloride extended-release tablets with others and to take steps to protect tramadol hydrochloride extended-release tablets from theft or misuse.\"\n }\n ]\n },\n {\n \"Term\": \"Cardiac arrest\",\n \"MEDDRACode\": \"10007515\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Cardiac arrest\",\n \"Probability\": \"0.002164185\",\n \"SemanticContext\": \"Cardiac arrest or arrhythmias will require advanced life-support techniques.\"\n }\n ]\n },\n {\n \"Term\": \"Stevens-Johnson syndrome\",\n \"MEDDRACode\": \"10042033\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Stevens-Johnson syndrome\",\n \"Probability\": \"0.7021256089\",\n \"SemanticContext\": \"Other reported hypersensitivity reactions include pruritus, hives, bronchospasm, angioedema, toxic epidermal necrolysis and Stevens-Johnson syndrome.\"\n }\n ]\n },\n {\n \"Term\": \"Drug withdrawal syndrome neonatal\",\n \"MEDDRACode\": \"10013756\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"neonatal withdrawal syndrome\",\n \"Probability\": \"0.6769106388\",\n \"SemanticContext\": \"Neonatal seizures, neonatal withdrawal syndrome, fetal death and stillbirth have been reported with tramadol during post-approval use of tramadol immediate-release products.\"\n }\n ]\n },\n {\n \"Term\": \"Psychomotor hyperactivity\",\n \"MEDDRACode\": \"10037211\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hyperactivity\",\n \"Probability\": \"0.758326292\",\n \"SemanticContext\": \"Neonatal opioid withdrawal syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea, and failure to gain weight.\"\n }\n ]\n },\n {\n \"Term\": \"Hypercapnia\",\n \"MEDDRACode\": \"10020591\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hypercapnia\",\n \"Probability\": \"0.2589081824\",\n \"SemanticContext\": \"Patients with Chronic Pulmonary Disease: Tramadol hydrochloride extended-release tablets-treated patients with significant chronic obstructive pulmonary disease or cor pulmonale, and those with a substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression are at increased risk of decreased respiratory drive including apnea, even at recommended dosages of tramadol hydrochloride extended-release tablets [see Warnings and Precautions 5.3 ].\"\n }\n ]\n },\n {\n \"Term\": \"Body temperature\",\n \"MEDDRACode\": \"10005906\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"body temperature\",\n \"Probability\": \"0.0003672838\",\n \"SemanticContext\": \"Get emergency medical help or call 911 right away, if you have: trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue, or throat, extreme drowsiness, light-headedness when changing positions, feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion.\"\n }\n ]\n },\n {\n \"Term\": \"Cold sweat\",\n \"MEDDRACode\": \"10009866\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"clammy\",\n \"Probability\": \"0.0042778552\",\n \"SemanticContext\": \"10 OVERDOSAGE Clinical Presentation Acute overdosage with tramadol hydrochloride extended-release tablets can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and, in some cases, pulmonary edema, bradycardia, QT prolongation, hypotension, partial or complete airway obstruction, atypical snoring, and death.\"\n }\n ]\n },\n {\n \"Term\": \"Metabolic disorder\",\n \"MEDDRACode\": \"10058097\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"metabolic disorders\",\n \"Probability\": \"0.2090661824\",\n \"SemanticContext\": \"Risk of seizures may also increase in patients with epilepsy, those with a history of seizures, or in patients with a recognized risk for seizure such as head trauma, metabolic disorders, alcohol and drug withdrawal, CNS infections .\"\n }\n ]\n },\n {\n \"Term\": \"Apnoea\",\n \"MEDDRACode\": \"10002974\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"apnea\",\n \"Probability\": \"0.0236812234\",\n \"SemanticContext\": \"Patients with Chronic Pulmonary Disease: Tramadol hydrochloride extended-release tablets-treated patients with significant chronic obstructive pulmonary disease or cor pulmonale, and those with a substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression are at increased risk of decreased respiratory drive including apnea, even at recommended dosages of tramadol hydrochloride extended-release tablets [see Warnings and Precautions 5.3 ].\"\n }\n ]\n },\n {\n \"Term\": \"Abortion spontaneous\",\n \"MEDDRACode\": \"10000234\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"miscarriage\",\n \"Probability\": \"0.6551926136\",\n \"SemanticContext\": \"Available data with tramadol hydrochloride extended-release tablets in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage.\"\n },\n {\n \"VerbatimTerm\": \"miscarriage\",\n \"Probability\": \"0.2355126441\",\n \"SemanticContext\": \"The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.\"\n },\n {\n \"VerbatimTerm\": \"miscarriage\",\n \"Probability\": \"0.7700802088\",\n \"SemanticContext\": \"In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.\"\n }\n ]\n },\n {\n \"Term\": \"Obesity\",\n \"MEDDRACode\": \"10029883\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"obesity\",\n \"Probability\": \"0.0197630525\",\n \"SemanticContext\": \"Risk factors include conditions associated with hypoventilation, such as postoperative status, obstructive sleep apnea, obesity, severe pulmonary disease, neuromuscular disease, and concomitant use of other medications that cause respiratory depression.\"\n },\n {\n \"VerbatimTerm\": \"obesity\",\n \"Probability\": \"0.0108148754\",\n \"SemanticContext\": \"Avoid giving tramadol hydrochloride extended-release tablets to children between 12 to 18 years of age who have risk factors for breathing problems such as obstructive sleep apnea, obesity, or underlying lung problems.\"\n },\n {\n \"VerbatimTerm\": \"obesity\",\n \"Probability\": \"0.0197630525\",\n \"SemanticContext\": \"Risk factors include conditions associated with hypoventilation, such as postoperative status, obstructive sleep apnea, obesity, severe pulmonary disease, neuromuscular disease, and concomitant use of other medications that cause respiratory depression.\"\n }\n ]\n },\n {\n \"Term\": \"Epilepsy\",\n \"MEDDRACode\": \"10015037\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"epilepsy\",\n \"Probability\": \"0.0095922053\",\n \"SemanticContext\": \"Risk is increased with higher than recommended doses and concomitant use of SSRIs, SNRIs, anorectics, tricyclic antidepressants and other tricyclic compounds, other opioids, MAOIs, neuroleptics, other drugs that reduce seizure threshold, in patients with epilepsy or at risk for seizures.\"\n },\n {\n \"VerbatimTerm\": \"epilepsy\",\n \"Probability\": \"0.0011930764\",\n \"SemanticContext\": \"Risk of seizures may also increase in patients with epilepsy, those with a history of seizures, or in patients with a recognized risk for seizure such as head trauma, metabolic disorders, alcohol and drug withdrawal, CNS infections .\"\n }\n ]\n },\n {\n \"Term\": \"Lymphoma\",\n \"MEDDRACode\": \"10025310\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"lymphoma\",\n \"Probability\": \"0.0237933993\",\n \"SemanticContext\": \"Mutagenesis Tramadol was mutagenic in the presence of metabolic activation in the mouse lymphoma assay.\"\n },\n {\n \"VerbatimTerm\": \"lymphoma\",\n \"Probability\": \"0.0252019465\",\n \"SemanticContext\": \"Tramadol was not mutagenic in the in vitro bacterial reverse mutation assay using Salmonella and E. coli Ames , the mouse lymphoma assay in the absence of metabolic activation, the in vitro chromosomal aberration assay, or the in vivo micronucleus assay in bone marrow.\"\n }\n ]\n },\n {\n \"Term\": \"Weight increased\",\n \"MEDDRACode\": \"10047899\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"weight gain\",\n \"Probability\": \"0.1745448411\",\n \"SemanticContext\": \"However, the excessive decrease in body weight gain observed in the rat study might have reduced their sensitivity to any potential carcinogenic effect of the drug.\"\n },\n {\n \"VerbatimTerm\": \"gain weight\",\n \"Probability\": \"0.9840490818\",\n \"SemanticContext\": \"Neonatal opioid withdrawal syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea, and failure to gain weight.\"\n }\n ]\n },\n {\n \"Term\": \"Stillbirth\",\n \"MEDDRACode\": \"10042062\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"stillbirth\",\n \"Probability\": \"0.8904594779\",\n \"SemanticContext\": \"Neonatal seizures, neonatal withdrawal syndrome, fetal death and stillbirth have been reported with tramadol during post-approval use of tramadol immediate-release products.\"\n }\n ]\n },\n {\n \"Term\": \"Uterine contractions during pregnancy\",\n \"MEDDRACode\": \"10049975\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"uterine contractions\",\n \"Probability\": \"0.0146881044\",\n \"SemanticContext\": \"Opioid analgesics, including tramadol hydrochloride extended-release tablets, can prolong labor through actions which temporarily reduce the strength, duration, and frequency of uterine contractions.\"\n }\n ]\n },\n {\n \"Term\": \"Cryptococcal meningoencephalitis\",\n \"MEDDRACode\": \"10084824\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"CME\",\n \"Probability\": \"0.0005894899\",\n \"SemanticContext\": \"To obtain further information on the opioid analgesic REMS and for a list of accredited REMS CME/CE, call 800-503-0784, or log on to www.opioidanalgesicrems.com .\"\n }\n ]\n },\n {\n \"Term\": \"Hospitalisation\",\n \"MEDDRACode\": \"10054112\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hospitalization\",\n \"Probability\": \"0.0272115767\",\n \"SemanticContext\": \"5.20 Hypoglycemia Cases of tramadol-associated hypoglycemia have been reported, some resulting in hospitalization.\"\n }\n ]\n },\n {\n \"Term\": \"Tremor\",\n \"MEDDRACode\": \"10044565\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"tremor\",\n \"Probability\": \"0.9980304241\",\n \"SemanticContext\": \"Eye disorders: vision blurred Gastrointestinal disorders: abdominal pain upper, dyspepsia, abdominal pain, sore throat General disorders: weakness, pain, feeling hot, influenza like illness, fall, rigors, lethargy, pyrexia, chest pain Infections and infestations: nasopharyngitis, upper respiratory tract infection, sinusitis, influenza, gastroenteritis viral, urinary tract infection, bronchitis Investigations: blood creatine phosphokinase increased, weight decreased Metabolism and nutrition disorders: appetite decreased Musculoskeletal, connective tissue and bone disorders: arthralgia, back pain, pain in limb, neck pain Nervous system disorders: tremor, paresthesia, hypoesthesia Psychiatric disorders: nervousness, anxiety, depression, restlessness Respiratory, thoracic and mediastinal disorders: sneezing, cough, rhinorrhea, nasal congestion, dyspnea, sinus congestion Skin and subcutaneous tissue disorders: sweating increased, dermatitis Vascular disorders: hot flushes, vasodilatation Adverse Reactions With Incidence Rates of 0.5% to \\n <1.0% and Serious Adverse Reactions Reported in at Least 2 patients During Clinical Trials Cardiac disorders: palpitations, myocardial infarction Ear and labyrinth disorders: tinnitus, vertigo Gastrointestinal disorders: flatulence, toothache, constipation aggravated, appendicitis, pancreatitis General disorders: feeling jittery, edema lower limb, shivering, joint swelling, malaise, drug withdrawal syndrome, peripheral swelling Hepato-biliary disorders: cholelithiasis, cholecystitis Infections and infestations: cellulitis, ear infection, gastroenteritis, pneumonia, viral infection Injury and poisoning: joint sprain, muscle injury Investigations: alanine aminotransferase increased, blood pressure increased, aspartate aminotransferase increased, heart rate increased, blood glucose increased, liver function tests abnormal Musculoskeletal, connective tissue and bone disorders: muscle cramps, muscle spasms, joint stiffness, muscle twitching, myalgia, osteoarthritis aggravated Nervous system disorders: migraine, sedation, syncope, disturbance in attention, dizziness aggravated Psychiatric disorders: euphoric mood, irritability, libido decreased, sleep disorder, agitation, disorientation, abnormal dreams Renal and urinary disorders: difficulty in micturition, urinary frequency, hematuria, dysuria, urinary retention Respiratory, thoracic and mediastinal disorders: yawning Skin and subcutaneous tissue disorders: contusion, piloerection, clamminess, night sweats, urticaria Vascular disorders: hypertension aggravated, hypertension, peripheral ischemia 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of tramadol.\"\n },\n {\n \"VerbatimTerm\": \"tremor\",\n \"Probability\": \"0.9656108022\",\n \"SemanticContext\": \"Neonatal opioid withdrawal syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea, and failure to gain weight.\"\n }\n ]\n },\n {\n \"Term\": \"Infertility\",\n \"MEDDRACode\": \"10021926\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": true,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"infertility\",\n \"Probability\": \"0.7413959503\",\n \"SemanticContext\": \"Chronic use of opioids may influence the hypothalamic-pituitary-gonadal axis, leading to androgen deficiency that may manifest as low libido, impotence, erectile dysfunction, amenorrhea, or infertility.\"\n },\n {\n \"VerbatimTerm\": \"Infertility\",\n \"Probability\": \"0.1034968793\",\n \"SemanticContext\": \"Infertility Inform patients that chronic use of opioids may cause reduced fertility.\"\n },\n {\n \"VerbatimTerm\": \"Infertility\",\n \"Probability\": \"0.0094166398\",\n \"SemanticContext\": \"8.3 Females and Males of Reproductive Potential Infertility Chronic use of opioids may cause reduced fertility in females and males of reproductive potential.\"\n }\n ]\n },\n {\n \"Term\": \"Completed suicide\",\n \"MEDDRACode\": \"10010144\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Suicide\",\n \"Probability\": \"0.1658405066\",\n \"SemanticContext\": \"Risk of Suicide : Do not use tramadol hydrochloride extended-release tablets in suicidal or addiction-prone patients.\"\n },\n {\n \"VerbatimTerm\": \"Suicide\",\n \"Probability\": \"0.9286555052\",\n \"SemanticContext\": \"6 ADVERSE REACTIONS The following serious adverse reactions are described in greater detail, in other sections: Addiction, Abuse, and Misuse [see Warnings and Precautions 5.1 ] Life-Threatening Respiratory Depression [see Warnings and Precautions 5.3 ] Ultra-Rapid Metabolism of Tramadol and Other Risk Factors for Life-Threatening Respiratory Depression in Children [see Warnings and Precautions 5.4 ] Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions 5.5 ] Interactions with Benzodiazepines and Other CNS Depressants [see Warnings and Precautions 5.7 ] Serotonin Syndrome [see Warnings and Precautions 5.8 ] Seizures [see Warnings and Precautions 5.9 ] Suicide [see Warnings and Precautions 5.10 ] Adrenal Insufficiency [see Warnings and Precautions 5.11 ] Severe Hypotension [see Warnings and Precautions 5.13 ] Gastrointestinal Adverse Reactions [see Warnings and Precautions 5.15 ] Hypersensitivity Reactions [see Warnings and Precautions 5.16 ] Withdrawal [see Warnings and Precautions 5.17 ] 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.\"\n },\n {\n \"VerbatimTerm\": \"Suicide\",\n \"Probability\": \"0.3995223939\",\n \"SemanticContext\": \"5.10 Suicide Risk Do not prescribe tramadol hydrochloride extended-release tablets for patients who are suicidal or addiction-prone.\"\n },\n {\n \"VerbatimTerm\": \"suicide\",\n \"Probability\": \"0.0709668398\",\n \"SemanticContext\": \"Rapid tapering of tramadol hydrochloride extended-release tablets in a patient physically dependent on opioids may lead to serious withdrawal symptoms, uncontrolled pain, and suicide.\"\n },\n {\n \"VerbatimTerm\": \"suicide\",\n \"Probability\": \"0.0141462088\",\n \"SemanticContext\": \"Rapid discontinuation of opioid analgesics in patients who are physically dependent on opioids has resulted in serious withdrawal symptoms, uncontrolled pain, and suicide.\"\n }\n ]\n },\n {\n \"Term\": \"Gastrointestinal obstruction\",\n \"MEDDRACode\": \"10061974\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": true,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"gastrointestinal obstruction\",\n \"Probability\": \"0.0200407803\",\n \"SemanticContext\": \"Known or suspected gastrointestinal obstruction, including paralytic ileus 4 .\"\n },\n {\n \"VerbatimTerm\": \"gastrointestinal obstruction\",\n \"Probability\": \"0.2302320004\",\n \"SemanticContext\": \"Tramadol hydrochloride extended-release tablets are also contraindicated in patients with: Significant respiratory depression [ see Warnings and Precautions 5.3 ] Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [ see Warnings and Precautions 5.12 ] Known or suspected gastrointestinal obstruction, including paralytic ileus [ see Warnings and Precautions 5.15 ] Hypersensitivity to tramadol e.g., anaphylaxis [ see Warnings and Precautions 5.16 , Adverse Reactions 6.2 ] Concurrent use of monoamine oxidase inhibitors MAOIs or use within the last 14 days [see Drug Interactions 7 ] .\"\n },\n {\n \"VerbatimTerm\": \"gastrointestinal obstruction\",\n \"Probability\": \"0.107794404\",\n \"SemanticContext\": \"5.15 Risks of Use in Patients with Gastrointestinal Conditions Tramadol hydrochloride extended-release tablets are contraindicated in patients with known or suspected gastrointestinal obstruction, including paralytic ileus.\"\n }\n ]\n },\n {\n \"Term\": \"Caregiver\",\n \"MEDDRACode\": \"10007664\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"caregiver\",\n \"Probability\": \"2.31336E-05\",\n \"SemanticContext\": \"Discuss availability of naloxone with the patient and caregiver and assess each patient’s need for access to naloxone, both when initiating and renewing treatment with tramadol hydrochloride extended-release tablets.\"\n },\n {\n \"VerbatimTerm\": \"caregiver\",\n \"Probability\": \"0.0001257658\",\n \"SemanticContext\": \"2.2 Patient Access to Naloxone for the Emergency Treatment of Opioid Overdose Discuss the availability of naloxone for the emergency treatment of opioid overdose with the patient and caregiver and assess the potential need for access to naloxone, both when initiating and renewing treatment with tramadol hydrochloride extended-release tablets [see Warnings and Precautions 5.3 , Patient Counseling Information 17 ].\"\n },\n {\n \"VerbatimTerm\": \"caregiver\",\n \"Probability\": \"0.000916034\",\n \"SemanticContext\": \"Frequent communication is important among the prescriber, other members of the healthcare team, the patient, and the caregiver/family during periods of changing analgesic requirements, including initial titration.\"\n },\n {\n \"VerbatimTerm\": \"caregiver\",\n \"Probability\": \"0.0001062753\",\n \"SemanticContext\": \"Patient Access to Naloxone for the Emergency Treatment of Opioid Overdose Discuss with the patient and caregiver the availability of naloxone for the emergency treatment of opioid overdose, both when initiating and renewing treatment with tramadol hydrochloride extended-release tablets.\"\n },\n {\n \"VerbatimTerm\": \"caregiver\",\n \"Probability\": \"1.78845E-05\",\n \"SemanticContext\": \"Emphasize the importance of doing this before an opioid emergency happens, so the patient and caregiver will know what to do.\"\n },\n {\n \"VerbatimTerm\": \"caregiver\",\n \"Probability\": \"1.42358E-05\",\n \"SemanticContext\": \"Patient Access to Naloxone for the Emergency Treatment of Opioid Overdose Discuss the availability of naloxone for the emergency treatment of opioid overdose with the patient and caregiver and assess the potential need for access to naloxone, both when initiating and renewing treatment with tramadol hydrochloride extended-release tablet.\"\n },\n {\n \"VerbatimTerm\": \"caregivers\",\n \"Probability\": \"1.3756E-05\",\n \"SemanticContext\": \"Inform patients and caregivers about the various ways to obtain naloxone as permitted by individual state naloxone dispensing and prescribing requirements or guidelines e.g., by prescription, directly from a pharmacist, or as part of a community-based program .\"\n },\n {\n \"VerbatimTerm\": \"caregivers\",\n \"Probability\": \"1.6759E-06\",\n \"SemanticContext\": \"Advise patients and caregivers that when medicines are no longer needed, they should be disposed of promptly.\"\n },\n {\n \"VerbatimTerm\": \"caregivers\",\n \"Probability\": \"0.000282675\",\n \"SemanticContext\": \"Educate patients and caregivers on how to recognize respiratory depression and emphasize the importance of calling 911 or getting emergency medical help right away in the event of a known or suspected overdose [see Warnings and Precautions 5.3 ] .\"\n },\n {\n \"VerbatimTerm\": \"caregivers\",\n \"Probability\": \"1.3756E-05\",\n \"SemanticContext\": \"Inform patients and caregivers about the various ways to obtain naloxone as permitted by individual state naloxone dispensing and prescribing requirements or guidelines e.g., by prescription, directly from a pharmacist, or as part of a community-based program [see Dosage and Administration 2.2 , Warnings and Precautions 5.3 ].\"\n },\n {\n \"VerbatimTerm\": \"caregivers\",\n \"Probability\": \"7.2259E-06\",\n \"SemanticContext\": \"Educate patients and caregivers on how to recognize the signs and symptoms of an overdose.\"\n },\n {\n \"VerbatimTerm\": \"caregivers\",\n \"Probability\": \"7.36042E-05\",\n \"SemanticContext\": \"Explain to patients and caregivers that naloxone’s effects are temporary, and that they must call 911 or get emergency medical help right away in all cases of known or suspected opioid overdose, even if naloxone is administered [ see Overdosage 10 ].\"\n },\n {\n \"VerbatimTerm\": \"caregivers\",\n \"Probability\": \"1.4589E-06\",\n \"SemanticContext\": \"If naloxone is prescribed, also advise patients and caregivers: How to treat with naloxone in the event of an opioid overdose To tell family and friends about their naloxone and to keep it in a place where family and friends can access it in an emergency To read the Patient Information or other educational material that will come with their naloxone.\"\n },\n {\n \"VerbatimTerm\": \"caregivers\",\n \"Probability\": \"0.0001551211\",\n \"SemanticContext\": \"Ultra-Rapid Metabolism of Tramadol and Other Risk Factors for Life-threatening Respiratory Depression in Children Advise caregivers that tramadol hydrochloride extended-release tablets are contraindicated in children younger than 12 years of age and in children younger than 18 years of age following tonsillectomy and/or adenoidectomy.\"\n },\n {\n \"VerbatimTerm\": \"caregivers\",\n \"Probability\": \"2.663E-05\",\n \"SemanticContext\": \"Advise caregivers of children 12 to 18 years of age receiving tramadol hydrochloride extended-release tablets to monitor for signs of respiratory depression [see Warnings and Precautions 5.4 ] .\"\n },\n {\n \"VerbatimTerm\": \"caregivers\",\n \"Probability\": \"5.92276E-05\",\n \"SemanticContext\": \"Interactions with Benzodiazepines and Other CNS Depressants Inform patients and caregivers that potentially fatal additive effects may occur if tramadol hydrochloride extended-release tablets are used with benzodiazepines or other CNS depressants, including alcohol, and not to use these concomitantly unless supervised by a healthcare provider [see Warnings and Precautions 5.7 , Drug Interactions 7 ].\"\n },\n {\n \"VerbatimTerm\": \"caregivers\",\n \"Probability\": \"1.066E-06\",\n \"SemanticContext\": \"Discuss the safe use, serious risks, and proper storage and disposal of opioid analgesics with patients and/or their caregivers every time these medicines are prescribed.\"\n },\n {\n \"VerbatimTerm\": \"caregivers\",\n \"Probability\": \"9.76445E-05\",\n \"SemanticContext\": \"Emphasize to patients and their caregivers the importance of reading the Medication Guide that they will receive from their pharmacist every time an opioid analgesic is dispensed to them.\"\n },\n {\n \"VerbatimTerm\": \"caregivers\",\n \"Probability\": \"0.000282675\",\n \"SemanticContext\": \"Educate patients and caregivers on how to recognize respiratory depression and emphasize the importance of calling 911 or getting emergency medical help right away in the event of a known or suspected overdose [see Patient Counseling Information 17 ].\"\n },\n {\n \"VerbatimTerm\": \"caregivers\",\n \"Probability\": \"1.3756E-05\",\n \"SemanticContext\": \"Inform patients and caregivers about the various ways to obtain naloxone as permitted by individual state naloxone dispensing and prescribing requirements or guidelines e.g., by prescription, directly from a pharmacist, or as part of a community-based program .\"\n },\n {\n \"VerbatimTerm\": \"caregivers\",\n \"Probability\": \"0.0003070533\",\n \"SemanticContext\": \"Educate patients and caregivers on how to recognize respiratory depression and emphasize the importance of calling 911 or getting emergency medical help, even if naloxone is administered [see Patient Counseling Information 17 ].\"\n },\n {\n \"VerbatimTerm\": \"caregivers\",\n \"Probability\": \"9.957E-07\",\n \"SemanticContext\": \"If naloxone is prescribed, educate patients and caregivers on how to treat with naloxone.\"\n },\n {\n \"VerbatimTerm\": \"caregivers\",\n \"Probability\": \"3.1107E-06\",\n \"SemanticContext\": \"As with adults, when prescribing opioids for adolescents, healthcare providers should choose the lowest effective dose for the shortest period of time and inform patients and caregivers about these risks and the signs of opioid overdose [ see Use in Specific Populations 8.4 , Overdosage 10 ].\"\n },\n {\n \"VerbatimTerm\": \"caregivers\",\n \"Probability\": \"1.94225E-05\",\n \"SemanticContext\": \"Advise both patients and caregivers about the risks of respiratory depression and sedation when tramadol hydrochloride extended-release tablets are used with benzodiazepines or other CNS depressants including alcohol and illicit drugs .\"\n }\n ]\n },\n {\n \"Term\": \"Breast feeding\",\n \"MEDDRACode\": \"10006247\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Breastfeeding\",\n \"Probability\": \"0.0540754497\",\n \"SemanticContext\": \"Lactation: Breastfeeding not recommended.\"\n },\n {\n \"VerbatimTerm\": \"breastfeeding\",\n \"Probability\": \"3.57277E-05\",\n \"SemanticContext\": \"Lactation Advise women that breastfeeding is not recommended during treatment with tramadol hydrochloride extended-release tablets [see Use in Specific Populations 8.2 ].\"\n },\n {\n \"VerbatimTerm\": \"breastfeeding\",\n \"Probability\": \"0.0007968545\",\n \"SemanticContext\": \"For this reason, breastfeeding is not recommended during treatment with Tramadol hydrochloride extended-release tablets [ see Use in Specific Populations 8.2 ].\"\n },\n {\n \"VerbatimTerm\": \"breastfeeding\",\n \"Probability\": \"1.72211E-05\",\n \"SemanticContext\": \"breastfeeding.\"\n }\n ]\n },\n {\n \"Term\": \"Brain neoplasm\",\n \"MEDDRACode\": \"10061019\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Brain Tumors\",\n \"Probability\": \"0.0009524226\",\n \"SemanticContext\": \"Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness: Monitor for sedation and respiratory depression.\"\n },\n {\n \"VerbatimTerm\": \"Brain Tumors\",\n \"Probability\": \"0.001504302\",\n \"SemanticContext\": \"5.14 Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness In patients who may be susceptible to the intracranial effects of CO 2 retention e.g., those with evidence of increased intracranial pressure or brain tumors , tramadol hydrochloride extended-release tablets may reduce respiratory drive, and the resultant CO 2 retention can further increase intracranial pressure.\"\n },\n {\n \"VerbatimTerm\": \"brain tumors\",\n \"Probability\": \"0.0184029937\",\n \"SemanticContext\": \"5.14 Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness In patients who may be susceptible to the intracranial effects of CO 2 retention e.g., those with evidence of increased intracranial pressure or brain tumors , tramadol hydrochloride extended-release tablets may reduce respiratory drive, and the resultant CO 2 retention can further increase intracranial pressure.\"\n }\n ]\n },\n {\n \"Term\": \"Vitamin E\",\n \"MEDDRACode\": \"10058765\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"vitamins\",\n \"Probability\": \"9.376E-07\",\n \"SemanticContext\": \"living in a household where there are small children or someone who has abused street or prescription drugs taking prescription or over-the-counter medicines, vitamins, or herbal supplements.\"\n }\n ]\n },\n {\n \"Term\": \"Hypotonia\",\n \"MEDDRACode\": \"10021118\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"muscle flaccidity\",\n \"Probability\": \"0.3245128691\",\n \"SemanticContext\": \"10 OVERDOSAGE Clinical Presentation Acute overdosage with tramadol hydrochloride extended-release tablets can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and, in some cases, pulmonary edema, bradycardia, QT prolongation, hypotension, partial or complete airway obstruction, atypical snoring, and death.\"\n }\n ]\n },\n {\n \"Term\": \"Snoring\",\n \"MEDDRACode\": \"10041235\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"snoring\",\n \"Probability\": \"0.5145705938\",\n \"SemanticContext\": \"10 OVERDOSAGE Clinical Presentation Acute overdosage with tramadol hydrochloride extended-release tablets can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and, in some cases, pulmonary edema, bradycardia, QT prolongation, hypotension, partial or complete airway obstruction, atypical snoring, and death.\"\n }\n ]\n },\n {\n \"Term\": \"Magnetic resonance imaging\",\n \"MEDDRACode\": \"10078223\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"NMRI\",\n \"Probability\": \"0.0002405643\",\n \"SemanticContext\": \"A slight but statistically significant increase in two common murine tumors, pulmonary and hepatic, was observed in an NMRI mouse carcinogenicity study, particularly in aged mice.\"\n }\n ]\n }\n ],\n \"IndicationTerms\": []\n }\n ]\n },\n {\n \"GenericName\": \"divalproex sodium\",\n \"MeddraVersion\": \"24.0\",\n \"Labels\": [\n {\n \"Id\": \"US80f63fd9-4a6b-4434-99f0-00dd62d2fb86\",\n \"NDCCode\": \"0378-0472\",\n \"UpdatedDate\": \"Jun 24, 2021\",\n \"LabelSource\": {\n \"Country\": \"us\",\n \"ProductId\": \"00332c65-edad-a153-9c78-628931daa732\",\n \"FileId\": \"80f63fd9-4a6b-4434-99f0-00dd62d2fb86\",\n \"Version\": \"25\"\n },\n \"AdverseEventTerms\": [\n {\n \"Term\": \"Abnormal dreams\",\n \"MEDDRACode\": \"10000125\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"abnormal dreams\",\n \"Probability\": \"0.9909309149\",\n \"SemanticContext\": \"Nervous System: Anxiety, confusion, abnormal gait, paresthesia, hypertonia, incoordination, abnormal dreams, personality disorder.\"\n },\n {\n \"VerbatimTerm\": \"Abnormal dreams\",\n \"Probability\": \"0.9966504574\",\n \"SemanticContext\": \"Nervous System: Abnormal dreams, confusion, paresthesia, speech disorder, and thinking abnormalities.\"\n }\n ]\n },\n {\n \"Term\": \"Anaemia\",\n \"MEDDRACode\": \"10002034\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Anemia\",\n \"Probability\": \"0.995331049\",\n \"SemanticContext\": \"Hemic and Lymphatic System: Anemia, Bleeding Time Increased, Ecchymosis, Leucopenia.\"\n },\n {\n \"VerbatimTerm\": \"anemia\",\n \"Probability\": \"0.9975397587\",\n \"SemanticContext\": \"Hematologic: Relative lymphocytosis, macrocytosis, leukopenia, anemia including macrocytic with or without folate deficiency, bone marrow suppression, pancytopenia, aplastic anemia, agranulocytosis, and acute intermittent porphyria.\"\n }\n ]\n },\n {\n \"Term\": \"Bleeding time prolonged\",\n \"MEDDRACode\": \"10005140\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Bleeding Time Increased\",\n \"Probability\": \"0.980712533\",\n \"SemanticContext\": \"Hemic and Lymphatic System: Anemia, Bleeding Time Increased, Ecchymosis, Leucopenia.\"\n }\n ]\n },\n {\n \"Term\": \"Breast enlargement\",\n \"MEDDRACode\": \"10006242\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"breast enlargement\",\n \"Probability\": \"0.988825798\",\n \"SemanticContext\": \"Endocrine: Irregular menses, secondary amenorrhea, hyperandrogenism, hirsutism, elevated testosterone level, breast enlargement, galactorrhea, parotid gland swelling, polycystic ovary disease, decreased carnitine concentrations, hyponatremia, hyperglycinemia, and inappropriate ADH secretion.\"\n }\n ]\n },\n {\n \"Term\": \"Aspartate aminotransferase increased\",\n \"MEDDRACode\": \"10003481\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"SGOT increased\",\n \"Probability\": \"0.9645526409\",\n \"SemanticContext\": \"Metabolic and Nutritional Disorders: SGOT increased, SGPT increased.\"\n }\n ]\n },\n {\n \"Term\": \"Azoospermia\",\n \"MEDDRACode\": \"10003883\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"azoospermia\",\n \"Probability\": \"0.9990925789\",\n \"SemanticContext\": \"Reproductive: Aspermia, azoospermia, decreased sperm count, decreased spermatozoa motility, male infertility, and abnormal spermatozoa morphology.\"\n }\n ]\n },\n {\n \"Term\": \"Fanconi syndrome\",\n \"MEDDRACode\": \"10016219\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Fanconi's syndrome\",\n \"Probability\": \"0.9324380755\",\n \"SemanticContext\": \"There have been rare reports of Fanconi's syndrome occurring chiefly in children.\"\n }\n ]\n },\n {\n \"Term\": \"Chest pain\",\n \"MEDDRACode\": \"10008479\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"chest pain\",\n \"Probability\": \"0.9612609148\",\n \"SemanticContext\": \"The following additional adverse reactions were reported by greater than 1% but less than 5% of the 358 patients treated with valproate in the controlled trials of complex partial seizures: Body as a Whole: Back pain, chest pain, malaise.\"\n },\n {\n \"VerbatimTerm\": \"Chest pain\",\n \"Probability\": \"0.8704602718\",\n \"SemanticContext\": \"The following additional adverse reactions were reported by greater than 1% but not more than 5% of the 202 valproate-treated patients in the controlled clinical trials: Body as a Whole: Chest pain.\"\n }\n ]\n },\n {\n \"Term\": \"Cough\",\n \"MEDDRACode\": \"10011224\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"cough increased\",\n \"Probability\": \"0.9997053146\",\n \"SemanticContext\": \"Respiratory System: Sinusitis, cough increased, pneumonia, epistaxis.\"\n }\n ]\n },\n {\n \"Term\": \"Cystitis\",\n \"MEDDRACode\": \"10011781\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Cystitis\",\n \"Probability\": \"0.9935743213\",\n \"SemanticContext\": \"Urogenital System: Cystitis, Urinary Tract Infection, Menstrual Disorder, Vaginitis.\"\n }\n ]\n },\n {\n \"Term\": \"Dry eye\",\n \"MEDDRACode\": \"10013774\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Dry Eyes\",\n \"Probability\": \"0.9772046208\",\n \"SemanticContext\": \"Special Senses: Conjunctivitis, Dry Eyes, Eye Disorder, Eye Pain, Photophobia, Taste Perversion.\"\n }\n ]\n },\n {\n \"Term\": \"Aggression\",\n \"MEDDRACode\": \"10001488\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"aggressiveness\",\n \"Probability\": \"0.7344085574\",\n \"SemanticContext\": \"Typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, poor judgment, aggressiveness, and possible hostility.\"\n }\n ]\n },\n {\n \"Term\": \"Bone pain\",\n \"MEDDRACode\": \"10006002\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"bone pain\",\n \"Probability\": \"0.9684117436\",\n \"SemanticContext\": \"Other: Allergic reaction, anaphylaxis, developmental delay, bone pain, bradycardia, and cutaneous vasculitis.\"\n }\n ]\n },\n {\n \"Term\": \"Carnitine decreased\",\n \"MEDDRACode\": \"10007668\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"decreased carnitine\",\n \"Probability\": \"0.9898204803\",\n \"SemanticContext\": \"Endocrine: Irregular menses, secondary amenorrhea, hyperandrogenism, hirsutism, elevated testosterone level, breast enlargement, galactorrhea, parotid gland swelling, polycystic ovary disease, decreased carnitine concentrations, hyponatremia, hyperglycinemia, and inappropriate ADH secretion.\"\n }\n ]\n },\n {\n \"Term\": \"Chills\",\n \"MEDDRACode\": \"10008531\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Chills\",\n \"Probability\": \"0.9943490624\",\n \"SemanticContext\": \"The following additional adverse reactions were reported by greater than 1% of the divalproex sodium extended-release tablets-treated patients in controlled clinical trials: Body as a Whole: Back Pain, Chills, Chills and Fever, Drug Level Increased, Flu Syndrome, Infection, Infection Fungal, Neck Rigidity.\"\n }\n ]\n },\n {\n \"Term\": \"Dermatitis bullous\",\n \"MEDDRACode\": \"10012441\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Vesiculobullous Rash\",\n \"Probability\": \"0.9878202081\",\n \"SemanticContext\": \"Skin and Appendages: Discoid Lupus Erythematosus, Erythema Nodosum, Furunculosis, Maculopapular Rash, Pruritus, Rash, Seborrhea, Sweating, Vesiculobullous Rash.\"\n }\n ]\n },\n {\n \"Term\": \"Disturbance in attention\",\n \"MEDDRACode\": \"10013496\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"disturbance in attention\",\n \"Probability\": \"0.9678075314\",\n \"SemanticContext\": \"Psychiatric: Emotional upset, psychosis, aggression, psychomotor hyperactivity, hostility, disturbance in attention, learning disorder, and behavioral deterioration.\"\n }\n ]\n },\n {\n \"Term\": \"Dysphagia\",\n \"MEDDRACode\": \"10013950\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Dysphagia\",\n \"Probability\": \"0.9815536737\",\n \"SemanticContext\": \"Digestive System: Constipation, Dry Mouth, Dysphagia, Fecal Incontinence, Flatulence, Gastroenteritis, Glossitis, Gum Hemorrhage, Mouth Ulceration.\"\n }\n ]\n },\n {\n \"Term\": \"Aplastic anaemia\",\n \"MEDDRACode\": \"10002967\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"aplastic anemia\",\n \"Probability\": \"0.9739876986\",\n \"SemanticContext\": \"Hematologic: Relative lymphocytosis, macrocytosis, leukopenia, anemia including macrocytic with or without folate deficiency, bone marrow suppression, pancytopenia, aplastic anemia, agranulocytosis, and acute intermittent porphyria.\"\n }\n ]\n },\n {\n \"Term\": \"Blood testosterone\",\n \"MEDDRACode\": \"10005811\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"testosterone\",\n \"Probability\": \"0.1060984135\",\n \"SemanticContext\": \"Endocrine: Irregular menses, secondary amenorrhea, hyperandrogenism, hirsutism, elevated testosterone level, breast enlargement, galactorrhea, parotid gland swelling, polycystic ovary disease, decreased carnitine concentrations, hyponatremia, hyperglycinemia, and inappropriate ADH secretion.\"\n }\n ]\n },\n {\n \"Term\": \"Gait disturbance\",\n \"MEDDRACode\": \"10017577\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Abnormal Gait\",\n \"Probability\": \"0.9924140573\",\n \"SemanticContext\": \"Nervous System: Abnormal Gait, Agitation, Catatonic Reaction, Dysarthria, Hallucinations, Hypertonia, Hypokinesia, Psychosis, Reflexes Increased, Sleep Disorder, Tardive Dyskinesia, Tremor.\"\n },\n {\n \"VerbatimTerm\": \"abnormal gait\",\n \"Probability\": \"0.9973154664\",\n \"SemanticContext\": \"Nervous System: Anxiety, confusion, abnormal gait, paresthesia, hypertonia, incoordination, abnormal dreams, personality disorder.\"\n },\n {\n \"VerbatimTerm\": \"Abnormal gait\",\n \"Probability\": \"0.9989032149\",\n \"SemanticContext\": \"Nervous System: Abnormal gait, dizziness, hypertonia, insomnia, nervousness, tremor, vertigo.\"\n }\n ]\n },\n {\n \"Term\": \"Hiccups\",\n \"MEDDRACode\": \"10020039\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Hiccup\",\n \"Probability\": \"0.9807238579\",\n \"SemanticContext\": \"Respiratory System: Hiccup, Rhinitis.\"\n }\n ]\n },\n {\n \"Term\": \"Hyponatraemia\",\n \"MEDDRACode\": \"10021036\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hyponatremia\",\n \"Probability\": \"0.9940767884\",\n \"SemanticContext\": \"Endocrine: Irregular menses, secondary amenorrhea, hyperandrogenism, hirsutism, elevated testosterone level, breast enlargement, galactorrhea, parotid gland swelling, polycystic ovary disease, decreased carnitine concentrations, hyponatremia, hyperglycinemia, and inappropriate ADH secretion.\"\n }\n ]\n },\n {\n \"Term\": \"Erythema nodosum\",\n \"MEDDRACode\": \"10015226\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Erythema Nodosum\",\n \"Probability\": \"0.9372683764\",\n \"SemanticContext\": \"Skin and Appendages: Discoid Lupus Erythematosus, Erythema Nodosum, Furunculosis, Maculopapular Rash, Pruritus, Rash, Seborrhea, Sweating, Vesiculobullous Rash.\"\n }\n ]\n },\n {\n \"Term\": \"Hyperhidrosis\",\n \"MEDDRACode\": \"10020642\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Sweating\",\n \"Probability\": \"0.994872272\",\n \"SemanticContext\": \"Skin and Appendages: Discoid Lupus Erythematosus, Erythema Nodosum, Furunculosis, Maculopapular Rash, Pruritus, Rash, Seborrhea, Sweating, Vesiculobullous Rash.\"\n }\n ]\n },\n {\n \"Term\": \"Enuresis\",\n \"MEDDRACode\": \"10014928\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Enuresis\",\n \"Probability\": \"0.9871176481\",\n \"SemanticContext\": \"Genitourinary: Enuresis and urinary tract infection.\"\n }\n ]\n },\n {\n \"Term\": \"Eye disorder\",\n \"MEDDRACode\": \"10015916\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Eye Disorder\",\n \"Probability\": \"0.09818995\",\n \"SemanticContext\": \"Special Senses: Conjunctivitis, Dry Eyes, Eye Disorder, Eye Pain, Photophobia, Taste Perversion.\"\n }\n ]\n },\n {\n \"Term\": \"Erythema multiforme\",\n \"MEDDRACode\": \"10015218\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"erythema multiforme\",\n \"Probability\": \"0.9933508039\",\n \"SemanticContext\": \"Dermatologic: Hair texture changes, hair color changes, photosensitivity, erythema multiforme, toxic epidermal necrolysis, nail and nail bed disorders, and Stevens-Johnson syndrome.\"\n }\n ]\n },\n {\n \"Term\": \"Dysmenorrhoea\",\n \"MEDDRACode\": \"10013935\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"dysmenorrhea\",\n \"Probability\": \"0.9542044401\",\n \"SemanticContext\": \"Urogenital System: Urinary incontinence, vaginitis, dysmenorrhea, amenorrhea, urinary frequency.\"\n }\n ]\n },\n {\n \"Term\": \"Gastroenteritis\",\n \"MEDDRACode\": \"10017888\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Gastroenteritis\",\n \"Probability\": \"0.9774335623\",\n \"SemanticContext\": \"Digestive System: Constipation, Dry Mouth, Dysphagia, Fecal Incontinence, Flatulence, Gastroenteritis, Glossitis, Gum Hemorrhage, Mouth Ulceration.\"\n }\n ]\n },\n {\n \"Term\": \"Gingival bleeding\",\n \"MEDDRACode\": \"10018276\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Gum Hemorrhage\",\n \"Probability\": \"0.8810765743\",\n \"SemanticContext\": \"Digestive System: Constipation, Dry Mouth, Dysphagia, Fecal Incontinence, Flatulence, Gastroenteritis, Glossitis, Gum Hemorrhage, Mouth Ulceration.\"\n }\n ]\n },\n {\n \"Term\": \"Glossitis\",\n \"MEDDRACode\": \"10018386\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Glossitis\",\n \"Probability\": \"0.983004868\",\n \"SemanticContext\": \"Digestive System: Constipation, Dry Mouth, Dysphagia, Fecal Incontinence, Flatulence, Gastroenteritis, Glossitis, Gum Hemorrhage, Mouth Ulceration.\"\n }\n ]\n },\n {\n \"Term\": \"Learning disorder\",\n \"MEDDRACode\": \"10061265\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"learning disorder\",\n \"Probability\": \"0.938210547\",\n \"SemanticContext\": \"Psychiatric: Emotional upset, psychosis, aggression, psychomotor hyperactivity, hostility, disturbance in attention, learning disorder, and behavioral deterioration.\"\n }\n ]\n },\n {\n \"Term\": \"Muscle spasms\",\n \"MEDDRACode\": \"10028334\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"leg cramps\",\n \"Probability\": \"0.9945492148\",\n \"SemanticContext\": \"Musculoskeletal System: Myalgia, twitching, arthralgia, leg cramps, myasthenia.\"\n },\n {\n \"VerbatimTerm\": \"Leg cramps\",\n \"Probability\": \"0.9877989292\",\n \"SemanticContext\": \"Musculoskeletal System: Leg cramps.\"\n }\n ]\n },\n {\n \"Term\": \"Alopecia\",\n \"MEDDRACode\": \"10001760\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hair loss\",\n \"Probability\": \"0.1268205643\",\n \"SemanticContext\": \"The common side effects of divalproex sodium extended-release tablets include: • nausea • headache • sleepiness • vomiting • weakness • tremor • dizziness • stomach pain • blurry vision • double vision • diarrhea • increased appetite • weight gain • hair loss • loss of appetite • problems with walking or coordination These are not all of the possible side effects of divalproex sodium extended-release tablets .\"\n }\n ]\n },\n {\n \"Term\": \"Amenorrhoea\",\n \"MEDDRACode\": \"10001928\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"secondary amenorrhea\",\n \"Probability\": \"0.9911459684\",\n \"SemanticContext\": \"Endocrine: Irregular menses, secondary amenorrhea, hyperandrogenism, hirsutism, elevated testosterone level, breast enlargement, galactorrhea, parotid gland swelling, polycystic ovary disease, decreased carnitine concentrations, hyponatremia, hyperglycinemia, and inappropriate ADH secretion.\"\n }\n ]\n },\n {\n \"Term\": \"Apathy\",\n \"MEDDRACode\": \"10002942\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"apathy\",\n \"Probability\": \"0.0458660424\",\n \"SemanticContext\": \"Neurologic: Paradoxical convulsion, parkinsonism There have been several reports of acute or subacute cognitive decline and behavioral changes apathy or irritability with cerebral pseudoatrophy on imaging associated with valproate therapy; both the cognitive/behavioral changes and cerebral pseudoatrophy reversed partially or fully after valproate discontinuation.\"\n }\n ]\n },\n {\n \"Term\": \"Anal incontinence\",\n \"MEDDRACode\": \"10077605\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Fecal Incontinence\",\n \"Probability\": \"0.8650379777\",\n \"SemanticContext\": \"Digestive System: Constipation, Dry Mouth, Dysphagia, Fecal Incontinence, Flatulence, Gastroenteritis, Glossitis, Gum Hemorrhage, Mouth Ulceration.\"\n }\n ]\n },\n {\n \"Term\": \"Aspermia\",\n \"MEDDRACode\": \"10003495\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Aspermia\",\n \"Probability\": \"0.9920116067\",\n \"SemanticContext\": \"Reproductive: Aspermia, azoospermia, decreased sperm count, decreased spermatozoa motility, male infertility, and abnormal spermatozoa morphology.\"\n }\n ]\n },\n {\n \"Term\": \"Lymphadenopathy\",\n \"MEDDRACode\": \"10025197\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"lymphadenopathy\",\n \"Probability\": \"0.1216285825\",\n \"SemanticContext\": \"Multiorgan Hypersensitivity Reactions: Instruct patients that a fever associated with other organ system involvement rash, lymphadenopathy, etc. may be drug-related and should be reported to the physician immediately [see Warnings and Precautions 5.12 ].\"\n },\n {\n \"VerbatimTerm\": \"lymphadenopathy\",\n \"Probability\": \"0.8716646433\",\n \"SemanticContext\": \"DRESS typically, although not exclusively, presents with fever, rash, lymphadenopathy, and/or facial swelling, in association with other organ system involvement, such as hepatitis, nephritis, hematological abnormalities, myocarditis, or myositis sometimes resembling an acute viral infection.\"\n },\n {\n \"VerbatimTerm\": \"lymphadenopathy\",\n \"Probability\": \"0.7959029078\",\n \"SemanticContext\": \"It is important to note that early manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident.\"\n }\n ]\n },\n {\n \"Term\": \"Nuchal rigidity\",\n \"MEDDRACode\": \"10058483\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Neck Rigidity\",\n \"Probability\": \"0.7855564356\",\n \"SemanticContext\": \"The following additional adverse reactions were reported by greater than 1% of the divalproex sodium extended-release tablets-treated patients in controlled clinical trials: Body as a Whole: Back Pain, Chills, Chills and Fever, Drug Level Increased, Flu Syndrome, Infection, Infection Fungal, Neck Rigidity.\"\n }\n ]\n },\n {\n \"Term\": \"Seizure\",\n \"MEDDRACode\": \"10039906\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"seizure\",\n \"Probability\": \"0.0931392014\",\n \"SemanticContext\": \"• Acute treatment of manic or mixed episodes associated with bipolar disorder, with or without psychotic features 1.1 • Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures 1.2 • Prophylaxis of migraine headaches 1.3 DOSAGE AND ADMINISTRATION • Divalproex sodium extended-release tablets are intended for once-a-day oral administration.\"\n },\n {\n \"VerbatimTerm\": \"seizure\",\n \"Probability\": \"0.0038475096\",\n \"SemanticContext\": \"• Absence Seizures: Start at 15 mg/kg/day, increasing at 1 week intervals by 5 to 10 mg/kg/day until seizure control or limiting side effects 2.2 .\"\n },\n {\n \"VerbatimTerm\": \"seizure\",\n \"Probability\": \"0.1445968449\",\n \"SemanticContext\": \"14.2 Epilepsy The efficacy of valproate in reducing the incidence of complex partial seizures CPS that occur in isolation or in association with other seizure types was established in two controlled trials.\"\n },\n {\n \"VerbatimTerm\": \"seizure\",\n \"Probability\": \"0.716172576\",\n \"SemanticContext\": \"A positive percent reduction indicates an improvement i.e., a decrease in seizure frequency , while a negative percent reduction indicates worsening.\"\n },\n {\n \"VerbatimTerm\": \"seizure\",\n \"Probability\": \"0.716172576\",\n \"SemanticContext\": \"A positive percent reduction indicates an improvement i.e., a decrease in seizure frequency , while a negative percent reduction indicates worsening.\"\n },\n {\n \"VerbatimTerm\": \"seizure\",\n \"Probability\": \"0.1193745434\",\n \"SemanticContext\": \"Carbapenem Antibiotics A clinically significant reduction in serum valproic acid concentration has been reported in patients receiving carbapenem antibiotics for example, ertapenem, imipenem, meropenem; this is not a complete list and may result in loss of seizure control.\"\n },\n {\n \"VerbatimTerm\": \"seizure\",\n \"Probability\": \"0.0092966557\",\n \"SemanticContext\": \"Alternative antibacterial or anticonvulsant therapy should be considered if serum valproic acid concentrations drop significantly or seizure control deteriorates [see Warnings and Precautions 5.13 ] .\"\n },\n {\n \"VerbatimTerm\": \"seizure\",\n \"Probability\": \"0.3922931552\",\n \"SemanticContext\": \"Estrogen-Containing Hormonal Contraceptives Estrogen-containing hormonal contraceptives may increase the clearance of valproate, which may result in decreased concentration of valproate and potentially increased seizure frequency.\"\n },\n {\n \"VerbatimTerm\": \"seizure\",\n \"Probability\": \"0.0350906551\",\n \"SemanticContext\": \"The benefit of improved seizure control with higher doses should be weighed against the possibility of a greater incidence of adverse reactions.\"\n },\n {\n \"VerbatimTerm\": \"seizure\",\n \"Probability\": \"0.0016919672\",\n \"SemanticContext\": \"The speed and duration of withdrawal of the concomitant AED can be highly variable, and patients should be monitored closely during this period for increased seizure frequency.\"\n },\n {\n \"VerbatimTerm\": \"seizure\",\n \"Probability\": \"0.0010120273\",\n \"SemanticContext\": \"Divalproex sodium extended-release tablets are also indicated for use as sole and adjunctive therapy in the treatment of simple and complex absence seizures in adults and children 10 years of age or older, and adjunctively in adults and children 10 years of age or older with multiple seizure types that include absence seizures.\"\n },\n {\n \"VerbatimTerm\": \"seizure\",\n \"Probability\": \"0.0629866719\",\n \"SemanticContext\": \"The rate of congenital malformations among babies born to epileptic mothers who used valproate during pregnancy has been shown to be about four times higher than the rate among babies born to epileptic mothers who used other anti-seizure monotherapies [see Warnings and Precautions 5.2 and Data Human ] .\"\n },\n {\n \"VerbatimTerm\": \"seizure\",\n \"Probability\": \"0.0812725127\",\n \"SemanticContext\": \"However, discontinuation of the drug may be considered prior to and during pregnancy in individual cases if the seizure disorder severity and frequency do not pose a serious threat to the patient.\"\n },\n {\n \"VerbatimTerm\": \"seizure\",\n \"Probability\": \"0.1322982311\",\n \"SemanticContext\": \"In patients with epilepsy, a loss of seizure control may also occur.\"\n },\n {\n \"VerbatimTerm\": \"seizure\",\n \"Probability\": \"0.190957427\",\n \"SemanticContext\": \"Patients on multiple anticonvulsants, children, those with congenital metabolic disorders, those with severe seizure disorders accompanied by mental retardation, and those with organic brain disease may be at particular risk.\"\n },\n {\n \"VerbatimTerm\": \"seizure\",\n \"Probability\": \"0.0287265778\",\n \"SemanticContext\": \"The rate of congenital malformations among babies born to mothers using valproate is about four times higher than the rate among babies born to epileptic mothers using other anti-seizure monotherapies.\"\n },\n {\n \"VerbatimTerm\": \"seizure\",\n \"Probability\": \"0.1231294274\",\n \"SemanticContext\": \"5.13 Interaction with Carbapenem Antibiotics Carbapenem antibiotics for example, ertapenem, imipenem, meropenem; this is not a complete list may reduce serum valproate concentrations to subtherapeutic levels, resulting in loss of seizure control.\"\n },\n {\n \"VerbatimTerm\": \"seizure\",\n \"Probability\": \"0.0014723539\",\n \"SemanticContext\": \"Alternative antibacterial or anticonvulsant therapy should be considered if serum valproate concentrations drop significantly or seizure control deteriorates [see Drug Interactions 7.1 ] .\"\n },\n {\n \"VerbatimTerm\": \"seizure\",\n \"Probability\": \"0.0066544116\",\n \"SemanticContext\": \"Stopping a seizure medicine suddenly in a patient who has epilepsy can cause seizures that will not stop status epilepticus .\"\n },\n {\n \"VerbatimTerm\": \"seizure\",\n \"Probability\": \"0.0047116578\",\n \"SemanticContext\": \"Divalproex Sodium Extended-Release Tablets are prescription medicines used: • to treat manic episodes associated with bipolar disorder • alone or with other medicines to treat: • complex partial seizures in adults and children 10 years of age and older • simple and complex absence seizures, with or without other seizure types • to prevent migraine headaches Who should not take divalproex sodium extended-release tablets?\"\n },\n {\n \"VerbatimTerm\": \"seizures\",\n \"Probability\": \"0.0012692213\",\n \"SemanticContext\": \"Clonazepam The concomitant use of valproate and clonazepam may induce absence status in patients with a history of absence type seizures.\"\n },\n {\n \"VerbatimTerm\": \"seizures\",\n \"Probability\": \"0.0304056704\",\n \"SemanticContext\": \"This reduction may be started at initiation of divalproex sodium extended-release tablets therapy, or delayed by 1 to 2 weeks if there is a concern that seizures are likely to occur with a reduction.\"\n },\n {\n \"VerbatimTerm\": \"seizures\",\n \"Probability\": \"0.0043767095\",\n \"SemanticContext\": \"\\n \\n Simple and Complex Absence Seizures\\n The recommended initial dose is 15 mg/kg/day, increasing at one week intervals by 5 to 10 mg/kg/day until seizures are controlled or side effects preclude further increases.\"\n },\n {\n \"VerbatimTerm\": \"seizures\",\n \"Probability\": \"0.0002569556\",\n \"SemanticContext\": \"Antiepilepsy drugs should not be abruptly discontinued in patients in whom the drug is administered to prevent major seizures because of the strong possibility of precipitating status epilepticus with attendant hypoxia and threat to life.\"\n },\n {\n \"VerbatimTerm\": \"seizures\",\n \"Probability\": \"0.28194049\",\n \"SemanticContext\": \"1.2 Epilepsy Divalproex sodium extended-release tablets are indicated as monotherapy and adjunctive therapy in the treatment of adult patients and pediatric patients down to the age of 10 years with complex partial seizures that occur either in isolation or in association with other types of seizures.\"\n },\n {\n \"VerbatimTerm\": \"seizures\",\n \"Probability\": \"0.0004670918\",\n \"SemanticContext\": \"\\n \\n Clinical Considerations\\n Disease-Associated Maternal and/or Embryo/Fetal Risk To prevent major seizures, women with epilepsy should not discontinue valproate abruptly, as this can precipitate status epilepticus with resulting maternal and fetal hypoxia and threat to life.\"\n },\n {\n \"VerbatimTerm\": \"seizures\",\n \"Probability\": \"0.1750675738\",\n \"SemanticContext\": \"Even minor seizures may pose some hazard to the developing embryo or fetus [see Warnings and Precautions 5.4 ] .\"\n },\n {\n \"VerbatimTerm\": \"seizures\",\n \"Probability\": \"0.0628330112\",\n \"SemanticContext\": \"To prevent major seizures, valproate should not be discontinued abruptly, as this can precipitate status epilepticus with resulting maternal and fetal hypoxia and threat to life.\"\n },\n {\n \"VerbatimTerm\": \"seizures\",\n \"Probability\": \"0.0007550716\",\n \"SemanticContext\": \"Stopping a seizure medicine suddenly in a patient who has epilepsy can cause seizures that will not stop status epilepticus .\"\n }\n ]\n },\n {\n \"Term\": \"Fungal infection\",\n \"MEDDRACode\": \"10017533\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Infection Fungal\",\n \"Probability\": \"0.3528418839\",\n \"SemanticContext\": \"The following additional adverse reactions were reported by greater than 1% of the divalproex sodium extended-release tablets-treated patients in controlled clinical trials: Body as a Whole: Back Pain, Chills, Chills and Fever, Drug Level Increased, Flu Syndrome, Infection, Infection Fungal, Neck Rigidity.\"\n }\n ]\n },\n {\n \"Term\": \"Arrhythmia\",\n \"MEDDRACode\": \"10003119\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Arrhythmia\",\n \"Probability\": \"0.9883683324\",\n \"SemanticContext\": \"Cardiovascular System: Arrhythmia, Hypertension, Hypotension, Postural Hypotension.\"\n }\n ]\n },\n {\n \"Term\": \"Arthralgia\",\n \"MEDDRACode\": \"10003239\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"arthralgia\",\n \"Probability\": \"0.9951396585\",\n \"SemanticContext\": \"Musculoskeletal System: Myalgia, twitching, arthralgia, leg cramps, myasthenia.\"\n }\n ]\n },\n {\n \"Term\": \"Drug level increased\",\n \"MEDDRACode\": \"10013722\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Drug Level Increased\",\n \"Probability\": \"0.9354239702\",\n \"SemanticContext\": \"The following additional adverse reactions were reported by greater than 1% of the divalproex sodium extended-release tablets-treated patients in controlled clinical trials: Body as a Whole: Back Pain, Chills, Chills and Fever, Drug Level Increased, Flu Syndrome, Infection, Infection Fungal, Neck Rigidity.\"\n }\n ]\n },\n {\n \"Term\": \"Muscular weakness\",\n \"MEDDRACode\": \"10028372\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"myasthenia\",\n \"Probability\": \"0.9705315828\",\n \"SemanticContext\": \"Musculoskeletal System: Myalgia, twitching, arthralgia, leg cramps, myasthenia.\"\n }\n ]\n },\n {\n \"Term\": \"Paraesthesia\",\n \"MEDDRACode\": \"10033775\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"paresthesia\",\n \"Probability\": \"0.9973115921\",\n \"SemanticContext\": \"Nervous System: Anxiety, confusion, abnormal gait, paresthesia, hypertonia, incoordination, abnormal dreams, personality disorder.\"\n },\n {\n \"VerbatimTerm\": \"paresthesia\",\n \"Probability\": \"0.999699235\",\n \"SemanticContext\": \"Nervous System: Abnormal dreams, confusion, paresthesia, speech disorder, and thinking abnormalities.\"\n }\n ]\n },\n {\n \"Term\": \"Flatulence\",\n \"MEDDRACode\": \"10016766\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Flatulence\",\n \"Probability\": \"0.7087936997\",\n \"SemanticContext\": \"Digestive System: Constipation, Dry Mouth, Dysphagia, Fecal Incontinence, Flatulence, Gastroenteritis, Glossitis, Gum Hemorrhage, Mouth Ulceration.\"\n },\n {\n \"VerbatimTerm\": \"flatulence\",\n \"Probability\": \"0.9909553528\",\n \"SemanticContext\": \"Digestive System: Increased appetite, flatulence, hematemesis, eructation, pancreatitis, periodontal abscess.\"\n },\n {\n \"VerbatimTerm\": \"flatulence\",\n \"Probability\": \"0.996756196\",\n \"SemanticContext\": \"Digestive System: Constipation, dry mouth, flatulence, and stomatitis.\"\n }\n ]\n },\n {\n \"Term\": \"Hyperreflexia\",\n \"MEDDRACode\": \"10020745\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Reflexes Increased\",\n \"Probability\": \"0.7483757734\",\n \"SemanticContext\": \"Nervous System: Abnormal Gait, Agitation, Catatonic Reaction, Dysarthria, Hallucinations, Hypertonia, Hypokinesia, Psychosis, Reflexes Increased, Sleep Disorder, Tardive Dyskinesia, Tremor.\"\n }\n ]\n },\n {\n \"Term\": \"Eye pain\",\n \"MEDDRACode\": \"10015958\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Eye Pain\",\n \"Probability\": \"0.960963726\",\n \"SemanticContext\": \"Special Senses: Conjunctivitis, Dry Eyes, Eye Disorder, Eye Pain, Photophobia, Taste Perversion.\"\n }\n ]\n },\n {\n \"Term\": \"Galactorrhoea\",\n \"MEDDRACode\": \"10017600\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"galactorrhea\",\n \"Probability\": \"0.9923930168\",\n \"SemanticContext\": \"Endocrine: Irregular menses, secondary amenorrhea, hyperandrogenism, hirsutism, elevated testosterone level, breast enlargement, galactorrhea, parotid gland swelling, polycystic ovary disease, decreased carnitine concentrations, hyponatremia, hyperglycinemia, and inappropriate ADH secretion.\"\n }\n ]\n },\n {\n \"Term\": \"Coordination abnormal\",\n \"MEDDRACode\": \"10010947\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"incoordination\",\n \"Probability\": \"0.9977550507\",\n \"SemanticContext\": \"Nervous System: Anxiety, confusion, abnormal gait, paresthesia, hypertonia, incoordination, abnormal dreams, personality disorder.\"\n }\n ]\n },\n {\n \"Term\": \"Dysarthria\",\n \"MEDDRACode\": \"10013887\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Dysarthria\",\n \"Probability\": \"0.9892647266\",\n \"SemanticContext\": \"Nervous System: Abnormal Gait, Agitation, Catatonic Reaction, Dysarthria, Hallucinations, Hypertonia, Hypokinesia, Psychosis, Reflexes Increased, Sleep Disorder, Tardive Dyskinesia, Tremor.\"\n }\n ]\n },\n {\n \"Term\": \"Dysgeusia\",\n \"MEDDRACode\": \"10013911\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Taste Perversion\",\n \"Probability\": \"0.9773311615\",\n \"SemanticContext\": \"Special Senses: Conjunctivitis, Dry Eyes, Eye Disorder, Eye Pain, Photophobia, Taste Perversion.\"\n },\n {\n \"VerbatimTerm\": \"Taste perversion\",\n \"Probability\": \"0.9983718395\",\n \"SemanticContext\": \"Special Senses: Taste perversion, abnormal vision, deafness, otitis media.\"\n }\n ]\n },\n {\n \"Term\": \"Eructation\",\n \"MEDDRACode\": \"10015137\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"eructation\",\n \"Probability\": \"0.9983333945\",\n \"SemanticContext\": \"Digestive System: Increased appetite, flatulence, hematemesis, eructation, pancreatitis, periodontal abscess.\"\n }\n ]\n },\n {\n \"Term\": \"Agranulocytosis\",\n \"MEDDRACode\": \"10001507\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"agranulocytosis\",\n \"Probability\": \"0.9860096574\",\n \"SemanticContext\": \"Hematologic: Relative lymphocytosis, macrocytosis, leukopenia, anemia including macrocytic with or without folate deficiency, bone marrow suppression, pancytopenia, aplastic anemia, agranulocytosis, and acute intermittent porphyria.\"\n }\n ]\n },\n {\n \"Term\": \"Bradycardia\",\n \"MEDDRACode\": \"10006093\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"bradycardia\",\n \"Probability\": \"0.9932594895\",\n \"SemanticContext\": \"Other: Allergic reaction, anaphylaxis, developmental delay, bone pain, bradycardia, and cutaneous vasculitis.\"\n }\n ]\n },\n {\n \"Term\": \"Anaphylactic reaction\",\n \"MEDDRACode\": \"10002198\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"anaphylaxis\",\n \"Probability\": \"0.9981523156\",\n \"SemanticContext\": \"Other: Allergic reaction, anaphylaxis, developmental delay, bone pain, bradycardia, and cutaneous vasculitis.\"\n }\n ]\n },\n {\n \"Term\": \"Catatonia\",\n \"MEDDRACode\": \"10007776\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Catatonic Reaction\",\n \"Probability\": \"0.9979024529\",\n \"SemanticContext\": \"Nervous System: Abnormal Gait, Agitation, Catatonic Reaction, Dysarthria, Hallucinations, Hypertonia, Hypokinesia, Psychosis, Reflexes Increased, Sleep Disorder, Tardive Dyskinesia, Tremor.\"\n }\n ]\n },\n {\n \"Term\": \"Agitation\",\n \"MEDDRACode\": \"10001497\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"agitated\",\n \"Probability\": \"5.48198E-05\",\n \"SemanticContext\": \"Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: • thoughts about suicide or dying • attempts to commit suicide • new or worse depression • new or worse anxiety • feeling agitated or restless • panic attacks • trouble sleeping insomnia • new or worse irritability • acting aggressive, being angry, or violent • acting on dangerous impulses • an extreme increase in activity and talking mania • other unusual changes in behavior or mood How can I watch for early symptoms of suicidal thoughts and actions?\"\n }\n ]\n },\n {\n \"Term\": \"Alanine aminotransferase increased\",\n \"MEDDRACode\": \"10001551\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"SGPT increased\",\n \"Probability\": \"0.9428708553\",\n \"SemanticContext\": \"Metabolic and Nutritional Disorders: SGOT increased, SGPT increased.\"\n }\n ]\n },\n {\n \"Term\": \"Deafness\",\n \"MEDDRACode\": \"10011878\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Hearing loss\",\n \"Probability\": \"0.8990303278\",\n \"SemanticContext\": \"Special Senses: Hearing loss.\"\n },\n {\n \"VerbatimTerm\": \"hearing loss\",\n \"Probability\": \"0.1039293408\",\n \"SemanticContext\": \"In utero exposure to valproate may also result in hearing impairment or hearing loss.\"\n },\n {\n \"VerbatimTerm\": \"hearing loss\",\n \"Probability\": \"0.0449592173\",\n \"SemanticContext\": \"Decreased hearing or hearing loss can also happen.\"\n }\n ]\n },\n {\n \"Term\": \"Haematemesis\",\n \"MEDDRACode\": \"10018830\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hematemesis\",\n \"Probability\": \"0.9924317598\",\n \"SemanticContext\": \"Digestive System: Increased appetite, flatulence, hematemesis, eructation, pancreatitis, periodontal abscess.\"\n }\n ]\n },\n {\n \"Term\": \"Hair colour changes\",\n \"MEDDRACode\": \"10019030\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hair color changes\",\n \"Probability\": \"0.7049741745\",\n \"SemanticContext\": \"Dermatologic: Hair texture changes, hair color changes, photosensitivity, erythema multiforme, toxic epidermal necrolysis, nail and nail bed disorders, and Stevens-Johnson syndrome.\"\n }\n ]\n },\n {\n \"Term\": \"Hypersensitivity\",\n \"MEDDRACode\": \"10020751\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": true,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hypersensitivity\",\n \"Probability\": \"0.3297498822\",\n \"SemanticContext\": \"POLG 4 , 5.1 • Suspected POLG-related disorder in children under two years of age 4 , 5.1 • Known hypersensitivity to the drug 4 , 5.12 • Urea cycle disorders 4 , 5.6 • Prophylaxis of migraine headaches: Pregnant women, women of childbearing potential not using effective contraception 4 , 8.1 WARNINGS AND PRECAUTIONS • Hepatotoxicity; evaluate high risk populations and monitor serum liver tests 5.1 • Birth defects, decreased IQ, and neurodevelopmental disorders following in utero exposure; should not be used to treat women with epilepsy or bipolar disorder who are pregnant or who plan to become pregnant or to treat a woman of childbearing potential unless other medications have failed to provide adequate symptom control or are otherwise unacceptable 5.2 , 5.3 , 5.4 • Pancreatitis; divalproex sodium extended-release tablets should ordinarily be discontinued 5.5 • Suicidal behavior or ideation; Antiepileptic drugs, including divalproex sodium extended-release tablets, increase the risk of suicidal thoughts or behavior 5.7 • Bleeding and other hematopoietic disorders; monitor platelet counts and coagulation tests 5.8 • Hyperammonemia and hyperammonemic encephalopathy; measure ammonia level if unexplained lethargy and vomiting or changes in mental status, and also with concomitant topiramate use; consider discontinuation of valproate therapy 5.6 , 5.9 , 5.10 • Hypothermia; Hypothermia has been reported during valproate therapy with or without associated hyperammonemia.\"\n },\n {\n \"VerbatimTerm\": \"hypersensitivity\",\n \"Probability\": \"0.0194758177\",\n \"SemanticContext\": \"• Divalproex sodium extended-release tablets are contraindicated in patients with known hypersensitivity to the drug [see Warnings and Precautions 5.12 ] .\"\n },\n {\n \"VerbatimTerm\": \"hypersensitivity\",\n \"Probability\": \"0.7747460604\",\n \"SemanticContext\": \"It is important to note that early manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident.\"\n },\n {\n \"VerbatimTerm\": \"Hypersensitivity\",\n \"Probability\": \"0.3599644899\",\n \"SemanticContext\": \"5.12 Drug Reaction with Eosinophilia and Systemic Symptoms DRESS /Multiorgan Hypersensitivity Reactions Drug Reaction with Eosinophilia and Systemic Symptoms DRESS , also known as Multiorgan Hypersensitivity, has been reported in patients taking valproate.\"\n }\n ]\n },\n {\n \"Term\": \"Hypertonia\",\n \"MEDDRACode\": \"10020852\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Hypertonia\",\n \"Probability\": \"0.922704339\",\n \"SemanticContext\": \"Nervous System: Abnormal Gait, Agitation, Catatonic Reaction, Dysarthria, Hallucinations, Hypertonia, Hypokinesia, Psychosis, Reflexes Increased, Sleep Disorder, Tardive Dyskinesia, Tremor.\"\n },\n {\n \"VerbatimTerm\": \"hypertonia\",\n \"Probability\": \"0.9976263642\",\n \"SemanticContext\": \"Nervous System: Anxiety, confusion, abnormal gait, paresthesia, hypertonia, incoordination, abnormal dreams, personality disorder.\"\n },\n {\n \"VerbatimTerm\": \"hypertonia\",\n \"Probability\": \"0.9996175766\",\n \"SemanticContext\": \"Nervous System: Abnormal gait, dizziness, hypertonia, insomnia, nervousness, tremor, vertigo.\"\n }\n ]\n },\n {\n \"Term\": \"Pyrexia\",\n \"MEDDRACode\": \"10037660\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"fever\",\n \"Probability\": \"0.9998005033\",\n \"SemanticContext\": \"Divalproex sodium extended-release tablets dosage should be increased slowly and with regular monitoring for fluid and nutritional intake 5.14 ADVERSE REACTIONS • Most common adverse reactions reported > 5% are abdominal pain, alopecia, amblyopia/blurred vision, amnesia, anorexia, asthenia, ataxia, back pain, bronchitis, constipation, depression, diarrhea, diplopia, dizziness, dyspnea, dyspepsia, ecchymosis, emotional lability, fever, flu syndrome, headache, increased appetite, infection, insomnia, nausea, nervousness, nystagmus, peripheral edema, pharyngitis, rash, rhinitis, somnolence, thinking abnormal, thrombocytopenia, tinnitus, tremor, vomiting, weight gain, weight loss 6.1 , 6.2 , 6.3 .\"\n },\n {\n \"VerbatimTerm\": \"fever\",\n \"Probability\": \"0.7882655859\",\n \"SemanticContext\": \"Multiorgan Hypersensitivity Reactions: Instruct patients that a fever associated with other organ system involvement rash, lymphadenopathy, etc. may be drug-related and should be reported to the physician immediately [see Warnings and Precautions 5.12 ].\"\n },\n {\n \"VerbatimTerm\": \"fever\",\n \"Probability\": \"0.9224016666\",\n \"SemanticContext\": \"DRESS typically, although not exclusively, presents with fever, rash, lymphadenopathy, and/or facial swelling, in association with other organ system involvement, such as hepatitis, nephritis, hematological abnormalities, myocarditis, or myositis sometimes resembling an acute viral infection.\"\n },\n {\n \"VerbatimTerm\": \"fever\",\n \"Probability\": \"0.9516626596\",\n \"SemanticContext\": \"It is important to note that early manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident.\"\n },\n {\n \"VerbatimTerm\": \"fever\",\n \"Probability\": \"0.8447295427\",\n \"SemanticContext\": \"• Allergic hypersensitivity reactions: fever, skin rash, hives, sores in your mouth, blistering and peeling of your skin, swelling of your lymph nodes, swelling of your face, eyes, lips, tongue, or throat, trouble swallowing or breathing.\"\n },\n {\n \"VerbatimTerm\": \"Fever\",\n \"Probability\": \"0.999931097\",\n \"SemanticContext\": \"Adverse Reactions Reported by = 5% of Patients Treated with Valproate During Placebo-Controlled Trial of Adjunctive Therapy for Complex Partial Seizures Body System/Event Divalproex Sodium Delayed- Release Tablets N = 77 % Placebo N = 70 % Body as a Whole Headache 31 21 Asthenia 27 7 Fever 6 4 Gastrointestinal System Nausea 48 14 Vomiting 27 7 Abdominal Pain 23 6 Diarrhea 13 6 Anorexia 12 0 Dyspepsia 8 4 Constipation 5 1 Nervous System Somnolence 27 11 Tremor 25 6 Dizziness 25 13 Diplopia 16 9 Amblyopia/Blurred Vision 12 9 Ataxia 8 1 Nystagmus 8 1 Emotional Lability 6 4 Thinking Abnormal 6 0 Amnesia 5 1 Respiratory System Flu Syndrome 12 9 Infection 12 6 Bronchitis 5 1 Rhinitis 5 4 Other Alopecia 6 1 Weight Loss 6 0 .\"\n }\n ]\n },\n {\n \"Term\": \"Rash maculo-papular\",\n \"MEDDRACode\": \"10037868\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Maculopapular Rash\",\n \"Probability\": \"0.981831789\",\n \"SemanticContext\": \"Skin and Appendages: Discoid Lupus Erythematosus, Erythema Nodosum, Furunculosis, Maculopapular Rash, Pruritus, Rash, Seborrhea, Sweating, Vesiculobullous Rash.\"\n }\n ]\n },\n {\n \"Term\": \"Sinusitis\",\n \"MEDDRACode\": \"10040753\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Sinusitis\",\n \"Probability\": \"0.9996634722\",\n \"SemanticContext\": \"Respiratory System: Sinusitis, cough increased, pneumonia, epistaxis.\"\n },\n {\n \"VerbatimTerm\": \"sinusitis\",\n \"Probability\": \"0.9988501072\",\n \"SemanticContext\": \"Respiratory System: Dyspnea, and sinusitis.\"\n }\n ]\n },\n {\n \"Term\": \"Haemorrhage\",\n \"MEDDRACode\": \"10055798\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Bleeding\",\n \"Probability\": \"0.5497496724\",\n \"SemanticContext\": \"POLG 4 , 5.1 • Suspected POLG-related disorder in children under two years of age 4 , 5.1 • Known hypersensitivity to the drug 4 , 5.12 • Urea cycle disorders 4 , 5.6 • Prophylaxis of migraine headaches: Pregnant women, women of childbearing potential not using effective contraception 4 , 8.1 WARNINGS AND PRECAUTIONS • Hepatotoxicity; evaluate high risk populations and monitor serum liver tests 5.1 • Birth defects, decreased IQ, and neurodevelopmental disorders following in utero exposure; should not be used to treat women with epilepsy or bipolar disorder who are pregnant or who plan to become pregnant or to treat a woman of childbearing potential unless other medications have failed to provide adequate symptom control or are otherwise unacceptable 5.2 , 5.3 , 5.4 • Pancreatitis; divalproex sodium extended-release tablets should ordinarily be discontinued 5.5 • Suicidal behavior or ideation; Antiepileptic drugs, including divalproex sodium extended-release tablets, increase the risk of suicidal thoughts or behavior 5.7 • Bleeding and other hematopoietic disorders; monitor platelet counts and coagulation tests 5.8 • Hyperammonemia and hyperammonemic encephalopathy; measure ammonia level if unexplained lethargy and vomiting or changes in mental status, and also with concomitant topiramate use; consider discontinuation of valproate therapy 5.6 , 5.9 , 5.10 • Hypothermia; Hypothermia has been reported during valproate therapy with or without associated hyperammonemia.\"\n },\n {\n \"VerbatimTerm\": \"Bleeding\",\n \"Probability\": \"0.9717290401\",\n \"SemanticContext\": \"6 ADVERSE REACTIONS The following serious adverse reactions are described below and elsewhere in the labeling: • Hepatic failure [see Warnings and Precautions 5.1 ] • Birth defects [see Warnings and Precautions 5.2 ] • Decreased IQ following in utero exposure [see Warnings and Precautions 5.3 ] • Pancreatitis [see Warnings and Precautions 5.5 ] • Hyperammonemic encephalopathy [see Warnings and Precautions 5.6 , 5.9 , 5.10 ] • Suicidal behavior and ideation [see Warnings and Precautions 5.7 ] • Bleeding and other hematopoietic disorders [see Warnings and Precautions 5.8 ] • Hypothermia [see Warnings and Precautions 5.11 ] • Drug Reaction with Eosinophilia and Systemic Symptoms DRESS /Multiorgan hypersensitivity reactions [see Warnings and Precautions 5.12 ] • Somnolence in the elderly [see Warnings and Precautions 5.14 ] Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.\"\n },\n {\n \"VerbatimTerm\": \"Bleeding\",\n \"Probability\": \"0.0930800736\",\n \"SemanticContext\": \"5.8 Bleeding and Other Hematopoietic Disorders Valproate is associated with dose-related thrombocytopenia.\"\n },\n {\n \"VerbatimTerm\": \"Bleeding\",\n \"Probability\": \"0.0220665038\",\n \"SemanticContext\": \"Divalproex sodium extended-release tablets can cause serious side effects including: • Bleeding problems: red or purple spots on your skin, bruising, pain and swelling into your joints due to bleeding or bleeding from your mouth or nose.\"\n },\n {\n \"VerbatimTerm\": \"bleeding\",\n \"Probability\": \"0.0026816428\",\n \"SemanticContext\": \"Divalproex sodium extended-release tablets can cause serious side effects including: • Bleeding problems: red or purple spots on your skin, bruising, pain and swelling into your joints due to bleeding or bleeding from your mouth or nose.\"\n },\n {\n \"VerbatimTerm\": \"bleeding\",\n \"Probability\": \"0.0013878942\",\n \"SemanticContext\": \"Divalproex sodium extended-release tablets can cause serious side effects including: • Bleeding problems: red or purple spots on your skin, bruising, pain and swelling into your joints due to bleeding or bleeding from your mouth or nose.\"\n },\n {\n \"VerbatimTerm\": \"bleeding\",\n \"Probability\": \"0.0013698637\",\n \"SemanticContext\": \"Monitor the breastfed infant for signs of liver damage including jaundice and unusual bruising or bleeding.\"\n }\n ]\n },\n {\n \"Term\": \"Nephropathy\",\n \"MEDDRACode\": \"10029151\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"renal diseases\",\n \"Probability\": \"0.0513813794\",\n \"SemanticContext\": \"Higher than expected free fractions occur in the elderly, in hyperlipidemic patients, and in patients with hepatic and renal diseases.\"\n },\n {\n \"VerbatimTerm\": \"Renal Disease\",\n \"Probability\": \"0.8222264647\",\n \"SemanticContext\": \"Renal Disease A slight reduction 27% in the unbound clearance of valproate has been reported in patients with renal failure creatinine clearance< 10 mL/minute ; however, hemodialysis typically reduces valproate concentrations by about 20%.\"\n }\n ]\n },\n {\n \"Term\": \"Muscle twitching\",\n \"MEDDRACode\": \"10028347\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"twitching\",\n \"Probability\": \"0.9919272661\",\n \"SemanticContext\": \"Musculoskeletal System: Myalgia, twitching, arthralgia, leg cramps, myasthenia.\"\n }\n ]\n },\n {\n \"Term\": \"Spermatozoa morphology abnormal\",\n \"MEDDRACode\": \"10041502\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"abnormal spermatozoa morphology\",\n \"Probability\": \"0.9368582368\",\n \"SemanticContext\": \"Reproductive: Aspermia, azoospermia, decreased sperm count, decreased spermatozoa motility, male infertility, and abnormal spermatozoa morphology.\"\n }\n ]\n },\n {\n \"Term\": \"Nail bed disorder\",\n \"MEDDRACode\": \"10070533\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"nail bed disorders\",\n \"Probability\": \"0.5693466663\",\n \"SemanticContext\": \"Dermatologic: Hair texture changes, hair color changes, photosensitivity, erythema multiforme, toxic epidermal necrolysis, nail and nail bed disorders, and Stevens-Johnson syndrome.\"\n }\n ]\n },\n {\n \"Term\": \"Orthostatic hypotension\",\n \"MEDDRACode\": \"10031127\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Postural Hypotension\",\n \"Probability\": \"0.9968428612\",\n \"SemanticContext\": \"Cardiovascular System: Arrhythmia, Hypertension, Hypotension, Postural Hypotension.\"\n }\n ]\n },\n {\n \"Term\": \"Pancytopenia\",\n \"MEDDRACode\": \"10033661\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"pancytopenia\",\n \"Probability\": \"0.9619626403\",\n \"SemanticContext\": \"Hematologic: Relative lymphocytosis, macrocytosis, leukopenia, anemia including macrocytic with or without folate deficiency, bone marrow suppression, pancytopenia, aplastic anemia, agranulocytosis, and acute intermittent porphyria.\"\n }\n ]\n },\n {\n \"Term\": \"Malaise\",\n \"MEDDRACode\": \"10025482\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"malaise\",\n \"Probability\": \"0.9824230671\",\n \"SemanticContext\": \"The following additional adverse reactions were reported by greater than 1% but less than 5% of the 358 patients treated with valproate in the controlled trials of complex partial seizures: Body as a Whole: Back pain, chest pain, malaise.\"\n },\n {\n \"VerbatimTerm\": \"malaise\",\n \"Probability\": \"0.9686166644\",\n \"SemanticContext\": \"Serious or fatal hepatotoxicity may be preceded by non-specific symptoms such as malaise, weakness, lethargy, facial edema, anorexia, and vomiting.\"\n }\n ]\n },\n {\n \"Term\": \"Conjunctivitis\",\n \"MEDDRACode\": \"10010741\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Conjunctivitis\",\n \"Probability\": \"0.9397568703\",\n \"SemanticContext\": \"Special Senses: Conjunctivitis, Dry Eyes, Eye Disorder, Eye Pain, Photophobia, Taste Perversion.\"\n }\n ]\n },\n {\n \"Term\": \"Cutaneous lupus erythematosus\",\n \"MEDDRACode\": \"10056509\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Discoid Lupus Erythematosus\",\n \"Probability\": \"0.9184057117\",\n \"SemanticContext\": \"Skin and Appendages: Discoid Lupus Erythematosus, Erythema Nodosum, Furunculosis, Maculopapular Rash, Pruritus, Rash, Seborrhea, Sweating, Vesiculobullous Rash.\"\n }\n ]\n },\n {\n \"Term\": \"Dry mouth\",\n \"MEDDRACode\": \"10013781\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Dry Mouth\",\n \"Probability\": \"0.9988011122\",\n \"SemanticContext\": \"Digestive System: Constipation, Dry Mouth, Dysphagia, Fecal Incontinence, Flatulence, Gastroenteritis, Glossitis, Gum Hemorrhage, Mouth Ulceration.\"\n },\n {\n \"VerbatimTerm\": \"dry mouth\",\n \"Probability\": \"0.9995740652\",\n \"SemanticContext\": \"Digestive System: Constipation, dry mouth, flatulence, and stomatitis.\"\n }\n ]\n },\n {\n \"Term\": \"Folate deficiency\",\n \"MEDDRACode\": \"10016880\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"folate deficiency\",\n \"Probability\": \"0.5416410565\",\n \"SemanticContext\": \"Hematologic: Relative lymphocytosis, macrocytosis, leukopenia, anemia including macrocytic with or without folate deficiency, bone marrow suppression, pancytopenia, aplastic anemia, agranulocytosis, and acute intermittent porphyria.\"\n }\n ]\n },\n {\n \"Term\": \"Polycystic ovaries\",\n \"MEDDRACode\": \"10036049\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"polycystic ovary\",\n \"Probability\": \"0.9888765812\",\n \"SemanticContext\": \"Endocrine: Irregular menses, secondary amenorrhea, hyperandrogenism, hirsutism, elevated testosterone level, breast enlargement, galactorrhea, parotid gland swelling, polycystic ovary disease, decreased carnitine concentrations, hyponatremia, hyperglycinemia, and inappropriate ADH secretion.\"\n }\n ]\n },\n {\n \"Term\": \"Seborrhoea\",\n \"MEDDRACode\": \"10039792\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Seborrhea\",\n \"Probability\": \"0.9938524961\",\n \"SemanticContext\": \"Skin and Appendages: Discoid Lupus Erythematosus, Erythema Nodosum, Furunculosis, Maculopapular Rash, Pruritus, Rash, Seborrhea, Sweating, Vesiculobullous Rash.\"\n }\n ]\n },\n {\n \"Term\": \"Tachycardia\",\n \"MEDDRACode\": \"10043071\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Tachycardia\",\n \"Probability\": \"0.9993935227\",\n \"SemanticContext\": \"Cardiovascular System: Tachycardia, hypertension, palpitation.\"\n }\n ]\n },\n {\n \"Term\": \"Tardive dyskinesia\",\n \"MEDDRACode\": \"10043118\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Tardive Dyskinesia\",\n \"Probability\": \"0.8465906978\",\n \"SemanticContext\": \"Nervous System: Abnormal Gait, Agitation, Catatonic Reaction, Dysarthria, Hallucinations, Hypertonia, Hypokinesia, Psychosis, Reflexes Increased, Sleep Disorder, Tardive Dyskinesia, Tremor.\"\n }\n ]\n },\n {\n \"Term\": \"Tooth abscess\",\n \"MEDDRACode\": \"10044016\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"periodontal abscess\",\n \"Probability\": \"0.9992673397\",\n \"SemanticContext\": \"Digestive System: Increased appetite, flatulence, hematemesis, eructation, pancreatitis, periodontal abscess.\"\n }\n ]\n },\n {\n \"Term\": \"Aura\",\n \"MEDDRACode\": \"10003791\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"aura\",\n \"Probability\": \"0.1037557423\",\n \"SemanticContext\": \"This trial recruited patients with a history of migraine headaches with or without aura occurring on average twice or more a month for the preceding three months.\"\n },\n {\n \"VerbatimTerm\": \"aura\",\n \"Probability\": \"0.7038972974\",\n \"SemanticContext\": \"POLG-related disorders should be suspected in patients with a family history or suggestive symptoms of a POLG-related disorder, including but not limited to unexplained encephalopathy, refractory epilepsy focal, myoclonic , status epilepticus at presentation, developmental delays, psychomotor regression, axonal sensorimotor neuropathy, myopathy cerebellar ataxia, ophthalmoplegia, or complicated migraine with occipital aura.\"\n }\n ]\n },\n {\n \"Term\": \"Hallucination\",\n \"MEDDRACode\": \"10019063\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Hallucinations\",\n \"Probability\": \"0.9041700363\",\n \"SemanticContext\": \"Nervous System: Abnormal Gait, Agitation, Catatonic Reaction, Dysarthria, Hallucinations, Hypertonia, Hypokinesia, Psychosis, Reflexes Increased, Sleep Disorder, Tardive Dyskinesia, Tremor.\"\n }\n ]\n },\n {\n \"Term\": \"Hyperandrogenism\",\n \"MEDDRACode\": \"10065597\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hyperandrogenism\",\n \"Probability\": \"0.9977650642\",\n \"SemanticContext\": \"Endocrine: Irregular menses, secondary amenorrhea, hyperandrogenism, hirsutism, elevated testosterone level, breast enlargement, galactorrhea, parotid gland swelling, polycystic ovary disease, decreased carnitine concentrations, hyponatremia, hyperglycinemia, and inappropriate ADH secretion.\"\n }\n ]\n },\n {\n \"Term\": \"Leukopenia\",\n \"MEDDRACode\": \"10024384\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Leucopenia\",\n \"Probability\": \"0.9977428913\",\n \"SemanticContext\": \"Hemic and Lymphatic System: Anemia, Bleeding Time Increased, Ecchymosis, Leucopenia.\"\n },\n {\n \"VerbatimTerm\": \"leukopenia\",\n \"Probability\": \"0.9960987568\",\n \"SemanticContext\": \"Hematologic: Relative lymphocytosis, macrocytosis, leukopenia, anemia including macrocytic with or without folate deficiency, bone marrow suppression, pancytopenia, aplastic anemia, agranulocytosis, and acute intermittent porphyria.\"\n }\n ]\n },\n {\n \"Term\": \"Menstrual disorder\",\n \"MEDDRACode\": \"10027327\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Menstrual Disorder\",\n \"Probability\": \"0.1003269851\",\n \"SemanticContext\": \"Urogenital System: Cystitis, Urinary Tract Infection, Menstrual Disorder, Vaginitis.\"\n }\n ]\n },\n {\n \"Term\": \"Creatinine renal clearance\",\n \"MEDDRACode\": \"10011371\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"creatinine clearance\",\n \"Probability\": \"0.0016773641\",\n \"SemanticContext\": \"Renal Disease A slight reduction 27% in the unbound clearance of valproate has been reported in patients with renal failure creatinine clearance < 10 mL/minute ; however, hemodialysis typically reduces valproate concentrations by about 20%.\"\n }\n ]\n },\n {\n \"Term\": \"Thinking abnormal\",\n \"MEDDRACode\": \"10043431\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"thinking abnormal\",\n \"Probability\": \"0.9971660376\",\n \"SemanticContext\": \"Divalproex sodium extended-release tablets dosage should be increased slowly and with regular monitoring for fluid and nutritional intake 5.14 ADVERSE REACTIONS • Most common adverse reactions reported > 5% are abdominal pain, alopecia, amblyopia/blurred vision, amnesia, anorexia, asthenia, ataxia, back pain, bronchitis, constipation, depression, diarrhea, diplopia, dizziness, dyspnea, dyspepsia, ecchymosis, emotional lability, fever, flu syndrome, headache, increased appetite, infection, insomnia, nausea, nervousness, nystagmus, peripheral edema, pharyngitis, rash, rhinitis, somnolence, thinking abnormal, thrombocytopenia, tinnitus, tremor, vomiting, weight gain, weight loss 6.1 , 6.2 , 6.3 .\"\n },\n {\n \"VerbatimTerm\": \"Thinking Abnormal\",\n \"Probability\": \"0.966661334\",\n \"SemanticContext\": \"Adverse Reactions Reported by = 5% of Patients Treated with Valproate During Placebo-Controlled Trial of Adjunctive Therapy for Complex Partial Seizures Body System/Event Divalproex Sodium Delayed- Release Tablets N = 77 % Placebo N = 70 % Body as a Whole Headache 31 21 Asthenia 27 7 Fever 6 4 Gastrointestinal System Nausea 48 14 Vomiting 27 7 Abdominal Pain 23 6 Diarrhea 13 6 Anorexia 12 0 Dyspepsia 8 4 Constipation 5 1 Nervous System Somnolence 27 11 Tremor 25 6 Dizziness 25 13 Diplopia 16 9 Amblyopia/Blurred Vision 12 9 Ataxia 8 1 Nystagmus 8 1 Emotional Lability 6 4 Thinking Abnormal 6 0 Amnesia 5 1 Respiratory System Flu Syndrome 12 9 Infection 12 6 Bronchitis 5 1 Rhinitis 5 4 Other Alopecia 6 1 Weight Loss 6 0 .\"\n }\n ]\n },\n {\n \"Term\": \"Tinnitus\",\n \"MEDDRACode\": \"10043882\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"tinnitus\",\n \"Probability\": \"0.9945785999\",\n \"SemanticContext\": \"Divalproex sodium extended-release tablets dosage should be increased slowly and with regular monitoring for fluid and nutritional intake 5.14 ADVERSE REACTIONS • Most common adverse reactions reported > 5% are abdominal pain, alopecia, amblyopia/blurred vision, amnesia, anorexia, asthenia, ataxia, back pain, bronchitis, constipation, depression, diarrhea, diplopia, dizziness, dyspnea, dyspepsia, ecchymosis, emotional lability, fever, flu syndrome, headache, increased appetite, infection, insomnia, nausea, nervousness, nystagmus, peripheral edema, pharyngitis, rash, rhinitis, somnolence, thinking abnormal, thrombocytopenia, tinnitus, tremor, vomiting, weight gain, weight loss 6.1 , 6.2 , 6.3 .\"\n },\n {\n \"VerbatimTerm\": \"Tinnitus\",\n \"Probability\": \"0.9854438901\",\n \"SemanticContext\": \"Body System/Event High Dose n = 131 % Low Dose n = 134 % Body as a Whole Asthenia 21 10 Digestive System Nausea 34 26 Diarrhea 23 19 Vomiting 23 15 Abdominal Pain 12 9 Anorexia 11 4 Dyspepsia 11 10 Hemic/Lymphatic System Thrombocytopenia 24 1 Ecchymosis 5 4 Metabolic/Nutritional Weight Gain 9 4 Peripheral Edema 8 3 Nervous System Tremor 57 19 Somnolence 30 18 Dizziness 18 13 Insomnia 15 9 Nervousness 11 7 Amnesia 7 4 Nystagmus 7 1 Depression 5 4 Respiratory System Infection 20 13 Pharyngitis 8 2 Dyspnea 5 1 Skin and Appendages Alopecia 24 13 Special Senses Amblyopia/Blurred Vision 8 4 Tinnitus 7 1 .\"\n },\n {\n \"VerbatimTerm\": \"Tinnitus\",\n \"Probability\": \"0.9579840899\",\n \"SemanticContext\": \"Special Senses: Tinnitus.\"\n }\n ]\n },\n {\n \"Term\": \"Osteopenia\",\n \"MEDDRACode\": \"10049088\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"osteopenia\",\n \"Probability\": \"0.4109115005\",\n \"SemanticContext\": \"Musculoskeletal: Fractures, decreased bone mineral density, osteopenia, osteoporosis, and weakness.\"\n }\n ]\n },\n {\n \"Term\": \"Pneumonia\",\n \"MEDDRACode\": \"10035664\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"pneumonia\",\n \"Probability\": \"0.998790741\",\n \"SemanticContext\": \"Respiratory System: Sinusitis, cough increased, pneumonia, epistaxis.\"\n }\n ]\n },\n {\n \"Term\": \"Tooth disorder\",\n \"MEDDRACode\": \"10044034\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"tooth disorder\",\n \"Probability\": \"0.7392593622\",\n \"SemanticContext\": \"Digestive System: Increased appetite, tooth disorder.\"\n }\n ]\n },\n {\n \"Term\": \"Urinary incontinence\",\n \"MEDDRACode\": \"10046543\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Urinary incontinence\",\n \"Probability\": \"0.8846955895\",\n \"SemanticContext\": \"Urogenital System: Urinary incontinence, vaginitis, dysmenorrhea, amenorrhea, urinary frequency.\"\n }\n ]\n },\n {\n \"Term\": \"Osteoporosis\",\n \"MEDDRACode\": \"10031282\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"osteoporosis\",\n \"Probability\": \"0.6079300046\",\n \"SemanticContext\": \"Musculoskeletal: Fractures, decreased bone mineral density, osteopenia, osteoporosis, and weakness.\"\n }\n ]\n },\n {\n \"Term\": \"Personality disorder\",\n \"MEDDRACode\": \"10034721\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"personality disorder\",\n \"Probability\": \"0.834683001\",\n \"SemanticContext\": \"Nervous System: Anxiety, confusion, abnormal gait, paresthesia, hypertonia, incoordination, abnormal dreams, personality disorder.\"\n }\n ]\n },\n {\n \"Term\": \"Petechiae\",\n \"MEDDRACode\": \"10034754\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Petechia\",\n \"Probability\": \"0.9964299202\",\n \"SemanticContext\": \"Hemic and Lymphatic System: Petechia.\"\n }\n ]\n },\n {\n \"Term\": \"Urinary tract infection\",\n \"MEDDRACode\": \"10046571\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Urinary Tract Infection\",\n \"Probability\": \"0.9385316372\",\n \"SemanticContext\": \"Urogenital System: Cystitis, Urinary Tract Infection, Menstrual Disorder, Vaginitis.\"\n },\n {\n \"VerbatimTerm\": \"urinary tract infection\",\n \"Probability\": \"0.9770430326\",\n \"SemanticContext\": \"Genitourinary: Enuresis and urinary tract infection.\"\n }\n ]\n },\n {\n \"Term\": \"Prophylaxis\",\n \"MEDDRACode\": \"10036898\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": true,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": true\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"prevention\",\n \"Probability\": \"0.0003823042\",\n \"SemanticContext\": \"While it is generally agreed that pharmacological treatment beyond an acute response in mania is desirable, both for maintenance of the initial response and for prevention of new manic episodes, there are no data to support the benefits of divalproex sodium extended-release tablets in such longer-term treatment i.e., beyond 3 weeks .\"\n },\n {\n \"VerbatimTerm\": \"Prevention\",\n \"Probability\": \"0.0005772114\",\n \"SemanticContext\": \"Based on published data from the CDC’s National Birth Defects Prevention Network, the risk of spina bifida in the general population is about 0.06 to 0.07% 6 to 7 in 10,000 births compared to the risk following in utero valproate exposure estimated to be approximately 1 to 2% 100 to 200 in 10,000 births .\"\n }\n ]\n },\n {\n \"Term\": \"Dry skin\",\n \"MEDDRACode\": \"10013786\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"dry skin\",\n \"Probability\": \"0.9639784098\",\n \"SemanticContext\": \"Skin and Appendages: Rash, pruritus, dry skin.\"\n }\n ]\n },\n {\n \"Term\": \"Hirsutism\",\n \"MEDDRACode\": \"10020112\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hirsutism\",\n \"Probability\": \"0.9985736609\",\n \"SemanticContext\": \"Endocrine: Irregular menses, secondary amenorrhea, hyperandrogenism, hirsutism, elevated testosterone level, breast enlargement, galactorrhea, parotid gland swelling, polycystic ovary disease, decreased carnitine concentrations, hyponatremia, hyperglycinemia, and inappropriate ADH secretion.\"\n }\n ]\n },\n {\n \"Term\": \"Metrorrhagia\",\n \"MEDDRACode\": \"10027514\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Metrorrhagia\",\n \"Probability\": \"0.9931451678\",\n \"SemanticContext\": \"Urogenital System: Metrorrhagia.\"\n }\n ]\n },\n {\n \"Term\": \"Injury\",\n \"MEDDRACode\": \"10022116\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": true\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"permanent injury\",\n \"Probability\": \"0.001311481\",\n \"SemanticContext\": \"This is particularly important when valproate use is considered for a condition not usually associated with permanent injury or death such as prophylaxis of migraine headache [see Contraindications 4 ] .\"\n },\n {\n \"VerbatimTerm\": \"permanent injury\",\n \"Probability\": \"0.0016429722\",\n \"SemanticContext\": \"This is especially important when valproate use is considered for a condition not usually associated with permanent injury or death such as prophylaxis of migraine headaches [see Contraindications 4 ] .\"\n }\n ]\n },\n {\n \"Term\": \"Furuncle\",\n \"MEDDRACode\": \"10017553\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Furunculosis\",\n \"Probability\": \"0.9928953052\",\n \"SemanticContext\": \"Skin and Appendages: Discoid Lupus Erythematosus, Erythema Nodosum, Furunculosis, Maculopapular Rash, Pruritus, Rash, Seborrhea, Sweating, Vesiculobullous Rash.\"\n }\n ]\n },\n {\n \"Term\": \"Hyperglycinaemia\",\n \"MEDDRACode\": \"10080883\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hyperglycinemia\",\n \"Probability\": \"0.9928351641\",\n \"SemanticContext\": \"Endocrine: Irregular menses, secondary amenorrhea, hyperandrogenism, hirsutism, elevated testosterone level, breast enlargement, galactorrhea, parotid gland swelling, polycystic ovary disease, decreased carnitine concentrations, hyponatremia, hyperglycinemia, and inappropriate ADH secretion.\"\n }\n ]\n },\n {\n \"Term\": \"Hypoproteinaemia\",\n \"MEDDRACode\": \"10021083\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Hypoproteinemia\",\n \"Probability\": \"0.9991828203\",\n \"SemanticContext\": \"Metabolic and Nutritional Disorders: Hypoproteinemia, Peripheral Edema.\"\n }\n ]\n },\n {\n \"Term\": \"Photophobia\",\n \"MEDDRACode\": \"10034960\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Photophobia\",\n \"Probability\": \"0.9906821251\",\n \"SemanticContext\": \"Special Senses: Conjunctivitis, Dry Eyes, Eye Disorder, Eye Pain, Photophobia, Taste Perversion.\"\n }\n ]\n },\n {\n \"Term\": \"Psychotic disorder\",\n \"MEDDRACode\": \"10061920\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"psychotic\",\n \"Probability\": \"0.0129472315\",\n \"SemanticContext\": \"• Acute treatment of manic or mixed episodes associated with bipolar disorder, with or without psychotic features 1.1 • Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures 1.2 • Prophylaxis of migraine headaches 1.3 DOSAGE AND ADMINISTRATION • Divalproex sodium extended-release tablets are intended for once-a-day oral administration.\"\n },\n {\n \"VerbatimTerm\": \"psychotic\",\n \"Probability\": \"0.0478684008\",\n \"SemanticContext\": \"Clozapine In psychotic patients n = 11 , no interaction was observed when valproate was co-administered with clozapine.\"\n },\n {\n \"VerbatimTerm\": \"psychotic\",\n \"Probability\": \"0.0155043006\",\n \"SemanticContext\": \"1 INDICATIONS AND USAGE 1.1 Mania Divalproex sodium extended-release tablets are a valproate and are indicated for the treatment of acute manic or mixed episodes associated with bipolar disorder, with or without psychotic features.\"\n }\n ]\n },\n {\n \"Term\": \"Speech disorder\",\n \"MEDDRACode\": \"10041466\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"speech disorder\",\n \"Probability\": \"0.9933882356\",\n \"SemanticContext\": \"Nervous System: Abnormal dreams, confusion, paresthesia, speech disorder, and thinking abnormalities.\"\n }\n ]\n },\n {\n \"Term\": \"Vasodilatation\",\n \"MEDDRACode\": \"10047141\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Vasodilatation\",\n \"Probability\": \"0.9445643425\",\n \"SemanticContext\": \"Cardiovascular System: Vasodilatation.\"\n }\n ]\n },\n {\n \"Term\": \"Focal dyscognitive seizures\",\n \"MEDDRACode\": \"10079424\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"complex partial seizures\",\n \"Probability\": \"0.1458826959\",\n \"SemanticContext\": \"• Acute treatment of manic or mixed episodes associated with bipolar disorder, with or without psychotic features 1.1 • Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures 1.2 • Prophylaxis of migraine headaches 1.3 DOSAGE AND ADMINISTRATION • Divalproex sodium extended-release tablets are intended for once-a-day oral administration.\"\n },\n {\n \"VerbatimTerm\": \"complex partial seizures\",\n \"Probability\": \"0.0817034841\",\n \"SemanticContext\": \"Table 4 lists treatment-emergent adverse reactions which were reported by = 5% of divalproex sodium delayed-release tablets-treated patients and for which the incidence was greater than in the placebo group, in the placebo-controlled trial of adjunctive therapy for treatment of complex partial seizures.\"\n },\n {\n \"VerbatimTerm\": \"complex partial seizures\",\n \"Probability\": \"0.5583145618\",\n \"SemanticContext\": \"Table 5 lists treatment-emergent adverse reactions which were reported by = 5% of patients in the high dose valproate group, and for which the incidence was greater than in the low dose group, in a controlled trial of divalproex sodium delayed-release tablets monotherapy treatment of complex partial seizures.\"\n },\n {\n \"VerbatimTerm\": \"complex partial seizures\",\n \"Probability\": \"0.8851357698\",\n \"SemanticContext\": \"The following additional adverse reactions were reported by greater than 1% but less than 5% of the 358 patients treated with valproate in the controlled trials of complex partial seizures: Body as a Whole: Back pain, chest pain, malaise.\"\n },\n {\n \"VerbatimTerm\": \"complex partial seizures\",\n \"Probability\": \"0.1014810205\",\n \"SemanticContext\": \"14.2 Epilepsy The efficacy of valproate in reducing the incidence of complex partial seizures CPS that occur in isolation or in association with other seizure types was established in two controlled trials.\"\n },\n {\n \"VerbatimTerm\": \"complex partial seizures\",\n \"Probability\": \"0.0039521456\",\n \"SemanticContext\": \"In a study of adjunctive therapy for complex partial seizures in which patients were receiving either carbamazepine or phenytoin in addition to valproate, no adjustment of carbamazepine or phenytoin dosage was needed [see Clinical Studies 14.2 ].\"\n },\n {\n \"VerbatimTerm\": \"complex partial seizures\",\n \"Probability\": \"0.0064847767\",\n \"SemanticContext\": \"1.2 Epilepsy Divalproex sodium extended-release tablets are indicated as monotherapy and adjunctive therapy in the treatment of adult patients and pediatric patients down to the age of 10 years with complex partial seizures that occur either in isolation or in association with other types of seizures.\"\n },\n {\n \"VerbatimTerm\": \"complex partial seizures\",\n \"Probability\": \"0.0010263324\",\n \"SemanticContext\": \"Divalproex Sodium Extended-Release Tablets are prescription medicines used: • to treat manic episodes associated with bipolar disorder • alone or with other medicines to treat: • complex partial seizures in adults and children 10 years of age and older • simple and complex absence seizures, with or without other seizure types • to prevent migraine headaches Who should not take divalproex sodium extended-release tablets?\"\n },\n {\n \"VerbatimTerm\": \"Complex Partial Seizures\",\n \"Probability\": \"0.0524543524\",\n \"SemanticContext\": \"• Complex Partial Seizures: Start at 10 to 15 mg/kg/day, increasing at 1 week intervals by 5 to 10 mg/kg/day to achieve optimal clinical response; if response is not satisfactory, check valproate plasma level; see full prescribing information for conversion to monotherapy 2.2 .\"\n },\n {\n \"VerbatimTerm\": \"Complex Partial Seizures\",\n \"Probability\": \"0.0083526671\",\n \"SemanticContext\": \"Adverse Reactions Reported by = 5% of Patients Treated with Valproate During Placebo-Controlled Trial of Adjunctive Therapy for Complex Partial Seizures Body System/Event Divalproex Sodium Delayed- Release Tablets N = 77 % Placebo N = 70 % Body as a Whole Headache 31 21 Asthenia 27 7 Fever 6 4 Gastrointestinal System Nausea 48 14 Vomiting 27 7 Abdominal Pain 23 6 Diarrhea 13 6 Anorexia 12 0 Dyspepsia 8 4 Constipation 5 1 Nervous System Somnolence 27 11 Tremor 25 6 Dizziness 25 13 Diplopia 16 9 Amblyopia/Blurred Vision 12 9 Ataxia 8 1 Nystagmus 8 1 Emotional Lability 6 4 Thinking Abnormal 6 0 Amnesia 5 1 Respiratory System Flu Syndrome 12 9 Infection 12 6 Bronchitis 5 1 Rhinitis 5 4 Other Alopecia 6 1 Weight Loss 6 0 .\"\n },\n {\n \"VerbatimTerm\": \"Complex Partial Seizures\",\n \"Probability\": \"0.0611994565\",\n \"SemanticContext\": \"Adverse Reactions Reported by = 5% of Patients in the High Dose Group in the Controlled Trial of Valproate Monotherapy for Complex Partial Seizures Headache was the only adverse event that occurred in = 5% of patients in the high dose group and at an equal or greater incidence in the low dose group.\"\n },\n {\n \"VerbatimTerm\": \"Complex Partial Seizures\",\n \"Probability\": \"0.0477591753\",\n \"SemanticContext\": \"\\n \\n Complex Partial Seizures\\n For adults and children 10 years of age or older.\"\n },\n {\n \"VerbatimTerm\": \"complex partial seizure\",\n \"Probability\": \"0.2623558044\",\n \"SemanticContext\": \"Figure 1 presents the proportion of patients X axis whose percentage reduction from baseline in complex partial seizure rates was at least as great as that indicated on the Y axis in the adjunctive therapy study.\"\n },\n {\n \"VerbatimTerm\": \"complex partial seizure\",\n \"Probability\": \"0.7073461413\",\n \"SemanticContext\": \"For example, 45% of patients treated with valproate had a = 50% reduction in complex partial seizure rate compared to 23% of patients treated with placebo.\"\n },\n {\n \"VerbatimTerm\": \"complex partial seizure\",\n \"Probability\": \"0.1409392953\",\n \"SemanticContext\": \"Figure 2 presents the proportion of patients X axis whose percentage reduction from baseline in complex partial seizure rates was at least as great as that indicated on the Y axis in the monotherapy study.\"\n },\n {\n \"VerbatimTerm\": \"complex partial seizure\",\n \"Probability\": \"0.2143341303\",\n \"SemanticContext\": \"For example, when switching from carbamazepine, phenytoin, phenobarbital or primidone monotherapy to high dose valproate monotherapy, 63% of patients experienced no change or a reduction in complex partial seizure rates compared to 54% of patients receiving low dose valproate.\"\n },\n {\n \"VerbatimTerm\": \"complex partial seizure\",\n \"Probability\": \"0.3000339568\",\n \"SemanticContext\": \"Figure 1: Proportion of patients X axis whose percentage reduction from baseline in complex partial seizure rates was at least as great as that indicated on the Y axis in the adjunctive therapy study Figure 2: Proportion of patients X axis whose percentage reduction from baseline in complex partial seizure rates was at least as great as that indicated on the Y axis in the monotherapy study 14.3 Migraine The results of a multicenter, randomized, double-blind, placebo-controlled, parallel-group clinical trial demonstrated the effectiveness of divalproex sodium extended-release tablets in the prophylactic treatment of migraine headache.\"\n },\n {\n \"VerbatimTerm\": \"complex partial seizure\",\n \"Probability\": \"0.0408869982\",\n \"SemanticContext\": \"Figure 1: Proportion of patients X axis whose percentage reduction from baseline in complex partial seizure rates was at least as great as that indicated on the Y axis in the adjunctive therapy study Figure 2: Proportion of patients X axis whose percentage reduction from baseline in complex partial seizure rates was at least as great as that indicated on the Y axis in the monotherapy study 14.3 Migraine The results of a multicenter, randomized, double-blind, placebo-controlled, parallel-group clinical trial demonstrated the effectiveness of divalproex sodium extended-release tablets in the prophylactic treatment of migraine headache.\"\n }\n ]\n },\n {\n \"Term\": \"Pregnancy\",\n \"MEDDRACode\": \"10036556\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": true,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": true,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Pregnancy\",\n \"Probability\": \"0.5668558478\",\n \"SemanticContext\": \"Therefore increased monitoring of valproate and concomitant drug concentrations and dosage adjustment are indicated whenever enzyme-inducing or inhibiting drugs are introduced or withdrawn 7.1 • Aspirin, carbapenem antibiotics, estrogen-containing hormonal contraceptives: Monitoring of valproate concentrations is recommended 7.1 • Co-administration of valproate can affect the pharmacokinetics of other drugs e.g., diazepam, ethosuximide, lamotrigine, phenytoin by inhibiting their metabolism or protein binding displacement 7.2 • Patients stabilized on rufinamide should begin valproate therapy at a low dose, and titrate to clinically effective dose 7.2 • Dosage adjustment of amitriptyline/nortriptyline, propofol, warfarin, and zidovudine may be necessary if used concomitantly with divalproex sodium extended-release tablets 7.2 • Topiramate: Hyperammonemia and encephalopathy 5.10 , 7.3 USE IN SPECIFIC POPULATIONS • Pregnancy: Divalproex sodium extended-release tablets can cause congenital malformations including neural tube defects, decreased IQ, and neurodevelopmental disorders 5.2 , 5.3 , 8.1 • Pediatric: Children under the age of two years are at considerably higher risk of fatal hepatotoxicity 5.1 , 8.4 • Geriatric: Reduce starting dose; increase dosage more slowly; monitor fluid and nutritional intake, and somnolence 5.14 , 8.5 See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.\"\n },\n {\n \"VerbatimTerm\": \"Pregnancy\",\n \"Probability\": \"0.0195518732\",\n \"SemanticContext\": \"Pregnancy Registry: Advise women of childbearing potential to discuss pregnancy planning with their doctor and to contact their doctor immediately if they think they are pregnant.\"\n },\n {\n \"VerbatimTerm\": \"Pregnancy\",\n \"Probability\": \"0.0001047579\",\n \"SemanticContext\": \"Encourage women who are taking divalproex sodium extended-release tablets to enroll in the North American Antiepileptic Drug NAAED Pregnancy Registry if they become pregnant.\"\n },\n {\n \"VerbatimTerm\": \"Pregnancy\",\n \"Probability\": \"0.0037083924\",\n \"SemanticContext\": \"8.1 Pregnancy\\n \\n Pregnancy Exposure Registry\\n There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs AEDs , including divalproex sodium extended-release tablets, during pregnancy.\"\n },\n {\n \"VerbatimTerm\": \"Pregnancy\",\n \"Probability\": \"0.0010255575\",\n \"SemanticContext\": \"8.1 Pregnancy\\n \\n Pregnancy Exposure Registry\\n There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs AEDs , including divalproex sodium extended-release tablets, during pregnancy.\"\n },\n {\n \"VerbatimTerm\": \"Pregnancy\",\n \"Probability\": \"0.0002781153\",\n \"SemanticContext\": \"Encourage women who are taking divalproex sodium extended-release tablets during pregnancy to enroll in the North American Antiepileptic Drug NAAED Pregnancy Registry by calling toll-free 1-888-233-2334 or visiting the website, http://www.aedpregnancyregistry.org/.\"\n },\n {\n \"VerbatimTerm\": \"Pregnancy\",\n \"Probability\": \"0.0282910764\",\n \"SemanticContext\": \"The NAAED Pregnancy Registry has reported a major malformation rate of 9-11% in the offspring of women exposed to an average of 1,000 mg/day of valproate monotherapy during pregnancy.\"\n },\n {\n \"VerbatimTerm\": \"Pregnancy\",\n \"Probability\": \"0.0084746182\",\n \"SemanticContext\": \"Pregnancy registry data show that maternal valproate use can cause neural tube defects and other structural abnormalities e.g., craniofacial defects, cardiovascular malformations, hypospadias, limb malformations .\"\n },\n {\n \"VerbatimTerm\": \"Pregnancy\",\n \"Probability\": \"0.0044600666\",\n \"SemanticContext\": \"Pregnancy Registry: If you become pregnant while taking divalproex sodium extended-release tablets, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry.\"\n },\n {\n \"VerbatimTerm\": \"Pregnancy\",\n \"Probability\": \"5.80883E-05\",\n \"SemanticContext\": \"Pregnancy Registry: If you become pregnant while taking divalproex sodium extended-release tablets, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry.\"\n },\n {\n \"VerbatimTerm\": \"pregnancy\",\n \"Probability\": \"0.0179282427\",\n \"SemanticContext\": \"1.4 Important Limitations Because of the risk to the fetus of decreased IQ, neurodevelopmental disorders, neural tube defects, and other major congenital malformations, which may occur very early in pregnancy, valproate should not be used to treat women with epilepsy or bipolar disorder who are pregnant or who plan to become pregnant unless other medications have failed to provide adequate symptom control or are otherwise unacceptable.\"\n },\n {\n \"VerbatimTerm\": \"pregnancy\",\n \"Probability\": \"6.49E-06\",\n \"SemanticContext\": \"Birth Defects and Decreased IQ: Inform pregnant women and women of childbearing potential including girls beginning the onset of puberty that use of valproate during pregnancy increases the risk of birth defects, decreased IQ, and neurodevelopmental disorders in children who were exposed in utero .\"\n },\n {\n \"VerbatimTerm\": \"pregnancy\",\n \"Probability\": \"2.36836E-05\",\n \"SemanticContext\": \"Pregnancy Registry: Advise women of childbearing potential to discuss pregnancy planning with their doctor and to contact their doctor immediately if they think they are pregnant.\"\n },\n {\n \"VerbatimTerm\": \"pregnancy\",\n \"Probability\": \"0.0001080232\",\n \"SemanticContext\": \"This registry is collecting information about the safety of antiepileptic drugs during pregnancy.\"\n },\n {\n \"VerbatimTerm\": \"pregnancy\",\n \"Probability\": \"0.0005278885\",\n \"SemanticContext\": \"8.1 Pregnancy\\n \\n Pregnancy Exposure Registry\\n There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs AEDs , including divalproex sodium extended-release tablets, during pregnancy.\"\n },\n {\n \"VerbatimTerm\": \"pregnancy\",\n \"Probability\": \"7.29942E-05\",\n \"SemanticContext\": \"8.1 Pregnancy\\n \\n Pregnancy Exposure Registry\\n There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs AEDs , including divalproex sodium extended-release tablets, during pregnancy.\"\n },\n {\n \"VerbatimTerm\": \"pregnancy\",\n \"Probability\": \"0.085192889\",\n \"SemanticContext\": \"8.1 Pregnancy\\n \\n Pregnancy Exposure Registry\\n There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs AEDs , including divalproex sodium extended-release tablets, during pregnancy.\"\n },\n {\n \"VerbatimTerm\": \"pregnancy\",\n \"Probability\": \"0.0017467439\",\n \"SemanticContext\": \"Encourage women who are taking divalproex sodium extended-release tablets during pregnancy to enroll in the North American Antiepileptic Drug NAAED Pregnancy Registry by calling toll-free 1-888-233-2334 or visiting the website, http://www.aedpregnancyregistry.org/.\"\n },\n {\n \"VerbatimTerm\": \"pregnancy\",\n \"Probability\": \"8.71254E-05\",\n \"SemanticContext\": \"Maternal valproate use during pregnancy for any indication increases the risk of congenital malformations, particularly neural tube defects including spina bifida, but also malformations involving other body systems e.g., craniofacial defects including oral clefts, cardiovascular malformations, hypospadias, limb malformations .\"\n },\n {\n \"VerbatimTerm\": \"pregnancy\",\n \"Probability\": \"0.0034448504\",\n \"SemanticContext\": \"The risk of major structural abnormalities is greatest during the first trimester; however, other serious developmental effects can occur with valproate use throughout pregnancy.\"\n },\n {\n \"VerbatimTerm\": \"pregnancy\",\n \"Probability\": \"0.0151028633\",\n \"SemanticContext\": \"The rate of congenital malformations among babies born to epileptic mothers who used valproate during pregnancy has been shown to be about four times higher than the rate among babies born to epileptic mothers who used other anti-seizure monotherapies [see Warnings and Precautions 5.2 and Data Human ] .\"\n },\n {\n \"VerbatimTerm\": \"pregnancy\",\n \"Probability\": \"0.0007795095\",\n \"SemanticContext\": \"An observational study has suggested that exposure to valproate products during pregnancy increases the risk of autism spectrum disorders [see Data Human ] .\"\n },\n {\n \"VerbatimTerm\": \"pregnancy\",\n \"Probability\": \"0.0126400888\",\n \"SemanticContext\": \"In animal studies, valproate administration during pregnancy resulted in fetal structural malformations similar to those seen in humans and neurobehavioral deficits in the offspring at clinically relevant doses [see Data Animal ] .\"\n },\n {\n \"VerbatimTerm\": \"pregnancy\",\n \"Probability\": \"0.0034379661\",\n \"SemanticContext\": \"There have been reports of hypoglycemia in neonates and fatal cases of hepatic failure in infants following maternal use of valproate during pregnancy.\"\n },\n {\n \"VerbatimTerm\": \"pregnancy\",\n \"Probability\": \"0.0002537668\",\n \"SemanticContext\": \"Evidence suggests that folic acid supplementation prior to conception and during the first trimester of pregnancy decreases the risk for congenital neural tube defects in the general population.\"\n },\n {\n \"VerbatimTerm\": \"pregnancy\",\n \"Probability\": \"0.0019991994\",\n \"SemanticContext\": \"Dietary folic acid supplementation both prior to conception and during pregnancy should be routinely recommended for patients using valproate [see Warnings and Precautions 5.2 , 5.4 ] .\"\n },\n {\n \"VerbatimTerm\": \"pregnancy\",\n \"Probability\": \"0.0006530583\",\n \"SemanticContext\": \"However, discontinuation of the drug may be considered prior to and during pregnancy in individual cases if the seizure disorder severity and frequency do not pose a serious threat to the patient.\"\n },\n {\n \"VerbatimTerm\": \"pregnancy\",\n \"Probability\": \"9.19669E-05\",\n \"SemanticContext\": \"If valproate is used in pregnancy, the clotting parameters should be monitored carefully in the mother.\"\n },\n {\n \"VerbatimTerm\": \"pregnancy\",\n \"Probability\": \"0.0051881969\",\n \"SemanticContext\": \"Fatal cases of hepatic failure in infants exposed to valproate in utero have also been reported following maternal use of valproate during pregnancy.\"\n },\n {\n \"VerbatimTerm\": \"pregnancy\",\n \"Probability\": \"0.0018342137\",\n \"SemanticContext\": \"Hypoglycemia has been reported in neonates whose mothers have taken valproate during pregnancy.\"\n },\n {\n \"VerbatimTerm\": \"pregnancy\",\n \"Probability\": \"0.0105241835\",\n \"SemanticContext\": \"The NAAED Pregnancy Registry has reported a major malformation rate of 9-11% in the offspring of women exposed to an average of 1,000 mg/day of valproate monotherapy during pregnancy.\"\n },\n {\n \"VerbatimTerm\": \"pregnancy\",\n \"Probability\": \"0.0016177893\",\n \"SemanticContext\": \"It is not known when during pregnancy cognitive effects in valproate-exposed children occur.\"\n },\n {\n \"VerbatimTerm\": \"pregnancy\",\n \"Probability\": \"0.0007997453\",\n \"SemanticContext\": \"Because the women in this study were exposed to AEDs throughout pregnancy, whether the risk for decreased IQ was related to a particular time period during pregnancy could not be assessed [see Warnings and Precautions 5.3 ] .\"\n },\n {\n \"VerbatimTerm\": \"pregnancy\",\n \"Probability\": \"0.0021776259\",\n \"SemanticContext\": \"Because the women in this study were exposed to AEDs throughout pregnancy, whether the risk for decreased IQ was related to a particular time period during pregnancy could not be assessed [see Warnings and Precautions 5.3 ] .\"\n },\n {\n \"VerbatimTerm\": \"pregnancy\",\n \"Probability\": \"0.0002996027\",\n \"SemanticContext\": \"An observational study has suggested that exposure to valproate products during pregnancy increases the risk of autism spectrum disorders.\"\n },\n {\n \"VerbatimTerm\": \"pregnancy\",\n \"Probability\": \"0.0034272075\",\n \"SemanticContext\": \"In this study, children born to mothers who had used valproate products during pregnancy had 2.9 times the risk 95% confidence interval [CI]: 1.7-4.9 of developing autism spectrum disorders compared to children born to mothers not exposed to valproate products during pregnancy.\"\n },\n {\n \"VerbatimTerm\": \"pregnancy\",\n \"Probability\": \"0.0125625134\",\n \"SemanticContext\": \"In this study, children born to mothers who had used valproate products during pregnancy had 2.9 times the risk 95% confidence interval [CI]: 1.7-4.9 of developing autism spectrum disorders compared to children born to mothers not exposed to valproate products during pregnancy.\"\n },\n {\n \"VerbatimTerm\": \"pregnancy\",\n \"Probability\": \"0.0144850314\",\n \"SemanticContext\": \"\\n Other\\n There are published case reports of fatal hepatic failure in offspring of women who used valproate during pregnancy.\"\n },\n {\n \"VerbatimTerm\": \"pregnancy\",\n \"Probability\": \"0.0005870163\",\n \"SemanticContext\": \"Evidence suggests that folic acid supplementation prior to conception and during the first trimester of pregnancy decreases the risk for congenital neural tube defects in the general population [see Use in Specific Populations 8.1 ] .\"\n },\n {\n \"VerbatimTerm\": \"pregnancy\",\n \"Probability\": \"0.0015519857\",\n \"SemanticContext\": \"It is not known when during pregnancy cognitive effects in valproate-exposed children occur.\"\n },\n {\n \"VerbatimTerm\": \"pregnancy\",\n \"Probability\": \"0.0003951788\",\n \"SemanticContext\": \"Because the women in this study were exposed to antiepileptic drugs throughout pregnancy, whether the risk for decreased IQ was related to a particular time period during pregnancy could not be assessed.\"\n },\n {\n \"VerbatimTerm\": \"pregnancy\",\n \"Probability\": \"0.0012077689\",\n \"SemanticContext\": \"Because the women in this study were exposed to antiepileptic drugs throughout pregnancy, whether the risk for decreased IQ was related to a particular time period during pregnancy could not be assessed.\"\n },\n {\n \"VerbatimTerm\": \"pregnancy\",\n \"Probability\": \"0.0078012049\",\n \"SemanticContext\": \"5.4 Use in Women of Childbearing Potential Because of the risk to the fetus of decreased IQ, neurodevelopmental disorders, and major congenital malformations including neural tube defects , which may occur very early in pregnancy, valproate should not be administered to a woman of childbearing potential unless other medications have failed to provide adequate symptom control or are otherwise unacceptable.\"\n },\n {\n \"VerbatimTerm\": \"pregnancy\",\n \"Probability\": \"3.51731E-05\",\n \"SemanticContext\": \"Women of childbearing potential should be counseled regularly regarding the relative risks and benefits of valproate use during pregnancy.\"\n },\n {\n \"VerbatimTerm\": \"pregnancy\",\n \"Probability\": \"0.0001566112\",\n \"SemanticContext\": \"This is especially important for women planning a pregnancy and for girls at the onset of puberty; alternative therapeutic options should be considered for these patients [see Boxed Warning and Use in Specific Populations 8.1 ] .\"\n },\n {\n \"VerbatimTerm\": \"pregnancy\",\n \"Probability\": \"0.0002537668\",\n \"SemanticContext\": \"Evidence suggests that folic acid supplementation prior to conception and during the first trimester of pregnancy decreases the risk for congenital neural tube defects in the general population.\"\n },\n {\n \"VerbatimTerm\": \"pregnancy\",\n \"Probability\": \"0.0006726086\",\n \"SemanticContext\": \"Dietary folic acid supplementation both prior to conception and during pregnancy should be routinely recommended for patients using valproate.\"\n },\n {\n \"VerbatimTerm\": \"pregnancy\",\n \"Probability\": \"0.009940356\",\n \"SemanticContext\": \"Prior to the initiation of divalproex sodium extended-release tablets therapy, evaluation for UCD should be considered in the following patients: 1 those with a history of unexplained encephalopathy or coma, encephalopathy associated with a protein load, pregnancy-related or postpartum encephalopathy, unexplained mental retardation, or history of elevated plasma ammonia or glutamine; 2 those with cyclical vomiting and lethargy, episodic extreme irritability, ataxia, low BUN, or protein avoidance; 3 those with a family history of UCD or a family history of unexplained infant deaths particularly males ; 4 those with other signs or symptoms of UCD.\"\n },\n {\n \"VerbatimTerm\": \"pregnancy\",\n \"Probability\": \"4.30745E-05\",\n \"SemanticContext\": \"It is recommended that patients receiving divalproex sodium extended-release tablets be monitored for blood counts and coagulation parameters prior to planned surgery and during pregnancy [see Use in Specific Populations 8.1 ] .\"\n },\n {\n \"VerbatimTerm\": \"pregnancy\",\n \"Probability\": \"2.54209E-05\",\n \"SemanticContext\": \"• If you take divalproex sodium extended-release tablets during pregnancy for any medical condition, your baby is at risk for serious birth defects that affect the brain and spinal cord and are called spina bifida or neural tube defects.\"\n },\n {\n \"VerbatimTerm\": \"pregnancy\",\n \"Probability\": \"0.0020805597\",\n \"SemanticContext\": \"These defects occur in 1 to 2 out of every 100 babies born to mothers who use this medicine during pregnancy.\"\n },\n {\n \"VerbatimTerm\": \"pregnancy\",\n \"Probability\": \"9.6862E-06\",\n \"SemanticContext\": \"• Taking folic acid supplements before getting pregnant and during early pregnancy can lower the chance of having a baby with a neural tube defect.\"\n },\n {\n \"VerbatimTerm\": \"pregnancy\",\n \"Probability\": \"2.02133E-05\",\n \"SemanticContext\": \"• If you take divalproex sodium extended-release tablets during pregnancy for any medical condition, your child is at risk for having lower IQ and may be at risk for developing autism or attention deficit/hyperactivity order.\"\n },\n {\n \"VerbatimTerm\": \"pregnancy\",\n \"Probability\": \"0.0066200197\",\n \"SemanticContext\": \"The purpose of this registry is to collect information about the safety of antiepileptic drugs during pregnancy.\"\n },\n {\n \"VerbatimTerm\": \"pregnancy\",\n \"Probability\": \"0.0004478991\",\n \"SemanticContext\": \"There have been reports of hepatic failure and clotting abnormalities in offspring of women who used valproate during pregnancy [see Use in Specific Populations 8.1 ] .\"\n },\n {\n \"VerbatimTerm\": \"pregnancy\",\n \"Probability\": \"0.0032554567\",\n \"SemanticContext\": \"None of the mothers received valproate during pregnancy, and infants were aged from 4 weeks to 19 weeks at the time of evaluation.\"\n },\n {\n \"VerbatimTerm\": \"pregnancies\",\n \"Probability\": \"0.0043000281\",\n \"SemanticContext\": \"All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.\"\n },\n {\n \"VerbatimTerm\": \"pregnancies\",\n \"Probability\": \"0.0507256091\",\n \"SemanticContext\": \"In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.\"\n }\n ]\n },\n {\n \"Term\": \"Depressed mood\",\n \"MEDDRACode\": \"10012374\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"depressed mood\",\n \"Probability\": \"0.0166497231\",\n \"SemanticContext\": \"A mixed episode is characterized by the criteria for a manic episode in conjunction with those for a major depressive episode depressed mood, loss of interest or pleasure in nearly all activities .\"\n }\n ]\n },\n {\n \"Term\": \"Abdominal pain upper\",\n \"MEDDRACode\": \"10000087\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"stomach pain\",\n \"Probability\": \"5.1837E-05\",\n \"SemanticContext\": \"Call your healthcare provider right away if you have any of these symptoms: • severe stomach pain that you may also feel in your back • nausea or vomiting that does not go away 4.\"\n },\n {\n \"VerbatimTerm\": \"stomach pain\",\n \"Probability\": \"0.6528974771\",\n \"SemanticContext\": \"The common side effects of divalproex sodium extended-release tablets include: • nausea • headache • sleepiness • vomiting • weakness • tremor • dizziness • stomach pain • blurry vision • double vision • diarrhea • increased appetite • weight gain • hair loss • loss of appetite • problems with walking or coordination These are not all of the possible side effects of divalproex sodium extended-release tablets .\"\n }\n ]\n },\n {\n \"Term\": \"Body temperature\",\n \"MEDDRACode\": \"10005906\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"body temperature\",\n \"Probability\": \"0.0001308918\",\n \"SemanticContext\": \"• Low body temperature hypothermia : drop in your body temperature to less than 95°F, feeling tired, confusion, coma.\"\n },\n {\n \"VerbatimTerm\": \"body temperature\",\n \"Probability\": \"8.09032E-05\",\n \"SemanticContext\": \"• Low body temperature hypothermia : drop in your body temperature to less than 95°F, feeling tired, confusion, coma.\"\n }\n ]\n },\n {\n \"Term\": \"Visual impairment\",\n \"MEDDRACode\": \"10047571\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"abnormal vision\",\n \"Probability\": \"0.9510657787\",\n \"SemanticContext\": \"Special Senses: Taste perversion, abnormal vision, deafness, otitis media.\"\n }\n ]\n },\n {\n \"Term\": \"Lymphocytosis\",\n \"MEDDRACode\": \"10025280\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"lymphocytosis\",\n \"Probability\": \"0.9508433342\",\n \"SemanticContext\": \"Hematologic: Relative lymphocytosis, macrocytosis, leukopenia, anemia including macrocytic with or without folate deficiency, bone marrow suppression, pancytopenia, aplastic anemia, agranulocytosis, and acute intermittent porphyria.\"\n }\n ]\n },\n {\n \"Term\": \"Macrocytosis\",\n \"MEDDRACode\": \"10025382\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"macrocytosis\",\n \"Probability\": \"0.9819021821\",\n \"SemanticContext\": \"Hematologic: Relative lymphocytosis, macrocytosis, leukopenia, anemia including macrocytic with or without folate deficiency, bone marrow suppression, pancytopenia, aplastic anemia, agranulocytosis, and acute intermittent porphyria.\"\n }\n ]\n },\n {\n \"Term\": \"Palpitations\",\n \"MEDDRACode\": \"10033557\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"palpitation\",\n \"Probability\": \"0.9985380173\",\n \"SemanticContext\": \"Cardiovascular System: Tachycardia, hypertension, palpitation.\"\n }\n ]\n },\n {\n \"Term\": \"Epistaxis\",\n \"MEDDRACode\": \"10015090\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"epistaxis\",\n \"Probability\": \"0.9996192455\",\n \"SemanticContext\": \"Respiratory System: Sinusitis, cough increased, pneumonia, epistaxis.\"\n }\n ]\n },\n {\n \"Term\": \"Migraine prophylaxis\",\n \"MEDDRACode\": \"10058734\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"migraine prophylaxis\",\n \"Probability\": \"0.3661016226\",\n \"SemanticContext\": \"The following additional adverse reactions were reported by greater than 1% but not more than 5% of divalproex sodium extended-release tablets-treated patients and with a greater incidence than placebo in the placebo-controlled clinical trial for migraine prophylaxis: Body as a Whole: Accidental injury, viral infection.\"\n }\n ]\n },\n {\n \"Term\": \"Protein total\",\n \"MEDDRACode\": \"10050537\",\n \"Overdose\": true,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"protein\",\n \"Probability\": \"2.3413E-06\",\n \"SemanticContext\": \"Therefore increased monitoring of valproate and concomitant drug concentrations and dosage adjustment are indicated whenever enzyme-inducing or inhibiting drugs are introduced or withdrawn 7.1 • Aspirin, carbapenem antibiotics, estrogen-containing hormonal contraceptives: Monitoring of valproate concentrations is recommended 7.1 • Co-administration of valproate can affect the pharmacokinetics of other drugs e.g., diazepam, ethosuximide, lamotrigine, phenytoin by inhibiting their metabolism or protein binding displacement 7.2 • Patients stabilized on rufinamide should begin valproate therapy at a low dose, and titrate to clinically effective dose 7.2 • Dosage adjustment of amitriptyline/nortriptyline, propofol, warfarin, and zidovudine may be necessary if used concomitantly with divalproex sodium extended-release tablets 7.2 • Topiramate: Hyperammonemia and encephalopathy 5.10 , 7.3 USE IN SPECIFIC POPULATIONS • Pregnancy: Divalproex sodium extended-release tablets can cause congenital malformations including neural tube defects, decreased IQ, and neurodevelopmental disorders 5.2 , 5.3 , 8.1 • Pediatric: Children under the age of two years are at considerably higher risk of fatal hepatotoxicity 5.1 , 8.4 • Geriatric: Reduce starting dose; increase dosage more slowly; monitor fluid and nutritional intake, and somnolence 5.14 , 8.5 See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.\"\n },\n {\n \"VerbatimTerm\": \"protein\",\n \"Probability\": \"0.0001078283\",\n \"SemanticContext\": \"One contributing factor is the nonlinear, concentration dependent protein binding of valproate which affects the clearance of the drug.\"\n },\n {\n \"VerbatimTerm\": \"protein\",\n \"Probability\": \"6.28417E-05\",\n \"SemanticContext\": \"Conversely, valproate may displace certain protein-bound drugs e.g., phenytoin, carbamazepine, warfarin, and tolbutamide [see Drug Interactions 7.2 for more detailed information on the pharmacokinetic interactions of valproate with other drugs].\"\n },\n {\n \"VerbatimTerm\": \"protein\",\n \"Probability\": \"9.91032E-05\",\n \"SemanticContext\": \"\\n \\n Drugs for Which a Potentially Important Interaction Has Been Observed\\n Aspirin A study involving the co-administration of aspirin at antipyretic doses 11 to 16 mg/kg with valproate to pediatric patients n = 6 revealed a decrease in protein binding and an inhibition of metabolism of valproate.\"\n },\n {\n \"VerbatimTerm\": \"protein\",\n \"Probability\": \"0.0007687509\",\n \"SemanticContext\": \"In overdose situations, the fraction of drug not bound to protein is high and hemodialysis or tandem hemodialysis plus hemoperfusion may result in significant removal of drug.\"\n },\n {\n \"VerbatimTerm\": \"protein\",\n \"Probability\": \"0.0001022725\",\n \"SemanticContext\": \"Prior to the initiation of divalproex sodium extended-release tablets therapy, evaluation for UCD should be considered in the following patients: 1 those with a history of unexplained encephalopathy or coma, encephalopathy associated with a protein load, pregnancy-related or postpartum encephalopathy, unexplained mental retardation, or history of elevated plasma ammonia or glutamine; 2 those with cyclical vomiting and lethargy, episodic extreme irritability, ataxia, low BUN, or protein avoidance; 3 those with a family history of UCD or a family history of unexplained infant deaths particularly males ; 4 those with other signs or symptoms of UCD.\"\n },\n {\n \"VerbatimTerm\": \"protein\",\n \"Probability\": \"0.0003350079\",\n \"SemanticContext\": \"Prior to the initiation of divalproex sodium extended-release tablets therapy, evaluation for UCD should be considered in the following patients: 1 those with a history of unexplained encephalopathy or coma, encephalopathy associated with a protein load, pregnancy-related or postpartum encephalopathy, unexplained mental retardation, or history of elevated plasma ammonia or glutamine; 2 those with cyclical vomiting and lethargy, episodic extreme irritability, ataxia, low BUN, or protein avoidance; 3 those with a family history of UCD or a family history of unexplained infant deaths particularly males ; 4 those with other signs or symptoms of UCD.\"\n },\n {\n \"VerbatimTerm\": \"protein\",\n \"Probability\": \"9.54329E-05\",\n \"SemanticContext\": \"Interpretation of valproic acid concentrations in children should include consideration of factors that affect hepatic metabolism and protein binding.\"\n },\n {\n \"VerbatimTerm\": \"Protein\",\n \"Probability\": \"8.80035E-05\",\n \"SemanticContext\": \"\\n \\n Distribution\\n Protein Binding The plasma protein binding of valproate is concentration dependent and the free fraction increases from approximately 10% at 40 mcg/mL to 18.5% at 130 mcg/mL.\"\n },\n {\n \"VerbatimTerm\": \"Protein\",\n \"Probability\": \"0.0002531111\",\n \"SemanticContext\": \"Protein binding of valproate is reduced in the elderly, in patients with chronic hepatic diseases, in patients with renal impairment, and in the presence of other drugs e.g., aspirin .\"\n },\n {\n \"VerbatimTerm\": \"Protein\",\n \"Probability\": \"8.4478E-06\",\n \"SemanticContext\": \"Protein binding in these patients is substantially reduced; thus, monitoring total concentrations may be misleading.\"\n }\n ]\n },\n {\n \"Term\": \"Sleep disorder\",\n \"MEDDRACode\": \"10040984\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Sleep Disorder\",\n \"Probability\": \"0.1636165977\",\n \"SemanticContext\": \"Nervous System: Abnormal Gait, Agitation, Catatonic Reaction, Dysarthria, Hallucinations, Hypertonia, Hypokinesia, Psychosis, Reflexes Increased, Sleep Disorder, Tardive Dyskinesia, Tremor.\"\n }\n ]\n },\n {\n \"Term\": \"Stevens-Johnson syndrome\",\n \"MEDDRACode\": \"10042033\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Stevens-Johnson syndrome\",\n \"Probability\": \"0.8732533455\",\n \"SemanticContext\": \"Dermatologic: Hair texture changes, hair color changes, photosensitivity, erythema multiforme, toxic epidermal necrolysis, nail and nail bed disorders, and Stevens-Johnson syndrome.\"\n },\n {\n \"VerbatimTerm\": \"Stevens-Johnson syndrome\",\n \"Probability\": \"0.4268019497\",\n \"SemanticContext\": \"Serious skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported with concomitant lamotrigine and valproate administration.\"\n }\n ]\n },\n {\n \"Term\": \"Cutaneous vasculitis\",\n \"MEDDRACode\": \"10011686\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"cutaneous vasculitis\",\n \"Probability\": \"0.9876130819\",\n \"SemanticContext\": \"Other: Allergic reaction, anaphylaxis, developmental delay, bone pain, bradycardia, and cutaneous vasculitis.\"\n }\n ]\n },\n {\n \"Term\": \"Nervousness\",\n \"MEDDRACode\": \"10029216\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"nervousness\",\n \"Probability\": \"0.9932854176\",\n \"SemanticContext\": \"Divalproex sodium extended-release tablets dosage should be increased slowly and with regular monitoring for fluid and nutritional intake 5.14 ADVERSE REACTIONS • Most common adverse reactions reported > 5% are abdominal pain, alopecia, amblyopia/blurred vision, amnesia, anorexia, asthenia, ataxia, back pain, bronchitis, constipation, depression, diarrhea, diplopia, dizziness, dyspnea, dyspepsia, ecchymosis, emotional lability, fever, flu syndrome, headache, increased appetite, infection, insomnia, nausea, nervousness, nystagmus, peripheral edema, pharyngitis, rash, rhinitis, somnolence, thinking abnormal, thrombocytopenia, tinnitus, tremor, vomiting, weight gain, weight loss 6.1 , 6.2 , 6.3 .\"\n },\n {\n \"VerbatimTerm\": \"nervousness\",\n \"Probability\": \"0.9967672825\",\n \"SemanticContext\": \"Nervous System: Abnormal gait, dizziness, hypertonia, insomnia, nervousness, tremor, vertigo.\"\n },\n {\n \"VerbatimTerm\": \"Nervousness\",\n \"Probability\": \"0.9665951729\",\n \"SemanticContext\": \"Body System/Event High Dose n = 131 % Low Dose n = 134 % Body as a Whole Asthenia 21 10 Digestive System Nausea 34 26 Diarrhea 23 19 Vomiting 23 15 Abdominal Pain 12 9 Anorexia 11 4 Dyspepsia 11 10 Hemic/Lymphatic System Thrombocytopenia 24 1 Ecchymosis 5 4 Metabolic/Nutritional Weight Gain 9 4 Peripheral Edema 8 3 Nervous System Tremor 57 19 Somnolence 30 18 Dizziness 18 13 Insomnia 15 9 Nervousness 11 7 Amnesia 7 4 Nystagmus 7 1 Depression 5 4 Respiratory System Infection 20 13 Pharyngitis 8 2 Dyspnea 5 1 Skin and Appendages Alopecia 24 13 Special Senses Amblyopia/Blurred Vision 8 4 Tinnitus 7 1 .\"\n }\n ]\n },\n {\n \"Term\": \"Mania\",\n \"MEDDRACode\": \"10026749\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Mania\",\n \"Probability\": \"0.0109266639\",\n \"SemanticContext\": \"• Mania: Initial dose is 25 mg/kg/day, increasing as rapidly as possible to achieve therapeutic response or desired plasma level 2.1 .\"\n },\n {\n \"VerbatimTerm\": \"Mania\",\n \"Probability\": \"0.0385811031\",\n \"SemanticContext\": \"6.1 Mania The incidence of treatment-emergent events has been ascertained based on combined data from two three week placebo-controlled clinical trials of divalproex sodium extended-release tablets in the treatment of manic episodes associated with bipolar disorder.\"\n },\n {\n \"VerbatimTerm\": \"Mania\",\n \"Probability\": \"0.0057014823\",\n \"SemanticContext\": \"\\n \\n Mania\\n In placebo-controlled clinical trials of acute mania, patients were dosed to clinical response with trough plasma concentrations between 85 and 125 mcg/mL [see Dosage and Administration 2.1 ] .\"\n },\n {\n \"VerbatimTerm\": \"Mania\",\n \"Probability\": \"0.3819102049\",\n \"SemanticContext\": \"14 CLINICAL STUDIES 14.1 Mania The effectiveness of divalproex sodium extended-release tablets for the treatment of acute mania is based in part on studies establishing the effectiveness of divalproex sodium delayed-release tablets for this indication.\"\n },\n {\n \"VerbatimTerm\": \"Mania\",\n \"Probability\": \"0.0290608704\",\n \"SemanticContext\": \"Patients were assessed on the Mania Rating Scale MRS; score ranges from 0-52 .\"\n },\n {\n \"VerbatimTerm\": \"Mania\",\n \"Probability\": \"0.0005094409\",\n \"SemanticContext\": \"2.1 Mania Divalproex sodium extended-release tablets are administered orally.\"\n },\n {\n \"VerbatimTerm\": \"Mania\",\n \"Probability\": \"0.5135875344\",\n \"SemanticContext\": \"1 INDICATIONS AND USAGE 1.1 Mania Divalproex sodium extended-release tablets are a valproate and are indicated for the treatment of acute manic or mixed episodes associated with bipolar disorder, with or without psychotic features.\"\n },\n {\n \"VerbatimTerm\": \"mania\",\n \"Probability\": \"0.0068282485\",\n \"SemanticContext\": \"While it is generally agreed that pharmacological treatment beyond an acute response in mania is desirable, both for maintenance of the initial response and for prevention of new manic episodes, there are no data to support the benefits of divalproex sodium extended-release tablets in such longer-term treatment i.e., beyond 3 weeks .\"\n },\n {\n \"VerbatimTerm\": \"mania\",\n \"Probability\": \"0.1927919686\",\n \"SemanticContext\": \"Typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, poor judgment, aggressiveness, and possible hostility.\"\n },\n {\n \"VerbatimTerm\": \"mania\",\n \"Probability\": \"0.0017849803\",\n \"SemanticContext\": \"The effectiveness of valproate for long-term use in mania, i.e., more than 3 weeks, has not been demonstrated in controlled clinical trials.\"\n },\n {\n \"VerbatimTerm\": \"mania\",\n \"Probability\": \"0.0004432499\",\n \"SemanticContext\": \"During the placebo controlled pediatric mania trial, one 1 in twenty 20 adolescents 5% treated with valproate developed increased plasma ammonia levels compared to no 0 patients treated with placebo.\"\n },\n {\n \"VerbatimTerm\": \"mania\",\n \"Probability\": \"0.0061172843\",\n \"SemanticContext\": \"Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: • thoughts about suicide or dying • attempts to commit suicide • new or worse depression • new or worse anxiety • feeling agitated or restless • panic attacks • trouble sleeping insomnia • new or worse irritability • acting aggressive, being angry, or violent • acting on dangerous impulses • an extreme increase in activity and talking mania • other unusual changes in behavior or mood How can I watch for early symptoms of suicidal thoughts and actions?\"\n },\n {\n \"VerbatimTerm\": \"mania\",\n \"Probability\": \"0.0385912955\",\n \"SemanticContext\": \"Two of the pediatric studies were double-blinded placebo-controlled trials to evaluate the efficacy of divalproex sodium extended-release tablets for the indications of mania 150 patients aged 10 to 17 years, 76 of whom were on divalproex sodium extended-release tablets and migraine 304 patients aged 12 to 17 years, 231 of whom were on divalproex sodium extended-release tablets .\"\n },\n {\n \"VerbatimTerm\": \"mania\",\n \"Probability\": \"0.0062241554\",\n \"SemanticContext\": \"Efficacy was not established for either the treatment of migraine or the treatment of mania.\"\n },\n {\n \"VerbatimTerm\": \"mania\",\n \"Probability\": \"0.4436513782\",\n \"SemanticContext\": \"The most common drug-related adverse reactions reported > 5% and twice the rate of placebo reported in the controlled pediatric mania study were nausea, upper abdominal pain, somnolence, increased ammonia, gastritis and rash.\"\n },\n {\n \"VerbatimTerm\": \"mania\",\n \"Probability\": \"0.1092708111\",\n \"SemanticContext\": \"Two six-month pediatric studies were conducted to evaluate the long-term safety of divalproex sodium extended-release tablets for the indication of mania 292 patients aged 10 to 17 years .\"\n },\n {\n \"VerbatimTerm\": \"mania\",\n \"Probability\": \"0.0076577961\",\n \"SemanticContext\": \"8.5 Geriatric Use No patients above the age of 65 years were enrolled in double-blind prospective clinical trials of mania associated with bipolar illness.\"\n }\n ]\n },\n {\n \"Term\": \"Nausea\",\n \"MEDDRACode\": \"10028813\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"nausea\",\n \"Probability\": \"0.9994184971\",\n \"SemanticContext\": \"Divalproex sodium extended-release tablets dosage should be increased slowly and with regular monitoring for fluid and nutritional intake 5.14 ADVERSE REACTIONS • Most common adverse reactions reported > 5% are abdominal pain, alopecia, amblyopia/blurred vision, amnesia, anorexia, asthenia, ataxia, back pain, bronchitis, constipation, depression, diarrhea, diplopia, dizziness, dyspnea, dyspepsia, ecchymosis, emotional lability, fever, flu syndrome, headache, increased appetite, infection, insomnia, nausea, nervousness, nystagmus, peripheral edema, pharyngitis, rash, rhinitis, somnolence, thinking abnormal, thrombocytopenia, tinnitus, tremor, vomiting, weight gain, weight loss 6.1 , 6.2 , 6.3 .\"\n },\n {\n \"VerbatimTerm\": \"nausea\",\n \"Probability\": \"0.9996685982\",\n \"SemanticContext\": \"Including the long term extension study, the adverse reactions reported as the primary reason for discontinuation by = 1% of 248 valproate-treated patients were alopecia 6% , nausea and/or vomiting 5% , weight gain 2% , tremor 2% , somnolence 1% , elevated SGOT and/or SGPT 1% , and depression 1% .\"\n },\n {\n \"VerbatimTerm\": \"nausea\",\n \"Probability\": \"0.1456774771\",\n \"SemanticContext\": \"Hepatotoxicity: Warn patients and guardians that nausea, vomiting, abdominal pain, anorexia, diarrhea, asthenia, and/or jaundice can be symptoms of hepatotoxicity and, therefore, require further medical evaluation promptly [see Warnings and Precautions 5.1 ] .\"\n },\n {\n \"VerbatimTerm\": \"nausea\",\n \"Probability\": \"0.4332001805\",\n \"SemanticContext\": \"Pancreatitis: Warn patients and guardians that abdominal pain, nausea, vomiting, and/or anorexia can be symptoms of pancreatitis and, therefore, require further medical evaluation promptly [see Warnings and Precautions 5.5 ].\"\n },\n {\n \"VerbatimTerm\": \"nausea\",\n \"Probability\": \"0.0014289618\",\n \"SemanticContext\": \"Patients and guardians should be warned that abdominal pain, nausea, vomiting, and/or anorexia can be symptoms of pancreatitis that require prompt medical evaluation.\"\n },\n {\n \"VerbatimTerm\": \"nausea\",\n \"Probability\": \"1.42355E-05\",\n \"SemanticContext\": \"Call your healthcare provider right away if you get any of the following symptoms: • nausea or vomiting that does not go away • loss of appetite • pain on the right side of your stomach abdomen • dark urine • swelling of your face • yellowing of your skin or the whites of your eyes In some cases, liver damage may continue despite stopping the drug.\"\n },\n {\n \"VerbatimTerm\": \"nausea\",\n \"Probability\": \"0.0001720786\",\n \"SemanticContext\": \"Call your healthcare provider right away if you have any of these symptoms: • severe stomach pain that you may also feel in your back • nausea or vomiting that does not go away 4.\"\n },\n {\n \"VerbatimTerm\": \"nausea\",\n \"Probability\": \"0.9945847988\",\n \"SemanticContext\": \"The common side effects of divalproex sodium extended-release tablets include: • nausea • headache • sleepiness • vomiting • weakness • tremor • dizziness • stomach pain • blurry vision • double vision • diarrhea • increased appetite • weight gain • hair loss • loss of appetite • problems with walking or coordination These are not all of the possible side effects of divalproex sodium extended-release tablets .\"\n },\n {\n \"VerbatimTerm\": \"nausea\",\n \"Probability\": \"0.9998620152\",\n \"SemanticContext\": \"The most common drug-related adverse reactions reported > 5% and twice the rate of placebo reported in the controlled pediatric mania study were nausea, upper abdominal pain, somnolence, increased ammonia, gastritis and rash.\"\n },\n {\n \"VerbatimTerm\": \"Nausea\",\n \"Probability\": \"0.9995312095\",\n \"SemanticContext\": \"Adverse Event Divalproex Sodium Extended-Release Tablets n = 338 % Placebo n = 263 % Somnolence 26 14 Dyspepsia 23 11 Nausea 19 13 Vomiting 13 5 Diarrhea 12 8 Dizziness 12 7 Pain 11 10 Abdominal Pain 10 5 Accidental Injury 6 5 Asthenia 6 5 Pharyngitis 6 5 .\"\n },\n {\n \"VerbatimTerm\": \"Nausea\",\n \"Probability\": \"0.9980255365\",\n \"SemanticContext\": \"Adverse Reactions Reported by = 5% of Patients Treated with Valproate During Placebo-Controlled Trial of Adjunctive Therapy for Complex Partial Seizures Body System/Event Divalproex Sodium Delayed- Release Tablets N = 77 % Placebo N = 70 % Body as a Whole Headache 31 21 Asthenia 27 7 Fever 6 4 Gastrointestinal System Nausea 48 14 Vomiting 27 7 Abdominal Pain 23 6 Diarrhea 13 6 Anorexia 12 0 Dyspepsia 8 4 Constipation 5 1 Nervous System Somnolence 27 11 Tremor 25 6 Dizziness 25 13 Diplopia 16 9 Amblyopia/Blurred Vision 12 9 Ataxia 8 1 Nystagmus 8 1 Emotional Lability 6 4 Thinking Abnormal 6 0 Amnesia 5 1 Respiratory System Flu Syndrome 12 9 Infection 12 6 Bronchitis 5 1 Rhinitis 5 4 Other Alopecia 6 1 Weight Loss 6 0 .\"\n },\n {\n \"VerbatimTerm\": \"Nausea\",\n \"Probability\": \"0.9988637567\",\n \"SemanticContext\": \"Body System/Event High Dose n = 131 % Low Dose n = 134 % Body as a Whole Asthenia 21 10 Digestive System Nausea 34 26 Diarrhea 23 19 Vomiting 23 15 Abdominal Pain 12 9 Anorexia 11 4 Dyspepsia 11 10 Hemic/Lymphatic System Thrombocytopenia 24 1 Ecchymosis 5 4 Metabolic/Nutritional Weight Gain 9 4 Peripheral Edema 8 3 Nervous System Tremor 57 19 Somnolence 30 18 Dizziness 18 13 Insomnia 15 9 Nervousness 11 7 Amnesia 7 4 Nystagmus 7 1 Depression 5 4 Respiratory System Infection 20 13 Pharyngitis 8 2 Dyspnea 5 1 Skin and Appendages Alopecia 24 13 Special Senses Amblyopia/Blurred Vision 8 4 Tinnitus 7 1 .\"\n },\n {\n \"VerbatimTerm\": \"Nausea\",\n \"Probability\": \"0.9991463423\",\n \"SemanticContext\": \"Body System Event Divalproex Sodium Extended-Release Tablets n = 122 % Placebo n = 115 % Gastrointestinal System Nausea 15 9 Dyspepsia 7 4 Diarrhea 7 3 Vomiting 7 2 Abdominal Pain 7 5 Nervous System Somnolence 7 2 Other Infection 15 14 .\"\n },\n {\n \"VerbatimTerm\": \"Nausea\",\n \"Probability\": \"0.9991129637\",\n \"SemanticContext\": \"Body System Reaction Divalproex Sodium Delayed-Release Tablets n = 202 % Placebo n = 81 % Gastrointestinal System Nausea 31 10 Dyspepsia 13 9 Diarrhea 12 7 Vomiting 11 1 Abdominal Pain 9 4 Increased Appetite 6 4 Nervous System Asthenia 20 9 Somnolence 17 5 Dizziness 12 6 Tremor 9 0 Other Weight Gain 8 2 Back Pain 8 6 Alopecia 7 1 .\"\n }\n ]\n },\n {\n \"Term\": \"Psychomotor hyperactivity\",\n \"MEDDRACode\": \"10037211\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"psychomotor hyperactivity\",\n \"Probability\": \"0.9886537194\",\n \"SemanticContext\": \"Psychiatric: Emotional upset, psychosis, aggression, psychomotor hyperactivity, hostility, disturbance in attention, learning disorder, and behavioral deterioration.\"\n }\n ]\n },\n {\n \"Term\": \"Vomiting\",\n \"MEDDRACode\": \"10047700\",\n \"Overdose\": true,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"emesis\",\n \"Probability\": \"0.0496498942\",\n \"SemanticContext\": \"The benefit of gastric lavage or emesis will vary with the time since ingestion.\"\n }\n ]\n },\n {\n \"Term\": \"Abortion spontaneous\",\n \"MEDDRACode\": \"10000234\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"miscarriage\",\n \"Probability\": \"0.7700802088\",\n \"SemanticContext\": \"In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.\"\n }\n ]\n },\n {\n \"Term\": \"Acute hepatic failure\",\n \"MEDDRACode\": \"10000804\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"acute liver failure\",\n \"Probability\": \"0.9547741413\",\n \"SemanticContext\": \"Valproate-induced acute liver failure and liver-related deaths have been reported in patients with hereditary neurometabolic syndromes caused by mutations in the gene for mitochondrial DNA polymerase ?\"\n }\n ]\n },\n {\n \"Term\": \"Cytomegalovirus test\",\n \"MEDDRACode\": \"10061806\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"CMV\",\n \"Probability\": \"4.584E-06\",\n \"SemanticContext\": \"5.17 Effect on HIV and CMV Viruses Replication There are in vitro studies that suggest valproate stimulates the replication of the HIV and CMV viruses under certain experimental conditions.\"\n },\n {\n \"VerbatimTerm\": \"CMV\",\n \"Probability\": \"0.0001762211\",\n \"SemanticContext\": \"5.17 Effect on HIV and CMV Viruses Replication There are in vitro studies that suggest valproate stimulates the replication of the HIV and CMV viruses under certain experimental conditions.\"\n },\n {\n \"VerbatimTerm\": \"CMV\",\n \"Probability\": \"3.609E-05\",\n \"SemanticContext\": \"Nevertheless, these data should be borne in mind when interpreting the results from regular monitoring of the viral load in HIV infected patients receiving valproate or when following CMV infected patients clinically.\"\n }\n ]\n },\n {\n \"Term\": \"Cytopenia\",\n \"MEDDRACode\": \"10066274\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"cytopenias\",\n \"Probability\": \"0.2256715\",\n \"SemanticContext\": \"Because of reports of cytopenias, inhibition of the secondary phase of platelet aggregation, and abnormal coagulation parameters, e.g., low fibrinogen, coagulation factor deficiencies, acquired von Willebrand’s disease , measurements of complete blood counts and coagulation tests are recommended before initiating therapy and at periodic intervals.\"\n }\n ]\n },\n {\n \"Term\": \"Full blood count\",\n \"MEDDRACode\": \"10017411\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"complete blood counts\",\n \"Probability\": \"0.0011069775\",\n \"SemanticContext\": \"Because of reports of cytopenias, inhibition of the secondary phase of platelet aggregation, and abnormal coagulation parameters, e.g., low fibrinogen, coagulation factor deficiencies, acquired von Willebrand’s disease , measurements of complete blood counts and coagulation tests are recommended before initiating therapy and at periodic intervals.\"\n }\n ]\n },\n {\n \"Term\": \"Haemodialysis\",\n \"MEDDRACode\": \"10018875\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hemodialysis\",\n \"Probability\": \"0.0012031794\",\n \"SemanticContext\": \"Renal Disease A slight reduction 27% in the unbound clearance of valproate has been reported in patients with renal failure creatinine clearance< 10 mL/minute ; however, hemodialysis typically reduces valproate concentrations by about 20%.\"\n },\n {\n \"VerbatimTerm\": \"hemodialysis\",\n \"Probability\": \"0.0026501715\",\n \"SemanticContext\": \"In overdose situations, the fraction of drug not bound to protein is high and hemodialysis or tandem hemodialysis plus hemoperfusion may result in significant removal of drug.\"\n },\n {\n \"VerbatimTerm\": \"hemodialysis\",\n \"Probability\": \"0.0001451969\",\n \"SemanticContext\": \"In overdose situations, the fraction of drug not bound to protein is high and hemodialysis or tandem hemodialysis plus hemoperfusion may result in significant removal of drug.\"\n }\n ]\n },\n {\n \"Term\": \"Crigler-Najjar syndrome\",\n \"MEDDRACode\": \"10011386\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"CNS\",\n \"Probability\": \"0.233169347\",\n \"SemanticContext\": \"CNS Distribution Valproate concentrations in cerebrospinal fluid CSF approximate unbound concentrations in plasma about 10% of total concentration .\"\n },\n {\n \"VerbatimTerm\": \"CNS\",\n \"Probability\": \"0.011197269\",\n \"SemanticContext\": \"CNS Depression: Since valproate products may produce CNS depression, especially when combined with another CNS depressant e.g., alcohol , advise patients not to engage in hazardous activities, such as driving an automobile or operating dangerous machinery, until it is known that they do not become drowsy from the drug.\"\n },\n {\n \"VerbatimTerm\": \"CNS\",\n \"Probability\": \"0.0114336908\",\n \"SemanticContext\": \"Naloxone has been reported to reverse the CNS depressant effects of valproate overdosage.\"\n }\n ]\n },\n {\n \"Term\": \"Analgesic drug level\",\n \"MEDDRACode\": \"10060090\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Acetaminophen\",\n \"Probability\": \"8.31085E-05\",\n \"SemanticContext\": \"\\n \\n Drugs for Which Either No Interaction or a Likely Clinically Unimportant Interaction Has Been Observed\\n Acetaminophen Valproate had no effect on any of the pharmacokinetic parameters of acetaminophen when it was concurrently administered to three epileptic patients.\"\n },\n {\n \"VerbatimTerm\": \"acetaminophen\",\n \"Probability\": \"9.53073E-05\",\n \"SemanticContext\": \"\\n \\n Drugs for Which Either No Interaction or a Likely Clinically Unimportant Interaction Has Been Observed\\n Acetaminophen Valproate had no effect on any of the pharmacokinetic parameters of acetaminophen when it was concurrently administered to three epileptic patients.\"\n }\n ]\n },\n {\n \"Term\": \"Affect lability\",\n \"MEDDRACode\": \"10054196\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"emotional lability\",\n \"Probability\": \"0.9287508726\",\n \"SemanticContext\": \"Divalproex sodium extended-release tablets dosage should be increased slowly and with regular monitoring for fluid and nutritional intake 5.14 ADVERSE REACTIONS • Most common adverse reactions reported > 5% are abdominal pain, alopecia, amblyopia/blurred vision, amnesia, anorexia, asthenia, ataxia, back pain, bronchitis, constipation, depression, diarrhea, diplopia, dizziness, dyspnea, dyspepsia, ecchymosis, emotional lability, fever, flu syndrome, headache, increased appetite, infection, insomnia, nausea, nervousness, nystagmus, peripheral edema, pharyngitis, rash, rhinitis, somnolence, thinking abnormal, thrombocytopenia, tinnitus, tremor, vomiting, weight gain, weight loss 6.1 , 6.2 , 6.3 .\"\n },\n {\n \"VerbatimTerm\": \"Emotional Lability\",\n \"Probability\": \"0.8188846111\",\n \"SemanticContext\": \"Adverse Reactions Reported by = 5% of Patients Treated with Valproate During Placebo-Controlled Trial of Adjunctive Therapy for Complex Partial Seizures Body System/Event Divalproex Sodium Delayed- Release Tablets N = 77 % Placebo N = 70 % Body as a Whole Headache 31 21 Asthenia 27 7 Fever 6 4 Gastrointestinal System Nausea 48 14 Vomiting 27 7 Abdominal Pain 23 6 Diarrhea 13 6 Anorexia 12 0 Dyspepsia 8 4 Constipation 5 1 Nervous System Somnolence 27 11 Tremor 25 6 Dizziness 25 13 Diplopia 16 9 Amblyopia/Blurred Vision 12 9 Ataxia 8 1 Nystagmus 8 1 Emotional Lability 6 4 Thinking Abnormal 6 0 Amnesia 5 1 Respiratory System Flu Syndrome 12 9 Infection 12 6 Bronchitis 5 1 Rhinitis 5 4 Other Alopecia 6 1 Weight Loss 6 0 .\"\n }\n ]\n },\n {\n \"Term\": \"Influenza\",\n \"MEDDRACode\": \"10022000\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"flu syndrome\",\n \"Probability\": \"0.999132514\",\n \"SemanticContext\": \"Divalproex sodium extended-release tablets dosage should be increased slowly and with regular monitoring for fluid and nutritional intake 5.14 ADVERSE REACTIONS • Most common adverse reactions reported > 5% are abdominal pain, alopecia, amblyopia/blurred vision, amnesia, anorexia, asthenia, ataxia, back pain, bronchitis, constipation, depression, diarrhea, diplopia, dizziness, dyspnea, dyspepsia, ecchymosis, emotional lability, fever, flu syndrome, headache, increased appetite, infection, insomnia, nausea, nervousness, nystagmus, peripheral edema, pharyngitis, rash, rhinitis, somnolence, thinking abnormal, thrombocytopenia, tinnitus, tremor, vomiting, weight gain, weight loss 6.1 , 6.2 , 6.3 .\"\n },\n {\n \"VerbatimTerm\": \"flu syndrome\",\n \"Probability\": \"0.9900759459\",\n \"SemanticContext\": \"Adverse Reactions Reported by > 5% of Divalproex Sodium Extended-Release Tablets-Treated Patients During the Migraine Placebo-Controlled Trial with a Greater Incidence than Patients Taking Placebo The following adverse reactions occurred in greater than 5% of divalproex sodium extended-release tablets-treated patients and at a greater incidence for placebo than for divalproex sodium extended-release tablets: asthenia and flu syndrome.\"\n },\n {\n \"VerbatimTerm\": \"flu syndrome\",\n \"Probability\": \"0.9724451303\",\n \"SemanticContext\": \"Adverse Reactions Reported by > 5% of Valproate-Treated Patients During Migraine Placebo-Controlled Trials with a Greater Incidence than Patients Taking Placebo The following adverse reactions occurred in greater than 5% of divalproex sodium delayed-release tablets-treated patients and at a greater incidence for placebo than for divalproex sodium delayed-release tablets: flu syndrome and pharyngitis.\"\n },\n {\n \"VerbatimTerm\": \"Flu Syndrome\",\n \"Probability\": \"0.087128371\",\n \"SemanticContext\": \"The following additional adverse reactions were reported by greater than 1% of the divalproex sodium extended-release tablets-treated patients in controlled clinical trials: Body as a Whole: Back Pain, Chills, Chills and Fever, Drug Level Increased, Flu Syndrome, Infection, Infection Fungal, Neck Rigidity.\"\n },\n {\n \"VerbatimTerm\": \"Flu Syndrome\",\n \"Probability\": \"0.9663661122\",\n \"SemanticContext\": \"Adverse Reactions Reported by = 5% of Patients Treated with Valproate During Placebo-Controlled Trial of Adjunctive Therapy for Complex Partial Seizures Body System/Event Divalproex Sodium Delayed- Release Tablets N = 77 % Placebo N = 70 % Body as a Whole Headache 31 21 Asthenia 27 7 Fever 6 4 Gastrointestinal System Nausea 48 14 Vomiting 27 7 Abdominal Pain 23 6 Diarrhea 13 6 Anorexia 12 0 Dyspepsia 8 4 Constipation 5 1 Nervous System Somnolence 27 11 Tremor 25 6 Dizziness 25 13 Diplopia 16 9 Amblyopia/Blurred Vision 12 9 Ataxia 8 1 Nystagmus 8 1 Emotional Lability 6 4 Thinking Abnormal 6 0 Amnesia 5 1 Respiratory System Flu Syndrome 12 9 Infection 12 6 Bronchitis 5 1 Rhinitis 5 4 Other Alopecia 6 1 Weight Loss 6 0 .\"\n }\n ]\n },\n {\n \"Term\": \"Dyspepsia\",\n \"MEDDRACode\": \"10013946\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"dyspepsia\",\n \"Probability\": \"0.9996887445\",\n \"SemanticContext\": \"Divalproex sodium extended-release tablets dosage should be increased slowly and with regular monitoring for fluid and nutritional intake 5.14 ADVERSE REACTIONS • Most common adverse reactions reported > 5% are abdominal pain, alopecia, amblyopia/blurred vision, amnesia, anorexia, asthenia, ataxia, back pain, bronchitis, constipation, depression, diarrhea, diplopia, dizziness, dyspnea, dyspepsia, ecchymosis, emotional lability, fever, flu syndrome, headache, increased appetite, infection, insomnia, nausea, nervousness, nystagmus, peripheral edema, pharyngitis, rash, rhinitis, somnolence, thinking abnormal, thrombocytopenia, tinnitus, tremor, vomiting, weight gain, weight loss 6.1 , 6.2 , 6.3 .\"\n },\n {\n \"VerbatimTerm\": \"Dyspepsia\",\n \"Probability\": \"0.9997763634\",\n \"SemanticContext\": \"Adverse Event Divalproex Sodium Extended-Release Tablets n = 338 % Placebo n = 263 % Somnolence 26 14 Dyspepsia 23 11 Nausea 19 13 Vomiting 13 5 Diarrhea 12 8 Dizziness 12 7 Pain 11 10 Abdominal Pain 10 5 Accidental Injury 6 5 Asthenia 6 5 Pharyngitis 6 5 .\"\n },\n {\n \"VerbatimTerm\": \"Dyspepsia\",\n \"Probability\": \"0.9997005463\",\n \"SemanticContext\": \"Adverse Reactions Reported by = 5% of Patients Treated with Valproate During Placebo-Controlled Trial of Adjunctive Therapy for Complex Partial Seizures Body System/Event Divalproex Sodium Delayed- Release Tablets N = 77 % Placebo N = 70 % Body as a Whole Headache 31 21 Asthenia 27 7 Fever 6 4 Gastrointestinal System Nausea 48 14 Vomiting 27 7 Abdominal Pain 23 6 Diarrhea 13 6 Anorexia 12 0 Dyspepsia 8 4 Constipation 5 1 Nervous System Somnolence 27 11 Tremor 25 6 Dizziness 25 13 Diplopia 16 9 Amblyopia/Blurred Vision 12 9 Ataxia 8 1 Nystagmus 8 1 Emotional Lability 6 4 Thinking Abnormal 6 0 Amnesia 5 1 Respiratory System Flu Syndrome 12 9 Infection 12 6 Bronchitis 5 1 Rhinitis 5 4 Other Alopecia 6 1 Weight Loss 6 0 .\"\n },\n {\n \"VerbatimTerm\": \"Dyspepsia\",\n \"Probability\": \"0.9995083809\",\n \"SemanticContext\": \"Body System/Event High Dose n = 131 % Low Dose n = 134 % Body as a Whole Asthenia 21 10 Digestive System Nausea 34 26 Diarrhea 23 19 Vomiting 23 15 Abdominal Pain 12 9 Anorexia 11 4 Dyspepsia 11 10 Hemic/Lymphatic System Thrombocytopenia 24 1 Ecchymosis 5 4 Metabolic/Nutritional Weight Gain 9 4 Peripheral Edema 8 3 Nervous System Tremor 57 19 Somnolence 30 18 Dizziness 18 13 Insomnia 15 9 Nervousness 11 7 Amnesia 7 4 Nystagmus 7 1 Depression 5 4 Respiratory System Infection 20 13 Pharyngitis 8 2 Dyspnea 5 1 Skin and Appendages Alopecia 24 13 Special Senses Amblyopia/Blurred Vision 8 4 Tinnitus 7 1 .\"\n },\n {\n \"VerbatimTerm\": \"Dyspepsia\",\n \"Probability\": \"0.9998464584\",\n \"SemanticContext\": \"Body System Event Divalproex Sodium Extended-Release Tablets n = 122 % Placebo n = 115 % Gastrointestinal System Nausea 15 9 Dyspepsia 7 4 Diarrhea 7 3 Vomiting 7 2 Abdominal Pain 7 5 Nervous System Somnolence 7 2 Other Infection 15 14 .\"\n },\n {\n \"VerbatimTerm\": \"Dyspepsia\",\n \"Probability\": \"0.9998312593\",\n \"SemanticContext\": \"Body System Reaction Divalproex Sodium Delayed-Release Tablets n = 202 % Placebo n = 81 % Gastrointestinal System Nausea 31 10 Dyspepsia 13 9 Diarrhea 12 7 Vomiting 11 1 Abdominal Pain 9 4 Increased Appetite 6 4 Nervous System Asthenia 20 9 Somnolence 17 5 Dizziness 12 6 Tremor 9 0 Other Weight Gain 8 2 Back Pain 8 6 Alopecia 7 1 .\"\n }\n ]\n },\n {\n \"Term\": \"Bronchitis\",\n \"MEDDRACode\": \"10006451\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"bronchitis\",\n \"Probability\": \"0.9984010458\",\n \"SemanticContext\": \"Divalproex sodium extended-release tablets dosage should be increased slowly and with regular monitoring for fluid and nutritional intake 5.14 ADVERSE REACTIONS • Most common adverse reactions reported > 5% are abdominal pain, alopecia, amblyopia/blurred vision, amnesia, anorexia, asthenia, ataxia, back pain, bronchitis, constipation, depression, diarrhea, diplopia, dizziness, dyspnea, dyspepsia, ecchymosis, emotional lability, fever, flu syndrome, headache, increased appetite, infection, insomnia, nausea, nervousness, nystagmus, peripheral edema, pharyngitis, rash, rhinitis, somnolence, thinking abnormal, thrombocytopenia, tinnitus, tremor, vomiting, weight gain, weight loss 6.1 , 6.2 , 6.3 .\"\n },\n {\n \"VerbatimTerm\": \"Bronchitis\",\n \"Probability\": \"0.9969331622\",\n \"SemanticContext\": \"Adverse Reactions Reported by = 5% of Patients Treated with Valproate During Placebo-Controlled Trial of Adjunctive Therapy for Complex Partial Seizures Body System/Event Divalproex Sodium Delayed- Release Tablets N = 77 % Placebo N = 70 % Body as a Whole Headache 31 21 Asthenia 27 7 Fever 6 4 Gastrointestinal System Nausea 48 14 Vomiting 27 7 Abdominal Pain 23 6 Diarrhea 13 6 Anorexia 12 0 Dyspepsia 8 4 Constipation 5 1 Nervous System Somnolence 27 11 Tremor 25 6 Dizziness 25 13 Diplopia 16 9 Amblyopia/Blurred Vision 12 9 Ataxia 8 1 Nystagmus 8 1 Emotional Lability 6 4 Thinking Abnormal 6 0 Amnesia 5 1 Respiratory System Flu Syndrome 12 9 Infection 12 6 Bronchitis 5 1 Rhinitis 5 4 Other Alopecia 6 1 Weight Loss 6 0 .\"\n }\n ]\n },\n {\n \"Term\": \"Blood albumin decreased\",\n \"MEDDRACode\": \"10005287\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"decreased albumin\",\n \"Probability\": \"0.0021126568\",\n \"SemanticContext\": \"Liver disease is also associated with decreased albumin concentrations and larger unbound fractions 2 to 2.6 fold increase of valproate.\"\n }\n ]\n },\n {\n \"Term\": \"Shift to the left\",\n \"MEDDRACode\": \"10056383\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"shifted to the left\",\n \"Probability\": \"0.0001569688\",\n \"SemanticContext\": \"Thus, in a display of this type, the curve for an effective treatment is shifted to the left of the curve for placebo.\"\n },\n {\n \"VerbatimTerm\": \"shifted to the left\",\n \"Probability\": \"0.0001207932\",\n \"SemanticContext\": \"Thus, in a display of this type, the curve for a more effective treatment is shifted to the left of the curve for a less effective treatment.\"\n }\n ]\n },\n {\n \"Term\": \"Drug interaction\",\n \"MEDDRACode\": \"10013710\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"interactions\",\n \"Probability\": \"0.0015653074\",\n \"SemanticContext\": \"The list is not exhaustive nor could it be, since new interactions are continuously being reported.\"\n },\n {\n \"VerbatimTerm\": \"interactions\",\n \"Probability\": \"0.0007103384\",\n \"SemanticContext\": \"The list is not exhaustive, since new interactions are continuously being reported.\"\n },\n {\n \"VerbatimTerm\": \"Interaction\",\n \"Probability\": \"9.1769E-06\",\n \"SemanticContext\": \"\\n \\n Drugs for Which a Potentially Important Interaction Has Been Observed\\n Aspirin A study involving the co-administration of aspirin at antipyretic doses 11 to 16 mg/kg with valproate to pediatric patients n = 6 revealed a decrease in protein binding and an inhibition of metabolism of valproate.\"\n },\n {\n \"VerbatimTerm\": \"Interaction\",\n \"Probability\": \"1.94782E-05\",\n \"SemanticContext\": \"\\n \\n Drugs for Which Either No Interaction or a Likely Clinically Unimportant Interaction Has Been Observed\\n Antacids A study involving the co-administration of valproate 500 mg with commonly administered antacids Maalox ® , Trisogel, and Titralac ™ - 160 mEq doses did not reveal any effect on the extent of absorption of valproate.\"\n },\n {\n \"VerbatimTerm\": \"Interaction\",\n \"Probability\": \"4.6617E-06\",\n \"SemanticContext\": \"\\n \\n Drugs for Which Either No Interaction or a Likely Clinically Unimportant Interaction Has Been Observed\\n Antacids A study involving the co-administration of valproate 500 mg with commonly administered antacids Maalox ® , Trisogel, and Titralac ™ - 160 mEq doses did not reveal any effect on the extent of absorption of valproate.\"\n },\n {\n \"VerbatimTerm\": \"Interaction\",\n \"Probability\": \"2.40534E-05\",\n \"SemanticContext\": \"\\n \\n Drugs for Which a Potentially Important Valproate Interaction Has Been Observed\\n Amitriptyline/Nortriptyline Administration of a single oral 50 mg dose of amitriptyline to 15 normal volunteers 10 males and 5 females who received valproate 500 mg BID resulted in a 21% decrease in plasma clearance of amitriptyline and a 34% decrease in the net clearance of nortriptyline.\"\n },\n {\n \"VerbatimTerm\": \"Interaction\",\n \"Probability\": \"1.95694E-05\",\n \"SemanticContext\": \"\\n \\n Drugs for Which Either No Interaction or a Likely Clinically Unimportant Interaction Has Been Observed\\n Acetaminophen Valproate had no effect on any of the pharmacokinetic parameters of acetaminophen when it was concurrently administered to three epileptic patients.\"\n },\n {\n \"VerbatimTerm\": \"Interaction\",\n \"Probability\": \"1.00128E-05\",\n \"SemanticContext\": \"\\n \\n Drugs for Which Either No Interaction or a Likely Clinically Unimportant Interaction Has Been Observed\\n Acetaminophen Valproate had no effect on any of the pharmacokinetic parameters of acetaminophen when it was concurrently administered to three epileptic patients.\"\n },\n {\n \"VerbatimTerm\": \"Interaction\",\n \"Probability\": \"0.002463609\",\n \"SemanticContext\": \"5.13 Interaction with Carbapenem Antibiotics Carbapenem antibiotics for example, ertapenem, imipenem, meropenem; this is not a complete list may reduce serum valproate concentrations to subtherapeutic levels, resulting in loss of seizure control.\"\n },\n {\n \"VerbatimTerm\": \"interaction\",\n \"Probability\": \"0.0001652241\",\n \"SemanticContext\": \"Whether or not the interaction observed in this study applies to adults is unknown, but caution should be observed if valproate and aspirin are to be co-administered.\"\n },\n {\n \"VerbatimTerm\": \"interaction\",\n \"Probability\": \"0.0001036083\",\n \"SemanticContext\": \"The mechanism of this interaction is not well understood.\"\n },\n {\n \"VerbatimTerm\": \"interaction\",\n \"Probability\": \"0.0006383657\",\n \"SemanticContext\": \"Primidone, which is metabolized to a barbiturate, may be involved in a similar interaction with valproate.\"\n },\n {\n \"VerbatimTerm\": \"interaction\",\n \"Probability\": \"0.0066023171\",\n \"SemanticContext\": \"Clozapine In psychotic patients n = 11 , no interaction was observed when valproate was co-administered with clozapine.\"\n },\n {\n \"VerbatimTerm\": \"interaction\",\n \"Probability\": \"0.0167013407\",\n \"SemanticContext\": \"Behavioral abnormalities including cognitive, locomotor, and social interaction deficits and brain histopathological changes have also been reported in mice and rat offspring exposed prenatally to clinically relevant doses of valproate.\"\n },\n {\n \"VerbatimTerm\": \"interaction\",\n \"Probability\": \"0.0010752976\",\n \"SemanticContext\": \"Although not studied, an interaction of topiramate and valproate may exacerbate existing defects or unmask deficiencies in susceptible persons.\"\n }\n ]\n },\n {\n \"Term\": \"Partial seizures\",\n \"MEDDRACode\": \"10061334\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"epilepsy focal\",\n \"Probability\": \"0.1843206584\",\n \"SemanticContext\": \"POLG-related disorders should be suspected in patients with a family history or suggestive symptoms of a POLG-related disorder, including but not limited to unexplained encephalopathy, refractory epilepsy focal, myoclonic , status epilepticus at presentation, developmental delays, psychomotor regression, axonal sensorimotor neuropathy, myopathy cerebellar ataxia, ophthalmoplegia, or complicated migraine with occipital aura.\"\n }\n ]\n },\n {\n \"Term\": \"Ileostomy\",\n \"MEDDRACode\": \"10021321\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"ileostomy\",\n \"Probability\": \"0.0029147863\",\n \"SemanticContext\": \"Some patients have had anatomic including ileostomy or colostomy or functional gastrointestinal disorders with shortened GI transit times.\"\n }\n ]\n },\n {\n \"Term\": \"Myocarditis\",\n \"MEDDRACode\": \"10028606\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"myocarditis\",\n \"Probability\": \"0.9913307428\",\n \"SemanticContext\": \"DRESS typically, although not exclusively, presents with fever, rash, lymphadenopathy, and/or facial swelling, in association with other organ system involvement, such as hepatitis, nephritis, hematological abnormalities, myocarditis, or myositis sometimes resembling an acute viral infection.\"\n }\n ]\n },\n {\n \"Term\": \"Euphoric mood\",\n \"MEDDRACode\": \"10015535\",\n \"Overdose\": true,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": true\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"higher\",\n \"Probability\": \"0.0163292885\",\n \"SemanticContext\": \"Children under the age of two years and patients with mitochondrial disorders are at higher risk.\"\n },\n {\n \"VerbatimTerm\": \"higher\",\n \"Probability\": \"0.0037188232\",\n \"SemanticContext\": \"Therefore increased monitoring of valproate and concomitant drug concentrations and dosage adjustment are indicated whenever enzyme-inducing or inhibiting drugs are introduced or withdrawn 7.1 • Aspirin, carbapenem antibiotics, estrogen-containing hormonal contraceptives: Monitoring of valproate concentrations is recommended 7.1 • Co-administration of valproate can affect the pharmacokinetics of other drugs e.g., diazepam, ethosuximide, lamotrigine, phenytoin by inhibiting their metabolism or protein binding displacement 7.2 • Patients stabilized on rufinamide should begin valproate therapy at a low dose, and titrate to clinically effective dose 7.2 • Dosage adjustment of amitriptyline/nortriptyline, propofol, warfarin, and zidovudine may be necessary if used concomitantly with divalproex sodium extended-release tablets 7.2 • Topiramate: Hyperammonemia and encephalopathy 5.10 , 7.3 USE IN SPECIFIC POPULATIONS • Pregnancy: Divalproex sodium extended-release tablets can cause congenital malformations including neural tube defects, decreased IQ, and neurodevelopmental disorders 5.2 , 5.3 , 8.1 • Pediatric: Children under the age of two years are at considerably higher risk of fatal hepatotoxicity 5.1 , 8.4 • Geriatric: Reduce starting dose; increase dosage more slowly; monitor fluid and nutritional intake, and somnolence 5.14 , 8.5 See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.\"\n },\n {\n \"VerbatimTerm\": \"higher\",\n \"Probability\": \"0.0017131865\",\n \"SemanticContext\": \"\\n \\n Epilepsy\\n The therapeutic range in epilepsy is commonly considered to be 50 to 100 mcg/mL of total valproate, although some patients may be controlled with lower or higher plasma concentrations.\"\n },\n {\n \"VerbatimTerm\": \"higher\",\n \"Probability\": \"0.0002990365\",\n \"SemanticContext\": \"Conversion from Divalproex Sodium Delayed-Release Tablets to Divalproex Sodium Extended-Release Tablets When divalproex sodium extended-release tablets are given in doses 8 to 20% higher than the total daily dose of divalproex sodium delayed-release tablets, the two formulations are bioequivalent.\"\n },\n {\n \"VerbatimTerm\": \"higher\",\n \"Probability\": \"0.0010672212\",\n \"SemanticContext\": \"In two randomized, crossover studies, multiple daily doses of divalproex sodium delayed-release tablets were compared to 8 to 20% higher once daily doses of divalproex sodium extended-release tablets.\"\n },\n {\n \"VerbatimTerm\": \"higher\",\n \"Probability\": \"0.0010593534\",\n \"SemanticContext\": \"Additionally, valproate C max was lower, and C min was either higher or not different, for divalproex sodium extended-release tablets relative to divalproex sodium delayed-release tablets regimens see Table 8 .\"\n },\n {\n \"VerbatimTerm\": \"higher\",\n \"Probability\": \"0.0145234466\",\n \"SemanticContext\": \"This figure shows that the proportion of patients achieving any particular level of improvement was consistently higher for valproate than for placebo.\"\n },\n {\n \"VerbatimTerm\": \"higher\",\n \"Probability\": \"0.0019272864\",\n \"SemanticContext\": \"This figure shows that the proportion of patients achieving any particular level of reduction was consistently higher for high dose valproate than for low dose valproate.\"\n },\n {\n \"VerbatimTerm\": \"higher\",\n \"Probability\": \"5.10243E-05\",\n \"SemanticContext\": \"Thus, patients on monotherapy will generally have longer half-lives and higher concentrations than patients receiving polytherapy with antiepilepsy drugs.\"\n },\n {\n \"VerbatimTerm\": \"higher\",\n \"Probability\": \"0.0002497137\",\n \"SemanticContext\": \"The benefit of improved seizure control with higher doses should be weighed against the possibility of a greater incidence of adverse reactions.\"\n },\n {\n \"VerbatimTerm\": \"higher\",\n \"Probability\": \"0.0001740456\",\n \"SemanticContext\": \"Some patients may be controlled with lower or higher serum concentrations [see Clinical Pharmacology 12.3 ].\"\n },\n {\n \"VerbatimTerm\": \"higher\",\n \"Probability\": \"0.0001073053\",\n \"SemanticContext\": \"2.4 Conversion from Divalproex Sodium Delayed-Release Tablets to Divalproex Sodium Extended-Release Tablets In adult patients and pediatric patients 10 years of age or older with epilepsy previously receiving divalproex sodium delayed-release tablets, divalproex sodium extended-release tablets should be administered once-daily using a dose 8 to 20% higher than the total daily dose of divalproex sodium delayed-release tablets Table 1 .\"\n },\n {\n \"VerbatimTerm\": \"higher\",\n \"Probability\": \"0.0001805127\",\n \"SemanticContext\": \"For patients whose divalproex sodium delayed-release tablets total daily dose cannot be directly converted to divalproex sodium extended-release tablets, consideration may be given at the clinician’s discretion to increase the patient’s divalproex sodium delayed-release tablets total daily dose to the next higher dosage before converting to the appropriate total daily dose of divalproex sodium extended-release tablets.\"\n },\n {\n \"VerbatimTerm\": \"higher\",\n \"Probability\": \"0.0003795326\",\n \"SemanticContext\": \"Dose Conversion Divalproex Sodium Delayed-Release Tablets Total Daily Dose mg Divalproex Sodium Extended-Release Tablets mg 500 These total daily doses of divalproex sodium delayed-release tablets cannot be directly converted to an 8 to 20% higher total daily dose of divalproex sodium extended-release tablets because the required dosing strengths of divalproex sodium extended-release tablets are not available.\"\n },\n {\n \"VerbatimTerm\": \"higher\",\n \"Probability\": \"0.0001948774\",\n \"SemanticContext\": \"Consideration may be given at the clinician’s discretion to increase the patient’s divalproex sodium delayed-release tablets total daily dose to the next higher dosage before converting to the appropriate total daily dose of divalproex sodium extended-release tablets.\"\n },\n {\n \"VerbatimTerm\": \"higher\",\n \"Probability\": \"5.08722E-05\",\n \"SemanticContext\": \"The benefit of improved therapeutic effect with higher doses should be weighed against the possibility of a greater incidence of adverse reactions.\"\n },\n {\n \"VerbatimTerm\": \"higher\",\n \"Probability\": \"0.0139448345\",\n \"SemanticContext\": \"The rate of congenital malformations among babies born to epileptic mothers who used valproate during pregnancy has been shown to be about four times higher than the rate among babies born to epileptic mothers who used other anti-seizure monotherapies [see Warnings and Precautions 5.2 and Data Human ] .\"\n },\n {\n \"VerbatimTerm\": \"higher\",\n \"Probability\": \"0.0004196167\",\n \"SemanticContext\": \"Epidemiological studies have indicated that children exposed to valproate in utero have lower IQ scores and a higher risk of neurodevelopmental disorders compared to children exposed to either another AED in utero or to no AEDs in utero [see Warnings and Precautions 5.3 and Data Human ] .\"\n },\n {\n \"VerbatimTerm\": \"higher\",\n \"Probability\": \"0.0019289553\",\n \"SemanticContext\": \"POLG e.g., Alpers- Huttenlocher Syndrome at a higher rate than those without these syndromes.\"\n },\n {\n \"VerbatimTerm\": \"higher\",\n \"Probability\": \"0.0025033355\",\n \"SemanticContext\": \"The rate of congenital malformations among babies born to mothers using valproate is about four times higher than the rate among babies born to epileptic mothers using other anti-seizure monotherapies.\"\n },\n {\n \"VerbatimTerm\": \"higher\",\n \"Probability\": \"0.0017239451\",\n \"SemanticContext\": \"The relative risk for suicidal thoughts or behavior was higher in clinical trials for epilepsy than in clinical trials for psychiatric or other conditions, but the absolute risk differences were similar for the epilepsy and psychiatric indications.\"\n },\n {\n \"VerbatimTerm\": \"higher\",\n \"Probability\": \"0.0002665222\",\n \"SemanticContext\": \"The therapeutic benefit which may accompany the higher doses should therefore be weighed against the possibility of a greater incidence of adverse effects.\"\n },\n {\n \"VerbatimTerm\": \"higher\",\n \"Probability\": \"0.0055559576\",\n \"SemanticContext\": \"A significantly higher proportion of valproate patients had somnolence compared to placebo, and although not statistically significant, there was a higher proportion of patients with dehydration.\"\n },\n {\n \"VerbatimTerm\": \"higher\",\n \"Probability\": \"0.0101881921\",\n \"SemanticContext\": \"A significantly higher proportion of valproate patients had somnolence compared to placebo, and although not statistically significant, there was a higher proportion of patients with dehydration.\"\n },\n {\n \"VerbatimTerm\": \"higher\",\n \"Probability\": \"0.0063354075\",\n \"SemanticContext\": \"Discontinuations for somnolence were also significantly higher than with placebo.\"\n },\n {\n \"VerbatimTerm\": \"higher\",\n \"Probability\": \"0.010728091\",\n \"SemanticContext\": \"There was a trend for the patients who experienced these events to have a lower baseline albumin concentration, lower valproate clearance, and a higher BUN.\"\n },\n {\n \"VerbatimTerm\": \"higher\",\n \"Probability\": \"0.000806421\",\n \"SemanticContext\": \"Pediatric patients i.e., between 3 months and 10 years have 50% higher clearances expressed on weight i.e., mL/min/kg than do adults.\"\n },\n {\n \"VerbatimTerm\": \"higher\",\n \"Probability\": \"0.0024160743\",\n \"SemanticContext\": \"A higher percentage of patients above 65 years of age reported accidental injury, infection, pain, somnolence, and tremor.\"\n },\n {\n \"VerbatimTerm\": \"high\",\n \"Probability\": \"0.0156855881\",\n \"SemanticContext\": \"POLG 4 , 5.1 • Suspected POLG-related disorder in children under two years of age 4 , 5.1 • Known hypersensitivity to the drug 4 , 5.12 • Urea cycle disorders 4 , 5.6 • Prophylaxis of migraine headaches: Pregnant women, women of childbearing potential not using effective contraception 4 , 8.1 WARNINGS AND PRECAUTIONS • Hepatotoxicity; evaluate high risk populations and monitor serum liver tests 5.1 • Birth defects, decreased IQ, and neurodevelopmental disorders following in utero exposure; should not be used to treat women with epilepsy or bipolar disorder who are pregnant or who plan to become pregnant or to treat a woman of childbearing potential unless other medications have failed to provide adequate symptom control or are otherwise unacceptable 5.2 , 5.3 , 5.4 • Pancreatitis; divalproex sodium extended-release tablets should ordinarily be discontinued 5.5 • Suicidal behavior or ideation; Antiepileptic drugs, including divalproex sodium extended-release tablets, increase the risk of suicidal thoughts or behavior 5.7 • Bleeding and other hematopoietic disorders; monitor platelet counts and coagulation tests 5.8 • Hyperammonemia and hyperammonemic encephalopathy; measure ammonia level if unexplained lethargy and vomiting or changes in mental status, and also with concomitant topiramate use; consider discontinuation of valproate therapy 5.6 , 5.9 , 5.10 • Hypothermia; Hypothermia has been reported during valproate therapy with or without associated hyperammonemia.\"\n },\n {\n \"VerbatimTerm\": \"high\",\n \"Probability\": \"0.00066486\",\n \"SemanticContext\": \"Table 5 lists treatment-emergent adverse reactions which were reported by = 5% of patients in the high dose valproate group, and for which the incidence was greater than in the low dose group, in a controlled trial of divalproex sodium delayed-release tablets monotherapy treatment of complex partial seizures.\"\n },\n {\n \"VerbatimTerm\": \"high\",\n \"Probability\": \"0.0011475682\",\n \"SemanticContext\": \"Adverse Reactions Reported by = 5% of Patients in the High Dose Group in the Controlled Trial of Valproate Monotherapy for Complex Partial Seizures Headache was the only adverse event that occurred in = 5% of patients in the high dose group and at an equal or greater incidence in the low dose group.\"\n },\n {\n \"VerbatimTerm\": \"high\",\n \"Probability\": \"0.0118479729\",\n \"SemanticContext\": \"The study compared the incidence of CPS among patients randomized to either a high or low dose treatment arm.\"\n },\n {\n \"VerbatimTerm\": \"high\",\n \"Probability\": \"0.0004388094\",\n \"SemanticContext\": \"In patients converted to divalproex sodium delayed-release tablets monotherapy, the mean total valproate concentrations during monotherapy were 71 and 123 mcg/mL in the low dose and high dose groups, respectively.\"\n },\n {\n \"VerbatimTerm\": \"high\",\n \"Probability\": \"0.0005512238\",\n \"SemanticContext\": \"Monotherapy Study Median Incidence of CPS per 8 Weeks Treatment Number of Patients Baseline Incidence Randomized Phase Incidence High dose Valproate 131 13.2 10.7 Reduction from baseline statistically significantly greater for high dose than low dose at p = 0.05 level.\"\n },\n {\n \"VerbatimTerm\": \"high\",\n \"Probability\": \"0.0007205904\",\n \"SemanticContext\": \"This figure shows that the proportion of patients achieving any particular level of reduction was consistently higher for high dose valproate than for low dose valproate.\"\n },\n {\n \"VerbatimTerm\": \"high\",\n \"Probability\": \"0.0001486838\",\n \"SemanticContext\": \"For example, when switching from carbamazepine, phenytoin, phenobarbital or primidone monotherapy to high dose valproate monotherapy, 63% of patients experienced no change or a reduction in complex partial seizure rates compared to 54% of patients receiving low dose valproate.\"\n },\n {\n \"VerbatimTerm\": \"high\",\n \"Probability\": \"0.0005930066\",\n \"SemanticContext\": \"Rufinamide concentrations were increased by< 16% to 70%, dependent on concentration of valproate with the larger increases being seen in pediatric patients at high doses or concentrations of valproate .\"\n },\n {\n \"VerbatimTerm\": \"high\",\n \"Probability\": \"0.0032949448\",\n \"SemanticContext\": \"Fatalities have been reported; however patients have recovered from valproate levels as high as 2,120 mcg/mL.\"\n },\n {\n \"VerbatimTerm\": \"high\",\n \"Probability\": \"0.0032086372\",\n \"SemanticContext\": \"In overdose situations, the fraction of drug not bound to protein is high and hemodialysis or tandem hemodialysis plus hemoperfusion may result in significant removal of drug.\"\n },\n {\n \"VerbatimTerm\": \"high\",\n \"Probability\": \"0.0002084672\",\n \"SemanticContext\": \"The primary findings were an increase in the incidence of subcutaneous fibrosarcomas in high-dose male rats receiving valproate and a dose-related trend for benign pulmonary adenomas in male mice receiving valproate.\"\n },\n {\n \"VerbatimTerm\": \"High\",\n \"Probability\": \"0.0007486045\",\n \"SemanticContext\": \"Adverse Reactions Reported by = 5% of Patients in the High Dose Group in the Controlled Trial of Valproate Monotherapy for Complex Partial Seizures Headache was the only adverse event that occurred in = 5% of patients in the high dose group and at an equal or greater incidence in the low dose group.\"\n },\n {\n \"VerbatimTerm\": \"High\",\n \"Probability\": \"0.0004275739\",\n \"SemanticContext\": \"Body System/Event High Dose n = 131 % Low Dose n = 134 % Body as a Whole Asthenia 21 10 Digestive System Nausea 34 26 Diarrhea 23 19 Vomiting 23 15 Abdominal Pain 12 9 Anorexia 11 4 Dyspepsia 11 10 Hemic/Lymphatic System Thrombocytopenia 24 1 Ecchymosis 5 4 Metabolic/Nutritional Weight Gain 9 4 Peripheral Edema 8 3 Nervous System Tremor 57 19 Somnolence 30 18 Dizziness 18 13 Insomnia 15 9 Nervousness 11 7 Amnesia 7 4 Nystagmus 7 1 Depression 5 4 Respiratory System Infection 20 13 Pharyngitis 8 2 Dyspnea 5 1 Skin and Appendages Alopecia 24 13 Special Senses Amblyopia/Blurred Vision 8 4 Tinnitus 7 1 .\"\n },\n {\n \"VerbatimTerm\": \"High\",\n \"Probability\": \"8.09614E-05\",\n \"SemanticContext\": \"Monotherapy Study Median Incidence of CPS per 8 Weeks Treatment Number of Patients Baseline Incidence Randomized Phase Incidence High dose Valproate 131 13.2 10.7 Reduction from baseline statistically significantly greater for high dose than low dose at p = 0.05 level.\"\n },\n {\n \"VerbatimTerm\": \"High\",\n \"Probability\": \"1.27878E-05\",\n \"SemanticContext\": \"• High ammonia levels in your blood: feeling tired, vomiting, changes in mental status.\"\n },\n {\n \"VerbatimTerm\": \"Higher\",\n \"Probability\": \"0.0048920512\",\n \"SemanticContext\": \"Higher than expected free fractions occur in the elderly, in hyperlipidemic patients, and in patients with hepatic and renal diseases.\"\n },\n {\n \"VerbatimTerm\": \"Higher\",\n \"Probability\": \"0.0065135062\",\n \"SemanticContext\": \"Bioavailability of Divalproex Sodium Extended-Release Tablets Relative to Divalproex Sodium Delayed-Release Tablets When Divalproex Sodium Extended-Release Tablets Dose is 8 to 20% Higher Study Population Regimens Relative Bioavailability Divalproex Sodium Extended-Release Tablets vs. Divalproex Sodium Delayed-Release Tablets AUC 24 C max C min Healthy Volunteers N = 35 1,000 & 1,500 mg Divalproex Sodium Extended-Release Tablets vs. 875 & 1,250 mg Divalproex Sodium Delayed-Release Tablets 1.059 0.882 1.173 Patients with epilepsy on concomitant enzyme- inducing antiepilepsy drugs N = 64 1,000 to 5,000 mg Divalproex Sodium Extended-Release Tablets vs. 875 to 4,250 mg Divalproex Sodium Delayed-Release Tablets 1.008 0.899 1.022 .\"\n }\n ]\n },\n {\n \"Term\": \"Bipolar disorder\",\n \"MEDDRACode\": \"10057667\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": true,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"bipolar disorder\",\n \"Probability\": \"0.0022497475\",\n \"SemanticContext\": \"• Acute treatment of manic or mixed episodes associated with bipolar disorder, with or without psychotic features 1.1 • Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures 1.2 • Prophylaxis of migraine headaches 1.3 DOSAGE AND ADMINISTRATION • Divalproex sodium extended-release tablets are intended for once-a-day oral administration.\"\n },\n {\n \"VerbatimTerm\": \"bipolar disorder\",\n \"Probability\": \"1.87228E-05\",\n \"SemanticContext\": \"POLG 4 , 5.1 • Suspected POLG-related disorder in children under two years of age 4 , 5.1 • Known hypersensitivity to the drug 4 , 5.12 • Urea cycle disorders 4 , 5.6 • Prophylaxis of migraine headaches: Pregnant women, women of childbearing potential not using effective contraception 4 , 8.1 WARNINGS AND PRECAUTIONS • Hepatotoxicity; evaluate high risk populations and monitor serum liver tests 5.1 • Birth defects, decreased IQ, and neurodevelopmental disorders following in utero exposure; should not be used to treat women with epilepsy or bipolar disorder who are pregnant or who plan to become pregnant or to treat a woman of childbearing potential unless other medications have failed to provide adequate symptom control or are otherwise unacceptable 5.2 , 5.3 , 5.4 • Pancreatitis; divalproex sodium extended-release tablets should ordinarily be discontinued 5.5 • Suicidal behavior or ideation; Antiepileptic drugs, including divalproex sodium extended-release tablets, increase the risk of suicidal thoughts or behavior 5.7 • Bleeding and other hematopoietic disorders; monitor platelet counts and coagulation tests 5.8 • Hyperammonemia and hyperammonemic encephalopathy; measure ammonia level if unexplained lethargy and vomiting or changes in mental status, and also with concomitant topiramate use; consider discontinuation of valproate therapy 5.6 , 5.9 , 5.10 • Hypothermia; Hypothermia has been reported during valproate therapy with or without associated hyperammonemia.\"\n },\n {\n \"VerbatimTerm\": \"bipolar disorder\",\n \"Probability\": \"0.0295159817\",\n \"SemanticContext\": \"6.1 Mania The incidence of treatment-emergent events has been ascertained based on combined data from two three week placebo-controlled clinical trials of divalproex sodium extended-release tablets in the treatment of manic episodes associated with bipolar disorder.\"\n },\n {\n \"VerbatimTerm\": \"bipolar disorder\",\n \"Probability\": \"0.0145922899\",\n \"SemanticContext\": \"1 INDICATIONS AND USAGE 1.1 Mania Divalproex sodium extended-release tablets are a valproate and are indicated for the treatment of acute manic or mixed episodes associated with bipolar disorder, with or without psychotic features.\"\n },\n {\n \"VerbatimTerm\": \"bipolar disorder\",\n \"Probability\": \"2.43865E-05\",\n \"SemanticContext\": \"1.4 Important Limitations Because of the risk to the fetus of decreased IQ, neurodevelopmental disorders, neural tube defects, and other major congenital malformations, which may occur very early in pregnancy, valproate should not be used to treat women with epilepsy or bipolar disorder who are pregnant or who plan to become pregnant unless other medications have failed to provide adequate symptom control or are otherwise unacceptable.\"\n },\n {\n \"VerbatimTerm\": \"bipolar disorder\",\n \"Probability\": \"0.0001538694\",\n \"SemanticContext\": \"For use in epilepsy or bipolar disorder, valproate should not be used to treat women who are pregnant or who plan to become pregnant unless other medications have failed to provide adequate symptom control or are otherwise unacceptable [see Boxed Warning and Warnings and Precautions 5.2 , 5.3 ] .\"\n },\n {\n \"VerbatimTerm\": \"bipolar disorder\",\n \"Probability\": \"1.41068E-05\",\n \"SemanticContext\": \"Divalproex Sodium Extended-Release Tablets are prescription medicines used: • to treat manic episodes associated with bipolar disorder • alone or with other medicines to treat: • complex partial seizures in adults and children 10 years of age and older • simple and complex absence seizures, with or without other seizure types • to prevent migraine headaches Who should not take divalproex sodium extended-release tablets?\"\n },\n {\n \"VerbatimTerm\": \"bipolar disorder\",\n \"Probability\": \"0.0005189478\",\n \"SemanticContext\": \"A published study of 6 breastfeeding mother-infant pairs measured serum valproate levels during maternal treatment for bipolar disorder 750 mg/day or 1,000 mg/day .\"\n }\n ]\n },\n {\n \"Term\": \"Blindness\",\n \"MEDDRACode\": \"10005169\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": true\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"blind\",\n \"Probability\": \"0.0007033646\",\n \"SemanticContext\": \"Divalproex sodium extended-release tablets’ effectiveness was confirmed in one randomized, double-blind, placebo-controlled, parallel group, 3-week, multicenter study.\"\n },\n {\n \"VerbatimTerm\": \"blind\",\n \"Probability\": \"0.0012423396\",\n \"SemanticContext\": \"Figure 1: Proportion of patients X axis whose percentage reduction from baseline in complex partial seizure rates was at least as great as that indicated on the Y axis in the adjunctive therapy study Figure 2: Proportion of patients X axis whose percentage reduction from baseline in complex partial seizure rates was at least as great as that indicated on the Y axis in the monotherapy study 14.3 Migraine The results of a multicenter, randomized, double-blind, placebo-controlled, parallel-group clinical trial demonstrated the effectiveness of divalproex sodium extended-release tablets in the prophylactic treatment of migraine headache.\"\n },\n {\n \"VerbatimTerm\": \"blind\",\n \"Probability\": \"0.0008020401\",\n \"SemanticContext\": \"5.14 Somnolence in the Elderly In a double-blind, multicenter trial of valproate in elderly patients with dementia mean age = 83 years , doses were increased by 125 mg/day to a target dose of 20 mg/kg/day.\"\n },\n {\n \"VerbatimTerm\": \"blind\",\n \"Probability\": \"0.0011940598\",\n \"SemanticContext\": \"8.5 Geriatric Use No patients above the age of 65 years were enrolled in double-blind prospective clinical trials of mania associated with bipolar illness.\"\n },\n {\n \"VerbatimTerm\": \"blinded\",\n \"Probability\": \"0.0008408427\",\n \"SemanticContext\": \"Two of the pediatric studies were double-blinded placebo-controlled trials to evaluate the efficacy of divalproex sodium extended-release tablets for the indications of mania 150 patients aged 10 to 17 years, 76 of whom were on divalproex sodium extended-release tablets and migraine 304 patients aged 12 to 17 years, 231 of whom were on divalproex sodium extended-release tablets .\"\n }\n ]\n },\n {\n \"Term\": \"Amblyopia\",\n \"MEDDRACode\": \"10001906\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"amblyopia\",\n \"Probability\": \"0.999445498\",\n \"SemanticContext\": \"Divalproex sodium extended-release tablets dosage should be increased slowly and with regular monitoring for fluid and nutritional intake 5.14 ADVERSE REACTIONS • Most common adverse reactions reported > 5% are abdominal pain, alopecia, amblyopia/blurred vision, amnesia, anorexia, asthenia, ataxia, back pain, bronchitis, constipation, depression, diarrhea, diplopia, dizziness, dyspnea, dyspepsia, ecchymosis, emotional lability, fever, flu syndrome, headache, increased appetite, infection, insomnia, nausea, nervousness, nystagmus, peripheral edema, pharyngitis, rash, rhinitis, somnolence, thinking abnormal, thrombocytopenia, tinnitus, tremor, vomiting, weight gain, weight loss 6.1 , 6.2 , 6.3 .\"\n },\n {\n \"VerbatimTerm\": \"Amblyopia\",\n \"Probability\": \"0.948682189\",\n \"SemanticContext\": \"Adverse Reactions Reported by = 5% of Patients Treated with Valproate During Placebo-Controlled Trial of Adjunctive Therapy for Complex Partial Seizures Body System/Event Divalproex Sodium Delayed- Release Tablets N = 77 % Placebo N = 70 % Body as a Whole Headache 31 21 Asthenia 27 7 Fever 6 4 Gastrointestinal System Nausea 48 14 Vomiting 27 7 Abdominal Pain 23 6 Diarrhea 13 6 Anorexia 12 0 Dyspepsia 8 4 Constipation 5 1 Nervous System Somnolence 27 11 Tremor 25 6 Dizziness 25 13 Diplopia 16 9 Amblyopia/Blurred Vision 12 9 Ataxia 8 1 Nystagmus 8 1 Emotional Lability 6 4 Thinking Abnormal 6 0 Amnesia 5 1 Respiratory System Flu Syndrome 12 9 Infection 12 6 Bronchitis 5 1 Rhinitis 5 4 Other Alopecia 6 1 Weight Loss 6 0 .\"\n },\n {\n \"VerbatimTerm\": \"Amblyopia\",\n \"Probability\": \"0.7330509424\",\n \"SemanticContext\": \"Body System/Event High Dose n = 131 % Low Dose n = 134 % Body as a Whole Asthenia 21 10 Digestive System Nausea 34 26 Diarrhea 23 19 Vomiting 23 15 Abdominal Pain 12 9 Anorexia 11 4 Dyspepsia 11 10 Hemic/Lymphatic System Thrombocytopenia 24 1 Ecchymosis 5 4 Metabolic/Nutritional Weight Gain 9 4 Peripheral Edema 8 3 Nervous System Tremor 57 19 Somnolence 30 18 Dizziness 18 13 Insomnia 15 9 Nervousness 11 7 Amnesia 7 4 Nystagmus 7 1 Depression 5 4 Respiratory System Infection 20 13 Pharyngitis 8 2 Dyspnea 5 1 Skin and Appendages Alopecia 24 13 Special Senses Amblyopia/Blurred Vision 8 4 Tinnitus 7 1 .\"\n }\n ]\n },\n {\n \"Term\": \"Infertility male\",\n \"MEDDRACode\": \"10021929\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"male infertility\",\n \"Probability\": \"0.961926043\",\n \"SemanticContext\": \"Reproductive: Aspermia, azoospermia, decreased sperm count, decreased spermatozoa motility, male infertility, and abnormal spermatozoa morphology.\"\n }\n ]\n },\n {\n \"Term\": \"Hypertension\",\n \"MEDDRACode\": \"10020772\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Hypertension\",\n \"Probability\": \"0.9845833182\",\n \"SemanticContext\": \"Cardiovascular System: Arrhythmia, Hypertension, Hypotension, Postural Hypotension.\"\n },\n {\n \"VerbatimTerm\": \"hypertension\",\n \"Probability\": \"0.9968014956\",\n \"SemanticContext\": \"Cardiovascular System: Tachycardia, hypertension, palpitation.\"\n }\n ]\n },\n {\n \"Term\": \"Vision blurred\",\n \"MEDDRACode\": \"10047513\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"blurred vision\",\n \"Probability\": \"0.9981638193\",\n \"SemanticContext\": \"Divalproex sodium extended-release tablets dosage should be increased slowly and with regular monitoring for fluid and nutritional intake 5.14 ADVERSE REACTIONS • Most common adverse reactions reported > 5% are abdominal pain, alopecia, amblyopia/blurred vision, amnesia, anorexia, asthenia, ataxia, back pain, bronchitis, constipation, depression, diarrhea, diplopia, dizziness, dyspnea, dyspepsia, ecchymosis, emotional lability, fever, flu syndrome, headache, increased appetite, infection, insomnia, nausea, nervousness, nystagmus, peripheral edema, pharyngitis, rash, rhinitis, somnolence, thinking abnormal, thrombocytopenia, tinnitus, tremor, vomiting, weight gain, weight loss 6.1 , 6.2 , 6.3 .\"\n },\n {\n \"VerbatimTerm\": \"Blurred Vision\",\n \"Probability\": \"0.9986255169\",\n \"SemanticContext\": \"Adverse Reactions Reported by = 5% of Patients Treated with Valproate During Placebo-Controlled Trial of Adjunctive Therapy for Complex Partial Seizures Body System/Event Divalproex Sodium Delayed- Release Tablets N = 77 % Placebo N = 70 % Body as a Whole Headache 31 21 Asthenia 27 7 Fever 6 4 Gastrointestinal System Nausea 48 14 Vomiting 27 7 Abdominal Pain 23 6 Diarrhea 13 6 Anorexia 12 0 Dyspepsia 8 4 Constipation 5 1 Nervous System Somnolence 27 11 Tremor 25 6 Dizziness 25 13 Diplopia 16 9 Amblyopia/Blurred Vision 12 9 Ataxia 8 1 Nystagmus 8 1 Emotional Lability 6 4 Thinking Abnormal 6 0 Amnesia 5 1 Respiratory System Flu Syndrome 12 9 Infection 12 6 Bronchitis 5 1 Rhinitis 5 4 Other Alopecia 6 1 Weight Loss 6 0 .\"\n },\n {\n \"VerbatimTerm\": \"Blurred Vision\",\n \"Probability\": \"0.98792243\",\n \"SemanticContext\": \"Body System/Event High Dose n = 131 % Low Dose n = 134 % Body as a Whole Asthenia 21 10 Digestive System Nausea 34 26 Diarrhea 23 19 Vomiting 23 15 Abdominal Pain 12 9 Anorexia 11 4 Dyspepsia 11 10 Hemic/Lymphatic System Thrombocytopenia 24 1 Ecchymosis 5 4 Metabolic/Nutritional Weight Gain 9 4 Peripheral Edema 8 3 Nervous System Tremor 57 19 Somnolence 30 18 Dizziness 18 13 Insomnia 15 9 Nervousness 11 7 Amnesia 7 4 Nystagmus 7 1 Depression 5 4 Respiratory System Infection 20 13 Pharyngitis 8 2 Dyspnea 5 1 Skin and Appendages Alopecia 24 13 Special Senses Amblyopia/Blurred Vision 8 4 Tinnitus 7 1 .\"\n }\n ]\n },\n {\n \"Term\": \"Eosinophilia\",\n \"MEDDRACode\": \"10014950\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Eosinophilia\",\n \"Probability\": \"0.4409525096\",\n \"SemanticContext\": \"This adverse reaction can also occur in patients using concomitant topiramate 5.11 • Drug Reaction with Eosinophilia and Systemic Symptoms DRESS /Multiorgan hypersensitivity reaction; discontinue divalproex sodium extended-release tablets 5.12 • Somnolence in the elderly can occur.\"\n },\n {\n \"VerbatimTerm\": \"Eosinophilia\",\n \"Probability\": \"0.8533858061\",\n \"SemanticContext\": \"6 ADVERSE REACTIONS The following serious adverse reactions are described below and elsewhere in the labeling: • Hepatic failure [see Warnings and Precautions 5.1 ] • Birth defects [see Warnings and Precautions 5.2 ] • Decreased IQ following in utero exposure [see Warnings and Precautions 5.3 ] • Pancreatitis [see Warnings and Precautions 5.5 ] • Hyperammonemic encephalopathy [see Warnings and Precautions 5.6 , 5.9 , 5.10 ] • Suicidal behavior and ideation [see Warnings and Precautions 5.7 ] • Bleeding and other hematopoietic disorders [see Warnings and Precautions 5.8 ] • Hypothermia [see Warnings and Precautions 5.11 ] • Drug Reaction with Eosinophilia and Systemic Symptoms DRESS /Multiorgan hypersensitivity reactions [see Warnings and Precautions 5.12 ] • Somnolence in the elderly [see Warnings and Precautions 5.14 ] Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.\"\n },\n {\n \"VerbatimTerm\": \"Eosinophilia\",\n \"Probability\": \"0.1488341093\",\n \"SemanticContext\": \"5.12 Drug Reaction with Eosinophilia and Systemic Symptoms DRESS /Multiorgan Hypersensitivity Reactions Drug Reaction with Eosinophilia and Systemic Symptoms DRESS , also known as Multiorgan Hypersensitivity, has been reported in patients taking valproate.\"\n },\n {\n \"VerbatimTerm\": \"Eosinophilia\",\n \"Probability\": \"0.5025363564\",\n \"SemanticContext\": \"5.12 Drug Reaction with Eosinophilia and Systemic Symptoms DRESS /Multiorgan Hypersensitivity Reactions Drug Reaction with Eosinophilia and Systemic Symptoms DRESS , also known as Multiorgan Hypersensitivity, has been reported in patients taking valproate.\"\n },\n {\n \"VerbatimTerm\": \"Eosinophilia\",\n \"Probability\": \"0.4713908434\",\n \"SemanticContext\": \"Eosinophilia is often present.\"\n }\n ]\n },\n {\n \"Term\": \"Bipolar I disorder\",\n \"MEDDRACode\": \"10004939\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"BID\",\n \"Probability\": \"0.0017656684\",\n \"SemanticContext\": \"In five multiple-dose studies in healthy subjects N = 82 and in subjects with epilepsy N = 86 , when administered under fasting and nonfasting conditions, divalproex sodium extended-release tablets given once daily produced an average bioavailability of 89% relative to an equal total daily dose of divalproex sodium delayed-release tablets given BID, TID, or QID.\"\n },\n {\n \"VerbatimTerm\": \"BID\",\n \"Probability\": \"0.003085345\",\n \"SemanticContext\": \"After multiple once-daily dosing of divalproex sodium extended-release tablets, the peak-to-trough fluctuation in plasma valproate concentrations was 10-20% lower than that of regular divalproex sodium delayed-release tablets given BID, TID, or QID.\"\n },\n {\n \"VerbatimTerm\": \"BID\",\n \"Probability\": \"0.0380659997\",\n \"SemanticContext\": \"Chlorpromazine A study involving the administration of 100 to 300 mg/day of chlorpromazine to schizophrenic patients already receiving valproate 200 mg BID revealed a 15% increase in trough plasma levels of valproate.\"\n },\n {\n \"VerbatimTerm\": \"BID\",\n \"Probability\": \"0.0060639679\",\n \"SemanticContext\": \"Haloperidol A study involving the administration of 6 to 10 mg/day of haloperidol to schizophrenic patients already receiving valproate 200 mg BID revealed no significant changes in valproate trough plasma levels.\"\n },\n {\n \"VerbatimTerm\": \"BID\",\n \"Probability\": \"0.0648370087\",\n \"SemanticContext\": \"\\n \\n Drugs for Which a Potentially Important Valproate Interaction Has Been Observed\\n Amitriptyline/Nortriptyline Administration of a single oral 50 mg dose of amitriptyline to 15 normal volunteers 10 males and 5 females who received valproate 500 mg BID resulted in a 21% decrease in plasma clearance of amitriptyline and a 34% decrease in the net clearance of nortriptyline.\"\n },\n {\n \"VerbatimTerm\": \"BID\",\n \"Probability\": \"0.0016240478\",\n \"SemanticContext\": \"Co-administration of valproate 250 mg BID for 14 days with phenobarbital to normal subjects n = 6 resulted in a 50% increase in half-life and a 30% decrease in plasma clearance of phenobarbital 60 mg single-dose .\"\n },\n {\n \"VerbatimTerm\": \"BID\",\n \"Probability\": \"0.0002063513\",\n \"SemanticContext\": \"Lithium Co-administration of valproate 500 mg BID and lithium carbonate 300 mg TID to normal male volunteers n = 16 had no effect on the steady-state kinetics of lithium.\"\n },\n {\n \"VerbatimTerm\": \"BID\",\n \"Probability\": \"6.95024E-05\",\n \"SemanticContext\": \"Lorazepam Concomitant administration of valproate 500 mg BID and lorazepam 1 mg BID in normal male volunteers n = 9 was accompanied by a 17% decrease in the plasma clearance of lorazepam.\"\n },\n {\n \"VerbatimTerm\": \"BID\",\n \"Probability\": \"0.0009397864\",\n \"SemanticContext\": \"Lorazepam Concomitant administration of valproate 500 mg BID and lorazepam 1 mg BID in normal male volunteers n = 9 was accompanied by a 17% decrease in the plasma clearance of lorazepam.\"\n },\n {\n \"VerbatimTerm\": \"BID\",\n \"Probability\": \"0.0004058182\",\n \"SemanticContext\": \"Co-administration of valproate 500 mg BID and olanzapine 5 mg to healthy adults n = 10 caused 15% reduction in Cmax and 35% reduction in AUC of olanzapine .\"\n },\n {\n \"VerbatimTerm\": \"BID\",\n \"Probability\": \"0.0007516742\",\n \"SemanticContext\": \"Oral Contraceptive Steroids Administration of a single-dose of ethinyloestradiol 50 mcg /levonorgestrel 250 mcg to 6 women on valproate 200 mg BID therapy for 2 months did not reveal any pharmacokinetic interaction.\"\n },\n {\n \"VerbatimTerm\": \"bipolar I disorder\",\n \"Probability\": \"0.0004081428\",\n \"SemanticContext\": \"The study was designed to evaluate the safety and efficacy of divalproex sodium extended-release tablets in the treatment of bipolar I disorder, manic or mixed type, in adults.\"\n },\n {\n \"VerbatimTerm\": \"bipolar I disorder\",\n \"Probability\": \"0.0003350973\",\n \"SemanticContext\": \"Adult male and female patients who had a current DSM-IV TR primary diagnosis of bipolar I disorder, manic or mixed type, and who were hospitalized for acute mania, were enrolled into this study.\"\n },\n {\n \"VerbatimTerm\": \"bipolar I disorder\",\n \"Probability\": \"0.0015787184\",\n \"SemanticContext\": \"The efficacy of divalproex sodium extended-release tablets is based in part on studies of divalproex sodium delayed-release tablets in this indication, and was confirmed in a 3-week trial with patients meeting DSM-IV TR criteria for bipolar I disorder, manic or mixed type, who were hospitalized for acute mania [see Clinical Studies 14.1 ] .\"\n }\n ]\n },\n {\n \"Term\": \"Parkinsonism\",\n \"MEDDRACode\": \"10034010\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"parkinsonism\",\n \"Probability\": \"0.6448007226\",\n \"SemanticContext\": \"Neurologic: Paradoxical convulsion, parkinsonism There have been several reports of acute or subacute cognitive decline and behavioral changes apathy or irritability with cerebral pseudoatrophy on imaging associated with valproate therapy; both the cognitive/behavioral changes and cerebral pseudoatrophy reversed partially or fully after valproate discontinuation.\"\n }\n ]\n },\n {\n \"Term\": \"Photosensitivity reaction\",\n \"MEDDRACode\": \"10034972\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"photosensitivity\",\n \"Probability\": \"0.9683701396\",\n \"SemanticContext\": \"Dermatologic: Hair texture changes, hair color changes, photosensitivity, erythema multiforme, toxic epidermal necrolysis, nail and nail bed disorders, and Stevens-Johnson syndrome.\"\n }\n ]\n },\n {\n \"Term\": \"Porphyria acute\",\n \"MEDDRACode\": \"10036182\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"acute intermittent porphyria\",\n \"Probability\": \"0.9857028723\",\n \"SemanticContext\": \"Hematologic: Relative lymphocytosis, macrocytosis, leukopenia, anemia including macrocytic with or without folate deficiency, bone marrow suppression, pancytopenia, aplastic anemia, agranulocytosis, and acute intermittent porphyria.\"\n }\n ]\n },\n {\n \"Term\": \"Hostility\",\n \"MEDDRACode\": \"10020400\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hostility\",\n \"Probability\": \"0.9826239347\",\n \"SemanticContext\": \"Psychiatric: Emotional upset, psychosis, aggression, psychomotor hyperactivity, hostility, disturbance in attention, learning disorder, and behavioral deterioration.\"\n },\n {\n \"VerbatimTerm\": \"hostility\",\n \"Probability\": \"0.8639603257\",\n \"SemanticContext\": \"Typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, poor judgment, aggressiveness, and possible hostility.\"\n }\n ]\n },\n {\n \"Term\": \"Alanine aminotransferase\",\n \"MEDDRACode\": \"10001546\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"SGPT\",\n \"Probability\": \"0.008747071\",\n \"SemanticContext\": \"Including the long term extension study, the adverse reactions reported as the primary reason for discontinuation by = 1% of 248 valproate-treated patients were alopecia 6% , nausea and/or vomiting 5% , weight gain 2% , tremor 2% , somnolence 1% , elevated SGOT and/or SGPT 1% , and depression 1% .\"\n }\n ]\n },\n {\n \"Term\": \"Aspartate aminotransferase\",\n \"MEDDRACode\": \"10003476\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"SGOT\",\n \"Probability\": \"0.0015085042\",\n \"SemanticContext\": \"Including the long term extension study, the adverse reactions reported as the primary reason for discontinuation by = 1% of 248 valproate-treated patients were alopecia 6% , nausea and/or vomiting 5% , weight gain 2% , tremor 2% , somnolence 1% , elevated SGOT and/or SGPT 1% , and depression 1% .\"\n }\n ]\n },\n {\n \"Term\": \"Barbiturates\",\n \"MEDDRACode\": \"10063229\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"barbiturate\",\n \"Probability\": \"0.0026415288\",\n \"SemanticContext\": \"There is evidence for severe CNS depression, with or without significant elevations of barbiturate or valproate serum concentrations.\"\n },\n {\n \"VerbatimTerm\": \"barbiturate\",\n \"Probability\": \"9.0125E-05\",\n \"SemanticContext\": \"All patients receiving concomitant barbiturate therapy should be closely monitored for neurological toxicity.\"\n },\n {\n \"VerbatimTerm\": \"barbiturate\",\n \"Probability\": \"4.33819E-05\",\n \"SemanticContext\": \"Serum barbiturate concentrations should be obtained, if possible, and the barbiturate dosage decreased, if appropriate.\"\n },\n {\n \"VerbatimTerm\": \"barbiturate\",\n \"Probability\": \"8.17449E-05\",\n \"SemanticContext\": \"Serum barbiturate concentrations should be obtained, if possible, and the barbiturate dosage decreased, if appropriate.\"\n },\n {\n \"VerbatimTerm\": \"barbiturate\",\n \"Probability\": \"0.0007034838\",\n \"SemanticContext\": \"Primidone, which is metabolized to a barbiturate, may be involved in a similar interaction with valproate.\"\n }\n ]\n },\n {\n \"Term\": \"Depressed level of consciousness\",\n \"MEDDRACode\": \"10012373\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"CNS depression\",\n \"Probability\": \"0.0235023201\",\n \"SemanticContext\": \"There is evidence for severe CNS depression, with or without significant elevations of barbiturate or valproate serum concentrations.\"\n },\n {\n \"VerbatimTerm\": \"CNS depression\",\n \"Probability\": \"0.1305465102\",\n \"SemanticContext\": \"CNS Depression: Since valproate products may produce CNS depression, especially when combined with another CNS depressant e.g., alcohol , advise patients not to engage in hazardous activities, such as driving an automobile or operating dangerous machinery, until it is known that they do not become drowsy from the drug.\"\n },\n {\n \"VerbatimTerm\": \"CNS Depression\",\n \"Probability\": \"0.0808881223\",\n \"SemanticContext\": \"CNS Depression: Since valproate products may produce CNS depression, especially when combined with another CNS depressant e.g., alcohol , advise patients not to engage in hazardous activities, such as driving an automobile or operating dangerous machinery, until it is known that they do not become drowsy from the drug.\"\n }\n ]\n },\n {\n \"Term\": \"Anxiety\",\n \"MEDDRACode\": \"10002855\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"worry\",\n \"Probability\": \"0.0001237094\",\n \"SemanticContext\": \"Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: • thoughts about suicide or dying • attempts to commit suicide • new or worse depression • new or worse anxiety • feeling agitated or restless • panic attacks • trouble sleeping insomnia • new or worse irritability • acting aggressive, being angry, or violent • acting on dangerous impulses • an extreme increase in activity and talking mania • other unusual changes in behavior or mood How can I watch for early symptoms of suicidal thoughts and actions?\"\n },\n {\n \"VerbatimTerm\": \"worried\",\n \"Probability\": \"6.09298E-05\",\n \"SemanticContext\": \"Call your healthcare provider between visits as needed, especially if you are worried about symptoms.\"\n }\n ]\n },\n {\n \"Term\": \"Mouth ulceration\",\n \"MEDDRACode\": \"10028034\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Mouth Ulceration\",\n \"Probability\": \"0.9853656292\",\n \"SemanticContext\": \"Digestive System: Constipation, Dry Mouth, Dysphagia, Fecal Incontinence, Flatulence, Gastroenteritis, Glossitis, Gum Hemorrhage, Mouth Ulceration.\"\n }\n ]\n },\n {\n \"Term\": \"Vertigo\",\n \"MEDDRACode\": \"10047340\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"vertigo\",\n \"Probability\": \"0.9967982769\",\n \"SemanticContext\": \"Nervous System: Abnormal gait, dizziness, hypertonia, insomnia, nervousness, tremor, vertigo.\"\n }\n ]\n },\n {\n \"Term\": \"Pain\",\n \"MEDDRACode\": \"10033371\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": true\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"pain\",\n \"Probability\": \"2.62021E-05\",\n \"SemanticContext\": \"Call your healthcare provider right away if you get any of the following symptoms: • nausea or vomiting that does not go away • loss of appetite • pain on the right side of your stomach abdomen • dark urine • swelling of your face • yellowing of your skin or the whites of your eyes In some cases, liver damage may continue despite stopping the drug.\"\n },\n {\n \"VerbatimTerm\": \"pain\",\n \"Probability\": \"0.061245501\",\n \"SemanticContext\": \"Divalproex sodium extended-release tablets can cause serious side effects including: • Bleeding problems: red or purple spots on your skin, bruising, pain and swelling into your joints due to bleeding or bleeding from your mouth or nose.\"\n },\n {\n \"VerbatimTerm\": \"pain\",\n \"Probability\": \"0.9919885397\",\n \"SemanticContext\": \"A higher percentage of patients above 65 years of age reported accidental injury, infection, pain, somnolence, and tremor.\"\n },\n {\n \"VerbatimTerm\": \"Pain\",\n \"Probability\": \"0.9948034286\",\n \"SemanticContext\": \"Adverse Event Divalproex Sodium Extended-Release Tablets n = 338 % Placebo n = 263 % Somnolence 26 14 Dyspepsia 23 11 Nausea 19 13 Vomiting 13 5 Diarrhea 12 8 Dizziness 12 7 Pain 11 10 Abdominal Pain 10 5 Accidental Injury 6 5 Asthenia 6 5 Pharyngitis 6 5 .\"\n }\n ]\n },\n {\n \"Term\": \"Diplopia\",\n \"MEDDRACode\": \"10013036\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"double vision\",\n \"Probability\": \"0.0097961128\",\n \"SemanticContext\": \"The common side effects of divalproex sodium extended-release tablets include: • nausea • headache • sleepiness • vomiting • weakness • tremor • dizziness • stomach pain • blurry vision • double vision • diarrhea • increased appetite • weight gain • hair loss • loss of appetite • problems with walking or coordination These are not all of the possible side effects of divalproex sodium extended-release tablets .\"\n }\n ]\n },\n {\n \"Term\": \"Increased appetite\",\n \"MEDDRACode\": \"10021654\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"increased appetite\",\n \"Probability\": \"0.9985856414\",\n \"SemanticContext\": \"Divalproex sodium extended-release tablets dosage should be increased slowly and with regular monitoring for fluid and nutritional intake 5.14 ADVERSE REACTIONS • Most common adverse reactions reported > 5% are abdominal pain, alopecia, amblyopia/blurred vision, amnesia, anorexia, asthenia, ataxia, back pain, bronchitis, constipation, depression, diarrhea, diplopia, dizziness, dyspnea, dyspepsia, ecchymosis, emotional lability, fever, flu syndrome, headache, increased appetite, infection, insomnia, nausea, nervousness, nystagmus, peripheral edema, pharyngitis, rash, rhinitis, somnolence, thinking abnormal, thrombocytopenia, tinnitus, tremor, vomiting, weight gain, weight loss 6.1 , 6.2 , 6.3 .\"\n },\n {\n \"VerbatimTerm\": \"increased appetite\",\n \"Probability\": \"0.0080786645\",\n \"SemanticContext\": \"The common side effects of divalproex sodium extended-release tablets include: • nausea • headache • sleepiness • vomiting • weakness • tremor • dizziness • stomach pain • blurry vision • double vision • diarrhea • increased appetite • weight gain • hair loss • loss of appetite • problems with walking or coordination These are not all of the possible side effects of divalproex sodium extended-release tablets .\"\n },\n {\n \"VerbatimTerm\": \"Increased appetite\",\n \"Probability\": \"0.9975969791\",\n \"SemanticContext\": \"Digestive System: Increased appetite, flatulence, hematemesis, eructation, pancreatitis, periodontal abscess.\"\n },\n {\n \"VerbatimTerm\": \"Increased appetite\",\n \"Probability\": \"0.9968136549\",\n \"SemanticContext\": \"Digestive System: Increased appetite, tooth disorder.\"\n },\n {\n \"VerbatimTerm\": \"Increased Appetite\",\n \"Probability\": \"0.9980422854\",\n \"SemanticContext\": \"Body System Reaction Divalproex Sodium Delayed-Release Tablets n = 202 % Placebo n = 81 % Gastrointestinal System Nausea 31 10 Dyspepsia 13 9 Diarrhea 12 7 Vomiting 11 1 Abdominal Pain 9 4 Increased Appetite 6 4 Nervous System Asthenia 20 9 Somnolence 17 5 Dizziness 12 6 Tremor 9 0 Other Weight Gain 8 2 Back Pain 8 6 Alopecia 7 1 .\"\n }\n ]\n },\n {\n \"Term\": \"Oedema peripheral\",\n \"MEDDRACode\": \"10030124\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"peripheral edema\",\n \"Probability\": \"0.9930137396\",\n \"SemanticContext\": \"Divalproex sodium extended-release tablets dosage should be increased slowly and with regular monitoring for fluid and nutritional intake 5.14 ADVERSE REACTIONS • Most common adverse reactions reported > 5% are abdominal pain, alopecia, amblyopia/blurred vision, amnesia, anorexia, asthenia, ataxia, back pain, bronchitis, constipation, depression, diarrhea, diplopia, dizziness, dyspnea, dyspepsia, ecchymosis, emotional lability, fever, flu syndrome, headache, increased appetite, infection, insomnia, nausea, nervousness, nystagmus, peripheral edema, pharyngitis, rash, rhinitis, somnolence, thinking abnormal, thrombocytopenia, tinnitus, tremor, vomiting, weight gain, weight loss 6.1 , 6.2 , 6.3 .\"\n },\n {\n \"VerbatimTerm\": \"Peripheral Edema\",\n \"Probability\": \"0.9978726506\",\n \"SemanticContext\": \"Metabolic and Nutritional Disorders: Hypoproteinemia, Peripheral Edema.\"\n },\n {\n \"VerbatimTerm\": \"Peripheral Edema\",\n \"Probability\": \"0.9962869883\",\n \"SemanticContext\": \"Body System/Event High Dose n = 131 % Low Dose n = 134 % Body as a Whole Asthenia 21 10 Digestive System Nausea 34 26 Diarrhea 23 19 Vomiting 23 15 Abdominal Pain 12 9 Anorexia 11 4 Dyspepsia 11 10 Hemic/Lymphatic System Thrombocytopenia 24 1 Ecchymosis 5 4 Metabolic/Nutritional Weight Gain 9 4 Peripheral Edema 8 3 Nervous System Tremor 57 19 Somnolence 30 18 Dizziness 18 13 Insomnia 15 9 Nervousness 11 7 Amnesia 7 4 Nystagmus 7 1 Depression 5 4 Respiratory System Infection 20 13 Pharyngitis 8 2 Dyspnea 5 1 Skin and Appendages Alopecia 24 13 Special Senses Amblyopia/Blurred Vision 8 4 Tinnitus 7 1 .\"\n },\n {\n \"VerbatimTerm\": \"Peripheral edema\",\n \"Probability\": \"0.9963710308\",\n \"SemanticContext\": \"Metabolic and Nutritional Disorders: Peripheral edema.\"\n }\n ]\n },\n {\n \"Term\": \"Fracture\",\n \"MEDDRACode\": \"10017076\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Fractures\",\n \"Probability\": \"0.6254512668\",\n \"SemanticContext\": \"Musculoskeletal: Fractures, decreased bone mineral density, osteopenia, osteoporosis, and weakness.\"\n }\n ]\n },\n {\n \"Term\": \"Liver disorder\",\n \"MEDDRACode\": \"10024670\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": true,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Hepatic disease\",\n \"Probability\": \"0.0695338845\",\n \"SemanticContext\": \"CONTRAINDICATIONS • Hepatic disease or significant hepatic dysfunction 4 , 5.1 • Known mitochondrial disorders caused by mutations in mitochondrial DNA polymerase ?\"\n },\n {\n \"VerbatimTerm\": \"hepatic diseases\",\n \"Probability\": \"0.0002989769\",\n \"SemanticContext\": \"Protein binding of valproate is reduced in the elderly, in patients with chronic hepatic diseases, in patients with renal impairment, and in the presence of other drugs e.g., aspirin .\"\n },\n {\n \"VerbatimTerm\": \"hepatic disease\",\n \"Probability\": \"0.0026960671\",\n \"SemanticContext\": \"Accordingly, monitoring of total concentrations may be misleading since free concentrations may be substantially elevated in patients with hepatic disease whereas total concentrations may appear to be normal [see Boxed Warning , Contraindications 4 , and Warnings and Precautions 5.1 ] .\"\n },\n {\n \"VerbatimTerm\": \"hepatic disease\",\n \"Probability\": \"0.0005848706\",\n \"SemanticContext\": \"4 CONTRAINDICATIONS • Divalproex sodium extended-release tablets should not be administered to patients with hepatic disease or significant hepatic dysfunction [see Warnings and Precautions 5.1 ] .\"\n },\n {\n \"VerbatimTerm\": \"hepatic disease\",\n \"Probability\": \"3.73727E-05\",\n \"SemanticContext\": \"Caution should be observed when administering valproate products to patients with a prior history of hepatic disease.\"\n }\n ]\n },\n {\n \"Term\": \"Dyspnoea\",\n \"MEDDRACode\": \"10013968\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"dyspnea\",\n \"Probability\": \"0.9997853637\",\n \"SemanticContext\": \"Divalproex sodium extended-release tablets dosage should be increased slowly and with regular monitoring for fluid and nutritional intake 5.14 ADVERSE REACTIONS • Most common adverse reactions reported > 5% are abdominal pain, alopecia, amblyopia/blurred vision, amnesia, anorexia, asthenia, ataxia, back pain, bronchitis, constipation, depression, diarrhea, diplopia, dizziness, dyspnea, dyspepsia, ecchymosis, emotional lability, fever, flu syndrome, headache, increased appetite, infection, insomnia, nausea, nervousness, nystagmus, peripheral edema, pharyngitis, rash, rhinitis, somnolence, thinking abnormal, thrombocytopenia, tinnitus, tremor, vomiting, weight gain, weight loss 6.1 , 6.2 , 6.3 .\"\n },\n {\n \"VerbatimTerm\": \"Dyspnea\",\n \"Probability\": \"0.9998235703\",\n \"SemanticContext\": \"Body System/Event High Dose n = 131 % Low Dose n = 134 % Body as a Whole Asthenia 21 10 Digestive System Nausea 34 26 Diarrhea 23 19 Vomiting 23 15 Abdominal Pain 12 9 Anorexia 11 4 Dyspepsia 11 10 Hemic/Lymphatic System Thrombocytopenia 24 1 Ecchymosis 5 4 Metabolic/Nutritional Weight Gain 9 4 Peripheral Edema 8 3 Nervous System Tremor 57 19 Somnolence 30 18 Dizziness 18 13 Insomnia 15 9 Nervousness 11 7 Amnesia 7 4 Nystagmus 7 1 Depression 5 4 Respiratory System Infection 20 13 Pharyngitis 8 2 Dyspnea 5 1 Skin and Appendages Alopecia 24 13 Special Senses Amblyopia/Blurred Vision 8 4 Tinnitus 7 1 .\"\n },\n {\n \"VerbatimTerm\": \"Dyspnea\",\n \"Probability\": \"0.9991309643\",\n \"SemanticContext\": \"Respiratory System: Dyspnea, and sinusitis.\"\n }\n ]\n },\n {\n \"Term\": \"Menstruation irregular\",\n \"MEDDRACode\": \"10027339\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Irregular menses\",\n \"Probability\": \"0.9657989144\",\n \"SemanticContext\": \"Endocrine: Irregular menses, secondary amenorrhea, hyperandrogenism, hirsutism, elevated testosterone level, breast enlargement, galactorrhea, parotid gland swelling, polycystic ovary disease, decreased carnitine concentrations, hyponatremia, hyperglycinemia, and inappropriate ADH secretion.\"\n }\n ]\n },\n {\n \"Term\": \"Elderly\",\n \"MEDDRACode\": \"10014348\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": true,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": true\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"elderly\",\n \"Probability\": \"0.0199134648\",\n \"SemanticContext\": \"This adverse reaction can also occur in patients using concomitant topiramate 5.11 • Drug Reaction with Eosinophilia and Systemic Symptoms DRESS /Multiorgan hypersensitivity reaction; discontinue divalproex sodium extended-release tablets 5.12 • Somnolence in the elderly can occur.\"\n },\n {\n \"VerbatimTerm\": \"elderly\",\n \"Probability\": \"0.0227977335\",\n \"SemanticContext\": \"6 ADVERSE REACTIONS The following serious adverse reactions are described below and elsewhere in the labeling: • Hepatic failure [see Warnings and Precautions 5.1 ] • Birth defects [see Warnings and Precautions 5.2 ] • Decreased IQ following in utero exposure [see Warnings and Precautions 5.3 ] • Pancreatitis [see Warnings and Precautions 5.5 ] • Hyperammonemic encephalopathy [see Warnings and Precautions 5.6 , 5.9 , 5.10 ] • Suicidal behavior and ideation [see Warnings and Precautions 5.7 ] • Bleeding and other hematopoietic disorders [see Warnings and Precautions 5.8 ] • Hypothermia [see Warnings and Precautions 5.11 ] • Drug Reaction with Eosinophilia and Systemic Symptoms DRESS /Multiorgan hypersensitivity reactions [see Warnings and Precautions 5.12 ] • Somnolence in the elderly [see Warnings and Precautions 5.14 ] Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.\"\n },\n {\n \"VerbatimTerm\": \"elderly\",\n \"Probability\": \"0.0034918785\",\n \"SemanticContext\": \"Higher than expected free fractions occur in the elderly, in hyperlipidemic patients, and in patients with hepatic and renal diseases.\"\n },\n {\n \"VerbatimTerm\": \"elderly\",\n \"Probability\": \"0.0001348257\",\n \"SemanticContext\": \"Protein binding of valproate is reduced in the elderly, in patients with chronic hepatic diseases, in patients with renal impairment, and in the presence of other drugs e.g., aspirin .\"\n },\n {\n \"VerbatimTerm\": \"elderly\",\n \"Probability\": \"2.6368E-05\",\n \"SemanticContext\": \"Elderly The capacity of elderly patients age range: 68 to 89 years to eliminate valproate has been shown to be reduced compared to younger adults age range: 22 to 26 years .\"\n },\n {\n \"VerbatimTerm\": \"elderly\",\n \"Probability\": \"6.07831E-05\",\n \"SemanticContext\": \"Accordingly, the initial dosage should be reduced in the elderly [see Dosage and Administration 2.4 ] .\"\n },\n {\n \"VerbatimTerm\": \"elderly\",\n \"Probability\": \"0.0002943575\",\n \"SemanticContext\": \"2.5 General Dosing Advice\\n \\n Dosing in Elderly Patients\\n Due to a decrease in unbound clearance of valproate and possibly a greater sensitivity to somnolence in the elderly, the starting dose should be reduced in these patients.\"\n },\n {\n \"VerbatimTerm\": \"elderly\",\n \"Probability\": \"8.58738E-05\",\n \"SemanticContext\": \"Starting doses in the elderly lower than 250 mg can only be achieved by the use of divalproex sodium delayed-release tablets.\"\n },\n {\n \"VerbatimTerm\": \"elderly\",\n \"Probability\": \"9.17112E-05\",\n \"SemanticContext\": \"5.14 Somnolence in the Elderly In a double-blind, multicenter trial of valproate in elderly patients with dementia mean age = 83 years , doses were increased by 125 mg/day to a target dose of 20 mg/kg/day.\"\n },\n {\n \"VerbatimTerm\": \"elderly\",\n \"Probability\": \"0.0002454221\",\n \"SemanticContext\": \"In elderly patients, dosage should be increased more slowly and with regular monitoring for fluid and nutritional intake, dehydration, somnolence, and other adverse reactions.\"\n },\n {\n \"VerbatimTerm\": \"elderly\",\n \"Probability\": \"2.181E-06\",\n \"SemanticContext\": \"• Drowsiness or sleepiness in the elderly.\"\n },\n {\n \"VerbatimTerm\": \"elderly\",\n \"Probability\": \"0.0028263628\",\n \"SemanticContext\": \"A study of elderly patients with dementia revealed drug related somnolence and discontinuation for somnolence [see Warnings and Precautions 5.14 ].\"\n },\n {\n \"VerbatimTerm\": \"elderly\",\n \"Probability\": \"0.0001320839\",\n \"SemanticContext\": \"The capacity of elderly patients age range: 68 to 89 years to eliminate valproate has been shown to be reduced compared to younger adults age range: 22 to 26 years [see Clinical Pharmacology 12.3 ].\"\n },\n {\n \"VerbatimTerm\": \"Elderly\",\n \"Probability\": \"0.0002673268\",\n \"SemanticContext\": \"Elderly The capacity of elderly patients age range: 68 to 89 years to eliminate valproate has been shown to be reduced compared to younger adults age range: 22 to 26 years .\"\n },\n {\n \"VerbatimTerm\": \"Elderly\",\n \"Probability\": \"4.6204E-06\",\n \"SemanticContext\": \"2.5 General Dosing Advice\\n \\n Dosing in Elderly Patients\\n Due to a decrease in unbound clearance of valproate and possibly a greater sensitivity to somnolence in the elderly, the starting dose should be reduced in these patients.\"\n },\n {\n \"VerbatimTerm\": \"Elderly\",\n \"Probability\": \"0.0009524524\",\n \"SemanticContext\": \"5.14 Somnolence in the Elderly In a double-blind, multicenter trial of valproate in elderly patients with dementia mean age = 83 years , doses were increased by 125 mg/day to a target dose of 20 mg/kg/day.\"\n }\n ]\n },\n {\n \"Term\": \"Otitis media\",\n \"MEDDRACode\": \"10033078\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"otitis media\",\n \"Probability\": \"0.9850934744\",\n \"SemanticContext\": \"Special Senses: Taste perversion, abnormal vision, deafness, otitis media.\"\n }\n ]\n },\n {\n \"Term\": \"Pollakiuria\",\n \"MEDDRACode\": \"10036018\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"urinary frequency\",\n \"Probability\": \"0.9339792728\",\n \"SemanticContext\": \"Urogenital System: Urinary incontinence, vaginitis, dysmenorrhea, amenorrhea, urinary frequency.\"\n }\n ]\n },\n {\n \"Term\": \"Pruritus\",\n \"MEDDRACode\": \"10037087\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Pruritus\",\n \"Probability\": \"0.9983364344\",\n \"SemanticContext\": \"Skin and Appendages: Discoid Lupus Erythematosus, Erythema Nodosum, Furunculosis, Maculopapular Rash, Pruritus, Rash, Seborrhea, Sweating, Vesiculobullous Rash.\"\n },\n {\n \"VerbatimTerm\": \"Pruritus\",\n \"Probability\": \"0.9961718321\",\n \"SemanticContext\": \"Skin and Appendages: Pruritus.\"\n },\n {\n \"VerbatimTerm\": \"pruritus\",\n \"Probability\": \"0.9991554022\",\n \"SemanticContext\": \"Skin and Appendages: Rash, pruritus, dry skin.\"\n }\n ]\n },\n {\n \"Term\": \"Tremor\",\n \"MEDDRACode\": \"10044565\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": true\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"tremor\",\n \"Probability\": \"0.9912760258\",\n \"SemanticContext\": \"Divalproex sodium extended-release tablets dosage should be increased slowly and with regular monitoring for fluid and nutritional intake 5.14 ADVERSE REACTIONS • Most common adverse reactions reported > 5% are abdominal pain, alopecia, amblyopia/blurred vision, amnesia, anorexia, asthenia, ataxia, back pain, bronchitis, constipation, depression, diarrhea, diplopia, dizziness, dyspnea, dyspepsia, ecchymosis, emotional lability, fever, flu syndrome, headache, increased appetite, infection, insomnia, nausea, nervousness, nystagmus, peripheral edema, pharyngitis, rash, rhinitis, somnolence, thinking abnormal, thrombocytopenia, tinnitus, tremor, vomiting, weight gain, weight loss 6.1 , 6.2 , 6.3 .\"\n },\n {\n \"VerbatimTerm\": \"tremor\",\n \"Probability\": \"0.9993228912\",\n \"SemanticContext\": \"Including the long term extension study, the adverse reactions reported as the primary reason for discontinuation by = 1% of 248 valproate-treated patients were alopecia 6% , nausea and/or vomiting 5% , weight gain 2% , tremor 2% , somnolence 1% , elevated SGOT and/or SGPT 1% , and depression 1% .\"\n },\n {\n \"VerbatimTerm\": \"tremor\",\n \"Probability\": \"0.9982662201\",\n \"SemanticContext\": \"Nervous System: Abnormal gait, dizziness, hypertonia, insomnia, nervousness, tremor, vertigo.\"\n },\n {\n \"VerbatimTerm\": \"tremor\",\n \"Probability\": \"0.5319097042\",\n \"SemanticContext\": \"The common side effects of divalproex sodium extended-release tablets include: • nausea • headache • sleepiness • vomiting • weakness • tremor • dizziness • stomach pain • blurry vision • double vision • diarrhea • increased appetite • weight gain • hair loss • loss of appetite • problems with walking or coordination These are not all of the possible side effects of divalproex sodium extended-release tablets .\"\n },\n {\n \"VerbatimTerm\": \"tremor\",\n \"Probability\": \"0.9846463799\",\n \"SemanticContext\": \"A higher percentage of patients above 65 years of age reported accidental injury, infection, pain, somnolence, and tremor.\"\n },\n {\n \"VerbatimTerm\": \"Tremor\",\n \"Probability\": \"0.9351301193\",\n \"SemanticContext\": \"Nervous System: Abnormal Gait, Agitation, Catatonic Reaction, Dysarthria, Hallucinations, Hypertonia, Hypokinesia, Psychosis, Reflexes Increased, Sleep Disorder, Tardive Dyskinesia, Tremor.\"\n },\n {\n \"VerbatimTerm\": \"Tremor\",\n \"Probability\": \"0.9992218018\",\n \"SemanticContext\": \"Adverse Reactions Reported by = 5% of Patients Treated with Valproate During Placebo-Controlled Trial of Adjunctive Therapy for Complex Partial Seizures Body System/Event Divalproex Sodium Delayed- Release Tablets N = 77 % Placebo N = 70 % Body as a Whole Headache 31 21 Asthenia 27 7 Fever 6 4 Gastrointestinal System Nausea 48 14 Vomiting 27 7 Abdominal Pain 23 6 Diarrhea 13 6 Anorexia 12 0 Dyspepsia 8 4 Constipation 5 1 Nervous System Somnolence 27 11 Tremor 25 6 Dizziness 25 13 Diplopia 16 9 Amblyopia/Blurred Vision 12 9 Ataxia 8 1 Nystagmus 8 1 Emotional Lability 6 4 Thinking Abnormal 6 0 Amnesia 5 1 Respiratory System Flu Syndrome 12 9 Infection 12 6 Bronchitis 5 1 Rhinitis 5 4 Other Alopecia 6 1 Weight Loss 6 0 .\"\n },\n {\n \"VerbatimTerm\": \"Tremor\",\n \"Probability\": \"0.9927176833\",\n \"SemanticContext\": \"Body System/Event High Dose n = 131 % Low Dose n = 134 % Body as a Whole Asthenia 21 10 Digestive System Nausea 34 26 Diarrhea 23 19 Vomiting 23 15 Abdominal Pain 12 9 Anorexia 11 4 Dyspepsia 11 10 Hemic/Lymphatic System Thrombocytopenia 24 1 Ecchymosis 5 4 Metabolic/Nutritional Weight Gain 9 4 Peripheral Edema 8 3 Nervous System Tremor 57 19 Somnolence 30 18 Dizziness 18 13 Insomnia 15 9 Nervousness 11 7 Amnesia 7 4 Nystagmus 7 1 Depression 5 4 Respiratory System Infection 20 13 Pharyngitis 8 2 Dyspnea 5 1 Skin and Appendages Alopecia 24 13 Special Senses Amblyopia/Blurred Vision 8 4 Tinnitus 7 1 .\"\n },\n {\n \"VerbatimTerm\": \"Tremor\",\n \"Probability\": \"0.9975381494\",\n \"SemanticContext\": \"Body System Reaction Divalproex Sodium Delayed-Release Tablets n = 202 % Placebo n = 81 % Gastrointestinal System Nausea 31 10 Dyspepsia 13 9 Diarrhea 12 7 Vomiting 11 1 Abdominal Pain 9 4 Increased Appetite 6 4 Nervous System Asthenia 20 9 Somnolence 17 5 Dizziness 12 6 Tremor 9 0 Other Weight Gain 8 2 Back Pain 8 6 Alopecia 7 1 .\"\n }\n ]\n },\n {\n \"Term\": \"Viral infection\",\n \"MEDDRACode\": \"10047461\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"viral infection\",\n \"Probability\": \"0.6653921604\",\n \"SemanticContext\": \"The following additional adverse reactions were reported by greater than 1% but not more than 5% of divalproex sodium extended-release tablets-treated patients and with a greater incidence than placebo in the placebo-controlled clinical trial for migraine prophylaxis: Body as a Whole: Accidental injury, viral infection.\"\n },\n {\n \"VerbatimTerm\": \"viral infection\",\n \"Probability\": \"0.1499640942\",\n \"SemanticContext\": \"DRESS typically, although not exclusively, presents with fever, rash, lymphadenopathy, and/or facial swelling, in association with other organ system involvement, such as hepatitis, nephritis, hematological abnormalities, myocarditis, or myositis sometimes resembling an acute viral infection.\"\n }\n ]\n },\n {\n \"Term\": \"Confusional state\",\n \"MEDDRACode\": \"10010305\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"confusion\",\n \"Probability\": \"0.9798250198\",\n \"SemanticContext\": \"Nervous System: Anxiety, confusion, abnormal gait, paresthesia, hypertonia, incoordination, abnormal dreams, personality disorder.\"\n },\n {\n \"VerbatimTerm\": \"confusion\",\n \"Probability\": \"0.9843269587\",\n \"SemanticContext\": \"Nervous System: Abnormal dreams, confusion, paresthesia, speech disorder, and thinking abnormalities.\"\n },\n {\n \"VerbatimTerm\": \"confusion\",\n \"Probability\": \"0.0269902647\",\n \"SemanticContext\": \"Consideration should be given to stopping valproate in patients who develop hypothermia, which may be manifested by a variety of clinical abnormalities including lethargy, confusion, coma, and significant alterations in other major organ systems such as the cardiovascular and respiratory systems.\"\n },\n {\n \"VerbatimTerm\": \"confusion\",\n \"Probability\": \"0.012347728\",\n \"SemanticContext\": \"• Low body temperature hypothermia : drop in your body temperature to less than 95°F, feeling tired, confusion, coma.\"\n }\n ]\n },\n {\n \"Term\": \"Hepatitis acute\",\n \"MEDDRACode\": \"10019727\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"acute hepatitis\",\n \"Probability\": \"0.2195571959\",\n \"SemanticContext\": \"In one study, the clearance of free valproate was decreased by 50% in 7 patients with cirrhosis and by 16% in 4 patients with acute hepatitis, compared with 6 healthy subjects.\"\n }\n ]\n },\n {\n \"Term\": \"Pancreatitis\",\n \"MEDDRACode\": \"10033645\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Pancreatitis\",\n \"Probability\": \"0.9806780219\",\n \"SemanticContext\": \"Monitor patients closely, and perform serum liver testing prior to therapy and at frequent intervals thereafter 5.1 • Fetal Risk, particularly neural tube defects, other major malformations, and decreased IQ 5.2 , 5.3 , 5.4 • Pancreatitis, including fatal hemorrhagic cases 5.5 INDICATIONS AND USAGE Divalproex sodium extended-release tablets are indicated for: .\"\n },\n {\n \"VerbatimTerm\": \"Pancreatitis\",\n \"Probability\": \"0.012858361\",\n \"SemanticContext\": \"POLG 4 , 5.1 • Suspected POLG-related disorder in children under two years of age 4 , 5.1 • Known hypersensitivity to the drug 4 , 5.12 • Urea cycle disorders 4 , 5.6 • Prophylaxis of migraine headaches: Pregnant women, women of childbearing potential not using effective contraception 4 , 8.1 WARNINGS AND PRECAUTIONS • Hepatotoxicity; evaluate high risk populations and monitor serum liver tests 5.1 • Birth defects, decreased IQ, and neurodevelopmental disorders following in utero exposure; should not be used to treat women with epilepsy or bipolar disorder who are pregnant or who plan to become pregnant or to treat a woman of childbearing potential unless other medications have failed to provide adequate symptom control or are otherwise unacceptable 5.2 , 5.3 , 5.4 • Pancreatitis; divalproex sodium extended-release tablets should ordinarily be discontinued 5.5 • Suicidal behavior or ideation; Antiepileptic drugs, including divalproex sodium extended-release tablets, increase the risk of suicidal thoughts or behavior 5.7 • Bleeding and other hematopoietic disorders; monitor platelet counts and coagulation tests 5.8 • Hyperammonemia and hyperammonemic encephalopathy; measure ammonia level if unexplained lethargy and vomiting or changes in mental status, and also with concomitant topiramate use; consider discontinuation of valproate therapy 5.6 , 5.9 , 5.10 • Hypothermia; Hypothermia has been reported during valproate therapy with or without associated hyperammonemia.\"\n },\n {\n \"VerbatimTerm\": \"Pancreatitis\",\n \"Probability\": \"0.9304661155\",\n \"SemanticContext\": \"6 ADVERSE REACTIONS The following serious adverse reactions are described below and elsewhere in the labeling: • Hepatic failure [see Warnings and Precautions 5.1 ] • Birth defects [see Warnings and Precautions 5.2 ] • Decreased IQ following in utero exposure [see Warnings and Precautions 5.3 ] • Pancreatitis [see Warnings and Precautions 5.5 ] • Hyperammonemic encephalopathy [see Warnings and Precautions 5.6 , 5.9 , 5.10 ] • Suicidal behavior and ideation [see Warnings and Precautions 5.7 ] • Bleeding and other hematopoietic disorders [see Warnings and Precautions 5.8 ] • Hypothermia [see Warnings and Precautions 5.11 ] • Drug Reaction with Eosinophilia and Systemic Symptoms DRESS /Multiorgan hypersensitivity reactions [see Warnings and Precautions 5.12 ] • Somnolence in the elderly [see Warnings and Precautions 5.14 ] Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.\"\n },\n {\n \"VerbatimTerm\": \"Pancreatitis\",\n \"Probability\": \"0.1482491195\",\n \"SemanticContext\": \"Pancreatitis: Warn patients and guardians that abdominal pain, nausea, vomiting, and/or anorexia can be symptoms of pancreatitis and, therefore, require further medical evaluation promptly [see Warnings and Precautions 5.5 ].\"\n },\n {\n \"VerbatimTerm\": \"Pancreatitis\",\n \"Probability\": \"0.248852998\",\n \"SemanticContext\": \"5.5 Pancreatitis Cases of life-threatening pancreatitis have been reported in both children and adults receiving valproate.\"\n },\n {\n \"VerbatimTerm\": \"pancreatitis\",\n \"Probability\": \"0.9985198379\",\n \"SemanticContext\": \"Digestive System: Increased appetite, flatulence, hematemesis, eructation, pancreatitis, periodontal abscess.\"\n },\n {\n \"VerbatimTerm\": \"pancreatitis\",\n \"Probability\": \"0.5869019032\",\n \"SemanticContext\": \"Pancreatitis: Warn patients and guardians that abdominal pain, nausea, vomiting, and/or anorexia can be symptoms of pancreatitis and, therefore, require further medical evaluation promptly [see Warnings and Precautions 5.5 ].\"\n },\n {\n \"VerbatimTerm\": \"pancreatitis\",\n \"Probability\": \"0.9002774954\",\n \"SemanticContext\": \"5.5 Pancreatitis Cases of life-threatening pancreatitis have been reported in both children and adults receiving valproate.\"\n },\n {\n \"VerbatimTerm\": \"pancreatitis\",\n \"Probability\": \"0.3669223785\",\n \"SemanticContext\": \"The rate based upon the reported cases exceeds that expected in the general population and there have been cases in which pancreatitis recurred after rechallenge with valproate.\"\n },\n {\n \"VerbatimTerm\": \"pancreatitis\",\n \"Probability\": \"0.8200125098\",\n \"SemanticContext\": \"In clinical trials, there were 2 cases of pancreatitis without alternative etiology in 2,416 patients, representing 1,044 patient-years experience.\"\n },\n {\n \"VerbatimTerm\": \"pancreatitis\",\n \"Probability\": \"0.0022407174\",\n \"SemanticContext\": \"Patients and guardians should be warned that abdominal pain, nausea, vomiting, and/or anorexia can be symptoms of pancreatitis that require prompt medical evaluation.\"\n },\n {\n \"VerbatimTerm\": \"pancreatitis\",\n \"Probability\": \"0.0001846552\",\n \"SemanticContext\": \"If pancreatitis is diagnosed, divalproex sodium extended-release tablets should ordinarily be discontinued.\"\n }\n ]\n },\n {\n \"Term\": \"Dehydration\",\n \"MEDDRACode\": \"10012174\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"dehydration\",\n \"Probability\": \"0.0620376766\",\n \"SemanticContext\": \"Dosage should be increased more slowly and with regular monitoring for fluid and nutritional intake, dehydration, somnolence, and other adverse reactions.\"\n },\n {\n \"VerbatimTerm\": \"dehydration\",\n \"Probability\": \"0.6207538843\",\n \"SemanticContext\": \"A significantly higher proportion of valproate patients had somnolence compared to placebo, and although not statistically significant, there was a higher proportion of patients with dehydration.\"\n },\n {\n \"VerbatimTerm\": \"dehydration\",\n \"Probability\": \"0.0588876009\",\n \"SemanticContext\": \"In elderly patients, dosage should be increased more slowly and with regular monitoring for fluid and nutritional intake, dehydration, somnolence, and other adverse reactions.\"\n }\n ]\n },\n {\n \"Term\": \"Developmental delay\",\n \"MEDDRACode\": \"10012559\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"developmental delay\",\n \"Probability\": \"0.9529127479\",\n \"SemanticContext\": \"Other: Allergic reaction, anaphylaxis, developmental delay, bone pain, bradycardia, and cutaneous vasculitis.\"\n },\n {\n \"VerbatimTerm\": \"developmental delays\",\n \"Probability\": \"0.5009804964\",\n \"SemanticContext\": \"POLG-related disorders should be suspected in patients with a family history or suggestive symptoms of a POLG-related disorder, including but not limited to unexplained encephalopathy, refractory epilepsy focal, myoclonic , status epilepticus at presentation, developmental delays, psychomotor regression, axonal sensorimotor neuropathy, myopathy cerebellar ataxia, ophthalmoplegia, or complicated migraine with occipital aura.\"\n }\n ]\n },\n {\n \"Term\": \"Hepatic failure\",\n \"MEDDRACode\": \"10019663\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": true,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"liver failure\",\n \"Probability\": \"0.8763386011\",\n \"SemanticContext\": \"Most of the reported cases of liver failure in patients with these syndromes have been identified in children and adolescents.\"\n }\n ]\n },\n {\n \"Term\": \"Irritability\",\n \"MEDDRACode\": \"10022998\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"irritability\",\n \"Probability\": \"0.1071279347\",\n \"SemanticContext\": \"Neurologic: Paradoxical convulsion, parkinsonism There have been several reports of acute or subacute cognitive decline and behavioral changes apathy or irritability with cerebral pseudoatrophy on imaging associated with valproate therapy; both the cognitive/behavioral changes and cerebral pseudoatrophy reversed partially or fully after valproate discontinuation.\"\n },\n {\n \"VerbatimTerm\": \"irritability\",\n \"Probability\": \"0.1187325716\",\n \"SemanticContext\": \"Prior to the initiation of divalproex sodium extended-release tablets therapy, evaluation for UCD should be considered in the following patients: 1 those with a history of unexplained encephalopathy or coma, encephalopathy associated with a protein load, pregnancy-related or postpartum encephalopathy, unexplained mental retardation, or history of elevated plasma ammonia or glutamine; 2 those with cyclical vomiting and lethargy, episodic extreme irritability, ataxia, low BUN, or protein avoidance; 3 those with a family history of UCD or a family history of unexplained infant deaths particularly males ; 4 those with other signs or symptoms of UCD.\"\n },\n {\n \"VerbatimTerm\": \"irritability\",\n \"Probability\": \"0.0004481673\",\n \"SemanticContext\": \"Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: • thoughts about suicide or dying • attempts to commit suicide • new or worse depression • new or worse anxiety • feeling agitated or restless • panic attacks • trouble sleeping insomnia • new or worse irritability • acting aggressive, being angry, or violent • acting on dangerous impulses • an extreme increase in activity and talking mania • other unusual changes in behavior or mood How can I watch for early symptoms of suicidal thoughts and actions?\"\n }\n ]\n },\n {\n \"Term\": \"Infusion\",\n \"MEDDRACode\": \"10060345\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"infusion\",\n \"Probability\": \"0.001306355\",\n \"SemanticContext\": \"12.3 Pharmacokinetics\\n \\n Absorption/Bioavailability\\n The absolute bioavailability of divalproex sodium extended-release tablets administered as a single dose after a meal was approximately 90% relative to intravenous infusion.\"\n }\n ]\n },\n {\n \"Term\": \"Planning to become pregnant\",\n \"MEDDRACode\": \"10076056\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"plan to become pregnant\",\n \"Probability\": \"6.6391E-06\",\n \"SemanticContext\": \"POLG 4 , 5.1 • Suspected POLG-related disorder in children under two years of age 4 , 5.1 • Known hypersensitivity to the drug 4 , 5.12 • Urea cycle disorders 4 , 5.6 • Prophylaxis of migraine headaches: Pregnant women, women of childbearing potential not using effective contraception 4 , 8.1 WARNINGS AND PRECAUTIONS • Hepatotoxicity; evaluate high risk populations and monitor serum liver tests 5.1 • Birth defects, decreased IQ, and neurodevelopmental disorders following in utero exposure; should not be used to treat women with epilepsy or bipolar disorder who are pregnant or who plan to become pregnant or to treat a woman of childbearing potential unless other medications have failed to provide adequate symptom control or are otherwise unacceptable 5.2 , 5.3 , 5.4 • Pancreatitis; divalproex sodium extended-release tablets should ordinarily be discontinued 5.5 • Suicidal behavior or ideation; Antiepileptic drugs, including divalproex sodium extended-release tablets, increase the risk of suicidal thoughts or behavior 5.7 • Bleeding and other hematopoietic disorders; monitor platelet counts and coagulation tests 5.8 • Hyperammonemia and hyperammonemic encephalopathy; measure ammonia level if unexplained lethargy and vomiting or changes in mental status, and also with concomitant topiramate use; consider discontinuation of valproate therapy 5.6 , 5.9 , 5.10 • Hypothermia; Hypothermia has been reported during valproate therapy with or without associated hyperammonemia.\"\n },\n {\n \"VerbatimTerm\": \"plan to become pregnant\",\n \"Probability\": \"4.8637E-06\",\n \"SemanticContext\": \"1.4 Important Limitations Because of the risk to the fetus of decreased IQ, neurodevelopmental disorders, neural tube defects, and other major congenital malformations, which may occur very early in pregnancy, valproate should not be used to treat women with epilepsy or bipolar disorder who are pregnant or who plan to become pregnant unless other medications have failed to provide adequate symptom control or are otherwise unacceptable.\"\n },\n {\n \"VerbatimTerm\": \"plan to become pregnant\",\n \"Probability\": \"1.5492E-06\",\n \"SemanticContext\": \"For use in epilepsy or bipolar disorder, valproate should not be used to treat women who are pregnant or who plan to become pregnant unless other medications have failed to provide adequate symptom control or are otherwise unacceptable [see Boxed Warning and Warnings and Precautions 5.2 , 5.3 ] .\"\n }\n ]\n },\n {\n \"Term\": \"Body surface area\",\n \"MEDDRACode\": \"10050311\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"body surface area\",\n \"Probability\": \"5.17733E-05\",\n \"SemanticContext\": \"Effect of Sex There are no differences in the body surface area adjusted unbound clearance between males and females 4.8 ± 0.17 and 4.7 ± 0.07 L/hr per 1.73 m 2 , respectively .\"\n },\n {\n \"VerbatimTerm\": \"body surface area\",\n \"Probability\": \"2.84165E-05\",\n \"SemanticContext\": \"Animal In developmental toxicity studies conducted in mice, rats, rabbits, and monkeys, increased rates of fetal structural abnormalities, intrauterine growth retardation, and embryo-fetal death occurred following administration of valproate to pregnant animals during organogenesis at clinically relevant doses calculated on a body surface area [mg/m 2 ] basis .\"\n }\n ]\n },\n {\n \"Term\": \"Hepatitis\",\n \"MEDDRACode\": \"10019717\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hepatitis\",\n \"Probability\": \"0.6965835094\",\n \"SemanticContext\": \"DRESS typically, although not exclusively, presents with fever, rash, lymphadenopathy, and/or facial swelling, in association with other organ system involvement, such as hepatitis, nephritis, hematological abnormalities, myocarditis, or myositis sometimes resembling an acute viral infection.\"\n }\n ]\n },\n {\n \"Term\": \"Hypokinesia\",\n \"MEDDRACode\": \"10021021\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Hypokinesia\",\n \"Probability\": \"0.7829802632\",\n \"SemanticContext\": \"Nervous System: Abnormal Gait, Agitation, Catatonic Reaction, Dysarthria, Hallucinations, Hypertonia, Hypokinesia, Psychosis, Reflexes Increased, Sleep Disorder, Tardive Dyskinesia, Tremor.\"\n }\n ]\n },\n {\n \"Term\": \"Puberty\",\n \"MEDDRACode\": \"10037280\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"puberty\",\n \"Probability\": \"1.77141E-05\",\n \"SemanticContext\": \"Birth Defects and Decreased IQ: Inform pregnant women and women of childbearing potential including girls beginning the onset of puberty that use of valproate during pregnancy increases the risk of birth defects, decreased IQ, and neurodevelopmental disorders in children who were exposed in utero .\"\n },\n {\n \"VerbatimTerm\": \"puberty\",\n \"Probability\": \"0.0006164908\",\n \"SemanticContext\": \"This is especially important for women planning a pregnancy and for girls at the onset of puberty; alternative therapeutic options should be considered for these patients [see Boxed Warning and Use in Specific Populations 8.1 ] .\"\n },\n {\n \"VerbatimTerm\": \"puberty\",\n \"Probability\": \"0.0007149577\",\n \"SemanticContext\": \"• All women of childbearing age including girls from the start of puberty should talk to their healthcare provider about using other possible treatments instead of divalproex sodium extended-release tablets.\"\n }\n ]\n },\n {\n \"Term\": \"Blister\",\n \"MEDDRACode\": \"10005191\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"blistering\",\n \"Probability\": \"0.0040048659\",\n \"SemanticContext\": \"• Allergic hypersensitivity reactions: fever, skin rash, hives, sores in your mouth, blistering and peeling of your skin, swelling of your lymph nodes, swelling of your face, eyes, lips, tongue, or throat, trouble swallowing or breathing.\"\n }\n ]\n },\n {\n \"Term\": \"Encephalopathy\",\n \"MEDDRACode\": \"10014625\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"encephalopathy\",\n \"Probability\": \"0.9927685261\",\n \"SemanticContext\": \"Therefore increased monitoring of valproate and concomitant drug concentrations and dosage adjustment are indicated whenever enzyme-inducing or inhibiting drugs are introduced or withdrawn 7.1 • Aspirin, carbapenem antibiotics, estrogen-containing hormonal contraceptives: Monitoring of valproate concentrations is recommended 7.1 • Co-administration of valproate can affect the pharmacokinetics of other drugs e.g., diazepam, ethosuximide, lamotrigine, phenytoin by inhibiting their metabolism or protein binding displacement 7.2 • Patients stabilized on rufinamide should begin valproate therapy at a low dose, and titrate to clinically effective dose 7.2 • Dosage adjustment of amitriptyline/nortriptyline, propofol, warfarin, and zidovudine may be necessary if used concomitantly with divalproex sodium extended-release tablets 7.2 • Topiramate: Hyperammonemia and encephalopathy 5.10 , 7.3 USE IN SPECIFIC POPULATIONS • Pregnancy: Divalproex sodium extended-release tablets can cause congenital malformations including neural tube defects, decreased IQ, and neurodevelopmental disorders 5.2 , 5.3 , 8.1 • Pediatric: Children under the age of two years are at considerably higher risk of fatal hepatotoxicity 5.1 , 8.4 • Geriatric: Reduce starting dose; increase dosage more slowly; monitor fluid and nutritional intake, and somnolence 5.14 , 8.5 See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.\"\n },\n {\n \"VerbatimTerm\": \"encephalopathy\",\n \"Probability\": \"0.0353494883\",\n \"SemanticContext\": \"There have been reports of acute or subacute encephalopathy in the absence of elevated ammonia levels, elevated valproate levels, or neuroimaging changes.\"\n },\n {\n \"VerbatimTerm\": \"encephalopathy\",\n \"Probability\": \"0.2593601942\",\n \"SemanticContext\": \"The encephalopathy reversed partially or fully after valproate discontinuation.\"\n },\n {\n \"VerbatimTerm\": \"encephalopathy\",\n \"Probability\": \"0.1909968555\",\n \"SemanticContext\": \"7.3 Topiramate Concomitant administration of valproate and topiramate has been associated with hyperammonemia with and without encephalopathy [see Contraindications 4 and Warnings and Precautions 5.6 , 5.9 , 5.10 ] .\"\n },\n {\n \"VerbatimTerm\": \"encephalopathy\",\n \"Probability\": \"0.2340704501\",\n \"SemanticContext\": \"POLG-related disorders should be suspected in patients with a family history or suggestive symptoms of a POLG-related disorder, including but not limited to unexplained encephalopathy, refractory epilepsy focal, myoclonic , status epilepticus at presentation, developmental delays, psychomotor regression, axonal sensorimotor neuropathy, myopathy cerebellar ataxia, ophthalmoplegia, or complicated migraine with occipital aura.\"\n },\n {\n \"VerbatimTerm\": \"encephalopathy\",\n \"Probability\": \"0.0061237812\",\n \"SemanticContext\": \"Prior to the initiation of divalproex sodium extended-release tablets therapy, evaluation for UCD should be considered in the following patients: 1 those with a history of unexplained encephalopathy or coma, encephalopathy associated with a protein load, pregnancy-related or postpartum encephalopathy, unexplained mental retardation, or history of elevated plasma ammonia or glutamine; 2 those with cyclical vomiting and lethargy, episodic extreme irritability, ataxia, low BUN, or protein avoidance; 3 those with a family history of UCD or a family history of unexplained infant deaths particularly males ; 4 those with other signs or symptoms of UCD.\"\n },\n {\n \"VerbatimTerm\": \"encephalopathy\",\n \"Probability\": \"0.0071353018\",\n \"SemanticContext\": \"Prior to the initiation of divalproex sodium extended-release tablets therapy, evaluation for UCD should be considered in the following patients: 1 those with a history of unexplained encephalopathy or coma, encephalopathy associated with a protein load, pregnancy-related or postpartum encephalopathy, unexplained mental retardation, or history of elevated plasma ammonia or glutamine; 2 those with cyclical vomiting and lethargy, episodic extreme irritability, ataxia, low BUN, or protein avoidance; 3 those with a family history of UCD or a family history of unexplained infant deaths particularly males ; 4 those with other signs or symptoms of UCD.\"\n },\n {\n \"VerbatimTerm\": \"encephalopathy\",\n \"Probability\": \"0.5494440794\",\n \"SemanticContext\": \"Prior to the initiation of divalproex sodium extended-release tablets therapy, evaluation for UCD should be considered in the following patients: 1 those with a history of unexplained encephalopathy or coma, encephalopathy associated with a protein load, pregnancy-related or postpartum encephalopathy, unexplained mental retardation, or history of elevated plasma ammonia or glutamine; 2 those with cyclical vomiting and lethargy, episodic extreme irritability, ataxia, low BUN, or protein avoidance; 3 those with a family history of UCD or a family history of unexplained infant deaths particularly males ; 4 those with other signs or symptoms of UCD.\"\n },\n {\n \"VerbatimTerm\": \"encephalopathy\",\n \"Probability\": \"0.0262789428\",\n \"SemanticContext\": \"5.10 Hyperammonemia and Encephalopathy Associated with Concomitant Topiramate Use Concomitant administration of topiramate and valproate has been associated with hyperammonemia with or without encephalopathy in patients who have tolerated either drug alone.\"\n },\n {\n \"VerbatimTerm\": \"encephalopathy\",\n \"Probability\": \"0.56650424\",\n \"SemanticContext\": \"Patients with inborn errors of metabolism or reduced hepatic mitochondrial activity may be at an increased risk for hyperammonemia with or without encephalopathy.\"\n },\n {\n \"VerbatimTerm\": \"Encephalopathy\",\n \"Probability\": \"0.3116610646\",\n \"SemanticContext\": \"5.10 Hyperammonemia and Encephalopathy Associated with Concomitant Topiramate Use Concomitant administration of topiramate and valproate has been associated with hyperammonemia with or without encephalopathy in patients who have tolerated either drug alone.\"\n }\n ]\n },\n {\n \"Term\": \"Platelet count\",\n \"MEDDRACode\": \"10035525\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"platelet counts\",\n \"Probability\": \"0.0020883977\",\n \"SemanticContext\": \"POLG 4 , 5.1 • Suspected POLG-related disorder in children under two years of age 4 , 5.1 • Known hypersensitivity to the drug 4 , 5.12 • Urea cycle disorders 4 , 5.6 • Prophylaxis of migraine headaches: Pregnant women, women of childbearing potential not using effective contraception 4 , 8.1 WARNINGS AND PRECAUTIONS • Hepatotoxicity; evaluate high risk populations and monitor serum liver tests 5.1 • Birth defects, decreased IQ, and neurodevelopmental disorders following in utero exposure; should not be used to treat women with epilepsy or bipolar disorder who are pregnant or who plan to become pregnant or to treat a woman of childbearing potential unless other medications have failed to provide adequate symptom control or are otherwise unacceptable 5.2 , 5.3 , 5.4 • Pancreatitis; divalproex sodium extended-release tablets should ordinarily be discontinued 5.5 • Suicidal behavior or ideation; Antiepileptic drugs, including divalproex sodium extended-release tablets, increase the risk of suicidal thoughts or behavior 5.7 • Bleeding and other hematopoietic disorders; monitor platelet counts and coagulation tests 5.8 • Hyperammonemia and hyperammonemic encephalopathy; measure ammonia level if unexplained lethargy and vomiting or changes in mental status, and also with concomitant topiramate use; consider discontinuation of valproate therapy 5.6 , 5.9 , 5.10 • Hypothermia; Hypothermia has been reported during valproate therapy with or without associated hyperammonemia.\"\n },\n {\n \"VerbatimTerm\": \"platelet counts\",\n \"Probability\": \"0.0162320435\",\n \"SemanticContext\": \"In a clinical trial of valproate as monotherapy in patients with epilepsy, 34/126 patients 27% receiving approximately 50 mg/kg/day on average, had at least one value of platelets = 75 x 10 9 /L. Approximately half of these patients had treatment discontinued, with return of platelet counts to normal.\"\n },\n {\n \"VerbatimTerm\": \"platelet counts\",\n \"Probability\": \"0.0031892359\",\n \"SemanticContext\": \"In the remaining patients, platelet counts normalized with continued treatment.\"\n }\n ]\n },\n {\n \"Term\": \"Myalgia\",\n \"MEDDRACode\": \"10028411\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Myalgia\",\n \"Probability\": \"0.9979831576\",\n \"SemanticContext\": \"Musculoskeletal System: Arthrosis, Myalgia.\"\n },\n {\n \"VerbatimTerm\": \"Myalgia\",\n \"Probability\": \"0.9993710518\",\n \"SemanticContext\": \"Musculoskeletal System: Myalgia, twitching, arthralgia, leg cramps, myasthenia.\"\n }\n ]\n },\n {\n \"Term\": \"Blood oestrogen\",\n \"MEDDRACode\": \"10005684\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"estrogen\",\n \"Probability\": \"3.77644E-05\",\n \"SemanticContext\": \"Therefore increased monitoring of valproate and concomitant drug concentrations and dosage adjustment are indicated whenever enzyme-inducing or inhibiting drugs are introduced or withdrawn 7.1 • Aspirin, carbapenem antibiotics, estrogen-containing hormonal contraceptives: Monitoring of valproate concentrations is recommended 7.1 • Co-administration of valproate can affect the pharmacokinetics of other drugs e.g., diazepam, ethosuximide, lamotrigine, phenytoin by inhibiting their metabolism or protein binding displacement 7.2 • Patients stabilized on rufinamide should begin valproate therapy at a low dose, and titrate to clinically effective dose 7.2 • Dosage adjustment of amitriptyline/nortriptyline, propofol, warfarin, and zidovudine may be necessary if used concomitantly with divalproex sodium extended-release tablets 7.2 • Topiramate: Hyperammonemia and encephalopathy 5.10 , 7.3 USE IN SPECIFIC POPULATIONS • Pregnancy: Divalproex sodium extended-release tablets can cause congenital malformations including neural tube defects, decreased IQ, and neurodevelopmental disorders 5.2 , 5.3 , 8.1 • Pediatric: Children under the age of two years are at considerably higher risk of fatal hepatotoxicity 5.1 , 8.4 • Geriatric: Reduce starting dose; increase dosage more slowly; monitor fluid and nutritional intake, and somnolence 5.14 , 8.5 See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.\"\n },\n {\n \"VerbatimTerm\": \"estrogen\",\n \"Probability\": \"1.63222E-05\",\n \"SemanticContext\": \"Prescribers should monitor serum valproate concentrations and clinical response when adding or discontinuing estrogen containing products.\"\n },\n {\n \"VerbatimTerm\": \"Estrogen\",\n \"Probability\": \"0.0003810823\",\n \"SemanticContext\": \"Estrogen-Containing Hormonal Contraceptives Estrogen-containing hormonal contraceptives may increase the clearance of valproate, which may result in decreased concentration of valproate and potentially increased seizure frequency.\"\n },\n {\n \"VerbatimTerm\": \"Estrogen\",\n \"Probability\": \"4.2632E-06\",\n \"SemanticContext\": \"Estrogen-Containing Hormonal Contraceptives Estrogen-containing hormonal contraceptives may increase the clearance of valproate, which may result in decreased concentration of valproate and potentially increased seizure frequency.\"\n }\n ]\n },\n {\n \"Term\": \"Asthenia\",\n \"MEDDRACode\": \"10003549\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"weakness\",\n \"Probability\": \"0.9917647243\",\n \"SemanticContext\": \"Musculoskeletal: Fractures, decreased bone mineral density, osteopenia, osteoporosis, and weakness.\"\n },\n {\n \"VerbatimTerm\": \"weakness\",\n \"Probability\": \"0.9604700804\",\n \"SemanticContext\": \"Serious or fatal hepatotoxicity may be preceded by non-specific symptoms such as malaise, weakness, lethargy, facial edema, anorexia, and vomiting.\"\n },\n {\n \"VerbatimTerm\": \"weakness\",\n \"Probability\": \"0.9220974445\",\n \"SemanticContext\": \"The common side effects of divalproex sodium extended-release tablets include: • nausea • headache • sleepiness • vomiting • weakness • tremor • dizziness • stomach pain • blurry vision • double vision • diarrhea • increased appetite • weight gain • hair loss • loss of appetite • problems with walking or coordination These are not all of the possible side effects of divalproex sodium extended-release tablets .\"\n }\n ]\n },\n {\n \"Term\": \"Decreased appetite\",\n \"MEDDRACode\": \"10061428\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"anorexia\",\n \"Probability\": \"0.9989972115\",\n \"SemanticContext\": \"Divalproex sodium extended-release tablets dosage should be increased slowly and with regular monitoring for fluid and nutritional intake 5.14 ADVERSE REACTIONS • Most common adverse reactions reported > 5% are abdominal pain, alopecia, amblyopia/blurred vision, amnesia, anorexia, asthenia, ataxia, back pain, bronchitis, constipation, depression, diarrhea, diplopia, dizziness, dyspnea, dyspepsia, ecchymosis, emotional lability, fever, flu syndrome, headache, increased appetite, infection, insomnia, nausea, nervousness, nystagmus, peripheral edema, pharyngitis, rash, rhinitis, somnolence, thinking abnormal, thrombocytopenia, tinnitus, tremor, vomiting, weight gain, weight loss 6.1 , 6.2 , 6.3 .\"\n },\n {\n \"VerbatimTerm\": \"anorexia\",\n \"Probability\": \"0.3594831526\",\n \"SemanticContext\": \"Hepatotoxicity: Warn patients and guardians that nausea, vomiting, abdominal pain, anorexia, diarrhea, asthenia, and/or jaundice can be symptoms of hepatotoxicity and, therefore, require further medical evaluation promptly [see Warnings and Precautions 5.1 ] .\"\n },\n {\n \"VerbatimTerm\": \"anorexia\",\n \"Probability\": \"0.7645022273\",\n \"SemanticContext\": \"Pancreatitis: Warn patients and guardians that abdominal pain, nausea, vomiting, and/or anorexia can be symptoms of pancreatitis and, therefore, require further medical evaluation promptly [see Warnings and Precautions 5.5 ].\"\n },\n {\n \"VerbatimTerm\": \"anorexia\",\n \"Probability\": \"0.7718826532\",\n \"SemanticContext\": \"Serious or fatal hepatotoxicity may be preceded by non-specific symptoms such as malaise, weakness, lethargy, facial edema, anorexia, and vomiting.\"\n },\n {\n \"VerbatimTerm\": \"anorexia\",\n \"Probability\": \"0.0013563037\",\n \"SemanticContext\": \"Patients and guardians should be warned that abdominal pain, nausea, vomiting, and/or anorexia can be symptoms of pancreatitis that require prompt medical evaluation.\"\n },\n {\n \"VerbatimTerm\": \"Anorexia\",\n \"Probability\": \"0.9990183115\",\n \"SemanticContext\": \"Adverse Reactions Reported by = 5% of Patients Treated with Valproate During Placebo-Controlled Trial of Adjunctive Therapy for Complex Partial Seizures Body System/Event Divalproex Sodium Delayed- Release Tablets N = 77 % Placebo N = 70 % Body as a Whole Headache 31 21 Asthenia 27 7 Fever 6 4 Gastrointestinal System Nausea 48 14 Vomiting 27 7 Abdominal Pain 23 6 Diarrhea 13 6 Anorexia 12 0 Dyspepsia 8 4 Constipation 5 1 Nervous System Somnolence 27 11 Tremor 25 6 Dizziness 25 13 Diplopia 16 9 Amblyopia/Blurred Vision 12 9 Ataxia 8 1 Nystagmus 8 1 Emotional Lability 6 4 Thinking Abnormal 6 0 Amnesia 5 1 Respiratory System Flu Syndrome 12 9 Infection 12 6 Bronchitis 5 1 Rhinitis 5 4 Other Alopecia 6 1 Weight Loss 6 0 .\"\n },\n {\n \"VerbatimTerm\": \"Anorexia\",\n \"Probability\": \"0.9985806942\",\n \"SemanticContext\": \"Body System/Event High Dose n = 131 % Low Dose n = 134 % Body as a Whole Asthenia 21 10 Digestive System Nausea 34 26 Diarrhea 23 19 Vomiting 23 15 Abdominal Pain 12 9 Anorexia 11 4 Dyspepsia 11 10 Hemic/Lymphatic System Thrombocytopenia 24 1 Ecchymosis 5 4 Metabolic/Nutritional Weight Gain 9 4 Peripheral Edema 8 3 Nervous System Tremor 57 19 Somnolence 30 18 Dizziness 18 13 Insomnia 15 9 Nervousness 11 7 Amnesia 7 4 Nystagmus 7 1 Depression 5 4 Respiratory System Infection 20 13 Pharyngitis 8 2 Dyspnea 5 1 Skin and Appendages Alopecia 24 13 Special Senses Amblyopia/Blurred Vision 8 4 Tinnitus 7 1 .\"\n }\n ]\n },\n {\n \"Term\": \"Swelling\",\n \"MEDDRACode\": \"10042674\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"swelling\",\n \"Probability\": \"4.40767E-05\",\n \"SemanticContext\": \"Call your healthcare provider right away if you get any of the following symptoms: • nausea or vomiting that does not go away • loss of appetite • pain on the right side of your stomach abdomen • dark urine • swelling of your face • yellowing of your skin or the whites of your eyes In some cases, liver damage may continue despite stopping the drug.\"\n },\n {\n \"VerbatimTerm\": \"swelling\",\n \"Probability\": \"0.0603713691\",\n \"SemanticContext\": \"Divalproex sodium extended-release tablets can cause serious side effects including: • Bleeding problems: red or purple spots on your skin, bruising, pain and swelling into your joints due to bleeding or bleeding from your mouth or nose.\"\n },\n {\n \"VerbatimTerm\": \"swelling\",\n \"Probability\": \"0.0018589199\",\n \"SemanticContext\": \"• Allergic hypersensitivity reactions: fever, skin rash, hives, sores in your mouth, blistering and peeling of your skin, swelling of your lymph nodes, swelling of your face, eyes, lips, tongue, or throat, trouble swallowing or breathing.\"\n },\n {\n \"VerbatimTerm\": \"swelling\",\n \"Probability\": \"0.0001619458\",\n \"SemanticContext\": \"• Allergic hypersensitivity reactions: fever, skin rash, hives, sores in your mouth, blistering and peeling of your skin, swelling of your lymph nodes, swelling of your face, eyes, lips, tongue, or throat, trouble swallowing or breathing.\"\n }\n ]\n },\n {\n \"Term\": \"Neurodevelopmental disorder\",\n \"MEDDRACode\": \"10064062\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"neurodevelopmental disorders\",\n \"Probability\": \"0.0005270541\",\n \"SemanticContext\": \"POLG 4 , 5.1 • Suspected POLG-related disorder in children under two years of age 4 , 5.1 • Known hypersensitivity to the drug 4 , 5.12 • Urea cycle disorders 4 , 5.6 • Prophylaxis of migraine headaches: Pregnant women, women of childbearing potential not using effective contraception 4 , 8.1 WARNINGS AND PRECAUTIONS • Hepatotoxicity; evaluate high risk populations and monitor serum liver tests 5.1 • Birth defects, decreased IQ, and neurodevelopmental disorders following in utero exposure; should not be used to treat women with epilepsy or bipolar disorder who are pregnant or who plan to become pregnant or to treat a woman of childbearing potential unless other medications have failed to provide adequate symptom control or are otherwise unacceptable 5.2 , 5.3 , 5.4 • Pancreatitis; divalproex sodium extended-release tablets should ordinarily be discontinued 5.5 • Suicidal behavior or ideation; Antiepileptic drugs, including divalproex sodium extended-release tablets, increase the risk of suicidal thoughts or behavior 5.7 • Bleeding and other hematopoietic disorders; monitor platelet counts and coagulation tests 5.8 • Hyperammonemia and hyperammonemic encephalopathy; measure ammonia level if unexplained lethargy and vomiting or changes in mental status, and also with concomitant topiramate use; consider discontinuation of valproate therapy 5.6 , 5.9 , 5.10 • Hypothermia; Hypothermia has been reported during valproate therapy with or without associated hyperammonemia.\"\n },\n {\n \"VerbatimTerm\": \"neurodevelopmental disorders\",\n \"Probability\": \"0.2827538848\",\n \"SemanticContext\": \"Therefore increased monitoring of valproate and concomitant drug concentrations and dosage adjustment are indicated whenever enzyme-inducing or inhibiting drugs are introduced or withdrawn 7.1 • Aspirin, carbapenem antibiotics, estrogen-containing hormonal contraceptives: Monitoring of valproate concentrations is recommended 7.1 • Co-administration of valproate can affect the pharmacokinetics of other drugs e.g., diazepam, ethosuximide, lamotrigine, phenytoin by inhibiting their metabolism or protein binding displacement 7.2 • Patients stabilized on rufinamide should begin valproate therapy at a low dose, and titrate to clinically effective dose 7.2 • Dosage adjustment of amitriptyline/nortriptyline, propofol, warfarin, and zidovudine may be necessary if used concomitantly with divalproex sodium extended-release tablets 7.2 • Topiramate: Hyperammonemia and encephalopathy 5.10 , 7.3 USE IN SPECIFIC POPULATIONS • Pregnancy: Divalproex sodium extended-release tablets can cause congenital malformations including neural tube defects, decreased IQ, and neurodevelopmental disorders 5.2 , 5.3 , 8.1 • Pediatric: Children under the age of two years are at considerably higher risk of fatal hepatotoxicity 5.1 , 8.4 • Geriatric: Reduce starting dose; increase dosage more slowly; monitor fluid and nutritional intake, and somnolence 5.14 , 8.5 See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.\"\n },\n {\n \"VerbatimTerm\": \"neurodevelopmental disorders\",\n \"Probability\": \"0.0136266053\",\n \"SemanticContext\": \"1.4 Important Limitations Because of the risk to the fetus of decreased IQ, neurodevelopmental disorders, neural tube defects, and other major congenital malformations, which may occur very early in pregnancy, valproate should not be used to treat women with epilepsy or bipolar disorder who are pregnant or who plan to become pregnant unless other medications have failed to provide adequate symptom control or are otherwise unacceptable.\"\n },\n {\n \"VerbatimTerm\": \"neurodevelopmental disorders\",\n \"Probability\": \"0.0041658282\",\n \"SemanticContext\": \"Birth Defects and Decreased IQ: Inform pregnant women and women of childbearing potential including girls beginning the onset of puberty that use of valproate during pregnancy increases the risk of birth defects, decreased IQ, and neurodevelopmental disorders in children who were exposed in utero .\"\n },\n {\n \"VerbatimTerm\": \"neurodevelopmental disorders\",\n \"Probability\": \"0.0018075407\",\n \"SemanticContext\": \"Epidemiological studies have indicated that children exposed to valproate in utero have lower IQ scores and a higher risk of neurodevelopmental disorders compared to children exposed to either another AED in utero or to no AEDs in utero [see Warnings and Precautions 5.3 and Data Human ] .\"\n },\n {\n \"VerbatimTerm\": \"neurodevelopmental disorders\",\n \"Probability\": \"0.0107151568\",\n \"SemanticContext\": \"5.4 Use in Women of Childbearing Potential Because of the risk to the fetus of decreased IQ, neurodevelopmental disorders, and major congenital malformations including neural tube defects , which may occur very early in pregnancy, valproate should not be administered to a woman of childbearing potential unless other medications have failed to provide adequate symptom control or are otherwise unacceptable.\"\n }\n ]\n },\n {\n \"Term\": \"Foetal death\",\n \"MEDDRACode\": \"10055690\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"fetal death\",\n \"Probability\": \"0.7911859751\",\n \"SemanticContext\": \"Animal In developmental toxicity studies conducted in mice, rats, rabbits, and monkeys, increased rates of fetal structural abnormalities, intrauterine growth retardation, and embryo-fetal death occurred following administration of valproate to pregnant animals during organogenesis at clinically relevant doses calculated on a body surface area [mg/m 2 ] basis .\"\n }\n ]\n },\n {\n \"Term\": \"Infant\",\n \"MEDDRACode\": \"10021731\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"infants\",\n \"Probability\": \"0.0612893105\",\n \"SemanticContext\": \"There have been reports of hypoglycemia in neonates and fatal cases of hepatic failure in infants following maternal use of valproate during pregnancy.\"\n },\n {\n \"VerbatimTerm\": \"infants\",\n \"Probability\": \"0.0477439761\",\n \"SemanticContext\": \"Fatal cases of hepatic failure in infants exposed to valproate in utero have also been reported following maternal use of valproate during pregnancy.\"\n },\n {\n \"VerbatimTerm\": \"infants\",\n \"Probability\": \"0.0286226273\",\n \"SemanticContext\": \"Valproate serum concentrations collected from breastfed infants aged 3 days postnatal to 12 weeks following delivery ranged from 0.7 mcg/mL to 4 mcg/mL, which were 1% to 6% of maternal serum valproate levels.\"\n },\n {\n \"VerbatimTerm\": \"infants\",\n \"Probability\": \"0.0151893198\",\n \"SemanticContext\": \"None of the mothers received valproate during pregnancy, and infants were aged from 4 weeks to 19 weeks at the time of evaluation.\"\n },\n {\n \"VerbatimTerm\": \"infants\",\n \"Probability\": \"0.03580755\",\n \"SemanticContext\": \"Similarly, in 2 published case reports with maternal doses of 500 mg/day or 750 mg/day during breastfeeding of infants aged 3 months and 1 month, infant exposure was 1.5% and 6% that of the mother, respectively.\"\n },\n {\n \"VerbatimTerm\": \"infant\",\n \"Probability\": \"0.0017375648\",\n \"SemanticContext\": \"Prior to the initiation of divalproex sodium extended-release tablets therapy, evaluation for UCD should be considered in the following patients: 1 those with a history of unexplained encephalopathy or coma, encephalopathy associated with a protein load, pregnancy-related or postpartum encephalopathy, unexplained mental retardation, or history of elevated plasma ammonia or glutamine; 2 those with cyclical vomiting and lethargy, episodic extreme irritability, ataxia, low BUN, or protein avoidance; 3 those with a family history of UCD or a family history of unexplained infant deaths particularly males ; 4 those with other signs or symptoms of UCD.\"\n },\n {\n \"VerbatimTerm\": \"infant\",\n \"Probability\": \"0.0009970069\",\n \"SemanticContext\": \"\\n Clinical Considerations The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for divalproex sodium delayed-release tablets and any potential adverse effects on the breastfed infant from divalproex sodium delayed-release tablets or from the underlying maternal condition.\"\n },\n {\n \"VerbatimTerm\": \"infant\",\n \"Probability\": \"0.0005721152\",\n \"SemanticContext\": \"Monitor the breastfed infant for signs of liver damage including jaundice and unusual bruising or bleeding.\"\n },\n {\n \"VerbatimTerm\": \"infant\",\n \"Probability\": \"0.0021819472\",\n \"SemanticContext\": \"A published study of 6 breastfeeding mother-infant pairs measured serum valproate levels during maternal treatment for bipolar disorder 750 mg/day or 1,000 mg/day .\"\n },\n {\n \"VerbatimTerm\": \"infant\",\n \"Probability\": \"0.0012480021\",\n \"SemanticContext\": \"With maternal serum valproate levels near or within the therapeutic range, infant exposure was 0.9% to 2.3% of maternal levels.\"\n },\n {\n \"VerbatimTerm\": \"infant\",\n \"Probability\": \"0.1007039547\",\n \"SemanticContext\": \"Similarly, in 2 published case reports with maternal doses of 500 mg/day or 750 mg/day during breastfeeding of infants aged 3 months and 1 month, infant exposure was 1.5% and 6% that of the mother, respectively.\"\n },\n {\n \"VerbatimTerm\": \"Infant\",\n \"Probability\": \"0.0017935932\",\n \"SemanticContext\": \"Infant serum levels ranged from 0.7 mcg/mL to 1.5 mcg/mL.\"\n }\n ]\n },\n {\n \"Term\": \"Renal impairment\",\n \"MEDDRACode\": \"10062237\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"renal impairment\",\n \"Probability\": \"4.44762E-05\",\n \"SemanticContext\": \"Protein binding of valproate is reduced in the elderly, in patients with chronic hepatic diseases, in patients with renal impairment, and in the presence of other drugs e.g., aspirin .\"\n }\n ]\n },\n {\n \"Term\": \"Skin exfoliation\",\n \"MEDDRACode\": \"10040844\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"peeling\",\n \"Probability\": \"0.0379733741\",\n \"SemanticContext\": \"• Allergic hypersensitivity reactions: fever, skin rash, hives, sores in your mouth, blistering and peeling of your skin, swelling of your lymph nodes, swelling of your face, eyes, lips, tongue, or throat, trouble swallowing or breathing.\"\n }\n ]\n },\n {\n \"Term\": \"Hepatic enzyme increased\",\n \"MEDDRACode\": \"10060795\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"elevated liver enzymes\",\n \"Probability\": \"0.2946716547\",\n \"SemanticContext\": \"\\n \\n Dose-Related Adverse Reactions\\n The frequency of adverse effects particularly elevated liver enzymes and thrombocytopenia may be dose-related.\"\n }\n ]\n },\n {\n \"Term\": \"Rash\",\n \"MEDDRACode\": \"10037844\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"rash\",\n \"Probability\": \"0.9993665814\",\n \"SemanticContext\": \"Divalproex sodium extended-release tablets dosage should be increased slowly and with regular monitoring for fluid and nutritional intake 5.14 ADVERSE REACTIONS • Most common adverse reactions reported > 5% are abdominal pain, alopecia, amblyopia/blurred vision, amnesia, anorexia, asthenia, ataxia, back pain, bronchitis, constipation, depression, diarrhea, diplopia, dizziness, dyspnea, dyspepsia, ecchymosis, emotional lability, fever, flu syndrome, headache, increased appetite, infection, insomnia, nausea, nervousness, nystagmus, peripheral edema, pharyngitis, rash, rhinitis, somnolence, thinking abnormal, thrombocytopenia, tinnitus, tremor, vomiting, weight gain, weight loss 6.1 , 6.2 , 6.3 .\"\n },\n {\n \"VerbatimTerm\": \"rash\",\n \"Probability\": \"0.4080234766\",\n \"SemanticContext\": \"Multiorgan Hypersensitivity Reactions: Instruct patients that a fever associated with other organ system involvement rash, lymphadenopathy, etc. may be drug-related and should be reported to the physician immediately [see Warnings and Precautions 5.12 ].\"\n },\n {\n \"VerbatimTerm\": \"rash\",\n \"Probability\": \"0.9549069405\",\n \"SemanticContext\": \"DRESS typically, although not exclusively, presents with fever, rash, lymphadenopathy, and/or facial swelling, in association with other organ system involvement, such as hepatitis, nephritis, hematological abnormalities, myocarditis, or myositis sometimes resembling an acute viral infection.\"\n },\n {\n \"VerbatimTerm\": \"rash\",\n \"Probability\": \"0.9042155147\",\n \"SemanticContext\": \"It is important to note that early manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident.\"\n },\n {\n \"VerbatimTerm\": \"rash\",\n \"Probability\": \"0.9965407848\",\n \"SemanticContext\": \"The most common drug-related adverse reactions reported > 5% and twice the rate of placebo reported in the controlled pediatric mania study were nausea, upper abdominal pain, somnolence, increased ammonia, gastritis and rash.\"\n },\n {\n \"VerbatimTerm\": \"Rash\",\n \"Probability\": \"0.9962269068\",\n \"SemanticContext\": \"Skin and Appendages: Discoid Lupus Erythematosus, Erythema Nodosum, Furunculosis, Maculopapular Rash, Pruritus, Rash, Seborrhea, Sweating, Vesiculobullous Rash.\"\n },\n {\n \"VerbatimTerm\": \"Rash\",\n \"Probability\": \"0.9988380671\",\n \"SemanticContext\": \"Skin and Appendages: Rash, pruritus, dry skin.\"\n },\n {\n \"VerbatimTerm\": \"Rash\",\n \"Probability\": \"0.9935836792\",\n \"SemanticContext\": \"Skin and Appendages: Rash.\"\n }\n ]\n },\n {\n \"Term\": \"Stomatitis\",\n \"MEDDRACode\": \"10042128\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"stomatitis\",\n \"Probability\": \"0.9988427162\",\n \"SemanticContext\": \"Digestive System: Constipation, dry mouth, flatulence, and stomatitis.\"\n }\n ]\n },\n {\n \"Term\": \"Sperm concentration decreased\",\n \"MEDDRACode\": \"10070925\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"decreased sperm count\",\n \"Probability\": \"0.998726964\",\n \"SemanticContext\": \"Reproductive: Aspermia, azoospermia, decreased sperm count, decreased spermatozoa motility, male infertility, and abnormal spermatozoa morphology.\"\n }\n ]\n },\n {\n \"Term\": \"Vaginal infection\",\n \"MEDDRACode\": \"10046914\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Vaginitis\",\n \"Probability\": \"0.7078217268\",\n \"SemanticContext\": \"Urogenital System: Cystitis, Urinary Tract Infection, Menstrual Disorder, Vaginitis.\"\n },\n {\n \"VerbatimTerm\": \"vaginitis\",\n \"Probability\": \"0.9024773836\",\n \"SemanticContext\": \"Urogenital System: Urinary incontinence, vaginitis, dysmenorrhea, amenorrhea, urinary frequency.\"\n }\n ]\n },\n {\n \"Term\": \"Blood albumin\",\n \"MEDDRACode\": \"10005285\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"albumin\",\n \"Probability\": \"0.0001757741\",\n \"SemanticContext\": \"There was a trend for the patients who experienced these events to have a lower baseline albumin concentration, lower valproate clearance, and a higher BUN.\"\n }\n ]\n },\n {\n \"Term\": \"Skin reaction\",\n \"MEDDRACode\": \"10040914\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"skin reactions\",\n \"Probability\": \"0.228138119\",\n \"SemanticContext\": \"Serious skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported with concomitant lamotrigine and valproate administration.\"\n }\n ]\n },\n {\n \"Term\": \"Back pain\",\n \"MEDDRACode\": \"10003988\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"back pain\",\n \"Probability\": \"0.9940738082\",\n \"SemanticContext\": \"Divalproex sodium extended-release tablets dosage should be increased slowly and with regular monitoring for fluid and nutritional intake 5.14 ADVERSE REACTIONS • Most common adverse reactions reported > 5% are abdominal pain, alopecia, amblyopia/blurred vision, amnesia, anorexia, asthenia, ataxia, back pain, bronchitis, constipation, depression, diarrhea, diplopia, dizziness, dyspnea, dyspepsia, ecchymosis, emotional lability, fever, flu syndrome, headache, increased appetite, infection, insomnia, nausea, nervousness, nystagmus, peripheral edema, pharyngitis, rash, rhinitis, somnolence, thinking abnormal, thrombocytopenia, tinnitus, tremor, vomiting, weight gain, weight loss 6.1 , 6.2 , 6.3 .\"\n },\n {\n \"VerbatimTerm\": \"Back Pain\",\n \"Probability\": \"0.9022341967\",\n \"SemanticContext\": \"The following additional adverse reactions were reported by greater than 1% of the divalproex sodium extended-release tablets-treated patients in controlled clinical trials: Body as a Whole: Back Pain, Chills, Chills and Fever, Drug Level Increased, Flu Syndrome, Infection, Infection Fungal, Neck Rigidity.\"\n },\n {\n \"VerbatimTerm\": \"Back Pain\",\n \"Probability\": \"0.9880701303\",\n \"SemanticContext\": \"Body System Reaction Divalproex Sodium Delayed-Release Tablets n = 202 % Placebo n = 81 % Gastrointestinal System Nausea 31 10 Dyspepsia 13 9 Diarrhea 12 7 Vomiting 11 1 Abdominal Pain 9 4 Increased Appetite 6 4 Nervous System Asthenia 20 9 Somnolence 17 5 Dizziness 12 6 Tremor 9 0 Other Weight Gain 8 2 Back Pain 8 6 Alopecia 7 1 .\"\n },\n {\n \"VerbatimTerm\": \"Back pain\",\n \"Probability\": \"0.9524037242\",\n \"SemanticContext\": \"The following additional adverse reactions were reported by greater than 1% but less than 5% of the 358 patients treated with valproate in the controlled trials of complex partial seizures: Body as a Whole: Back pain, chest pain, malaise.\"\n }\n ]\n },\n {\n \"Term\": \"Product residue present\",\n \"MEDDRACode\": \"10081359\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Medication Residue\",\n \"Probability\": \"0.0031593442\",\n \"SemanticContext\": \"Medication Residue in the Stool: Instruct patients to notify their healthcare provider if they notice a medication residue in the stool [see Warnings and Precautions 5.18 ] .\"\n },\n {\n \"VerbatimTerm\": \"Medication Residue\",\n \"Probability\": \"0.0016549826\",\n \"SemanticContext\": \"5.18 Medication Residue in the Stool There have been rare reports of medication residue in the stool.\"\n },\n {\n \"VerbatimTerm\": \"medication residue\",\n \"Probability\": \"7.63394E-05\",\n \"SemanticContext\": \"Medication Residue in the Stool: Instruct patients to notify their healthcare provider if they notice a medication residue in the stool [see Warnings and Precautions 5.18 ] .\"\n },\n {\n \"VerbatimTerm\": \"medication residue\",\n \"Probability\": \"0.0012463927\",\n \"SemanticContext\": \"5.18 Medication Residue in the Stool There have been rare reports of medication residue in the stool.\"\n },\n {\n \"VerbatimTerm\": \"medication residue\",\n \"Probability\": \"9.161E-07\",\n \"SemanticContext\": \"It is recommended that plasma valproate levels be checked in patients who experience medication residue in the stool, and patients’ clinical condition should be monitored.\"\n },\n {\n \"VerbatimTerm\": \"medication residues\",\n \"Probability\": \"0.0049948096\",\n \"SemanticContext\": \"In some reports, medication residues have occurred in the context of diarrhea.\"\n }\n ]\n },\n {\n \"Term\": \"Gastritis\",\n \"MEDDRACode\": \"10017853\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"gastritis\",\n \"Probability\": \"0.9783545732\",\n \"SemanticContext\": \"The most common drug-related adverse reactions reported > 5% and twice the rate of placebo reported in the controlled pediatric mania study were nausea, upper abdominal pain, somnolence, increased ammonia, gastritis and rash.\"\n }\n ]\n },\n {\n \"Term\": \"Limb malformation\",\n \"MEDDRACode\": \"10024500\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"limb malformations\",\n \"Probability\": \"0.2216427922\",\n \"SemanticContext\": \"Maternal valproate use during pregnancy for any indication increases the risk of congenital malformations, particularly neural tube defects including spina bifida, but also malformations involving other body systems e.g., craniofacial defects including oral clefts, cardiovascular malformations, hypospadias, limb malformations .\"\n },\n {\n \"VerbatimTerm\": \"limb malformations\",\n \"Probability\": \"0.4597173631\",\n \"SemanticContext\": \"The major congenital malformations included cases of neural tube defects, cardiovascular malformations, craniofacial defects e.g., oral clefts, craniosynostosis , hypospadias, limb malformations e.g., clubfoot, polydactyly , and other malformations of varying severity involving other body systems [see Warnings and Precautions 5.2 ] .\"\n },\n {\n \"VerbatimTerm\": \"limb malformations\",\n \"Probability\": \"0.2799103558\",\n \"SemanticContext\": \"Pregnancy registry data show that maternal valproate use can cause neural tube defects and other structural abnormalities e.g., craniofacial defects, cardiovascular malformations, hypospadias, limb malformations .\"\n }\n ]\n },\n {\n \"Term\": \"Antiretroviral therapy\",\n \"MEDDRACode\": \"10067326\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"antiretroviral therapy\",\n \"Probability\": \"3.7331E-06\",\n \"SemanticContext\": \"Additionally, the relevance of these in vitro findings is uncertain for patients receiving maximally suppressive antiretroviral therapy.\"\n }\n ]\n },\n {\n \"Term\": \"Investigation\",\n \"MEDDRACode\": \"10062026\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"investigation\",\n \"Probability\": \"1.3426E-06\",\n \"SemanticContext\": \"Appropriate interventions for treatment of hyperammonemia should be initiated, and such patients should undergo investigation for underlying urea cycle disorders [see Contraindications 4 and Warnings and Precautions 5.6 , 5.10 ] .\"\n }\n ]\n },\n {\n \"Term\": \"Platelet aggregation test\",\n \"MEDDRACode\": \"10084286\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"platelet aggregation\",\n \"Probability\": \"0.0095758736\",\n \"SemanticContext\": \"Because of reports of cytopenias, inhibition of the secondary phase of platelet aggregation, and abnormal coagulation parameters, e.g., low fibrinogen, coagulation factor deficiencies, acquired von Willebrand’s disease , measurements of complete blood counts and coagulation tests are recommended before initiating therapy and at periodic intervals.\"\n }\n ]\n },\n {\n \"Term\": \"Epilepsy\",\n \"MEDDRACode\": \"10015037\",\n \"Overdose\": true,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"epilepsy\",\n \"Probability\": \"9.11922E-05\",\n \"SemanticContext\": \"POLG 4 , 5.1 • Suspected POLG-related disorder in children under two years of age 4 , 5.1 • Known hypersensitivity to the drug 4 , 5.12 • Urea cycle disorders 4 , 5.6 • Prophylaxis of migraine headaches: Pregnant women, women of childbearing potential not using effective contraception 4 , 8.1 WARNINGS AND PRECAUTIONS • Hepatotoxicity; evaluate high risk populations and monitor serum liver tests 5.1 • Birth defects, decreased IQ, and neurodevelopmental disorders following in utero exposure; should not be used to treat women with epilepsy or bipolar disorder who are pregnant or who plan to become pregnant or to treat a woman of childbearing potential unless other medications have failed to provide adequate symptom control or are otherwise unacceptable 5.2 , 5.3 , 5.4 • Pancreatitis; divalproex sodium extended-release tablets should ordinarily be discontinued 5.5 • Suicidal behavior or ideation; Antiepileptic drugs, including divalproex sodium extended-release tablets, increase the risk of suicidal thoughts or behavior 5.7 • Bleeding and other hematopoietic disorders; monitor platelet counts and coagulation tests 5.8 • Hyperammonemia and hyperammonemic encephalopathy; measure ammonia level if unexplained lethargy and vomiting or changes in mental status, and also with concomitant topiramate use; consider discontinuation of valproate therapy 5.6 , 5.9 , 5.10 • Hypothermia; Hypothermia has been reported during valproate therapy with or without associated hyperammonemia.\"\n },\n {\n \"VerbatimTerm\": \"epilepsy\",\n \"Probability\": \"0.0061536133\",\n \"SemanticContext\": \"It has been suggested that its activity in epilepsy is related to increased brain concentrations of gamma-aminobutyric acid GABA .\"\n },\n {\n \"VerbatimTerm\": \"epilepsy\",\n \"Probability\": \"0.0003302097\",\n \"SemanticContext\": \"\\n \\n Epilepsy\\n The therapeutic range in epilepsy is commonly considered to be 50 to 100 mcg/mL of total valproate, although some patients may be controlled with lower or higher plasma concentrations.\"\n },\n {\n \"VerbatimTerm\": \"epilepsy\",\n \"Probability\": \"0.0012047589\",\n \"SemanticContext\": \"In five multiple-dose studies in healthy subjects N = 82 and in subjects with epilepsy N = 86 , when administered under fasting and nonfasting conditions, divalproex sodium extended-release tablets given once daily produced an average bioavailability of 89% relative to an equal total daily dose of divalproex sodium delayed-release tablets given BID, TID, or QID.\"\n },\n {\n \"VerbatimTerm\": \"epilepsy\",\n \"Probability\": \"0.0009659231\",\n \"SemanticContext\": \"Bioavailability of Divalproex Sodium Extended-Release Tablets Relative to Divalproex Sodium Delayed-Release Tablets When Divalproex Sodium Extended-Release Tablets Dose is 8 to 20% Higher Study Population Regimens Relative Bioavailability Divalproex Sodium Extended-Release Tablets vs. Divalproex Sodium Delayed-Release Tablets AUC 24 C max C min Healthy Volunteers N = 35 1,000 & 1,500 mg Divalproex Sodium Extended-Release Tablets vs. 875 & 1,250 mg Divalproex Sodium Delayed-Release Tablets 1.059 0.882 1.173 Patients with epilepsy on concomitant enzyme- inducing antiepilepsy drugs N = 64 1,000 to 5,000 mg Divalproex Sodium Extended-Release Tablets vs. 875 to 4,250 mg Divalproex Sodium Delayed-Release Tablets 1.008 0.899 1.022 .\"\n },\n {\n \"VerbatimTerm\": \"epilepsy\",\n \"Probability\": \"0.0188133419\",\n \"SemanticContext\": \"Felbamate A study involving the co-administration of 1,200 mg/day of felbamate with valproate to patients with epilepsy n = 10 revealed an increase in mean valproate peak concentration by 35% from 86 to 115 mcg/mL compared to valproate alone.\"\n },\n {\n \"VerbatimTerm\": \"epilepsy\",\n \"Probability\": \"0.0112774372\",\n \"SemanticContext\": \"In patients with epilepsy, there have been reports of breakthrough seizures occurring with the combination of valproate and phenytoin.\"\n },\n {\n \"VerbatimTerm\": \"epilepsy\",\n \"Probability\": \"0.0028853118\",\n \"SemanticContext\": \"2.4 Conversion from Divalproex Sodium Delayed-Release Tablets to Divalproex Sodium Extended-Release Tablets In adult patients and pediatric patients 10 years of age or older with epilepsy previously receiving divalproex sodium delayed-release tablets, divalproex sodium extended-release tablets should be administered once-daily using a dose 8 to 20% higher than the total daily dose of divalproex sodium delayed-release tablets Table 1 .\"\n },\n {\n \"VerbatimTerm\": \"epilepsy\",\n \"Probability\": \"0.0001808703\",\n \"SemanticContext\": \"1.4 Important Limitations Because of the risk to the fetus of decreased IQ, neurodevelopmental disorders, neural tube defects, and other major congenital malformations, which may occur very early in pregnancy, valproate should not be used to treat women with epilepsy or bipolar disorder who are pregnant or who plan to become pregnant unless other medications have failed to provide adequate symptom control or are otherwise unacceptable.\"\n },\n {\n \"VerbatimTerm\": \"epilepsy\",\n \"Probability\": \"8.82977E-05\",\n \"SemanticContext\": \"Because naloxone could theoretically also reverse the antiepileptic effects of valproate, it should be used with caution in patients with epilepsy.\"\n },\n {\n \"VerbatimTerm\": \"epilepsy\",\n \"Probability\": \"0.0002942979\",\n \"SemanticContext\": \"For use in epilepsy or bipolar disorder, valproate should not be used to treat women who are pregnant or who plan to become pregnant unless other medications have failed to provide adequate symptom control or are otherwise unacceptable [see Boxed Warning and Warnings and Precautions 5.2 , 5.3 ] .\"\n },\n {\n \"VerbatimTerm\": \"epilepsy\",\n \"Probability\": \"0.0001572073\",\n \"SemanticContext\": \"Women with epilepsy who become pregnant while taking valproate should not discontinue valproate abruptly, as this can precipitate status epilepticus with resulting maternal and fetal hypoxia and threat to life.\"\n },\n {\n \"VerbatimTerm\": \"epilepsy\",\n \"Probability\": \"0.0003810227\",\n \"SemanticContext\": \"\\n \\n Clinical Considerations\\n Disease-Associated Maternal and/or Embryo/Fetal Risk To prevent major seizures, women with epilepsy should not discontinue valproate abruptly, as this can precipitate status epilepticus with resulting maternal and fetal hypoxia and threat to life.\"\n },\n {\n \"VerbatimTerm\": \"epilepsy\",\n \"Probability\": \"0.0035018325\",\n \"SemanticContext\": \"In patients with epilepsy, a loss of seizure control may also occur.\"\n },\n {\n \"VerbatimTerm\": \"epilepsy\",\n \"Probability\": \"0.020272702\",\n \"SemanticContext\": \"In progressively older patient groups experience in epilepsy has indicated that the incidence of fatal hepatotoxicity decreases considerably.\"\n },\n {\n \"VerbatimTerm\": \"epilepsy\",\n \"Probability\": \"0.0045858622\",\n \"SemanticContext\": \"The relative risk for suicidal thoughts or behavior was higher in clinical trials for epilepsy than in clinical trials for psychiatric or other conditions, but the absolute risk differences were similar for the epilepsy and psychiatric indications.\"\n },\n {\n \"VerbatimTerm\": \"epilepsy\",\n \"Probability\": \"0.0663732886\",\n \"SemanticContext\": \"The relative risk for suicidal thoughts or behavior was higher in clinical trials for epilepsy than in clinical trials for psychiatric or other conditions, but the absolute risk differences were similar for the epilepsy and psychiatric indications.\"\n },\n {\n \"VerbatimTerm\": \"epilepsy\",\n \"Probability\": \"0.0181140602\",\n \"SemanticContext\": \"In a clinical trial of valproate as monotherapy in patients with epilepsy, 34/126 patients 27% receiving approximately 50 mg/kg/day on average, had at least one value of platelets = 75 x 10 9 /L. Approximately half of these patients had treatment discontinued, with return of platelet counts to normal.\"\n },\n {\n \"VerbatimTerm\": \"epilepsy\",\n \"Probability\": \"9.48465E-05\",\n \"SemanticContext\": \"Stopping a seizure medicine suddenly in a patient who has epilepsy can cause seizures that will not stop status epilepticus .\"\n },\n {\n \"VerbatimTerm\": \"epilepsy\",\n \"Probability\": \"0.0035583377\",\n \"SemanticContext\": \"\\n \\n Data\\n \\n \\n Human In a published study, breast milk and maternal blood samples were obtained from 11 epilepsy patients taking valproate at doses ranging from 300 mg/day to 2,400 mg/day on postnatal days 3 to 6.\"\n },\n {\n \"VerbatimTerm\": \"epilepsy\",\n \"Probability\": \"0.0004531443\",\n \"SemanticContext\": \"Pregnant women receiving monotherapy for epilepsy were enrolled with assessments of their children at ages 3 years and 6 years.\"\n },\n {\n \"VerbatimTerm\": \"epilepsy\",\n \"Probability\": \"0.0706548989\",\n \"SemanticContext\": \"Above the age of 2 years, experience in epilepsy has indicated that the incidence of fatal hepatotoxicity decreases considerably in progressively older patient groups.\"\n },\n {\n \"VerbatimTerm\": \"Epilepsy\",\n \"Probability\": \"0.0053657591\",\n \"SemanticContext\": \"6.2 Epilepsy Based on a placebo-controlled trial of adjunctive therapy for treatment of complex partial seizures, divalproex sodium delayed-release tablets were generally well tolerated with most adverse reactions rated as mild to moderate in severity.\"\n },\n {\n \"VerbatimTerm\": \"Epilepsy\",\n \"Probability\": \"0.0010503829\",\n \"SemanticContext\": \"\\n \\n Epilepsy\\n The therapeutic range in epilepsy is commonly considered to be 50 to 100 mcg/mL of total valproate, although some patients may be controlled with lower or higher plasma concentrations.\"\n },\n {\n \"VerbatimTerm\": \"Epilepsy\",\n \"Probability\": \"0.003769964\",\n \"SemanticContext\": \"14.2 Epilepsy The efficacy of valproate in reducing the incidence of complex partial seizures CPS that occur in isolation or in association with other seizure types was established in two controlled trials.\"\n },\n {\n \"VerbatimTerm\": \"Epilepsy\",\n \"Probability\": \"0.0010685623\",\n \"SemanticContext\": \"2.2 Epilepsy Divalproex sodium extended-release tablets are administered orally, and must be swallowed whole.\"\n },\n {\n \"VerbatimTerm\": \"Epilepsy\",\n \"Probability\": \"0.0480808318\",\n \"SemanticContext\": \"1.2 Epilepsy Divalproex sodium extended-release tablets are indicated as monotherapy and adjunctive therapy in the treatment of adult patients and pediatric patients down to the age of 10 years with complex partial seizures that occur either in isolation or in association with other types of seizures.\"\n },\n {\n \"VerbatimTerm\": \"Epilepsy\",\n \"Probability\": \"0.2558816075\",\n \"SemanticContext\": \"Risk by Indication for Antiepileptic Drugs in the Pooled Analysis Indication Placebo Patients with Events Per 1,000 Patients Drug Patients with Events Per 1,000 Patients Relative Risk: Incidence of Events in Drug Patients/Incidence in Placebo Patients Risk Difference: Additional Drug Patients with Events Per 1,000 Patients Epilepsy 1.0 3.4 3.5 2.4 Psychiatric 5.7 8.5 1.5 2.9 Other 1.0 1.8 1.9 0.9 Total 2.4 4.3 1.8 1.9 .\"\n },\n {\n \"VerbatimTerm\": \"Epilepsy\",\n \"Probability\": \"0.0070702434\",\n \"SemanticContext\": \"Epilepsy and many other illnesses for which AEDs are prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behavior.\"\n }\n ]\n },\n {\n \"Term\": \"Haemostasis\",\n \"MEDDRACode\": \"10067439\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hemostasis\",\n \"Probability\": \"0.0017955303\",\n \"SemanticContext\": \"Evidence of hemorrhage, bruising, or a disorder of hemostasis/coagulation is an indication for reduction of the dosage or withdrawal of therapy.\"\n }\n ]\n },\n {\n \"Term\": \"Swelling face\",\n \"MEDDRACode\": \"10042682\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"facial swelling\",\n \"Probability\": \"0.566518724\",\n \"SemanticContext\": \"DRESS typically, although not exclusively, presents with fever, rash, lymphadenopathy, and/or facial swelling, in association with other organ system involvement, such as hepatitis, nephritis, hematological abnormalities, myocarditis, or myositis sometimes resembling an acute viral infection.\"\n }\n ]\n },\n {\n \"Term\": \"Urea cycle disorder\",\n \"MEDDRACode\": \"10080020\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": true,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Urea cycle disorders\",\n \"Probability\": \"0.0742026269\",\n \"SemanticContext\": \"POLG 4 , 5.1 • Suspected POLG-related disorder in children under two years of age 4 , 5.1 • Known hypersensitivity to the drug 4 , 5.12 • Urea cycle disorders 4 , 5.6 • Prophylaxis of migraine headaches: Pregnant women, women of childbearing potential not using effective contraception 4 , 8.1 WARNINGS AND PRECAUTIONS • Hepatotoxicity; evaluate high risk populations and monitor serum liver tests 5.1 • Birth defects, decreased IQ, and neurodevelopmental disorders following in utero exposure; should not be used to treat women with epilepsy or bipolar disorder who are pregnant or who plan to become pregnant or to treat a woman of childbearing potential unless other medications have failed to provide adequate symptom control or are otherwise unacceptable 5.2 , 5.3 , 5.4 • Pancreatitis; divalproex sodium extended-release tablets should ordinarily be discontinued 5.5 • Suicidal behavior or ideation; Antiepileptic drugs, including divalproex sodium extended-release tablets, increase the risk of suicidal thoughts or behavior 5.7 • Bleeding and other hematopoietic disorders; monitor platelet counts and coagulation tests 5.8 • Hyperammonemia and hyperammonemic encephalopathy; measure ammonia level if unexplained lethargy and vomiting or changes in mental status, and also with concomitant topiramate use; consider discontinuation of valproate therapy 5.6 , 5.9 , 5.10 • Hypothermia; Hypothermia has been reported during valproate therapy with or without associated hyperammonemia.\"\n },\n {\n \"VerbatimTerm\": \"urea cycle disorders\",\n \"Probability\": \"0.003100723\",\n \"SemanticContext\": \"• Divalproex sodium extended-release tablets are contraindicated in patients with known urea cycle disorders [see Warnings and Precautions 5.6 ] .\"\n },\n {\n \"VerbatimTerm\": \"urea cycle disorders\",\n \"Probability\": \"0.0022931397\",\n \"SemanticContext\": \"5.6 Urea Cycle Disorders Divalproex sodium extended-release tablets are contraindicated in patients with known urea cycle disorders UCD .\"\n },\n {\n \"VerbatimTerm\": \"urea cycle disorders\",\n \"Probability\": \"0.0041189492\",\n \"SemanticContext\": \"Hyperammonemic encephalopathy, sometimes fatal, has been reported following initiation of valproate therapy in patients with urea cycle disorders, a group of uncommon genetic abnormalities, particularly ornithine transcarbamylase deficiency.\"\n },\n {\n \"VerbatimTerm\": \"urea cycle disorders\",\n \"Probability\": \"0.0020882785\",\n \"SemanticContext\": \"Patients who develop symptoms of unexplained hyperammonemic encephalopathy while receiving valproate therapy should receive prompt treatment including discontinuation of valproate therapy and be evaluated for underlying urea cycle disorders [see Contraindications 4 and Warnings and Precautions 5.10 ].\"\n },\n {\n \"VerbatimTerm\": \"urea cycle disorders\",\n \"Probability\": \"0.0001697242\",\n \"SemanticContext\": \"Appropriate interventions for treatment of hyperammonemia should be initiated, and such patients should undergo investigation for underlying urea cycle disorders [see Contraindications 4 and Warnings and Precautions 5.6 , 5.10 ] .\"\n },\n {\n \"VerbatimTerm\": \"Urea Cycle Disorders\",\n \"Probability\": \"0.0358223915\",\n \"SemanticContext\": \"5.6 Urea Cycle Disorders Divalproex sodium extended-release tablets are contraindicated in patients with known urea cycle disorders UCD .\"\n },\n {\n \"VerbatimTerm\": \"UCD\",\n \"Probability\": \"0.006492734\",\n \"SemanticContext\": \"5.6 Urea Cycle Disorders Divalproex sodium extended-release tablets are contraindicated in patients with known urea cycle disorders UCD .\"\n },\n {\n \"VerbatimTerm\": \"UCD\",\n \"Probability\": \"0.0045463443\",\n \"SemanticContext\": \"Prior to the initiation of divalproex sodium extended-release tablets therapy, evaluation for UCD should be considered in the following patients: 1 those with a history of unexplained encephalopathy or coma, encephalopathy associated with a protein load, pregnancy-related or postpartum encephalopathy, unexplained mental retardation, or history of elevated plasma ammonia or glutamine; 2 those with cyclical vomiting and lethargy, episodic extreme irritability, ataxia, low BUN, or protein avoidance; 3 those with a family history of UCD or a family history of unexplained infant deaths particularly males ; 4 those with other signs or symptoms of UCD.\"\n },\n {\n \"VerbatimTerm\": \"UCD\",\n \"Probability\": \"0.0004498363\",\n \"SemanticContext\": \"Prior to the initiation of divalproex sodium extended-release tablets therapy, evaluation for UCD should be considered in the following patients: 1 those with a history of unexplained encephalopathy or coma, encephalopathy associated with a protein load, pregnancy-related or postpartum encephalopathy, unexplained mental retardation, or history of elevated plasma ammonia or glutamine; 2 those with cyclical vomiting and lethargy, episodic extreme irritability, ataxia, low BUN, or protein avoidance; 3 those with a family history of UCD or a family history of unexplained infant deaths particularly males ; 4 those with other signs or symptoms of UCD.\"\n },\n {\n \"VerbatimTerm\": \"UCD\",\n \"Probability\": \"0.0047532916\",\n \"SemanticContext\": \"Prior to the initiation of divalproex sodium extended-release tablets therapy, evaluation for UCD should be considered in the following patients: 1 those with a history of unexplained encephalopathy or coma, encephalopathy associated with a protein load, pregnancy-related or postpartum encephalopathy, unexplained mental retardation, or history of elevated plasma ammonia or glutamine; 2 those with cyclical vomiting and lethargy, episodic extreme irritability, ataxia, low BUN, or protein avoidance; 3 those with a family history of UCD or a family history of unexplained infant deaths particularly males ; 4 those with other signs or symptoms of UCD.\"\n },\n {\n \"VerbatimTerm\": \"urea cycle disorder\",\n \"Probability\": \"0.0006091893\",\n \"SemanticContext\": \"• have a genetic problem called urea cycle disorder • are taking it to prevent migraine headaches and are either pregnant or may become pregnant because you are not using effective birth control contraception What should I tell my healthcare provider before taking divalproex sodium extended-release tablets?\"\n }\n ]\n },\n {\n \"Term\": \"Contraception\",\n \"MEDDRACode\": \"10010808\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": true,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"contraception\",\n \"Probability\": \"0.0155035257\",\n \"SemanticContext\": \"POLG 4 , 5.1 • Suspected POLG-related disorder in children under two years of age 4 , 5.1 • Known hypersensitivity to the drug 4 , 5.12 • Urea cycle disorders 4 , 5.6 • Prophylaxis of migraine headaches: Pregnant women, women of childbearing potential not using effective contraception 4 , 8.1 WARNINGS AND PRECAUTIONS • Hepatotoxicity; evaluate high risk populations and monitor serum liver tests 5.1 • Birth defects, decreased IQ, and neurodevelopmental disorders following in utero exposure; should not be used to treat women with epilepsy or bipolar disorder who are pregnant or who plan to become pregnant or to treat a woman of childbearing potential unless other medications have failed to provide adequate symptom control or are otherwise unacceptable 5.2 , 5.3 , 5.4 • Pancreatitis; divalproex sodium extended-release tablets should ordinarily be discontinued 5.5 • Suicidal behavior or ideation; Antiepileptic drugs, including divalproex sodium extended-release tablets, increase the risk of suicidal thoughts or behavior 5.7 • Bleeding and other hematopoietic disorders; monitor platelet counts and coagulation tests 5.8 • Hyperammonemia and hyperammonemic encephalopathy; measure ammonia level if unexplained lethargy and vomiting or changes in mental status, and also with concomitant topiramate use; consider discontinuation of valproate therapy 5.6 , 5.9 , 5.10 • Hypothermia; Hypothermia has been reported during valproate therapy with or without associated hyperammonemia.\"\n },\n {\n \"VerbatimTerm\": \"contraception\",\n \"Probability\": \"0.0002244115\",\n \"SemanticContext\": \"Women of childbearing potential were allowed in the trial if they were deemed to be practicing an effective method of contraception.\"\n },\n {\n \"VerbatimTerm\": \"contraception\",\n \"Probability\": \"0.007065028\",\n \"SemanticContext\": \"• For use in prophylaxis of migraine headaches: divalproex sodium extended-release tablets are contraindicated in women who are pregnant and in women of childbearing potential who are not using effective contraception [see Warnings and Precautions 5.2 , 5.3 , 5.4 and Use in Specific Populations 8.1 ] .\"\n },\n {\n \"VerbatimTerm\": \"contraception\",\n \"Probability\": \"0.0009587109\",\n \"SemanticContext\": \"For prophylaxis of migraine headaches, divalproex sodium extended-release tablets are contraindicated in women who are pregnant and in women of childbearing potential who are not using effective contraception [see Contraindications 4 ] .\"\n },\n {\n \"VerbatimTerm\": \"contraception\",\n \"Probability\": \"8.06093E-05\",\n \"SemanticContext\": \"Advise women to use effective contraception while taking valproate.\"\n },\n {\n \"VerbatimTerm\": \"contraception\",\n \"Probability\": \"0.0004735887\",\n \"SemanticContext\": \"\\n \\n Risk Summary\\n For use in prophylaxis of migraine headaches, valproate is contraindicated in women who are pregnant and in women of childbearing potential who are not using effective contraception [see Contraindications 4 ] .\"\n },\n {\n \"VerbatimTerm\": \"contraception\",\n \"Probability\": \"3.38583E-05\",\n \"SemanticContext\": \"Women should use effective contraception while using valproate.\"\n },\n {\n \"VerbatimTerm\": \"contraception\",\n \"Probability\": \"7.68243E-05\",\n \"SemanticContext\": \"If the decision is made to use divalproex sodium extended-release tablets, you should use effective birth control contraception .\"\n },\n {\n \"VerbatimTerm\": \"contraception\",\n \"Probability\": \"6.7549E-06\",\n \"SemanticContext\": \"• have a genetic problem called urea cycle disorder • are taking it to prevent migraine headaches and are either pregnant or may become pregnant because you are not using effective birth control contraception What should I tell my healthcare provider before taking divalproex sodium extended-release tablets?\"\n }\n ]\n },\n {\n \"Term\": \"Drug clearance\",\n \"MEDDRACode\": \"10077254\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Clearance Drugs\",\n \"Probability\": \"2.44278E-05\",\n \"SemanticContext\": \"7 DRUG INTERACTIONS 7.1 Effects of Co-Administered Drugs on Valproate Clearance Drugs that affect the level of expression of hepatic enzymes, particularly those that elevate levels of glucuronosyltransferases such as ritonavir , may increase the clearance of valproate.\"\n }\n ]\n },\n {\n \"Term\": \"Infection\",\n \"MEDDRACode\": \"10021789\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": true\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"infection\",\n \"Probability\": \"0.9967054129\",\n \"SemanticContext\": \"Divalproex sodium extended-release tablets dosage should be increased slowly and with regular monitoring for fluid and nutritional intake 5.14 ADVERSE REACTIONS • Most common adverse reactions reported > 5% are abdominal pain, alopecia, amblyopia/blurred vision, amnesia, anorexia, asthenia, ataxia, back pain, bronchitis, constipation, depression, diarrhea, diplopia, dizziness, dyspnea, dyspepsia, ecchymosis, emotional lability, fever, flu syndrome, headache, increased appetite, infection, insomnia, nausea, nervousness, nystagmus, peripheral edema, pharyngitis, rash, rhinitis, somnolence, thinking abnormal, thrombocytopenia, tinnitus, tremor, vomiting, weight gain, weight loss 6.1 , 6.2 , 6.3 .\"\n },\n {\n \"VerbatimTerm\": \"infection\",\n \"Probability\": \"0.9853366017\",\n \"SemanticContext\": \"A higher percentage of patients above 65 years of age reported accidental injury, infection, pain, somnolence, and tremor.\"\n },\n {\n \"VerbatimTerm\": \"Infection\",\n \"Probability\": \"0.1346544027\",\n \"SemanticContext\": \"The following additional adverse reactions were reported by greater than 1% of the divalproex sodium extended-release tablets-treated patients in controlled clinical trials: Body as a Whole: Back Pain, Chills, Chills and Fever, Drug Level Increased, Flu Syndrome, Infection, Infection Fungal, Neck Rigidity.\"\n },\n {\n \"VerbatimTerm\": \"Infection\",\n \"Probability\": \"0.9638997316\",\n \"SemanticContext\": \"Adverse Reactions Reported by = 5% of Patients Treated with Valproate During Placebo-Controlled Trial of Adjunctive Therapy for Complex Partial Seizures Body System/Event Divalproex Sodium Delayed- Release Tablets N = 77 % Placebo N = 70 % Body as a Whole Headache 31 21 Asthenia 27 7 Fever 6 4 Gastrointestinal System Nausea 48 14 Vomiting 27 7 Abdominal Pain 23 6 Diarrhea 13 6 Anorexia 12 0 Dyspepsia 8 4 Constipation 5 1 Nervous System Somnolence 27 11 Tremor 25 6 Dizziness 25 13 Diplopia 16 9 Amblyopia/Blurred Vision 12 9 Ataxia 8 1 Nystagmus 8 1 Emotional Lability 6 4 Thinking Abnormal 6 0 Amnesia 5 1 Respiratory System Flu Syndrome 12 9 Infection 12 6 Bronchitis 5 1 Rhinitis 5 4 Other Alopecia 6 1 Weight Loss 6 0 .\"\n },\n {\n \"VerbatimTerm\": \"Infection\",\n \"Probability\": \"0.9881008267\",\n \"SemanticContext\": \"Body System/Event High Dose n = 131 % Low Dose n = 134 % Body as a Whole Asthenia 21 10 Digestive System Nausea 34 26 Diarrhea 23 19 Vomiting 23 15 Abdominal Pain 12 9 Anorexia 11 4 Dyspepsia 11 10 Hemic/Lymphatic System Thrombocytopenia 24 1 Ecchymosis 5 4 Metabolic/Nutritional Weight Gain 9 4 Peripheral Edema 8 3 Nervous System Tremor 57 19 Somnolence 30 18 Dizziness 18 13 Insomnia 15 9 Nervousness 11 7 Amnesia 7 4 Nystagmus 7 1 Depression 5 4 Respiratory System Infection 20 13 Pharyngitis 8 2 Dyspnea 5 1 Skin and Appendages Alopecia 24 13 Special Senses Amblyopia/Blurred Vision 8 4 Tinnitus 7 1 .\"\n },\n {\n \"VerbatimTerm\": \"Infection\",\n \"Probability\": \"0.9357817173\",\n \"SemanticContext\": \"Body System Event Divalproex Sodium Extended-Release Tablets n = 122 % Placebo n = 115 % Gastrointestinal System Nausea 15 9 Dyspepsia 7 4 Diarrhea 7 3 Vomiting 7 2 Abdominal Pain 7 5 Nervous System Somnolence 7 2 Other Infection 15 14 .\"\n }\n ]\n },\n {\n \"Term\": \"Rhinitis\",\n \"MEDDRACode\": \"10039083\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"rhinitis\",\n \"Probability\": \"0.9986149073\",\n \"SemanticContext\": \"Divalproex sodium extended-release tablets dosage should be increased slowly and with regular monitoring for fluid and nutritional intake 5.14 ADVERSE REACTIONS • Most common adverse reactions reported > 5% are abdominal pain, alopecia, amblyopia/blurred vision, amnesia, anorexia, asthenia, ataxia, back pain, bronchitis, constipation, depression, diarrhea, diplopia, dizziness, dyspnea, dyspepsia, ecchymosis, emotional lability, fever, flu syndrome, headache, increased appetite, infection, insomnia, nausea, nervousness, nystagmus, peripheral edema, pharyngitis, rash, rhinitis, somnolence, thinking abnormal, thrombocytopenia, tinnitus, tremor, vomiting, weight gain, weight loss 6.1 , 6.2 , 6.3 .\"\n },\n {\n \"VerbatimTerm\": \"rhinitis\",\n \"Probability\": \"0.9956593513\",\n \"SemanticContext\": \"Respiratory System: Pharyngitis, rhinitis.\"\n },\n {\n \"VerbatimTerm\": \"Rhinitis\",\n \"Probability\": \"0.9781750441\",\n \"SemanticContext\": \"Respiratory System: Hiccup, Rhinitis.\"\n },\n {\n \"VerbatimTerm\": \"Rhinitis\",\n \"Probability\": \"0.9916796684\",\n \"SemanticContext\": \"Adverse Reactions Reported by = 5% of Patients Treated with Valproate During Placebo-Controlled Trial of Adjunctive Therapy for Complex Partial Seizures Body System/Event Divalproex Sodium Delayed- Release Tablets N = 77 % Placebo N = 70 % Body as a Whole Headache 31 21 Asthenia 27 7 Fever 6 4 Gastrointestinal System Nausea 48 14 Vomiting 27 7 Abdominal Pain 23 6 Diarrhea 13 6 Anorexia 12 0 Dyspepsia 8 4 Constipation 5 1 Nervous System Somnolence 27 11 Tremor 25 6 Dizziness 25 13 Diplopia 16 9 Amblyopia/Blurred Vision 12 9 Ataxia 8 1 Nystagmus 8 1 Emotional Lability 6 4 Thinking Abnormal 6 0 Amnesia 5 1 Respiratory System Flu Syndrome 12 9 Infection 12 6 Bronchitis 5 1 Rhinitis 5 4 Other Alopecia 6 1 Weight Loss 6 0 .\"\n }\n ]\n },\n {\n \"Term\": \"Migraine\",\n \"MEDDRACode\": \"10027599\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": true,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": true\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"complicated migraine\",\n \"Probability\": \"0.9659855366\",\n \"SemanticContext\": \"POLG-related disorders should be suspected in patients with a family history or suggestive symptoms of a POLG-related disorder, including but not limited to unexplained encephalopathy, refractory epilepsy focal, myoclonic , status epilepticus at presentation, developmental delays, psychomotor regression, axonal sensorimotor neuropathy, myopathy cerebellar ataxia, ophthalmoplegia, or complicated migraine with occipital aura.\"\n }\n ]\n },\n {\n \"Term\": \"Hepatic enzyme\",\n \"MEDDRACode\": \"10060793\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Hepatic enzyme\",\n \"Probability\": \"0.0107915998\",\n \"SemanticContext\": \"DRUG INTERACTIONS • Hepatic enzyme-inducing drugs e.g., phenytoin, carbamazepine, phenobarbital, primidone, rifampin can increase valproate clearance, while enzyme inhibitors e.g., felbamate can decrease valproate clearance.\"\n },\n {\n \"VerbatimTerm\": \"hepatic enzymes\",\n \"Probability\": \"0.0001555979\",\n \"SemanticContext\": \"7 DRUG INTERACTIONS 7.1 Effects of Co-Administered Drugs on Valproate Clearance Drugs that affect the level of expression of hepatic enzymes, particularly those that elevate levels of glucuronosyltransferases such as ritonavir , may increase the clearance of valproate.\"\n }\n ]\n },\n {\n \"Term\": \"Coagulation test\",\n \"MEDDRACode\": \"10063556\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"coagulation tests\",\n \"Probability\": \"0.004778564\",\n \"SemanticContext\": \"POLG 4 , 5.1 • Suspected POLG-related disorder in children under two years of age 4 , 5.1 • Known hypersensitivity to the drug 4 , 5.12 • Urea cycle disorders 4 , 5.6 • Prophylaxis of migraine headaches: Pregnant women, women of childbearing potential not using effective contraception 4 , 8.1 WARNINGS AND PRECAUTIONS • Hepatotoxicity; evaluate high risk populations and monitor serum liver tests 5.1 • Birth defects, decreased IQ, and neurodevelopmental disorders following in utero exposure; should not be used to treat women with epilepsy or bipolar disorder who are pregnant or who plan to become pregnant or to treat a woman of childbearing potential unless other medications have failed to provide adequate symptom control or are otherwise unacceptable 5.2 , 5.3 , 5.4 • Pancreatitis; divalproex sodium extended-release tablets should ordinarily be discontinued 5.5 • Suicidal behavior or ideation; Antiepileptic drugs, including divalproex sodium extended-release tablets, increase the risk of suicidal thoughts or behavior 5.7 • Bleeding and other hematopoietic disorders; monitor platelet counts and coagulation tests 5.8 • Hyperammonemia and hyperammonemic encephalopathy; measure ammonia level if unexplained lethargy and vomiting or changes in mental status, and also with concomitant topiramate use; consider discontinuation of valproate therapy 5.6 , 5.9 , 5.10 • Hypothermia; Hypothermia has been reported during valproate therapy with or without associated hyperammonemia.\"\n },\n {\n \"VerbatimTerm\": \"coagulation tests\",\n \"Probability\": \"0.000161171\",\n \"SemanticContext\": \"The therapeutic relevance of this is unknown; however, coagulation tests should be monitored if valproate therapy is instituted in patients taking anticoagulants.\"\n },\n {\n \"VerbatimTerm\": \"coagulation tests\",\n \"Probability\": \"0.00218454\",\n \"SemanticContext\": \"Because of reports of cytopenias, inhibition of the secondary phase of platelet aggregation, and abnormal coagulation parameters, e.g., low fibrinogen, coagulation factor deficiencies, acquired von Willebrand’s disease , measurements of complete blood counts and coagulation tests are recommended before initiating therapy and at periodic intervals.\"\n }\n ]\n },\n {\n \"Term\": \"Woman of childbearing potential\",\n \"MEDDRACode\": \"10078742\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": true,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"women of childbearing potential\",\n \"Probability\": \"0.0009716451\",\n \"SemanticContext\": \"POLG 4 , 5.1 • Suspected POLG-related disorder in children under two years of age 4 , 5.1 • Known hypersensitivity to the drug 4 , 5.12 • Urea cycle disorders 4 , 5.6 • Prophylaxis of migraine headaches: Pregnant women, women of childbearing potential not using effective contraception 4 , 8.1 WARNINGS AND PRECAUTIONS • Hepatotoxicity; evaluate high risk populations and monitor serum liver tests 5.1 • Birth defects, decreased IQ, and neurodevelopmental disorders following in utero exposure; should not be used to treat women with epilepsy or bipolar disorder who are pregnant or who plan to become pregnant or to treat a woman of childbearing potential unless other medications have failed to provide adequate symptom control or are otherwise unacceptable 5.2 , 5.3 , 5.4 • Pancreatitis; divalproex sodium extended-release tablets should ordinarily be discontinued 5.5 • Suicidal behavior or ideation; Antiepileptic drugs, including divalproex sodium extended-release tablets, increase the risk of suicidal thoughts or behavior 5.7 • Bleeding and other hematopoietic disorders; monitor platelet counts and coagulation tests 5.8 • Hyperammonemia and hyperammonemic encephalopathy; measure ammonia level if unexplained lethargy and vomiting or changes in mental status, and also with concomitant topiramate use; consider discontinuation of valproate therapy 5.6 , 5.9 , 5.10 • Hypothermia; Hypothermia has been reported during valproate therapy with or without associated hyperammonemia.\"\n },\n {\n \"VerbatimTerm\": \"women of childbearing potential\",\n \"Probability\": \"0.0006654859\",\n \"SemanticContext\": \"• For use in prophylaxis of migraine headaches: divalproex sodium extended-release tablets are contraindicated in women who are pregnant and in women of childbearing potential who are not using effective contraception [see Warnings and Precautions 5.2 , 5.3 , 5.4 and Use in Specific Populations 8.1 ] .\"\n },\n {\n \"VerbatimTerm\": \"women of childbearing potential\",\n \"Probability\": \"0.0004147291\",\n \"SemanticContext\": \"For prophylaxis of migraine headaches, divalproex sodium extended-release tablets are contraindicated in women who are pregnant and in women of childbearing potential who are not using effective contraception [see Contraindications 4 ] .\"\n },\n {\n \"VerbatimTerm\": \"women of childbearing potential\",\n \"Probability\": \"5.0429E-06\",\n \"SemanticContext\": \"Birth Defects and Decreased IQ: Inform pregnant women and women of childbearing potential including girls beginning the onset of puberty that use of valproate during pregnancy increases the risk of birth defects, decreased IQ, and neurodevelopmental disorders in children who were exposed in utero .\"\n },\n {\n \"VerbatimTerm\": \"women of childbearing potential\",\n \"Probability\": \"3.96711E-05\",\n \"SemanticContext\": \"Pregnancy Registry: Advise women of childbearing potential to discuss pregnancy planning with their doctor and to contact their doctor immediately if they think they are pregnant.\"\n },\n {\n \"VerbatimTerm\": \"women of childbearing potential\",\n \"Probability\": \"1.24752E-05\",\n \"SemanticContext\": \"\\n \\n Risk Summary\\n For use in prophylaxis of migraine headaches, valproate is contraindicated in women who are pregnant and in women of childbearing potential who are not using effective contraception [see Contraindications 4 ] .\"\n },\n {\n \"VerbatimTerm\": \"woman of childbearing potential\",\n \"Probability\": \"3.684E-07\",\n \"SemanticContext\": \"POLG 4 , 5.1 • Suspected POLG-related disorder in children under two years of age 4 , 5.1 • Known hypersensitivity to the drug 4 , 5.12 • Urea cycle disorders 4 , 5.6 • Prophylaxis of migraine headaches: Pregnant women, women of childbearing potential not using effective contraception 4 , 8.1 WARNINGS AND PRECAUTIONS • Hepatotoxicity; evaluate high risk populations and monitor serum liver tests 5.1 • Birth defects, decreased IQ, and neurodevelopmental disorders following in utero exposure; should not be used to treat women with epilepsy or bipolar disorder who are pregnant or who plan to become pregnant or to treat a woman of childbearing potential unless other medications have failed to provide adequate symptom control or are otherwise unacceptable 5.2 , 5.3 , 5.4 • Pancreatitis; divalproex sodium extended-release tablets should ordinarily be discontinued 5.5 • Suicidal behavior or ideation; Antiepileptic drugs, including divalproex sodium extended-release tablets, increase the risk of suicidal thoughts or behavior 5.7 • Bleeding and other hematopoietic disorders; monitor platelet counts and coagulation tests 5.8 • Hyperammonemia and hyperammonemic encephalopathy; measure ammonia level if unexplained lethargy and vomiting or changes in mental status, and also with concomitant topiramate use; consider discontinuation of valproate therapy 5.6 , 5.9 , 5.10 • Hypothermia; Hypothermia has been reported during valproate therapy with or without associated hyperammonemia.\"\n },\n {\n \"VerbatimTerm\": \"woman of childbearing potential\",\n \"Probability\": \"4.8215E-06\",\n \"SemanticContext\": \"Valproate should not be administered to a woman of childbearing potential unless other medications have failed to provide adequate symptom control or are otherwise unacceptable [see Warnings and Precautions 5.2 , 5.3 , 5.4 , Use in Specific Populations 8.1 , and Patient Counseling Information 17 ] .\"\n },\n {\n \"VerbatimTerm\": \"woman of childbearing potential\",\n \"Probability\": \"2.66262E-05\",\n \"SemanticContext\": \"5.4 Use in Women of Childbearing Potential Because of the risk to the fetus of decreased IQ, neurodevelopmental disorders, and major congenital malformations including neural tube defects , which may occur very early in pregnancy, valproate should not be administered to a woman of childbearing potential unless other medications have failed to provide adequate symptom control or are otherwise unacceptable.\"\n },\n {\n \"VerbatimTerm\": \"Women of childbearing potential\",\n \"Probability\": \"0.0009729266\",\n \"SemanticContext\": \"Women of childbearing potential were allowed in the trial if they were deemed to be practicing an effective method of contraception.\"\n },\n {\n \"VerbatimTerm\": \"Women of childbearing potential\",\n \"Probability\": \"0.0001660883\",\n \"SemanticContext\": \"Women of childbearing potential should be counseled regularly regarding the relative risks and benefits of valproate use during pregnancy.\"\n },\n {\n \"VerbatimTerm\": \"Women of Childbearing Potential\",\n \"Probability\": \"2.15746E-05\",\n \"SemanticContext\": \"5.4 Use in Women of Childbearing Potential Because of the risk to the fetus of decreased IQ, neurodevelopmental disorders, and major congenital malformations including neural tube defects , which may occur very early in pregnancy, valproate should not be administered to a woman of childbearing potential unless other medications have failed to provide adequate symptom control or are otherwise unacceptable.\"\n }\n ]\n },\n {\n \"Term\": \"Status epilepticus\",\n \"MEDDRACode\": \"10041962\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"status epilepticus\",\n \"Probability\": \"0.0421165526\",\n \"SemanticContext\": \"Antiepilepsy drugs should not be abruptly discontinued in patients in whom the drug is administered to prevent major seizures because of the strong possibility of precipitating status epilepticus with attendant hypoxia and threat to life.\"\n },\n {\n \"VerbatimTerm\": \"status epilepticus\",\n \"Probability\": \"0.0010746717\",\n \"SemanticContext\": \"Women with epilepsy who become pregnant while taking valproate should not discontinue valproate abruptly, as this can precipitate status epilepticus with resulting maternal and fetal hypoxia and threat to life.\"\n },\n {\n \"VerbatimTerm\": \"status epilepticus\",\n \"Probability\": \"0.0020182133\",\n \"SemanticContext\": \"\\n \\n Clinical Considerations\\n Disease-Associated Maternal and/or Embryo/Fetal Risk To prevent major seizures, women with epilepsy should not discontinue valproate abruptly, as this can precipitate status epilepticus with resulting maternal and fetal hypoxia and threat to life.\"\n },\n {\n \"VerbatimTerm\": \"status epilepticus\",\n \"Probability\": \"0.1246788204\",\n \"SemanticContext\": \"POLG-related disorders should be suspected in patients with a family history or suggestive symptoms of a POLG-related disorder, including but not limited to unexplained encephalopathy, refractory epilepsy focal, myoclonic , status epilepticus at presentation, developmental delays, psychomotor regression, axonal sensorimotor neuropathy, myopathy cerebellar ataxia, ophthalmoplegia, or complicated migraine with occipital aura.\"\n },\n {\n \"VerbatimTerm\": \"status epilepticus\",\n \"Probability\": \"0.0099689364\",\n \"SemanticContext\": \"To prevent major seizures, valproate should not be discontinued abruptly, as this can precipitate status epilepticus with resulting maternal and fetal hypoxia and threat to life.\"\n },\n {\n \"VerbatimTerm\": \"status epilepticus\",\n \"Probability\": \"0.0006943047\",\n \"SemanticContext\": \"Stopping a seizure medicine suddenly in a patient who has epilepsy can cause seizures that will not stop status epilepticus .\"\n }\n ]\n },\n {\n \"Term\": \"Oral contraception\",\n \"MEDDRACode\": \"10030970\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Oral Contraceptive\",\n \"Probability\": \"0.0010797679\",\n \"SemanticContext\": \"Oral Contraceptive Steroids Administration of a single-dose of ethinyloestradiol 50 mcg /levonorgestrel 250 mcg to 6 women on valproate 200 mg BID therapy for 2 months did not reveal any pharmacokinetic interaction.\"\n }\n ]\n },\n {\n \"Term\": \"Hyperammonaemic encephalopathy\",\n \"MEDDRACode\": \"10067327\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hyperammonemic encephalopathy\",\n \"Probability\": \"0.440554589\",\n \"SemanticContext\": \"POLG 4 , 5.1 • Suspected POLG-related disorder in children under two years of age 4 , 5.1 • Known hypersensitivity to the drug 4 , 5.12 • Urea cycle disorders 4 , 5.6 • Prophylaxis of migraine headaches: Pregnant women, women of childbearing potential not using effective contraception 4 , 8.1 WARNINGS AND PRECAUTIONS • Hepatotoxicity; evaluate high risk populations and monitor serum liver tests 5.1 • Birth defects, decreased IQ, and neurodevelopmental disorders following in utero exposure; should not be used to treat women with epilepsy or bipolar disorder who are pregnant or who plan to become pregnant or to treat a woman of childbearing potential unless other medications have failed to provide adequate symptom control or are otherwise unacceptable 5.2 , 5.3 , 5.4 • Pancreatitis; divalproex sodium extended-release tablets should ordinarily be discontinued 5.5 • Suicidal behavior or ideation; Antiepileptic drugs, including divalproex sodium extended-release tablets, increase the risk of suicidal thoughts or behavior 5.7 • Bleeding and other hematopoietic disorders; monitor platelet counts and coagulation tests 5.8 • Hyperammonemia and hyperammonemic encephalopathy; measure ammonia level if unexplained lethargy and vomiting or changes in mental status, and also with concomitant topiramate use; consider discontinuation of valproate therapy 5.6 , 5.9 , 5.10 • Hypothermia; Hypothermia has been reported during valproate therapy with or without associated hyperammonemia.\"\n },\n {\n \"VerbatimTerm\": \"hyperammonemic encephalopathy\",\n \"Probability\": \"0.0122207105\",\n \"SemanticContext\": \"Hyperammonemia: Inform patients of the signs and symptoms associated with hyperammonemic encephalopathy and to notify the prescriber if any of these symptoms occur [see Warnings and Precautions 5.9 , 5.10 ].\"\n },\n {\n \"VerbatimTerm\": \"hyperammonemic encephalopathy\",\n \"Probability\": \"0.0020614266\",\n \"SemanticContext\": \"Patients who develop symptoms of unexplained hyperammonemic encephalopathy while receiving valproate therapy should receive prompt treatment including discontinuation of valproate therapy and be evaluated for underlying urea cycle disorders [see Contraindications 4 and Warnings and Precautions 5.10 ].\"\n },\n {\n \"VerbatimTerm\": \"hyperammonemic encephalopathy\",\n \"Probability\": \"0.0040290058\",\n \"SemanticContext\": \"In patients who develop unexplained lethargy and vomiting or changes in mental status, hyperammonemic encephalopathy should be considered and an ammonia level should be measured.\"\n },\n {\n \"VerbatimTerm\": \"hyperammonemic encephalopathy\",\n \"Probability\": \"0.8916022778\",\n \"SemanticContext\": \"Clinical symptoms of hyperammonemic encephalopathy often include acute alterations in level of consciousness and/or cognitive function with lethargy or vomiting.\"\n },\n {\n \"VerbatimTerm\": \"hyperammonemic encephalopathy\",\n \"Probability\": \"0.0115370452\",\n \"SemanticContext\": \"In patients who develop unexplained lethargy, vomiting, or changes in mental status, hyperammonemic encephalopathy should be considered and an ammonia level should be measured [see Contraindications 4 and Warnings and Precautions 5.6 , 5.9 ].\"\n },\n {\n \"VerbatimTerm\": \"Hyperammonemic encephalopathy\",\n \"Probability\": \"0.9752137661\",\n \"SemanticContext\": \"6 ADVERSE REACTIONS The following serious adverse reactions are described below and elsewhere in the labeling: • Hepatic failure [see Warnings and Precautions 5.1 ] • Birth defects [see Warnings and Precautions 5.2 ] • Decreased IQ following in utero exposure [see Warnings and Precautions 5.3 ] • Pancreatitis [see Warnings and Precautions 5.5 ] • Hyperammonemic encephalopathy [see Warnings and Precautions 5.6 , 5.9 , 5.10 ] • Suicidal behavior and ideation [see Warnings and Precautions 5.7 ] • Bleeding and other hematopoietic disorders [see Warnings and Precautions 5.8 ] • Hypothermia [see Warnings and Precautions 5.11 ] • Drug Reaction with Eosinophilia and Systemic Symptoms DRESS /Multiorgan hypersensitivity reactions [see Warnings and Precautions 5.12 ] • Somnolence in the elderly [see Warnings and Precautions 5.14 ] Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.\"\n },\n {\n \"VerbatimTerm\": \"Hyperammonemic encephalopathy\",\n \"Probability\": \"0.9068799615\",\n \"SemanticContext\": \"Hyperammonemic encephalopathy, sometimes fatal, has been reported following initiation of valproate therapy in patients with urea cycle disorders, a group of uncommon genetic abnormalities, particularly ornithine transcarbamylase deficiency.\"\n }\n ]\n },\n {\n \"Term\": \"Fasting\",\n \"MEDDRACode\": \"10068315\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"fasting\",\n \"Probability\": \"0.0001480877\",\n \"SemanticContext\": \"In five multiple-dose studies in healthy subjects N = 82 and in subjects with epilepsy N = 86 , when administered under fasting and nonfasting conditions, divalproex sodium extended-release tablets given once daily produced an average bioavailability of 89% relative to an equal total daily dose of divalproex sodium delayed-release tablets given BID, TID, or QID.\"\n },\n {\n \"VerbatimTerm\": \"fasting\",\n \"Probability\": \"0.0002182424\",\n \"SemanticContext\": \"\\n \\n Special Populations\\n Effect of Age Pediatric The valproate pharmacokinetic profile following administration of divalproex sodium extended-release tablets was characterized in a multiple- dose, non-fasting, open label, multi-center study in children and adolescents.\"\n }\n ]\n },\n {\n \"Term\": \"Pharyngitis\",\n \"MEDDRACode\": \"10034835\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"pharyngitis\",\n \"Probability\": \"0.9991945028\",\n \"SemanticContext\": \"Divalproex sodium extended-release tablets dosage should be increased slowly and with regular monitoring for fluid and nutritional intake 5.14 ADVERSE REACTIONS • Most common adverse reactions reported > 5% are abdominal pain, alopecia, amblyopia/blurred vision, amnesia, anorexia, asthenia, ataxia, back pain, bronchitis, constipation, depression, diarrhea, diplopia, dizziness, dyspnea, dyspepsia, ecchymosis, emotional lability, fever, flu syndrome, headache, increased appetite, infection, insomnia, nausea, nervousness, nystagmus, peripheral edema, pharyngitis, rash, rhinitis, somnolence, thinking abnormal, thrombocytopenia, tinnitus, tremor, vomiting, weight gain, weight loss 6.1 , 6.2 , 6.3 .\"\n },\n {\n \"VerbatimTerm\": \"pharyngitis\",\n \"Probability\": \"0.9987927079\",\n \"SemanticContext\": \"Adverse Reactions Reported by > 5% of Valproate-Treated Patients During Migraine Placebo-Controlled Trials with a Greater Incidence than Patients Taking Placebo The following adverse reactions occurred in greater than 5% of divalproex sodium delayed-release tablets-treated patients and at a greater incidence for placebo than for divalproex sodium delayed-release tablets: flu syndrome and pharyngitis.\"\n },\n {\n \"VerbatimTerm\": \"Pharyngitis\",\n \"Probability\": \"0.9992247224\",\n \"SemanticContext\": \"Adverse Event Divalproex Sodium Extended-Release Tablets n = 338 % Placebo n = 263 % Somnolence 26 14 Dyspepsia 23 11 Nausea 19 13 Vomiting 13 5 Diarrhea 12 8 Dizziness 12 7 Pain 11 10 Abdominal Pain 10 5 Accidental Injury 6 5 Asthenia 6 5 Pharyngitis 6 5 .\"\n },\n {\n \"VerbatimTerm\": \"Pharyngitis\",\n \"Probability\": \"0.9998808503\",\n \"SemanticContext\": \"Body System/Event High Dose n = 131 % Low Dose n = 134 % Body as a Whole Asthenia 21 10 Digestive System Nausea 34 26 Diarrhea 23 19 Vomiting 23 15 Abdominal Pain 12 9 Anorexia 11 4 Dyspepsia 11 10 Hemic/Lymphatic System Thrombocytopenia 24 1 Ecchymosis 5 4 Metabolic/Nutritional Weight Gain 9 4 Peripheral Edema 8 3 Nervous System Tremor 57 19 Somnolence 30 18 Dizziness 18 13 Insomnia 15 9 Nervousness 11 7 Amnesia 7 4 Nystagmus 7 1 Depression 5 4 Respiratory System Infection 20 13 Pharyngitis 8 2 Dyspnea 5 1 Skin and Appendages Alopecia 24 13 Special Senses Amblyopia/Blurred Vision 8 4 Tinnitus 7 1 .\"\n },\n {\n \"VerbatimTerm\": \"Pharyngitis\",\n \"Probability\": \"0.9993289709\",\n \"SemanticContext\": \"Respiratory System: Pharyngitis, rhinitis.\"\n }\n ]\n },\n {\n \"Term\": \"Blood sodium\",\n \"MEDDRACode\": \"10005799\",\n \"Overdose\": true,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": true,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": true,\n \"PediatricUse\": true,\n \"GeriatricUse\": true\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"SODIUM\",\n \"Probability\": \"6.49133E-05\",\n \"SemanticContext\": \"HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS safely and effectively.\"\n },\n {\n \"VerbatimTerm\": \"SODIUM\",\n \"Probability\": \"0.0013912022\",\n \"SemanticContext\": \"See full prescribing information for DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS.\"\n },\n {\n \"VerbatimTerm\": \"SODIUM\",\n \"Probability\": \"0.0027015209\",\n \"SemanticContext\": \"DIVALPROEX SODIUM extended-release tablets, for oral use Initial U.S. Approval: 2000 WARNING: LIFE THREATENING ADVERSE REACTIONS See full prescribing information for complete boxed warning • Hepatotoxicity, including fatalities, usually during the first 6 months of treatment.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0435005426\",\n \"SemanticContext\": \"Monitor patients closely, and perform serum liver testing prior to therapy and at frequent intervals thereafter 5.1 • Fetal Risk, particularly neural tube defects, other major malformations, and decreased IQ 5.2 , 5.3 , 5.4 • Pancreatitis, including fatal hemorrhagic cases 5.5 INDICATIONS AND USAGE Divalproex sodium extended-release tablets are indicated for: .\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0046831965\",\n \"SemanticContext\": \"• Acute treatment of manic or mixed episodes associated with bipolar disorder, with or without psychotic features 1.1 • Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures 1.2 • Prophylaxis of migraine headaches 1.3 DOSAGE AND ADMINISTRATION • Divalproex sodium extended-release tablets are intended for once-a-day oral administration.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0005131066\",\n \"SemanticContext\": \"Divalproex sodium extended-release tablets should be swallowed whole and should not be crushed or chewed 2.1 , 2.2 .\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0001122925\",\n \"SemanticContext\": \"POLG 4 , 5.1 • Suspected POLG-related disorder in children under two years of age 4 , 5.1 • Known hypersensitivity to the drug 4 , 5.12 • Urea cycle disorders 4 , 5.6 • Prophylaxis of migraine headaches: Pregnant women, women of childbearing potential not using effective contraception 4 , 8.1 WARNINGS AND PRECAUTIONS • Hepatotoxicity; evaluate high risk populations and monitor serum liver tests 5.1 • Birth defects, decreased IQ, and neurodevelopmental disorders following in utero exposure; should not be used to treat women with epilepsy or bipolar disorder who are pregnant or who plan to become pregnant or to treat a woman of childbearing potential unless other medications have failed to provide adequate symptom control or are otherwise unacceptable 5.2 , 5.3 , 5.4 • Pancreatitis; divalproex sodium extended-release tablets should ordinarily be discontinued 5.5 • Suicidal behavior or ideation; Antiepileptic drugs, including divalproex sodium extended-release tablets, increase the risk of suicidal thoughts or behavior 5.7 • Bleeding and other hematopoietic disorders; monitor platelet counts and coagulation tests 5.8 • Hyperammonemia and hyperammonemic encephalopathy; measure ammonia level if unexplained lethargy and vomiting or changes in mental status, and also with concomitant topiramate use; consider discontinuation of valproate therapy 5.6 , 5.9 , 5.10 • Hypothermia; Hypothermia has been reported during valproate therapy with or without associated hyperammonemia.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0017935336\",\n \"SemanticContext\": \"POLG 4 , 5.1 • Suspected POLG-related disorder in children under two years of age 4 , 5.1 • Known hypersensitivity to the drug 4 , 5.12 • Urea cycle disorders 4 , 5.6 • Prophylaxis of migraine headaches: Pregnant women, women of childbearing potential not using effective contraception 4 , 8.1 WARNINGS AND PRECAUTIONS • Hepatotoxicity; evaluate high risk populations and monitor serum liver tests 5.1 • Birth defects, decreased IQ, and neurodevelopmental disorders following in utero exposure; should not be used to treat women with epilepsy or bipolar disorder who are pregnant or who plan to become pregnant or to treat a woman of childbearing potential unless other medications have failed to provide adequate symptom control or are otherwise unacceptable 5.2 , 5.3 , 5.4 • Pancreatitis; divalproex sodium extended-release tablets should ordinarily be discontinued 5.5 • Suicidal behavior or ideation; Antiepileptic drugs, including divalproex sodium extended-release tablets, increase the risk of suicidal thoughts or behavior 5.7 • Bleeding and other hematopoietic disorders; monitor platelet counts and coagulation tests 5.8 • Hyperammonemia and hyperammonemic encephalopathy; measure ammonia level if unexplained lethargy and vomiting or changes in mental status, and also with concomitant topiramate use; consider discontinuation of valproate therapy 5.6 , 5.9 , 5.10 • Hypothermia; Hypothermia has been reported during valproate therapy with or without associated hyperammonemia.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0056106746\",\n \"SemanticContext\": \"This adverse reaction can also occur in patients using concomitant topiramate 5.11 • Drug Reaction with Eosinophilia and Systemic Symptoms DRESS /Multiorgan hypersensitivity reaction; discontinue divalproex sodium extended-release tablets 5.12 • Somnolence in the elderly can occur.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0010018945\",\n \"SemanticContext\": \"Divalproex sodium extended-release tablets dosage should be increased slowly and with regular monitoring for fluid and nutritional intake 5.14 ADVERSE REACTIONS • Most common adverse reactions reported > 5% are abdominal pain, alopecia, amblyopia/blurred vision, amnesia, anorexia, asthenia, ataxia, back pain, bronchitis, constipation, depression, diarrhea, diplopia, dizziness, dyspnea, dyspepsia, ecchymosis, emotional lability, fever, flu syndrome, headache, increased appetite, infection, insomnia, nausea, nervousness, nystagmus, peripheral edema, pharyngitis, rash, rhinitis, somnolence, thinking abnormal, thrombocytopenia, tinnitus, tremor, vomiting, weight gain, weight loss 6.1 , 6.2 , 6.3 .\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"1.00315E-05\",\n \"SemanticContext\": \"Therefore increased monitoring of valproate and concomitant drug concentrations and dosage adjustment are indicated whenever enzyme-inducing or inhibiting drugs are introduced or withdrawn 7.1 • Aspirin, carbapenem antibiotics, estrogen-containing hormonal contraceptives: Monitoring of valproate concentrations is recommended 7.1 • Co-administration of valproate can affect the pharmacokinetics of other drugs e.g., diazepam, ethosuximide, lamotrigine, phenytoin by inhibiting their metabolism or protein binding displacement 7.2 • Patients stabilized on rufinamide should begin valproate therapy at a low dose, and titrate to clinically effective dose 7.2 • Dosage adjustment of amitriptyline/nortriptyline, propofol, warfarin, and zidovudine may be necessary if used concomitantly with divalproex sodium extended-release tablets 7.2 • Topiramate: Hyperammonemia and encephalopathy 5.10 , 7.3 USE IN SPECIFIC POPULATIONS • Pregnancy: Divalproex sodium extended-release tablets can cause congenital malformations including neural tube defects, decreased IQ, and neurodevelopmental disorders 5.2 , 5.3 , 8.1 • Pediatric: Children under the age of two years are at considerably higher risk of fatal hepatotoxicity 5.1 , 8.4 • Geriatric: Reduce starting dose; increase dosage more slowly; monitor fluid and nutritional intake, and somnolence 5.14 , 8.5 See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0125052333\",\n \"SemanticContext\": \"Therefore increased monitoring of valproate and concomitant drug concentrations and dosage adjustment are indicated whenever enzyme-inducing or inhibiting drugs are introduced or withdrawn 7.1 • Aspirin, carbapenem antibiotics, estrogen-containing hormonal contraceptives: Monitoring of valproate concentrations is recommended 7.1 • Co-administration of valproate can affect the pharmacokinetics of other drugs e.g., diazepam, ethosuximide, lamotrigine, phenytoin by inhibiting their metabolism or protein binding displacement 7.2 • Patients stabilized on rufinamide should begin valproate therapy at a low dose, and titrate to clinically effective dose 7.2 • Dosage adjustment of amitriptyline/nortriptyline, propofol, warfarin, and zidovudine may be necessary if used concomitantly with divalproex sodium extended-release tablets 7.2 • Topiramate: Hyperammonemia and encephalopathy 5.10 , 7.3 USE IN SPECIFIC POPULATIONS • Pregnancy: Divalproex sodium extended-release tablets can cause congenital malformations including neural tube defects, decreased IQ, and neurodevelopmental disorders 5.2 , 5.3 , 8.1 • Pediatric: Children under the age of two years are at considerably higher risk of fatal hepatotoxicity 5.1 , 8.4 • Geriatric: Reduce starting dose; increase dosage more slowly; monitor fluid and nutritional intake, and somnolence 5.14 , 8.5 See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0024825037\",\n \"SemanticContext\": \"6.1 Mania The incidence of treatment-emergent events has been ascertained based on combined data from two three week placebo-controlled clinical trials of divalproex sodium extended-release tablets in the treatment of manic episodes associated with bipolar disorder.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0104982257\",\n \"SemanticContext\": \"Table 3 summarizes those adverse reactions reported for patients in these trials where the incidence rate in the divalproex sodium extended-release tablets-treated group was greater than 5% and greater than the placebo incidence.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0112992823\",\n \"SemanticContext\": \"Adverse Reactions Reported by > 5% of Divalproex Sodium Extended-Release Tablets-Treated Patients During Placebo-Controlled Trials of Acute Mania The following adverse reactions/event occurred at an equal or greater incidence for placebo than for divalproex sodium extended-release tablets: headache.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0047432482\",\n \"SemanticContext\": \"The following additional adverse reactions were reported by greater than 1% of the divalproex sodium extended-release tablets-treated patients in controlled clinical trials: Body as a Whole: Back Pain, Chills, Chills and Fever, Drug Level Increased, Flu Syndrome, Infection, Infection Fungal, Neck Rigidity.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0077465475\",\n \"SemanticContext\": \"6.2 Epilepsy Based on a placebo-controlled trial of adjunctive therapy for treatment of complex partial seizures, divalproex sodium delayed-release tablets were generally well tolerated with most adverse reactions rated as mild to moderate in severity.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0004927516\",\n \"SemanticContext\": \"Intolerance was the primary reason for discontinuation in the divalproex sodium delayed-release tablets-treated patients 6% , compared to 1% of placebo-treated patients.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0018423796\",\n \"SemanticContext\": \"Table 4 lists treatment-emergent adverse reactions which were reported by = 5% of divalproex sodium delayed-release tablets-treated patients and for which the incidence was greater than in the placebo group, in the placebo-controlled trial of adjunctive therapy for treatment of complex partial seizures.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"5.43862E-05\",\n \"SemanticContext\": \"Since patients were also treated with other antiepilepsy drugs, it is not possible, in most cases, to determine whether the following adverse reactions can be ascribed to divalproex sodium delayed-release tablets alone, or the combination of divalproex sodium delayed-release tablets and other antiepilepsy drugs.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"1.98937E-05\",\n \"SemanticContext\": \"Since patients were also treated with other antiepilepsy drugs, it is not possible, in most cases, to determine whether the following adverse reactions can be ascribed to divalproex sodium delayed-release tablets alone, or the combination of divalproex sodium delayed-release tablets and other antiepilepsy drugs.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0002524853\",\n \"SemanticContext\": \"Table 5 lists treatment-emergent adverse reactions which were reported by = 5% of patients in the high dose valproate group, and for which the incidence was greater than in the low dose group, in a controlled trial of divalproex sodium delayed-release tablets monotherapy treatment of complex partial seizures.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"4.58724E-05\",\n \"SemanticContext\": \"Since patients were being titrated off another antiepilepsy drug during the first portion of the trial, it is not possible, in many cases, to determine whether the following adverse reactions can be ascribed to divalproex sodium delayed-release tablets alone, or the combination of valproate and other antiepilepsy drugs.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.004950434\",\n \"SemanticContext\": \"Table 6 includes those adverse reactions reported for patients in the placebo-controlled trial where the incidence rate in the divalproex sodium extended-release tablets-treated group was greater than 5% and was greater than that for placebo patients.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0033129454\",\n \"SemanticContext\": \"Adverse Reactions Reported by > 5% of Divalproex Sodium Extended-Release Tablets-Treated Patients During the Migraine Placebo-Controlled Trial with a Greater Incidence than Patients Taking Placebo The following adverse reactions occurred in greater than 5% of divalproex sodium extended-release tablets-treated patients and at a greater incidence for placebo than for divalproex sodium extended-release tablets: asthenia and flu syndrome.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0503053963\",\n \"SemanticContext\": \"Adverse Reactions Reported by > 5% of Divalproex Sodium Extended-Release Tablets-Treated Patients During the Migraine Placebo-Controlled Trial with a Greater Incidence than Patients Taking Placebo The following adverse reactions occurred in greater than 5% of divalproex sodium extended-release tablets-treated patients and at a greater incidence for placebo than for divalproex sodium extended-release tablets: asthenia and flu syndrome.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0053058863\",\n \"SemanticContext\": \"The following additional adverse reactions were reported by greater than 1% but not more than 5% of divalproex sodium extended-release tablets-treated patients and with a greater incidence than placebo in the placebo-controlled clinical trial for migraine prophylaxis: Body as a Whole: Accidental injury, viral infection.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0019024909\",\n \"SemanticContext\": \"Adverse Reactions Reported by > 5% of Valproate-Treated Patients During Migraine Placebo-Controlled Trials with a Greater Incidence than Patients Taking Placebo The following adverse reactions occurred in greater than 5% of divalproex sodium delayed-release tablets-treated patients and at a greater incidence for placebo than for divalproex sodium delayed-release tablets: flu syndrome and pharyngitis.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0776303411\",\n \"SemanticContext\": \"Adverse Reactions Reported by > 5% of Valproate-Treated Patients During Migraine Placebo-Controlled Trials with a Greater Incidence than Patients Taking Placebo The following adverse reactions occurred in greater than 5% of divalproex sodium delayed-release tablets-treated patients and at a greater incidence for placebo than for divalproex sodium delayed-release tablets: flu syndrome and pharyngitis.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0003755689\",\n \"SemanticContext\": \"6.4 Postmarketing Experience The following adverse reactions have been identified during post approval use of divalproex sodium delayed-release tablets.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"7.92195E-05\",\n \"SemanticContext\": \"11 DESCRIPTION Divalproex sodium is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship and formed during the partial neutralization of valproic acid with 0.5 equivalent of sodium hydroxide.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0001573861\",\n \"SemanticContext\": \"11 DESCRIPTION Divalproex sodium is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship and formed during the partial neutralization of valproic acid with 0.5 equivalent of sodium hydroxide.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0002756715\",\n \"SemanticContext\": \"11 DESCRIPTION Divalproex sodium is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship and formed during the partial neutralization of valproic acid with 0.5 equivalent of sodium hydroxide.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0018240809\",\n \"SemanticContext\": \"Chemically it is designated as sodium hydrogen bis 2-propylpentanoate .\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0009719133\",\n \"SemanticContext\": \"Divalproex sodium has the following structure: Divalproex sodium, USP occurs as a white crystalline powder with a characteristic odor.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0001680255\",\n \"SemanticContext\": \"Divalproex sodium has the following structure: Divalproex sodium, USP occurs as a white crystalline powder with a characteristic odor.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0002092421\",\n \"SemanticContext\": \"Divalproex sodium extended-release 250 and 500 mg tablets are for oral administration.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0010204911\",\n \"SemanticContext\": \"Divalproex sodium extended-release tablets, USP contain divalproex sodium in a once-a-day extended-release formulation equivalent to 250 or 500 mg of valproic acid.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.000166595\",\n \"SemanticContext\": \"Divalproex sodium extended-release tablets, USP contain divalproex sodium in a once-a-day extended-release formulation equivalent to 250 or 500 mg of valproic acid.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0008141696\",\n \"SemanticContext\": \"Divalproex Sodium Structural Formula 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Divalproex sodium dissociates to the valproate ion in the gastrointestinal tract.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"4.84643E-05\",\n \"SemanticContext\": \"12.3 Pharmacokinetics\\n \\n Absorption/Bioavailability\\n The absolute bioavailability of divalproex sodium extended-release tablets administered as a single dose after a meal was approximately 90% relative to intravenous infusion.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"9.4745E-06\",\n \"SemanticContext\": \"When given in equal total daily doses, the bioavailability of divalproex sodium extended-release tablets is less than that of divalproex sodium delayed-release tablets.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0002223849\",\n \"SemanticContext\": \"When given in equal total daily doses, the bioavailability of divalproex sodium extended-release tablets is less than that of divalproex sodium delayed-release tablets.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"3.51891E-05\",\n \"SemanticContext\": \"In five multiple-dose studies in healthy subjects N = 82 and in subjects with epilepsy N = 86 , when administered under fasting and nonfasting conditions, divalproex sodium extended-release tablets given once daily produced an average bioavailability of 89% relative to an equal total daily dose of divalproex sodium delayed-release tablets given BID, TID, or QID.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"4.65167E-05\",\n \"SemanticContext\": \"In five multiple-dose studies in healthy subjects N = 82 and in subjects with epilepsy N = 86 , when administered under fasting and nonfasting conditions, divalproex sodium extended-release tablets given once daily produced an average bioavailability of 89% relative to an equal total daily dose of divalproex sodium delayed-release tablets given BID, TID, or QID.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.000217706\",\n \"SemanticContext\": \"The median time to maximum plasma valproate concentrations C max after divalproex sodium extended-release tablets administration ranged from 4 to 17 hours.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"2.29599E-05\",\n \"SemanticContext\": \"After multiple once-daily dosing of divalproex sodium extended-release tablets, the peak-to-trough fluctuation in plasma valproate concentrations was 10-20% lower than that of regular divalproex sodium delayed-release tablets given BID, TID, or QID.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"3.39094E-05\",\n \"SemanticContext\": \"After multiple once-daily dosing of divalproex sodium extended-release tablets, the peak-to-trough fluctuation in plasma valproate concentrations was 10-20% lower than that of regular divalproex sodium delayed-release tablets given BID, TID, or QID.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"6.11182E-05\",\n \"SemanticContext\": \"Conversion from Divalproex Sodium Delayed-Release Tablets to Divalproex Sodium Extended-Release Tablets When divalproex sodium extended-release tablets are given in doses 8 to 20% higher than the total daily dose of divalproex sodium delayed-release tablets, the two formulations are bioequivalent.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0001397431\",\n \"SemanticContext\": \"Conversion from Divalproex Sodium Delayed-Release Tablets to Divalproex Sodium Extended-Release Tablets When divalproex sodium extended-release tablets are given in doses 8 to 20% higher than the total daily dose of divalproex sodium delayed-release tablets, the two formulations are bioequivalent.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.000103684\",\n \"SemanticContext\": \"In two randomized, crossover studies, multiple daily doses of divalproex sodium delayed-release tablets were compared to 8 to 20% higher once daily doses of divalproex sodium extended-release tablets.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0006410182\",\n \"SemanticContext\": \"In two randomized, crossover studies, multiple daily doses of divalproex sodium delayed-release tablets were compared to 8 to 20% higher once daily doses of divalproex sodium extended-release tablets.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0006854832\",\n \"SemanticContext\": \"In these two studies, divalproex sodium extended-release tablets and divalproex sodium delayed-release tablets regimens were equivalent with respect to area under the curve AUC; a measure of the extent of bioavailability .\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0002080798\",\n \"SemanticContext\": \"In these two studies, divalproex sodium extended-release tablets and divalproex sodium delayed-release tablets regimens were equivalent with respect to area under the curve AUC; a measure of the extent of bioavailability .\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0003964603\",\n \"SemanticContext\": \"Additionally, valproate C max was lower, and C min was either higher or not different, for divalproex sodium extended-release tablets relative to divalproex sodium delayed-release tablets regimens see Table 8 .\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.000688374\",\n \"SemanticContext\": \"Additionally, valproate C max was lower, and C min was either higher or not different, for divalproex sodium extended-release tablets relative to divalproex sodium delayed-release tablets regimens see Table 8 .\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"1.00964E-05\",\n \"SemanticContext\": \"Concomitant antiepilepsy drugs topiramate, phenobarbital, carbamazepine, phenytoin, and lamotrigine were evaluated that induce the cytochrome P450 isozyme system did not significantly alter valproate bioavailability when converting between divalproex sodium delayed-release tablets and divalproex sodium extended-release tablets.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.000399977\",\n \"SemanticContext\": \"Concomitant antiepilepsy drugs topiramate, phenobarbital, carbamazepine, phenytoin, and lamotrigine were evaluated that induce the cytochrome P450 isozyme system did not significantly alter valproate bioavailability when converting between divalproex sodium delayed-release tablets and divalproex sodium extended-release tablets.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"9.9788E-05\",\n \"SemanticContext\": \"\\n \\n Special Populations\\n Effect of Age Pediatric The valproate pharmacokinetic profile following administration of divalproex sodium extended-release tablets was characterized in a multiple- dose, non-fasting, open label, multi-center study in children and adolescents.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.000173986\",\n \"SemanticContext\": \"Divalproex sodium extended-release tablets once daily doses ranged from 250-1,750 mg.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"5.07393E-05\",\n \"SemanticContext\": \"Once daily administration of divalproex sodium extended-release tablets in pediatric patients 10-17 years produced plasma VPA concentration-time profiles similar to those that have been observed in adults.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.000364542\",\n \"SemanticContext\": \"14 CLINICAL STUDIES 14.1 Mania The effectiveness of divalproex sodium extended-release tablets for the treatment of acute mania is based in part on studies establishing the effectiveness of divalproex sodium delayed-release tablets for this indication.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0005919337\",\n \"SemanticContext\": \"14 CLINICAL STUDIES 14.1 Mania The effectiveness of divalproex sodium extended-release tablets for the treatment of acute mania is based in part on studies establishing the effectiveness of divalproex sodium delayed-release tablets for this indication.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0004021525\",\n \"SemanticContext\": \"Divalproex sodium extended-release tablets’ effectiveness was confirmed in one randomized, double-blind, placebo-controlled, parallel group, 3-week, multicenter study.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"6.02204E-05\",\n \"SemanticContext\": \"The study was designed to evaluate the safety and efficacy of divalproex sodium extended-release tablets in the treatment of bipolar I disorder, manic or mixed type, in adults.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0005854666\",\n \"SemanticContext\": \"Divalproex sodium extended-release tablets were initiated at a dose of 25 mg/kg/day given once daily, increased by 500 mg/day on Day 3, then adjusted to achieve plasma valproate concentrations in the range of 85-125 mcg/mL.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0001090978\",\n \"SemanticContext\": \"Mean daily divalproex sodium extended-release tablets doses for observed cases were 2,362 mg range: 500-4,000 , 2,874 mg range: 1,500-4,500 , 2,993 mg range: 1,500-4,500 , 3,181 mg range: 1,500-5,000 , and 3,353 mg range: 1,500-5,500 at Days 1, 5, 10, 15, and 21, respectively.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0037550032\",\n \"SemanticContext\": \"Divalproex sodium extended-release tablets were significantly more effective than placebo in reduction of the MRS total score.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0001373589\",\n \"SemanticContext\": \"In one, multi-clinic, placebo controlled study employing an add-on design adjunctive therapy , 144 patients who continued to suffer eight or more CPS per 8 weeks during an 8 week period of monotherapy with doses of either carbamazepine or phenytoin sufficient to assure plasma concentrations within the \\\"therapeutic range\\\" were randomized to receive, in addition to their original antiepilepsy drug AED , either divalproex sodium delayed-release tablets or placebo.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0001669824\",\n \"SemanticContext\": \"In patients converted to divalproex sodium delayed-release tablets monotherapy, the mean total valproate concentrations during monotherapy were 71 and 123 mcg/mL in the low dose and high dose groups, respectively.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0013636351\",\n \"SemanticContext\": \"Figure 1: Proportion of patients X axis whose percentage reduction from baseline in complex partial seizure rates was at least as great as that indicated on the Y axis in the adjunctive therapy study Figure 2: Proportion of patients X axis whose percentage reduction from baseline in complex partial seizure rates was at least as great as that indicated on the Y axis in the monotherapy study 14.3 Migraine The results of a multicenter, randomized, double-blind, placebo-controlled, parallel-group clinical trial demonstrated the effectiveness of divalproex sodium extended-release tablets in the prophylactic treatment of migraine headache.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0006920993\",\n \"SemanticContext\": \"Patients who experienced = 2 migraine headaches in the 4-week baseline period were randomized in a 1:1 ratio to divalproex sodium extended-release tablets or placebo and treated for 12 weeks.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0014367104\",\n \"SemanticContext\": \"Ninety-eight of 114 divalproex sodium extended-release tablets-treated patients 86% and 100 of 110 placebo-treated patients 91% treated at least two weeks maintained the 1,000 mg once daily dose for the duration of their treatment periods.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0017522871\",\n \"SemanticContext\": \"Patients 50 male, 187 female ranging in age from 16 to 69 were treated with divalproex sodium extended-release tablets N = 122 or placebo N = 115 .\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0033548772\",\n \"SemanticContext\": \"The mean reduction in 4-week migraine headache rate was 1.2 from a baseline mean of 4.4 in the divalproex sodium extended-release tablets group, versus 0.6 from a baseline mean of 4.2 in the placebo group.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0006311536\",\n \"SemanticContext\": \"4 CONTRAINDICATIONS • Divalproex sodium extended-release tablets should not be administered to patients with hepatic disease or significant hepatic dysfunction [see Warnings and Precautions 5.1 ] .\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0004659295\",\n \"SemanticContext\": \"• Divalproex sodium extended-release tablets are contraindicated in patients known to have mitochondrial disorders caused by mutations in mitochondrial DNA polymerase ?\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0016283691\",\n \"SemanticContext\": \"• Divalproex sodium extended-release tablets are contraindicated in patients with known hypersensitivity to the drug [see Warnings and Precautions 5.12 ] .\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0025183558\",\n \"SemanticContext\": \"• Divalproex sodium extended-release tablets are contraindicated in patients with known urea cycle disorders [see Warnings and Precautions 5.6 ] .\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"1.22405E-05\",\n \"SemanticContext\": \"• For use in prophylaxis of migraine headaches: divalproex sodium extended-release tablets are contraindicated in women who are pregnant and in women of childbearing potential who are not using effective contraception [see Warnings and Precautions 5.2 , 5.3 , 5.4 and Use in Specific Populations 8.1 ] .\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0567440689\",\n \"SemanticContext\": \"2 DOSAGE AND ADMINISTRATION Divalproex sodium extended-release tablets are an extended-release product intended for once-a-day oral administration.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"4.58723E-05\",\n \"SemanticContext\": \"Divalproex sodium extended-release tablets should be swallowed whole and should not be crushed or chewed.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"2.78649E-05\",\n \"SemanticContext\": \"2.1 Mania Divalproex sodium extended-release tablets are administered orally.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"5.14348E-05\",\n \"SemanticContext\": \"There is no body of evidence available from controlled trials to guide a clinician in the longer term management of a patient who improves during divalproex sodium extended-release tablets treatment of an acute manic episode.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"5.3343E-05\",\n \"SemanticContext\": \"While it is generally agreed that pharmacological treatment beyond an acute response in mania is desirable, both for maintenance of the initial response and for prevention of new manic episodes, there are no data to support the benefits of divalproex sodium extended-release tablets in such longer-term treatment i.e., beyond 3 weeks .\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0001417398\",\n \"SemanticContext\": \"2.2 Epilepsy Divalproex sodium extended-release tablets are administered orally, and must be swallowed whole.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0001186996\",\n \"SemanticContext\": \"As divalproex sodium extended-release tablets dosage is titrated upward, concentrations of clonazepam, diazepam, ethosuximide, lamotrigine, tolbutamide, phenobarbital, carbamazepine, and/or phenytoin may be affected [see Drug Interactions 7.2 ].\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0005478561\",\n \"SemanticContext\": \"Monotherapy Initial Therapy Divalproex sodium extended-release tablets have not been systematically studied as initial therapy.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"6.13786E-05\",\n \"SemanticContext\": \"This reduction may be started at initiation of divalproex sodium extended-release tablets therapy, or delayed by 1 to 2 weeks if there is a concern that seizures are likely to occur with a reduction.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0003011525\",\n \"SemanticContext\": \"Adjunctive Therapy Divalproex sodium extended-release tablets may be added to the patient's regimen at a dosage of 10 to 15 mg/kg/day.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0001930892\",\n \"SemanticContext\": \"As divalproex sodium extended-release tablets dosage is titrated upward, blood concentrations of phenobarbital and/or phenytoin may be affected [see Drug Interactions 7.2 ] .\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0001580119\",\n \"SemanticContext\": \"2.3 Migraine Divalproex sodium extended-release tablets are indicated for prophylaxis of migraine headaches in adults.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"1.76624E-05\",\n \"SemanticContext\": \"Although doses other than 1,000 mg once daily of divalproex sodium extended-release tablets have not been evaluated in patients with migraine, the effective dose range of divalproex sodium delayed-release tablets in these patients is 500-1,000 mg/day.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"8.37831E-05\",\n \"SemanticContext\": \"Although doses other than 1,000 mg once daily of divalproex sodium extended-release tablets have not been evaluated in patients with migraine, the effective dose range of divalproex sodium delayed-release tablets in these patients is 500-1,000 mg/day.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"5.78743E-05\",\n \"SemanticContext\": \"As with other valproate products, doses of divalproex sodium extended-release tablets should be individualized and dose adjustment may be necessary.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"6.3464E-06\",\n \"SemanticContext\": \"If a patient requires smaller dose adjustments than that available with divalproex sodium extended-release tablets, divalproex sodium delayed-release tablets should be used instead.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0001773536\",\n \"SemanticContext\": \"If a patient requires smaller dose adjustments than that available with divalproex sodium extended-release tablets, divalproex sodium delayed-release tablets should be used instead.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0001145456\",\n \"SemanticContext\": \"2.4 Conversion from Divalproex Sodium Delayed-Release Tablets to Divalproex Sodium Extended-Release Tablets In adult patients and pediatric patients 10 years of age or older with epilepsy previously receiving divalproex sodium delayed-release tablets, divalproex sodium extended-release tablets should be administered once-daily using a dose 8 to 20% higher than the total daily dose of divalproex sodium delayed-release tablets Table 1 .\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0005858541\",\n \"SemanticContext\": \"2.4 Conversion from Divalproex Sodium Delayed-Release Tablets to Divalproex Sodium Extended-Release Tablets In adult patients and pediatric patients 10 years of age or older with epilepsy previously receiving divalproex sodium delayed-release tablets, divalproex sodium extended-release tablets should be administered once-daily using a dose 8 to 20% higher than the total daily dose of divalproex sodium delayed-release tablets Table 1 .\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0004508197\",\n \"SemanticContext\": \"2.4 Conversion from Divalproex Sodium Delayed-Release Tablets to Divalproex Sodium Extended-Release Tablets In adult patients and pediatric patients 10 years of age or older with epilepsy previously receiving divalproex sodium delayed-release tablets, divalproex sodium extended-release tablets should be administered once-daily using a dose 8 to 20% higher than the total daily dose of divalproex sodium delayed-release tablets Table 1 .\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"9.3618E-06\",\n \"SemanticContext\": \"For patients whose divalproex sodium delayed-release tablets total daily dose cannot be directly converted to divalproex sodium extended-release tablets, consideration may be given at the clinician’s discretion to increase the patient’s divalproex sodium delayed-release tablets total daily dose to the next higher dosage before converting to the appropriate total daily dose of divalproex sodium extended-release tablets.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"3.86462E-05\",\n \"SemanticContext\": \"For patients whose divalproex sodium delayed-release tablets total daily dose cannot be directly converted to divalproex sodium extended-release tablets, consideration may be given at the clinician’s discretion to increase the patient’s divalproex sodium delayed-release tablets total daily dose to the next higher dosage before converting to the appropriate total daily dose of divalproex sodium extended-release tablets.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"2.72667E-05\",\n \"SemanticContext\": \"For patients whose divalproex sodium delayed-release tablets total daily dose cannot be directly converted to divalproex sodium extended-release tablets, consideration may be given at the clinician’s discretion to increase the patient’s divalproex sodium delayed-release tablets total daily dose to the next higher dosage before converting to the appropriate total daily dose of divalproex sodium extended-release tablets.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"2.46391E-05\",\n \"SemanticContext\": \"For patients whose divalproex sodium delayed-release tablets total daily dose cannot be directly converted to divalproex sodium extended-release tablets, consideration may be given at the clinician’s discretion to increase the patient’s divalproex sodium delayed-release tablets total daily dose to the next higher dosage before converting to the appropriate total daily dose of divalproex sodium extended-release tablets.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"6.33513E-05\",\n \"SemanticContext\": \"Dose Conversion Divalproex Sodium Delayed-Release Tablets Total Daily Dose mg Divalproex Sodium Extended-Release Tablets mg 500 These total daily doses of divalproex sodium delayed-release tablets cannot be directly converted to an 8 to 20% higher total daily dose of divalproex sodium extended-release tablets because the required dosing strengths of divalproex sodium extended-release tablets are not available.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.000148803\",\n \"SemanticContext\": \"Dose Conversion Divalproex Sodium Delayed-Release Tablets Total Daily Dose mg Divalproex Sodium Extended-Release Tablets mg 500 These total daily doses of divalproex sodium delayed-release tablets cannot be directly converted to an 8 to 20% higher total daily dose of divalproex sodium extended-release tablets because the required dosing strengths of divalproex sodium extended-release tablets are not available.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0002112389\",\n \"SemanticContext\": \"Dose Conversion Divalproex Sodium Delayed-Release Tablets Total Daily Dose mg Divalproex Sodium Extended-Release Tablets mg 500 These total daily doses of divalproex sodium delayed-release tablets cannot be directly converted to an 8 to 20% higher total daily dose of divalproex sodium extended-release tablets because the required dosing strengths of divalproex sodium extended-release tablets are not available.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"2.2512E-05\",\n \"SemanticContext\": \"Consideration may be given at the clinician’s discretion to increase the patient’s divalproex sodium delayed-release tablets total daily dose to the next higher dosage before converting to the appropriate total daily dose of divalproex sodium extended-release tablets.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"2.46391E-05\",\n \"SemanticContext\": \"Consideration may be given at the clinician’s discretion to increase the patient’s divalproex sodium delayed-release tablets total daily dose to the next higher dosage before converting to the appropriate total daily dose of divalproex sodium extended-release tablets.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"2.88524E-05\",\n \"SemanticContext\": \"There is insufficient data to allow a conversion factor recommendation for patients with divalproex sodium delayed-release tablets doses above 3,125 mg/day.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0001200015\",\n \"SemanticContext\": \"Plasma valproate C min concentrations for divalproex sodium extended-release tablets on average are equivalent to divalproex sodium delayed-release tablets, but may vary across patients after conversion.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0007574558\",\n \"SemanticContext\": \"Plasma valproate C min concentrations for divalproex sodium extended-release tablets on average are equivalent to divalproex sodium delayed-release tablets, but may vary across patients after conversion.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"4.02014E-05\",\n \"SemanticContext\": \"Starting doses in the elderly lower than 250 mg can only be achieved by the use of divalproex sodium delayed-release tablets.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"2.2736E-06\",\n \"SemanticContext\": \"\\n \\n Compliance\\n Patients should be informed to take divalproex sodium extended-release tablets every day as prescribed.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"7.97993E-05\",\n \"SemanticContext\": \"3 DOSAGE FORMS AND STRENGTHS Divalproex Sodium Extended-Release Tablets, USP are available containing divalproex sodium, USP equivalent to 250 mg or 500 mg of valproic acid.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0083453357\",\n \"SemanticContext\": \"1 INDICATIONS AND USAGE 1.1 Mania Divalproex sodium extended-release tablets are a valproate and are indicated for the treatment of acute manic or mixed episodes associated with bipolar disorder, with or without psychotic features.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0001077515\",\n \"SemanticContext\": \"The efficacy of divalproex sodium extended-release tablets is based in part on studies of divalproex sodium delayed-release tablets in this indication, and was confirmed in a 3-week trial with patients meeting DSM-IV TR criteria for bipolar I disorder, manic or mixed type, who were hospitalized for acute mania [see Clinical Studies 14.1 ] .\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0003052652\",\n \"SemanticContext\": \"The efficacy of divalproex sodium extended-release tablets is based in part on studies of divalproex sodium delayed-release tablets in this indication, and was confirmed in a 3-week trial with patients meeting DSM-IV TR criteria for bipolar I disorder, manic or mixed type, who were hospitalized for acute mania [see Clinical Studies 14.1 ] .\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"2.0598E-06\",\n \"SemanticContext\": \"Therefore, healthcare providers who elect to use divalproex sodium extended-release tablets for extended periods should continually reevaluate the long-term risk-benefits of the drug for the individual patient.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0029949844\",\n \"SemanticContext\": \"1.2 Epilepsy Divalproex sodium extended-release tablets are indicated as monotherapy and adjunctive therapy in the treatment of adult patients and pediatric patients down to the age of 10 years with complex partial seizures that occur either in isolation or in association with other types of seizures.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0014244318\",\n \"SemanticContext\": \"Divalproex sodium extended-release tablets are also indicated for use as sole and adjunctive therapy in the treatment of simple and complex absence seizures in adults and children 10 years of age or older, and adjunctively in adults and children 10 years of age or older with multiple seizure types that include absence seizures.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0001491308\",\n \"SemanticContext\": \"1.3 Migraine Divalproex sodium extended-release tablets are indicated for prophylaxis of migraine headaches.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0003613532\",\n \"SemanticContext\": \"There is no evidence that divalproex sodium extended-release tablets are useful in the acute treatment of migraine headaches.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"8.75465E-05\",\n \"SemanticContext\": \"For prophylaxis of migraine headaches, divalproex sodium extended-release tablets are contraindicated in women who are pregnant and in women of childbearing potential who are not using effective contraception [see Contraindications 4 ] .\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"1.1083E-05\",\n \"SemanticContext\": \"Encourage women who are taking divalproex sodium extended-release tablets to enroll in the North American Antiepileptic Drug NAAED Pregnancy Registry if they become pregnant.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0002800226\",\n \"SemanticContext\": \"Suicidal Thinking and Behavior: Counsel patients, their caregivers, and families that AEDs, including divalproex sodium extended-release tablets, may increase the risk of suicidal thoughts and behavior and to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0017377734\",\n \"SemanticContext\": \"8.1 Pregnancy\\n \\n Pregnancy Exposure Registry\\n There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs AEDs , including divalproex sodium extended-release tablets, during pregnancy.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"1.48602E-05\",\n \"SemanticContext\": \"Encourage women who are taking divalproex sodium extended-release tablets during pregnancy to enroll in the North American Antiepileptic Drug NAAED Pregnancy Registry by calling toll-free 1-888-233-2334 or visiting the website, http://www.aedpregnancyregistry.org/.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"6.63971E-05\",\n \"SemanticContext\": \"When divalproex sodium extended-release tablets are used in this patient group, it should be used with extreme caution and as a sole agent.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"7.6944E-05\",\n \"SemanticContext\": \"\\n \\n Patients with Known or Suspected Mitochondrial Disease\\n Divalproex sodium extended-release tablets are contraindicated in patients known to have mitochondrial disorders caused by POLG mutations and children under two years of age who are clinically suspected of having a mitochondrial disorder [see Contraindications 4 ] .\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0001361668\",\n \"SemanticContext\": \"In patients over two years of age who are clinically suspected of having a hereditary mitochondrial disease, divalproex sodium extended-release tablets should only be used after other anticonvulsants have failed.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"4.9122E-06\",\n \"SemanticContext\": \"This older group of patients should be closely monitored during treatment with divalproex sodium extended-release tablets for the development of acute liver injury with regular clinical assessments and serum liver test monitoring.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"3.8377E-06\",\n \"SemanticContext\": \"If pancreatitis is diagnosed, divalproex sodium extended-release tablets should ordinarily be discontinued.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0090587437\",\n \"SemanticContext\": \"5.6 Urea Cycle Disorders Divalproex sodium extended-release tablets are contraindicated in patients with known urea cycle disorders UCD .\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0001758635\",\n \"SemanticContext\": \"Prior to the initiation of divalproex sodium extended-release tablets therapy, evaluation for UCD should be considered in the following patients: 1 those with a history of unexplained encephalopathy or coma, encephalopathy associated with a protein load, pregnancy-related or postpartum encephalopathy, unexplained mental retardation, or history of elevated plasma ammonia or glutamine; 2 those with cyclical vomiting and lethargy, episodic extreme irritability, ataxia, low BUN, or protein avoidance; 3 those with a family history of UCD or a family history of unexplained infant deaths particularly males ; 4 those with other signs or symptoms of UCD.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0016611814\",\n \"SemanticContext\": \"5.7 Suicidal Behavior and Ideation Antiepileptic drugs AEDs , including divalproex sodium extended-release tablets, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"3.9595E-06\",\n \"SemanticContext\": \"Anyone considering prescribing divalproex sodium extended-release tablets or any other AED must balance the risk of suicidal thoughts or behavior with the risk of untreated illness.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"3.07718E-05\",\n \"SemanticContext\": \"It is recommended that patients receiving divalproex sodium extended-release tablets be monitored for blood counts and coagulation parameters prior to planned surgery and during pregnancy [see Use in Specific Populations 8.1 ] .\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"1.12E-06\",\n \"SemanticContext\": \"Medication Guide Divalproex Sodium Extended-Release Tablets, USP dye val' proe ex soe' dee um Read this Medication Guide before you start taking divalproex sodium extended-release tablets and each time you get a refill.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"4.806E-06\",\n \"SemanticContext\": \"What is the most important information I should know about divalproex sodium extended-release tablets?\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"6.0736E-06\",\n \"SemanticContext\": \"Do not stop taking divalproex sodium extended-release tablets without first talking to your healthcare provider.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"6.69286E-05\",\n \"SemanticContext\": \"Stopping divalproex sodium extended-release tablets suddenly can cause serious problems.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0063241124\",\n \"SemanticContext\": \"Divalproex sodium extended-release tablets can cause serious side effects, including: 1.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"4.49158E-05\",\n \"SemanticContext\": \"Divalproex sodium extended-release tablets may harm your unborn baby.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"4.6899E-06\",\n \"SemanticContext\": \"• If you take divalproex sodium extended-release tablets during pregnancy for any medical condition, your baby is at risk for serious birth defects that affect the brain and spinal cord and are called spina bifida or neural tube defects.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"3.6134E-06\",\n \"SemanticContext\": \"• If you take divalproex sodium extended-release tablets during pregnancy for any medical condition, your child is at risk for having lower IQ and may be at risk for developing autism or attention deficit/hyperactivity order.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"3.4519E-06\",\n \"SemanticContext\": \"• Women who are pregnant must not take divalproex sodium extended-release tablets to prevent migraine headaches.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"4.55415E-05\",\n \"SemanticContext\": \"• All women of childbearing age including girls from the start of puberty should talk to their healthcare provider about using other possible treatments instead of divalproex sodium extended-release tablets.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"3.5631E-06\",\n \"SemanticContext\": \"If the decision is made to use divalproex sodium extended-release tablets, you should use effective birth control contraception .\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"3.2434E-06\",\n \"SemanticContext\": \"• Tell your healthcare provider right away if you become pregnant while taking divalproex sodium extended-release tablets.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"5.351E-07\",\n \"SemanticContext\": \"You and your healthcare provider should decide if you will continue to take divalproex sodium extended-release tablets while you are pregnant.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"1.733E-06\",\n \"SemanticContext\": \"Pregnancy Registry: If you become pregnant while taking divalproex sodium extended-release tablets, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0006048977\",\n \"SemanticContext\": \"Like other antiepileptic drugs, divalproex sodium extended-release tablets may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"1.7281E-06\",\n \"SemanticContext\": \"Do not stop divalproex sodium extended-release tablets without first talking to a healthcare provider.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"6.16023E-05\",\n \"SemanticContext\": \"Stopping divalproex sodium extended-release tablets suddenly can cause serious problems.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"1.4976E-05\",\n \"SemanticContext\": \"What are divalproex sodium extended-release tablets?\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0003021359\",\n \"SemanticContext\": \"Divalproex sodium comes in different dosage forms with different usages.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"1.28491E-05\",\n \"SemanticContext\": \"Divalproex Sodium Extended-Release Tablets are prescription medicines used: • to treat manic episodes associated with bipolar disorder • alone or with other medicines to treat: • complex partial seizures in adults and children 10 years of age and older • simple and complex absence seizures, with or without other seizure types • to prevent migraine headaches Who should not take divalproex sodium extended-release tablets?\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"4.7651E-06\",\n \"SemanticContext\": \"Do not take divalproex sodium extended-release tablets if you: • have liver problems • have or think you have a genetic liver problem caused by a mitochondrial disorder e.g., Alpers-Huttenlocher syndrome • are allergic to divalproex sodium, valproic acid, sodium valproate, or any of the ingredients in divalproex sodium extended-release tablets.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"3.20131E-05\",\n \"SemanticContext\": \"Do not take divalproex sodium extended-release tablets if you: • have liver problems • have or think you have a genetic liver problem caused by a mitochondrial disorder e.g., Alpers-Huttenlocher syndrome • are allergic to divalproex sodium, valproic acid, sodium valproate, or any of the ingredients in divalproex sodium extended-release tablets.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"5.31736E-05\",\n \"SemanticContext\": \"Do not take divalproex sodium extended-release tablets if you: • have liver problems • have or think you have a genetic liver problem caused by a mitochondrial disorder e.g., Alpers-Huttenlocher syndrome • are allergic to divalproex sodium, valproic acid, sodium valproate, or any of the ingredients in divalproex sodium extended-release tablets.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0006126761\",\n \"SemanticContext\": \"Do not take divalproex sodium extended-release tablets if you: • have liver problems • have or think you have a genetic liver problem caused by a mitochondrial disorder e.g., Alpers-Huttenlocher syndrome • are allergic to divalproex sodium, valproic acid, sodium valproate, or any of the ingredients in divalproex sodium extended-release tablets.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"3.81336E-05\",\n \"SemanticContext\": \"See the end of this leaflet for a complete list of ingredients in divalproex sodium extended-release tablets.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"9.521E-07\",\n \"SemanticContext\": \"• have a genetic problem called urea cycle disorder • are taking it to prevent migraine headaches and are either pregnant or may become pregnant because you are not using effective birth control contraception What should I tell my healthcare provider before taking divalproex sodium extended-release tablets?\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"2.5179E-06\",\n \"SemanticContext\": \"Before you take divalproex sodium extended-release tablets, tell your healthcare provider if you: • have a genetic liver problem caused by a mitochondrial disorder e.g., Alpers-Huttenlocher syndrome • drink alcohol • are pregnant or breastfeeding.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"1.86439E-05\",\n \"SemanticContext\": \"Divalproex sodium can pass into breast milk.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"1.8772E-06\",\n \"SemanticContext\": \"Talk to your healthcare provider about the best way to feed your baby if you take divalproex sodium extended-release tablets.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"6.99675E-05\",\n \"SemanticContext\": \"Taking divalproex sodium extended-release tablets with certain other medicines can cause side effects or affect how well they work.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"1.53714E-05\",\n \"SemanticContext\": \"How should I take divalproex sodium extended-release tablets?\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0001652241\",\n \"SemanticContext\": \"• Take divalproex sodium extended-release tablets exactly as your healthcare provider tells you.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"6.442E-07\",\n \"SemanticContext\": \"Your healthcare provider will tell you how many divalproex sodium extended-release tablets to take and when to take them.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"6.1973E-06\",\n \"SemanticContext\": \"• Do not change your dose of divalproex sodium extended-release tablets without talking to your healthcare provider.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"1.6712E-06\",\n \"SemanticContext\": \"• Do not stop taking divalproex sodium extended-release tablets without first talking to your healthcare provider.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"3.33756E-05\",\n \"SemanticContext\": \"Stopping divalproex sodium extended-release tablets suddenly can cause serious problems.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"7.13841E-05\",\n \"SemanticContext\": \"• Swallow divalproex sodium extended-release tablets whole.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"2.2652E-05\",\n \"SemanticContext\": \"Do not crush or chew divalproex sodium extended-release tablets.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"7.277E-07\",\n \"SemanticContext\": \"Tell your healthcare provider if you cannot swallow divalproex sodium extended-release tablets whole.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"1.36492E-05\",\n \"SemanticContext\": \"• If you take too many divalproex sodium extended-release tablets, call your healthcare provider or local Poison Control Center right away.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"3.1714E-06\",\n \"SemanticContext\": \"What should I avoid while taking divalproex sodium extended-release tablets?\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0054807961\",\n \"SemanticContext\": \"• Divalproex sodium extended-release tablets can cause drowsiness and dizziness.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"7.043E-07\",\n \"SemanticContext\": \"Do not drink alcohol or take other medicines that make you sleepy or dizzy while taking divalproex sodium extended-release tablets, until you talk with your doctor.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"5.90701E-05\",\n \"SemanticContext\": \"Taking divalproex sodium extended-release tablets with alcohol or drugs that cause sleepiness or dizziness may make your sleepiness or dizziness worse.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"1.6285E-06\",\n \"SemanticContext\": \"• Do not drive a car or operate dangerous machinery until you know how divalproex sodium extended-release tablets affect you.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0001395047\",\n \"SemanticContext\": \"Divalproex sodium extended-release tablets can slow your thinking and motor skills.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"2.25756E-05\",\n \"SemanticContext\": \"What are the possible side effects of divalproex sodium extended-release tablets?\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"8.2512E-06\",\n \"SemanticContext\": \"• See “What is the most important information I should know about divalproex sodium extended-release tablets?”\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0033013523\",\n \"SemanticContext\": \"Divalproex sodium extended-release tablets can cause serious side effects including: • Bleeding problems: red or purple spots on your skin, bruising, pain and swelling into your joints due to bleeding or bleeding from your mouth or nose.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"9.2644E-06\",\n \"SemanticContext\": \"Your doctor may start you at a lower dose of divalproex sodium extended-release tablets.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0010730624\",\n \"SemanticContext\": \"The common side effects of divalproex sodium extended-release tablets include: • nausea • headache • sleepiness • vomiting • weakness • tremor • dizziness • stomach pain • blurry vision • double vision • diarrhea • increased appetite • weight gain • hair loss • loss of appetite • problems with walking or coordination These are not all of the possible side effects of divalproex sodium extended-release tablets .\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0002046824\",\n \"SemanticContext\": \"The common side effects of divalproex sodium extended-release tablets include: • nausea • headache • sleepiness • vomiting • weakness • tremor • dizziness • stomach pain • blurry vision • double vision • diarrhea • increased appetite • weight gain • hair loss • loss of appetite • problems with walking or coordination These are not all of the possible side effects of divalproex sodium extended-release tablets .\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0001450777\",\n \"SemanticContext\": \"How should I store divalproex sodium extended-release tablets?\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0005859435\",\n \"SemanticContext\": \"• Store divalproex sodium extended-release tablets between 20° to 25°C 68° to 77°F .\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0003105402\",\n \"SemanticContext\": \"Keep divalproex sodium extended-release tablets and all medicines out of the reach of children.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"7.00204E-05\",\n \"SemanticContext\": \"General information about the safe and effective use of divalproex sodium extended-release tablets Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"3.5986E-06\",\n \"SemanticContext\": \"Do not use divalproex sodium extended-release tablets for a condition for which they were not prescribed.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"6.032E-06\",\n \"SemanticContext\": \"Do not give divalproex sodium extended-release tablets to other people, even if they have the same symptoms that you have.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"3.40218E-05\",\n \"SemanticContext\": \"This Medication Guide summarizes the most important information about divalproex sodium extended-release tablets.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"2.4682E-06\",\n \"SemanticContext\": \"You can ask your pharmacist or healthcare provider for information about divalproex sodium extended-release tablets that is written for health professionals.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0034464598\",\n \"SemanticContext\": \"What are the ingredients in divalproex sodium extended-release tablets?\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0002090335\",\n \"SemanticContext\": \"Active ingredient: divalproex sodium Inactive ingredients: ammonium hydroxide, colloidal anhydrous silica, colloidal silicon dioxide, dibutyl sebacate, ethylcellulose, hydroxyethyl cellulose, hypromellose, oleic acid, polydextrose, polyethylene glycol, silicified microcrystalline cellulose, titanium dioxide and triacetin.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"7.50563E-05\",\n \"SemanticContext\": \"There are no data to assess the effects of divalproex sodium delayed-release tablets on milk production or excretion.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"2.50528E-05\",\n \"SemanticContext\": \"\\n Clinical Considerations The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for divalproex sodium delayed-release tablets and any potential adverse effects on the breastfed infant from divalproex sodium delayed-release tablets or from the underlying maternal condition.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"2.28709E-05\",\n \"SemanticContext\": \"\\n Clinical Considerations The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for divalproex sodium delayed-release tablets and any potential adverse effects on the breastfed infant from divalproex sodium delayed-release tablets or from the underlying maternal condition.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"6.63971E-05\",\n \"SemanticContext\": \"When divalproex sodium extended-release tablets are used in this patient group, it should be used with extreme caution and as a sole agent.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0001526773\",\n \"SemanticContext\": \"\\n \\n Pediatric Clinical Trials\\n Divalproex sodium delayed-release tablets were studied in seven pediatric clinical trials.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"5.89443E-05\",\n \"SemanticContext\": \"Two of the pediatric studies were double-blinded placebo-controlled trials to evaluate the efficacy of divalproex sodium extended-release tablets for the indications of mania 150 patients aged 10 to 17 years, 76 of whom were on divalproex sodium extended-release tablets and migraine 304 patients aged 12 to 17 years, 231 of whom were on divalproex sodium extended-release tablets .\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.000223577\",\n \"SemanticContext\": \"Two of the pediatric studies were double-blinded placebo-controlled trials to evaluate the efficacy of divalproex sodium extended-release tablets for the indications of mania 150 patients aged 10 to 17 years, 76 of whom were on divalproex sodium extended-release tablets and migraine 304 patients aged 12 to 17 years, 231 of whom were on divalproex sodium extended-release tablets .\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0014825761\",\n \"SemanticContext\": \"Two of the pediatric studies were double-blinded placebo-controlled trials to evaluate the efficacy of divalproex sodium extended-release tablets for the indications of mania 150 patients aged 10 to 17 years, 76 of whom were on divalproex sodium extended-release tablets and migraine 304 patients aged 12 to 17 years, 231 of whom were on divalproex sodium extended-release tablets .\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0009412169\",\n \"SemanticContext\": \"Two six-month pediatric studies were conducted to evaluate the long-term safety of divalproex sodium extended-release tablets for the indication of mania 292 patients aged 10 to 17 years .\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0012792945\",\n \"SemanticContext\": \"Two twelve-month pediatric studies were conducted to evaluate the long-term safety of divalproex sodium extended-release tablets for the indication of migraine 353 patients aged 12 to 17 years .\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.00020051\",\n \"SemanticContext\": \"One twelve-month study was conducted to evaluate the safety of divalproex sodium delayed-release capsules in the indication of partial seizures 169 patients aged 3 to 10 years .\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0007611513\",\n \"SemanticContext\": \"In these seven clinical trials, the safety and tolerability of divalproex sodium delayed-release tablets in pediatric patients were shown to be comparable to those in adults [see Adverse Reactions 6 ] .\"\n },\n {\n \"VerbatimTerm\": \"Sodium\",\n \"Probability\": \"0.0010531843\",\n \"SemanticContext\": \"Adverse Reactions Reported by > 5% of Divalproex Sodium Extended-Release Tablets-Treated Patients During Placebo-Controlled Trials of Acute Mania The following adverse reactions/event occurred at an equal or greater incidence for placebo than for divalproex sodium extended-release tablets: headache.\"\n },\n {\n \"VerbatimTerm\": \"Sodium\",\n \"Probability\": \"0.0015843213\",\n \"SemanticContext\": \"Adverse Event Divalproex Sodium Extended-Release Tablets n = 338 % Placebo n = 263 % Somnolence 26 14 Dyspepsia 23 11 Nausea 19 13 Vomiting 13 5 Diarrhea 12 8 Dizziness 12 7 Pain 11 10 Abdominal Pain 10 5 Accidental Injury 6 5 Asthenia 6 5 Pharyngitis 6 5 .\"\n },\n {\n \"VerbatimTerm\": \"Sodium\",\n \"Probability\": \"0.0049470365\",\n \"SemanticContext\": \"Adverse Reactions Reported by = 5% of Patients Treated with Valproate During Placebo-Controlled Trial of Adjunctive Therapy for Complex Partial Seizures Body System/Event Divalproex Sodium Delayed- Release Tablets N = 77 % Placebo N = 70 % Body as a Whole Headache 31 21 Asthenia 27 7 Fever 6 4 Gastrointestinal System Nausea 48 14 Vomiting 27 7 Abdominal Pain 23 6 Diarrhea 13 6 Anorexia 12 0 Dyspepsia 8 4 Constipation 5 1 Nervous System Somnolence 27 11 Tremor 25 6 Dizziness 25 13 Diplopia 16 9 Amblyopia/Blurred Vision 12 9 Ataxia 8 1 Nystagmus 8 1 Emotional Lability 6 4 Thinking Abnormal 6 0 Amnesia 5 1 Respiratory System Flu Syndrome 12 9 Infection 12 6 Bronchitis 5 1 Rhinitis 5 4 Other Alopecia 6 1 Weight Loss 6 0 .\"\n },\n {\n \"VerbatimTerm\": \"Sodium\",\n \"Probability\": \"0.0012609959\",\n \"SemanticContext\": \"Adverse Reactions Reported by > 5% of Divalproex Sodium Extended-Release Tablets-Treated Patients During the Migraine Placebo-Controlled Trial with a Greater Incidence than Patients Taking Placebo The following adverse reactions occurred in greater than 5% of divalproex sodium extended-release tablets-treated patients and at a greater incidence for placebo than for divalproex sodium extended-release tablets: asthenia and flu syndrome.\"\n },\n {\n \"VerbatimTerm\": \"Sodium\",\n \"Probability\": \"0.0021958649\",\n \"SemanticContext\": \"Body System Event Divalproex Sodium Extended-Release Tablets n = 122 % Placebo n = 115 % Gastrointestinal System Nausea 15 9 Dyspepsia 7 4 Diarrhea 7 3 Vomiting 7 2 Abdominal Pain 7 5 Nervous System Somnolence 7 2 Other Infection 15 14 .\"\n },\n {\n \"VerbatimTerm\": \"Sodium\",\n \"Probability\": \"0.0017828047\",\n \"SemanticContext\": \"Body System Reaction Divalproex Sodium Delayed-Release Tablets n = 202 % Placebo n = 81 % Gastrointestinal System Nausea 31 10 Dyspepsia 13 9 Diarrhea 12 7 Vomiting 11 1 Abdominal Pain 9 4 Increased Appetite 6 4 Nervous System Asthenia 20 9 Somnolence 17 5 Dizziness 12 6 Tremor 9 0 Other Weight Gain 8 2 Back Pain 8 6 Alopecia 7 1 .\"\n },\n {\n \"VerbatimTerm\": \"Sodium\",\n \"Probability\": \"0.0002192259\",\n \"SemanticContext\": \"Divalproex Sodium Structural Formula 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Divalproex sodium dissociates to the valproate ion in the gastrointestinal tract.\"\n },\n {\n \"VerbatimTerm\": \"Sodium\",\n \"Probability\": \"0.006590426\",\n \"SemanticContext\": \"Conversion from Divalproex Sodium Delayed-Release Tablets to Divalproex Sodium Extended-Release Tablets When divalproex sodium extended-release tablets are given in doses 8 to 20% higher than the total daily dose of divalproex sodium delayed-release tablets, the two formulations are bioequivalent.\"\n },\n {\n \"VerbatimTerm\": \"Sodium\",\n \"Probability\": \"0.0021954179\",\n \"SemanticContext\": \"Conversion from Divalproex Sodium Delayed-Release Tablets to Divalproex Sodium Extended-Release Tablets When divalproex sodium extended-release tablets are given in doses 8 to 20% higher than the total daily dose of divalproex sodium delayed-release tablets, the two formulations are bioequivalent.\"\n },\n {\n \"VerbatimTerm\": \"Sodium\",\n \"Probability\": \"0.0042236149\",\n \"SemanticContext\": \"Bioavailability of Divalproex Sodium Extended-Release Tablets Relative to Divalproex Sodium Delayed-Release Tablets When Divalproex Sodium Extended-Release Tablets Dose is 8 to 20% Higher Study Population Regimens Relative Bioavailability Divalproex Sodium Extended-Release Tablets vs. Divalproex Sodium Delayed-Release Tablets AUC 24 C max C min Healthy Volunteers N = 35 1,000 & 1,500 mg Divalproex Sodium Extended-Release Tablets vs. 875 & 1,250 mg Divalproex Sodium Delayed-Release Tablets 1.059 0.882 1.173 Patients with epilepsy on concomitant enzyme- inducing antiepilepsy drugs N = 64 1,000 to 5,000 mg Divalproex Sodium Extended-Release Tablets vs. 875 to 4,250 mg Divalproex Sodium Delayed-Release Tablets 1.008 0.899 1.022 .\"\n },\n {\n \"VerbatimTerm\": \"Sodium\",\n \"Probability\": \"0.001591444\",\n \"SemanticContext\": \"Bioavailability of Divalproex Sodium Extended-Release Tablets Relative to Divalproex Sodium Delayed-Release Tablets When Divalproex Sodium Extended-Release Tablets Dose is 8 to 20% Higher Study Population Regimens Relative Bioavailability Divalproex Sodium Extended-Release Tablets vs. Divalproex Sodium Delayed-Release Tablets AUC 24 C max C min Healthy Volunteers N = 35 1,000 & 1,500 mg Divalproex Sodium Extended-Release Tablets vs. 875 & 1,250 mg Divalproex Sodium Delayed-Release Tablets 1.059 0.882 1.173 Patients with epilepsy on concomitant enzyme- inducing antiepilepsy drugs N = 64 1,000 to 5,000 mg Divalproex Sodium Extended-Release Tablets vs. 875 to 4,250 mg Divalproex Sodium Delayed-Release Tablets 1.008 0.899 1.022 .\"\n },\n {\n \"VerbatimTerm\": \"Sodium\",\n \"Probability\": \"0.0011775494\",\n \"SemanticContext\": \"Bioavailability of Divalproex Sodium Extended-Release Tablets Relative to Divalproex Sodium Delayed-Release Tablets When Divalproex Sodium Extended-Release Tablets Dose is 8 to 20% Higher Study Population Regimens Relative Bioavailability Divalproex Sodium Extended-Release Tablets vs. Divalproex Sodium Delayed-Release Tablets AUC 24 C max C min Healthy Volunteers N = 35 1,000 & 1,500 mg Divalproex Sodium Extended-Release Tablets vs. 875 & 1,250 mg Divalproex Sodium Delayed-Release Tablets 1.059 0.882 1.173 Patients with epilepsy on concomitant enzyme- inducing antiepilepsy drugs N = 64 1,000 to 5,000 mg Divalproex Sodium Extended-Release Tablets vs. 875 to 4,250 mg Divalproex Sodium Delayed-Release Tablets 1.008 0.899 1.022 .\"\n },\n {\n \"VerbatimTerm\": \"Sodium\",\n \"Probability\": \"0.0012516081\",\n \"SemanticContext\": \"Bioavailability of Divalproex Sodium Extended-Release Tablets Relative to Divalproex Sodium Delayed-Release Tablets When Divalproex Sodium Extended-Release Tablets Dose is 8 to 20% Higher Study Population Regimens Relative Bioavailability Divalproex Sodium Extended-Release Tablets vs. Divalproex Sodium Delayed-Release Tablets AUC 24 C max C min Healthy Volunteers N = 35 1,000 & 1,500 mg Divalproex Sodium Extended-Release Tablets vs. 875 & 1,250 mg Divalproex Sodium Delayed-Release Tablets 1.059 0.882 1.173 Patients with epilepsy on concomitant enzyme- inducing antiepilepsy drugs N = 64 1,000 to 5,000 mg Divalproex Sodium Extended-Release Tablets vs. 875 to 4,250 mg Divalproex Sodium Delayed-Release Tablets 1.008 0.899 1.022 .\"\n },\n {\n \"VerbatimTerm\": \"Sodium\",\n \"Probability\": \"0.001722157\",\n \"SemanticContext\": \"Bioavailability of Divalproex Sodium Extended-Release Tablets Relative to Divalproex Sodium Delayed-Release Tablets When Divalproex Sodium Extended-Release Tablets Dose is 8 to 20% Higher Study Population Regimens Relative Bioavailability Divalproex Sodium Extended-Release Tablets vs. Divalproex Sodium Delayed-Release Tablets AUC 24 C max C min Healthy Volunteers N = 35 1,000 & 1,500 mg Divalproex Sodium Extended-Release Tablets vs. 875 & 1,250 mg Divalproex Sodium Delayed-Release Tablets 1.059 0.882 1.173 Patients with epilepsy on concomitant enzyme- inducing antiepilepsy drugs N = 64 1,000 to 5,000 mg Divalproex Sodium Extended-Release Tablets vs. 875 to 4,250 mg Divalproex Sodium Delayed-Release Tablets 1.008 0.899 1.022 .\"\n },\n {\n \"VerbatimTerm\": \"Sodium\",\n \"Probability\": \"0.0037840903\",\n \"SemanticContext\": \"Bioavailability of Divalproex Sodium Extended-Release Tablets Relative to Divalproex Sodium Delayed-Release Tablets When Divalproex Sodium Extended-Release Tablets Dose is 8 to 20% Higher Study Population Regimens Relative Bioavailability Divalproex Sodium Extended-Release Tablets vs. Divalproex Sodium Delayed-Release Tablets AUC 24 C max C min Healthy Volunteers N = 35 1,000 & 1,500 mg Divalproex Sodium Extended-Release Tablets vs. 875 & 1,250 mg Divalproex Sodium Delayed-Release Tablets 1.059 0.882 1.173 Patients with epilepsy on concomitant enzyme- inducing antiepilepsy drugs N = 64 1,000 to 5,000 mg Divalproex Sodium Extended-Release Tablets vs. 875 to 4,250 mg Divalproex Sodium Delayed-Release Tablets 1.008 0.899 1.022 .\"\n },\n {\n \"VerbatimTerm\": \"Sodium\",\n \"Probability\": \"0.0005382001\",\n \"SemanticContext\": \"Bioavailability of Divalproex Sodium Extended-Release Tablets Relative to Divalproex Sodium Delayed-Release Tablets When Divalproex Sodium Extended-Release Tablets Dose is 8 to 20% Higher Study Population Regimens Relative Bioavailability Divalproex Sodium Extended-Release Tablets vs. Divalproex Sodium Delayed-Release Tablets AUC 24 C max C min Healthy Volunteers N = 35 1,000 & 1,500 mg Divalproex Sodium Extended-Release Tablets vs. 875 & 1,250 mg Divalproex Sodium Delayed-Release Tablets 1.059 0.882 1.173 Patients with epilepsy on concomitant enzyme- inducing antiepilepsy drugs N = 64 1,000 to 5,000 mg Divalproex Sodium Extended-Release Tablets vs. 875 to 4,250 mg Divalproex Sodium Delayed-Release Tablets 1.008 0.899 1.022 .\"\n },\n {\n \"VerbatimTerm\": \"Sodium\",\n \"Probability\": \"0.00431633\",\n \"SemanticContext\": \"Bioavailability of Divalproex Sodium Extended-Release Tablets Relative to Divalproex Sodium Delayed-Release Tablets When Divalproex Sodium Extended-Release Tablets Dose is 8 to 20% Higher Study Population Regimens Relative Bioavailability Divalproex Sodium Extended-Release Tablets vs. Divalproex Sodium Delayed-Release Tablets AUC 24 C max C min Healthy Volunteers N = 35 1,000 & 1,500 mg Divalproex Sodium Extended-Release Tablets vs. 875 & 1,250 mg Divalproex Sodium Delayed-Release Tablets 1.059 0.882 1.173 Patients with epilepsy on concomitant enzyme- inducing antiepilepsy drugs N = 64 1,000 to 5,000 mg Divalproex Sodium Extended-Release Tablets vs. 875 to 4,250 mg Divalproex Sodium Delayed-Release Tablets 1.008 0.899 1.022 .\"\n },\n {\n \"VerbatimTerm\": \"Sodium\",\n \"Probability\": \"0.0012958944\",\n \"SemanticContext\": \"Bioavailability of Divalproex Sodium Extended-Release Tablets Relative to Divalproex Sodium Delayed-Release Tablets When Divalproex Sodium Extended-Release Tablets Dose is 8 to 20% Higher Study Population Regimens Relative Bioavailability Divalproex Sodium Extended-Release Tablets vs. Divalproex Sodium Delayed-Release Tablets AUC 24 C max C min Healthy Volunteers N = 35 1,000 & 1,500 mg Divalproex Sodium Extended-Release Tablets vs. 875 & 1,250 mg Divalproex Sodium Delayed-Release Tablets 1.059 0.882 1.173 Patients with epilepsy on concomitant enzyme- inducing antiepilepsy drugs N = 64 1,000 to 5,000 mg Divalproex Sodium Extended-Release Tablets vs. 875 to 4,250 mg Divalproex Sodium Delayed-Release Tablets 1.008 0.899 1.022 .\"\n },\n {\n \"VerbatimTerm\": \"Sodium\",\n \"Probability\": \"0.0013999343\",\n \"SemanticContext\": \"Adjunctive Therapy Study Median Incidence of CPS per 8 Weeks Add-on Treatment Number of Patients Baseline Incidence Experimental Incidence Divalproex Sodium Delayed-Release Tablets 75 16.0 8.9 Reduction from baseline statistically significantly greater for valproate than placebo at p = 0.05 level.\"\n },\n {\n \"VerbatimTerm\": \"Sodium\",\n \"Probability\": \"0.0042876005\",\n \"SemanticContext\": \"2.4 Conversion from Divalproex Sodium Delayed-Release Tablets to Divalproex Sodium Extended-Release Tablets In adult patients and pediatric patients 10 years of age or older with epilepsy previously receiving divalproex sodium delayed-release tablets, divalproex sodium extended-release tablets should be administered once-daily using a dose 8 to 20% higher than the total daily dose of divalproex sodium delayed-release tablets Table 1 .\"\n },\n {\n \"VerbatimTerm\": \"Sodium\",\n \"Probability\": \"0.0015136898\",\n \"SemanticContext\": \"2.4 Conversion from Divalproex Sodium Delayed-Release Tablets to Divalproex Sodium Extended-Release Tablets In adult patients and pediatric patients 10 years of age or older with epilepsy previously receiving divalproex sodium delayed-release tablets, divalproex sodium extended-release tablets should be administered once-daily using a dose 8 to 20% higher than the total daily dose of divalproex sodium delayed-release tablets Table 1 .\"\n },\n {\n \"VerbatimTerm\": \"Sodium\",\n \"Probability\": \"0.0018637776\",\n \"SemanticContext\": \"Dose Conversion Divalproex Sodium Delayed-Release Tablets Total Daily Dose mg Divalproex Sodium Extended-Release Tablets mg 500 These total daily doses of divalproex sodium delayed-release tablets cannot be directly converted to an 8 to 20% higher total daily dose of divalproex sodium extended-release tablets because the required dosing strengths of divalproex sodium extended-release tablets are not available.\"\n },\n {\n \"VerbatimTerm\": \"Sodium\",\n \"Probability\": \"0.0003483295\",\n \"SemanticContext\": \"Dose Conversion Divalproex Sodium Delayed-Release Tablets Total Daily Dose mg Divalproex Sodium Extended-Release Tablets mg 500 These total daily doses of divalproex sodium delayed-release tablets cannot be directly converted to an 8 to 20% higher total daily dose of divalproex sodium extended-release tablets because the required dosing strengths of divalproex sodium extended-release tablets are not available.\"\n },\n {\n \"VerbatimTerm\": \"Sodium\",\n \"Probability\": \"0.0039240718\",\n \"SemanticContext\": \"3 DOSAGE FORMS AND STRENGTHS Divalproex Sodium Extended-Release Tablets, USP are available containing divalproex sodium, USP equivalent to 250 mg or 500 mg of valproic acid.\"\n },\n {\n \"VerbatimTerm\": \"Sodium\",\n \"Probability\": \"0.0012040138\",\n \"SemanticContext\": \"Medication Guide Divalproex Sodium Extended-Release Tablets, USP dye val' proe ex soe' dee um Read this Medication Guide before you start taking divalproex sodium extended-release tablets and each time you get a refill.\"\n },\n {\n \"VerbatimTerm\": \"Sodium\",\n \"Probability\": \"0.0024767518\",\n \"SemanticContext\": \"Divalproex Sodium Extended-Release Tablets are prescription medicines used: • to treat manic episodes associated with bipolar disorder • alone or with other medicines to treat: • complex partial seizures in adults and children 10 years of age and older • simple and complex absence seizures, with or without other seizure types • to prevent migraine headaches Who should not take divalproex sodium extended-release tablets?\"\n }\n ]\n },\n {\n \"Term\": \"Inflammation\",\n \"MEDDRACode\": \"10061218\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Inflammation\",\n \"Probability\": \"0.0574619472\",\n \"SemanticContext\": \"Inflammation of your pancreas that can cause death.\"\n }\n ]\n },\n {\n \"Term\": \"Haemoperfusion\",\n \"MEDDRACode\": \"10067395\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hemoperfusion\",\n \"Probability\": \"0.0008619428\",\n \"SemanticContext\": \"In overdose situations, the fraction of drug not bound to protein is high and hemodialysis or tandem hemodialysis plus hemoperfusion may result in significant removal of drug.\"\n }\n ]\n },\n {\n \"Term\": \"Ammonia increased\",\n \"MEDDRACode\": \"10001946\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"increased ammonia\",\n \"Probability\": \"0.9959754944\",\n \"SemanticContext\": \"The most common drug-related adverse reactions reported > 5% and twice the rate of placebo reported in the controlled pediatric mania study were nausea, upper abdominal pain, somnolence, increased ammonia, gastritis and rash.\"\n }\n ]\n },\n {\n \"Term\": \"Nephropathy toxic\",\n \"MEDDRACode\": \"10029155\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"nephrotoxicity\",\n \"Probability\": \"0.1291068792\",\n \"SemanticContext\": \"\\n \\n Juvenile Animal Toxicology\\n In studies of valproate in immature animals, toxic effects not observed in adult animals included retinal dysplasia in rats treated during the neonatal period from postnatal day 4 and nephrotoxicity in rats treated during the neonatal and juvenile from postnatal day 14 periods.\"\n }\n ]\n },\n {\n \"Term\": \"Hepatotoxicity\",\n \"MEDDRACode\": \"10019851\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Hepatotoxicity\",\n \"Probability\": \"0.9297802448\",\n \"SemanticContext\": \"DIVALPROEX SODIUM extended-release tablets, for oral use Initial U.S. Approval: 2000 WARNING: LIFE THREATENING ADVERSE REACTIONS See full prescribing information for complete boxed warning • Hepatotoxicity, including fatalities, usually during the first 6 months of treatment.\"\n },\n {\n \"VerbatimTerm\": \"Hepatotoxicity\",\n \"Probability\": \"0.7499395013\",\n \"SemanticContext\": \"POLG 4 , 5.1 • Suspected POLG-related disorder in children under two years of age 4 , 5.1 • Known hypersensitivity to the drug 4 , 5.12 • Urea cycle disorders 4 , 5.6 • Prophylaxis of migraine headaches: Pregnant women, women of childbearing potential not using effective contraception 4 , 8.1 WARNINGS AND PRECAUTIONS • Hepatotoxicity; evaluate high risk populations and monitor serum liver tests 5.1 • Birth defects, decreased IQ, and neurodevelopmental disorders following in utero exposure; should not be used to treat women with epilepsy or bipolar disorder who are pregnant or who plan to become pregnant or to treat a woman of childbearing potential unless other medications have failed to provide adequate symptom control or are otherwise unacceptable 5.2 , 5.3 , 5.4 • Pancreatitis; divalproex sodium extended-release tablets should ordinarily be discontinued 5.5 • Suicidal behavior or ideation; Antiepileptic drugs, including divalproex sodium extended-release tablets, increase the risk of suicidal thoughts or behavior 5.7 • Bleeding and other hematopoietic disorders; monitor platelet counts and coagulation tests 5.8 • Hyperammonemia and hyperammonemic encephalopathy; measure ammonia level if unexplained lethargy and vomiting or changes in mental status, and also with concomitant topiramate use; consider discontinuation of valproate therapy 5.6 , 5.9 , 5.10 • Hypothermia; Hypothermia has been reported during valproate therapy with or without associated hyperammonemia.\"\n },\n {\n \"VerbatimTerm\": \"Hepatotoxicity\",\n \"Probability\": \"0.3628948331\",\n \"SemanticContext\": \"Hepatotoxicity: Warn patients and guardians that nausea, vomiting, abdominal pain, anorexia, diarrhea, asthenia, and/or jaundice can be symptoms of hepatotoxicity and, therefore, require further medical evaluation promptly [see Warnings and Precautions 5.1 ] .\"\n },\n {\n \"VerbatimTerm\": \"Hepatotoxicity\",\n \"Probability\": \"0.9912317991\",\n \"SemanticContext\": \"5 WARNINGS AND PRECAUTIONS 5.1 Hepatotoxicity\\n \\n General Information on Hepatotoxicity\\n Hepatic failure resulting in fatalities has occurred in patients receiving valproate.\"\n },\n {\n \"VerbatimTerm\": \"Hepatotoxicity\",\n \"Probability\": \"0.995629549\",\n \"SemanticContext\": \"5 WARNINGS AND PRECAUTIONS 5.1 Hepatotoxicity\\n \\n General Information on Hepatotoxicity\\n Hepatic failure resulting in fatalities has occurred in patients receiving valproate.\"\n },\n {\n \"VerbatimTerm\": \"hepatotoxicity\",\n \"Probability\": \"0.9791493416\",\n \"SemanticContext\": \"Therefore increased monitoring of valproate and concomitant drug concentrations and dosage adjustment are indicated whenever enzyme-inducing or inhibiting drugs are introduced or withdrawn 7.1 • Aspirin, carbapenem antibiotics, estrogen-containing hormonal contraceptives: Monitoring of valproate concentrations is recommended 7.1 • Co-administration of valproate can affect the pharmacokinetics of other drugs e.g., diazepam, ethosuximide, lamotrigine, phenytoin by inhibiting their metabolism or protein binding displacement 7.2 • Patients stabilized on rufinamide should begin valproate therapy at a low dose, and titrate to clinically effective dose 7.2 • Dosage adjustment of amitriptyline/nortriptyline, propofol, warfarin, and zidovudine may be necessary if used concomitantly with divalproex sodium extended-release tablets 7.2 • Topiramate: Hyperammonemia and encephalopathy 5.10 , 7.3 USE IN SPECIFIC POPULATIONS • Pregnancy: Divalproex sodium extended-release tablets can cause congenital malformations including neural tube defects, decreased IQ, and neurodevelopmental disorders 5.2 , 5.3 , 8.1 • Pediatric: Children under the age of two years are at considerably higher risk of fatal hepatotoxicity 5.1 , 8.4 • Geriatric: Reduce starting dose; increase dosage more slowly; monitor fluid and nutritional intake, and somnolence 5.14 , 8.5 See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.\"\n },\n {\n \"VerbatimTerm\": \"hepatotoxicity\",\n \"Probability\": \"0.4483152628\",\n \"SemanticContext\": \"Hepatotoxicity: Warn patients and guardians that nausea, vomiting, abdominal pain, anorexia, diarrhea, asthenia, and/or jaundice can be symptoms of hepatotoxicity and, therefore, require further medical evaluation promptly [see Warnings and Precautions 5.1 ] .\"\n },\n {\n \"VerbatimTerm\": \"hepatotoxicity\",\n \"Probability\": \"0.850551784\",\n \"SemanticContext\": \"Serious or fatal hepatotoxicity may be preceded by non-specific symptoms such as malaise, weakness, lethargy, facial edema, anorexia, and vomiting.\"\n },\n {\n \"VerbatimTerm\": \"hepatotoxicity\",\n \"Probability\": \"0.8688514233\",\n \"SemanticContext\": \"Experience has indicated that children under the age of two years are at a considerably increased risk of developing fatal hepatotoxicity, especially those with the aforementioned conditions.\"\n },\n {\n \"VerbatimTerm\": \"hepatotoxicity\",\n \"Probability\": \"0.7602065206\",\n \"SemanticContext\": \"In progressively older patient groups experience in epilepsy has indicated that the incidence of fatal hepatotoxicity decreases considerably.\"\n },\n {\n \"VerbatimTerm\": \"hepatotoxicity\",\n \"Probability\": \"0.9460277557\",\n \"SemanticContext\": \"8.4 Pediatric Use Experience has indicated that pediatric patients under the age of two years are at a considerably increased risk of developing fatal hepatotoxicity, especially those with the aforementioned conditions [see Boxed Warning and Warnings and Precautions 5.1 ] .\"\n },\n {\n \"VerbatimTerm\": \"hepatotoxicity\",\n \"Probability\": \"0.9188592434\",\n \"SemanticContext\": \"Above the age of 2 years, experience in epilepsy has indicated that the incidence of fatal hepatotoxicity decreases considerably in progressively older patient groups.\"\n }\n ]\n },\n {\n \"Term\": \"Neural tube defect\",\n \"MEDDRACode\": \"10052046\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"neural tube defects\",\n \"Probability\": \"0.0016273856\",\n \"SemanticContext\": \"Monitor patients closely, and perform serum liver testing prior to therapy and at frequent intervals thereafter 5.1 • Fetal Risk, particularly neural tube defects, other major malformations, and decreased IQ 5.2 , 5.3 , 5.4 • Pancreatitis, including fatal hemorrhagic cases 5.5 INDICATIONS AND USAGE Divalproex sodium extended-release tablets are indicated for: .\"\n },\n {\n \"VerbatimTerm\": \"neural tube defects\",\n \"Probability\": \"0.138079077\",\n \"SemanticContext\": \"Therefore increased monitoring of valproate and concomitant drug concentrations and dosage adjustment are indicated whenever enzyme-inducing or inhibiting drugs are introduced or withdrawn 7.1 • Aspirin, carbapenem antibiotics, estrogen-containing hormonal contraceptives: Monitoring of valproate concentrations is recommended 7.1 • Co-administration of valproate can affect the pharmacokinetics of other drugs e.g., diazepam, ethosuximide, lamotrigine, phenytoin by inhibiting their metabolism or protein binding displacement 7.2 • Patients stabilized on rufinamide should begin valproate therapy at a low dose, and titrate to clinically effective dose 7.2 • Dosage adjustment of amitriptyline/nortriptyline, propofol, warfarin, and zidovudine may be necessary if used concomitantly with divalproex sodium extended-release tablets 7.2 • Topiramate: Hyperammonemia and encephalopathy 5.10 , 7.3 USE IN SPECIFIC POPULATIONS • Pregnancy: Divalproex sodium extended-release tablets can cause congenital malformations including neural tube defects, decreased IQ, and neurodevelopmental disorders 5.2 , 5.3 , 8.1 • Pediatric: Children under the age of two years are at considerably higher risk of fatal hepatotoxicity 5.1 , 8.4 • Geriatric: Reduce starting dose; increase dosage more slowly; monitor fluid and nutritional intake, and somnolence 5.14 , 8.5 See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.\"\n },\n {\n \"VerbatimTerm\": \"neural tube defects\",\n \"Probability\": \"0.0107966065\",\n \"SemanticContext\": \"1.4 Important Limitations Because of the risk to the fetus of decreased IQ, neurodevelopmental disorders, neural tube defects, and other major congenital malformations, which may occur very early in pregnancy, valproate should not be used to treat women with epilepsy or bipolar disorder who are pregnant or who plan to become pregnant unless other medications have failed to provide adequate symptom control or are otherwise unacceptable.\"\n },\n {\n \"VerbatimTerm\": \"neural tube defects\",\n \"Probability\": \"0.0511983931\",\n \"SemanticContext\": \"Maternal valproate use during pregnancy for any indication increases the risk of congenital malformations, particularly neural tube defects including spina bifida, but also malformations involving other body systems e.g., craniofacial defects including oral clefts, cardiovascular malformations, hypospadias, limb malformations .\"\n },\n {\n \"VerbatimTerm\": \"neural tube defects\",\n \"Probability\": \"0.0076093972\",\n \"SemanticContext\": \"Evidence suggests that folic acid supplementation prior to conception and during the first trimester of pregnancy decreases the risk for congenital neural tube defects in the general population.\"\n },\n {\n \"VerbatimTerm\": \"neural tube defects\",\n \"Probability\": \"0.0037229359\",\n \"SemanticContext\": \"It is not known whether the risk of neural tube defects or decreased IQ in the offspring of women receiving valproate is reduced by folic acid supplementation.\"\n },\n {\n \"VerbatimTerm\": \"neural tube defects\",\n \"Probability\": \"0.0216173828\",\n \"SemanticContext\": \"\\n \\n Data\\n Human\\n Neural Tube Defects and Other Structural Abnormalities\\n There is an extensive body of evidence demonstrating that exposure to valproate in utero increases the risk of neural tube defects and other structural abnormalities.\"\n },\n {\n \"VerbatimTerm\": \"neural tube defects\",\n \"Probability\": \"0.0835230649\",\n \"SemanticContext\": \"The major congenital malformations included cases of neural tube defects, cardiovascular malformations, craniofacial defects e.g., oral clefts, craniosynostosis , hypospadias, limb malformations e.g., clubfoot, polydactyly , and other malformations of varying severity involving other body systems [see Warnings and Precautions 5.2 ] .\"\n },\n {\n \"VerbatimTerm\": \"neural tube defects\",\n \"Probability\": \"0.0641598403\",\n \"SemanticContext\": \"In mice, in addition to other malformations, fetal neural tube defects have been reported following valproate administration during critical periods of organogenesis, and the teratogenic response correlated with peak maternal drug levels.\"\n },\n {\n \"VerbatimTerm\": \"neural tube defects\",\n \"Probability\": \"0.0041614473\",\n \"SemanticContext\": \"Pregnancy registry data show that maternal valproate use can cause neural tube defects and other structural abnormalities e.g., craniofacial defects, cardiovascular malformations, hypospadias, limb malformations .\"\n },\n {\n \"VerbatimTerm\": \"neural tube defects\",\n \"Probability\": \"0.0056136847\",\n \"SemanticContext\": \"Evidence suggests that folic acid supplementation prior to conception and during the first trimester of pregnancy decreases the risk for congenital neural tube defects in the general population [see Use in Specific Populations 8.1 ] .\"\n },\n {\n \"VerbatimTerm\": \"neural tube defects\",\n \"Probability\": \"0.0266726017\",\n \"SemanticContext\": \"5.4 Use in Women of Childbearing Potential Because of the risk to the fetus of decreased IQ, neurodevelopmental disorders, and major congenital malformations including neural tube defects , which may occur very early in pregnancy, valproate should not be administered to a woman of childbearing potential unless other medications have failed to provide adequate symptom control or are otherwise unacceptable.\"\n },\n {\n \"VerbatimTerm\": \"neural tube defects\",\n \"Probability\": \"0.0076093972\",\n \"SemanticContext\": \"Evidence suggests that folic acid supplementation prior to conception and during the first trimester of pregnancy decreases the risk for congenital neural tube defects in the general population.\"\n },\n {\n \"VerbatimTerm\": \"neural tube defects\",\n \"Probability\": \"0.0037229359\",\n \"SemanticContext\": \"It is not known whether the risk of neural tube defects or decreased IQ in the offspring of women receiving valproate is reduced by folic acid supplementation.\"\n },\n {\n \"VerbatimTerm\": \"neural tube defects\",\n \"Probability\": \"0.0034258962\",\n \"SemanticContext\": \"• If you take divalproex sodium extended-release tablets during pregnancy for any medical condition, your baby is at risk for serious birth defects that affect the brain and spinal cord and are called spina bifida or neural tube defects.\"\n },\n {\n \"VerbatimTerm\": \"Neural Tube Defects\",\n \"Probability\": \"0.0024042726\",\n \"SemanticContext\": \"\\n \\n Data\\n Human\\n Neural Tube Defects and Other Structural Abnormalities\\n There is an extensive body of evidence demonstrating that exposure to valproate in utero increases the risk of neural tube defects and other structural abnormalities.\"\n },\n {\n \"VerbatimTerm\": \"neural tube defect\",\n \"Probability\": \"0.0020681024\",\n \"SemanticContext\": \"• Taking folic acid supplements before getting pregnant and during early pregnancy can lower the chance of having a baby with a neural tube defect.\"\n }\n ]\n },\n {\n \"Term\": \"Pressure of speech\",\n \"MEDDRACode\": \"10036649\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"pressure of speech\",\n \"Probability\": \"0.0128978789\",\n \"SemanticContext\": \"Typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, poor judgment, aggressiveness, and possible hostility.\"\n }\n ]\n },\n {\n \"Term\": \"Attention deficit hyperactivity disorder\",\n \"MEDDRACode\": \"10083622\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"attention deficit/hyperactivity disorder\",\n \"Probability\": \"0.0432600677\",\n \"SemanticContext\": \"Although the available studies have methodological limitations, the weight of the evidence supports a causal association between valproate exposure in utero and subsequent adverse effects on neurodevelopment, including increases in autism spectrum disorders and attention deficit/hyperactivity disorder ADHD .\"\n },\n {\n \"VerbatimTerm\": \"ADHD\",\n \"Probability\": \"0.1445619166\",\n \"SemanticContext\": \"Although the available studies have methodological limitations, the weight of the evidence supports a causal association between valproate exposure in utero and subsequent adverse effects on neurodevelopment, including increases in autism spectrum disorders and attention deficit/hyperactivity disorder ADHD .\"\n },\n {\n \"VerbatimTerm\": \"ADHD\",\n \"Probability\": \"0.3152777553\",\n \"SemanticContext\": \"Another observational study found that children who were exposed to valproate in utero had an increased risk of ADHD adjusted HR 1.48; 95% CI, 1.09-2.00 compared with the unexposed children.\"\n },\n {\n \"VerbatimTerm\": \"ADHD\",\n \"Probability\": \"0.1392495036\",\n \"SemanticContext\": \"Because these studies were observational in nature, conclusions regarding a causal association between in utero valproate exposure and an increased risk of autism spectrum disorder and ADHD cannot be considered definitive.\"\n }\n ]\n },\n {\n \"Term\": \"Ophthalmoplegia\",\n \"MEDDRACode\": \"10030875\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"ophthalmoplegia\",\n \"Probability\": \"0.5701482296\",\n \"SemanticContext\": \"POLG-related disorders should be suspected in patients with a family history or suggestive symptoms of a POLG-related disorder, including but not limited to unexplained encephalopathy, refractory epilepsy focal, myoclonic , status epilepticus at presentation, developmental delays, psychomotor regression, axonal sensorimotor neuropathy, myopathy cerebellar ataxia, ophthalmoplegia, or complicated migraine with occipital aura.\"\n }\n ]\n },\n {\n \"Term\": \"Diarrhoea\",\n \"MEDDRACode\": \"10012735\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"diarrhea\",\n \"Probability\": \"0.9992311597\",\n \"SemanticContext\": \"Divalproex sodium extended-release tablets dosage should be increased slowly and with regular monitoring for fluid and nutritional intake 5.14 ADVERSE REACTIONS • Most common adverse reactions reported > 5% are abdominal pain, alopecia, amblyopia/blurred vision, amnesia, anorexia, asthenia, ataxia, back pain, bronchitis, constipation, depression, diarrhea, diplopia, dizziness, dyspnea, dyspepsia, ecchymosis, emotional lability, fever, flu syndrome, headache, increased appetite, infection, insomnia, nausea, nervousness, nystagmus, peripheral edema, pharyngitis, rash, rhinitis, somnolence, thinking abnormal, thrombocytopenia, tinnitus, tremor, vomiting, weight gain, weight loss 6.1 , 6.2 , 6.3 .\"\n },\n {\n \"VerbatimTerm\": \"diarrhea\",\n \"Probability\": \"0.4835095406\",\n \"SemanticContext\": \"Hepatotoxicity: Warn patients and guardians that nausea, vomiting, abdominal pain, anorexia, diarrhea, asthenia, and/or jaundice can be symptoms of hepatotoxicity and, therefore, require further medical evaluation promptly [see Warnings and Precautions 5.1 ] .\"\n },\n {\n \"VerbatimTerm\": \"diarrhea\",\n \"Probability\": \"0.1799241006\",\n \"SemanticContext\": \"In some reports, medication residues have occurred in the context of diarrhea.\"\n },\n {\n \"VerbatimTerm\": \"diarrhea\",\n \"Probability\": \"0.0189216733\",\n \"SemanticContext\": \"The common side effects of divalproex sodium extended-release tablets include: • nausea • headache • sleepiness • vomiting • weakness • tremor • dizziness • stomach pain • blurry vision • double vision • diarrhea • increased appetite • weight gain • hair loss • loss of appetite • problems with walking or coordination These are not all of the possible side effects of divalproex sodium extended-release tablets .\"\n },\n {\n \"VerbatimTerm\": \"Diarrhea\",\n \"Probability\": \"0.9992780685\",\n \"SemanticContext\": \"Adverse Event Divalproex Sodium Extended-Release Tablets n = 338 % Placebo n = 263 % Somnolence 26 14 Dyspepsia 23 11 Nausea 19 13 Vomiting 13 5 Diarrhea 12 8 Dizziness 12 7 Pain 11 10 Abdominal Pain 10 5 Accidental Injury 6 5 Asthenia 6 5 Pharyngitis 6 5 .\"\n },\n {\n \"VerbatimTerm\": \"Diarrhea\",\n \"Probability\": \"0.9994931221\",\n \"SemanticContext\": \"Adverse Reactions Reported by = 5% of Patients Treated with Valproate During Placebo-Controlled Trial of Adjunctive Therapy for Complex Partial Seizures Body System/Event Divalproex Sodium Delayed- Release Tablets N = 77 % Placebo N = 70 % Body as a Whole Headache 31 21 Asthenia 27 7 Fever 6 4 Gastrointestinal System Nausea 48 14 Vomiting 27 7 Abdominal Pain 23 6 Diarrhea 13 6 Anorexia 12 0 Dyspepsia 8 4 Constipation 5 1 Nervous System Somnolence 27 11 Tremor 25 6 Dizziness 25 13 Diplopia 16 9 Amblyopia/Blurred Vision 12 9 Ataxia 8 1 Nystagmus 8 1 Emotional Lability 6 4 Thinking Abnormal 6 0 Amnesia 5 1 Respiratory System Flu Syndrome 12 9 Infection 12 6 Bronchitis 5 1 Rhinitis 5 4 Other Alopecia 6 1 Weight Loss 6 0 .\"\n },\n {\n \"VerbatimTerm\": \"Diarrhea\",\n \"Probability\": \"0.9997125864\",\n \"SemanticContext\": \"Body System/Event High Dose n = 131 % Low Dose n = 134 % Body as a Whole Asthenia 21 10 Digestive System Nausea 34 26 Diarrhea 23 19 Vomiting 23 15 Abdominal Pain 12 9 Anorexia 11 4 Dyspepsia 11 10 Hemic/Lymphatic System Thrombocytopenia 24 1 Ecchymosis 5 4 Metabolic/Nutritional Weight Gain 9 4 Peripheral Edema 8 3 Nervous System Tremor 57 19 Somnolence 30 18 Dizziness 18 13 Insomnia 15 9 Nervousness 11 7 Amnesia 7 4 Nystagmus 7 1 Depression 5 4 Respiratory System Infection 20 13 Pharyngitis 8 2 Dyspnea 5 1 Skin and Appendages Alopecia 24 13 Special Senses Amblyopia/Blurred Vision 8 4 Tinnitus 7 1 .\"\n },\n {\n \"VerbatimTerm\": \"Diarrhea\",\n \"Probability\": \"0.9997261763\",\n \"SemanticContext\": \"Body System Event Divalproex Sodium Extended-Release Tablets n = 122 % Placebo n = 115 % Gastrointestinal System Nausea 15 9 Dyspepsia 7 4 Diarrhea 7 3 Vomiting 7 2 Abdominal Pain 7 5 Nervous System Somnolence 7 2 Other Infection 15 14 .\"\n },\n {\n \"VerbatimTerm\": \"Diarrhea\",\n \"Probability\": \"0.9996962547\",\n \"SemanticContext\": \"Body System Reaction Divalproex Sodium Delayed-Release Tablets n = 202 % Placebo n = 81 % Gastrointestinal System Nausea 31 10 Dyspepsia 13 9 Diarrhea 12 7 Vomiting 11 1 Abdominal Pain 9 4 Increased Appetite 6 4 Nervous System Asthenia 20 9 Somnolence 17 5 Dizziness 12 6 Tremor 9 0 Other Weight Gain 8 2 Back Pain 8 6 Alopecia 7 1 .\"\n }\n ]\n },\n {\n \"Term\": \"Abdominal pain\",\n \"MEDDRACode\": \"10000081\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"abdominal pain\",\n \"Probability\": \"0.9995800257\",\n \"SemanticContext\": \"Divalproex sodium extended-release tablets dosage should be increased slowly and with regular monitoring for fluid and nutritional intake 5.14 ADVERSE REACTIONS • Most common adverse reactions reported > 5% are abdominal pain, alopecia, amblyopia/blurred vision, amnesia, anorexia, asthenia, ataxia, back pain, bronchitis, constipation, depression, diarrhea, diplopia, dizziness, dyspnea, dyspepsia, ecchymosis, emotional lability, fever, flu syndrome, headache, increased appetite, infection, insomnia, nausea, nervousness, nystagmus, peripheral edema, pharyngitis, rash, rhinitis, somnolence, thinking abnormal, thrombocytopenia, tinnitus, tremor, vomiting, weight gain, weight loss 6.1 , 6.2 , 6.3 .\"\n },\n {\n \"VerbatimTerm\": \"abdominal pain\",\n \"Probability\": \"0.4782573879\",\n \"SemanticContext\": \"Hepatotoxicity: Warn patients and guardians that nausea, vomiting, abdominal pain, anorexia, diarrhea, asthenia, and/or jaundice can be symptoms of hepatotoxicity and, therefore, require further medical evaluation promptly [see Warnings and Precautions 5.1 ] .\"\n },\n {\n \"VerbatimTerm\": \"abdominal pain\",\n \"Probability\": \"0.222599417\",\n \"SemanticContext\": \"Pancreatitis: Warn patients and guardians that abdominal pain, nausea, vomiting, and/or anorexia can be symptoms of pancreatitis and, therefore, require further medical evaluation promptly [see Warnings and Precautions 5.5 ].\"\n },\n {\n \"VerbatimTerm\": \"abdominal pain\",\n \"Probability\": \"0.0072559416\",\n \"SemanticContext\": \"Patients and guardians should be warned that abdominal pain, nausea, vomiting, and/or anorexia can be symptoms of pancreatitis that require prompt medical evaluation.\"\n },\n {\n \"VerbatimTerm\": \"Abdominal Pain\",\n \"Probability\": \"0.9925793409\",\n \"SemanticContext\": \"Adverse Event Divalproex Sodium Extended-Release Tablets n = 338 % Placebo n = 263 % Somnolence 26 14 Dyspepsia 23 11 Nausea 19 13 Vomiting 13 5 Diarrhea 12 8 Dizziness 12 7 Pain 11 10 Abdominal Pain 10 5 Accidental Injury 6 5 Asthenia 6 5 Pharyngitis 6 5 .\"\n },\n {\n \"VerbatimTerm\": \"Abdominal Pain\",\n \"Probability\": \"0.9990614653\",\n \"SemanticContext\": \"Adverse Reactions Reported by = 5% of Patients Treated with Valproate During Placebo-Controlled Trial of Adjunctive Therapy for Complex Partial Seizures Body System/Event Divalproex Sodium Delayed- Release Tablets N = 77 % Placebo N = 70 % Body as a Whole Headache 31 21 Asthenia 27 7 Fever 6 4 Gastrointestinal System Nausea 48 14 Vomiting 27 7 Abdominal Pain 23 6 Diarrhea 13 6 Anorexia 12 0 Dyspepsia 8 4 Constipation 5 1 Nervous System Somnolence 27 11 Tremor 25 6 Dizziness 25 13 Diplopia 16 9 Amblyopia/Blurred Vision 12 9 Ataxia 8 1 Nystagmus 8 1 Emotional Lability 6 4 Thinking Abnormal 6 0 Amnesia 5 1 Respiratory System Flu Syndrome 12 9 Infection 12 6 Bronchitis 5 1 Rhinitis 5 4 Other Alopecia 6 1 Weight Loss 6 0 .\"\n },\n {\n \"VerbatimTerm\": \"Abdominal Pain\",\n \"Probability\": \"0.9985197783\",\n \"SemanticContext\": \"Body System/Event High Dose n = 131 % Low Dose n = 134 % Body as a Whole Asthenia 21 10 Digestive System Nausea 34 26 Diarrhea 23 19 Vomiting 23 15 Abdominal Pain 12 9 Anorexia 11 4 Dyspepsia 11 10 Hemic/Lymphatic System Thrombocytopenia 24 1 Ecchymosis 5 4 Metabolic/Nutritional Weight Gain 9 4 Peripheral Edema 8 3 Nervous System Tremor 57 19 Somnolence 30 18 Dizziness 18 13 Insomnia 15 9 Nervousness 11 7 Amnesia 7 4 Nystagmus 7 1 Depression 5 4 Respiratory System Infection 20 13 Pharyngitis 8 2 Dyspnea 5 1 Skin and Appendages Alopecia 24 13 Special Senses Amblyopia/Blurred Vision 8 4 Tinnitus 7 1 .\"\n },\n {\n \"VerbatimTerm\": \"Abdominal Pain\",\n \"Probability\": \"0.9991407394\",\n \"SemanticContext\": \"Body System Event Divalproex Sodium Extended-Release Tablets n = 122 % Placebo n = 115 % Gastrointestinal System Nausea 15 9 Dyspepsia 7 4 Diarrhea 7 3 Vomiting 7 2 Abdominal Pain 7 5 Nervous System Somnolence 7 2 Other Infection 15 14 .\"\n },\n {\n \"VerbatimTerm\": \"Abdominal Pain\",\n \"Probability\": \"0.998888433\",\n \"SemanticContext\": \"Body System Reaction Divalproex Sodium Delayed-Release Tablets n = 202 % Placebo n = 81 % Gastrointestinal System Nausea 31 10 Dyspepsia 13 9 Diarrhea 12 7 Vomiting 11 1 Abdominal Pain 9 4 Increased Appetite 6 4 Nervous System Asthenia 20 9 Somnolence 17 5 Dizziness 12 6 Tremor 9 0 Other Weight Gain 8 2 Back Pain 8 6 Alopecia 7 1 .\"\n }\n ]\n },\n {\n \"Term\": \"Depression\",\n \"MEDDRACode\": \"10012378\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"depressive episode\",\n \"Probability\": \"0.3083687127\",\n \"SemanticContext\": \"A mixed episode is characterized by the criteria for a manic episode in conjunction with those for a major depressive episode depressed mood, loss of interest or pleasure in nearly all activities .\"\n }\n ]\n },\n {\n \"Term\": \"Headache\",\n \"MEDDRACode\": \"10019211\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": true,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": true\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"headaches\",\n \"Probability\": \"0.005746305\",\n \"SemanticContext\": \"Patients with cluster or chronic daily headaches were excluded.\"\n },\n {\n \"VerbatimTerm\": \"headache\",\n \"Probability\": \"0.9997842312\",\n \"SemanticContext\": \"Divalproex sodium extended-release tablets dosage should be increased slowly and with regular monitoring for fluid and nutritional intake 5.14 ADVERSE REACTIONS • Most common adverse reactions reported > 5% are abdominal pain, alopecia, amblyopia/blurred vision, amnesia, anorexia, asthenia, ataxia, back pain, bronchitis, constipation, depression, diarrhea, diplopia, dizziness, dyspnea, dyspepsia, ecchymosis, emotional lability, fever, flu syndrome, headache, increased appetite, infection, insomnia, nausea, nervousness, nystagmus, peripheral edema, pharyngitis, rash, rhinitis, somnolence, thinking abnormal, thrombocytopenia, tinnitus, tremor, vomiting, weight gain, weight loss 6.1 , 6.2 , 6.3 .\"\n },\n {\n \"VerbatimTerm\": \"headache\",\n \"Probability\": \"0.9986303449\",\n \"SemanticContext\": \"Adverse Reactions Reported by > 5% of Divalproex Sodium Extended-Release Tablets-Treated Patients During Placebo-Controlled Trials of Acute Mania The following adverse reactions/event occurred at an equal or greater incidence for placebo than for divalproex sodium extended-release tablets: headache.\"\n },\n {\n \"VerbatimTerm\": \"headache\",\n \"Probability\": \"0.9918507338\",\n \"SemanticContext\": \"The common side effects of divalproex sodium extended-release tablets include: • nausea • headache • sleepiness • vomiting • weakness • tremor • dizziness • stomach pain • blurry vision • double vision • diarrhea • increased appetite • weight gain • hair loss • loss of appetite • problems with walking or coordination These are not all of the possible side effects of divalproex sodium extended-release tablets .\"\n },\n {\n \"VerbatimTerm\": \"Headache\",\n \"Probability\": \"0.9984025955\",\n \"SemanticContext\": \"Adverse Reactions Reported by = 5% of Patients Treated with Valproate During Placebo-Controlled Trial of Adjunctive Therapy for Complex Partial Seizures Body System/Event Divalproex Sodium Delayed- Release Tablets N = 77 % Placebo N = 70 % Body as a Whole Headache 31 21 Asthenia 27 7 Fever 6 4 Gastrointestinal System Nausea 48 14 Vomiting 27 7 Abdominal Pain 23 6 Diarrhea 13 6 Anorexia 12 0 Dyspepsia 8 4 Constipation 5 1 Nervous System Somnolence 27 11 Tremor 25 6 Dizziness 25 13 Diplopia 16 9 Amblyopia/Blurred Vision 12 9 Ataxia 8 1 Nystagmus 8 1 Emotional Lability 6 4 Thinking Abnormal 6 0 Amnesia 5 1 Respiratory System Flu Syndrome 12 9 Infection 12 6 Bronchitis 5 1 Rhinitis 5 4 Other Alopecia 6 1 Weight Loss 6 0 .\"\n },\n {\n \"VerbatimTerm\": \"Headache\",\n \"Probability\": \"0.616309762\",\n \"SemanticContext\": \"Adverse Reactions Reported by = 5% of Patients in the High Dose Group in the Controlled Trial of Valproate Monotherapy for Complex Partial Seizures Headache was the only adverse event that occurred in = 5% of patients in the high dose group and at an equal or greater incidence in the low dose group.\"\n }\n ]\n },\n {\n \"Term\": \"Petit mal epilepsy\",\n \"MEDDRACode\": \"10034759\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"absence seizures\",\n \"Probability\": \"0.1969368458\",\n \"SemanticContext\": \"• Acute treatment of manic or mixed episodes associated with bipolar disorder, with or without psychotic features 1.1 • Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures 1.2 • Prophylaxis of migraine headaches 1.3 DOSAGE AND ADMINISTRATION • Divalproex sodium extended-release tablets are intended for once-a-day oral administration.\"\n },\n {\n \"VerbatimTerm\": \"absence seizures\",\n \"Probability\": \"0.6604750156\",\n \"SemanticContext\": \"• Acute treatment of manic or mixed episodes associated with bipolar disorder, with or without psychotic features 1.1 • Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures 1.2 • Prophylaxis of migraine headaches 1.3 DOSAGE AND ADMINISTRATION • Divalproex sodium extended-release tablets are intended for once-a-day oral administration.\"\n },\n {\n \"VerbatimTerm\": \"absence seizures\",\n \"Probability\": \"0.0005783737\",\n \"SemanticContext\": \"However, therapeutic valproate serum concentration for most patients with absence seizures is considered to range from 50 to 100 mcg/mL.\"\n },\n {\n \"VerbatimTerm\": \"absence seizures\",\n \"Probability\": \"0.0004038811\",\n \"SemanticContext\": \"Divalproex sodium extended-release tablets are also indicated for use as sole and adjunctive therapy in the treatment of simple and complex absence seizures in adults and children 10 years of age or older, and adjunctively in adults and children 10 years of age or older with multiple seizure types that include absence seizures.\"\n },\n {\n \"VerbatimTerm\": \"absence seizures\",\n \"Probability\": \"0.2869247198\",\n \"SemanticContext\": \"Divalproex sodium extended-release tablets are also indicated for use as sole and adjunctive therapy in the treatment of simple and complex absence seizures in adults and children 10 years of age or older, and adjunctively in adults and children 10 years of age or older with multiple seizure types that include absence seizures.\"\n },\n {\n \"VerbatimTerm\": \"absence seizures\",\n \"Probability\": \"0.002974987\",\n \"SemanticContext\": \"Divalproex Sodium Extended-Release Tablets are prescription medicines used: • to treat manic episodes associated with bipolar disorder • alone or with other medicines to treat: • complex partial seizures in adults and children 10 years of age and older • simple and complex absence seizures, with or without other seizure types • to prevent migraine headaches Who should not take divalproex sodium extended-release tablets?\"\n },\n {\n \"VerbatimTerm\": \"Absence Seizures\",\n \"Probability\": \"0.0605036318\",\n \"SemanticContext\": \"• Absence Seizures: Start at 15 mg/kg/day, increasing at 1 week intervals by 5 to 10 mg/kg/day until seizure control or limiting side effects 2.2 .\"\n },\n {\n \"VerbatimTerm\": \"Absence Seizures\",\n \"Probability\": \"0.017790854\",\n \"SemanticContext\": \"\\n \\n Simple and Complex Absence Seizures\\n The recommended initial dose is 15 mg/kg/day, increasing at one week intervals by 5 to 10 mg/kg/day until seizures are controlled or side effects preclude further increases.\"\n }\n ]\n },\n {\n \"Term\": \"Thrombocytopenia\",\n \"MEDDRACode\": \"10043554\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"thrombocytopenia\",\n \"Probability\": \"0.9948995709\",\n \"SemanticContext\": \"Divalproex sodium extended-release tablets dosage should be increased slowly and with regular monitoring for fluid and nutritional intake 5.14 ADVERSE REACTIONS • Most common adverse reactions reported > 5% are abdominal pain, alopecia, amblyopia/blurred vision, amnesia, anorexia, asthenia, ataxia, back pain, bronchitis, constipation, depression, diarrhea, diplopia, dizziness, dyspnea, dyspepsia, ecchymosis, emotional lability, fever, flu syndrome, headache, increased appetite, infection, insomnia, nausea, nervousness, nystagmus, peripheral edema, pharyngitis, rash, rhinitis, somnolence, thinking abnormal, thrombocytopenia, tinnitus, tremor, vomiting, weight gain, weight loss 6.1 , 6.2 , 6.3 .\"\n },\n {\n \"VerbatimTerm\": \"thrombocytopenia\",\n \"Probability\": \"0.5790242553\",\n \"SemanticContext\": \"The probability of thrombocytopenia increases significantly at total trough valproate plasma concentrations above 110 mcg/mL in females and 135 mcg/mL in males.\"\n },\n {\n \"VerbatimTerm\": \"thrombocytopenia\",\n \"Probability\": \"0.7134728432\",\n \"SemanticContext\": \"\\n \\n Dose-Related Adverse Reactions\\n The frequency of adverse effects particularly elevated liver enzymes and thrombocytopenia may be dose-related.\"\n },\n {\n \"VerbatimTerm\": \"thrombocytopenia\",\n \"Probability\": \"0.9560083151\",\n \"SemanticContext\": \"The probability of thrombocytopenia appears to increase significantly at total valproate concentrations of = 110 mcg/mL females or = 135 mcg/mL males [see Warnings and Precautions 5.8 ] .\"\n },\n {\n \"VerbatimTerm\": \"thrombocytopenia\",\n \"Probability\": \"0.0216133893\",\n \"SemanticContext\": \"Pregnant women taking valproate may develop hepatic failure or clotting abnormalities including thrombocytopenia, hypofibrinogenemia, and/or decrease in other coagulation factors, which may result in hemorrhagic complications in the neonate including death [see Warnings and Precautions 5.1 , 5.8 ] .\"\n },\n {\n \"VerbatimTerm\": \"thrombocytopenia\",\n \"Probability\": \"0.2150763571\",\n \"SemanticContext\": \"Maternal Adverse Reactions Pregnant women taking valproate may develop clotting abnormalities including thrombocytopenia, hypofibrinogenemia, and/or decrease in other coagulation factors, which may result in hemorrhagic complications in the neonate including death [see Warnings and Precautions 5.8 ] .\"\n },\n {\n \"VerbatimTerm\": \"thrombocytopenia\",\n \"Probability\": \"0.7653138638\",\n \"SemanticContext\": \"5.8 Bleeding and Other Hematopoietic Disorders Valproate is associated with dose-related thrombocytopenia.\"\n },\n {\n \"VerbatimTerm\": \"thrombocytopenia\",\n \"Probability\": \"0.9110882878\",\n \"SemanticContext\": \"In this study, the probability of thrombocytopenia appeared to increase significantly at total valproate concentrations of = 110 mcg/mL females or = 135 mcg/mL males .\"\n },\n {\n \"VerbatimTerm\": \"Thrombocytopenia\",\n \"Probability\": \"0.9976724386\",\n \"SemanticContext\": \"Body System/Event High Dose n = 131 % Low Dose n = 134 % Body as a Whole Asthenia 21 10 Digestive System Nausea 34 26 Diarrhea 23 19 Vomiting 23 15 Abdominal Pain 12 9 Anorexia 11 4 Dyspepsia 11 10 Hemic/Lymphatic System Thrombocytopenia 24 1 Ecchymosis 5 4 Metabolic/Nutritional Weight Gain 9 4 Peripheral Edema 8 3 Nervous System Tremor 57 19 Somnolence 30 18 Dizziness 18 13 Insomnia 15 9 Nervousness 11 7 Amnesia 7 4 Nystagmus 7 1 Depression 5 4 Respiratory System Infection 20 13 Pharyngitis 8 2 Dyspnea 5 1 Skin and Appendages Alopecia 24 13 Special Senses Amblyopia/Blurred Vision 8 4 Tinnitus 7 1 .\"\n }\n ]\n },\n {\n \"Term\": \"Ecchymosis\",\n \"MEDDRACode\": \"10014080\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"ecchymosis\",\n \"Probability\": \"0.999491632\",\n \"SemanticContext\": \"Divalproex sodium extended-release tablets dosage should be increased slowly and with regular monitoring for fluid and nutritional intake 5.14 ADVERSE REACTIONS • Most common adverse reactions reported > 5% are abdominal pain, alopecia, amblyopia/blurred vision, amnesia, anorexia, asthenia, ataxia, back pain, bronchitis, constipation, depression, diarrhea, diplopia, dizziness, dyspnea, dyspepsia, ecchymosis, emotional lability, fever, flu syndrome, headache, increased appetite, infection, insomnia, nausea, nervousness, nystagmus, peripheral edema, pharyngitis, rash, rhinitis, somnolence, thinking abnormal, thrombocytopenia, tinnitus, tremor, vomiting, weight gain, weight loss 6.1 , 6.2 , 6.3 .\"\n },\n {\n \"VerbatimTerm\": \"Ecchymosis\",\n \"Probability\": \"0.9921833277\",\n \"SemanticContext\": \"Hemic and Lymphatic System: Anemia, Bleeding Time Increased, Ecchymosis, Leucopenia.\"\n },\n {\n \"VerbatimTerm\": \"Ecchymosis\",\n \"Probability\": \"0.9988539219\",\n \"SemanticContext\": \"Body System/Event High Dose n = 131 % Low Dose n = 134 % Body as a Whole Asthenia 21 10 Digestive System Nausea 34 26 Diarrhea 23 19 Vomiting 23 15 Abdominal Pain 12 9 Anorexia 11 4 Dyspepsia 11 10 Hemic/Lymphatic System Thrombocytopenia 24 1 Ecchymosis 5 4 Metabolic/Nutritional Weight Gain 9 4 Peripheral Edema 8 3 Nervous System Tremor 57 19 Somnolence 30 18 Dizziness 18 13 Insomnia 15 9 Nervousness 11 7 Amnesia 7 4 Nystagmus 7 1 Depression 5 4 Respiratory System Infection 20 13 Pharyngitis 8 2 Dyspnea 5 1 Skin and Appendages Alopecia 24 13 Special Senses Amblyopia/Blurred Vision 8 4 Tinnitus 7 1 .\"\n },\n {\n \"VerbatimTerm\": \"Ecchymosis\",\n \"Probability\": \"0.9962645173\",\n \"SemanticContext\": \"Hemic and Lymphatic System: Ecchymosis.\"\n }\n ]\n },\n {\n \"Term\": \"Thyroid function test\",\n \"MEDDRACode\": \"10043729\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Thyroid Function Tests\",\n \"Probability\": \"7.56128E-05\",\n \"SemanticContext\": \"5.16 Effect on Ketone and Thyroid Function Tests Valproate is partially eliminated in the urine as a keto-metabolite which may lead to a false interpretation of the urine ketone test.\"\n },\n {\n \"VerbatimTerm\": \"thyroid function tests\",\n \"Probability\": \"0.000919193\",\n \"SemanticContext\": \"There have been reports of altered thyroid function tests associated with valproate.\"\n }\n ]\n },\n {\n \"Term\": \"Contusion\",\n \"MEDDRACode\": \"10050584\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": true,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"bruising\",\n \"Probability\": \"0.2219047844\",\n \"SemanticContext\": \"Evidence of hemorrhage, bruising, or a disorder of hemostasis/coagulation is an indication for reduction of the dosage or withdrawal of therapy.\"\n },\n {\n \"VerbatimTerm\": \"bruising\",\n \"Probability\": \"0.0198255479\",\n \"SemanticContext\": \"Divalproex sodium extended-release tablets can cause serious side effects including: • Bleeding problems: red or purple spots on your skin, bruising, pain and swelling into your joints due to bleeding or bleeding from your mouth or nose.\"\n },\n {\n \"VerbatimTerm\": \"bruising\",\n \"Probability\": \"0.0006873906\",\n \"SemanticContext\": \"Monitor the breastfed infant for signs of liver damage including jaundice and unusual bruising or bleeding.\"\n }\n ]\n },\n {\n \"Term\": \"Subcutaneous emphysema\",\n \"MEDDRACode\": \"10042344\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"SCE\",\n \"Probability\": \"0.0422506332\",\n \"SemanticContext\": \"Increased frequencies of sister chromatid exchange SCE have been reported in a study of epileptic children taking valproate; this association was not observed in another study conducted in adults.\"\n }\n ]\n },\n {\n \"Term\": \"Weight decreased\",\n \"MEDDRACode\": \"10047895\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"weight loss\",\n \"Probability\": \"0.9981104732\",\n \"SemanticContext\": \"Divalproex sodium extended-release tablets dosage should be increased slowly and with regular monitoring for fluid and nutritional intake 5.14 ADVERSE REACTIONS • Most common adverse reactions reported > 5% are abdominal pain, alopecia, amblyopia/blurred vision, amnesia, anorexia, asthenia, ataxia, back pain, bronchitis, constipation, depression, diarrhea, diplopia, dizziness, dyspnea, dyspepsia, ecchymosis, emotional lability, fever, flu syndrome, headache, increased appetite, infection, insomnia, nausea, nervousness, nystagmus, peripheral edema, pharyngitis, rash, rhinitis, somnolence, thinking abnormal, thrombocytopenia, tinnitus, tremor, vomiting, weight gain, weight loss 6.1 , 6.2 , 6.3 .\"\n },\n {\n \"VerbatimTerm\": \"weight loss\",\n \"Probability\": \"0.7735226154\",\n \"SemanticContext\": \"In some patients with somnolence approximately one-half , there was associated reduced nutritional intake and weight loss.\"\n },\n {\n \"VerbatimTerm\": \"Weight Loss\",\n \"Probability\": \"0.9913440943\",\n \"SemanticContext\": \"Adverse Reactions Reported by = 5% of Patients Treated with Valproate During Placebo-Controlled Trial of Adjunctive Therapy for Complex Partial Seizures Body System/Event Divalproex Sodium Delayed- Release Tablets N = 77 % Placebo N = 70 % Body as a Whole Headache 31 21 Asthenia 27 7 Fever 6 4 Gastrointestinal System Nausea 48 14 Vomiting 27 7 Abdominal Pain 23 6 Diarrhea 13 6 Anorexia 12 0 Dyspepsia 8 4 Constipation 5 1 Nervous System Somnolence 27 11 Tremor 25 6 Dizziness 25 13 Diplopia 16 9 Amblyopia/Blurred Vision 12 9 Ataxia 8 1 Nystagmus 8 1 Emotional Lability 6 4 Thinking Abnormal 6 0 Amnesia 5 1 Respiratory System Flu Syndrome 12 9 Infection 12 6 Bronchitis 5 1 Rhinitis 5 4 Other Alopecia 6 1 Weight Loss 6 0 .\"\n }\n ]\n },\n {\n \"Term\": \"Axillary web syndrome\",\n \"MEDDRACode\": \"10074387\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"cord\",\n \"Probability\": \"0.0029174984\",\n \"SemanticContext\": \"• If you take divalproex sodium extended-release tablets during pregnancy for any medical condition, your baby is at risk for serious birth defects that affect the brain and spinal cord and are called spina bifida or neural tube defects.\"\n }\n ]\n },\n {\n \"Term\": \"Liver injury\",\n \"MEDDRACode\": \"10067125\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": true,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"liver damage\",\n \"Probability\": \"0.4483857155\",\n \"SemanticContext\": \"Serious liver damage that can cause death, especially in children younger than 2 years old.\"\n },\n {\n \"VerbatimTerm\": \"liver damage\",\n \"Probability\": \"0.288215071\",\n \"SemanticContext\": \"The risk of getting this serious liver damage is more likely to happen within the first 6 months of treatment.\"\n },\n {\n \"VerbatimTerm\": \"liver damage\",\n \"Probability\": \"0.0012180507\",\n \"SemanticContext\": \"Call your healthcare provider right away if you get any of the following symptoms: • nausea or vomiting that does not go away • loss of appetite • pain on the right side of your stomach abdomen • dark urine • swelling of your face • yellowing of your skin or the whites of your eyes In some cases, liver damage may continue despite stopping the drug.\"\n },\n {\n \"VerbatimTerm\": \"liver damage\",\n \"Probability\": \"0.004353404\",\n \"SemanticContext\": \"Monitor the breastfed infant for signs of liver damage including jaundice and unusual bruising or bleeding.\"\n }\n ]\n },\n {\n \"Term\": \"Lethargy\",\n \"MEDDRACode\": \"10024264\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"lethargy\",\n \"Probability\": \"0.0715110004\",\n \"SemanticContext\": \"POLG 4 , 5.1 • Suspected POLG-related disorder in children under two years of age 4 , 5.1 • Known hypersensitivity to the drug 4 , 5.12 • Urea cycle disorders 4 , 5.6 • Prophylaxis of migraine headaches: Pregnant women, women of childbearing potential not using effective contraception 4 , 8.1 WARNINGS AND PRECAUTIONS • Hepatotoxicity; evaluate high risk populations and monitor serum liver tests 5.1 • Birth defects, decreased IQ, and neurodevelopmental disorders following in utero exposure; should not be used to treat women with epilepsy or bipolar disorder who are pregnant or who plan to become pregnant or to treat a woman of childbearing potential unless other medications have failed to provide adequate symptom control or are otherwise unacceptable 5.2 , 5.3 , 5.4 • Pancreatitis; divalproex sodium extended-release tablets should ordinarily be discontinued 5.5 • Suicidal behavior or ideation; Antiepileptic drugs, including divalproex sodium extended-release tablets, increase the risk of suicidal thoughts or behavior 5.7 • Bleeding and other hematopoietic disorders; monitor platelet counts and coagulation tests 5.8 • Hyperammonemia and hyperammonemic encephalopathy; measure ammonia level if unexplained lethargy and vomiting or changes in mental status, and also with concomitant topiramate use; consider discontinuation of valproate therapy 5.6 , 5.9 , 5.10 • Hypothermia; Hypothermia has been reported during valproate therapy with or without associated hyperammonemia.\"\n },\n {\n \"VerbatimTerm\": \"lethargy\",\n \"Probability\": \"0.8943120241\",\n \"SemanticContext\": \"Serious or fatal hepatotoxicity may be preceded by non-specific symptoms such as malaise, weakness, lethargy, facial edema, anorexia, and vomiting.\"\n },\n {\n \"VerbatimTerm\": \"lethargy\",\n \"Probability\": \"0.0871585608\",\n \"SemanticContext\": \"Prior to the initiation of divalproex sodium extended-release tablets therapy, evaluation for UCD should be considered in the following patients: 1 those with a history of unexplained encephalopathy or coma, encephalopathy associated with a protein load, pregnancy-related or postpartum encephalopathy, unexplained mental retardation, or history of elevated plasma ammonia or glutamine; 2 those with cyclical vomiting and lethargy, episodic extreme irritability, ataxia, low BUN, or protein avoidance; 3 those with a family history of UCD or a family history of unexplained infant deaths particularly males ; 4 those with other signs or symptoms of UCD.\"\n },\n {\n \"VerbatimTerm\": \"lethargy\",\n \"Probability\": \"0.0035308301\",\n \"SemanticContext\": \"In patients who develop unexplained lethargy and vomiting or changes in mental status, hyperammonemic encephalopathy should be considered and an ammonia level should be measured.\"\n },\n {\n \"VerbatimTerm\": \"lethargy\",\n \"Probability\": \"0.2458622754\",\n \"SemanticContext\": \"Clinical symptoms of hyperammonemic encephalopathy often include acute alterations in level of consciousness and/or cognitive function with lethargy or vomiting.\"\n },\n {\n \"VerbatimTerm\": \"lethargy\",\n \"Probability\": \"0.002435267\",\n \"SemanticContext\": \"In patients who develop unexplained lethargy, vomiting, or changes in mental status, hyperammonemic encephalopathy should be considered and an ammonia level should be measured [see Contraindications 4 and Warnings and Precautions 5.6 , 5.9 ].\"\n },\n {\n \"VerbatimTerm\": \"lethargy\",\n \"Probability\": \"0.0539004505\",\n \"SemanticContext\": \"Consideration should be given to stopping valproate in patients who develop hypothermia, which may be manifested by a variety of clinical abnormalities including lethargy, confusion, coma, and significant alterations in other major organ systems such as the cardiovascular and respiratory systems.\"\n }\n ]\n },\n {\n \"Term\": \"Decreased interest\",\n \"MEDDRACode\": \"10011971\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"loss of interest\",\n \"Probability\": \"0.0161013007\",\n \"SemanticContext\": \"A mixed episode is characterized by the criteria for a manic episode in conjunction with those for a major depressive episode depressed mood, loss of interest or pleasure in nearly all activities .\"\n }\n ]\n },\n {\n \"Term\": \"Hypernatraemia\",\n \"MEDDRACode\": \"10020679\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hypernatremia\",\n \"Probability\": \"0.8985642195\",\n \"SemanticContext\": \"10 OVERDOSAGE Overdosage with valproate may result in somnolence, heart block, deep coma, and hypernatremia.\"\n }\n ]\n },\n {\n \"Term\": \"Coma\",\n \"MEDDRACode\": \"10010071\",\n \"Overdose\": true,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"coma\",\n \"Probability\": \"0.5017525554\",\n \"SemanticContext\": \"10 OVERDOSAGE Overdosage with valproate may result in somnolence, heart block, deep coma, and hypernatremia.\"\n },\n {\n \"VerbatimTerm\": \"coma\",\n \"Probability\": \"0.0038277209\",\n \"SemanticContext\": \"Prior to the initiation of divalproex sodium extended-release tablets therapy, evaluation for UCD should be considered in the following patients: 1 those with a history of unexplained encephalopathy or coma, encephalopathy associated with a protein load, pregnancy-related or postpartum encephalopathy, unexplained mental retardation, or history of elevated plasma ammonia or glutamine; 2 those with cyclical vomiting and lethargy, episodic extreme irritability, ataxia, low BUN, or protein avoidance; 3 those with a family history of UCD or a family history of unexplained infant deaths particularly males ; 4 those with other signs or symptoms of UCD.\"\n },\n {\n \"VerbatimTerm\": \"coma\",\n \"Probability\": \"0.08847785\",\n \"SemanticContext\": \"Consideration should be given to stopping valproate in patients who develop hypothermia, which may be manifested by a variety of clinical abnormalities including lethargy, confusion, coma, and significant alterations in other major organ systems such as the cardiovascular and respiratory systems.\"\n },\n {\n \"VerbatimTerm\": \"coma\",\n \"Probability\": \"0.0283014476\",\n \"SemanticContext\": \"• Low body temperature hypothermia : drop in your body temperature to less than 95°F, feeling tired, confusion, coma.\"\n }\n ]\n },\n {\n \"Term\": \"Foetal growth restriction\",\n \"MEDDRACode\": \"10070531\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"intrauterine growth retardation\",\n \"Probability\": \"0.0652641356\",\n \"SemanticContext\": \"Animal In developmental toxicity studies conducted in mice, rats, rabbits, and monkeys, increased rates of fetal structural abnormalities, intrauterine growth retardation, and embryo-fetal death occurred following administration of valproate to pregnant animals during organogenesis at clinically relevant doses calculated on a body surface area [mg/m 2 ] basis .\"\n }\n ]\n },\n {\n \"Term\": \"Hypoglycaemia\",\n \"MEDDRACode\": \"10020993\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hypoglycemia\",\n \"Probability\": \"0.8634712696\",\n \"SemanticContext\": \"There have been reports of hypoglycemia in neonates and fatal cases of hepatic failure in infants following maternal use of valproate during pregnancy.\"\n },\n {\n \"VerbatimTerm\": \"Hypoglycemia\",\n \"Probability\": \"0.8844848871\",\n \"SemanticContext\": \"Hypoglycemia has been reported in neonates whose mothers have taken valproate during pregnancy.\"\n }\n ]\n },\n {\n \"Term\": \"Flight of ideas\",\n \"MEDDRACode\": \"10016777\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"flight of ideas\",\n \"Probability\": \"0.5304279327\",\n \"SemanticContext\": \"Typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, poor judgment, aggressiveness, and possible hostility.\"\n }\n ]\n },\n {\n \"Term\": \"Phytotherapy\",\n \"MEDDRACode\": \"10063339\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"herbal supplements\",\n \"Probability\": \"3.481E-07\",\n \"SemanticContext\": \"• have or have had depression, mood problems, or suicidal thoughts or behavior • have any other medical conditions Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, herbal supplements and medicines that you take for a short period of time.\"\n }\n ]\n },\n {\n \"Term\": \"Loss of consciousness\",\n \"MEDDRACode\": \"10024855\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"loss of consciousness\",\n \"Probability\": \"0.0135723352\",\n \"SemanticContext\": \"Simple absence is defined as very brief clouding of the sensorium or loss of consciousness accompanied by certain generalized epileptic discharges without other detectable clinical signs.\"\n }\n ]\n },\n {\n \"Term\": \"Hypofibrinogenaemia\",\n \"MEDDRACode\": \"10051125\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hypofibrinogenemia\",\n \"Probability\": \"0.0061581135\",\n \"SemanticContext\": \"Pregnant women taking valproate may develop hepatic failure or clotting abnormalities including thrombocytopenia, hypofibrinogenemia, and/or decrease in other coagulation factors, which may result in hemorrhagic complications in the neonate including death [see Warnings and Precautions 5.1 , 5.8 ] .\"\n },\n {\n \"VerbatimTerm\": \"hypofibrinogenemia\",\n \"Probability\": \"0.2136088014\",\n \"SemanticContext\": \"Maternal Adverse Reactions Pregnant women taking valproate may develop clotting abnormalities including thrombocytopenia, hypofibrinogenemia, and/or decrease in other coagulation factors, which may result in hemorrhagic complications in the neonate including death [see Warnings and Precautions 5.8 ] .\"\n }\n ]\n },\n {\n \"Term\": \"Autism spectrum disorder\",\n \"MEDDRACode\": \"10063844\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"autism spectrum disorders\",\n \"Probability\": \"0.0064019561\",\n \"SemanticContext\": \"An observational study has suggested that exposure to valproate products during pregnancy increases the risk of autism spectrum disorders [see Data Human ] .\"\n },\n {\n \"VerbatimTerm\": \"autism spectrum disorders\",\n \"Probability\": \"0.0247002244\",\n \"SemanticContext\": \"Although the available studies have methodological limitations, the weight of the evidence supports a causal association between valproate exposure in utero and subsequent adverse effects on neurodevelopment, including increases in autism spectrum disorders and attention deficit/hyperactivity disorder ADHD .\"\n },\n {\n \"VerbatimTerm\": \"autism spectrum disorders\",\n \"Probability\": \"0.0089754164\",\n \"SemanticContext\": \"An observational study has suggested that exposure to valproate products during pregnancy increases the risk of autism spectrum disorders.\"\n },\n {\n \"VerbatimTerm\": \"autism spectrum disorders\",\n \"Probability\": \"0.0012430251\",\n \"SemanticContext\": \"In this study, children born to mothers who had used valproate products during pregnancy had 2.9 times the risk 95% confidence interval [CI]: 1.7-4.9 of developing autism spectrum disorders compared to children born to mothers not exposed to valproate products during pregnancy.\"\n },\n {\n \"VerbatimTerm\": \"autism spectrum disorders\",\n \"Probability\": \"0.0071278214\",\n \"SemanticContext\": \"The absolute risks for autism spectrum disorders were 4.4% 95% CI: 2.6%-7.5% in valproate-exposed children and 1.5% 95% CI: 1.5%-1.6% in children not exposed to valproate products.\"\n },\n {\n \"VerbatimTerm\": \"autism spectrum disorder\",\n \"Probability\": \"0.0397929251\",\n \"SemanticContext\": \"Because these studies were observational in nature, conclusions regarding a causal association between in utero valproate exposure and an increased risk of autism spectrum disorder and ADHD cannot be considered definitive.\"\n }\n ]\n },\n {\n \"Term\": \"Spina bifida\",\n \"MEDDRACode\": \"10041524\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"spina bifida\",\n \"Probability\": \"0.0018415451\",\n \"SemanticContext\": \"Maternal valproate use during pregnancy for any indication increases the risk of congenital malformations, particularly neural tube defects including spina bifida, but also malformations involving other body systems e.g., craniofacial defects including oral clefts, cardiovascular malformations, hypospadias, limb malformations .\"\n },\n {\n \"VerbatimTerm\": \"spina bifida\",\n \"Probability\": \"0.0037001371\",\n \"SemanticContext\": \"Based on published data from the CDC’s National Birth Defects Prevention Network, the risk of spina bifida in the general population is about 0.06 to 0.07% 6 to 7 in 10,000 births compared to the risk following in utero valproate exposure estimated to be approximately 1 to 2% 100 to 200 in 10,000 births .\"\n },\n {\n \"VerbatimTerm\": \"spina bifida\",\n \"Probability\": \"0.0031412244\",\n \"SemanticContext\": \"• If you take divalproex sodium extended-release tablets during pregnancy for any medical condition, your baby is at risk for serious birth defects that affect the brain and spinal cord and are called spina bifida or neural tube defects.\"\n }\n ]\n },\n {\n \"Term\": \"Blood urea\",\n \"MEDDRACode\": \"10005845\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"BUN\",\n \"Probability\": \"0.0002291799\",\n \"SemanticContext\": \"Prior to the initiation of divalproex sodium extended-release tablets therapy, evaluation for UCD should be considered in the following patients: 1 those with a history of unexplained encephalopathy or coma, encephalopathy associated with a protein load, pregnancy-related or postpartum encephalopathy, unexplained mental retardation, or history of elevated plasma ammonia or glutamine; 2 those with cyclical vomiting and lethargy, episodic extreme irritability, ataxia, low BUN, or protein avoidance; 3 those with a family history of UCD or a family history of unexplained infant deaths particularly males ; 4 those with other signs or symptoms of UCD.\"\n },\n {\n \"VerbatimTerm\": \"BUN\",\n \"Probability\": \"0.0001887083\",\n \"SemanticContext\": \"There was a trend for the patients who experienced these events to have a lower baseline albumin concentration, lower valproate clearance, and a higher BUN.\"\n }\n ]\n },\n {\n \"Term\": \"Functional gastrointestinal disorder\",\n \"MEDDRACode\": \"10071275\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"functional gastrointestinal disorders\",\n \"Probability\": \"0.0105230212\",\n \"SemanticContext\": \"Some patients have had anatomic including ileostomy or colostomy or functional gastrointestinal disorders with shortened GI transit times.\"\n }\n ]\n },\n {\n \"Term\": \"Hypoacusis\",\n \"MEDDRACode\": \"10048865\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Decreased hearing\",\n \"Probability\": \"0.0200748742\",\n \"SemanticContext\": \"Decreased hearing or hearing loss can also happen.\"\n }\n ]\n },\n {\n \"Term\": \"Somnolence\",\n \"MEDDRACode\": \"10041349\",\n \"Overdose\": true,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"sleepy\",\n \"Probability\": \"1.48146E-05\",\n \"SemanticContext\": \"Do not drink alcohol or take other medicines that make you sleepy or dizzy while taking divalproex sodium extended-release tablets, until you talk with your doctor.\"\n }\n ]\n },\n {\n \"Term\": \"Liver function test normal\",\n \"MEDDRACode\": \"10060106\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"normal liver function tests\",\n \"Probability\": \"0.0040411949\",\n \"SemanticContext\": \"5.9 Hyperammonemia Hyperammonemia has been reported in association with valproate therapy and may be present despite normal liver function tests.\"\n }\n ]\n },\n {\n \"Term\": \"Mitochondrial DNA mutation\",\n \"MEDDRACode\": \"10052641\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"POLG mutation\",\n \"Probability\": \"0.0008790195\",\n \"SemanticContext\": \"POLG mutation testing should be performed in accordance with current clinical practice for the diagnostic evaluation of such disorders.\"\n }\n ]\n },\n {\n \"Term\": \"Physical examination\",\n \"MEDDRACode\": \"10034986\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"physical examination\",\n \"Probability\": \"2.9263E-06\",\n \"SemanticContext\": \"However, healthcare providers should not rely totally on serum biochemistry since these tests may not be abnormal in all instances, but should also consider the results of careful interim medical history and physical examination.\"\n }\n ]\n },\n {\n \"Term\": \"Dementia\",\n \"MEDDRACode\": \"10012267\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": true\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"dementia\",\n \"Probability\": \"0.003543824\",\n \"SemanticContext\": \"5.14 Somnolence in the Elderly In a double-blind, multicenter trial of valproate in elderly patients with dementia mean age = 83 years , doses were increased by 125 mg/day to a target dose of 20 mg/kg/day.\"\n },\n {\n \"VerbatimTerm\": \"dementia\",\n \"Probability\": \"0.0827053785\",\n \"SemanticContext\": \"A study of elderly patients with dementia revealed drug related somnolence and discontinuation for somnolence [see Warnings and Precautions 5.14 ].\"\n }\n ]\n },\n {\n \"Term\": \"Myositis\",\n \"MEDDRACode\": \"10028653\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"myositis\",\n \"Probability\": \"0.9755246043\",\n \"SemanticContext\": \"DRESS typically, although not exclusively, presents with fever, rash, lymphadenopathy, and/or facial swelling, in association with other organ system involvement, such as hepatitis, nephritis, hematological abnormalities, myocarditis, or myositis sometimes resembling an acute viral infection.\"\n }\n ]\n },\n {\n \"Term\": \"Viral load\",\n \"MEDDRACode\": \"10062178\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"viral load\",\n \"Probability\": \"3.0991E-06\",\n \"SemanticContext\": \"Nevertheless, these data should be borne in mind when interpreting the results from regular monitoring of the viral load in HIV infected patients receiving valproate or when following CMV infected patients clinically.\"\n }\n ]\n },\n {\n \"Term\": \"Completed suicide\",\n \"MEDDRACode\": \"10010144\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"suicides\",\n \"Probability\": \"0.7865370512\",\n \"SemanticContext\": \"There were four suicides in drug-treated patients in the trials and none in placebo-treated patients, but the number is too small to allow any conclusion about drug effect on suicide.\"\n },\n {\n \"VerbatimTerm\": \"suicide\",\n \"Probability\": \"0.0930285752\",\n \"SemanticContext\": \"There were four suicides in drug-treated patients in the trials and none in placebo-treated patients, but the number is too small to allow any conclusion about drug effect on suicide.\"\n },\n {\n \"VerbatimTerm\": \"suicide\",\n \"Probability\": \"0.0009311736\",\n \"SemanticContext\": \"Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: • thoughts about suicide or dying • attempts to commit suicide • new or worse depression • new or worse anxiety • feeling agitated or restless • panic attacks • trouble sleeping insomnia • new or worse irritability • acting aggressive, being angry, or violent • acting on dangerous impulses • an extreme increase in activity and talking mania • other unusual changes in behavior or mood How can I watch for early symptoms of suicidal thoughts and actions?\"\n },\n {\n \"VerbatimTerm\": \"suicide\",\n \"Probability\": \"0.0007375479\",\n \"SemanticContext\": \"Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: • thoughts about suicide or dying • attempts to commit suicide • new or worse depression • new or worse anxiety • feeling agitated or restless • panic attacks • trouble sleeping insomnia • new or worse irritability • acting aggressive, being angry, or violent • acting on dangerous impulses • an extreme increase in activity and talking mania • other unusual changes in behavior or mood How can I watch for early symptoms of suicidal thoughts and actions?\"\n }\n ]\n },\n {\n \"Term\": \"Hypospadias\",\n \"MEDDRACode\": \"10021093\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hypospadias\",\n \"Probability\": \"0.104878217\",\n \"SemanticContext\": \"Maternal valproate use during pregnancy for any indication increases the risk of congenital malformations, particularly neural tube defects including spina bifida, but also malformations involving other body systems e.g., craniofacial defects including oral clefts, cardiovascular malformations, hypospadias, limb malformations .\"\n },\n {\n \"VerbatimTerm\": \"hypospadias\",\n \"Probability\": \"0.2925127149\",\n \"SemanticContext\": \"The major congenital malformations included cases of neural tube defects, cardiovascular malformations, craniofacial defects e.g., oral clefts, craniosynostosis , hypospadias, limb malformations e.g., clubfoot, polydactyly , and other malformations of varying severity involving other body systems [see Warnings and Precautions 5.2 ] .\"\n },\n {\n \"VerbatimTerm\": \"hypospadias\",\n \"Probability\": \"0.1464551687\",\n \"SemanticContext\": \"Pregnancy registry data show that maternal valproate use can cause neural tube defects and other structural abnormalities e.g., craniofacial defects, cardiovascular malformations, hypospadias, limb malformations .\"\n }\n ]\n },\n {\n \"Term\": \"Dysplasia\",\n \"MEDDRACode\": \"10058314\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"dysplasia\",\n \"Probability\": \"0.0210524499\",\n \"SemanticContext\": \"\\n \\n Juvenile Animal Toxicology\\n In studies of valproate in immature animals, toxic effects not observed in adult animals included retinal dysplasia in rats treated during the neonatal period from postnatal day 4 and nephrotoxicity in rats treated during the neonatal and juvenile from postnatal day 14 periods.\"\n }\n ]\n },\n {\n \"Term\": \"Testicular atrophy\",\n \"MEDDRACode\": \"10043298\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"testicular atrophy\",\n \"Probability\": \"0.1829211414\",\n \"SemanticContext\": \"\\n \\n Impairment of Fertility\\n In chronic toxicity studies in juvenile and adult rats and dogs, administration of valproate resulted in testicular atrophy and reduced spermatogenesis at oral doses of 400 mg/kg/day or greater in rats approximately equal to or greater than the maximum recommended human dose MRHD on a mg/m 2 basis and 150 mg/kg/day or greater in dogs approximately equal to or greater than the MRHD on a mg/m 2 basis .\"\n }\n ]\n },\n {\n \"Term\": \"Hypoxia\",\n \"MEDDRACode\": \"10021143\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hypoxia\",\n \"Probability\": \"0.0331251323\",\n \"SemanticContext\": \"Antiepilepsy drugs should not be abruptly discontinued in patients in whom the drug is administered to prevent major seizures because of the strong possibility of precipitating status epilepticus with attendant hypoxia and threat to life.\"\n },\n {\n \"VerbatimTerm\": \"hypoxia\",\n \"Probability\": \"0.0039750636\",\n \"SemanticContext\": \"Women with epilepsy who become pregnant while taking valproate should not discontinue valproate abruptly, as this can precipitate status epilepticus with resulting maternal and fetal hypoxia and threat to life.\"\n },\n {\n \"VerbatimTerm\": \"hypoxia\",\n \"Probability\": \"0.0130774975\",\n \"SemanticContext\": \"\\n \\n Clinical Considerations\\n Disease-Associated Maternal and/or Embryo/Fetal Risk To prevent major seizures, women with epilepsy should not discontinue valproate abruptly, as this can precipitate status epilepticus with resulting maternal and fetal hypoxia and threat to life.\"\n },\n {\n \"VerbatimTerm\": \"hypoxia\",\n \"Probability\": \"0.01091066\",\n \"SemanticContext\": \"To prevent major seizures, valproate should not be discontinued abruptly, as this can precipitate status epilepticus with resulting maternal and fetal hypoxia and threat to life.\"\n }\n ]\n },\n {\n \"Term\": \"Sedation\",\n \"MEDDRACode\": \"10039897\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"sedation\",\n \"Probability\": \"0.0018721521\",\n \"SemanticContext\": \"Monitor patients closely for signs of increased sedation or cardiorespiratory depression.\"\n }\n ]\n },\n {\n \"Term\": \"Caregiver\",\n \"MEDDRACode\": \"10007664\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"caregivers\",\n \"Probability\": \"0.000103805\",\n \"SemanticContext\": \"Suicidal Thinking and Behavior: Counsel patients, their caregivers, and families that AEDs, including divalproex sodium extended-release tablets, may increase the risk of suicidal thoughts and behavior and to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm.\"\n },\n {\n \"VerbatimTerm\": \"caregivers\",\n \"Probability\": \"0.0006474853\",\n \"SemanticContext\": \"Instruct patients, caregivers, and families to report behaviors of concern immediately to the healthcare providers [see Warnings and Precautions 5.7 ] .\"\n }\n ]\n },\n {\n \"Term\": \"Dizziness\",\n \"MEDDRACode\": \"10013573\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"dizziness\",\n \"Probability\": \"0.9994745255\",\n \"SemanticContext\": \"Divalproex sodium extended-release tablets dosage should be increased slowly and with regular monitoring for fluid and nutritional intake 5.14 ADVERSE REACTIONS • Most common adverse reactions reported > 5% are abdominal pain, alopecia, amblyopia/blurred vision, amnesia, anorexia, asthenia, ataxia, back pain, bronchitis, constipation, depression, diarrhea, diplopia, dizziness, dyspnea, dyspepsia, ecchymosis, emotional lability, fever, flu syndrome, headache, increased appetite, infection, insomnia, nausea, nervousness, nystagmus, peripheral edema, pharyngitis, rash, rhinitis, somnolence, thinking abnormal, thrombocytopenia, tinnitus, tremor, vomiting, weight gain, weight loss 6.1 , 6.2 , 6.3 .\"\n },\n {\n \"VerbatimTerm\": \"dizziness\",\n \"Probability\": \"0.9998942614\",\n \"SemanticContext\": \"Nervous System: Abnormal gait, dizziness, hypertonia, insomnia, nervousness, tremor, vertigo.\"\n },\n {\n \"VerbatimTerm\": \"dizziness\",\n \"Probability\": \"0.8074320555\",\n \"SemanticContext\": \"• Divalproex sodium extended-release tablets can cause drowsiness and dizziness.\"\n },\n {\n \"VerbatimTerm\": \"dizziness\",\n \"Probability\": \"0.0571581125\",\n \"SemanticContext\": \"Taking divalproex sodium extended-release tablets with alcohol or drugs that cause sleepiness or dizziness may make your sleepiness or dizziness worse.\"\n },\n {\n \"VerbatimTerm\": \"dizziness\",\n \"Probability\": \"0.0067454278\",\n \"SemanticContext\": \"Taking divalproex sodium extended-release tablets with alcohol or drugs that cause sleepiness or dizziness may make your sleepiness or dizziness worse.\"\n },\n {\n \"VerbatimTerm\": \"dizziness\",\n \"Probability\": \"0.7708300352\",\n \"SemanticContext\": \"The common side effects of divalproex sodium extended-release tablets include: • nausea • headache • sleepiness • vomiting • weakness • tremor • dizziness • stomach pain • blurry vision • double vision • diarrhea • increased appetite • weight gain • hair loss • loss of appetite • problems with walking or coordination These are not all of the possible side effects of divalproex sodium extended-release tablets .\"\n },\n {\n \"VerbatimTerm\": \"Dizziness\",\n \"Probability\": \"0.999345541\",\n \"SemanticContext\": \"Adverse Event Divalproex Sodium Extended-Release Tablets n = 338 % Placebo n = 263 % Somnolence 26 14 Dyspepsia 23 11 Nausea 19 13 Vomiting 13 5 Diarrhea 12 8 Dizziness 12 7 Pain 11 10 Abdominal Pain 10 5 Accidental Injury 6 5 Asthenia 6 5 Pharyngitis 6 5 .\"\n },\n {\n \"VerbatimTerm\": \"Dizziness\",\n \"Probability\": \"0.9996170998\",\n \"SemanticContext\": \"Adverse Reactions Reported by = 5% of Patients Treated with Valproate During Placebo-Controlled Trial of Adjunctive Therapy for Complex Partial Seizures Body System/Event Divalproex Sodium Delayed- Release Tablets N = 77 % Placebo N = 70 % Body as a Whole Headache 31 21 Asthenia 27 7 Fever 6 4 Gastrointestinal System Nausea 48 14 Vomiting 27 7 Abdominal Pain 23 6 Diarrhea 13 6 Anorexia 12 0 Dyspepsia 8 4 Constipation 5 1 Nervous System Somnolence 27 11 Tremor 25 6 Dizziness 25 13 Diplopia 16 9 Amblyopia/Blurred Vision 12 9 Ataxia 8 1 Nystagmus 8 1 Emotional Lability 6 4 Thinking Abnormal 6 0 Amnesia 5 1 Respiratory System Flu Syndrome 12 9 Infection 12 6 Bronchitis 5 1 Rhinitis 5 4 Other Alopecia 6 1 Weight Loss 6 0 .\"\n },\n {\n \"VerbatimTerm\": \"Dizziness\",\n \"Probability\": \"0.9998309612\",\n \"SemanticContext\": \"Body System/Event High Dose n = 131 % Low Dose n = 134 % Body as a Whole Asthenia 21 10 Digestive System Nausea 34 26 Diarrhea 23 19 Vomiting 23 15 Abdominal Pain 12 9 Anorexia 11 4 Dyspepsia 11 10 Hemic/Lymphatic System Thrombocytopenia 24 1 Ecchymosis 5 4 Metabolic/Nutritional Weight Gain 9 4 Peripheral Edema 8 3 Nervous System Tremor 57 19 Somnolence 30 18 Dizziness 18 13 Insomnia 15 9 Nervousness 11 7 Amnesia 7 4 Nystagmus 7 1 Depression 5 4 Respiratory System Infection 20 13 Pharyngitis 8 2 Dyspnea 5 1 Skin and Appendages Alopecia 24 13 Special Senses Amblyopia/Blurred Vision 8 4 Tinnitus 7 1 .\"\n },\n {\n \"VerbatimTerm\": \"Dizziness\",\n \"Probability\": \"0.9998195171\",\n \"SemanticContext\": \"Body System Reaction Divalproex Sodium Delayed-Release Tablets n = 202 % Placebo n = 81 % Gastrointestinal System Nausea 31 10 Dyspepsia 13 9 Diarrhea 12 7 Vomiting 11 1 Abdominal Pain 9 4 Increased Appetite 6 4 Nervous System Asthenia 20 9 Somnolence 17 5 Dizziness 12 6 Tremor 9 0 Other Weight Gain 8 2 Back Pain 8 6 Alopecia 7 1 .\"\n }\n ]\n },\n {\n \"Term\": \"Panic attack\",\n \"MEDDRACode\": \"10033664\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"panic attacks\",\n \"Probability\": \"0.0001401603\",\n \"SemanticContext\": \"Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: • thoughts about suicide or dying • attempts to commit suicide • new or worse depression • new or worse anxiety • feeling agitated or restless • panic attacks • trouble sleeping insomnia • new or worse irritability • acting aggressive, being angry, or violent • acting on dangerous impulses • an extreme increase in activity and talking mania • other unusual changes in behavior or mood How can I watch for early symptoms of suicidal thoughts and actions?\"\n }\n ]\n },\n {\n \"Term\": \"Atrioventricular block\",\n \"MEDDRACode\": \"10003671\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"heart block\",\n \"Probability\": \"0.9496566057\",\n \"SemanticContext\": \"10 OVERDOSAGE Overdosage with valproate may result in somnolence, heart block, deep coma, and hypernatremia.\"\n }\n ]\n },\n {\n \"Term\": \"Inborn error of metabolism\",\n \"MEDDRACode\": \"10062018\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"inborn errors of metabolism\",\n \"Probability\": \"9.69565E-05\",\n \"SemanticContext\": \"Patients with inborn errors of metabolism or reduced hepatic mitochondrial activity may be at an increased risk for hyperammonemia with or without encephalopathy.\"\n }\n ]\n },\n {\n \"Term\": \"Neuropathy peripheral\",\n \"MEDDRACode\": \"10029331\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"neuropathy\",\n \"Probability\": \"0.8392677307\",\n \"SemanticContext\": \"POLG-related disorders should be suspected in patients with a family history or suggestive symptoms of a POLG-related disorder, including but not limited to unexplained encephalopathy, refractory epilepsy focal, myoclonic , status epilepticus at presentation, developmental delays, psychomotor regression, axonal sensorimotor neuropathy, myopathy cerebellar ataxia, ophthalmoplegia, or complicated migraine with occipital aura.\"\n }\n ]\n },\n {\n \"Term\": \"Von Willebrand's disease\",\n \"MEDDRACode\": \"10047715\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"von Willebrand’s disease\",\n \"Probability\": \"0.0021495521\",\n \"SemanticContext\": \"Because of reports of cytopenias, inhibition of the secondary phase of platelet aggregation, and abnormal coagulation parameters, e.g., low fibrinogen, coagulation factor deficiencies, acquired von Willebrand’s disease , measurements of complete blood counts and coagulation tests are recommended before initiating therapy and at periodic intervals.\"\n }\n ]\n },\n {\n \"Term\": \"Vitamin supplementation\",\n \"MEDDRACode\": \"10054128\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"folic acid supplementation\",\n \"Probability\": \"8.67281E-05\",\n \"SemanticContext\": \"Evidence suggests that folic acid supplementation prior to conception and during the first trimester of pregnancy decreases the risk for congenital neural tube defects in the general population.\"\n },\n {\n \"VerbatimTerm\": \"folic acid supplementation\",\n \"Probability\": \"0.0001715422\",\n \"SemanticContext\": \"It is not known whether the risk of neural tube defects or decreased IQ in the offspring of women receiving valproate is reduced by folic acid supplementation.\"\n },\n {\n \"VerbatimTerm\": \"folic acid supplementation\",\n \"Probability\": \"2.01587E-05\",\n \"SemanticContext\": \"Dietary folic acid supplementation both prior to conception and during pregnancy should be routinely recommended for patients using valproate [see Warnings and Precautions 5.2 , 5.4 ] .\"\n },\n {\n \"VerbatimTerm\": \"folic acid supplementation\",\n \"Probability\": \"0.000169903\",\n \"SemanticContext\": \"Evidence suggests that folic acid supplementation prior to conception and during the first trimester of pregnancy decreases the risk for congenital neural tube defects in the general population [see Use in Specific Populations 8.1 ] .\"\n },\n {\n \"VerbatimTerm\": \"folic acid supplementation\",\n \"Probability\": \"8.67281E-05\",\n \"SemanticContext\": \"Evidence suggests that folic acid supplementation prior to conception and during the first trimester of pregnancy decreases the risk for congenital neural tube defects in the general population.\"\n },\n {\n \"VerbatimTerm\": \"folic acid supplementation\",\n \"Probability\": \"0.0001715422\",\n \"SemanticContext\": \"It is not known whether the risk of neural tube defects or decreased IQ in the offspring of women receiving valproate is reduced by folic acid supplementation.\"\n },\n {\n \"VerbatimTerm\": \"folic acid supplementation\",\n \"Probability\": \"1.07677E-05\",\n \"SemanticContext\": \"Dietary folic acid supplementation both prior to conception and during pregnancy should be routinely recommended for patients using valproate.\"\n }\n ]\n },\n {\n \"Term\": \"Amnesia\",\n \"MEDDRACode\": \"10001949\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"amnesia\",\n \"Probability\": \"0.989554882\",\n \"SemanticContext\": \"Divalproex sodium extended-release tablets dosage should be increased slowly and with regular monitoring for fluid and nutritional intake 5.14 ADVERSE REACTIONS • Most common adverse reactions reported > 5% are abdominal pain, alopecia, amblyopia/blurred vision, amnesia, anorexia, asthenia, ataxia, back pain, bronchitis, constipation, depression, diarrhea, diplopia, dizziness, dyspnea, dyspepsia, ecchymosis, emotional lability, fever, flu syndrome, headache, increased appetite, infection, insomnia, nausea, nervousness, nystagmus, peripheral edema, pharyngitis, rash, rhinitis, somnolence, thinking abnormal, thrombocytopenia, tinnitus, tremor, vomiting, weight gain, weight loss 6.1 , 6.2 , 6.3 .\"\n },\n {\n \"VerbatimTerm\": \"Amnesia\",\n \"Probability\": \"0.9065850377\",\n \"SemanticContext\": \"Adverse Reactions Reported by = 5% of Patients Treated with Valproate During Placebo-Controlled Trial of Adjunctive Therapy for Complex Partial Seizures Body System/Event Divalproex Sodium Delayed- Release Tablets N = 77 % Placebo N = 70 % Body as a Whole Headache 31 21 Asthenia 27 7 Fever 6 4 Gastrointestinal System Nausea 48 14 Vomiting 27 7 Abdominal Pain 23 6 Diarrhea 13 6 Anorexia 12 0 Dyspepsia 8 4 Constipation 5 1 Nervous System Somnolence 27 11 Tremor 25 6 Dizziness 25 13 Diplopia 16 9 Amblyopia/Blurred Vision 12 9 Ataxia 8 1 Nystagmus 8 1 Emotional Lability 6 4 Thinking Abnormal 6 0 Amnesia 5 1 Respiratory System Flu Syndrome 12 9 Infection 12 6 Bronchitis 5 1 Rhinitis 5 4 Other Alopecia 6 1 Weight Loss 6 0 .\"\n },\n {\n \"VerbatimTerm\": \"Amnesia\",\n \"Probability\": \"0.9815474749\",\n \"SemanticContext\": \"Body System/Event High Dose n = 131 % Low Dose n = 134 % Body as a Whole Asthenia 21 10 Digestive System Nausea 34 26 Diarrhea 23 19 Vomiting 23 15 Abdominal Pain 12 9 Anorexia 11 4 Dyspepsia 11 10 Hemic/Lymphatic System Thrombocytopenia 24 1 Ecchymosis 5 4 Metabolic/Nutritional Weight Gain 9 4 Peripheral Edema 8 3 Nervous System Tremor 57 19 Somnolence 30 18 Dizziness 18 13 Insomnia 15 9 Nervousness 11 7 Amnesia 7 4 Nystagmus 7 1 Depression 5 4 Respiratory System Infection 20 13 Pharyngitis 8 2 Dyspnea 5 1 Skin and Appendages Alopecia 24 13 Special Senses Amblyopia/Blurred Vision 8 4 Tinnitus 7 1 .\"\n }\n ]\n },\n {\n \"Term\": \"Myelodysplastic syndrome\",\n \"MEDDRACode\": \"10028533\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"myelodysplasia\",\n \"Probability\": \"0.2967339754\",\n \"SemanticContext\": \"Valproate use has also been associated with decreases in other cell lines and myelodysplasia.\"\n }\n ]\n },\n {\n \"Term\": \"Illness\",\n \"MEDDRACode\": \"10080284\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": true\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"illness\",\n \"Probability\": \"0.1576815546\",\n \"SemanticContext\": \"Anyone considering prescribing divalproex sodium extended-release tablets or any other AED must balance the risk of suicidal thoughts or behavior with the risk of untreated illness.\"\n },\n {\n \"VerbatimTerm\": \"illness\",\n \"Probability\": \"0.0005437434\",\n \"SemanticContext\": \"Should suicidal thoughts and behavior emerge during treatment, the prescriber needs to consider whether the emergence of these symptoms in any given patient may be related to the illness being treated.\"\n },\n {\n \"VerbatimTerm\": \"illness\",\n \"Probability\": \"0.0035179853\",\n \"SemanticContext\": \"8.5 Geriatric Use No patients above the age of 65 years were enrolled in double-blind prospective clinical trials of mania associated with bipolar illness.\"\n },\n {\n \"VerbatimTerm\": \"illness\",\n \"Probability\": \"0.0154417455\",\n \"SemanticContext\": \"It is not clear whether these events indicate additional risk or whether they result from preexisting medical illness and concomitant medication use among these patients.\"\n },\n {\n \"VerbatimTerm\": \"illnesses\",\n \"Probability\": \"0.0960356593\",\n \"SemanticContext\": \"Epilepsy and many other illnesses for which AEDs are prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behavior.\"\n }\n ]\n },\n {\n \"Term\": \"Blood fibrinogen\",\n \"MEDDRACode\": \"10005517\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"fibrinogen\",\n \"Probability\": \"0.0001559556\",\n \"SemanticContext\": \"Because of reports of cytopenias, inhibition of the secondary phase of platelet aggregation, and abnormal coagulation parameters, e.g., low fibrinogen, coagulation factor deficiencies, acquired von Willebrand’s disease , measurements of complete blood counts and coagulation tests are recommended before initiating therapy and at periodic intervals.\"\n }\n ]\n },\n {\n \"Term\": \"Discharge\",\n \"MEDDRACode\": \"10080907\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"discharges\",\n \"Probability\": \"0.0009220243\",\n \"SemanticContext\": \"Simple absence is defined as very brief clouding of the sensorium or loss of consciousness accompanied by certain generalized epileptic discharges without other detectable clinical signs.\"\n }\n ]\n },\n {\n \"Term\": \"Nystagmus\",\n \"MEDDRACode\": \"10029864\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"nystagmus\",\n \"Probability\": \"0.9989904165\",\n \"SemanticContext\": \"Divalproex sodium extended-release tablets dosage should be increased slowly and with regular monitoring for fluid and nutritional intake 5.14 ADVERSE REACTIONS • Most common adverse reactions reported > 5% are abdominal pain, alopecia, amblyopia/blurred vision, amnesia, anorexia, asthenia, ataxia, back pain, bronchitis, constipation, depression, diarrhea, diplopia, dizziness, dyspnea, dyspepsia, ecchymosis, emotional lability, fever, flu syndrome, headache, increased appetite, infection, insomnia, nausea, nervousness, nystagmus, peripheral edema, pharyngitis, rash, rhinitis, somnolence, thinking abnormal, thrombocytopenia, tinnitus, tremor, vomiting, weight gain, weight loss 6.1 , 6.2 , 6.3 .\"\n },\n {\n \"VerbatimTerm\": \"Nystagmus\",\n \"Probability\": \"0.9964539409\",\n \"SemanticContext\": \"Adverse Reactions Reported by = 5% of Patients Treated with Valproate During Placebo-Controlled Trial of Adjunctive Therapy for Complex Partial Seizures Body System/Event Divalproex Sodium Delayed- Release Tablets N = 77 % Placebo N = 70 % Body as a Whole Headache 31 21 Asthenia 27 7 Fever 6 4 Gastrointestinal System Nausea 48 14 Vomiting 27 7 Abdominal Pain 23 6 Diarrhea 13 6 Anorexia 12 0 Dyspepsia 8 4 Constipation 5 1 Nervous System Somnolence 27 11 Tremor 25 6 Dizziness 25 13 Diplopia 16 9 Amblyopia/Blurred Vision 12 9 Ataxia 8 1 Nystagmus 8 1 Emotional Lability 6 4 Thinking Abnormal 6 0 Amnesia 5 1 Respiratory System Flu Syndrome 12 9 Infection 12 6 Bronchitis 5 1 Rhinitis 5 4 Other Alopecia 6 1 Weight Loss 6 0 .\"\n },\n {\n \"VerbatimTerm\": \"Nystagmus\",\n \"Probability\": \"0.9973387122\",\n \"SemanticContext\": \"Body System/Event High Dose n = 131 % Low Dose n = 134 % Body as a Whole Asthenia 21 10 Digestive System Nausea 34 26 Diarrhea 23 19 Vomiting 23 15 Abdominal Pain 12 9 Anorexia 11 4 Dyspepsia 11 10 Hemic/Lymphatic System Thrombocytopenia 24 1 Ecchymosis 5 4 Metabolic/Nutritional Weight Gain 9 4 Peripheral Edema 8 3 Nervous System Tremor 57 19 Somnolence 30 18 Dizziness 18 13 Insomnia 15 9 Nervousness 11 7 Amnesia 7 4 Nystagmus 7 1 Depression 5 4 Respiratory System Infection 20 13 Pharyngitis 8 2 Dyspnea 5 1 Skin and Appendages Alopecia 24 13 Special Senses Amblyopia/Blurred Vision 8 4 Tinnitus 7 1 .\"\n }\n ]\n },\n {\n \"Term\": \"Weight increased\",\n \"MEDDRACode\": \"10047899\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"weight gain\",\n \"Probability\": \"0.9928863049\",\n \"SemanticContext\": \"Divalproex sodium extended-release tablets dosage should be increased slowly and with regular monitoring for fluid and nutritional intake 5.14 ADVERSE REACTIONS • Most common adverse reactions reported > 5% are abdominal pain, alopecia, amblyopia/blurred vision, amnesia, anorexia, asthenia, ataxia, back pain, bronchitis, constipation, depression, diarrhea, diplopia, dizziness, dyspnea, dyspepsia, ecchymosis, emotional lability, fever, flu syndrome, headache, increased appetite, infection, insomnia, nausea, nervousness, nystagmus, peripheral edema, pharyngitis, rash, rhinitis, somnolence, thinking abnormal, thrombocytopenia, tinnitus, tremor, vomiting, weight gain, weight loss 6.1 , 6.2 , 6.3 .\"\n },\n {\n \"VerbatimTerm\": \"weight gain\",\n \"Probability\": \"0.9992649555\",\n \"SemanticContext\": \"Including the long term extension study, the adverse reactions reported as the primary reason for discontinuation by = 1% of 248 valproate-treated patients were alopecia 6% , nausea and/or vomiting 5% , weight gain 2% , tremor 2% , somnolence 1% , elevated SGOT and/or SGPT 1% , and depression 1% .\"\n },\n {\n \"VerbatimTerm\": \"weight gain\",\n \"Probability\": \"0.9966635704\",\n \"SemanticContext\": \"Metabolic and Nutritional Disorders: Edema, weight gain.\"\n },\n {\n \"VerbatimTerm\": \"weight gain\",\n \"Probability\": \"0.0860957801\",\n \"SemanticContext\": \"The common side effects of divalproex sodium extended-release tablets include: • nausea • headache • sleepiness • vomiting • weakness • tremor • dizziness • stomach pain • blurry vision • double vision • diarrhea • increased appetite • weight gain • hair loss • loss of appetite • problems with walking or coordination These are not all of the possible side effects of divalproex sodium extended-release tablets .\"\n },\n {\n \"VerbatimTerm\": \"Weight Gain\",\n \"Probability\": \"0.9948019981\",\n \"SemanticContext\": \"Body System/Event High Dose n = 131 % Low Dose n = 134 % Body as a Whole Asthenia 21 10 Digestive System Nausea 34 26 Diarrhea 23 19 Vomiting 23 15 Abdominal Pain 12 9 Anorexia 11 4 Dyspepsia 11 10 Hemic/Lymphatic System Thrombocytopenia 24 1 Ecchymosis 5 4 Metabolic/Nutritional Weight Gain 9 4 Peripheral Edema 8 3 Nervous System Tremor 57 19 Somnolence 30 18 Dizziness 18 13 Insomnia 15 9 Nervousness 11 7 Amnesia 7 4 Nystagmus 7 1 Depression 5 4 Respiratory System Infection 20 13 Pharyngitis 8 2 Dyspnea 5 1 Skin and Appendages Alopecia 24 13 Special Senses Amblyopia/Blurred Vision 8 4 Tinnitus 7 1 .\"\n },\n {\n \"VerbatimTerm\": \"Weight Gain\",\n \"Probability\": \"0.9965561032\",\n \"SemanticContext\": \"Body System Reaction Divalproex Sodium Delayed-Release Tablets n = 202 % Placebo n = 81 % Gastrointestinal System Nausea 31 10 Dyspepsia 13 9 Diarrhea 12 7 Vomiting 11 1 Abdominal Pain 9 4 Increased Appetite 6 4 Nervous System Asthenia 20 9 Somnolence 17 5 Dizziness 12 6 Tremor 9 0 Other Weight Gain 8 2 Back Pain 8 6 Alopecia 7 1 .\"\n },\n {\n \"VerbatimTerm\": \"Weight gain\",\n \"Probability\": \"0.8931987882\",\n \"SemanticContext\": \"Metabolism and Nutrition: Weight gain.\"\n }\n ]\n },\n {\n \"Term\": \"Suicidal behaviour\",\n \"MEDDRACode\": \"10065604\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Suicidal behavior\",\n \"Probability\": \"0.4429201186\",\n \"SemanticContext\": \"POLG 4 , 5.1 • Suspected POLG-related disorder in children under two years of age 4 , 5.1 • Known hypersensitivity to the drug 4 , 5.12 • Urea cycle disorders 4 , 5.6 • Prophylaxis of migraine headaches: Pregnant women, women of childbearing potential not using effective contraception 4 , 8.1 WARNINGS AND PRECAUTIONS • Hepatotoxicity; evaluate high risk populations and monitor serum liver tests 5.1 • Birth defects, decreased IQ, and neurodevelopmental disorders following in utero exposure; should not be used to treat women with epilepsy or bipolar disorder who are pregnant or who plan to become pregnant or to treat a woman of childbearing potential unless other medications have failed to provide adequate symptom control or are otherwise unacceptable 5.2 , 5.3 , 5.4 • Pancreatitis; divalproex sodium extended-release tablets should ordinarily be discontinued 5.5 • Suicidal behavior or ideation; Antiepileptic drugs, including divalproex sodium extended-release tablets, increase the risk of suicidal thoughts or behavior 5.7 • Bleeding and other hematopoietic disorders; monitor platelet counts and coagulation tests 5.8 • Hyperammonemia and hyperammonemic encephalopathy; measure ammonia level if unexplained lethargy and vomiting or changes in mental status, and also with concomitant topiramate use; consider discontinuation of valproate therapy 5.6 , 5.9 , 5.10 • Hypothermia; Hypothermia has been reported during valproate therapy with or without associated hyperammonemia.\"\n },\n {\n \"VerbatimTerm\": \"Suicidal behavior\",\n \"Probability\": \"0.8217705488\",\n \"SemanticContext\": \"6 ADVERSE REACTIONS The following serious adverse reactions are described below and elsewhere in the labeling: • Hepatic failure [see Warnings and Precautions 5.1 ] • Birth defects [see Warnings and Precautions 5.2 ] • Decreased IQ following in utero exposure [see Warnings and Precautions 5.3 ] • Pancreatitis [see Warnings and Precautions 5.5 ] • Hyperammonemic encephalopathy [see Warnings and Precautions 5.6 , 5.9 , 5.10 ] • Suicidal behavior and ideation [see Warnings and Precautions 5.7 ] • Bleeding and other hematopoietic disorders [see Warnings and Precautions 5.8 ] • Hypothermia [see Warnings and Precautions 5.11 ] • Drug Reaction with Eosinophilia and Systemic Symptoms DRESS /Multiorgan hypersensitivity reactions [see Warnings and Precautions 5.12 ] • Somnolence in the elderly [see Warnings and Precautions 5.14 ] Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.\"\n },\n {\n \"VerbatimTerm\": \"Suicidal Behavior\",\n \"Probability\": \"0.4268934727\",\n \"SemanticContext\": \"5.7 Suicidal Behavior and Ideation Antiepileptic drugs AEDs , including divalproex sodium extended-release tablets, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication.\"\n },\n {\n \"VerbatimTerm\": \"suicidal behavior\",\n \"Probability\": \"0.9179433584\",\n \"SemanticContext\": \"In these trials, which had a median treatment duration of 12 weeks, the estimated incidence rate of suicidal behavior or ideation among 27,863 AED-treated patients was 0.43%, compared to 0.24% among 16,029 placebo-treated patients, representing an increase of approximately one case of suicidal thinking or behavior for every 530 patients treated.\"\n }\n ]\n },\n {\n \"Term\": \"Jaundice\",\n \"MEDDRACode\": \"10023126\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": true,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"jaundice\",\n \"Probability\": \"0.2584928274\",\n \"SemanticContext\": \"Hepatotoxicity: Warn patients and guardians that nausea, vomiting, abdominal pain, anorexia, diarrhea, asthenia, and/or jaundice can be symptoms of hepatotoxicity and, therefore, require further medical evaluation promptly [see Warnings and Precautions 5.1 ] .\"\n },\n {\n \"VerbatimTerm\": \"jaundice\",\n \"Probability\": \"0.0020905137\",\n \"SemanticContext\": \"Monitor the breastfed infant for signs of liver damage including jaundice and unusual bruising or bleeding.\"\n }\n ]\n },\n {\n \"Term\": \"Ataxia\",\n \"MEDDRACode\": \"10003591\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"ataxia\",\n \"Probability\": \"0.998503089\",\n \"SemanticContext\": \"Divalproex sodium extended-release tablets dosage should be increased slowly and with regular monitoring for fluid and nutritional intake 5.14 ADVERSE REACTIONS • Most common adverse reactions reported > 5% are abdominal pain, alopecia, amblyopia/blurred vision, amnesia, anorexia, asthenia, ataxia, back pain, bronchitis, constipation, depression, diarrhea, diplopia, dizziness, dyspnea, dyspepsia, ecchymosis, emotional lability, fever, flu syndrome, headache, increased appetite, infection, insomnia, nausea, nervousness, nystagmus, peripheral edema, pharyngitis, rash, rhinitis, somnolence, thinking abnormal, thrombocytopenia, tinnitus, tremor, vomiting, weight gain, weight loss 6.1 , 6.2 , 6.3 .\"\n },\n {\n \"VerbatimTerm\": \"ataxia\",\n \"Probability\": \"0.1483168304\",\n \"SemanticContext\": \"Prior to the initiation of divalproex sodium extended-release tablets therapy, evaluation for UCD should be considered in the following patients: 1 those with a history of unexplained encephalopathy or coma, encephalopathy associated with a protein load, pregnancy-related or postpartum encephalopathy, unexplained mental retardation, or history of elevated plasma ammonia or glutamine; 2 those with cyclical vomiting and lethargy, episodic extreme irritability, ataxia, low BUN, or protein avoidance; 3 those with a family history of UCD or a family history of unexplained infant deaths particularly males ; 4 those with other signs or symptoms of UCD.\"\n },\n {\n \"VerbatimTerm\": \"Ataxia\",\n \"Probability\": \"0.9977740049\",\n \"SemanticContext\": \"Adverse Reactions Reported by = 5% of Patients Treated with Valproate During Placebo-Controlled Trial of Adjunctive Therapy for Complex Partial Seizures Body System/Event Divalproex Sodium Delayed- Release Tablets N = 77 % Placebo N = 70 % Body as a Whole Headache 31 21 Asthenia 27 7 Fever 6 4 Gastrointestinal System Nausea 48 14 Vomiting 27 7 Abdominal Pain 23 6 Diarrhea 13 6 Anorexia 12 0 Dyspepsia 8 4 Constipation 5 1 Nervous System Somnolence 27 11 Tremor 25 6 Dizziness 25 13 Diplopia 16 9 Amblyopia/Blurred Vision 12 9 Ataxia 8 1 Nystagmus 8 1 Emotional Lability 6 4 Thinking Abnormal 6 0 Amnesia 5 1 Respiratory System Flu Syndrome 12 9 Infection 12 6 Bronchitis 5 1 Rhinitis 5 4 Other Alopecia 6 1 Weight Loss 6 0 .\"\n }\n ]\n },\n {\n \"Term\": \"Hyperammonaemia\",\n \"MEDDRACode\": \"10020575\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Hyperammonemia\",\n \"Probability\": \"0.1863477826\",\n \"SemanticContext\": \"POLG 4 , 5.1 • Suspected POLG-related disorder in children under two years of age 4 , 5.1 • Known hypersensitivity to the drug 4 , 5.12 • Urea cycle disorders 4 , 5.6 • Prophylaxis of migraine headaches: Pregnant women, women of childbearing potential not using effective contraception 4 , 8.1 WARNINGS AND PRECAUTIONS • Hepatotoxicity; evaluate high risk populations and monitor serum liver tests 5.1 • Birth defects, decreased IQ, and neurodevelopmental disorders following in utero exposure; should not be used to treat women with epilepsy or bipolar disorder who are pregnant or who plan to become pregnant or to treat a woman of childbearing potential unless other medications have failed to provide adequate symptom control or are otherwise unacceptable 5.2 , 5.3 , 5.4 • Pancreatitis; divalproex sodium extended-release tablets should ordinarily be discontinued 5.5 • Suicidal behavior or ideation; Antiepileptic drugs, including divalproex sodium extended-release tablets, increase the risk of suicidal thoughts or behavior 5.7 • Bleeding and other hematopoietic disorders; monitor platelet counts and coagulation tests 5.8 • Hyperammonemia and hyperammonemic encephalopathy; measure ammonia level if unexplained lethargy and vomiting or changes in mental status, and also with concomitant topiramate use; consider discontinuation of valproate therapy 5.6 , 5.9 , 5.10 • Hypothermia; Hypothermia has been reported during valproate therapy with or without associated hyperammonemia.\"\n },\n {\n \"VerbatimTerm\": \"Hyperammonemia\",\n \"Probability\": \"0.9892342091\",\n \"SemanticContext\": \"Therefore increased monitoring of valproate and concomitant drug concentrations and dosage adjustment are indicated whenever enzyme-inducing or inhibiting drugs are introduced or withdrawn 7.1 • Aspirin, carbapenem antibiotics, estrogen-containing hormonal contraceptives: Monitoring of valproate concentrations is recommended 7.1 • Co-administration of valproate can affect the pharmacokinetics of other drugs e.g., diazepam, ethosuximide, lamotrigine, phenytoin by inhibiting their metabolism or protein binding displacement 7.2 • Patients stabilized on rufinamide should begin valproate therapy at a low dose, and titrate to clinically effective dose 7.2 • Dosage adjustment of amitriptyline/nortriptyline, propofol, warfarin, and zidovudine may be necessary if used concomitantly with divalproex sodium extended-release tablets 7.2 • Topiramate: Hyperammonemia and encephalopathy 5.10 , 7.3 USE IN SPECIFIC POPULATIONS • Pregnancy: Divalproex sodium extended-release tablets can cause congenital malformations including neural tube defects, decreased IQ, and neurodevelopmental disorders 5.2 , 5.3 , 8.1 • Pediatric: Children under the age of two years are at considerably higher risk of fatal hepatotoxicity 5.1 , 8.4 • Geriatric: Reduce starting dose; increase dosage more slowly; monitor fluid and nutritional intake, and somnolence 5.14 , 8.5 See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.\"\n },\n {\n \"VerbatimTerm\": \"Hyperammonemia\",\n \"Probability\": \"0.310801506\",\n \"SemanticContext\": \"Hyperammonemia: Inform patients of the signs and symptoms associated with hyperammonemic encephalopathy and to notify the prescriber if any of these symptoms occur [see Warnings and Precautions 5.9 , 5.10 ].\"\n },\n {\n \"VerbatimTerm\": \"Hyperammonemia\",\n \"Probability\": \"0.5114983916\",\n \"SemanticContext\": \"5.9 Hyperammonemia Hyperammonemia has been reported in association with valproate therapy and may be present despite normal liver function tests.\"\n },\n {\n \"VerbatimTerm\": \"Hyperammonemia\",\n \"Probability\": \"0.6520287991\",\n \"SemanticContext\": \"5.9 Hyperammonemia Hyperammonemia has been reported in association with valproate therapy and may be present despite normal liver function tests.\"\n },\n {\n \"VerbatimTerm\": \"Hyperammonemia\",\n \"Probability\": \"0.0721611679\",\n \"SemanticContext\": \"Hyperammonemia should also be considered in patients who present with hypothermia [see Warnings and Precautions 5.11 ] .\"\n },\n {\n \"VerbatimTerm\": \"Hyperammonemia\",\n \"Probability\": \"0.2203319371\",\n \"SemanticContext\": \"5.10 Hyperammonemia and Encephalopathy Associated with Concomitant Topiramate Use Concomitant administration of topiramate and valproate has been associated with hyperammonemia with or without encephalopathy in patients who have tolerated either drug alone.\"\n },\n {\n \"VerbatimTerm\": \"hyperammonemia\",\n \"Probability\": \"0.0153502226\",\n \"SemanticContext\": \"POLG 4 , 5.1 • Suspected POLG-related disorder in children under two years of age 4 , 5.1 • Known hypersensitivity to the drug 4 , 5.12 • Urea cycle disorders 4 , 5.6 • Prophylaxis of migraine headaches: Pregnant women, women of childbearing potential not using effective contraception 4 , 8.1 WARNINGS AND PRECAUTIONS • Hepatotoxicity; evaluate high risk populations and monitor serum liver tests 5.1 • Birth defects, decreased IQ, and neurodevelopmental disorders following in utero exposure; should not be used to treat women with epilepsy or bipolar disorder who are pregnant or who plan to become pregnant or to treat a woman of childbearing potential unless other medications have failed to provide adequate symptom control or are otherwise unacceptable 5.2 , 5.3 , 5.4 • Pancreatitis; divalproex sodium extended-release tablets should ordinarily be discontinued 5.5 • Suicidal behavior or ideation; Antiepileptic drugs, including divalproex sodium extended-release tablets, increase the risk of suicidal thoughts or behavior 5.7 • Bleeding and other hematopoietic disorders; monitor platelet counts and coagulation tests 5.8 • Hyperammonemia and hyperammonemic encephalopathy; measure ammonia level if unexplained lethargy and vomiting or changes in mental status, and also with concomitant topiramate use; consider discontinuation of valproate therapy 5.6 , 5.9 , 5.10 • Hypothermia; Hypothermia has been reported during valproate therapy with or without associated hyperammonemia.\"\n },\n {\n \"VerbatimTerm\": \"hyperammonemia\",\n \"Probability\": \"0.1166206002\",\n \"SemanticContext\": \"7.3 Topiramate Concomitant administration of valproate and topiramate has been associated with hyperammonemia with and without encephalopathy [see Contraindications 4 and Warnings and Precautions 5.6 , 5.9 , 5.10 ] .\"\n },\n {\n \"VerbatimTerm\": \"hyperammonemia\",\n \"Probability\": \"0.0005066693\",\n \"SemanticContext\": \"Appropriate interventions for treatment of hyperammonemia should be initiated, and such patients should undergo investigation for underlying urea cycle disorders [see Contraindications 4 and Warnings and Precautions 5.6 , 5.10 ] .\"\n },\n {\n \"VerbatimTerm\": \"hyperammonemia\",\n \"Probability\": \"0.069299221\",\n \"SemanticContext\": \"5.10 Hyperammonemia and Encephalopathy Associated with Concomitant Topiramate Use Concomitant administration of topiramate and valproate has been associated with hyperammonemia with or without encephalopathy in patients who have tolerated either drug alone.\"\n },\n {\n \"VerbatimTerm\": \"hyperammonemia\",\n \"Probability\": \"0.7632671595\",\n \"SemanticContext\": \"Hypothermia can also be a manifestation of hyperammonemia [see Warnings and Precautions 5.11 ] .\"\n },\n {\n \"VerbatimTerm\": \"hyperammonemia\",\n \"Probability\": \"0.7706104517\",\n \"SemanticContext\": \"Patients with inborn errors of metabolism or reduced hepatic mitochondrial activity may be at an increased risk for hyperammonemia with or without encephalopathy.\"\n },\n {\n \"VerbatimTerm\": \"hyperammonemia\",\n \"Probability\": \"0.1863314211\",\n \"SemanticContext\": \"5.11 Hypothermia Hypothermia, defined as an unintentional drop in body core temperature to< 35°C 95°F , has been reported in association with valproate therapy both in conjunction with and in the absence of hyperammonemia.\"\n }\n ]\n },\n {\n \"Term\": \"Nephritis\",\n \"MEDDRACode\": \"10029117\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"nephritis\",\n \"Probability\": \"0.839153409\",\n \"SemanticContext\": \"DRESS typically, although not exclusively, presents with fever, rash, lymphadenopathy, and/or facial swelling, in association with other organ system involvement, such as hepatitis, nephritis, hematological abnormalities, myocarditis, or myositis sometimes resembling an acute viral infection.\"\n }\n ]\n },\n {\n \"Term\": \"Congenital anomaly\",\n \"MEDDRACode\": \"10010356\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Birth defects\",\n \"Probability\": \"0.0101186633\",\n \"SemanticContext\": \"POLG 4 , 5.1 • Suspected POLG-related disorder in children under two years of age 4 , 5.1 • Known hypersensitivity to the drug 4 , 5.12 • Urea cycle disorders 4 , 5.6 • Prophylaxis of migraine headaches: Pregnant women, women of childbearing potential not using effective contraception 4 , 8.1 WARNINGS AND PRECAUTIONS • Hepatotoxicity; evaluate high risk populations and monitor serum liver tests 5.1 • Birth defects, decreased IQ, and neurodevelopmental disorders following in utero exposure; should not be used to treat women with epilepsy or bipolar disorder who are pregnant or who plan to become pregnant or to treat a woman of childbearing potential unless other medications have failed to provide adequate symptom control or are otherwise unacceptable 5.2 , 5.3 , 5.4 • Pancreatitis; divalproex sodium extended-release tablets should ordinarily be discontinued 5.5 • Suicidal behavior or ideation; Antiepileptic drugs, including divalproex sodium extended-release tablets, increase the risk of suicidal thoughts or behavior 5.7 • Bleeding and other hematopoietic disorders; monitor platelet counts and coagulation tests 5.8 • Hyperammonemia and hyperammonemic encephalopathy; measure ammonia level if unexplained lethargy and vomiting or changes in mental status, and also with concomitant topiramate use; consider discontinuation of valproate therapy 5.6 , 5.9 , 5.10 • Hypothermia; Hypothermia has been reported during valproate therapy with or without associated hyperammonemia.\"\n },\n {\n \"VerbatimTerm\": \"Birth defects\",\n \"Probability\": \"0.9211676717\",\n \"SemanticContext\": \"6 ADVERSE REACTIONS The following serious adverse reactions are described below and elsewhere in the labeling: • Hepatic failure [see Warnings and Precautions 5.1 ] • Birth defects [see Warnings and Precautions 5.2 ] • Decreased IQ following in utero exposure [see Warnings and Precautions 5.3 ] • Pancreatitis [see Warnings and Precautions 5.5 ] • Hyperammonemic encephalopathy [see Warnings and Precautions 5.6 , 5.9 , 5.10 ] • Suicidal behavior and ideation [see Warnings and Precautions 5.7 ] • Bleeding and other hematopoietic disorders [see Warnings and Precautions 5.8 ] • Hypothermia [see Warnings and Precautions 5.11 ] • Drug Reaction with Eosinophilia and Systemic Symptoms DRESS /Multiorgan hypersensitivity reactions [see Warnings and Precautions 5.12 ] • Somnolence in the elderly [see Warnings and Precautions 5.14 ] Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.\"\n },\n {\n \"VerbatimTerm\": \"Birth defects\",\n \"Probability\": \"0.1470319927\",\n \"SemanticContext\": \"• Birth defects may occur even in children born to women who are not taking any medicines and do not have other risk factors.\"\n },\n {\n \"VerbatimTerm\": \"Birth Defects\",\n \"Probability\": \"0.2720544338\",\n \"SemanticContext\": \"Birth Defects and Decreased IQ: Inform pregnant women and women of childbearing potential including girls beginning the onset of puberty that use of valproate during pregnancy increases the risk of birth defects, decreased IQ, and neurodevelopmental disorders in children who were exposed in utero .\"\n },\n {\n \"VerbatimTerm\": \"Birth Defects\",\n \"Probability\": \"0.0865357816\",\n \"SemanticContext\": \"Based on published data from the CDC’s National Birth Defects Prevention Network, the risk of spina bifida in the general population is about 0.06 to 0.07% 6 to 7 in 10,000 births compared to the risk following in utero valproate exposure estimated to be approximately 1 to 2% 100 to 200 in 10,000 births .\"\n },\n {\n \"VerbatimTerm\": \"Birth Defects\",\n \"Probability\": \"0.069480747\",\n \"SemanticContext\": \"5.2 Structural Birth Defects Valproate can cause fetal harm when administered to a pregnant woman.\"\n },\n {\n \"VerbatimTerm\": \"birth defects\",\n \"Probability\": \"0.1370095611\",\n \"SemanticContext\": \"Birth Defects and Decreased IQ: Inform pregnant women and women of childbearing potential including girls beginning the onset of puberty that use of valproate during pregnancy increases the risk of birth defects, decreased IQ, and neurodevelopmental disorders in children who were exposed in utero .\"\n },\n {\n \"VerbatimTerm\": \"birth defects\",\n \"Probability\": \"0.0714996159\",\n \"SemanticContext\": \"In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.\"\n },\n {\n \"VerbatimTerm\": \"birth defects\",\n \"Probability\": \"0.0001780391\",\n \"SemanticContext\": \"• If you take divalproex sodium extended-release tablets during pregnancy for any medical condition, your baby is at risk for serious birth defects that affect the brain and spinal cord and are called spina bifida or neural tube defects.\"\n },\n {\n \"VerbatimTerm\": \"birth defects\",\n \"Probability\": \"0.0145025849\",\n \"SemanticContext\": \"Other birth defects that affect the structures of the heart, head, arms, legs, and the opening where the urine comes out urethra on the bottom of the penis can also happen.\"\n },\n {\n \"VerbatimTerm\": \"birth defects\",\n \"Probability\": \"0.0091016889\",\n \"SemanticContext\": \"• There may be other medicines to treat your condition that have a lower chance of causing birth defects, decreased IQ, or other disorders in your child.\"\n },\n {\n \"VerbatimTerm\": \"birth defect\",\n \"Probability\": \"0.0706795454\",\n \"SemanticContext\": \"All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.\"\n }\n ]\n },\n {\n \"Term\": \"Ammonia\",\n \"MEDDRACode\": \"10050287\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"ammonia\",\n \"Probability\": \"0.0019883513\",\n \"SemanticContext\": \"POLG 4 , 5.1 • Suspected POLG-related disorder in children under two years of age 4 , 5.1 • Known hypersensitivity to the drug 4 , 5.12 • Urea cycle disorders 4 , 5.6 • Prophylaxis of migraine headaches: Pregnant women, women of childbearing potential not using effective contraception 4 , 8.1 WARNINGS AND PRECAUTIONS • Hepatotoxicity; evaluate high risk populations and monitor serum liver tests 5.1 • Birth defects, decreased IQ, and neurodevelopmental disorders following in utero exposure; should not be used to treat women with epilepsy or bipolar disorder who are pregnant or who plan to become pregnant or to treat a woman of childbearing potential unless other medications have failed to provide adequate symptom control or are otherwise unacceptable 5.2 , 5.3 , 5.4 • Pancreatitis; divalproex sodium extended-release tablets should ordinarily be discontinued 5.5 • Suicidal behavior or ideation; Antiepileptic drugs, including divalproex sodium extended-release tablets, increase the risk of suicidal thoughts or behavior 5.7 • Bleeding and other hematopoietic disorders; monitor platelet counts and coagulation tests 5.8 • Hyperammonemia and hyperammonemic encephalopathy; measure ammonia level if unexplained lethargy and vomiting or changes in mental status, and also with concomitant topiramate use; consider discontinuation of valproate therapy 5.6 , 5.9 , 5.10 • Hypothermia; Hypothermia has been reported during valproate therapy with or without associated hyperammonemia.\"\n },\n {\n \"VerbatimTerm\": \"ammonia\",\n \"Probability\": \"0.0019852221\",\n \"SemanticContext\": \"There have been reports of acute or subacute encephalopathy in the absence of elevated ammonia levels, elevated valproate levels, or neuroimaging changes.\"\n },\n {\n \"VerbatimTerm\": \"ammonia\",\n \"Probability\": \"3.79384E-05\",\n \"SemanticContext\": \"It may be prudent to examine blood ammonia levels in patients in whom the onset of hypothermia has been reported [see Warnings and Precautions 5.9 , 5.11 ] .\"\n },\n {\n \"VerbatimTerm\": \"ammonia\",\n \"Probability\": \"0.0002066791\",\n \"SemanticContext\": \"Prior to the initiation of divalproex sodium extended-release tablets therapy, evaluation for UCD should be considered in the following patients: 1 those with a history of unexplained encephalopathy or coma, encephalopathy associated with a protein load, pregnancy-related or postpartum encephalopathy, unexplained mental retardation, or history of elevated plasma ammonia or glutamine; 2 those with cyclical vomiting and lethargy, episodic extreme irritability, ataxia, low BUN, or protein avoidance; 3 those with a family history of UCD or a family history of unexplained infant deaths particularly males ; 4 those with other signs or symptoms of UCD.\"\n },\n {\n \"VerbatimTerm\": \"ammonia\",\n \"Probability\": \"6.97912E-05\",\n \"SemanticContext\": \"In patients who develop unexplained lethargy and vomiting or changes in mental status, hyperammonemic encephalopathy should be considered and an ammonia level should be measured.\"\n },\n {\n \"VerbatimTerm\": \"ammonia\",\n \"Probability\": \"6.21616E-05\",\n \"SemanticContext\": \"If ammonia is increased, valproate therapy should be discontinued.\"\n },\n {\n \"VerbatimTerm\": \"ammonia\",\n \"Probability\": \"0.0020001531\",\n \"SemanticContext\": \"During the placebo controlled pediatric mania trial, one 1 in twenty 20 adolescents 5% treated with valproate developed increased plasma ammonia levels compared to no 0 patients treated with placebo.\"\n },\n {\n \"VerbatimTerm\": \"ammonia\",\n \"Probability\": \"0.0005972981\",\n \"SemanticContext\": \"Asymptomatic elevations of ammonia are more common and when present, require close monitoring of plasma ammonia levels.\"\n },\n {\n \"VerbatimTerm\": \"ammonia\",\n \"Probability\": \"1.54495E-05\",\n \"SemanticContext\": \"Asymptomatic elevations of ammonia are more common and when present, require close monitoring of plasma ammonia levels.\"\n },\n {\n \"VerbatimTerm\": \"ammonia\",\n \"Probability\": \"0.0002159774\",\n \"SemanticContext\": \"In patients who develop unexplained lethargy, vomiting, or changes in mental status, hyperammonemic encephalopathy should be considered and an ammonia level should be measured [see Contraindications 4 and Warnings and Precautions 5.6 , 5.9 ].\"\n },\n {\n \"VerbatimTerm\": \"ammonia\",\n \"Probability\": \"7.9403E-06\",\n \"SemanticContext\": \"Clinical management and assessment should include examination of blood ammonia levels.\"\n },\n {\n \"VerbatimTerm\": \"ammonia\",\n \"Probability\": \"8.6794E-06\",\n \"SemanticContext\": \"• High ammonia levels in your blood: feeling tired, vomiting, changes in mental status.\"\n }\n ]\n },\n {\n \"Term\": \"Insomnia\",\n \"MEDDRACode\": \"10022437\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"insomnia\",\n \"Probability\": \"0.9956718683\",\n \"SemanticContext\": \"Divalproex sodium extended-release tablets dosage should be increased slowly and with regular monitoring for fluid and nutritional intake 5.14 ADVERSE REACTIONS • Most common adverse reactions reported > 5% are abdominal pain, alopecia, amblyopia/blurred vision, amnesia, anorexia, asthenia, ataxia, back pain, bronchitis, constipation, depression, diarrhea, diplopia, dizziness, dyspnea, dyspepsia, ecchymosis, emotional lability, fever, flu syndrome, headache, increased appetite, infection, insomnia, nausea, nervousness, nystagmus, peripheral edema, pharyngitis, rash, rhinitis, somnolence, thinking abnormal, thrombocytopenia, tinnitus, tremor, vomiting, weight gain, weight loss 6.1 , 6.2 , 6.3 .\"\n },\n {\n \"VerbatimTerm\": \"insomnia\",\n \"Probability\": \"0.9990977645\",\n \"SemanticContext\": \"Nervous System: Abnormal gait, dizziness, hypertonia, insomnia, nervousness, tremor, vertigo.\"\n },\n {\n \"VerbatimTerm\": \"insomnia\",\n \"Probability\": \"5.69821E-05\",\n \"SemanticContext\": \"Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: • thoughts about suicide or dying • attempts to commit suicide • new or worse depression • new or worse anxiety • feeling agitated or restless • panic attacks • trouble sleeping insomnia • new or worse irritability • acting aggressive, being angry, or violent • acting on dangerous impulses • an extreme increase in activity and talking mania • other unusual changes in behavior or mood How can I watch for early symptoms of suicidal thoughts and actions?\"\n },\n {\n \"VerbatimTerm\": \"Insomnia\",\n \"Probability\": \"0.9841618538\",\n \"SemanticContext\": \"Body System/Event High Dose n = 131 % Low Dose n = 134 % Body as a Whole Asthenia 21 10 Digestive System Nausea 34 26 Diarrhea 23 19 Vomiting 23 15 Abdominal Pain 12 9 Anorexia 11 4 Dyspepsia 11 10 Hemic/Lymphatic System Thrombocytopenia 24 1 Ecchymosis 5 4 Metabolic/Nutritional Weight Gain 9 4 Peripheral Edema 8 3 Nervous System Tremor 57 19 Somnolence 30 18 Dizziness 18 13 Insomnia 15 9 Nervousness 11 7 Amnesia 7 4 Nystagmus 7 1 Depression 5 4 Respiratory System Infection 20 13 Pharyngitis 8 2 Dyspnea 5 1 Skin and Appendages Alopecia 24 13 Special Senses Amblyopia/Blurred Vision 8 4 Tinnitus 7 1 .\"\n }\n ]\n },\n {\n \"Term\": \"Weight\",\n \"MEDDRACode\": \"10047890\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"weight\",\n \"Probability\": \"4.5912E-05\",\n \"SemanticContext\": \"Although the available studies have methodological limitations, the weight of the evidence supports a causal association between valproate exposure in utero and subsequent adverse effects on neurodevelopment, including increases in autism spectrum disorders and attention deficit/hyperactivity disorder ADHD .\"\n },\n {\n \"VerbatimTerm\": \"weight\",\n \"Probability\": \"0.0001604855\",\n \"SemanticContext\": \"Although all of the available studies have methodological limitations, the weight of the evidence supports the conclusion that valproate exposure in utero can cause decreased IQ in children.\"\n },\n {\n \"VerbatimTerm\": \"weight\",\n \"Probability\": \"0.0037432909\",\n \"SemanticContext\": \"Pediatric patients i.e., between 3 months and 10 years have 50% higher clearances expressed on weight i.e., mL/min/kg than do adults.\"\n }\n ]\n },\n {\n \"Term\": \"Talipes\",\n \"MEDDRACode\": \"10043101\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"clubfoot\",\n \"Probability\": \"0.1331163645\",\n \"SemanticContext\": \"The major congenital malformations included cases of neural tube defects, cardiovascular malformations, craniofacial defects e.g., oral clefts, craniosynostosis , hypospadias, limb malformations e.g., clubfoot, polydactyly , and other malformations of varying severity involving other body systems [see Warnings and Precautions 5.2 ] .\"\n }\n ]\n },\n {\n \"Term\": \"Coagulation factor\",\n \"MEDDRACode\": \"10059744\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"coagulation factors\",\n \"Probability\": \"0.1126421392\",\n \"SemanticContext\": \"Pregnant women taking valproate may develop hepatic failure or clotting abnormalities including thrombocytopenia, hypofibrinogenemia, and/or decrease in other coagulation factors, which may result in hemorrhagic complications in the neonate including death [see Warnings and Precautions 5.1 , 5.8 ] .\"\n },\n {\n \"VerbatimTerm\": \"coagulation factors\",\n \"Probability\": \"0.374545455\",\n \"SemanticContext\": \"Maternal Adverse Reactions Pregnant women taking valproate may develop clotting abnormalities including thrombocytopenia, hypofibrinogenemia, and/or decrease in other coagulation factors, which may result in hemorrhagic complications in the neonate including death [see Warnings and Precautions 5.8 ] .\"\n }\n ]\n },\n {\n \"Term\": \"Blood count\",\n \"MEDDRACode\": \"10064196\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"blood counts\",\n \"Probability\": \"0.0004715621\",\n \"SemanticContext\": \"It is recommended that patients receiving divalproex sodium extended-release tablets be monitored for blood counts and coagulation parameters prior to planned surgery and during pregnancy [see Use in Specific Populations 8.1 ] .\"\n }\n ]\n },\n {\n \"Term\": \"Cerebellar ataxia\",\n \"MEDDRACode\": \"10008025\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"cerebellar ataxia\",\n \"Probability\": \"0.7867012024\",\n \"SemanticContext\": \"POLG-related disorders should be suspected in patients with a family history or suggestive symptoms of a POLG-related disorder, including but not limited to unexplained encephalopathy, refractory epilepsy focal, myoclonic , status epilepticus at presentation, developmental delays, psychomotor regression, axonal sensorimotor neuropathy, myopathy cerebellar ataxia, ophthalmoplegia, or complicated migraine with occipital aura.\"\n }\n ]\n },\n {\n \"Term\": \"Ornithine transcarbamoylase deficiency\",\n \"MEDDRACode\": \"10052450\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"ornithine transcarbamylase deficiency\",\n \"Probability\": \"0.012401998\",\n \"SemanticContext\": \"Hyperammonemic encephalopathy, sometimes fatal, has been reported following initiation of valproate therapy in patients with urea cycle disorders, a group of uncommon genetic abnormalities, particularly ornithine transcarbamylase deficiency.\"\n }\n ]\n },\n {\n \"Term\": \"Grandiosity\",\n \"MEDDRACode\": \"10018671\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"grandiosity\",\n \"Probability\": \"0.6809375882\",\n \"SemanticContext\": \"Typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, poor judgment, aggressiveness, and possible hostility.\"\n }\n ]\n },\n {\n \"Term\": \"Polydactyly\",\n \"MEDDRACode\": \"10036063\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"polydactyly\",\n \"Probability\": \"0.3856777847\",\n \"SemanticContext\": \"The major congenital malformations included cases of neural tube defects, cardiovascular malformations, craniofacial defects e.g., oral clefts, craniosynostosis , hypospadias, limb malformations e.g., clubfoot, polydactyly , and other malformations of varying severity involving other body systems [see Warnings and Precautions 5.2 ] .\"\n }\n ]\n },\n {\n \"Term\": \"Metabolic disorder\",\n \"MEDDRACode\": \"10058097\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"metabolic disorders\",\n \"Probability\": \"0.0075079501\",\n \"SemanticContext\": \"Patients on multiple anticonvulsants, children, those with congenital metabolic disorders, those with severe seizure disorders accompanied by mental retardation, and those with organic brain disease may be at particular risk.\"\n }\n ]\n },\n {\n \"Term\": \"Restlessness\",\n \"MEDDRACode\": \"10038743\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"restless\",\n \"Probability\": \"1.00877E-05\",\n \"SemanticContext\": \"Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: • thoughts about suicide or dying • attempts to commit suicide • new or worse depression • new or worse anxiety • feeling agitated or restless • panic attacks • trouble sleeping insomnia • new or worse irritability • acting aggressive, being angry, or violent • acting on dangerous impulses • an extreme increase in activity and talking mania • other unusual changes in behavior or mood How can I watch for early symptoms of suicidal thoughts and actions?\"\n }\n ]\n },\n {\n \"Term\": \"Breast feeding\",\n \"MEDDRACode\": \"10006247\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": true,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"breastfeeding\",\n \"Probability\": \"6.01289E-05\",\n \"SemanticContext\": \"Before you take divalproex sodium extended-release tablets, tell your healthcare provider if you: • have a genetic liver problem caused by a mitochondrial disorder e.g., Alpers-Huttenlocher syndrome • drink alcohol • are pregnant or breastfeeding.\"\n },\n {\n \"VerbatimTerm\": \"breastfeeding\",\n \"Probability\": \"0.0001245141\",\n \"SemanticContext\": \"\\n Clinical Considerations The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for divalproex sodium delayed-release tablets and any potential adverse effects on the breastfed infant from divalproex sodium delayed-release tablets or from the underlying maternal condition.\"\n },\n {\n \"VerbatimTerm\": \"breastfeeding\",\n \"Probability\": \"0.0009456873\",\n \"SemanticContext\": \"A published study of 6 breastfeeding mother-infant pairs measured serum valproate levels during maternal treatment for bipolar disorder 750 mg/day or 1,000 mg/day .\"\n },\n {\n \"VerbatimTerm\": \"breastfeeding\",\n \"Probability\": \"0.002110213\",\n \"SemanticContext\": \"Similarly, in 2 published case reports with maternal doses of 500 mg/day or 750 mg/day during breastfeeding of infants aged 3 months and 1 month, infant exposure was 1.5% and 6% that of the mother, respectively.\"\n },\n {\n \"VerbatimTerm\": \"breastfeeding\",\n \"Probability\": \"0.0007019639\",\n \"SemanticContext\": \"Mothers continued AED therapy during the breastfeeding period.\"\n },\n {\n \"VerbatimTerm\": \"breastfed\",\n \"Probability\": \"0.0069723427\",\n \"SemanticContext\": \"Valproate serum concentrations collected from breastfed infants aged 3 days postnatal to 12 weeks following delivery ranged from 0.7 mcg/mL to 4 mcg/mL, which were 1% to 6% of maternal serum valproate levels.\"\n },\n {\n \"VerbatimTerm\": \"breastfed\",\n \"Probability\": \"0.0006335676\",\n \"SemanticContext\": \"\\n Clinical Considerations The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for divalproex sodium delayed-release tablets and any potential adverse effects on the breastfed infant from divalproex sodium delayed-release tablets or from the underlying maternal condition.\"\n },\n {\n \"VerbatimTerm\": \"breastfed\",\n \"Probability\": \"0.0003715754\",\n \"SemanticContext\": \"Monitor the breastfed infant for signs of liver damage including jaundice and unusual bruising or bleeding.\"\n },\n {\n \"VerbatimTerm\": \"breastfed\",\n \"Probability\": \"0.0003733635\",\n \"SemanticContext\": \"Adjusted IQs measured at 3 years for breastfed and non-breastfed children were 93 n = 11 and 90 n = 24 , respectively.\"\n },\n {\n \"VerbatimTerm\": \"breastfed\",\n \"Probability\": \"0.000507772\",\n \"SemanticContext\": \"Adjusted IQs measured at 3 years for breastfed and non-breastfed children were 93 n = 11 and 90 n = 24 , respectively.\"\n },\n {\n \"VerbatimTerm\": \"breastfed\",\n \"Probability\": \"0.0015356243\",\n \"SemanticContext\": \"At 6 years, the scores for breastfed and non-breastfed children were 106 n = 11 and 94 n = 25 , respectively p = 0.04 .\"\n },\n {\n \"VerbatimTerm\": \"breastfed\",\n \"Probability\": \"0.0004484653\",\n \"SemanticContext\": \"At 6 years, the scores for breastfed and non-breastfed children were 106 n = 11 and 94 n = 25 , respectively p = 0.04 .\"\n }\n ]\n },\n {\n \"Term\": \"Gastric lavage\",\n \"MEDDRACode\": \"10017792\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"gastric lavage\",\n \"Probability\": \"0.0002068579\",\n \"SemanticContext\": \"The benefit of gastric lavage or emesis will vary with the time since ingestion.\"\n }\n ]\n },\n {\n \"Term\": \"Craniosynostosis\",\n \"MEDDRACode\": \"10049889\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"craniosynostosis\",\n \"Probability\": \"0.4438747764\",\n \"SemanticContext\": \"The major congenital malformations included cases of neural tube defects, cardiovascular malformations, craniofacial defects e.g., oral clefts, craniosynostosis , hypospadias, limb malformations e.g., clubfoot, polydactyly , and other malformations of varying severity involving other body systems [see Warnings and Precautions 5.2 ] .\"\n }\n ]\n },\n {\n \"Term\": \"Blood ketone body\",\n \"MEDDRACode\": \"10057593\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Ketone\",\n \"Probability\": \"0.0001612306\",\n \"SemanticContext\": \"5.16 Effect on Ketone and Thyroid Function Tests Valproate is partially eliminated in the urine as a keto-metabolite which may lead to a false interpretation of the urine ketone test.\"\n },\n {\n \"VerbatimTerm\": \"ketone\",\n \"Probability\": \"0.000240922\",\n \"SemanticContext\": \"5.16 Effect on Ketone and Thyroid Function Tests Valproate is partially eliminated in the urine as a keto-metabolite which may lead to a false interpretation of the urine ketone test.\"\n }\n ]\n },\n {\n \"Term\": \"Intellectual disability\",\n \"MEDDRACode\": \"10067989\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"mental retardation\",\n \"Probability\": \"0.0578224659\",\n \"SemanticContext\": \"Patients on multiple anticonvulsants, children, those with congenital metabolic disorders, those with severe seizure disorders accompanied by mental retardation, and those with organic brain disease may be at particular risk.\"\n },\n {\n \"VerbatimTerm\": \"mental retardation\",\n \"Probability\": \"0.2414073646\",\n \"SemanticContext\": \"Prior to the initiation of divalproex sodium extended-release tablets therapy, evaluation for UCD should be considered in the following patients: 1 those with a history of unexplained encephalopathy or coma, encephalopathy associated with a protein load, pregnancy-related or postpartum encephalopathy, unexplained mental retardation, or history of elevated plasma ammonia or glutamine; 2 those with cyclical vomiting and lethargy, episodic extreme irritability, ataxia, low BUN, or protein avoidance; 3 those with a family history of UCD or a family history of unexplained infant deaths particularly males ; 4 those with other signs or symptoms of UCD.\"\n }\n ]\n },\n {\n \"Term\": \"Myopathy\",\n \"MEDDRACode\": \"10028641\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"myopathy\",\n \"Probability\": \"0.7805333138\",\n \"SemanticContext\": \"POLG-related disorders should be suspected in patients with a family history or suggestive symptoms of a POLG-related disorder, including but not limited to unexplained encephalopathy, refractory epilepsy focal, myoclonic , status epilepticus at presentation, developmental delays, psychomotor regression, axonal sensorimotor neuropathy, myopathy cerebellar ataxia, ophthalmoplegia, or complicated migraine with occipital aura.\"\n }\n ]\n },\n {\n \"Term\": \"Ultrasound scan\",\n \"MEDDRACode\": \"10045434\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"U.S.\",\n \"Probability\": \"0.0006572902\",\n \"SemanticContext\": \"DIVALPROEX SODIUM extended-release tablets, for oral use Initial U.S. Approval: 2000 WARNING: LIFE THREATENING ADVERSE REACTIONS See full prescribing information for complete boxed warning • Hepatotoxicity, including fatalities, usually during the first 6 months of treatment.\"\n },\n {\n \"VerbatimTerm\": \"U.S.\",\n \"Probability\": \"0.0001934171\",\n \"SemanticContext\": \"In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.\"\n },\n {\n \"VerbatimTerm\": \"U.S.\",\n \"Probability\": \"0.000469327\",\n \"SemanticContext\": \"This Medication Guide has been approved by the U.S. Food and Drug Administration.\"\n }\n ]\n },\n {\n \"Term\": \"Poisoning\",\n \"MEDDRACode\": \"10061355\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Poison\",\n \"Probability\": \"3.9107E-06\",\n \"SemanticContext\": \"• If you take too many divalproex sodium extended-release tablets, call your healthcare provider or local Poison Control Center right away.\"\n }\n ]\n },\n {\n \"Term\": \"Vitamin E\",\n \"MEDDRACode\": \"10058765\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"vitamins\",\n \"Probability\": \"1.212E-07\",\n \"SemanticContext\": \"• have or have had depression, mood problems, or suicidal thoughts or behavior • have any other medical conditions Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, herbal supplements and medicines that you take for a short period of time.\"\n }\n ]\n },\n {\n \"Term\": \"Overdose\",\n \"MEDDRACode\": \"10033295\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"overdose\",\n \"Probability\": \"0.1864914596\",\n \"SemanticContext\": \"In overdose situations, the fraction of drug not bound to protein is high and hemodialysis or tandem hemodialysis plus hemoperfusion may result in significant removal of drug.\"\n }\n ]\n },\n {\n \"Term\": \"Adenoma benign\",\n \"MEDDRACode\": \"10001233\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"adenomas\",\n \"Probability\": \"0.0009712875\",\n \"SemanticContext\": \"The primary findings were an increase in the incidence of subcutaneous fibrosarcomas in high-dose male rats receiving valproate and a dose-related trend for benign pulmonary adenomas in male mice receiving valproate.\"\n }\n ]\n },\n {\n \"Term\": \"Coagulation factor deficiency\",\n \"MEDDRACode\": \"10067787\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"coagulation factor deficiencies\",\n \"Probability\": \"0.0442228913\",\n \"SemanticContext\": \"Because of reports of cytopenias, inhibition of the secondary phase of platelet aggregation, and abnormal coagulation parameters, e.g., low fibrinogen, coagulation factor deficiencies, acquired von Willebrand’s disease , measurements of complete blood counts and coagulation tests are recommended before initiating therapy and at periodic intervals.\"\n }\n ]\n },\n {\n \"Term\": \"Hypotension\",\n \"MEDDRACode\": \"10021097\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Hypotension\",\n \"Probability\": \"0.9970086217\",\n \"SemanticContext\": \"Cardiovascular System: Arrhythmia, Hypertension, Hypotension, Postural Hypotension.\"\n }\n ]\n },\n {\n \"Term\": \"Inappropriate antidiuretic hormone secretion\",\n \"MEDDRACode\": \"10053198\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"inappropriate ADH secretion\",\n \"Probability\": \"0.6339398026\",\n \"SemanticContext\": \"Endocrine: Irregular menses, secondary amenorrhea, hyperandrogenism, hirsutism, elevated testosterone level, breast enlargement, galactorrhea, parotid gland swelling, polycystic ovary disease, decreased carnitine concentrations, hyponatremia, hyperglycinemia, and inappropriate ADH secretion.\"\n }\n ]\n },\n {\n \"Term\": \"Osteoarthritis\",\n \"MEDDRACode\": \"10031161\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Arthrosis\",\n \"Probability\": \"0.7984292507\",\n \"SemanticContext\": \"Musculoskeletal System: Arthrosis, Myalgia.\"\n }\n ]\n },\n {\n \"Term\": \"Toxic epidermal necrolysis\",\n \"MEDDRACode\": \"10044223\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"toxic epidermal necrolysis\",\n \"Probability\": \"0.963704586\",\n \"SemanticContext\": \"Dermatologic: Hair texture changes, hair color changes, photosensitivity, erythema multiforme, toxic epidermal necrolysis, nail and nail bed disorders, and Stevens-Johnson syndrome.\"\n },\n {\n \"VerbatimTerm\": \"toxic epidermal necrolysis\",\n \"Probability\": \"0.2512135804\",\n \"SemanticContext\": \"Serious skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported with concomitant lamotrigine and valproate administration.\"\n }\n ]\n },\n {\n \"Term\": \"Drug level\",\n \"MEDDRACode\": \"10061823\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"drug levels\",\n \"Probability\": \"0.0007281601\",\n \"SemanticContext\": \"In mice, in addition to other malformations, fetal neural tube defects have been reported following valproate administration during critical periods of organogenesis, and the teratogenic response correlated with peak maternal drug levels.\"\n }\n ]\n },\n {\n \"Term\": \"Renal failure\",\n \"MEDDRACode\": \"10038435\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"renal failure\",\n \"Probability\": \"0.00722\",\n \"SemanticContext\": \"Renal Disease A slight reduction 27% in the unbound clearance of valproate has been reported in patients with renal failure creatinine clearance< 10 mL/minute ; however, hemodialysis typically reduces valproate concentrations by about 20%.\"\n },\n {\n \"VerbatimTerm\": \"renal failure\",\n \"Probability\": \"0.0003153682\",\n \"SemanticContext\": \"Therefore, no dosage adjustment appears to be necessary in patients with renal failure.\"\n }\n ]\n },\n {\n \"Term\": \"Congenital nephrotic syndrome\",\n \"MEDDRACode\": \"10060737\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"CNS\",\n \"Probability\": \"0.233169347\",\n \"SemanticContext\": \"CNS Distribution Valproate concentrations in cerebrospinal fluid CSF approximate unbound concentrations in plasma about 10% of total concentration .\"\n },\n {\n \"VerbatimTerm\": \"CNS\",\n \"Probability\": \"0.011197269\",\n \"SemanticContext\": \"CNS Depression: Since valproate products may produce CNS depression, especially when combined with another CNS depressant e.g., alcohol , advise patients not to engage in hazardous activities, such as driving an automobile or operating dangerous machinery, until it is known that they do not become drowsy from the drug.\"\n },\n {\n \"VerbatimTerm\": \"CNS\",\n \"Probability\": \"0.0114336908\",\n \"SemanticContext\": \"Naloxone has been reported to reverse the CNS depressant effects of valproate overdosage.\"\n }\n ]\n },\n {\n \"Term\": \"Constipation\",\n \"MEDDRACode\": \"10010774\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"constipation\",\n \"Probability\": \"0.999160409\",\n \"SemanticContext\": \"Divalproex sodium extended-release tablets dosage should be increased slowly and with regular monitoring for fluid and nutritional intake 5.14 ADVERSE REACTIONS • Most common adverse reactions reported > 5% are abdominal pain, alopecia, amblyopia/blurred vision, amnesia, anorexia, asthenia, ataxia, back pain, bronchitis, constipation, depression, diarrhea, diplopia, dizziness, dyspnea, dyspepsia, ecchymosis, emotional lability, fever, flu syndrome, headache, increased appetite, infection, insomnia, nausea, nervousness, nystagmus, peripheral edema, pharyngitis, rash, rhinitis, somnolence, thinking abnormal, thrombocytopenia, tinnitus, tremor, vomiting, weight gain, weight loss 6.1 , 6.2 , 6.3 .\"\n },\n {\n \"VerbatimTerm\": \"Constipation\",\n \"Probability\": \"0.9849228859\",\n \"SemanticContext\": \"Digestive System: Constipation, Dry Mouth, Dysphagia, Fecal Incontinence, Flatulence, Gastroenteritis, Glossitis, Gum Hemorrhage, Mouth Ulceration.\"\n },\n {\n \"VerbatimTerm\": \"Constipation\",\n \"Probability\": \"0.9995205402\",\n \"SemanticContext\": \"Adverse Reactions Reported by = 5% of Patients Treated with Valproate During Placebo-Controlled Trial of Adjunctive Therapy for Complex Partial Seizures Body System/Event Divalproex Sodium Delayed- Release Tablets N = 77 % Placebo N = 70 % Body as a Whole Headache 31 21 Asthenia 27 7 Fever 6 4 Gastrointestinal System Nausea 48 14 Vomiting 27 7 Abdominal Pain 23 6 Diarrhea 13 6 Anorexia 12 0 Dyspepsia 8 4 Constipation 5 1 Nervous System Somnolence 27 11 Tremor 25 6 Dizziness 25 13 Diplopia 16 9 Amblyopia/Blurred Vision 12 9 Ataxia 8 1 Nystagmus 8 1 Emotional Lability 6 4 Thinking Abnormal 6 0 Amnesia 5 1 Respiratory System Flu Syndrome 12 9 Infection 12 6 Bronchitis 5 1 Rhinitis 5 4 Other Alopecia 6 1 Weight Loss 6 0 .\"\n },\n {\n \"VerbatimTerm\": \"Constipation\",\n \"Probability\": \"0.9997503757\",\n \"SemanticContext\": \"Digestive System: Constipation, dry mouth, flatulence, and stomatitis.\"\n }\n ]\n },\n {\n \"Term\": \"Hypothermia\",\n \"MEDDRACode\": \"10021113\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Hypothermia\",\n \"Probability\": \"0.3195399046\",\n \"SemanticContext\": \"POLG 4 , 5.1 • Suspected POLG-related disorder in children under two years of age 4 , 5.1 • Known hypersensitivity to the drug 4 , 5.12 • Urea cycle disorders 4 , 5.6 • Prophylaxis of migraine headaches: Pregnant women, women of childbearing potential not using effective contraception 4 , 8.1 WARNINGS AND PRECAUTIONS • Hepatotoxicity; evaluate high risk populations and monitor serum liver tests 5.1 • Birth defects, decreased IQ, and neurodevelopmental disorders following in utero exposure; should not be used to treat women with epilepsy or bipolar disorder who are pregnant or who plan to become pregnant or to treat a woman of childbearing potential unless other medications have failed to provide adequate symptom control or are otherwise unacceptable 5.2 , 5.3 , 5.4 • Pancreatitis; divalproex sodium extended-release tablets should ordinarily be discontinued 5.5 • Suicidal behavior or ideation; Antiepileptic drugs, including divalproex sodium extended-release tablets, increase the risk of suicidal thoughts or behavior 5.7 • Bleeding and other hematopoietic disorders; monitor platelet counts and coagulation tests 5.8 • Hyperammonemia and hyperammonemic encephalopathy; measure ammonia level if unexplained lethargy and vomiting or changes in mental status, and also with concomitant topiramate use; consider discontinuation of valproate therapy 5.6 , 5.9 , 5.10 • Hypothermia; Hypothermia has been reported during valproate therapy with or without associated hyperammonemia.\"\n },\n {\n \"VerbatimTerm\": \"Hypothermia\",\n \"Probability\": \"0.5600782037\",\n \"SemanticContext\": \"POLG 4 , 5.1 • Suspected POLG-related disorder in children under two years of age 4 , 5.1 • Known hypersensitivity to the drug 4 , 5.12 • Urea cycle disorders 4 , 5.6 • Prophylaxis of migraine headaches: Pregnant women, women of childbearing potential not using effective contraception 4 , 8.1 WARNINGS AND PRECAUTIONS • Hepatotoxicity; evaluate high risk populations and monitor serum liver tests 5.1 • Birth defects, decreased IQ, and neurodevelopmental disorders following in utero exposure; should not be used to treat women with epilepsy or bipolar disorder who are pregnant or who plan to become pregnant or to treat a woman of childbearing potential unless other medications have failed to provide adequate symptom control or are otherwise unacceptable 5.2 , 5.3 , 5.4 • Pancreatitis; divalproex sodium extended-release tablets should ordinarily be discontinued 5.5 • Suicidal behavior or ideation; Antiepileptic drugs, including divalproex sodium extended-release tablets, increase the risk of suicidal thoughts or behavior 5.7 • Bleeding and other hematopoietic disorders; monitor platelet counts and coagulation tests 5.8 • Hyperammonemia and hyperammonemic encephalopathy; measure ammonia level if unexplained lethargy and vomiting or changes in mental status, and also with concomitant topiramate use; consider discontinuation of valproate therapy 5.6 , 5.9 , 5.10 • Hypothermia; Hypothermia has been reported during valproate therapy with or without associated hyperammonemia.\"\n },\n {\n \"VerbatimTerm\": \"Hypothermia\",\n \"Probability\": \"0.967176497\",\n \"SemanticContext\": \"6 ADVERSE REACTIONS The following serious adverse reactions are described below and elsewhere in the labeling: • Hepatic failure [see Warnings and Precautions 5.1 ] • Birth defects [see Warnings and Precautions 5.2 ] • Decreased IQ following in utero exposure [see Warnings and Precautions 5.3 ] • Pancreatitis [see Warnings and Precautions 5.5 ] • Hyperammonemic encephalopathy [see Warnings and Precautions 5.6 , 5.9 , 5.10 ] • Suicidal behavior and ideation [see Warnings and Precautions 5.7 ] • Bleeding and other hematopoietic disorders [see Warnings and Precautions 5.8 ] • Hypothermia [see Warnings and Precautions 5.11 ] • Drug Reaction with Eosinophilia and Systemic Symptoms DRESS /Multiorgan hypersensitivity reactions [see Warnings and Precautions 5.12 ] • Somnolence in the elderly [see Warnings and Precautions 5.14 ] Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.\"\n },\n {\n \"VerbatimTerm\": \"Hypothermia\",\n \"Probability\": \"0.0797993541\",\n \"SemanticContext\": \"Hypothermia can also be a manifestation of hyperammonemia [see Warnings and Precautions 5.11 ] .\"\n },\n {\n \"VerbatimTerm\": \"Hypothermia\",\n \"Probability\": \"0.4569534659\",\n \"SemanticContext\": \"5.11 Hypothermia Hypothermia, defined as an unintentional drop in body core temperature to < 35°C 95°F , has been reported in association with valproate therapy both in conjunction with and in the absence of hyperammonemia.\"\n },\n {\n \"VerbatimTerm\": \"Hypothermia\",\n \"Probability\": \"0.256223321\",\n \"SemanticContext\": \"5.11 Hypothermia Hypothermia, defined as an unintentional drop in body core temperature to < 35°C 95°F , has been reported in association with valproate therapy both in conjunction with and in the absence of hyperammonemia.\"\n },\n {\n \"VerbatimTerm\": \"hypothermia\",\n \"Probability\": \"0.0118187964\",\n \"SemanticContext\": \"Concomitant administration of topiramate with valproate has also been associated with hypothermia in patients who have tolerated either drug alone.\"\n },\n {\n \"VerbatimTerm\": \"hypothermia\",\n \"Probability\": \"0.0443597138\",\n \"SemanticContext\": \"It may be prudent to examine blood ammonia levels in patients in whom the onset of hypothermia has been reported [see Warnings and Precautions 5.9 , 5.11 ] .\"\n },\n {\n \"VerbatimTerm\": \"hypothermia\",\n \"Probability\": \"0.0066879392\",\n \"SemanticContext\": \"Hyperammonemia should also be considered in patients who present with hypothermia [see Warnings and Precautions 5.11 ] .\"\n },\n {\n \"VerbatimTerm\": \"hypothermia\",\n \"Probability\": \"8.47856E-05\",\n \"SemanticContext\": \"Consideration should be given to stopping valproate in patients who develop hypothermia, which may be manifested by a variety of clinical abnormalities including lethargy, confusion, coma, and significant alterations in other major organ systems such as the cardiovascular and respiratory systems.\"\n },\n {\n \"VerbatimTerm\": \"hypothermia\",\n \"Probability\": \"0.0026441514\",\n \"SemanticContext\": \"• Low body temperature hypothermia : drop in your body temperature to less than 95°F, feeling tired, confusion, coma.\"\n }\n ]\n },\n {\n \"Term\": \"Oedema\",\n \"MEDDRACode\": \"10030095\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"edema\",\n \"Probability\": \"0.6936820745\",\n \"SemanticContext\": \"Serious or fatal hepatotoxicity may be preceded by non-specific symptoms such as malaise, weakness, lethargy, facial edema, anorexia, and vomiting.\"\n },\n {\n \"VerbatimTerm\": \"Edema\",\n \"Probability\": \"0.9988139868\",\n \"SemanticContext\": \"Metabolic and Nutritional Disorders: Edema, weight gain.\"\n }\n ]\n },\n {\n \"Term\": \"Social avoidant behaviour\",\n \"MEDDRACode\": \"10041243\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"withdrawn\",\n \"Probability\": \"1.92411E-05\",\n \"SemanticContext\": \"Therefore increased monitoring of valproate and concomitant drug concentrations and dosage adjustment are indicated whenever enzyme-inducing or inhibiting drugs are introduced or withdrawn 7.1 • Aspirin, carbapenem antibiotics, estrogen-containing hormonal contraceptives: Monitoring of valproate concentrations is recommended 7.1 • Co-administration of valproate can affect the pharmacokinetics of other drugs e.g., diazepam, ethosuximide, lamotrigine, phenytoin by inhibiting their metabolism or protein binding displacement 7.2 • Patients stabilized on rufinamide should begin valproate therapy at a low dose, and titrate to clinically effective dose 7.2 • Dosage adjustment of amitriptyline/nortriptyline, propofol, warfarin, and zidovudine may be necessary if used concomitantly with divalproex sodium extended-release tablets 7.2 • Topiramate: Hyperammonemia and encephalopathy 5.10 , 7.3 USE IN SPECIFIC POPULATIONS • Pregnancy: Divalproex sodium extended-release tablets can cause congenital malformations including neural tube defects, decreased IQ, and neurodevelopmental disorders 5.2 , 5.3 , 8.1 • Pediatric: Children under the age of two years are at considerably higher risk of fatal hepatotoxicity 5.1 , 8.4 • Geriatric: Reduce starting dose; increase dosage more slowly; monitor fluid and nutritional intake, and somnolence 5.14 , 8.5 See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.\"\n },\n {\n \"VerbatimTerm\": \"withdrawn\",\n \"Probability\": \"1.80159E-05\",\n \"SemanticContext\": \"Because of these changes in valproate clearance, monitoring of antiepileptic concentrations should be intensified whenever concomitant antiepileptics are introduced or withdrawn.\"\n },\n {\n \"VerbatimTerm\": \"withdrawn\",\n \"Probability\": \"8.1273E-05\",\n \"SemanticContext\": \"Because of these changes in valproate clearance, monitoring of valproate and concomitant drug concentrations should be increased whenever enzyme inducing drugs are introduced or withdrawn.\"\n }\n ]\n },\n {\n \"Term\": \"Urticaria\",\n \"MEDDRACode\": \"10046735\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hives\",\n \"Probability\": \"0.2656555772\",\n \"SemanticContext\": \"• Allergic hypersensitivity reactions: fever, skin rash, hives, sores in your mouth, blistering and peeling of your skin, swelling of your lymph nodes, swelling of your face, eyes, lips, tongue, or throat, trouble swallowing or breathing.\"\n }\n ]\n },\n {\n \"Term\": \"Fibrosarcoma\",\n \"MEDDRACode\": \"10016632\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"fibrosarcomas\",\n \"Probability\": \"0.0022759438\",\n \"SemanticContext\": \"The primary findings were an increase in the incidence of subcutaneous fibrosarcomas in high-dose male rats receiving valproate and a dose-related trend for benign pulmonary adenomas in male mice receiving valproate.\"\n }\n ]\n },\n {\n \"Term\": \"Coagulopathy\",\n \"MEDDRACode\": \"10009802\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": true,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"abnormal coagulation\",\n \"Probability\": \"0.1180441082\",\n \"SemanticContext\": \"Because of reports of cytopenias, inhibition of the secondary phase of platelet aggregation, and abnormal coagulation parameters, e.g., low fibrinogen, coagulation factor deficiencies, acquired von Willebrand’s disease , measurements of complete blood counts and coagulation tests are recommended before initiating therapy and at periodic intervals.\"\n }\n ]\n },\n {\n \"Term\": \"Cognitive test\",\n \"MEDDRACode\": \"10083267\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"cognitive test\",\n \"Probability\": \"1.28859E-05\",\n \"SemanticContext\": \"Published epidemiological studies have indicated that children exposed to valproate in utero have lower cognitive test scores than children exposed in utero to either another antiepileptic drug or to no antiepileptic drugs.\"\n }\n ]\n },\n {\n \"Term\": \"Colostomy\",\n \"MEDDRACode\": \"10010041\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"colostomy\",\n \"Probability\": \"0.0010541677\",\n \"SemanticContext\": \"Some patients have had anatomic including ileostomy or colostomy or functional gastrointestinal disorders with shortened GI transit times.\"\n }\n ]\n },\n {\n \"Term\": \"Enzyme induction\",\n \"MEDDRACode\": \"10048652\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"enzyme induction\",\n \"Probability\": \"0.0005766153\",\n \"SemanticContext\": \"5.15 Monitoring: Drug Plasma Concentration Since valproate may interact with concurrently administered drugs which are capable of enzyme induction, periodic plasma concentration determinations of valproate and concomitant drugs are recommended during the early course of therapy [see Drug Interactions 7 ] .\"\n }\n ]\n }\n ],\n \"IndicationTerms\": []\n }\n ]\n },\n {\n \"GenericName\": \"fluticasone propionate\",\n \"MeddraVersion\": \"24.0\",\n \"Labels\": [\n {\n \"Id\": \"US17680d67-138b-4b5b-8520-21ae59ab7622\",\n \"NDCCode\": \"0173-0600\",\n \"UpdatedDate\": \"Nov 19, 2020\",\n \"LabelSource\": {\n \"Country\": \"us\",\n \"ProductId\": \"001f22f8-a83d-495f-9196-d0264ef4d76e\",\n \"FileId\": \"17680d67-138b-4b5b-8520-21ae59ab7622\",\n \"Version\": \"29\"\n },\n \"AdverseEventTerms\": [\n {\n \"Term\": \"Acne\",\n \"MEDDRACode\": \"10000496\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"acne\",\n \"Probability\": \"0.9833589792\",\n \"SemanticContext\": \"Additional Adverse Reactions Other adverse reactions not previously listed, whether considered drug-related or not by the investigators, that were reported more frequently by subjects with asthma treated with FLOVENT DISKUS compared with subjects treated with placebo include the following: palpitations; soft tissue injuries; contusions and hematomas; wounds and lacerations; burns; poisoning and toxicity; pressure-induced disorders; hoarseness/dysphonia; epistaxis; ear, nose, throat, and tonsil signs and symptoms; ear, nose, and throat polyps; allergic ear, nose, and throat disorders; throat constriction; fluid disturbances; weight gain; appetite disturbances; keratitis and conjunctivitis; blepharoconjunctivitis; gastrointestinal signs and symptoms; oral ulcerations; dental discomfort and pain; oral erythema and rashes; mouth and tongue disorders; oral discomfort and pain; tooth decay; cholecystitis; arthralgia and articular rheumatism; muscle cramps and spasms; musculoskeletal inflammation; dizziness; sleep disorders; migraines; paralysis of cranial nerves; edema and swelling; bacterial infections; fungal infections; mobility disorders; mood disorders; bacterial reproductive infections; photodermatitis; dermatitis and dermatosis; viral skin infections; eczema; pruritus; acne and folliculitis; urinary infections.\"\n }\n ]\n },\n {\n \"Term\": \"Arthralgia\",\n \"MEDDRACode\": \"10003239\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"arthralgia\",\n \"Probability\": \"0.981823802\",\n \"SemanticContext\": \"Additional Adverse Reactions Other adverse reactions not previously listed, whether considered drug-related or not by the investigators, that were reported more frequently by subjects with asthma treated with FLOVENT DISKUS compared with subjects treated with placebo include the following: palpitations; soft tissue injuries; contusions and hematomas; wounds and lacerations; burns; poisoning and toxicity; pressure-induced disorders; hoarseness/dysphonia; epistaxis; ear, nose, throat, and tonsil signs and symptoms; ear, nose, and throat polyps; allergic ear, nose, and throat disorders; throat constriction; fluid disturbances; weight gain; appetite disturbances; keratitis and conjunctivitis; blepharoconjunctivitis; gastrointestinal signs and symptoms; oral ulcerations; dental discomfort and pain; oral erythema and rashes; mouth and tongue disorders; oral discomfort and pain; tooth decay; cholecystitis; arthralgia and articular rheumatism; muscle cramps and spasms; musculoskeletal inflammation; dizziness; sleep disorders; migraines; paralysis of cranial nerves; edema and swelling; bacterial infections; fungal infections; mobility disorders; mood disorders; bacterial reproductive infections; photodermatitis; dermatitis and dermatosis; viral skin infections; eczema; pruritus; acne and folliculitis; urinary infections.\"\n },\n {\n \"VerbatimTerm\": \"Arthralgia\",\n \"Probability\": \"0.9868935347\",\n \"SemanticContext\": \"Musculoskeletal: Arthralgia and articular rheumatism 17% and 3% and muscle pain 12% and 0% .\"\n }\n ]\n },\n {\n \"Term\": \"Aggression\",\n \"MEDDRACode\": \"10001488\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"aggression\",\n \"Probability\": \"0.985976696\",\n \"SemanticContext\": \"Psychiatry Agitation, aggression, anxiety, depression, and restlessness.\"\n }\n ]\n },\n {\n \"Term\": \"Dysphonia\",\n \"MEDDRACode\": \"10013952\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"dysphonia\",\n \"Probability\": \"0.9753425121\",\n \"SemanticContext\": \"Additional Adverse Reactions Other adverse reactions not previously listed, whether considered drug-related or not by the investigators, that were reported more frequently by subjects with asthma treated with FLOVENT DISKUS compared with subjects treated with placebo include the following: palpitations; soft tissue injuries; contusions and hematomas; wounds and lacerations; burns; poisoning and toxicity; pressure-induced disorders; hoarseness/dysphonia; epistaxis; ear, nose, throat, and tonsil signs and symptoms; ear, nose, and throat polyps; allergic ear, nose, and throat disorders; throat constriction; fluid disturbances; weight gain; appetite disturbances; keratitis and conjunctivitis; blepharoconjunctivitis; gastrointestinal signs and symptoms; oral ulcerations; dental discomfort and pain; oral erythema and rashes; mouth and tongue disorders; oral discomfort and pain; tooth decay; cholecystitis; arthralgia and articular rheumatism; muscle cramps and spasms; musculoskeletal inflammation; dizziness; sleep disorders; migraines; paralysis of cranial nerves; edema and swelling; bacterial infections; fungal infections; mobility disorders; mood disorders; bacterial reproductive infections; photodermatitis; dermatitis and dermatosis; viral skin infections; eczema; pruritus; acne and folliculitis; urinary infections.\"\n },\n {\n \"VerbatimTerm\": \"dysphonia\",\n \"Probability\": \"0.9956540465\",\n \"SemanticContext\": \"Ear, Nose, and Throat: Hoarseness/dysphonia 9% and 0% , nasal congestion/blockage 16% and 0% , oral candidiasis 31% and 21% , rhinitis 13% and 9% , sinusitis/sinus infection 33% and 12% , throat irritation 10% and 9% , and upper respiratory tract infection 31% and 24% .\"\n }\n ]\n },\n {\n \"Term\": \"Epistaxis\",\n \"MEDDRACode\": \"10015090\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"epistaxis\",\n \"Probability\": \"0.9836176038\",\n \"SemanticContext\": \"Additional Adverse Reactions Other adverse reactions not previously listed, whether considered drug-related or not by the investigators, that were reported more frequently by subjects with asthma treated with FLOVENT DISKUS compared with subjects treated with placebo include the following: palpitations; soft tissue injuries; contusions and hematomas; wounds and lacerations; burns; poisoning and toxicity; pressure-induced disorders; hoarseness/dysphonia; epistaxis; ear, nose, throat, and tonsil signs and symptoms; ear, nose, and throat polyps; allergic ear, nose, and throat disorders; throat constriction; fluid disturbances; weight gain; appetite disturbances; keratitis and conjunctivitis; blepharoconjunctivitis; gastrointestinal signs and symptoms; oral ulcerations; dental discomfort and pain; oral erythema and rashes; mouth and tongue disorders; oral discomfort and pain; tooth decay; cholecystitis; arthralgia and articular rheumatism; muscle cramps and spasms; musculoskeletal inflammation; dizziness; sleep disorders; migraines; paralysis of cranial nerves; edema and swelling; bacterial infections; fungal infections; mobility disorders; mood disorders; bacterial reproductive infections; photodermatitis; dermatitis and dermatosis; viral skin infections; eczema; pruritus; acne and folliculitis; urinary infections.\"\n }\n ]\n },\n {\n \"Term\": \"Agitation\",\n \"MEDDRACode\": \"10001497\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Agitation\",\n \"Probability\": \"0.991224885\",\n \"SemanticContext\": \"Psychiatry Agitation, aggression, anxiety, depression, and restlessness.\"\n }\n ]\n },\n {\n \"Term\": \"Anxiety\",\n \"MEDDRACode\": \"10002855\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"anxiety\",\n \"Probability\": \"0.9944185019\",\n \"SemanticContext\": \"Psychiatry Agitation, aggression, anxiety, depression, and restlessness.\"\n }\n ]\n },\n {\n \"Term\": \"Cushingoid\",\n \"MEDDRACode\": \"10011655\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Cushingoid\",\n \"Probability\": \"0.2457225919\",\n \"SemanticContext\": \"Endocrine and Metabolic Cushingoid features, growth velocity reduction in children/adolescents, hyperglycemia, and osteoporosis.\"\n }\n ]\n },\n {\n \"Term\": \"Dental caries\",\n \"MEDDRACode\": \"10012318\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"tooth decay\",\n \"Probability\": \"0.9763673544\",\n \"SemanticContext\": \"Additional Adverse Reactions Other adverse reactions not previously listed, whether considered drug-related or not by the investigators, that were reported more frequently by subjects with asthma treated with FLOVENT DISKUS compared with subjects treated with placebo include the following: palpitations; soft tissue injuries; contusions and hematomas; wounds and lacerations; burns; poisoning and toxicity; pressure-induced disorders; hoarseness/dysphonia; epistaxis; ear, nose, throat, and tonsil signs and symptoms; ear, nose, and throat polyps; allergic ear, nose, and throat disorders; throat constriction; fluid disturbances; weight gain; appetite disturbances; keratitis and conjunctivitis; blepharoconjunctivitis; gastrointestinal signs and symptoms; oral ulcerations; dental discomfort and pain; oral erythema and rashes; mouth and tongue disorders; oral discomfort and pain; tooth decay; cholecystitis; arthralgia and articular rheumatism; muscle cramps and spasms; musculoskeletal inflammation; dizziness; sleep disorders; migraines; paralysis of cranial nerves; edema and swelling; bacterial infections; fungal infections; mobility disorders; mood disorders; bacterial reproductive infections; photodermatitis; dermatitis and dermatosis; viral skin infections; eczema; pruritus; acne and folliculitis; urinary infections.\"\n }\n ]\n },\n {\n \"Term\": \"Dental discomfort\",\n \"MEDDRACode\": \"10054217\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"dental discomfort\",\n \"Probability\": \"0.8380454183\",\n \"SemanticContext\": \"Additional Adverse Reactions Other adverse reactions not previously listed, whether considered drug-related or not by the investigators, that were reported more frequently by subjects with asthma treated with FLOVENT DISKUS compared with subjects treated with placebo include the following: palpitations; soft tissue injuries; contusions and hematomas; wounds and lacerations; burns; poisoning and toxicity; pressure-induced disorders; hoarseness/dysphonia; epistaxis; ear, nose, throat, and tonsil signs and symptoms; ear, nose, and throat polyps; allergic ear, nose, and throat disorders; throat constriction; fluid disturbances; weight gain; appetite disturbances; keratitis and conjunctivitis; blepharoconjunctivitis; gastrointestinal signs and symptoms; oral ulcerations; dental discomfort and pain; oral erythema and rashes; mouth and tongue disorders; oral discomfort and pain; tooth decay; cholecystitis; arthralgia and articular rheumatism; muscle cramps and spasms; musculoskeletal inflammation; dizziness; sleep disorders; migraines; paralysis of cranial nerves; edema and swelling; bacterial infections; fungal infections; mobility disorders; mood disorders; bacterial reproductive infections; photodermatitis; dermatitis and dermatosis; viral skin infections; eczema; pruritus; acne and folliculitis; urinary infections.\"\n }\n ]\n },\n {\n \"Term\": \"Conjunctivitis\",\n \"MEDDRACode\": \"10010741\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"conjunctivitis\",\n \"Probability\": \"0.9823349714\",\n \"SemanticContext\": \"Additional Adverse Reactions Other adverse reactions not previously listed, whether considered drug-related or not by the investigators, that were reported more frequently by subjects with asthma treated with FLOVENT DISKUS compared with subjects treated with placebo include the following: palpitations; soft tissue injuries; contusions and hematomas; wounds and lacerations; burns; poisoning and toxicity; pressure-induced disorders; hoarseness/dysphonia; epistaxis; ear, nose, throat, and tonsil signs and symptoms; ear, nose, and throat polyps; allergic ear, nose, and throat disorders; throat constriction; fluid disturbances; weight gain; appetite disturbances; keratitis and conjunctivitis; blepharoconjunctivitis; gastrointestinal signs and symptoms; oral ulcerations; dental discomfort and pain; oral erythema and rashes; mouth and tongue disorders; oral discomfort and pain; tooth decay; cholecystitis; arthralgia and articular rheumatism; muscle cramps and spasms; musculoskeletal inflammation; dizziness; sleep disorders; migraines; paralysis of cranial nerves; edema and swelling; bacterial infections; fungal infections; mobility disorders; mood disorders; bacterial reproductive infections; photodermatitis; dermatitis and dermatosis; viral skin infections; eczema; pruritus; acne and folliculitis; urinary infections.\"\n },\n {\n \"VerbatimTerm\": \"conjunctivitis\",\n \"Probability\": \"0.0016796291\",\n \"SemanticContext\": \"Transfer of patients from systemic corticosteroid therapy to FLOVENT DISKUS may unmask allergic conditions previously suppressed by the systemic corticosteroid therapy e.g., rhinitis, conjunctivitis, eczema, arthritis, eosinophilic conditions .\"\n }\n ]\n },\n {\n \"Term\": \"Migraine\",\n \"MEDDRACode\": \"10027599\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"migraines\",\n \"Probability\": \"0.9920248985\",\n \"SemanticContext\": \"Additional Adverse Reactions Other adverse reactions not previously listed, whether considered drug-related or not by the investigators, that were reported more frequently by subjects with asthma treated with FLOVENT DISKUS compared with subjects treated with placebo include the following: palpitations; soft tissue injuries; contusions and hematomas; wounds and lacerations; burns; poisoning and toxicity; pressure-induced disorders; hoarseness/dysphonia; epistaxis; ear, nose, throat, and tonsil signs and symptoms; ear, nose, and throat polyps; allergic ear, nose, and throat disorders; throat constriction; fluid disturbances; weight gain; appetite disturbances; keratitis and conjunctivitis; blepharoconjunctivitis; gastrointestinal signs and symptoms; oral ulcerations; dental discomfort and pain; oral erythema and rashes; mouth and tongue disorders; oral discomfort and pain; tooth decay; cholecystitis; arthralgia and articular rheumatism; muscle cramps and spasms; musculoskeletal inflammation; dizziness; sleep disorders; migraines; paralysis of cranial nerves; edema and swelling; bacterial infections; fungal infections; mobility disorders; mood disorders; bacterial reproductive infections; photodermatitis; dermatitis and dermatosis; viral skin infections; eczema; pruritus; acne and folliculitis; urinary infections.\"\n }\n ]\n },\n {\n \"Term\": \"Chest discomfort\",\n \"MEDDRACode\": \"10008469\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"chest tightness\",\n \"Probability\": \"0.9974161386\",\n \"SemanticContext\": \"Respiratory Asthma exacerbation, bronchospasm, chest tightness, dyspnea, immediate bronchospasm, pneumonia, and wheeze.\"\n }\n ]\n },\n {\n \"Term\": \"Dermatosis\",\n \"MEDDRACode\": \"10048768\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"dermatosis\",\n \"Probability\": \"0.922711134\",\n \"SemanticContext\": \"Additional Adverse Reactions Other adverse reactions not previously listed, whether considered drug-related or not by the investigators, that were reported more frequently by subjects with asthma treated with FLOVENT DISKUS compared with subjects treated with placebo include the following: palpitations; soft tissue injuries; contusions and hematomas; wounds and lacerations; burns; poisoning and toxicity; pressure-induced disorders; hoarseness/dysphonia; epistaxis; ear, nose, throat, and tonsil signs and symptoms; ear, nose, and throat polyps; allergic ear, nose, and throat disorders; throat constriction; fluid disturbances; weight gain; appetite disturbances; keratitis and conjunctivitis; blepharoconjunctivitis; gastrointestinal signs and symptoms; oral ulcerations; dental discomfort and pain; oral erythema and rashes; mouth and tongue disorders; oral discomfort and pain; tooth decay; cholecystitis; arthralgia and articular rheumatism; muscle cramps and spasms; musculoskeletal inflammation; dizziness; sleep disorders; migraines; paralysis of cranial nerves; edema and swelling; bacterial infections; fungal infections; mobility disorders; mood disorders; bacterial reproductive infections; photodermatitis; dermatitis and dermatosis; viral skin infections; eczema; pruritus; acne and folliculitis; urinary infections.\"\n }\n ]\n },\n {\n \"Term\": \"Dizziness\",\n \"MEDDRACode\": \"10013573\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"dizziness\",\n \"Probability\": \"0.9685988426\",\n \"SemanticContext\": \"Additional Adverse Reactions Other adverse reactions not previously listed, whether considered drug-related or not by the investigators, that were reported more frequently by subjects with asthma treated with FLOVENT DISKUS compared with subjects treated with placebo include the following: palpitations; soft tissue injuries; contusions and hematomas; wounds and lacerations; burns; poisoning and toxicity; pressure-induced disorders; hoarseness/dysphonia; epistaxis; ear, nose, throat, and tonsil signs and symptoms; ear, nose, and throat polyps; allergic ear, nose, and throat disorders; throat constriction; fluid disturbances; weight gain; appetite disturbances; keratitis and conjunctivitis; blepharoconjunctivitis; gastrointestinal signs and symptoms; oral ulcerations; dental discomfort and pain; oral erythema and rashes; mouth and tongue disorders; oral discomfort and pain; tooth decay; cholecystitis; arthralgia and articular rheumatism; muscle cramps and spasms; musculoskeletal inflammation; dizziness; sleep disorders; migraines; paralysis of cranial nerves; edema and swelling; bacterial infections; fungal infections; mobility disorders; mood disorders; bacterial reproductive infections; photodermatitis; dermatitis and dermatosis; viral skin infections; eczema; pruritus; acne and folliculitis; urinary infections.\"\n }\n ]\n },\n {\n \"Term\": \"Ecchymosis\",\n \"MEDDRACode\": \"10014080\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"ecchymoses\",\n \"Probability\": \"0.8594121933\",\n \"SemanticContext\": \"Skin Contusions and ecchymoses.\"\n }\n ]\n },\n {\n \"Term\": \"Infestation\",\n \"MEDDRACode\": \"10061217\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Infestations\",\n \"Probability\": \"0.337605834\",\n \"SemanticContext\": \"Infections and Infestations Esophageal candidiasis.\"\n }\n ]\n },\n {\n \"Term\": \"Respiratory tract infection\",\n \"MEDDRACode\": \"10062352\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"respiratory infection\",\n \"Probability\": \"0.9857274294\",\n \"SemanticContext\": \"Adverse Reactions with FLOVENT DISKUS with >3% Incidence and More Common than Placebo in Subjects with Asthma Adverse Event FLOVENT DISKUS 50 mcg Twice Daily n = 178 % FLOVENT DISKUS 100 mcg Twice Daily n = 305 % FLOVENT DISKUS 250 mcg Twice Daily n = 86 % FLOVENT DISKUS 500 mcg Twice Daily n = 64 % Placebo n = 543 % Ear, nose, and throat Upper respiratory tract infection 20 18 21 14 16 Throat irritation 13 13 3 22 8 Sinusitis/sinus infection 9 10 6 6 6 Upper respiratory inflammation 5 5 0 5 3 Rhinitis 4 3 1 2 2 Oral candidiasis \\n <1 9 6 5 7 Gastrointestinal Nausea and vomiting 8 4 1 2 4 Gastrointestinal discomfort and pain 4 3 2 2 3 Viral gastrointestinal infection 4 3 3 5 1 Non-site specific Fever 7 7 1 2 4 Viral infection 2 2 0 5 2 Lower respiratory Viral respiratory infection 4 5 1 2 4 Cough 3 5 1 5 4 Bronchitis 2 3 0 8 1 Neurological Headache 12 12 2 14 7 Musculoskeletal and trauma Muscle injury 2 0 1 5 1 Musculoskeletal pain 4 3 2 5 2 Injury 2 \\n <1 0 5 \\n <1 .\"\n },\n {\n \"VerbatimTerm\": \"respiratory infections\",\n \"Probability\": \"0.99435848\",\n \"SemanticContext\": \"Lower Respiratory: Cough 9% and 3% and viral respiratory infections 9% and 6% .\"\n }\n ]\n },\n {\n \"Term\": \"Affective disorder\",\n \"MEDDRACode\": \"10001443\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"mood disorders\",\n \"Probability\": \"0.749492228\",\n \"SemanticContext\": \"Additional Adverse Reactions Other adverse reactions not previously listed, whether considered drug-related or not by the investigators, that were reported more frequently by subjects with asthma treated with FLOVENT DISKUS compared with subjects treated with placebo include the following: palpitations; soft tissue injuries; contusions and hematomas; wounds and lacerations; burns; poisoning and toxicity; pressure-induced disorders; hoarseness/dysphonia; epistaxis; ear, nose, throat, and tonsil signs and symptoms; ear, nose, and throat polyps; allergic ear, nose, and throat disorders; throat constriction; fluid disturbances; weight gain; appetite disturbances; keratitis and conjunctivitis; blepharoconjunctivitis; gastrointestinal signs and symptoms; oral ulcerations; dental discomfort and pain; oral erythema and rashes; mouth and tongue disorders; oral discomfort and pain; tooth decay; cholecystitis; arthralgia and articular rheumatism; muscle cramps and spasms; musculoskeletal inflammation; dizziness; sleep disorders; migraines; paralysis of cranial nerves; edema and swelling; bacterial infections; fungal infections; mobility disorders; mood disorders; bacterial reproductive infections; photodermatitis; dermatitis and dermatosis; viral skin infections; eczema; pruritus; acne and folliculitis; urinary infections.\"\n }\n ]\n },\n {\n \"Term\": \"Cholecystitis\",\n \"MEDDRACode\": \"10008612\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"cholecystitis\",\n \"Probability\": \"0.8898516893\",\n \"SemanticContext\": \"Additional Adverse Reactions Other adverse reactions not previously listed, whether considered drug-related or not by the investigators, that were reported more frequently by subjects with asthma treated with FLOVENT DISKUS compared with subjects treated with placebo include the following: palpitations; soft tissue injuries; contusions and hematomas; wounds and lacerations; burns; poisoning and toxicity; pressure-induced disorders; hoarseness/dysphonia; epistaxis; ear, nose, throat, and tonsil signs and symptoms; ear, nose, and throat polyps; allergic ear, nose, and throat disorders; throat constriction; fluid disturbances; weight gain; appetite disturbances; keratitis and conjunctivitis; blepharoconjunctivitis; gastrointestinal signs and symptoms; oral ulcerations; dental discomfort and pain; oral erythema and rashes; mouth and tongue disorders; oral discomfort and pain; tooth decay; cholecystitis; arthralgia and articular rheumatism; muscle cramps and spasms; musculoskeletal inflammation; dizziness; sleep disorders; migraines; paralysis of cranial nerves; edema and swelling; bacterial infections; fungal infections; mobility disorders; mood disorders; bacterial reproductive infections; photodermatitis; dermatitis and dermatosis; viral skin infections; eczema; pruritus; acne and folliculitis; urinary infections.\"\n }\n ]\n },\n {\n \"Term\": \"Oedema\",\n \"MEDDRACode\": \"10030095\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"edema\",\n \"Probability\": \"0.9883309007\",\n \"SemanticContext\": \"Additional Adverse Reactions Other adverse reactions not previously listed, whether considered drug-related or not by the investigators, that were reported more frequently by subjects with asthma treated with FLOVENT DISKUS compared with subjects treated with placebo include the following: palpitations; soft tissue injuries; contusions and hematomas; wounds and lacerations; burns; poisoning and toxicity; pressure-induced disorders; hoarseness/dysphonia; epistaxis; ear, nose, throat, and tonsil signs and symptoms; ear, nose, and throat polyps; allergic ear, nose, and throat disorders; throat constriction; fluid disturbances; weight gain; appetite disturbances; keratitis and conjunctivitis; blepharoconjunctivitis; gastrointestinal signs and symptoms; oral ulcerations; dental discomfort and pain; oral erythema and rashes; mouth and tongue disorders; oral discomfort and pain; tooth decay; cholecystitis; arthralgia and articular rheumatism; muscle cramps and spasms; musculoskeletal inflammation; dizziness; sleep disorders; migraines; paralysis of cranial nerves; edema and swelling; bacterial infections; fungal infections; mobility disorders; mood disorders; bacterial reproductive infections; photodermatitis; dermatitis and dermatosis; viral skin infections; eczema; pruritus; acne and folliculitis; urinary infections.\"\n }\n ]\n },\n {\n \"Term\": \"Psychomotor hyperactivity\",\n \"MEDDRACode\": \"10037211\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hyperactivity\",\n \"Probability\": \"0.9859768152\",\n \"SemanticContext\": \"Behavioral changes, including hyperactivity and irritability, have been reported very rarely and primarily in children.\"\n }\n ]\n },\n {\n \"Term\": \"Dyspnoea\",\n \"MEDDRACode\": \"10013968\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"dyspnea\",\n \"Probability\": \"0.9979641438\",\n \"SemanticContext\": \"Respiratory Asthma exacerbation, bronchospasm, chest tightness, dyspnea, immediate bronchospasm, pneumonia, and wheeze.\"\n }\n ]\n },\n {\n \"Term\": \"Folliculitis\",\n \"MEDDRACode\": \"10016936\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"folliculitis\",\n \"Probability\": \"0.9909840822\",\n \"SemanticContext\": \"Additional Adverse Reactions Other adverse reactions not previously listed, whether considered drug-related or not by the investigators, that were reported more frequently by subjects with asthma treated with FLOVENT DISKUS compared with subjects treated with placebo include the following: palpitations; soft tissue injuries; contusions and hematomas; wounds and lacerations; burns; poisoning and toxicity; pressure-induced disorders; hoarseness/dysphonia; epistaxis; ear, nose, throat, and tonsil signs and symptoms; ear, nose, and throat polyps; allergic ear, nose, and throat disorders; throat constriction; fluid disturbances; weight gain; appetite disturbances; keratitis and conjunctivitis; blepharoconjunctivitis; gastrointestinal signs and symptoms; oral ulcerations; dental discomfort and pain; oral erythema and rashes; mouth and tongue disorders; oral discomfort and pain; tooth decay; cholecystitis; arthralgia and articular rheumatism; muscle cramps and spasms; musculoskeletal inflammation; dizziness; sleep disorders; migraines; paralysis of cranial nerves; edema and swelling; bacterial infections; fungal infections; mobility disorders; mood disorders; bacterial reproductive infections; photodermatitis; dermatitis and dermatosis; viral skin infections; eczema; pruritus; acne and folliculitis; urinary infections.\"\n }\n ]\n },\n {\n \"Term\": \"Aphonia\",\n \"MEDDRACode\": \"10002953\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Aphonia\",\n \"Probability\": \"0.353900522\",\n \"SemanticContext\": \"Ear, Nose, and Throat Aphonia, facial and oropharyngeal edema, and throat soreness.\"\n }\n ]\n },\n {\n \"Term\": \"Erythema\",\n \"MEDDRACode\": \"10015150\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"erythema\",\n \"Probability\": \"0.9713189602\",\n \"SemanticContext\": \"Additional Adverse Reactions Other adverse reactions not previously listed, whether considered drug-related or not by the investigators, that were reported more frequently by subjects with asthma treated with FLOVENT DISKUS compared with subjects treated with placebo include the following: palpitations; soft tissue injuries; contusions and hematomas; wounds and lacerations; burns; poisoning and toxicity; pressure-induced disorders; hoarseness/dysphonia; epistaxis; ear, nose, throat, and tonsil signs and symptoms; ear, nose, and throat polyps; allergic ear, nose, and throat disorders; throat constriction; fluid disturbances; weight gain; appetite disturbances; keratitis and conjunctivitis; blepharoconjunctivitis; gastrointestinal signs and symptoms; oral ulcerations; dental discomfort and pain; oral erythema and rashes; mouth and tongue disorders; oral discomfort and pain; tooth decay; cholecystitis; arthralgia and articular rheumatism; muscle cramps and spasms; musculoskeletal inflammation; dizziness; sleep disorders; migraines; paralysis of cranial nerves; edema and swelling; bacterial infections; fungal infections; mobility disorders; mood disorders; bacterial reproductive infections; photodermatitis; dermatitis and dermatosis; viral skin infections; eczema; pruritus; acne and folliculitis; urinary infections.\"\n }\n ]\n },\n {\n \"Term\": \"Fungal infection\",\n \"MEDDRACode\": \"10017533\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"fungal infections\",\n \"Probability\": \"0.9737936854\",\n \"SemanticContext\": \"Additional Adverse Reactions Other adverse reactions not previously listed, whether considered drug-related or not by the investigators, that were reported more frequently by subjects with asthma treated with FLOVENT DISKUS compared with subjects treated with placebo include the following: palpitations; soft tissue injuries; contusions and hematomas; wounds and lacerations; burns; poisoning and toxicity; pressure-induced disorders; hoarseness/dysphonia; epistaxis; ear, nose, throat, and tonsil signs and symptoms; ear, nose, and throat polyps; allergic ear, nose, and throat disorders; throat constriction; fluid disturbances; weight gain; appetite disturbances; keratitis and conjunctivitis; blepharoconjunctivitis; gastrointestinal signs and symptoms; oral ulcerations; dental discomfort and pain; oral erythema and rashes; mouth and tongue disorders; oral discomfort and pain; tooth decay; cholecystitis; arthralgia and articular rheumatism; muscle cramps and spasms; musculoskeletal inflammation; dizziness; sleep disorders; migraines; paralysis of cranial nerves; edema and swelling; bacterial infections; fungal infections; mobility disorders; mood disorders; bacterial reproductive infections; photodermatitis; dermatitis and dermatosis; viral skin infections; eczema; pruritus; acne and folliculitis; urinary infections.\"\n }\n ]\n },\n {\n \"Term\": \"Paralysis\",\n \"MEDDRACode\": \"10033799\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"paralysis\",\n \"Probability\": \"0.9753426313\",\n \"SemanticContext\": \"Additional Adverse Reactions Other adverse reactions not previously listed, whether considered drug-related or not by the investigators, that were reported more frequently by subjects with asthma treated with FLOVENT DISKUS compared with subjects treated with placebo include the following: palpitations; soft tissue injuries; contusions and hematomas; wounds and lacerations; burns; poisoning and toxicity; pressure-induced disorders; hoarseness/dysphonia; epistaxis; ear, nose, throat, and tonsil signs and symptoms; ear, nose, and throat polyps; allergic ear, nose, and throat disorders; throat constriction; fluid disturbances; weight gain; appetite disturbances; keratitis and conjunctivitis; blepharoconjunctivitis; gastrointestinal signs and symptoms; oral ulcerations; dental discomfort and pain; oral erythema and rashes; mouth and tongue disorders; oral discomfort and pain; tooth decay; cholecystitis; arthralgia and articular rheumatism; muscle cramps and spasms; musculoskeletal inflammation; dizziness; sleep disorders; migraines; paralysis of cranial nerves; edema and swelling; bacterial infections; fungal infections; mobility disorders; mood disorders; bacterial reproductive infections; photodermatitis; dermatitis and dermatosis; viral skin infections; eczema; pruritus; acne and folliculitis; urinary infections.\"\n }\n ]\n },\n {\n \"Term\": \"Gastrointestinal viral infection\",\n \"MEDDRACode\": \"10069049\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Viral gastrointestinal infection\",\n \"Probability\": \"0.9925435781\",\n \"SemanticContext\": \"Adverse Reactions with FLOVENT DISKUS with >3% Incidence and More Common than Placebo in Subjects with Asthma Adverse Event FLOVENT DISKUS 50 mcg Twice Daily n = 178 % FLOVENT DISKUS 100 mcg Twice Daily n = 305 % FLOVENT DISKUS 250 mcg Twice Daily n = 86 % FLOVENT DISKUS 500 mcg Twice Daily n = 64 % Placebo n = 543 % Ear, nose, and throat Upper respiratory tract infection 20 18 21 14 16 Throat irritation 13 13 3 22 8 Sinusitis/sinus infection 9 10 6 6 6 Upper respiratory inflammation 5 5 0 5 3 Rhinitis 4 3 1 2 2 Oral candidiasis \\n <1 9 6 5 7 Gastrointestinal Nausea and vomiting 8 4 1 2 4 Gastrointestinal discomfort and pain 4 3 2 2 3 Viral gastrointestinal infection 4 3 3 5 1 Non-site specific Fever 7 7 1 2 4 Viral infection 2 2 0 5 2 Lower respiratory Viral respiratory infection 4 5 1 2 4 Cough 3 5 1 5 4 Bronchitis 2 3 0 8 1 Neurological Headache 12 12 2 14 7 Musculoskeletal and trauma Muscle injury 2 0 1 5 1 Musculoskeletal pain 4 3 2 5 2 Injury 2 \\n <1 0 5 \\n <1 .\"\n }\n ]\n },\n {\n \"Term\": \"Dermatitis\",\n \"MEDDRACode\": \"10012431\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"dermatitis\",\n \"Probability\": \"0.9946469069\",\n \"SemanticContext\": \"Additional Adverse Reactions Other adverse reactions not previously listed, whether considered drug-related or not by the investigators, that were reported more frequently by subjects with asthma treated with FLOVENT DISKUS compared with subjects treated with placebo include the following: palpitations; soft tissue injuries; contusions and hematomas; wounds and lacerations; burns; poisoning and toxicity; pressure-induced disorders; hoarseness/dysphonia; epistaxis; ear, nose, throat, and tonsil signs and symptoms; ear, nose, and throat polyps; allergic ear, nose, and throat disorders; throat constriction; fluid disturbances; weight gain; appetite disturbances; keratitis and conjunctivitis; blepharoconjunctivitis; gastrointestinal signs and symptoms; oral ulcerations; dental discomfort and pain; oral erythema and rashes; mouth and tongue disorders; oral discomfort and pain; tooth decay; cholecystitis; arthralgia and articular rheumatism; muscle cramps and spasms; musculoskeletal inflammation; dizziness; sleep disorders; migraines; paralysis of cranial nerves; edema and swelling; bacterial infections; fungal infections; mobility disorders; mood disorders; bacterial reproductive infections; photodermatitis; dermatitis and dermatosis; viral skin infections; eczema; pruritus; acne and folliculitis; urinary infections.\"\n }\n ]\n },\n {\n \"Term\": \"Bacterial infection\",\n \"MEDDRACode\": \"10060945\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"bacterial infections\",\n \"Probability\": \"0.7578201294\",\n \"SemanticContext\": \"Additional Adverse Reactions Other adverse reactions not previously listed, whether considered drug-related or not by the investigators, that were reported more frequently by subjects with asthma treated with FLOVENT DISKUS compared with subjects treated with placebo include the following: palpitations; soft tissue injuries; contusions and hematomas; wounds and lacerations; burns; poisoning and toxicity; pressure-induced disorders; hoarseness/dysphonia; epistaxis; ear, nose, throat, and tonsil signs and symptoms; ear, nose, and throat polyps; allergic ear, nose, and throat disorders; throat constriction; fluid disturbances; weight gain; appetite disturbances; keratitis and conjunctivitis; blepharoconjunctivitis; gastrointestinal signs and symptoms; oral ulcerations; dental discomfort and pain; oral erythema and rashes; mouth and tongue disorders; oral discomfort and pain; tooth decay; cholecystitis; arthralgia and articular rheumatism; muscle cramps and spasms; musculoskeletal inflammation; dizziness; sleep disorders; migraines; paralysis of cranial nerves; edema and swelling; bacterial infections; fungal infections; mobility disorders; mood disorders; bacterial reproductive infections; photodermatitis; dermatitis and dermatosis; viral skin infections; eczema; pruritus; acne and folliculitis; urinary infections.\"\n }\n ]\n },\n {\n \"Term\": \"Contusion\",\n \"MEDDRACode\": \"10050584\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"contusions\",\n \"Probability\": \"0.1622567177\",\n \"SemanticContext\": \"Additional Adverse Reactions Other adverse reactions not previously listed, whether considered drug-related or not by the investigators, that were reported more frequently by subjects with asthma treated with FLOVENT DISKUS compared with subjects treated with placebo include the following: palpitations; soft tissue injuries; contusions and hematomas; wounds and lacerations; burns; poisoning and toxicity; pressure-induced disorders; hoarseness/dysphonia; epistaxis; ear, nose, throat, and tonsil signs and symptoms; ear, nose, and throat polyps; allergic ear, nose, and throat disorders; throat constriction; fluid disturbances; weight gain; appetite disturbances; keratitis and conjunctivitis; blepharoconjunctivitis; gastrointestinal signs and symptoms; oral ulcerations; dental discomfort and pain; oral erythema and rashes; mouth and tongue disorders; oral discomfort and pain; tooth decay; cholecystitis; arthralgia and articular rheumatism; muscle cramps and spasms; musculoskeletal inflammation; dizziness; sleep disorders; migraines; paralysis of cranial nerves; edema and swelling; bacterial infections; fungal infections; mobility disorders; mood disorders; bacterial reproductive infections; photodermatitis; dermatitis and dermatosis; viral skin infections; eczema; pruritus; acne and folliculitis; urinary infections.\"\n },\n {\n \"VerbatimTerm\": \"Contusions\",\n \"Probability\": \"0.8187150955\",\n \"SemanticContext\": \"Skin Contusions and ecchymoses.\"\n }\n ]\n },\n {\n \"Term\": \"Flatulence\",\n \"MEDDRACode\": \"10016766\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"wounds\",\n \"Probability\": \"0.1224925816\",\n \"SemanticContext\": \"Additional Adverse Reactions Other adverse reactions not previously listed, whether considered drug-related or not by the investigators, that were reported more frequently by subjects with asthma treated with FLOVENT DISKUS compared with subjects treated with placebo include the following: palpitations; soft tissue injuries; contusions and hematomas; wounds and lacerations; burns; poisoning and toxicity; pressure-induced disorders; hoarseness/dysphonia; epistaxis; ear, nose, throat, and tonsil signs and symptoms; ear, nose, and throat polyps; allergic ear, nose, and throat disorders; throat constriction; fluid disturbances; weight gain; appetite disturbances; keratitis and conjunctivitis; blepharoconjunctivitis; gastrointestinal signs and symptoms; oral ulcerations; dental discomfort and pain; oral erythema and rashes; mouth and tongue disorders; oral discomfort and pain; tooth decay; cholecystitis; arthralgia and articular rheumatism; muscle cramps and spasms; musculoskeletal inflammation; dizziness; sleep disorders; migraines; paralysis of cranial nerves; edema and swelling; bacterial infections; fungal infections; mobility disorders; mood disorders; bacterial reproductive infections; photodermatitis; dermatitis and dermatosis; viral skin infections; eczema; pruritus; acne and folliculitis; urinary infections.\"\n }\n ]\n },\n {\n \"Term\": \"Muscle injury\",\n \"MEDDRACode\": \"10028314\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Muscle injury\",\n \"Probability\": \"0.9903355241\",\n \"SemanticContext\": \"Adverse Reactions with FLOVENT DISKUS with >3% Incidence and More Common than Placebo in Subjects with Asthma Adverse Event FLOVENT DISKUS 50 mcg Twice Daily n = 178 % FLOVENT DISKUS 100 mcg Twice Daily n = 305 % FLOVENT DISKUS 250 mcg Twice Daily n = 86 % FLOVENT DISKUS 500 mcg Twice Daily n = 64 % Placebo n = 543 % Ear, nose, and throat Upper respiratory tract infection 20 18 21 14 16 Throat irritation 13 13 3 22 8 Sinusitis/sinus infection 9 10 6 6 6 Upper respiratory inflammation 5 5 0 5 3 Rhinitis 4 3 1 2 2 Oral candidiasis \\n <1 9 6 5 7 Gastrointestinal Nausea and vomiting 8 4 1 2 4 Gastrointestinal discomfort and pain 4 3 2 2 3 Viral gastrointestinal infection 4 3 3 5 1 Non-site specific Fever 7 7 1 2 4 Viral infection 2 2 0 5 2 Lower respiratory Viral respiratory infection 4 5 1 2 4 Cough 3 5 1 5 4 Bronchitis 2 3 0 8 1 Neurological Headache 12 12 2 14 7 Musculoskeletal and trauma Muscle injury 2 0 1 5 1 Musculoskeletal pain 4 3 2 5 2 Injury 2 \\n <1 0 5 \\n <1 .\"\n }\n ]\n },\n {\n \"Term\": \"Sleep disorder\",\n \"MEDDRACode\": \"10040984\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"sleep disorders\",\n \"Probability\": \"0.2644661069\",\n \"SemanticContext\": \"Additional Adverse Reactions Other adverse reactions not previously listed, whether considered drug-related or not by the investigators, that were reported more frequently by subjects with asthma treated with FLOVENT DISKUS compared with subjects treated with placebo include the following: palpitations; soft tissue injuries; contusions and hematomas; wounds and lacerations; burns; poisoning and toxicity; pressure-induced disorders; hoarseness/dysphonia; epistaxis; ear, nose, throat, and tonsil signs and symptoms; ear, nose, and throat polyps; allergic ear, nose, and throat disorders; throat constriction; fluid disturbances; weight gain; appetite disturbances; keratitis and conjunctivitis; blepharoconjunctivitis; gastrointestinal signs and symptoms; oral ulcerations; dental discomfort and pain; oral erythema and rashes; mouth and tongue disorders; oral discomfort and pain; tooth decay; cholecystitis; arthralgia and articular rheumatism; muscle cramps and spasms; musculoskeletal inflammation; dizziness; sleep disorders; migraines; paralysis of cranial nerves; edema and swelling; bacterial infections; fungal infections; mobility disorders; mood disorders; bacterial reproductive infections; photodermatitis; dermatitis and dermatosis; viral skin infections; eczema; pruritus; acne and folliculitis; urinary infections.\"\n }\n ]\n },\n {\n \"Term\": \"Tongue disorder\",\n \"MEDDRACode\": \"10043951\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"tongue disorders\",\n \"Probability\": \"0.8895780444\",\n \"SemanticContext\": \"Additional Adverse Reactions Other adverse reactions not previously listed, whether considered drug-related or not by the investigators, that were reported more frequently by subjects with asthma treated with FLOVENT DISKUS compared with subjects treated with placebo include the following: palpitations; soft tissue injuries; contusions and hematomas; wounds and lacerations; burns; poisoning and toxicity; pressure-induced disorders; hoarseness/dysphonia; epistaxis; ear, nose, throat, and tonsil signs and symptoms; ear, nose, and throat polyps; allergic ear, nose, and throat disorders; throat constriction; fluid disturbances; weight gain; appetite disturbances; keratitis and conjunctivitis; blepharoconjunctivitis; gastrointestinal signs and symptoms; oral ulcerations; dental discomfort and pain; oral erythema and rashes; mouth and tongue disorders; oral discomfort and pain; tooth decay; cholecystitis; arthralgia and articular rheumatism; muscle cramps and spasms; musculoskeletal inflammation; dizziness; sleep disorders; migraines; paralysis of cranial nerves; edema and swelling; bacterial infections; fungal infections; mobility disorders; mood disorders; bacterial reproductive infections; photodermatitis; dermatitis and dermatosis; viral skin infections; eczema; pruritus; acne and folliculitis; urinary infections.\"\n }\n ]\n },\n {\n \"Term\": \"Viral infection\",\n \"MEDDRACode\": \"10047461\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Viral infection\",\n \"Probability\": \"0.9907428622\",\n \"SemanticContext\": \"Adverse Reactions with FLOVENT DISKUS with >3% Incidence and More Common than Placebo in Subjects with Asthma Adverse Event FLOVENT DISKUS 50 mcg Twice Daily n = 178 % FLOVENT DISKUS 100 mcg Twice Daily n = 305 % FLOVENT DISKUS 250 mcg Twice Daily n = 86 % FLOVENT DISKUS 500 mcg Twice Daily n = 64 % Placebo n = 543 % Ear, nose, and throat Upper respiratory tract infection 20 18 21 14 16 Throat irritation 13 13 3 22 8 Sinusitis/sinus infection 9 10 6 6 6 Upper respiratory inflammation 5 5 0 5 3 Rhinitis 4 3 1 2 2 Oral candidiasis \\n <1 9 6 5 7 Gastrointestinal Nausea and vomiting 8 4 1 2 4 Gastrointestinal discomfort and pain 4 3 2 2 3 Viral gastrointestinal infection 4 3 3 5 1 Non-site specific Fever 7 7 1 2 4 Viral infection 2 2 0 5 2 Lower respiratory Viral respiratory infection 4 5 1 2 4 Cough 3 5 1 5 4 Bronchitis 2 3 0 8 1 Neurological Headache 12 12 2 14 7 Musculoskeletal and trauma Muscle injury 2 0 1 5 1 Musculoskeletal pain 4 3 2 5 2 Injury 2 \\n <1 0 5 \\n <1 .\"\n }\n ]\n },\n {\n \"Term\": \"Haematoma\",\n \"MEDDRACode\": \"10018852\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hematomas\",\n \"Probability\": \"0.3520362973\",\n \"SemanticContext\": \"Additional Adverse Reactions Other adverse reactions not previously listed, whether considered drug-related or not by the investigators, that were reported more frequently by subjects with asthma treated with FLOVENT DISKUS compared with subjects treated with placebo include the following: palpitations; soft tissue injuries; contusions and hematomas; wounds and lacerations; burns; poisoning and toxicity; pressure-induced disorders; hoarseness/dysphonia; epistaxis; ear, nose, throat, and tonsil signs and symptoms; ear, nose, and throat polyps; allergic ear, nose, and throat disorders; throat constriction; fluid disturbances; weight gain; appetite disturbances; keratitis and conjunctivitis; blepharoconjunctivitis; gastrointestinal signs and symptoms; oral ulcerations; dental discomfort and pain; oral erythema and rashes; mouth and tongue disorders; oral discomfort and pain; tooth decay; cholecystitis; arthralgia and articular rheumatism; muscle cramps and spasms; musculoskeletal inflammation; dizziness; sleep disorders; migraines; paralysis of cranial nerves; edema and swelling; bacterial infections; fungal infections; mobility disorders; mood disorders; bacterial reproductive infections; photodermatitis; dermatitis and dermatosis; viral skin infections; eczema; pruritus; acne and folliculitis; urinary infections.\"\n }\n ]\n },\n {\n \"Term\": \"Mouth ulceration\",\n \"MEDDRACode\": \"10028034\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"oral ulcerations\",\n \"Probability\": \"0.9901427031\",\n \"SemanticContext\": \"Additional Adverse Reactions Other adverse reactions not previously listed, whether considered drug-related or not by the investigators, that were reported more frequently by subjects with asthma treated with FLOVENT DISKUS compared with subjects treated with placebo include the following: palpitations; soft tissue injuries; contusions and hematomas; wounds and lacerations; burns; poisoning and toxicity; pressure-induced disorders; hoarseness/dysphonia; epistaxis; ear, nose, throat, and tonsil signs and symptoms; ear, nose, and throat polyps; allergic ear, nose, and throat disorders; throat constriction; fluid disturbances; weight gain; appetite disturbances; keratitis and conjunctivitis; blepharoconjunctivitis; gastrointestinal signs and symptoms; oral ulcerations; dental discomfort and pain; oral erythema and rashes; mouth and tongue disorders; oral discomfort and pain; tooth decay; cholecystitis; arthralgia and articular rheumatism; muscle cramps and spasms; musculoskeletal inflammation; dizziness; sleep disorders; migraines; paralysis of cranial nerves; edema and swelling; bacterial infections; fungal infections; mobility disorders; mood disorders; bacterial reproductive infections; photodermatitis; dermatitis and dermatosis; viral skin infections; eczema; pruritus; acne and folliculitis; urinary infections.\"\n }\n ]\n },\n {\n \"Term\": \"Restlessness\",\n \"MEDDRACode\": \"10038743\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"restlessness\",\n \"Probability\": \"0.9767006636\",\n \"SemanticContext\": \"Psychiatry Agitation, aggression, anxiety, depression, and restlessness.\"\n }\n ]\n },\n {\n \"Term\": \"Soft tissue injury\",\n \"MEDDRACode\": \"10041291\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"soft tissue injuries\",\n \"Probability\": \"0.0446206331\",\n \"SemanticContext\": \"Additional Adverse Reactions Other adverse reactions not previously listed, whether considered drug-related or not by the investigators, that were reported more frequently by subjects with asthma treated with FLOVENT DISKUS compared with subjects treated with placebo include the following: palpitations; soft tissue injuries; contusions and hematomas; wounds and lacerations; burns; poisoning and toxicity; pressure-induced disorders; hoarseness/dysphonia; epistaxis; ear, nose, throat, and tonsil signs and symptoms; ear, nose, and throat polyps; allergic ear, nose, and throat disorders; throat constriction; fluid disturbances; weight gain; appetite disturbances; keratitis and conjunctivitis; blepharoconjunctivitis; gastrointestinal signs and symptoms; oral ulcerations; dental discomfort and pain; oral erythema and rashes; mouth and tongue disorders; oral discomfort and pain; tooth decay; cholecystitis; arthralgia and articular rheumatism; muscle cramps and spasms; musculoskeletal inflammation; dizziness; sleep disorders; migraines; paralysis of cranial nerves; edema and swelling; bacterial infections; fungal infections; mobility disorders; mood disorders; bacterial reproductive infections; photodermatitis; dermatitis and dermatosis; viral skin infections; eczema; pruritus; acne and folliculitis; urinary infections.\"\n }\n ]\n },\n {\n \"Term\": \"Viral skin infection\",\n \"MEDDRACode\": \"10065173\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"viral skin infections\",\n \"Probability\": \"0.8911868334\",\n \"SemanticContext\": \"Additional Adverse Reactions Other adverse reactions not previously listed, whether considered drug-related or not by the investigators, that were reported more frequently by subjects with asthma treated with FLOVENT DISKUS compared with subjects treated with placebo include the following: palpitations; soft tissue injuries; contusions and hematomas; wounds and lacerations; burns; poisoning and toxicity; pressure-induced disorders; hoarseness/dysphonia; epistaxis; ear, nose, throat, and tonsil signs and symptoms; ear, nose, and throat polyps; allergic ear, nose, and throat disorders; throat constriction; fluid disturbances; weight gain; appetite disturbances; keratitis and conjunctivitis; blepharoconjunctivitis; gastrointestinal signs and symptoms; oral ulcerations; dental discomfort and pain; oral erythema and rashes; mouth and tongue disorders; oral discomfort and pain; tooth decay; cholecystitis; arthralgia and articular rheumatism; muscle cramps and spasms; musculoskeletal inflammation; dizziness; sleep disorders; migraines; paralysis of cranial nerves; edema and swelling; bacterial infections; fungal infections; mobility disorders; mood disorders; bacterial reproductive infections; photodermatitis; dermatitis and dermatosis; viral skin infections; eczema; pruritus; acne and folliculitis; urinary infections.\"\n }\n ]\n },\n {\n \"Term\": \"Pneumonia\",\n \"MEDDRACode\": \"10035664\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"pneumonia\",\n \"Probability\": \"0.9899986982\",\n \"SemanticContext\": \"Respiratory Asthma exacerbation, bronchospasm, chest tightness, dyspnea, immediate bronchospasm, pneumonia, and wheeze.\"\n }\n ]\n },\n {\n \"Term\": \"Hyperglycaemia\",\n \"MEDDRACode\": \"10020635\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hyperglycemia\",\n \"Probability\": \"0.8123788834\",\n \"SemanticContext\": \"Endocrine and Metabolic Cushingoid features, growth velocity reduction in children/adolescents, hyperglycemia, and osteoporosis.\"\n }\n ]\n },\n {\n \"Term\": \"Eczema\",\n \"MEDDRACode\": \"10014184\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"eczema\",\n \"Probability\": \"0.9963409305\",\n \"SemanticContext\": \"Additional Adverse Reactions Other adverse reactions not previously listed, whether considered drug-related or not by the investigators, that were reported more frequently by subjects with asthma treated with FLOVENT DISKUS compared with subjects treated with placebo include the following: palpitations; soft tissue injuries; contusions and hematomas; wounds and lacerations; burns; poisoning and toxicity; pressure-induced disorders; hoarseness/dysphonia; epistaxis; ear, nose, throat, and tonsil signs and symptoms; ear, nose, and throat polyps; allergic ear, nose, and throat disorders; throat constriction; fluid disturbances; weight gain; appetite disturbances; keratitis and conjunctivitis; blepharoconjunctivitis; gastrointestinal signs and symptoms; oral ulcerations; dental discomfort and pain; oral erythema and rashes; mouth and tongue disorders; oral discomfort and pain; tooth decay; cholecystitis; arthralgia and articular rheumatism; muscle cramps and spasms; musculoskeletal inflammation; dizziness; sleep disorders; migraines; paralysis of cranial nerves; edema and swelling; bacterial infections; fungal infections; mobility disorders; mood disorders; bacterial reproductive infections; photodermatitis; dermatitis and dermatosis; viral skin infections; eczema; pruritus; acne and folliculitis; urinary infections.\"\n },\n {\n \"VerbatimTerm\": \"eczema\",\n \"Probability\": \"0.0034358501\",\n \"SemanticContext\": \"Transfer of patients from systemic corticosteroid therapy to FLOVENT DISKUS may unmask allergic conditions previously suppressed by the systemic corticosteroid therapy e.g., rhinitis, conjunctivitis, eczema, arthritis, eosinophilic conditions .\"\n }\n ]\n },\n {\n \"Term\": \"Throat tightness\",\n \"MEDDRACode\": \"10043528\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"throat constriction\",\n \"Probability\": \"0.9382199049\",\n \"SemanticContext\": \"Additional Adverse Reactions Other adverse reactions not previously listed, whether considered drug-related or not by the investigators, that were reported more frequently by subjects with asthma treated with FLOVENT DISKUS compared with subjects treated with placebo include the following: palpitations; soft tissue injuries; contusions and hematomas; wounds and lacerations; burns; poisoning and toxicity; pressure-induced disorders; hoarseness/dysphonia; epistaxis; ear, nose, throat, and tonsil signs and symptoms; ear, nose, and throat polyps; allergic ear, nose, and throat disorders; throat constriction; fluid disturbances; weight gain; appetite disturbances; keratitis and conjunctivitis; blepharoconjunctivitis; gastrointestinal signs and symptoms; oral ulcerations; dental discomfort and pain; oral erythema and rashes; mouth and tongue disorders; oral discomfort and pain; tooth decay; cholecystitis; arthralgia and articular rheumatism; muscle cramps and spasms; musculoskeletal inflammation; dizziness; sleep disorders; migraines; paralysis of cranial nerves; edema and swelling; bacterial infections; fungal infections; mobility disorders; mood disorders; bacterial reproductive infections; photodermatitis; dermatitis and dermatosis; viral skin infections; eczema; pruritus; acne and folliculitis; urinary infections.\"\n }\n ]\n },\n {\n \"Term\": \"Blister\",\n \"MEDDRACode\": \"10005191\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"blister\",\n \"Probability\": \"1.40001E-05\",\n \"SemanticContext\": \"FLOVENT DISKUS is an orange plastic inhaler containing a foil blister strip.\"\n },\n {\n \"VerbatimTerm\": \"blister\",\n \"Probability\": \"0.0001847744\",\n \"SemanticContext\": \"Each blister on the strip contains a white powder mix of micronized fluticasone propionate 50, 100, or 250 mcg in 12.5 mg of formulation containing lactose monohydrate which contains milk proteins .\"\n },\n {\n \"VerbatimTerm\": \"blister\",\n \"Probability\": \"0.0017883778\",\n \"SemanticContext\": \"3 DOSAGE FORMS AND STRENGTHS Inhalation powder: Inhaler containing a foil blister strip of powder formulation for oral inhalation.\"\n },\n {\n \"VerbatimTerm\": \"blister\",\n \"Probability\": \"0.0018694401\",\n \"SemanticContext\": \"The strip contains fluticasone propionate 50, 100, or 250 mcg per blister.\"\n },\n {\n \"VerbatimTerm\": \"blisters\",\n \"Probability\": \"0.000259012\",\n \"SemanticContext\": \"All doses were delivered by inhalation of the contents of 1 or 2 blisters from FLOVENT DISKUS twice daily.\"\n }\n ]\n },\n {\n \"Term\": \"Malaise\",\n \"MEDDRACode\": \"10025482\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Malaise and fatigue\",\n \"Probability\": \"0.9721945524\",\n \"SemanticContext\": \"Non-Site Specific: Malaise and fatigue 16% and 9% and pain 10% and 3% .\"\n }\n ]\n },\n {\n \"Term\": \"Oesophageal candidiasis\",\n \"MEDDRACode\": \"10030154\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Esophageal candidiasis\",\n \"Probability\": \"0.9023780823\",\n \"SemanticContext\": \"Infections and Infestations Esophageal candidiasis.\"\n }\n ]\n },\n {\n \"Term\": \"Weight increased\",\n \"MEDDRACode\": \"10047899\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"weight gain\",\n \"Probability\": \"0.9469360113\",\n \"SemanticContext\": \"Additional Adverse Reactions Other adverse reactions not previously listed, whether considered drug-related or not by the investigators, that were reported more frequently by subjects with asthma treated with FLOVENT DISKUS compared with subjects treated with placebo include the following: palpitations; soft tissue injuries; contusions and hematomas; wounds and lacerations; burns; poisoning and toxicity; pressure-induced disorders; hoarseness/dysphonia; epistaxis; ear, nose, throat, and tonsil signs and symptoms; ear, nose, and throat polyps; allergic ear, nose, and throat disorders; throat constriction; fluid disturbances; weight gain; appetite disturbances; keratitis and conjunctivitis; blepharoconjunctivitis; gastrointestinal signs and symptoms; oral ulcerations; dental discomfort and pain; oral erythema and rashes; mouth and tongue disorders; oral discomfort and pain; tooth decay; cholecystitis; arthralgia and articular rheumatism; muscle cramps and spasms; musculoskeletal inflammation; dizziness; sleep disorders; migraines; paralysis of cranial nerves; edema and swelling; bacterial infections; fungal infections; mobility disorders; mood disorders; bacterial reproductive infections; photodermatitis; dermatitis and dermatosis; viral skin infections; eczema; pruritus; acne and folliculitis; urinary infections.\"\n }\n ]\n },\n {\n \"Term\": \"Hepatocellular carcinoma\",\n \"MEDDRACode\": \"10073071\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hepatoma\",\n \"Probability\": \"0.0210370421\",\n \"SemanticContext\": \"Other metabolites detected in vitro using cultured human hepatoma cells have not been detected in man.\"\n }\n ]\n },\n {\n \"Term\": \"Protein total\",\n \"MEDDRACode\": \"10050537\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": true,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"proteins\",\n \"Probability\": \"4.88621E-05\",\n \"SemanticContext\": \"4 • Severe hypersensitivity to milk proteins or demonstrated hypersensitivity to fluticasone propionate.\"\n },\n {\n \"VerbatimTerm\": \"proteins\",\n \"Probability\": \"0.0022843778\",\n \"SemanticContext\": \"Each blister on the strip contains a white powder mix of micronized fluticasone propionate 50, 100, or 250 mcg in 12.5 mg of formulation containing lactose monohydrate which contains milk proteins .\"\n },\n {\n \"VerbatimTerm\": \"proteins\",\n \"Probability\": \"0.0004078448\",\n \"SemanticContext\": \"4 CONTRAINDICATIONS The use of FLOVENT DISKUS is contraindicated in the following conditions: • Primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required [see Warnings and Precautions 5.2 ] • Severe hypersensitivity to milk proteins or demonstrated hypersensitivity to fluticasone propionate [see Warnings and Precautions 5.6 , Adverse Reactions 6.2 , Description 11 ]\"\n }\n ]\n },\n {\n \"Term\": \"Blood cortisol\",\n \"MEDDRACode\": \"10005455\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"serum cortisol\",\n \"Probability\": \"9.3663E-06\",\n \"SemanticContext\": \"12.2 Pharmacodynamics In clinical trials with fluticasone propionate inhalation powder using dosages up to and including 250 mcg twice daily, occasional abnormal short cosyntropin tests peak serum cortisol \\n <18 mcg/dL assessed by radioimmunoassay were noted both in subjects receiving fluticasone propionate and in subjects receiving placebo.\"\n },\n {\n \"VerbatimTerm\": \"serum cortisol\",\n \"Probability\": \"4.48701E-05\",\n \"SemanticContext\": \"In a 2-year trial carried out with the DISKHALER inhalation device in 64 subjects with mild, persistent asthma mean FEV 1 91% of predicted randomized to fluticasone propionate 500 mcg twice daily or placebo, no subject receiving fluticasone propionate had an abnormal response to 6-hour cosyntropin infusion peak serum cortisol \\n <18 mcg/dL .\"\n },\n {\n \"VerbatimTerm\": \"serum cortisol\",\n \"Probability\": \"2.82629E-05\",\n \"SemanticContext\": \"No subject had an abnormal response peak serum cortisol \\n <18 mcg/dL after dosing with placebo or fluticasone propionate 220 mcg twice daily.\"\n },\n {\n \"VerbatimTerm\": \"serum cortisol\",\n \"Probability\": \"0.000282079\",\n \"SemanticContext\": \"This significant increase in plasma fluticasone propionate exposure resulted in a significant decrease 86% in serum cortisol AUC.\"\n },\n {\n \"VerbatimTerm\": \"serum cortisol\",\n \"Probability\": \"3.49251E-05\",\n \"SemanticContext\": \"This increase in plasma fluticasone propionate concentration resulted in a decrease 45% in serum cortisol AUC.\"\n },\n {\n \"VerbatimTerm\": \"serum cortisol\",\n \"Probability\": \"0.0004963577\",\n \"SemanticContext\": \"Ritonavir A drug interaction trial with fluticasone propionate aqueous nasal spray in healthy subjects has shown that ritonavir a strong CYP3A4 inhibitor can significantly increase plasma fluticasone propionate exposure, resulting in significantly reduced serum cortisol concentrations [see Clinical Pharmacology 12.3 ] .\"\n }\n ]\n },\n {\n \"Term\": \"Hypersensitivity\",\n \"MEDDRACode\": \"10020751\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": true,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hypersensitivity\",\n \"Probability\": \"0.0007226765\",\n \"SemanticContext\": \"4 • Severe hypersensitivity to milk proteins or demonstrated hypersensitivity to fluticasone propionate.\"\n },\n {\n \"VerbatimTerm\": \"hypersensitivity\",\n \"Probability\": \"0.0039631128\",\n \"SemanticContext\": \"4 • Severe hypersensitivity to milk proteins or demonstrated hypersensitivity to fluticasone propionate.\"\n },\n {\n \"VerbatimTerm\": \"hypersensitivity\",\n \"Probability\": \"0.0416257381\",\n \"SemanticContext\": \"4 CONTRAINDICATIONS The use of FLOVENT DISKUS is contraindicated in the following conditions: • Primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required [see Warnings and Precautions 5.2 ] • Severe hypersensitivity to milk proteins or demonstrated hypersensitivity to fluticasone propionate [see Warnings and Precautions 5.6 , Adverse Reactions 6.2 , Description 11 ]\"\n },\n {\n \"VerbatimTerm\": \"hypersensitivity\",\n \"Probability\": \"0.0282382965\",\n \"SemanticContext\": \"4 CONTRAINDICATIONS The use of FLOVENT DISKUS is contraindicated in the following conditions: • Primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required [see Warnings and Precautions 5.2 ] • Severe hypersensitivity to milk proteins or demonstrated hypersensitivity to fluticasone propionate [see Warnings and Precautions 5.6 , Adverse Reactions 6.2 , Description 11 ]\"\n }\n ]\n },\n {\n \"Term\": \"Osteoporosis\",\n \"MEDDRACode\": \"10031282\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"osteoporosis\",\n \"Probability\": \"0.0886414051\",\n \"SemanticContext\": \"Endocrine and Metabolic Cushingoid features, growth velocity reduction in children/adolescents, hyperglycemia, and osteoporosis.\"\n },\n {\n \"VerbatimTerm\": \"osteoporosis\",\n \"Probability\": \"0.0002349317\",\n \"SemanticContext\": \"Patients with major risk factors for decreased bone mineral content, such as prolonged immobilization, family history of osteoporosis, postmenopausal status, tobacco use, advanced age, poor nutrition, or chronic use of drugs that can reduce bone mass e.g., anticonvulsants, oral corticosteroids , should be monitored and treated with established standards of care.\"\n }\n ]\n },\n {\n \"Term\": \"Polyp\",\n \"MEDDRACode\": \"10061529\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"polyps\",\n \"Probability\": \"0.8153855801\",\n \"SemanticContext\": \"Additional Adverse Reactions Other adverse reactions not previously listed, whether considered drug-related or not by the investigators, that were reported more frequently by subjects with asthma treated with FLOVENT DISKUS compared with subjects treated with placebo include the following: palpitations; soft tissue injuries; contusions and hematomas; wounds and lacerations; burns; poisoning and toxicity; pressure-induced disorders; hoarseness/dysphonia; epistaxis; ear, nose, throat, and tonsil signs and symptoms; ear, nose, and throat polyps; allergic ear, nose, and throat disorders; throat constriction; fluid disturbances; weight gain; appetite disturbances; keratitis and conjunctivitis; blepharoconjunctivitis; gastrointestinal signs and symptoms; oral ulcerations; dental discomfort and pain; oral erythema and rashes; mouth and tongue disorders; oral discomfort and pain; tooth decay; cholecystitis; arthralgia and articular rheumatism; muscle cramps and spasms; musculoskeletal inflammation; dizziness; sleep disorders; migraines; paralysis of cranial nerves; edema and swelling; bacterial infections; fungal infections; mobility disorders; mood disorders; bacterial reproductive infections; photodermatitis; dermatitis and dermatosis; viral skin infections; eczema; pruritus; acne and folliculitis; urinary infections.\"\n }\n ]\n },\n {\n \"Term\": \"Immunosuppression\",\n \"MEDDRACode\": \"10062016\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Immunosuppression\",\n \"Probability\": \"0.4564237297\",\n \"SemanticContext\": \"6 ADVERSE REACTIONS Systemic and local corticosteroid use may result in the following: • Candida albicans infection [see Warnings and Precautions 5.1 ] • Immunosuppression [see Warnings and Precautions 5.3 ] • Hypercorticism and adrenal suppression [see Warnings and Precautions 5.5 ] • Reduction in bone mineral density [see Warnings and Precautions 5.7 ] • Growth effects [see Warnings and Precautions 5.8 ] • Glaucoma and cataracts [see Warnings and Precautions 5.9 ] 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.\"\n },\n {\n \"VerbatimTerm\": \"Immunosuppression\",\n \"Probability\": \"0.0006824136\",\n \"SemanticContext\": \"Immunosuppression Warn patients who are on immunosuppressant doses of corticosteroids to avoid exposure to chickenpox or measles and, if exposed, to consult their physicians without delay.\"\n },\n {\n \"VerbatimTerm\": \"Immunosuppression\",\n \"Probability\": \"0.0014138818\",\n \"SemanticContext\": \"5.3 Immunosuppression Persons who are using drugs that suppress the immune system are more susceptible to infections than healthy individuals.\"\n }\n ]\n },\n {\n \"Term\": \"Weight\",\n \"MEDDRACode\": \"10047890\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"weight\",\n \"Probability\": \"0.0013873577000000001\",\n \"SemanticContext\": \"The active component of FLOVENT DISKUS 50 mcg, FLOVENT DISKUS 100 mcg, and FLOVENT DISKUS 250 mcg is fluticasone propionate, a corticosteroid having the chemical name S- fluoromethyl 6a,9-difluoro-11ß,17-dihydroxy-16a-methyl-3-oxoandrosta-1,4-diene-17ß-carbothioate, 17-propionate and the following chemical structure: Fluticasone propionate is a white powder with a molecular weight of 500.6, and the empirical formula is C 25 H 31 F 3 O 5 S.\"\n },\n {\n \"VerbatimTerm\": \"weight\",\n \"Probability\": \"0.0001392066\",\n \"SemanticContext\": \"In animals, teratogenicity characteristic of corticosteroids, decreased fetal body weight, and/or skeletal variations in rats, mice, and rabbits were observed with subcutaneously administered maternal toxic doses of fluticasone propionate less than the maximum recommended human daily inhaled dose MRHDID on a mcg/m 2 basis.\"\n },\n {\n \"VerbatimTerm\": \"weight\",\n \"Probability\": \"3.19191E-05\",\n \"SemanticContext\": \"However, fluticasone propionate administered via inhalation to rats decreased fetal body weight, but did not induce teratogenicity at a maternal toxic dose less than the MRHDID on a mcg/m 2 basis.\"\n },\n {\n \"VerbatimTerm\": \"weight\",\n \"Probability\": \"0.0182159841\",\n \"SemanticContext\": \"Omphalocele, decreased body weight, and skeletal variations were observed in rat fetuses, in the presence of maternal toxicity, at a dose approximately 0.5 times the MRHDID on a mcg/m 2 basis with a maternal subcutaneous dose of 100 mcg/kg/day .\"\n },\n {\n \"VerbatimTerm\": \"weight\",\n \"Probability\": \"0.0001376867\",\n \"SemanticContext\": \"In a pre- and post-natal development study in pregnant rats dosed from late gestation through delivery and lactation Gestation Day 17 to Postpartum Day 22 , fluticasone propionate was not associated with decreases in pup body weight, and had no effects on developmental landmarks, learning, memory, reflexes, or fertility at doses up to 0.2 times the MRHDID on a mcg/m 2 basis with maternal subcutaneous doses up to 50 mcg/kg/day .\"\n },\n {\n \"VerbatimTerm\": \"weights\",\n \"Probability\": \"0.0002176464\",\n \"SemanticContext\": \"In an embryofetal development study with pregnant rats dosed by the inhalation route throughout the period of organogenesis, fluticasone propionate produced decreased fetal body weights and skeletal variations, in the presence of maternal toxicity, at a dose approximately 0.13 times the MRHDID on a mcg/m 2 basis with a maternal inhalation dose of 25.7 mcg/kg/day ; however, there was no evidence of teratogenicity.\"\n },\n {\n \"VerbatimTerm\": \"weights\",\n \"Probability\": \"4.11083E-05\",\n \"SemanticContext\": \"In an embryofetal development study in pregnant rabbits that were dosed by the subcutaneous route throughout organogenesis, fluticasone propionate produced reductions of fetal body weights, in the presence of maternal toxicity, at doses approximately 0.006 times the MRHDID and higher on a mcg/m 2 basis with a maternal subcutaneous dose of 0.57 mcg/kg/day .\"\n }\n ]\n },\n {\n \"Term\": \"Muscle spasms\",\n \"MEDDRACode\": \"10028334\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"spasms\",\n \"Probability\": \"0.835983634\",\n \"SemanticContext\": \"Additional Adverse Reactions Other adverse reactions not previously listed, whether considered drug-related or not by the investigators, that were reported more frequently by subjects with asthma treated with FLOVENT DISKUS compared with subjects treated with placebo include the following: palpitations; soft tissue injuries; contusions and hematomas; wounds and lacerations; burns; poisoning and toxicity; pressure-induced disorders; hoarseness/dysphonia; epistaxis; ear, nose, throat, and tonsil signs and symptoms; ear, nose, and throat polyps; allergic ear, nose, and throat disorders; throat constriction; fluid disturbances; weight gain; appetite disturbances; keratitis and conjunctivitis; blepharoconjunctivitis; gastrointestinal signs and symptoms; oral ulcerations; dental discomfort and pain; oral erythema and rashes; mouth and tongue disorders; oral discomfort and pain; tooth decay; cholecystitis; arthralgia and articular rheumatism; muscle cramps and spasms; musculoskeletal inflammation; dizziness; sleep disorders; migraines; paralysis of cranial nerves; edema and swelling; bacterial infections; fungal infections; mobility disorders; mood disorders; bacterial reproductive infections; photodermatitis; dermatitis and dermatosis; viral skin infections; eczema; pruritus; acne and folliculitis; urinary infections.\"\n }\n ]\n },\n {\n \"Term\": \"Palpitations\",\n \"MEDDRACode\": \"10033557\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"palpitations\",\n \"Probability\": \"0.653914392\",\n \"SemanticContext\": \"Additional Adverse Reactions Other adverse reactions not previously listed, whether considered drug-related or not by the investigators, that were reported more frequently by subjects with asthma treated with FLOVENT DISKUS compared with subjects treated with placebo include the following: palpitations; soft tissue injuries; contusions and hematomas; wounds and lacerations; burns; poisoning and toxicity; pressure-induced disorders; hoarseness/dysphonia; epistaxis; ear, nose, throat, and tonsil signs and symptoms; ear, nose, and throat polyps; allergic ear, nose, and throat disorders; throat constriction; fluid disturbances; weight gain; appetite disturbances; keratitis and conjunctivitis; blepharoconjunctivitis; gastrointestinal signs and symptoms; oral ulcerations; dental discomfort and pain; oral erythema and rashes; mouth and tongue disorders; oral discomfort and pain; tooth decay; cholecystitis; arthralgia and articular rheumatism; muscle cramps and spasms; musculoskeletal inflammation; dizziness; sleep disorders; migraines; paralysis of cranial nerves; edema and swelling; bacterial infections; fungal infections; mobility disorders; mood disorders; bacterial reproductive infections; photodermatitis; dermatitis and dermatosis; viral skin infections; eczema; pruritus; acne and folliculitis; urinary infections.\"\n }\n ]\n },\n {\n \"Term\": \"Euphoric mood\",\n \"MEDDRACode\": \"10015535\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"high\",\n \"Probability\": \"0.0011562109\",\n \"SemanticContext\": \"5.4 • Hypercorticism and adrenal suppression may occur with very high dosages or at the regular dosage in susceptible individuals.\"\n },\n {\n \"VerbatimTerm\": \"high\",\n \"Probability\": \"0.0002599955\",\n \"SemanticContext\": \"This is explained by a combination of a relatively high local anti-inflammatory effect, negligible oral systemic bioavailability \\n <1% , and the minimal pharmacological activity of the only metabolite detected in man.\"\n },\n {\n \"VerbatimTerm\": \"high\",\n \"Probability\": \"0.0016691983\",\n \"SemanticContext\": \"Distribution Following intravenous administration, the initial disposition phase for fluticasone propionate was rapid and consistent with its high lipid solubility and tissue binding.\"\n },\n {\n \"VerbatimTerm\": \"high\",\n \"Probability\": \"0.0142895281\",\n \"SemanticContext\": \"Metabolism The total clearance of fluticasone propionate is high average, 1,093 mL/min , with renal clearance accounting for \\n <0.02% of the total.\"\n },\n {\n \"VerbatimTerm\": \"higher\",\n \"Probability\": \"4.2858E-06\",\n \"SemanticContext\": \"For other patients, and for patients who do not respond adequately to the starting dosage after 2 weeks of therapy, higher dosages may provide additional asthma control.\"\n },\n {\n \"VerbatimTerm\": \"higher\",\n \"Probability\": \"6.31494E-05\",\n \"SemanticContext\": \"If a dosage regimen fails to provide adequate control of asthma, the therapeutic regimen should be re-evaluated and additional therapeutic options, e.g., replacing the current strength with a higher strength, initiating an ICS and long-acting beta2-agonist LABA combination product, or initiating oral corticosteroids, should be considered.\"\n },\n {\n \"VerbatimTerm\": \"higher\",\n \"Probability\": \"4.58857E-05\",\n \"SemanticContext\": \"In an embryofetal development study in pregnant rabbits that were dosed by the subcutaneous route throughout organogenesis, fluticasone propionate produced reductions of fetal body weights, in the presence of maternal toxicity, at doses approximately 0.006 times the MRHDID and higher on a mcg/m 2 basis with a maternal subcutaneous dose of 0.57 mcg/kg/day .\"\n },\n {\n \"VerbatimTerm\": \"higher\",\n \"Probability\": \"2.39467E-05\",\n \"SemanticContext\": \"Since fluticasone propionate is absorbed into the circulation and can be systemically active at higher doses, the beneficial effects of FLOVENT DISKUS in minimizing HPA dysfunction may be expected only when recommended dosages are not exceeded and individual patients are titrated to the lowest effective dose.\"\n },\n {\n \"VerbatimTerm\": \"higher\",\n \"Probability\": \"0.000302434\",\n \"SemanticContext\": \"An imbalance in the proportion of children entering puberty between groups and a higher dropout rate in the placebo group due to poorly controlled asthma may be confounding factors in interpreting these data.\"\n }\n ]\n },\n {\n \"Term\": \"Injury\",\n \"MEDDRACode\": \"10022116\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"trauma\",\n \"Probability\": \"0.167681843\",\n \"SemanticContext\": \"Adverse Reactions with FLOVENT DISKUS with >3% Incidence and More Common than Placebo in Subjects with Asthma Adverse Event FLOVENT DISKUS 50 mcg Twice Daily n = 178 % FLOVENT DISKUS 100 mcg Twice Daily n = 305 % FLOVENT DISKUS 250 mcg Twice Daily n = 86 % FLOVENT DISKUS 500 mcg Twice Daily n = 64 % Placebo n = 543 % Ear, nose, and throat Upper respiratory tract infection 20 18 21 14 16 Throat irritation 13 13 3 22 8 Sinusitis/sinus infection 9 10 6 6 6 Upper respiratory inflammation 5 5 0 5 3 Rhinitis 4 3 1 2 2 Oral candidiasis \\n <1 9 6 5 7 Gastrointestinal Nausea and vomiting 8 4 1 2 4 Gastrointestinal discomfort and pain 4 3 2 2 3 Viral gastrointestinal infection 4 3 3 5 1 Non-site specific Fever 7 7 1 2 4 Viral infection 2 2 0 5 2 Lower respiratory Viral respiratory infection 4 5 1 2 4 Cough 3 5 1 5 4 Bronchitis 2 3 0 8 1 Neurological Headache 12 12 2 14 7 Musculoskeletal and trauma Muscle injury 2 0 1 5 1 Musculoskeletal pain 4 3 2 5 2 Injury 2 \\n <1 0 5 \\n <1 .\"\n },\n {\n \"VerbatimTerm\": \"trauma\",\n \"Probability\": \"0.2753378451\",\n \"SemanticContext\": \"During this period of HPA suppression, patients may exhibit signs and symptoms of adrenal insufficiency when exposed to trauma, surgery, or infection particularly gastroenteritis or other conditions associated with severe electrolyte loss.\"\n }\n ]\n },\n {\n \"Term\": \"Nasal congestion\",\n \"MEDDRACode\": \"10028735\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"nasal congestion\",\n \"Probability\": \"0.9975882769\",\n \"SemanticContext\": \"Ear, Nose, and Throat: Hoarseness/dysphonia 9% and 0% , nasal congestion/blockage 16% and 0% , oral candidiasis 31% and 21% , rhinitis 13% and 9% , sinusitis/sinus infection 33% and 12% , throat irritation 10% and 9% , and upper respiratory tract infection 31% and 24% .\"\n }\n ]\n },\n {\n \"Term\": \"Myalgia\",\n \"MEDDRACode\": \"10028411\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"muscle pain\",\n \"Probability\": \"0.9990658164\",\n \"SemanticContext\": \"Musculoskeletal: Arthralgia and articular rheumatism 17% and 3% and muscle pain 12% and 0% .\"\n }\n ]\n },\n {\n \"Term\": \"Neutrophil count\",\n \"MEDDRACode\": \"10029363\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"neutrophils\",\n \"Probability\": \"0.0004151165\",\n \"SemanticContext\": \"Corticosteroids have been shown to have a wide range of actions on multiple cell types e.g., mast cells, eosinophils, neutrophils, macrophages, lymphocytes and mediators e.g., histamine, eicosanoids, leukotrienes, cytokines involved in inflammation.\"\n }\n ]\n },\n {\n \"Term\": \"Rash\",\n \"MEDDRACode\": \"10037844\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"rashes\",\n \"Probability\": \"0.9771840572\",\n \"SemanticContext\": \"Additional Adverse Reactions Other adverse reactions not previously listed, whether considered drug-related or not by the investigators, that were reported more frequently by subjects with asthma treated with FLOVENT DISKUS compared with subjects treated with placebo include the following: palpitations; soft tissue injuries; contusions and hematomas; wounds and lacerations; burns; poisoning and toxicity; pressure-induced disorders; hoarseness/dysphonia; epistaxis; ear, nose, throat, and tonsil signs and symptoms; ear, nose, and throat polyps; allergic ear, nose, and throat disorders; throat constriction; fluid disturbances; weight gain; appetite disturbances; keratitis and conjunctivitis; blepharoconjunctivitis; gastrointestinal signs and symptoms; oral ulcerations; dental discomfort and pain; oral erythema and rashes; mouth and tongue disorders; oral discomfort and pain; tooth decay; cholecystitis; arthralgia and articular rheumatism; muscle cramps and spasms; musculoskeletal inflammation; dizziness; sleep disorders; migraines; paralysis of cranial nerves; edema and swelling; bacterial infections; fungal infections; mobility disorders; mood disorders; bacterial reproductive infections; photodermatitis; dermatitis and dermatosis; viral skin infections; eczema; pruritus; acne and folliculitis; urinary infections.\"\n },\n {\n \"VerbatimTerm\": \"rash\",\n \"Probability\": \"0.9962642193\",\n \"SemanticContext\": \"Immune System Disorders Immediate and delayed hypersensitivity reactions, including anaphylaxis, rash, angioedema, and bronchospasm, have been reported.\"\n },\n {\n \"VerbatimTerm\": \"rash\",\n \"Probability\": \"0.7274650931\",\n \"SemanticContext\": \"Immediate Hypersensitivity Reactions Advise patients that immediate hypersensitivity reactions e.g., urticaria, angioedema, rash, bronchospasm, hypotension , including anaphylaxis, may occur after administration of FLOVENT DISKUS.\"\n },\n {\n \"VerbatimTerm\": \"rash\",\n \"Probability\": \"0.9545768499\",\n \"SemanticContext\": \"5.6 Immediate Hypersensitivity Reactions Immediate hypersensitivity reactions e.g., urticaria, angioedema, rash, bronchospasm, hypotension , including anaphylaxis, may occur after administration of FLOVENT DISKUS.\"\n }\n ]\n },\n {\n \"Term\": \"Oropharyngeal oedema\",\n \"MEDDRACode\": \"10078783\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"oropharyngeal edema\",\n \"Probability\": \"0.4898994267\",\n \"SemanticContext\": \"Ear, Nose, and Throat Aphonia, facial and oropharyngeal edema, and throat soreness.\"\n }\n ]\n },\n {\n \"Term\": \"Angioedema\",\n \"MEDDRACode\": \"10002424\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"angioedema\",\n \"Probability\": \"0.9939269423\",\n \"SemanticContext\": \"Immune System Disorders Immediate and delayed hypersensitivity reactions, including anaphylaxis, rash, angioedema, and bronchospasm, have been reported.\"\n },\n {\n \"VerbatimTerm\": \"angioedema\",\n \"Probability\": \"0.7973918319\",\n \"SemanticContext\": \"Immediate Hypersensitivity Reactions Advise patients that immediate hypersensitivity reactions e.g., urticaria, angioedema, rash, bronchospasm, hypotension , including anaphylaxis, may occur after administration of FLOVENT DISKUS.\"\n },\n {\n \"VerbatimTerm\": \"angioedema\",\n \"Probability\": \"0.866838932\",\n \"SemanticContext\": \"5.6 Immediate Hypersensitivity Reactions Immediate hypersensitivity reactions e.g., urticaria, angioedema, rash, bronchospasm, hypotension , including anaphylaxis, may occur after administration of FLOVENT DISKUS.\"\n }\n ]\n },\n {\n \"Term\": \"Depression\",\n \"MEDDRACode\": \"10012378\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"depression\",\n \"Probability\": \"0.9967316389\",\n \"SemanticContext\": \"Psychiatry Agitation, aggression, anxiety, depression, and restlessness.\"\n },\n {\n \"VerbatimTerm\": \"depression\",\n \"Probability\": \"0.0027211308\",\n \"SemanticContext\": \"During withdrawal from oral corticosteroids, some patients may experience symptoms of systemically active corticosteroid withdrawal e.g., joint and/or muscular pain, lassitude, depression despite maintenance or even improvement of respiratory function.\"\n }\n ]\n },\n {\n \"Term\": \"Exomphalos\",\n \"MEDDRACode\": \"10015677\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Omphalocele\",\n \"Probability\": \"0.4041037261\",\n \"SemanticContext\": \"Omphalocele, decreased body weight, and skeletal variations were observed in rat fetuses, in the presence of maternal toxicity, at a dose approximately 0.5 times the MRHDID on a mcg/m 2 basis with a maternal subcutaneous dose of 100 mcg/kg/day .\"\n }\n ]\n },\n {\n \"Term\": \"Pre-eclampsia\",\n \"MEDDRACode\": \"10036485\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"pre-eclampsia\",\n \"Probability\": \"0.7957988977\",\n \"SemanticContext\": \"Clinical Considerations Disease-Associated Maternal and/or Embryofetal Risk: In women with poorly or moderately controlled asthma, there is an increased risk of several perinatal outcomes such as pre-eclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate.\"\n }\n ]\n },\n {\n \"Term\": \"Arthritis\",\n \"MEDDRACode\": \"10003246\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"arthritis\",\n \"Probability\": \"0.0006000102\",\n \"SemanticContext\": \"Transfer of patients from systemic corticosteroid therapy to FLOVENT DISKUS may unmask allergic conditions previously suppressed by the systemic corticosteroid therapy e.g., rhinitis, conjunctivitis, eczema, arthritis, eosinophilic conditions .\"\n }\n ]\n },\n {\n \"Term\": \"Lymphocyte count\",\n \"MEDDRACode\": \"10025251\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"lymphocytes\",\n \"Probability\": \"3.37004E-05\",\n \"SemanticContext\": \"Corticosteroids have been shown to have a wide range of actions on multiple cell types e.g., mast cells, eosinophils, neutrophils, macrophages, lymphocytes and mediators e.g., histamine, eicosanoids, leukotrienes, cytokines involved in inflammation.\"\n },\n {\n \"VerbatimTerm\": \"lymphocytes\",\n \"Probability\": \"7.23148E-05\",\n \"SemanticContext\": \"No significant clastogenic effect was seen in cultured human peripheral lymphocytes in vitro or in the in vivo mouse micronucleus test.\"\n }\n ]\n },\n {\n \"Term\": \"Oropharyngeal candidiasis\",\n \"MEDDRACode\": \"10050346\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"oropharyngeal candidiasis\",\n \"Probability\": \"0.0101721585\",\n \"SemanticContext\": \"After inhalation, the patient should rinse his/her mouth with water without swallowing to help reduce the risk of oropharyngeal candidiasis.\"\n },\n {\n \"VerbatimTerm\": \"oropharyngeal candidiasis\",\n \"Probability\": \"0.0011299253\",\n \"SemanticContext\": \"If oropharyngeal candidiasis develops, treat it with appropriate local or systemic i.e., oral antifungal therapy while still continuing therapy with FLOVENT DISKUS, but at times therapy with FLOVENT DISKUS may need to be temporarily interrupted under close medical supervision.\"\n },\n {\n \"VerbatimTerm\": \"oropharyngeal candidiasis\",\n \"Probability\": \"0.0111936629\",\n \"SemanticContext\": \"Advise the patient to rinse his/her mouth with water without swallowing following inhalation to help reduce the risk of oropharyngeal candidiasis.\"\n }\n ]\n },\n {\n \"Term\": \"Cushing's syndrome\",\n \"MEDDRACode\": \"10011652\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Cushing’s syndrome\",\n \"Probability\": \"0.063380897\",\n \"SemanticContext\": \"During postmarketing use, there have been reports of clinically significant drug interactions in patients receiving fluticasone propionate and ritonavir, resulting in systemic corticosteroid effects including Cushing’s syndrome and adrenal suppression.\"\n }\n ]\n },\n {\n \"Term\": \"Hepatic function abnormal\",\n \"MEDDRACode\": \"10019670\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Hepatic impairment\",\n \"Probability\": \"0.9607480764\",\n \"SemanticContext\": \"USE IN SPECIFIC POPULATIONS Hepatic impairment: Monitor patients for signs of increased drug exposure.\"\n }\n ]\n },\n {\n \"Term\": \"Musculoskeletal pain\",\n \"MEDDRACode\": \"10028391\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Musculoskeletal pain\",\n \"Probability\": \"0.9854755402\",\n \"SemanticContext\": \"Adverse Reactions with FLOVENT DISKUS with >3% Incidence and More Common than Placebo in Subjects with Asthma Adverse Event FLOVENT DISKUS 50 mcg Twice Daily n = 178 % FLOVENT DISKUS 100 mcg Twice Daily n = 305 % FLOVENT DISKUS 250 mcg Twice Daily n = 86 % FLOVENT DISKUS 500 mcg Twice Daily n = 64 % Placebo n = 543 % Ear, nose, and throat Upper respiratory tract infection 20 18 21 14 16 Throat irritation 13 13 3 22 8 Sinusitis/sinus infection 9 10 6 6 6 Upper respiratory inflammation 5 5 0 5 3 Rhinitis 4 3 1 2 2 Oral candidiasis \\n <1 9 6 5 7 Gastrointestinal Nausea and vomiting 8 4 1 2 4 Gastrointestinal discomfort and pain 4 3 2 2 3 Viral gastrointestinal infection 4 3 3 5 1 Non-site specific Fever 7 7 1 2 4 Viral infection 2 2 0 5 2 Lower respiratory Viral respiratory infection 4 5 1 2 4 Cough 3 5 1 5 4 Bronchitis 2 3 0 8 1 Neurological Headache 12 12 2 14 7 Musculoskeletal and trauma Muscle injury 2 0 1 5 1 Musculoskeletal pain 4 3 2 5 2 Injury 2 \\n <1 0 5 \\n <1 .\"\n }\n ]\n },\n {\n \"Term\": \"Throat irritation\",\n \"MEDDRACode\": \"10043521\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"throat irritation\",\n \"Probability\": \"0.9983466268\",\n \"SemanticContext\": \"5.9 ADVERSE REACTIONS Most common adverse reactions incidence >3% include upper respiratory tract infection or inflammation, throat irritation, sinusitis, rhinitis, oral candidiasis, nausea and vomiting, gastrointestinal discomfort, fever, cough, bronchitis, and headache.\"\n },\n {\n \"VerbatimTerm\": \"throat irritation\",\n \"Probability\": \"0.9998372793\",\n \"SemanticContext\": \"Ear, Nose, and Throat: Hoarseness/dysphonia 9% and 0% , nasal congestion/blockage 16% and 0% , oral candidiasis 31% and 21% , rhinitis 13% and 9% , sinusitis/sinus infection 33% and 12% , throat irritation 10% and 9% , and upper respiratory tract infection 31% and 24% .\"\n },\n {\n \"VerbatimTerm\": \"Throat irritation\",\n \"Probability\": \"0.9997739792\",\n \"SemanticContext\": \"Adverse Reactions with FLOVENT DISKUS with >3% Incidence and More Common than Placebo in Subjects with Asthma Adverse Event FLOVENT DISKUS 50 mcg Twice Daily n = 178 % FLOVENT DISKUS 100 mcg Twice Daily n = 305 % FLOVENT DISKUS 250 mcg Twice Daily n = 86 % FLOVENT DISKUS 500 mcg Twice Daily n = 64 % Placebo n = 543 % Ear, nose, and throat Upper respiratory tract infection 20 18 21 14 16 Throat irritation 13 13 3 22 8 Sinusitis/sinus infection 9 10 6 6 6 Upper respiratory inflammation 5 5 0 5 3 Rhinitis 4 3 1 2 2 Oral candidiasis \\n <1 9 6 5 7 Gastrointestinal Nausea and vomiting 8 4 1 2 4 Gastrointestinal discomfort and pain 4 3 2 2 3 Viral gastrointestinal infection 4 3 3 5 1 Non-site specific Fever 7 7 1 2 4 Viral infection 2 2 0 5 2 Lower respiratory Viral respiratory infection 4 5 1 2 4 Cough 3 5 1 5 4 Bronchitis 2 3 0 8 1 Neurological Headache 12 12 2 14 7 Musculoskeletal and trauma Muscle injury 2 0 1 5 1 Musculoskeletal pain 4 3 2 5 2 Injury 2 \\n <1 0 5 \\n <1 .\"\n }\n ]\n },\n {\n \"Term\": \"Adrenal suppression\",\n \"MEDDRACode\": \"10001382\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"adrenal suppression\",\n \"Probability\": \"0.8074725866\",\n \"SemanticContext\": \"5.4 • Hypercorticism and adrenal suppression may occur with very high dosages or at the regular dosage in susceptible individuals.\"\n },\n {\n \"VerbatimTerm\": \"adrenal suppression\",\n \"Probability\": \"0.977378726\",\n \"SemanticContext\": \"6 ADVERSE REACTIONS Systemic and local corticosteroid use may result in the following: • Candida albicans infection [see Warnings and Precautions 5.1 ] • Immunosuppression [see Warnings and Precautions 5.3 ] • Hypercorticism and adrenal suppression [see Warnings and Precautions 5.5 ] • Reduction in bone mineral density [see Warnings and Precautions 5.7 ] • Growth effects [see Warnings and Precautions 5.8 ] • Glaucoma and cataracts [see Warnings and Precautions 5.9 ] 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.\"\n },\n {\n \"VerbatimTerm\": \"adrenal suppression\",\n \"Probability\": \"0.7024898529\",\n \"SemanticContext\": \"During postmarketing use, there have been reports of clinically significant drug interactions in patients receiving fluticasone propionate and ritonavir, resulting in systemic corticosteroid effects including Cushing’s syndrome and adrenal suppression.\"\n },\n {\n \"VerbatimTerm\": \"adrenal suppression\",\n \"Probability\": \"0.3630555868\",\n \"SemanticContext\": \"Hypercorticism and Adrenal Suppression Advise patients that FLOVENT DISKUS may cause systemic corticosteroid effects of hypercorticism and adrenal suppression.\"\n },\n {\n \"VerbatimTerm\": \"adrenal suppression\",\n \"Probability\": \"0.8280739188\",\n \"SemanticContext\": \"It is possible that systemic corticosteroid effects such as hypercorticism and adrenal suppression including adrenal crisis may appear in a small number of patients who are sensitive to these effects.\"\n },\n {\n \"VerbatimTerm\": \"Adrenal Suppression\",\n \"Probability\": \"0.8601299524\",\n \"SemanticContext\": \"Hypercorticism and Adrenal Suppression Advise patients that FLOVENT DISKUS may cause systemic corticosteroid effects of hypercorticism and adrenal suppression.\"\n },\n {\n \"VerbatimTerm\": \"Adrenal Suppression\",\n \"Probability\": \"0.1161272228\",\n \"SemanticContext\": \"5.5 Hypercorticism and Adrenal Suppression Fluticasone propionate will often help control asthma symptoms with less suppression of HPA function than therapeutically equivalent oral doses of prednisone.\"\n }\n ]\n },\n {\n \"Term\": \"Immune system disorder\",\n \"MEDDRACode\": \"10021425\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Immune System Disorders\",\n \"Probability\": \"0.1258746684\",\n \"SemanticContext\": \"Immune System Disorders Immediate and delayed hypersensitivity reactions, including anaphylaxis, rash, angioedema, and bronchospasm, have been reported.\"\n }\n ]\n },\n {\n \"Term\": \"Oral discomfort\",\n \"MEDDRACode\": \"10030973\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"oral discomfort\",\n \"Probability\": \"0.9339675307\",\n \"SemanticContext\": \"Additional Adverse Reactions Other adverse reactions not previously listed, whether considered drug-related or not by the investigators, that were reported more frequently by subjects with asthma treated with FLOVENT DISKUS compared with subjects treated with placebo include the following: palpitations; soft tissue injuries; contusions and hematomas; wounds and lacerations; burns; poisoning and toxicity; pressure-induced disorders; hoarseness/dysphonia; epistaxis; ear, nose, throat, and tonsil signs and symptoms; ear, nose, and throat polyps; allergic ear, nose, and throat disorders; throat constriction; fluid disturbances; weight gain; appetite disturbances; keratitis and conjunctivitis; blepharoconjunctivitis; gastrointestinal signs and symptoms; oral ulcerations; dental discomfort and pain; oral erythema and rashes; mouth and tongue disorders; oral discomfort and pain; tooth decay; cholecystitis; arthralgia and articular rheumatism; muscle cramps and spasms; musculoskeletal inflammation; dizziness; sleep disorders; migraines; paralysis of cranial nerves; edema and swelling; bacterial infections; fungal infections; mobility disorders; mood disorders; bacterial reproductive infections; photodermatitis; dermatitis and dermatosis; viral skin infections; eczema; pruritus; acne and folliculitis; urinary infections.\"\n }\n ]\n },\n {\n \"Term\": \"Cataract\",\n \"MEDDRACode\": \"10007739\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"cataracts\",\n \"Probability\": \"0.0079569817\",\n \"SemanticContext\": \"5.8 • Glaucoma and cataracts may occur with long-term use of ICS.\"\n },\n {\n \"VerbatimTerm\": \"cataracts\",\n \"Probability\": \"0.4098172188\",\n \"SemanticContext\": \"6 ADVERSE REACTIONS Systemic and local corticosteroid use may result in the following: • Candida albicans infection [see Warnings and Precautions 5.1 ] • Immunosuppression [see Warnings and Precautions 5.3 ] • Hypercorticism and adrenal suppression [see Warnings and Precautions 5.5 ] • Reduction in bone mineral density [see Warnings and Precautions 5.7 ] • Growth effects [see Warnings and Precautions 5.8 ] • Glaucoma and cataracts [see Warnings and Precautions 5.9 ] 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.\"\n },\n {\n \"VerbatimTerm\": \"cataracts\",\n \"Probability\": \"0.0146808624\",\n \"SemanticContext\": \"Glaucoma and Cataracts Advise patients that long-term use of ICS may increase the risk of some eye problems cataracts or glaucoma ; consider regular eye examinations.\"\n },\n {\n \"VerbatimTerm\": \"cataracts\",\n \"Probability\": \"0.7605460286\",\n \"SemanticContext\": \"5.9 Glaucoma and Cataracts Glaucoma, increased intraocular pressure, and cataracts have been reported in patients following the long-term administration of ICS, including fluticasone propionate.\"\n },\n {\n \"VerbatimTerm\": \"Cataracts\",\n \"Probability\": \"0.1028958857\",\n \"SemanticContext\": \"Eye Cataracts.\"\n },\n {\n \"VerbatimTerm\": \"Cataracts\",\n \"Probability\": \"0.0043638945\",\n \"SemanticContext\": \"Glaucoma and Cataracts Advise patients that long-term use of ICS may increase the risk of some eye problems cataracts or glaucoma ; consider regular eye examinations.\"\n },\n {\n \"VerbatimTerm\": \"Cataracts\",\n \"Probability\": \"0.2591816783\",\n \"SemanticContext\": \"5.9 Glaucoma and Cataracts Glaucoma, increased intraocular pressure, and cataracts have been reported in patients following the long-term administration of ICS, including fluticasone propionate.\"\n }\n ]\n },\n {\n \"Term\": \"Forced expiratory volume\",\n \"MEDDRACode\": \"10016984\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"forced expiratory volume\",\n \"Probability\": \"8.03959E-05\",\n \"SemanticContext\": \"Lung function mean forced expiratory volume in 1 second [FEV 1 ] or morning peak expiratory flow [AM PEF] , beta-agonist use, and asthma symptoms should be carefully monitored during withdrawal of oral corticosteroids.\"\n }\n ]\n },\n {\n \"Term\": \"Rheumatic disorder\",\n \"MEDDRACode\": \"10072736\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"rheumatism\",\n \"Probability\": \"0.5125899315\",\n \"SemanticContext\": \"Additional Adverse Reactions Other adverse reactions not previously listed, whether considered drug-related or not by the investigators, that were reported more frequently by subjects with asthma treated with FLOVENT DISKUS compared with subjects treated with placebo include the following: palpitations; soft tissue injuries; contusions and hematomas; wounds and lacerations; burns; poisoning and toxicity; pressure-induced disorders; hoarseness/dysphonia; epistaxis; ear, nose, throat, and tonsil signs and symptoms; ear, nose, and throat polyps; allergic ear, nose, and throat disorders; throat constriction; fluid disturbances; weight gain; appetite disturbances; keratitis and conjunctivitis; blepharoconjunctivitis; gastrointestinal signs and symptoms; oral ulcerations; dental discomfort and pain; oral erythema and rashes; mouth and tongue disorders; oral discomfort and pain; tooth decay; cholecystitis; arthralgia and articular rheumatism; muscle cramps and spasms; musculoskeletal inflammation; dizziness; sleep disorders; migraines; paralysis of cranial nerves; edema and swelling; bacterial infections; fungal infections; mobility disorders; mood disorders; bacterial reproductive infections; photodermatitis; dermatitis and dermatosis; viral skin infections; eczema; pruritus; acne and folliculitis; urinary infections.\"\n },\n {\n \"VerbatimTerm\": \"rheumatism\",\n \"Probability\": \"0.8300318718\",\n \"SemanticContext\": \"Musculoskeletal: Arthralgia and articular rheumatism 17% and 3% and muscle pain 12% and 0% .\"\n }\n ]\n },\n {\n \"Term\": \"Anaphylactic reaction\",\n \"MEDDRACode\": \"10002198\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Anaphylactic reactions\",\n \"Probability\": \"0.9399628639\",\n \"SemanticContext\": \"Anaphylactic reactions in patients with severe milk protein allergy have been reported.\"\n },\n {\n \"VerbatimTerm\": \"anaphylactic reactions\",\n \"Probability\": \"0.1522035003\",\n \"SemanticContext\": \"There have been reports of anaphylactic reactions in patients with severe milk protein allergy after inhalation of powder products containing lactose; therefore, patients with severe milk protein allergy should not take FLOVENT DISKUS.\"\n },\n {\n \"VerbatimTerm\": \"anaphylactic reactions\",\n \"Probability\": \"0.1522710919\",\n \"SemanticContext\": \"There have been reports of anaphylactic reactions in patients with severe milk protein allergy after inhalation of powder products containing lactose; therefore, patients with severe milk protein allergy should not use FLOVENT DISKUS [see Contraindications 4 ] .\"\n }\n ]\n },\n {\n \"Term\": \"Irritability\",\n \"MEDDRACode\": \"10022998\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"irritability\",\n \"Probability\": \"0.9862595201\",\n \"SemanticContext\": \"Behavioral changes, including hyperactivity and irritability, have been reported very rarely and primarily in children.\"\n }\n ]\n },\n {\n \"Term\": \"Skin laceration\",\n \"MEDDRACode\": \"10058818\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"lacerations\",\n \"Probability\": \"0.091411829\",\n \"SemanticContext\": \"Additional Adverse Reactions Other adverse reactions not previously listed, whether considered drug-related or not by the investigators, that were reported more frequently by subjects with asthma treated with FLOVENT DISKUS compared with subjects treated with placebo include the following: palpitations; soft tissue injuries; contusions and hematomas; wounds and lacerations; burns; poisoning and toxicity; pressure-induced disorders; hoarseness/dysphonia; epistaxis; ear, nose, throat, and tonsil signs and symptoms; ear, nose, and throat polyps; allergic ear, nose, and throat disorders; throat constriction; fluid disturbances; weight gain; appetite disturbances; keratitis and conjunctivitis; blepharoconjunctivitis; gastrointestinal signs and symptoms; oral ulcerations; dental discomfort and pain; oral erythema and rashes; mouth and tongue disorders; oral discomfort and pain; tooth decay; cholecystitis; arthralgia and articular rheumatism; muscle cramps and spasms; musculoskeletal inflammation; dizziness; sleep disorders; migraines; paralysis of cranial nerves; edema and swelling; bacterial infections; fungal infections; mobility disorders; mood disorders; bacterial reproductive infections; photodermatitis; dermatitis and dermatosis; viral skin infections; eczema; pruritus; acne and folliculitis; urinary infections.\"\n }\n ]\n },\n {\n \"Term\": \"Wound\",\n \"MEDDRACode\": \"10052428\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"wounds\",\n \"Probability\": \"0.1224925816\",\n \"SemanticContext\": \"Additional Adverse Reactions Other adverse reactions not previously listed, whether considered drug-related or not by the investigators, that were reported more frequently by subjects with asthma treated with FLOVENT DISKUS compared with subjects treated with placebo include the following: palpitations; soft tissue injuries; contusions and hematomas; wounds and lacerations; burns; poisoning and toxicity; pressure-induced disorders; hoarseness/dysphonia; epistaxis; ear, nose, throat, and tonsil signs and symptoms; ear, nose, and throat polyps; allergic ear, nose, and throat disorders; throat constriction; fluid disturbances; weight gain; appetite disturbances; keratitis and conjunctivitis; blepharoconjunctivitis; gastrointestinal signs and symptoms; oral ulcerations; dental discomfort and pain; oral erythema and rashes; mouth and tongue disorders; oral discomfort and pain; tooth decay; cholecystitis; arthralgia and articular rheumatism; muscle cramps and spasms; musculoskeletal inflammation; dizziness; sleep disorders; migraines; paralysis of cranial nerves; edema and swelling; bacterial infections; fungal infections; mobility disorders; mood disorders; bacterial reproductive infections; photodermatitis; dermatitis and dermatosis; viral skin infections; eczema; pruritus; acne and folliculitis; urinary infections.\"\n }\n ]\n },\n {\n \"Term\": \"Glaucoma\",\n \"MEDDRACode\": \"10018304\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Glaucoma\",\n \"Probability\": \"0.0078057945\",\n \"SemanticContext\": \"5.8 • Glaucoma and cataracts may occur with long-term use of ICS.\"\n },\n {\n \"VerbatimTerm\": \"Glaucoma\",\n \"Probability\": \"0.3123202324\",\n \"SemanticContext\": \"6 ADVERSE REACTIONS Systemic and local corticosteroid use may result in the following: • Candida albicans infection [see Warnings and Precautions 5.1 ] • Immunosuppression [see Warnings and Precautions 5.3 ] • Hypercorticism and adrenal suppression [see Warnings and Precautions 5.5 ] • Reduction in bone mineral density [see Warnings and Precautions 5.7 ] • Growth effects [see Warnings and Precautions 5.8 ] • Glaucoma and cataracts [see Warnings and Precautions 5.9 ] 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.\"\n },\n {\n \"VerbatimTerm\": \"Glaucoma\",\n \"Probability\": \"0.0089251697\",\n \"SemanticContext\": \"Glaucoma and Cataracts Advise patients that long-term use of ICS may increase the risk of some eye problems cataracts or glaucoma ; consider regular eye examinations.\"\n },\n {\n \"VerbatimTerm\": \"Glaucoma\",\n \"Probability\": \"0.0701450408\",\n \"SemanticContext\": \"5.9 Glaucoma and Cataracts Glaucoma, increased intraocular pressure, and cataracts have been reported in patients following the long-term administration of ICS, including fluticasone propionate.\"\n },\n {\n \"VerbatimTerm\": \"Glaucoma\",\n \"Probability\": \"0.5074494481\",\n \"SemanticContext\": \"5.9 Glaucoma and Cataracts Glaucoma, increased intraocular pressure, and cataracts have been reported in patients following the long-term administration of ICS, including fluticasone propionate.\"\n },\n {\n \"VerbatimTerm\": \"glaucoma\",\n \"Probability\": \"0.0076968968\",\n \"SemanticContext\": \"Glaucoma and Cataracts Advise patients that long-term use of ICS may increase the risk of some eye problems cataracts or glaucoma ; consider regular eye examinations.\"\n }\n ]\n },\n {\n \"Term\": \"Headache\",\n \"MEDDRACode\": \"10019211\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"headache\",\n \"Probability\": \"0.9422562122\",\n \"SemanticContext\": \"5.9 ADVERSE REACTIONS Most common adverse reactions incidence >3% include upper respiratory tract infection or inflammation, throat irritation, sinusitis, rhinitis, oral candidiasis, nausea and vomiting, gastrointestinal discomfort, fever, cough, bronchitis, and headache.\"\n },\n {\n \"VerbatimTerm\": \"Headache\",\n \"Probability\": \"0.9988883734\",\n \"SemanticContext\": \"Adverse Reactions with FLOVENT DISKUS with >3% Incidence and More Common than Placebo in Subjects with Asthma Adverse Event FLOVENT DISKUS 50 mcg Twice Daily n = 178 % FLOVENT DISKUS 100 mcg Twice Daily n = 305 % FLOVENT DISKUS 250 mcg Twice Daily n = 86 % FLOVENT DISKUS 500 mcg Twice Daily n = 64 % Placebo n = 543 % Ear, nose, and throat Upper respiratory tract infection 20 18 21 14 16 Throat irritation 13 13 3 22 8 Sinusitis/sinus infection 9 10 6 6 6 Upper respiratory inflammation 5 5 0 5 3 Rhinitis 4 3 1 2 2 Oral candidiasis \\n <1 9 6 5 7 Gastrointestinal Nausea and vomiting 8 4 1 2 4 Gastrointestinal discomfort and pain 4 3 2 2 3 Viral gastrointestinal infection 4 3 3 5 1 Non-site specific Fever 7 7 1 2 4 Viral infection 2 2 0 5 2 Lower respiratory Viral respiratory infection 4 5 1 2 4 Cough 3 5 1 5 4 Bronchitis 2 3 0 8 1 Neurological Headache 12 12 2 14 7 Musculoskeletal and trauma Muscle injury 2 0 1 5 1 Musculoskeletal pain 4 3 2 5 2 Injury 2 \\n <1 0 5 undefined<1 .\"\n }\n ]\n },\n {\n \"Term\": \"Sinusitis\",\n \"MEDDRACode\": \"10040753\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"sinusitis\",\n \"Probability\": \"0.996843338\",\n \"SemanticContext\": \"5.9 ADVERSE REACTIONS Most common adverse reactions incidence >3% include upper respiratory tract infection or inflammation, throat irritation, sinusitis, rhinitis, oral candidiasis, nausea and vomiting, gastrointestinal discomfort, fever, cough, bronchitis, and headache.\"\n },\n {\n \"VerbatimTerm\": \"sinusitis\",\n \"Probability\": \"0.9989818335\",\n \"SemanticContext\": \"Ear, Nose, and Throat: Hoarseness/dysphonia 9% and 0% , nasal congestion/blockage 16% and 0% , oral candidiasis 31% and 21% , rhinitis 13% and 9% , sinusitis/sinus infection 33% and 12% , throat irritation 10% and 9% , and upper respiratory tract infection 31% and 24% .\"\n },\n {\n \"VerbatimTerm\": \"Sinusitis\",\n \"Probability\": \"0.993277669\",\n \"SemanticContext\": \"Adverse Reactions with FLOVENT DISKUS with >3% Incidence and More Common than Placebo in Subjects with Asthma Adverse Event FLOVENT DISKUS 50 mcg Twice Daily n = 178 % FLOVENT DISKUS 100 mcg Twice Daily n = 305 % FLOVENT DISKUS 250 mcg Twice Daily n = 86 % FLOVENT DISKUS 500 mcg Twice Daily n = 64 % Placebo n = 543 % Ear, nose, and throat Upper respiratory tract infection 20 18 21 14 16 Throat irritation 13 13 3 22 8 Sinusitis/sinus infection 9 10 6 6 6 Upper respiratory inflammation 5 5 0 5 3 Rhinitis 4 3 1 2 2 Oral candidiasis undefined<1 9 6 5 7 Gastrointestinal Nausea and vomiting 8 4 1 2 4 Gastrointestinal discomfort and pain 4 3 2 2 3 Viral gastrointestinal infection 4 3 3 5 1 Non-site specific Fever 7 7 1 2 4 Viral infection 2 2 0 5 2 Lower respiratory Viral respiratory infection 4 5 1 2 4 Cough 3 5 1 5 4 Bronchitis 2 3 0 8 1 Neurological Headache 12 12 2 14 7 Musculoskeletal and trauma Muscle injury 2 0 1 5 1 Musculoskeletal pain 4 3 2 5 2 Injury 2 undefined<1 0 5 undefined<1 .\"\n }\n ]\n },\n {\n \"Term\": \"Candida infection\",\n \"MEDDRACode\": \"10074170\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"thrush\",\n \"Probability\": \"0.0007463694\",\n \"SemanticContext\": \"Advise patients to rinse the mouth with water without swallowing after inhalation to help reduce the risk of thrush.\"\n }\n ]\n },\n {\n \"Term\": \"Bronchitis\",\n \"MEDDRACode\": \"10006451\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"bronchitis\",\n \"Probability\": \"0.9931755662\",\n \"SemanticContext\": \"5.9 ADVERSE REACTIONS Most common adverse reactions incidence >3% include upper respiratory tract infection or inflammation, throat irritation, sinusitis, rhinitis, oral candidiasis, nausea and vomiting, gastrointestinal discomfort, fever, cough, bronchitis, and headache.\"\n },\n {\n \"VerbatimTerm\": \"Bronchitis\",\n \"Probability\": \"0.9975373745\",\n \"SemanticContext\": \"Adverse Reactions with FLOVENT DISKUS with >3% Incidence and More Common than Placebo in Subjects with Asthma Adverse Event FLOVENT DISKUS 50 mcg Twice Daily n = 178 % FLOVENT DISKUS 100 mcg Twice Daily n = 305 % FLOVENT DISKUS 250 mcg Twice Daily n = 86 % FLOVENT DISKUS 500 mcg Twice Daily n = 64 % Placebo n = 543 % Ear, nose, and throat Upper respiratory tract infection 20 18 21 14 16 Throat irritation 13 13 3 22 8 Sinusitis/sinus infection 9 10 6 6 6 Upper respiratory inflammation 5 5 0 5 3 Rhinitis 4 3 1 2 2 Oral candidiasis undefined<1 9 6 5 7 Gastrointestinal Nausea and vomiting 8 4 1 2 4 Gastrointestinal discomfort and pain 4 3 2 2 3 Viral gastrointestinal infection 4 3 3 5 1 Non-site specific Fever 7 7 1 2 4 Viral infection 2 2 0 5 2 Lower respiratory Viral respiratory infection 4 5 1 2 4 Cough 3 5 1 5 4 Bronchitis 2 3 0 8 1 Neurological Headache 12 12 2 14 7 Musculoskeletal and trauma Muscle injury 2 0 1 5 1 Musculoskeletal pain 4 3 2 5 2 Injury 2 undefined<1 0 5 undefined<1 .\"\n }\n ]\n },\n {\n \"Term\": \"Oral candidiasis\",\n \"MEDDRACode\": \"10030963\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"oral candidiasis\",\n \"Probability\": \"0.9964903593\",\n \"SemanticContext\": \"5.9 ADVERSE REACTIONS Most common adverse reactions incidence >3% include upper respiratory tract infection or inflammation, throat irritation, sinusitis, rhinitis, oral candidiasis, nausea and vomiting, gastrointestinal discomfort, fever, cough, bronchitis, and headache.\"\n },\n {\n \"VerbatimTerm\": \"oral candidiasis\",\n \"Probability\": \"0.9953526258\",\n \"SemanticContext\": \"Ear, Nose, and Throat: Hoarseness/dysphonia 9% and 0% , nasal congestion/blockage 16% and 0% , oral candidiasis 31% and 21% , rhinitis 13% and 9% , sinusitis/sinus infection 33% and 12% , throat irritation 10% and 9% , and upper respiratory tract infection 31% and 24% .\"\n },\n {\n \"VerbatimTerm\": \"Oral candidiasis\",\n \"Probability\": \"0.9844297767\",\n \"SemanticContext\": \"Adverse Reactions with FLOVENT DISKUS with >3% Incidence and More Common than Placebo in Subjects with Asthma Adverse Event FLOVENT DISKUS 50 mcg Twice Daily n = 178 % FLOVENT DISKUS 100 mcg Twice Daily n = 305 % FLOVENT DISKUS 250 mcg Twice Daily n = 86 % FLOVENT DISKUS 500 mcg Twice Daily n = 64 % Placebo n = 543 % Ear, nose, and throat Upper respiratory tract infection 20 18 21 14 16 Throat irritation 13 13 3 22 8 Sinusitis/sinus infection 9 10 6 6 6 Upper respiratory inflammation 5 5 0 5 3 Rhinitis 4 3 1 2 2 Oral candidiasis undefined<1 9 6 5 7 Gastrointestinal Nausea and vomiting 8 4 1 2 4 Gastrointestinal discomfort and pain 4 3 2 2 3 Viral gastrointestinal infection 4 3 3 5 1 Non-site specific Fever 7 7 1 2 4 Viral infection 2 2 0 5 2 Lower respiratory Viral respiratory infection 4 5 1 2 4 Cough 3 5 1 5 4 Bronchitis 2 3 0 8 1 Neurological Headache 12 12 2 14 7 Musculoskeletal and trauma Muscle injury 2 0 1 5 1 Musculoskeletal pain 4 3 2 5 2 Injury 2 undefined<1 0 5 undefined<1 .\"\n }\n ]\n },\n {\n \"Term\": \"Pyrexia\",\n \"MEDDRACode\": \"10037660\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"fever\",\n \"Probability\": \"0.9922297001\",\n \"SemanticContext\": \"5.9 ADVERSE REACTIONS Most common adverse reactions incidence >3% include upper respiratory tract infection or inflammation, throat irritation, sinusitis, rhinitis, oral candidiasis, nausea and vomiting, gastrointestinal discomfort, fever, cough, bronchitis, and headache.\"\n },\n {\n \"VerbatimTerm\": \"Fever\",\n \"Probability\": \"0.9995918274\",\n \"SemanticContext\": \"Adverse Reactions with FLOVENT DISKUS with >3% Incidence and More Common than Placebo in Subjects with Asthma Adverse Event FLOVENT DISKUS 50 mcg Twice Daily n = 178 % FLOVENT DISKUS 100 mcg Twice Daily n = 305 % FLOVENT DISKUS 250 mcg Twice Daily n = 86 % FLOVENT DISKUS 500 mcg Twice Daily n = 64 % Placebo n = 543 % Ear, nose, and throat Upper respiratory tract infection 20 18 21 14 16 Throat irritation 13 13 3 22 8 Sinusitis/sinus infection 9 10 6 6 6 Upper respiratory inflammation 5 5 0 5 3 Rhinitis 4 3 1 2 2 Oral candidiasis undefined<1 9 6 5 7 Gastrointestinal Nausea and vomiting 8 4 1 2 4 Gastrointestinal discomfort and pain 4 3 2 2 3 Viral gastrointestinal infection 4 3 3 5 1 Non-site specific Fever 7 7 1 2 4 Viral infection 2 2 0 5 2 Lower respiratory Viral respiratory infection 4 5 1 2 4 Cough 3 5 1 5 4 Bronchitis 2 3 0 8 1 Neurological Headache 12 12 2 14 7 Musculoskeletal and trauma Muscle injury 2 0 1 5 1 Musculoskeletal pain 4 3 2 5 2 Injury 2 undefined<1 0 5 undefined<1 .\"\n }\n ]\n },\n {\n \"Term\": \"Bronchospasm\",\n \"MEDDRACode\": \"10006482\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"bronchospasm\",\n \"Probability\": \"0.000221312\",\n \"SemanticContext\": \"• Not indicated for relief of acute bronchospasm.\"\n },\n {\n \"VerbatimTerm\": \"bronchospasm\",\n \"Probability\": \"0.9778017998\",\n \"SemanticContext\": \"Immune System Disorders Immediate and delayed hypersensitivity reactions, including anaphylaxis, rash, angioedema, and bronchospasm, have been reported.\"\n },\n {\n \"VerbatimTerm\": \"bronchospasm\",\n \"Probability\": \"0.9969232082\",\n \"SemanticContext\": \"Respiratory Asthma exacerbation, bronchospasm, chest tightness, dyspnea, immediate bronchospasm, pneumonia, and wheeze.\"\n },\n {\n \"VerbatimTerm\": \"bronchospasm\",\n \"Probability\": \"0.980907917\",\n \"SemanticContext\": \"Respiratory Asthma exacerbation, bronchospasm, chest tightness, dyspnea, immediate bronchospasm, pneumonia, and wheeze.\"\n },\n {\n \"VerbatimTerm\": \"bronchospasm\",\n \"Probability\": \"0.071371913\",\n \"SemanticContext\": \"Important Limitation of Use FLOVENT DISKUS is NOT indicated for the relief of acute bronchospasm.\"\n },\n {\n \"VerbatimTerm\": \"bronchospasm\",\n \"Probability\": \"0.6606639028\",\n \"SemanticContext\": \"Immediate Hypersensitivity Reactions Advise patients that immediate hypersensitivity reactions e.g., urticaria, angioedema, rash, bronchospasm, hypotension , including anaphylaxis, may occur after administration of FLOVENT DISKUS.\"\n },\n {\n \"VerbatimTerm\": \"bronchospasm\",\n \"Probability\": \"0.0094596744\",\n \"SemanticContext\": \"5.2 Acute Asthma Episodes FLOVENT DISKUS is not to be regarded as a bronchodilator and is not indicated for rapid relief of bronchospasm.\"\n },\n {\n \"VerbatimTerm\": \"bronchospasm\",\n \"Probability\": \"0.9431171417\",\n \"SemanticContext\": \"5.6 Immediate Hypersensitivity Reactions Immediate hypersensitivity reactions e.g., urticaria, angioedema, rash, bronchospasm, hypotension , including anaphylaxis, may occur after administration of FLOVENT DISKUS.\"\n },\n {\n \"VerbatimTerm\": \"bronchospasm\",\n \"Probability\": \"0.9870648384\",\n \"SemanticContext\": \"5.10 Paradoxical Bronchospasm As with other inhaled medicines, bronchospasm may occur with an immediate increase in wheezing after dosing.\"\n },\n {\n \"VerbatimTerm\": \"bronchospasm\",\n \"Probability\": \"0.0058836639\",\n \"SemanticContext\": \"If bronchospasm occurs following dosing with FLOVENT DISKUS, it should be treated immediately with an inhaled, short-acting bronchodilator; FLOVENT DISKUS should be discontinued immediately; and alternative therapy should be instituted.\"\n }\n ]\n },\n {\n \"Term\": \"Pruritus\",\n \"MEDDRACode\": \"10037087\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"pruritus\",\n \"Probability\": \"0.9981715679\",\n \"SemanticContext\": \"Additional Adverse Reactions Other adverse reactions not previously listed, whether considered drug-related or not by the investigators, that were reported more frequently by subjects with asthma treated with FLOVENT DISKUS compared with subjects treated with placebo include the following: palpitations; soft tissue injuries; contusions and hematomas; wounds and lacerations; burns; poisoning and toxicity; pressure-induced disorders; hoarseness/dysphonia; epistaxis; ear, nose, throat, and tonsil signs and symptoms; ear, nose, and throat polyps; allergic ear, nose, and throat disorders; throat constriction; fluid disturbances; weight gain; appetite disturbances; keratitis and conjunctivitis; blepharoconjunctivitis; gastrointestinal signs and symptoms; oral ulcerations; dental discomfort and pain; oral erythema and rashes; mouth and tongue disorders; oral discomfort and pain; tooth decay; cholecystitis; arthralgia and articular rheumatism; muscle cramps and spasms; musculoskeletal inflammation; dizziness; sleep disorders; migraines; paralysis of cranial nerves; edema and swelling; bacterial infections; fungal infections; mobility disorders; mood disorders; bacterial reproductive infections; photodermatitis; dermatitis and dermatosis; viral skin infections; eczema; pruritus; acne and folliculitis; urinary infections.\"\n },\n {\n \"VerbatimTerm\": \"Pruritus\",\n \"Probability\": \"0.9993585944\",\n \"SemanticContext\": \"Skin: Pruritus 6% and 0% and skin rashes 8% and 3% .\"\n }\n ]\n },\n {\n \"Term\": \"Urinary tract infection\",\n \"MEDDRACode\": \"10046571\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"urinary infections\",\n \"Probability\": \"0.9731265306\",\n \"SemanticContext\": \"Additional Adverse Reactions Other adverse reactions not previously listed, whether considered drug-related or not by the investigators, that were reported more frequently by subjects with asthma treated with FLOVENT DISKUS compared with subjects treated with placebo include the following: palpitations; soft tissue injuries; contusions and hematomas; wounds and lacerations; burns; poisoning and toxicity; pressure-induced disorders; hoarseness/dysphonia; epistaxis; ear, nose, throat, and tonsil signs and symptoms; ear, nose, and throat polyps; allergic ear, nose, and throat disorders; throat constriction; fluid disturbances; weight gain; appetite disturbances; keratitis and conjunctivitis; blepharoconjunctivitis; gastrointestinal signs and symptoms; oral ulcerations; dental discomfort and pain; oral erythema and rashes; mouth and tongue disorders; oral discomfort and pain; tooth decay; cholecystitis; arthralgia and articular rheumatism; muscle cramps and spasms; musculoskeletal inflammation; dizziness; sleep disorders; migraines; paralysis of cranial nerves; edema and swelling; bacterial infections; fungal infections; mobility disorders; mood disorders; bacterial reproductive infections; photodermatitis; dermatitis and dermatosis; viral skin infections; eczema; pruritus; acne and folliculitis; urinary infections.\"\n }\n ]\n },\n {\n \"Term\": \"Drug interaction\",\n \"MEDDRACode\": \"10013710\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"DRUG INTERACTIONS\",\n \"Probability\": \"2.95824E-05\",\n \"SemanticContext\": \"DRUG INTERACTIONS Strong cytochrome P450 3A4 inhibitors e.g., ritonavir, ketoconazole : Use not recommended.\"\n },\n {\n \"VerbatimTerm\": \"DRUG INTERACTIONS\",\n \"Probability\": \"0.0010208189\",\n \"SemanticContext\": \"7 DRUG INTERACTIONS 7.1 Inhibitors of Cytochrome P450 3A4 Fluticasone propionate is a substrate of CYP3A4.\"\n },\n {\n \"VerbatimTerm\": \"Drug Interaction\",\n \"Probability\": \"0.0002706647\",\n \"SemanticContext\": \"Drug Interaction Studies Inhibitors of Cytochrome P450 3A4: Ritonavir: Fluticasone propionate is a substrate of CYP3A4.\"\n },\n {\n \"VerbatimTerm\": \"drug interaction\",\n \"Probability\": \"1.4205E-06\",\n \"SemanticContext\": \"Coadministration of fluticasone propionate and the strong CYP3A4 inhibitor ritonavir is not recommended based upon a multiple-dose, crossover drug interaction trial in 18 healthy subjects.\"\n },\n {\n \"VerbatimTerm\": \"drug interaction\",\n \"Probability\": \"6.59751E-05\",\n \"SemanticContext\": \"Erythromycin: In a multiple-dose drug interaction trial, coadministration of orally inhaled fluticasone propionate 500 mcg twice daily and erythromycin 333 mg 3 times daily did not affect fluticasone propionate pharmacokinetics.\"\n },\n {\n \"VerbatimTerm\": \"drug interaction\",\n \"Probability\": \"0.0002785921\",\n \"SemanticContext\": \"Ritonavir A drug interaction trial with fluticasone propionate aqueous nasal spray in healthy subjects has shown that ritonavir a strong CYP3A4 inhibitor can significantly increase plasma fluticasone propionate exposure, resulting in significantly reduced serum cortisol concentrations [see Clinical Pharmacology 12.3 ] .\"\n },\n {\n \"VerbatimTerm\": \"drug interactions\",\n \"Probability\": \"0.0005182326\",\n \"SemanticContext\": \"During postmarketing use, there have been reports of clinically significant drug interactions in patients receiving fluticasone propionate and ritonavir, resulting in systemic corticosteroid effects including Cushing’s syndrome and adrenal suppression.\"\n },\n {\n \"VerbatimTerm\": \"Drug Interactions\",\n \"Probability\": \"0.0001924634\",\n \"SemanticContext\": \"5.11 Drug Interactions with Strong Cytochrome P450 3A4 Inhibitors The use of strong cytochrome P450 3A4 CYP3A4 inhibitors e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin with FLOVENT DISKUS is not recommended because increased systemic corticosteroid adverse effects may occur [see Drug Interactions 7.1 , Clinical Pharmacology 12.3 ] .\"\n },\n {\n \"VerbatimTerm\": \"Drug Interactions\",\n \"Probability\": \"0.0001262724\",\n \"SemanticContext\": \"5.11 Drug Interactions with Strong Cytochrome P450 3A4 Inhibitors The use of strong cytochrome P450 3A4 CYP3A4 inhibitors e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin with FLOVENT DISKUS is not recommended because increased systemic corticosteroid adverse effects may occur [see Drug Interactions 7.1 , Clinical Pharmacology 12.3 ] .\"\n }\n ]\n },\n {\n \"Term\": \"Asthma\",\n \"MEDDRACode\": \"10003553\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": true,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"asthma\",\n \"Probability\": \"4.31854E-05\",\n \"SemanticContext\": \"• Maintenance treatment of asthma as prophylactic therapy in patients aged 4 years and older.\"\n },\n {\n \"VerbatimTerm\": \"asthma\",\n \"Probability\": \"1.9965E-06\",\n \"SemanticContext\": \"• Starting dosage is based on prior asthma therapy and disease severity.\"\n },\n {\n \"VerbatimTerm\": \"asthma\",\n \"Probability\": \"0.0002032518\",\n \"SemanticContext\": \"2.2 • Treatment of asthma in patients aged 12 years and older: 100 mcg twice daily up to a maximum recommended dosage of 1,000 mcg twice daily.\"\n },\n {\n \"VerbatimTerm\": \"asthma\",\n \"Probability\": \"0.0003043413\",\n \"SemanticContext\": \"2.2 • Treatment of asthma in patients aged 4 to 11 years: 50 mcg twice daily up to a maximum recommended dosage of 100 mcg twice daily.\"\n },\n {\n \"VerbatimTerm\": \"asthma\",\n \"Probability\": \"8.7772E-06\",\n \"SemanticContext\": \"CONTRAINDICATIONS • Primary treatment of status asthmaticus or acute episodes of asthma requiring intensive measures.\"\n },\n {\n \"VerbatimTerm\": \"asthma\",\n \"Probability\": \"0.0027558208\",\n \"SemanticContext\": \"Additional Adverse Reactions Other adverse reactions not previously listed, whether considered drug-related or not by the investigators, that were reported more frequently by subjects with asthma treated with FLOVENT DISKUS compared with subjects treated with placebo include the following: palpitations; soft tissue injuries; contusions and hematomas; wounds and lacerations; burns; poisoning and toxicity; pressure-induced disorders; hoarseness/dysphonia; epistaxis; ear, nose, throat, and tonsil signs and symptoms; ear, nose, and throat polyps; allergic ear, nose, and throat disorders; throat constriction; fluid disturbances; weight gain; appetite disturbances; keratitis and conjunctivitis; blepharoconjunctivitis; gastrointestinal signs and symptoms; oral ulcerations; dental discomfort and pain; oral erythema and rashes; mouth and tongue disorders; oral discomfort and pain; tooth decay; cholecystitis; arthralgia and articular rheumatism; muscle cramps and spasms; musculoskeletal inflammation; dizziness; sleep disorders; migraines; paralysis of cranial nerves; edema and swelling; bacterial infections; fungal infections; mobility disorders; mood disorders; bacterial reproductive infections; photodermatitis; dermatitis and dermatosis; viral skin infections; eczema; pruritus; acne and folliculitis; urinary infections.\"\n },\n {\n \"VerbatimTerm\": \"asthma\",\n \"Probability\": \"4.36897E-05\",\n \"SemanticContext\": \"In the first 16 weeks of a 52-week clinical trial in adult subjects with asthma who previously required oral corticosteroids daily doses of 5 to 40 mg oral prednisone , the effects of FLOVENT DISKUS 500 mcg twice daily n = 41 and 1,000 mcg twice daily n = 36 were compared with placebo n = 34 for the frequency of reported adverse events.\"\n },\n {\n \"VerbatimTerm\": \"asthma\",\n \"Probability\": \"0.0083404481\",\n \"SemanticContext\": \"In children with asthma aged 4 and 8 years, mean PIF through FLOVENT DISKUS was 70 and 104 L/min, respectively range: 48 to 123 L/min .\"\n },\n {\n \"VerbatimTerm\": \"asthma\",\n \"Probability\": \"0.0025484264\",\n \"SemanticContext\": \"Inflammation is an important component in the pathogenesis of asthma.\"\n },\n {\n \"VerbatimTerm\": \"asthma\",\n \"Probability\": \"0.00017488\",\n \"SemanticContext\": \"These anti-inflammatory actions of corticosteroids contribute to their efficacy in asthma.\"\n },\n {\n \"VerbatimTerm\": \"asthma\",\n \"Probability\": \"4.46863E-05\",\n \"SemanticContext\": \"Though effective for the treatment of asthma, corticosteroids do not affect asthma symptoms immediately.\"\n },\n {\n \"VerbatimTerm\": \"asthma\",\n \"Probability\": \"8.34616E-05\",\n \"SemanticContext\": \"Though effective for the treatment of asthma, corticosteroids do not affect asthma symptoms immediately.\"\n },\n {\n \"VerbatimTerm\": \"asthma\",\n \"Probability\": \"8.37535E-05\",\n \"SemanticContext\": \"When corticosteroids are discontinued, asthma stability may persist for several days or longer.\"\n },\n {\n \"VerbatimTerm\": \"asthma\",\n \"Probability\": \"0.0007517636\",\n \"SemanticContext\": \"Trials in subjects with asthma have shown a favorable ratio between topical anti-inflammatory activity and systemic corticosteroid effects with recommended doses of orally inhaled fluticasone propionate.\"\n },\n {\n \"VerbatimTerm\": \"asthma\",\n \"Probability\": \"0.0256779194\",\n \"SemanticContext\": \"In a 2-year trial carried out with the DISKHALER inhalation device in 64 subjects with mild, persistent asthma mean FEV 1 91% of predicted randomized to fluticasone propionate 500 mcg twice daily or placebo, no subject receiving fluticasone propionate had an abnormal response to 6-hour cosyntropin infusion peak serum cortisol undefined<18 mcg/dL .\"\n },\n {\n \"VerbatimTerm\": \"asthma\",\n \"Probability\": \"0.0006563663\",\n \"SemanticContext\": \"The potential systemic effects of inhaled fluticasone propionate on the HPA axis were also studied in subjects with asthma.\"\n },\n {\n \"VerbatimTerm\": \"asthma\",\n \"Probability\": \"0.0006968975\",\n \"SemanticContext\": \"Peak steady-state fluticasone propionate plasma concentrations in adult subjects with asthma N = 11 ranged from undetectable to 266 pg/mL after a 500-mcg twice-daily dose of fluticasone propionate inhalation powder using the DISKUS inhaler.\"\n },\n {\n \"VerbatimTerm\": \"asthma\",\n \"Probability\": \"0.0017336309\",\n \"SemanticContext\": \"Pediatric Patients: In a clinical trial conducted in subjects aged 4 to 11 years with mild to moderate asthma, fluticasone propionate concentrations were obtained in 61 subjects at 20 and 40 minutes after dosing with 50 and 100 mcg twice daily of fluticasone propionate inhalation powder using the DISKUS.\"\n },\n {\n \"VerbatimTerm\": \"asthma\",\n \"Probability\": \"0.0008534193\",\n \"SemanticContext\": \"14 CLINICAL STUDIES 14.1 Adult and Adolescent Subjects Aged 12 Years and Older Four randomized, double-blind, parallel-group, placebo-controlled, U.S. clinical trials were conducted in 1,036 adult and adolescent subjects aged 12 years and older with asthma to assess the efficacy and safety of FLOVENT DISKUS in the treatment of asthma.\"\n },\n {\n \"VerbatimTerm\": \"asthma\",\n \"Probability\": \"0.0045742691\",\n \"SemanticContext\": \"14 CLINICAL STUDIES 14.1 Adult and Adolescent Subjects Aged 12 Years and Older Four randomized, double-blind, parallel-group, placebo-controlled, U.S. clinical trials were conducted in 1,036 adult and adolescent subjects aged 12 years and older with asthma to assess the efficacy and safety of FLOVENT DISKUS in the treatment of asthma.\"\n },\n {\n \"VerbatimTerm\": \"asthma\",\n \"Probability\": \"0.0001967251\",\n \"SemanticContext\": \"Fixed dosages of 100, 250, and 500 mcg twice daily were compared with placebo to provide information about appropriate dosing to cover a range of asthma severity.\"\n },\n {\n \"VerbatimTerm\": \"asthma\",\n \"Probability\": \"0.0433956683\",\n \"SemanticContext\": \"These trials used predetermined criteria for lack of efficacy indicators of worsening asthma , resulting in withdrawal of more patients in the placebo group.\"\n },\n {\n \"VerbatimTerm\": \"asthma\",\n \"Probability\": \"2.50735E-05\",\n \"SemanticContext\": \"Subjects on all dosages of FLOVENT DISKUS were also less likely to discontinue study participation due to asthma deterioration as defined by predetermined criteria for lack of efficacy including lung function and subject-recorded variables such as AM PEF, albuterol use, and nighttime awakenings due to asthma compared with placebo.\"\n },\n {\n \"VerbatimTerm\": \"asthma\",\n \"Probability\": \"0.0011367202\",\n \"SemanticContext\": \"Subjects on all dosages of FLOVENT DISKUS were also less likely to discontinue study participation due to asthma deterioration as defined by predetermined criteria for lack of efficacy including lung function and subject-recorded variables such as AM PEF, albuterol use, and nighttime awakenings due to asthma compared with placebo.\"\n },\n {\n \"VerbatimTerm\": \"asthma\",\n \"Probability\": \"0.0001117795\",\n \"SemanticContext\": \"In a clinical trial of 111 subjects with severe asthma requiring chronic oral prednisone therapy average baseline daily prednisone dose was 14 mg , fluticasone propionate given by inhalation powder at doses of 500 and 1,000 mcg twice daily was evaluated.\"\n },\n {\n \"VerbatimTerm\": \"asthma\",\n \"Probability\": \"0.0049238503\",\n \"SemanticContext\": \"Accompanying the reduction in oral corticosteroid use, subjects treated with fluticasone propionate had significantly improved lung function and fewer asthma symptoms as compared with the placebo group.\"\n },\n {\n \"VerbatimTerm\": \"asthma\",\n \"Probability\": \"0.0003062785\",\n \"SemanticContext\": \"In this trial, subjects on active treatment were significantly less likely to discontinue treatment due to asthma deterioration as defined by predetermined criteria for lack of efficacy including lung function and subject-recorded variables such as AM PEF, albuterol use, and nighttime awakenings due to asthma .\"\n },\n {\n \"VerbatimTerm\": \"asthma\",\n \"Probability\": \"0.0013523996\",\n \"SemanticContext\": \"In this trial, subjects on active treatment were significantly less likely to discontinue treatment due to asthma deterioration as defined by predetermined criteria for lack of efficacy including lung function and subject-recorded variables such as AM PEF, albuterol use, and nighttime awakenings due to asthma .\"\n },\n {\n \"VerbatimTerm\": \"asthma\",\n \"Probability\": \"0.0048274994\",\n \"SemanticContext\": \"Two other 12-week placebo-controlled clinical trials were conducted in 504 pediatric subjects with asthma, approximately half of whom were receiving ICS at baseline.\"\n },\n {\n \"VerbatimTerm\": \"asthma\",\n \"Probability\": \"0.0056014955\",\n \"SemanticContext\": \"Pulmonary function improved significantly compared with placebo by the first week of treatment, and subjects treated with FLOVENT DISKUS were also less likely to discontinue trial participation due to asthma deterioration.\"\n },\n {\n \"VerbatimTerm\": \"asthma\",\n \"Probability\": \"2.36206E-05\",\n \"SemanticContext\": \"4 CONTRAINDICATIONS The use of FLOVENT DISKUS is contraindicated in the following conditions: • Primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required [see Warnings and Precautions 5.2 ] • Severe hypersensitivity to milk proteins or demonstrated hypersensitivity to fluticasone propionate [see Warnings and Precautions 5.6 , Adverse Reactions 6.2 , Description 11 ]\"\n },\n {\n \"VerbatimTerm\": \"asthma\",\n \"Probability\": \"9.7015E-06\",\n \"SemanticContext\": \"2.2 Recommended Dosage Adult and Adolescent Patients Aged 12 Years and Older The starting dosage is based on previous asthma therapy and asthma severity, including consideration of patients’ current control of asthma symptoms and risk of future exacerbation.\"\n },\n {\n \"VerbatimTerm\": \"asthma\",\n \"Probability\": \"5.452E-06\",\n \"SemanticContext\": \"2.2 Recommended Dosage Adult and Adolescent Patients Aged 12 Years and Older The starting dosage is based on previous asthma therapy and asthma severity, including consideration of patients’ current control of asthma symptoms and risk of future exacerbation.\"\n },\n {\n \"VerbatimTerm\": \"asthma\",\n \"Probability\": \"4.719E-06\",\n \"SemanticContext\": \"2.2 Recommended Dosage Adult and Adolescent Patients Aged 12 Years and Older The starting dosage is based on previous asthma therapy and asthma severity, including consideration of patients’ current control of asthma symptoms and risk of future exacerbation.\"\n },\n {\n \"VerbatimTerm\": \"asthma\",\n \"Probability\": \"9.42916E-05\",\n \"SemanticContext\": \"For other patients, and for patients who do not respond adequately to the starting dosage after 2 weeks of therapy, higher dosages may provide additional asthma control.\"\n },\n {\n \"VerbatimTerm\": \"asthma\",\n \"Probability\": \"6.83656E-05\",\n \"SemanticContext\": \"Pediatric Patients Aged 4 to 11 Years The starting dosage is based on previous asthma therapy and asthma severity, including consideration of patients’ current control of asthma symptoms and risk of future exacerbation.\"\n },\n {\n \"VerbatimTerm\": \"asthma\",\n \"Probability\": \"3.89216E-05\",\n \"SemanticContext\": \"Pediatric Patients Aged 4 to 11 Years The starting dosage is based on previous asthma therapy and asthma severity, including consideration of patients’ current control of asthma symptoms and risk of future exacerbation.\"\n },\n {\n \"VerbatimTerm\": \"asthma\",\n \"Probability\": \"2.1039E-05\",\n \"SemanticContext\": \"Pediatric Patients Aged 4 to 11 Years The starting dosage is based on previous asthma therapy and asthma severity, including consideration of patients’ current control of asthma symptoms and risk of future exacerbation.\"\n },\n {\n \"VerbatimTerm\": \"asthma\",\n \"Probability\": \"0.0002955794\",\n \"SemanticContext\": \"For other patients, and for patients who do not respond adequately to the starting dosage after 2 weeks of therapy, increasing the dosage to 100 mcg twice daily may provide additional asthma control.\"\n },\n {\n \"VerbatimTerm\": \"asthma\",\n \"Probability\": \"3.092E-07\",\n \"SemanticContext\": \"If a dosage regimen fails to provide adequate control of asthma, the therapeutic regimen should be re-evaluated and additional therapeutic options, e.g., replacing the current strength with a higher strength, initiating an ICS and long-acting beta2-agonist LABA combination product, or initiating oral corticosteroids, should be considered.\"\n },\n {\n \"VerbatimTerm\": \"asthma\",\n \"Probability\": \"0.0013205409\",\n \"SemanticContext\": \"After asthma stability has been achieved, titrate to the lowest effective dosage to reduce the possibility of side effects.\"\n },\n {\n \"VerbatimTerm\": \"asthma\",\n \"Probability\": \"0.0001181755\",\n \"SemanticContext\": \"1 INDICATIONS AND USAGE Flovent DISKUS is indicated for the maintenance treatment of asthma as prophylactic therapy in patients aged 4 years and older.\"\n },\n {\n \"VerbatimTerm\": \"asthma\",\n \"Probability\": \"1.7089E-06\",\n \"SemanticContext\": \"Advise patients to treat acute asthma symptoms with an inhaled, short-acting beta 2 -agonist such as albuterol.\"\n },\n {\n \"VerbatimTerm\": \"asthma\",\n \"Probability\": \"0.000225395\",\n \"SemanticContext\": \"Instruct patients to contact their physicians immediately if there is deterioration of their asthma.\"\n },\n {\n \"VerbatimTerm\": \"asthma\",\n \"Probability\": \"0.0003329217\",\n \"SemanticContext\": \"Clinical Considerations Disease-Associated Maternal and/or Embryofetal Risk: In women with poorly or moderately controlled asthma, there is an increased risk of several perinatal outcomes such as pre-eclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate.\"\n },\n {\n \"VerbatimTerm\": \"asthma\",\n \"Probability\": \"3.94742E-05\",\n \"SemanticContext\": \"Pregnant women with asthma should be closely monitored and medication adjusted as necessary to maintain optimal asthma control.\"\n },\n {\n \"VerbatimTerm\": \"asthma\",\n \"Probability\": \"9.2378E-06\",\n \"SemanticContext\": \"Pregnant women with asthma should be closely monitored and medication adjusted as necessary to maintain optimal asthma control.\"\n },\n {\n \"VerbatimTerm\": \"asthma\",\n \"Probability\": \"1.08517E-05\",\n \"SemanticContext\": \"Patients should be instructed to contact their physicians immediately when episodes of asthma that are not responsive to bronchodilators occur during the course of treatment with FLOVENT DISKUS.\"\n },\n {\n \"VerbatimTerm\": \"asthma\",\n \"Probability\": \"0.0003095567\",\n \"SemanticContext\": \"5.4 Transferring Patients from Systemic Corticosteroid Therapy Particular care is needed for patients who have been transferred from systemically active corticosteroids to ICS because deaths due to adrenal insufficiency have occurred in patients with asthma during and after transfer from systemic corticosteroids to less systemically available ICS.\"\n },\n {\n \"VerbatimTerm\": \"asthma\",\n \"Probability\": \"6.98557E-05\",\n \"SemanticContext\": \"Although FLOVENT DISKUS may control asthma symptoms during these episodes, in recommended doses it supplies less than normal physiological amounts of glucocorticoid systemically and does NOT provide the mineralocorticoid activity that is necessary for coping with these emergencies.\"\n },\n {\n \"VerbatimTerm\": \"asthma\",\n \"Probability\": \"5.34029E-05\",\n \"SemanticContext\": \"During periods of stress or a severe asthma attack, patients who have been withdrawn from systemic corticosteroids should be instructed to resume oral corticosteroids in large doses immediately and to contact their physicians for further instruction.\"\n },\n {\n \"VerbatimTerm\": \"asthma\",\n \"Probability\": \"1.20376E-05\",\n \"SemanticContext\": \"These patients should also be instructed to carry a warning card indicating that they may need supplementary systemic corticosteroids during periods of stress or a severe asthma attack.\"\n },\n {\n \"VerbatimTerm\": \"asthma\",\n \"Probability\": \"0.0013704896\",\n \"SemanticContext\": \"Lung function mean forced expiratory volume in 1 second [FEV 1 ] or morning peak expiratory flow [AM PEF] , beta-agonist use, and asthma symptoms should be carefully monitored during withdrawal of oral corticosteroids.\"\n },\n {\n \"VerbatimTerm\": \"asthma\",\n \"Probability\": \"0.0001557767\",\n \"SemanticContext\": \"5.5 Hypercorticism and Adrenal Suppression Fluticasone propionate will often help control asthma symptoms with less suppression of HPA function than therapeutically equivalent oral doses of prednisone.\"\n },\n {\n \"VerbatimTerm\": \"asthma\",\n \"Probability\": \"1.82719E-05\",\n \"SemanticContext\": \"If such effects occur, FLOVENT DISKUS should be reduced slowly, consistent with accepted procedures for reducing systemic corticosteroids, and other treatments for management of asthma symptoms should be considered.\"\n },\n {\n \"VerbatimTerm\": \"asthma\",\n \"Probability\": \"0.0008525252\",\n \"SemanticContext\": \"A 2-year trial in 160 subjects females aged 18 to 40 years, males 18 to 50 with asthma receiving chlorofluorocarbon CFC -propelled fluticasone propionate inhalation aerosol 88 or 440 mcg twice daily demonstrated no statistically significant changes in BMD at any time point 24, 52, 76, and 104 weeks of double-blind treatment as assessed by dual-energy x-ray absorptiometry at lumbar regions L1 through L4.\"\n },\n {\n \"VerbatimTerm\": \"asthma\",\n \"Probability\": \"0.0027586818\",\n \"SemanticContext\": \"A reduction of growth velocity in children or teenagers may occur as a result of poorly controlled asthma or from use of corticosteroids, including ICS.\"\n },\n {\n \"VerbatimTerm\": \"asthma\",\n \"Probability\": \"0.0026093721\",\n \"SemanticContext\": \"An imbalance in the proportion of children entering puberty between groups and a higher dropout rate in the placebo group due to poorly controlled asthma may be confounding factors in interpreting these data.\"\n },\n {\n \"VerbatimTerm\": \"Asthma\",\n \"Probability\": \"1.89674E-05\",\n \"SemanticContext\": \"Adverse Reactions with FLOVENT DISKUS with >3% Incidence and More Common than Placebo in Subjects with Asthma Adverse Event FLOVENT DISKUS 50 mcg Twice Daily n = 178 % FLOVENT DISKUS 100 mcg Twice Daily n = 305 % FLOVENT DISKUS 250 mcg Twice Daily n = 86 % FLOVENT DISKUS 500 mcg Twice Daily n = 64 % Placebo n = 543 % Ear, nose, and throat Upper respiratory tract infection 20 18 21 14 16 Throat irritation 13 13 3 22 8 Sinusitis/sinus infection 9 10 6 6 6 Upper respiratory inflammation 5 5 0 5 3 Rhinitis 4 3 1 2 2 Oral candidiasis undefined<1 9 6 5 7 Gastrointestinal Nausea and vomiting 8 4 1 2 4 Gastrointestinal discomfort and pain 4 3 2 2 3 Viral gastrointestinal infection 4 3 3 5 1 Non-site specific Fever 7 7 1 2 4 Viral infection 2 2 0 5 2 Lower respiratory Viral respiratory infection 4 5 1 2 4 Cough 3 5 1 5 4 Bronchitis 2 3 0 8 1 Neurological Headache 12 12 2 14 7 Musculoskeletal and trauma Muscle injury 2 0 1 5 1 Musculoskeletal pain 4 3 2 5 2 Injury 2 undefined<1 0 5 undefined<1 .\"\n },\n {\n \"VerbatimTerm\": \"Asthma\",\n \"Probability\": \"0.0006322861\",\n \"SemanticContext\": \"Status Asthmaticus and Acute Asthma Symptoms Inform patients that FLOVENT DISKUS is not a bronchodilator and is not intended for use as rescue medicine for acute asthma exacerbations.\"\n },\n {\n \"VerbatimTerm\": \"Asthma\",\n \"Probability\": \"0.000257194\",\n \"SemanticContext\": \"5.2 Acute Asthma Episodes FLOVENT DISKUS is not to be regarded as a bronchodilator and is not indicated for rapid relief of bronchospasm.\"\n }\n ]\n },\n {\n \"Term\": \"Pain\",\n \"MEDDRACode\": \"10033371\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"pain\",\n \"Probability\": \"0.9997110963\",\n \"SemanticContext\": \"Adverse Reactions with FLOVENT DISKUS with >3% Incidence and More Common than Placebo in Subjects with Asthma Adverse Event FLOVENT DISKUS 50 mcg Twice Daily n = 178 % FLOVENT DISKUS 100 mcg Twice Daily n = 305 % FLOVENT DISKUS 250 mcg Twice Daily n = 86 % FLOVENT DISKUS 500 mcg Twice Daily n = 64 % Placebo n = 543 % Ear, nose, and throat Upper respiratory tract infection 20 18 21 14 16 Throat irritation 13 13 3 22 8 Sinusitis/sinus infection 9 10 6 6 6 Upper respiratory inflammation 5 5 0 5 3 Rhinitis 4 3 1 2 2 Oral candidiasis undefined<1 9 6 5 7 Gastrointestinal Nausea and vomiting 8 4 1 2 4 Gastrointestinal discomfort and pain 4 3 2 2 3 Viral gastrointestinal infection 4 3 3 5 1 Non-site specific Fever 7 7 1 2 4 Viral infection 2 2 0 5 2 Lower respiratory Viral respiratory infection 4 5 1 2 4 Cough 3 5 1 5 4 Bronchitis 2 3 0 8 1 Neurological Headache 12 12 2 14 7 Musculoskeletal and trauma Muscle injury 2 0 1 5 1 Musculoskeletal pain 4 3 2 5 2 Injury 2 undefined<1 0 5 undefined<1 .\"\n },\n {\n \"VerbatimTerm\": \"pain\",\n \"Probability\": \"0.8612538576\",\n \"SemanticContext\": \"Additional Adverse Reactions Other adverse reactions not previously listed, whether considered drug-related or not by the investigators, that were reported more frequently by subjects with asthma treated with FLOVENT DISKUS compared with subjects treated with placebo include the following: palpitations; soft tissue injuries; contusions and hematomas; wounds and lacerations; burns; poisoning and toxicity; pressure-induced disorders; hoarseness/dysphonia; epistaxis; ear, nose, throat, and tonsil signs and symptoms; ear, nose, and throat polyps; allergic ear, nose, and throat disorders; throat constriction; fluid disturbances; weight gain; appetite disturbances; keratitis and conjunctivitis; blepharoconjunctivitis; gastrointestinal signs and symptoms; oral ulcerations; dental discomfort and pain; oral erythema and rashes; mouth and tongue disorders; oral discomfort and pain; tooth decay; cholecystitis; arthralgia and articular rheumatism; muscle cramps and spasms; musculoskeletal inflammation; dizziness; sleep disorders; migraines; paralysis of cranial nerves; edema and swelling; bacterial infections; fungal infections; mobility disorders; mood disorders; bacterial reproductive infections; photodermatitis; dermatitis and dermatosis; viral skin infections; eczema; pruritus; acne and folliculitis; urinary infections.\"\n },\n {\n \"VerbatimTerm\": \"pain\",\n \"Probability\": \"0.9635714293\",\n \"SemanticContext\": \"Additional Adverse Reactions Other adverse reactions not previously listed, whether considered drug-related or not by the investigators, that were reported more frequently by subjects with asthma treated with FLOVENT DISKUS compared with subjects treated with placebo include the following: palpitations; soft tissue injuries; contusions and hematomas; wounds and lacerations; burns; poisoning and toxicity; pressure-induced disorders; hoarseness/dysphonia; epistaxis; ear, nose, throat, and tonsil signs and symptoms; ear, nose, and throat polyps; allergic ear, nose, and throat disorders; throat constriction; fluid disturbances; weight gain; appetite disturbances; keratitis and conjunctivitis; blepharoconjunctivitis; gastrointestinal signs and symptoms; oral ulcerations; dental discomfort and pain; oral erythema and rashes; mouth and tongue disorders; oral discomfort and pain; tooth decay; cholecystitis; arthralgia and articular rheumatism; muscle cramps and spasms; musculoskeletal inflammation; dizziness; sleep disorders; migraines; paralysis of cranial nerves; edema and swelling; bacterial infections; fungal infections; mobility disorders; mood disorders; bacterial reproductive infections; photodermatitis; dermatitis and dermatosis; viral skin infections; eczema; pruritus; acne and folliculitis; urinary infections.\"\n },\n {\n \"VerbatimTerm\": \"pain\",\n \"Probability\": \"0.9772595763\",\n \"SemanticContext\": \"Non-Site Specific: Malaise and fatigue 16% and 9% and pain 10% and 3% .\"\n }\n ]\n },\n {\n \"Term\": \"Blood methanol\",\n \"MEDDRACode\": \"10005663\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"methanol\",\n \"Probability\": \"0.0013303161\",\n \"SemanticContext\": \"It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol.\"\n }\n ]\n },\n {\n \"Term\": \"Drug ineffective\",\n \"MEDDRACode\": \"10013709\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"lack of efficacy\",\n \"Probability\": \"0.0006563663\",\n \"SemanticContext\": \"These trials used predetermined criteria for lack of efficacy indicators of worsening asthma , resulting in withdrawal of more patients in the placebo group.\"\n },\n {\n \"VerbatimTerm\": \"lack of efficacy\",\n \"Probability\": \"0.0004661083\",\n \"SemanticContext\": \"Subjects on all dosages of FLOVENT DISKUS were also less likely to discontinue study participation due to asthma deterioration as defined by predetermined criteria for lack of efficacy including lung function and subject-recorded variables such as AM PEF, albuterol use, and nighttime awakenings due to asthma compared with placebo.\"\n },\n {\n \"VerbatimTerm\": \"lack of efficacy\",\n \"Probability\": \"0.0017722547\",\n \"SemanticContext\": \"In this trial, subjects on active treatment were significantly less likely to discontinue treatment due to asthma deterioration as defined by predetermined criteria for lack of efficacy including lung function and subject-recorded variables such as AM PEF, albuterol use, and nighttime awakenings due to asthma .\"\n }\n ]\n },\n {\n \"Term\": \"Obstructive airways disorder\",\n \"MEDDRACode\": \"10061877\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"obstructive lung disease\",\n \"Probability\": \"0.0036890805\",\n \"SemanticContext\": \"In adult subjects with obstructive lung disease and severely compromised lung function mean FEV 1 20% to 30% of predicted , mean peak inspiratory flow PIF through the DISKUS inhaler was 82.4 L/min range: 46.1 to 115.3 L/min .\"\n }\n ]\n },\n {\n \"Term\": \"Eosinophil count\",\n \"MEDDRACode\": \"10014941\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"eosinophils\",\n \"Probability\": \"0.0010050833\",\n \"SemanticContext\": \"Corticosteroids have been shown to have a wide range of actions on multiple cell types e.g., mast cells, eosinophils, neutrophils, macrophages, lymphocytes and mediators e.g., histamine, eicosanoids, leukotrienes, cytokines involved in inflammation.\"\n }\n ]\n },\n {\n \"Term\": \"Primary ciliary dyskinesia\",\n \"MEDDRACode\": \"10069713\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"ICS\",\n \"Probability\": \"0.0371358693\",\n \"SemanticContext\": \"FLOVENT DISKUS fluticasone propionate inhalation powder , for oral inhalation use Initial U.S. Approval: 1994 INDICATIONS AND USAGE FLOVENT DISKUS is an inhaled corticosteroid ICS indicated for: .\"\n },\n {\n \"VerbatimTerm\": \"ICS\",\n \"Probability\": \"0.3359710872\",\n \"SemanticContext\": \"5.8 • Glaucoma and cataracts may occur with long-term use of ICS.\"\n },\n {\n \"VerbatimTerm\": \"ICS\",\n \"Probability\": \"0.0075316131\",\n \"SemanticContext\": \"The incidence of common adverse reactions in Table 1 is based upon 7 placebo-controlled U.S. clinical trials in which 1,176 pediatric, adolescent, and adult subjects 466 females and 710 males previously treated with as-needed bronchodilators and/or ICS were treated twice daily for up to 12 weeks with FLOVENT DISKUS doses of 50 to 500 mcg or placebo.\"\n },\n {\n \"VerbatimTerm\": \"ICS\",\n \"Probability\": \"0.0016358495\",\n \"SemanticContext\": \"Subjects in these trials included those inadequately controlled with bronchodilators alone and those already maintained on daily ICS.\"\n },\n {\n \"VerbatimTerm\": \"ICS\",\n \"Probability\": \"0.6502251625\",\n \"SemanticContext\": \"A 12-Week Clinical Trial Evaluating FLOVENT DISKUS 500 mcg Twice Daily in Adults and Adolescents Receiving Inhaled Corticosteroids or Bronchodilators Alone 14.2 Pediatric Subjects Aged 4 to 11 Years A 12-week, placebo-controlled clinical trial was conducted in 437 pediatric subjects 177 received FLOVENT DISKUS , approximately half of whom were receiving ICS at baseline.\"\n },\n {\n \"VerbatimTerm\": \"ICS\",\n \"Probability\": \"0.6518317461\",\n \"SemanticContext\": \"Two other 12-week placebo-controlled clinical trials were conducted in 504 pediatric subjects with asthma, approximately half of whom were receiving ICS at baseline.\"\n },\n {\n \"VerbatimTerm\": \"ICS\",\n \"Probability\": \"9.35867E-05\",\n \"SemanticContext\": \"The recommended starting dosage for patients aged 12 years and older who are not on an inhaled corticosteroid ICS is 100 mcg twice daily, approximately 12 hours apart.\"\n },\n {\n \"VerbatimTerm\": \"ICS\",\n \"Probability\": \"0.002346158\",\n \"SemanticContext\": \"For patients aged 4 to 11 years not on an ICS, the recommended starting dosage is 50 mcg twice daily, approximately 12 hours apart.\"\n },\n {\n \"VerbatimTerm\": \"ICS\",\n \"Probability\": \"0.0014580786\",\n \"SemanticContext\": \"If a dosage regimen fails to provide adequate control of asthma, the therapeutic regimen should be re-evaluated and additional therapeutic options, e.g., replacing the current strength with a higher strength, initiating an ICS and long-acting beta2-agonist LABA combination product, or initiating oral corticosteroids, should be considered.\"\n },\n {\n \"VerbatimTerm\": \"ICS\",\n \"Probability\": \"0.009306699\",\n \"SemanticContext\": \"Glaucoma and Cataracts Advise patients that long-term use of ICS may increase the risk of some eye problems cataracts or glaucoma ; consider regular eye examinations.\"\n },\n {\n \"VerbatimTerm\": \"ICS\",\n \"Probability\": \"0.0749792755\",\n \"SemanticContext\": \"ICS should be used with caution, if at all, in patients with active or quiescent tuberculosis infections of the respiratory tract; systemic fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex.\"\n },\n {\n \"VerbatimTerm\": \"ICS\",\n \"Probability\": \"0.1109933257\",\n \"SemanticContext\": \"5.4 Transferring Patients from Systemic Corticosteroid Therapy Particular care is needed for patients who have been transferred from systemically active corticosteroids to ICS because deaths due to adrenal insufficiency have occurred in patients with asthma during and after transfer from systemic corticosteroids to less systemically available ICS.\"\n },\n {\n \"VerbatimTerm\": \"ICS\",\n \"Probability\": \"0.0283521712\",\n \"SemanticContext\": \"5.4 Transferring Patients from Systemic Corticosteroid Therapy Particular care is needed for patients who have been transferred from systemically active corticosteroids to ICS because deaths due to adrenal insufficiency have occurred in patients with asthma during and after transfer from systemic corticosteroids to less systemically available ICS.\"\n },\n {\n \"VerbatimTerm\": \"ICS\",\n \"Probability\": \"0.0314073265\",\n \"SemanticContext\": \"Because of the possibility of significant systemic absorption of ICS in sensitive patients, patients treated with FLOVENT DISKUS should be observed carefully for any evidence of systemic corticosteroid effects.\"\n },\n {\n \"VerbatimTerm\": \"ICS\",\n \"Probability\": \"0.4428220391\",\n \"SemanticContext\": \"5.7 Reduction in Bone Mineral Density Decreases in bone mineral density BMD have been observed with long-term administration of products containing ICS.\"\n },\n {\n \"VerbatimTerm\": \"ICS\",\n \"Probability\": \"0.557782948\",\n \"SemanticContext\": \"5.9 Glaucoma and Cataracts Glaucoma, increased intraocular pressure, and cataracts have been reported in patients following the long-term administration of ICS, including fluticasone propionate.\"\n },\n {\n \"VerbatimTerm\": \"ICS\",\n \"Probability\": \"0.5863746405\",\n \"SemanticContext\": \"Cases of serious eosinophilic conditions have also been reported with other ICS in this clinical setting.\"\n },\n {\n \"VerbatimTerm\": \"ICS\",\n \"Probability\": \"0.0693159401\",\n \"SemanticContext\": \"A reduction of growth velocity in children or teenagers may occur as a result of poorly controlled asthma or from use of corticosteroids, including ICS.\"\n },\n {\n \"VerbatimTerm\": \"ICS\",\n \"Probability\": \"0.0024684072\",\n \"SemanticContext\": \"The effects of long-term treatment of children and adolescents with ICS, including fluticasone propionate, on final adult height are not known.\"\n },\n {\n \"VerbatimTerm\": \"ICS\",\n \"Probability\": \"0.4312343299\",\n \"SemanticContext\": \"Controlled clinical trials have shown that ICS may cause a reduction in growth in pediatric patients.\"\n }\n ]\n },\n {\n \"Term\": \"Peak expiratory flow rate\",\n \"MEDDRACode\": \"10034192\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"PEF\",\n \"Probability\": \"0.0002774298\",\n \"SemanticContext\": \"Subjects on all dosages of FLOVENT DISKUS were also less likely to discontinue study participation due to asthma deterioration as defined by predetermined criteria for lack of efficacy including lung function and subject-recorded variables such as AM PEF, albuterol use, and nighttime awakenings due to asthma compared with placebo.\"\n },\n {\n \"VerbatimTerm\": \"PEF\",\n \"Probability\": \"0.0098034441\",\n \"SemanticContext\": \"AM PEF was also significantly improved with doses of fluticasone propionate 50 and 100 mcg twice daily 26% and 27% change from baseline at Endpoint, respectively compared with placebo 14% change .\"\n },\n {\n \"VerbatimTerm\": \"PEF\",\n \"Probability\": \"0.0001984537\",\n \"SemanticContext\": \"In this trial, subjects on active treatment were significantly less likely to discontinue treatment due to asthma deterioration as defined by predetermined criteria for lack of efficacy including lung function and subject-recorded variables such as AM PEF, albuterol use, and nighttime awakenings due to asthma .\"\n },\n {\n \"VerbatimTerm\": \"PEF\",\n \"Probability\": \"0.0002494156\",\n \"SemanticContext\": \"Lung function mean forced expiratory volume in 1 second [FEV 1 ] or morning peak expiratory flow [AM PEF] , beta-agonist use, and asthma symptoms should be carefully monitored during withdrawal of oral corticosteroids.\"\n }\n ]\n },\n {\n \"Term\": \"Hyperphenylalaninaemia\",\n \"MEDDRACode\": \"10084106\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"HPA\",\n \"Probability\": \"0.0012985468\",\n \"SemanticContext\": \"The potential systemic effects of inhaled fluticasone propionate on the HPA axis were also studied in subjects with asthma.\"\n },\n {\n \"VerbatimTerm\": \"HPA\",\n \"Probability\": \"0.0845170021\",\n \"SemanticContext\": \"After withdrawal from systemic corticosteroids, a number of months are required for recovery of hypothalamic-pituitary-adrenal HPA function.\"\n },\n {\n \"VerbatimTerm\": \"HPA\",\n \"Probability\": \"0.0010977089\",\n \"SemanticContext\": \"During this period of HPA suppression, patients may exhibit signs and symptoms of adrenal insufficiency when exposed to trauma, surgery, or infection particularly gastroenteritis or other conditions associated with severe electrolyte loss.\"\n },\n {\n \"VerbatimTerm\": \"HPA\",\n \"Probability\": \"0.00028494\",\n \"SemanticContext\": \"5.5 Hypercorticism and Adrenal Suppression Fluticasone propionate will often help control asthma symptoms with less suppression of HPA function than therapeutically equivalent oral doses of prednisone.\"\n },\n {\n \"VerbatimTerm\": \"HPA\",\n \"Probability\": \"2.49286E-05\",\n \"SemanticContext\": \"Since fluticasone propionate is absorbed into the circulation and can be systemically active at higher doses, the beneficial effects of FLOVENT DISKUS in minimizing HPA dysfunction may be expected only when recommended dosages are not exceeded and individual patients are titrated to the lowest effective dose.\"\n },\n {\n \"VerbatimTerm\": \"HPA\",\n \"Probability\": \"0.0008812249\",\n \"SemanticContext\": \"This effect was observed in the absence of laboratory evidence of HPA axis suppression, suggesting that growth velocity is a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly used tests of HPA axis function.\"\n },\n {\n \"VerbatimTerm\": \"HPA\",\n \"Probability\": \"0.0043768287\",\n \"SemanticContext\": \"This effect was observed in the absence of laboratory evidence of HPA axis suppression, suggesting that growth velocity is a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly used tests of HPA axis function.\"\n }\n ]\n },\n {\n \"Term\": \"Pulmonary function test\",\n \"MEDDRACode\": \"10059914\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"lung function\",\n \"Probability\": \"1.99112E-05\",\n \"SemanticContext\": \"In adult subjects with obstructive lung disease and severely compromised lung function mean FEV 1 20% to 30% of predicted , mean peak inspiratory flow PIF through the DISKUS inhaler was 82.4 L/min range: 46.1 to 115.3 L/min .\"\n },\n {\n \"VerbatimTerm\": \"lung function\",\n \"Probability\": \"0.0004418194\",\n \"SemanticContext\": \"Therefore, pulmonary function results at Endpoint the last evaluable FEV 1 result, including most patients’ lung function data are also displayed.\"\n },\n {\n \"VerbatimTerm\": \"lung function\",\n \"Probability\": \"0.0001153489\",\n \"SemanticContext\": \"Subjects on all dosages of FLOVENT DISKUS were also less likely to discontinue study participation due to asthma deterioration as defined by predetermined criteria for lack of efficacy including lung function and subject-recorded variables such as AM PEF, albuterol use, and nighttime awakenings due to asthma compared with placebo.\"\n },\n {\n \"VerbatimTerm\": \"lung function\",\n \"Probability\": \"0.0106672347\",\n \"SemanticContext\": \"Accompanying the reduction in oral corticosteroid use, subjects treated with fluticasone propionate had significantly improved lung function and fewer asthma symptoms as compared with the placebo group.\"\n },\n {\n \"VerbatimTerm\": \"lung function\",\n \"Probability\": \"0.0001684129\",\n \"SemanticContext\": \"In this trial, subjects on active treatment were significantly less likely to discontinue treatment due to asthma deterioration as defined by predetermined criteria for lack of efficacy including lung function and subject-recorded variables such as AM PEF, albuterol use, and nighttime awakenings due to asthma .\"\n },\n {\n \"VerbatimTerm\": \"lung function\",\n \"Probability\": \"0.0009562075\",\n \"SemanticContext\": \"In these trials, FLOVENT DISKUS was efficacious at doses of 50 and 100 mcg twice daily when compared with placebo on major endpoints including lung function and symptom scores.\"\n },\n {\n \"VerbatimTerm\": \"lung function\",\n \"Probability\": \"0.0008622408\",\n \"SemanticContext\": \"Data from this open-label extension suggested that lung function improvements could be maintained up to 1 year.\"\n },\n {\n \"VerbatimTerm\": \"Lung function\",\n \"Probability\": \"0.0006359816\",\n \"SemanticContext\": \"Lung function mean forced expiratory volume in 1 second [FEV 1 ] or morning peak expiratory flow [AM PEF] , beta-agonist use, and asthma symptoms should be carefully monitored during withdrawal of oral corticosteroids.\"\n }\n ]\n },\n {\n \"Term\": \"Keratitis\",\n \"MEDDRACode\": \"10023332\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"keratitis\",\n \"Probability\": \"0.9877349138\",\n \"SemanticContext\": \"Additional Adverse Reactions Other adverse reactions not previously listed, whether considered drug-related or not by the investigators, that were reported more frequently by subjects with asthma treated with FLOVENT DISKUS compared with subjects treated with placebo include the following: palpitations; soft tissue injuries; contusions and hematomas; wounds and lacerations; burns; poisoning and toxicity; pressure-induced disorders; hoarseness/dysphonia; epistaxis; ear, nose, throat, and tonsil signs and symptoms; ear, nose, and throat polyps; allergic ear, nose, and throat disorders; throat constriction; fluid disturbances; weight gain; appetite disturbances; keratitis and conjunctivitis; blepharoconjunctivitis; gastrointestinal signs and symptoms; oral ulcerations; dental discomfort and pain; oral erythema and rashes; mouth and tongue disorders; oral discomfort and pain; tooth decay; cholecystitis; arthralgia and articular rheumatism; muscle cramps and spasms; musculoskeletal inflammation; dizziness; sleep disorders; migraines; paralysis of cranial nerves; edema and swelling; bacterial infections; fungal infections; mobility disorders; mood disorders; bacterial reproductive infections; photodermatitis; dermatitis and dermatosis; viral skin infections; eczema; pruritus; acne and folliculitis; urinary infections.\"\n }\n ]\n },\n {\n \"Term\": \"Localised infection\",\n \"MEDDRACode\": \"10024774\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"localized infections\",\n \"Probability\": \"0.0817276537\",\n \"SemanticContext\": \"Local Effects Inform patients that localized infections with Candida albicans occurred in the mouth and pharynx in some patients.\"\n },\n {\n \"VerbatimTerm\": \"localized infections\",\n \"Probability\": \"0.1628757417\",\n \"SemanticContext\": \"5 WARNINGS AND PRECAUTIONS 5.1 Local Effects of Inhaled Corticosteroids In clinical trials, the development of localized infections of the mouth and pharynx with Candida albicans has occurred in subjects treated with FLOVENT DISKUS.\"\n }\n ]\n },\n {\n \"Term\": \"Status asthmaticus\",\n \"MEDDRACode\": \"10041961\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": true,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"status asthmaticus\",\n \"Probability\": \"0.0001452565\",\n \"SemanticContext\": \"CONTRAINDICATIONS • Primary treatment of status asthmaticus or acute episodes of asthma requiring intensive measures.\"\n },\n {\n \"VerbatimTerm\": \"status asthmaticus\",\n \"Probability\": \"3.50721E-05\",\n \"SemanticContext\": \"4 CONTRAINDICATIONS The use of FLOVENT DISKUS is contraindicated in the following conditions: • Primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required [see Warnings and Precautions 5.2 ] • Severe hypersensitivity to milk proteins or demonstrated hypersensitivity to fluticasone propionate [see Warnings and Precautions 5.6 , Adverse Reactions 6.2 , Description 11 ]\"\n },\n {\n \"VerbatimTerm\": \"Status Asthmaticus\",\n \"Probability\": \"0.0059672594\",\n \"SemanticContext\": \"Status Asthmaticus and Acute Asthma Symptoms Inform patients that FLOVENT DISKUS is not a bronchodilator and is not intended for use as rescue medicine for acute asthma exacerbations.\"\n }\n ]\n },\n {\n \"Term\": \"Teratogenicity\",\n \"MEDDRACode\": \"10043275\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"teratogenicity\",\n \"Probability\": \"0.0084794164\",\n \"SemanticContext\": \"In animals, teratogenicity characteristic of corticosteroids, decreased fetal body weight, and/or skeletal variations in rats, mice, and rabbits were observed with subcutaneously administered maternal toxic doses of fluticasone propionate less than the maximum recommended human daily inhaled dose MRHDID on a mcg/m 2 basis.\"\n },\n {\n \"VerbatimTerm\": \"teratogenicity\",\n \"Probability\": \"0.0001952946\",\n \"SemanticContext\": \"However, fluticasone propionate administered via inhalation to rats decreased fetal body weight, but did not induce teratogenicity at a maternal toxic dose less than the MRHDID on a mcg/m 2 basis.\"\n },\n {\n \"VerbatimTerm\": \"teratogenicity\",\n \"Probability\": \"0.0038514137\",\n \"SemanticContext\": \"In an embryofetal development study with pregnant rats dosed by the inhalation route throughout the period of organogenesis, fluticasone propionate produced decreased fetal body weights and skeletal variations, in the presence of maternal toxicity, at a dose approximately 0.13 times the MRHDID on a mcg/m 2 basis with a maternal inhalation dose of 25.7 mcg/kg/day ; however, there was no evidence of teratogenicity.\"\n },\n {\n \"VerbatimTerm\": \"Teratogenicity\",\n \"Probability\": \"0.0224041045\",\n \"SemanticContext\": \"Teratogenicity was evident based upon a finding of cleft palate for 1 fetus at a dose approximately 0.04 times the MRHDID on a mcg/m 2 basis with a maternal subcutaneous dose of 4 mcg/kg/day .\"\n }\n ]\n },\n {\n \"Term\": \"Bone density decreased\",\n \"MEDDRACode\": \"10049470\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"decreased bone mineral content\",\n \"Probability\": \"0.0050367117\",\n \"SemanticContext\": \"Patients with major risk factors for decreased bone mineral content, such as prolonged immobilization, family history of osteoporosis, postmenopausal status, tobacco use, advanced age, poor nutrition, or chronic use of drugs that can reduce bone mass e.g., anticonvulsants, oral corticosteroids , should be monitored and treated with established standards of care.\"\n }\n ]\n },\n {\n \"Term\": \"Bronchospasm paradoxical\",\n \"MEDDRACode\": \"10006486\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Paradoxical Bronchospasm\",\n \"Probability\": \"0.6498098373\",\n \"SemanticContext\": \"5.10 Paradoxical Bronchospasm As with other inhaled medicines, bronchospasm may occur with an immediate increase in wheezing after dosing.\"\n }\n ]\n },\n {\n \"Term\": \"Rhinitis\",\n \"MEDDRACode\": \"10039083\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"rhinitis\",\n \"Probability\": \"0.9953584671\",\n \"SemanticContext\": \"5.9 ADVERSE REACTIONS Most common adverse reactions incidence >3% include upper respiratory tract infection or inflammation, throat irritation, sinusitis, rhinitis, oral candidiasis, nausea and vomiting, gastrointestinal discomfort, fever, cough, bronchitis, and headache.\"\n },\n {\n \"VerbatimTerm\": \"rhinitis\",\n \"Probability\": \"0.9989284277\",\n \"SemanticContext\": \"Ear, Nose, and Throat: Hoarseness/dysphonia 9% and 0% , nasal congestion/blockage 16% and 0% , oral candidiasis 31% and 21% , rhinitis 13% and 9% , sinusitis/sinus infection 33% and 12% , throat irritation 10% and 9% , and upper respiratory tract infection 31% and 24% .\"\n },\n {\n \"VerbatimTerm\": \"rhinitis\",\n \"Probability\": \"0.0013443232\",\n \"SemanticContext\": \"Transfer of patients from systemic corticosteroid therapy to FLOVENT DISKUS may unmask allergic conditions previously suppressed by the systemic corticosteroid therapy e.g., rhinitis, conjunctivitis, eczema, arthritis, eosinophilic conditions .\"\n },\n {\n \"VerbatimTerm\": \"Rhinitis\",\n \"Probability\": \"0.9961410761\",\n \"SemanticContext\": \"Adverse Reactions with FLOVENT DISKUS with >3% Incidence and More Common than Placebo in Subjects with Asthma Adverse Event FLOVENT DISKUS 50 mcg Twice Daily n = 178 % FLOVENT DISKUS 100 mcg Twice Daily n = 305 % FLOVENT DISKUS 250 mcg Twice Daily n = 86 % FLOVENT DISKUS 500 mcg Twice Daily n = 64 % Placebo n = 543 % Ear, nose, and throat Upper respiratory tract infection 20 18 21 14 16 Throat irritation 13 13 3 22 8 Sinusitis/sinus infection 9 10 6 6 6 Upper respiratory inflammation 5 5 0 5 3 Rhinitis 4 3 1 2 2 Oral candidiasis undefined<1 9 6 5 7 Gastrointestinal Nausea and vomiting 8 4 1 2 4 Gastrointestinal discomfort and pain 4 3 2 2 3 Viral gastrointestinal infection 4 3 3 5 1 Non-site specific Fever 7 7 1 2 4 Viral infection 2 2 0 5 2 Lower respiratory Viral respiratory infection 4 5 1 2 4 Cough 3 5 1 5 4 Bronchitis 2 3 0 8 1 Neurological Headache 12 12 2 14 7 Musculoskeletal and trauma Muscle injury 2 0 1 5 1 Musculoskeletal pain 4 3 2 5 2 Injury 2 undefined<1 0 5 undefined<1 .\"\n }\n ]\n },\n {\n \"Term\": \"Poisoning\",\n \"MEDDRACode\": \"10061355\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"poisoning\",\n \"Probability\": \"0.6609646082\",\n \"SemanticContext\": \"Additional Adverse Reactions Other adverse reactions not previously listed, whether considered drug-related or not by the investigators, that were reported more frequently by subjects with asthma treated with FLOVENT DISKUS compared with subjects treated with placebo include the following: palpitations; soft tissue injuries; contusions and hematomas; wounds and lacerations; burns; poisoning and toxicity; pressure-induced disorders; hoarseness/dysphonia; epistaxis; ear, nose, throat, and tonsil signs and symptoms; ear, nose, and throat polyps; allergic ear, nose, and throat disorders; throat constriction; fluid disturbances; weight gain; appetite disturbances; keratitis and conjunctivitis; blepharoconjunctivitis; gastrointestinal signs and symptoms; oral ulcerations; dental discomfort and pain; oral erythema and rashes; mouth and tongue disorders; oral discomfort and pain; tooth decay; cholecystitis; arthralgia and articular rheumatism; muscle cramps and spasms; musculoskeletal inflammation; dizziness; sleep disorders; migraines; paralysis of cranial nerves; edema and swelling; bacterial infections; fungal infections; mobility disorders; mood disorders; bacterial reproductive infections; photodermatitis; dermatitis and dermatosis; viral skin infections; eczema; pruritus; acne and folliculitis; urinary infections.\"\n }\n ]\n },\n {\n \"Term\": \"Swelling\",\n \"MEDDRACode\": \"10042674\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"swelling\",\n \"Probability\": \"0.9559099078\",\n \"SemanticContext\": \"Additional Adverse Reactions Other adverse reactions not previously listed, whether considered drug-related or not by the investigators, that were reported more frequently by subjects with asthma treated with FLOVENT DISKUS compared with subjects treated with placebo include the following: palpitations; soft tissue injuries; contusions and hematomas; wounds and lacerations; burns; poisoning and toxicity; pressure-induced disorders; hoarseness/dysphonia; epistaxis; ear, nose, throat, and tonsil signs and symptoms; ear, nose, and throat polyps; allergic ear, nose, and throat disorders; throat constriction; fluid disturbances; weight gain; appetite disturbances; keratitis and conjunctivitis; blepharoconjunctivitis; gastrointestinal signs and symptoms; oral ulcerations; dental discomfort and pain; oral erythema and rashes; mouth and tongue disorders; oral discomfort and pain; tooth decay; cholecystitis; arthralgia and articular rheumatism; muscle cramps and spasms; musculoskeletal inflammation; dizziness; sleep disorders; migraines; paralysis of cranial nerves; edema and swelling; bacterial infections; fungal infections; mobility disorders; mood disorders; bacterial reproductive infections; photodermatitis; dermatitis and dermatosis; viral skin infections; eczema; pruritus; acne and folliculitis; urinary infections.\"\n }\n ]\n },\n {\n \"Term\": \"Thermal burn\",\n \"MEDDRACode\": \"10053615\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"burns\",\n \"Probability\": \"0.1052271724\",\n \"SemanticContext\": \"Additional Adverse Reactions Other adverse reactions not previously listed, whether considered drug-related or not by the investigators, that were reported more frequently by subjects with asthma treated with FLOVENT DISKUS compared with subjects treated with placebo include the following: palpitations; soft tissue injuries; contusions and hematomas; wounds and lacerations; burns; poisoning and toxicity; pressure-induced disorders; hoarseness/dysphonia; epistaxis; ear, nose, throat, and tonsil signs and symptoms; ear, nose, and throat polyps; allergic ear, nose, and throat disorders; throat constriction; fluid disturbances; weight gain; appetite disturbances; keratitis and conjunctivitis; blepharoconjunctivitis; gastrointestinal signs and symptoms; oral ulcerations; dental discomfort and pain; oral erythema and rashes; mouth and tongue disorders; oral discomfort and pain; tooth decay; cholecystitis; arthralgia and articular rheumatism; muscle cramps and spasms; musculoskeletal inflammation; dizziness; sleep disorders; migraines; paralysis of cranial nerves; edema and swelling; bacterial infections; fungal infections; mobility disorders; mood disorders; bacterial reproductive infections; photodermatitis; dermatitis and dermatosis; viral skin infections; eczema; pruritus; acne and folliculitis; urinary infections.\"\n }\n ]\n },\n {\n \"Term\": \"Fracture\",\n \"MEDDRACode\": \"10017076\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"fracture\",\n \"Probability\": \"0.0061963499\",\n \"SemanticContext\": \"The clinical significance of small changes in BMD with regard to long-term consequences such as fracture is unknown.\"\n }\n ]\n },\n {\n \"Term\": \"Gastroenteritis\",\n \"MEDDRACode\": \"10017888\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"gastroenteritis\",\n \"Probability\": \"0.2840141058\",\n \"SemanticContext\": \"During this period of HPA suppression, patients may exhibit signs and symptoms of adrenal insufficiency when exposed to trauma, surgery, or infection particularly gastroenteritis or other conditions associated with severe electrolyte loss.\"\n }\n ]\n },\n {\n \"Term\": \"Globulin\",\n \"MEDDRACode\": \"10018342\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"globulin\",\n \"Probability\": \"1.04044E-05\",\n \"SemanticContext\": \"If a patient is exposed to chickenpox, prophylaxis with varicella zoster immune globulin VZIG may be indicated.\"\n }\n ]\n },\n {\n \"Term\": \"Immunoglobulins\",\n \"MEDDRACode\": \"10021496\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"immunoglobulin\",\n \"Probability\": \"3.25984E-05\",\n \"SemanticContext\": \"If a patient is exposed to measles, prophylaxis with pooled intramuscular immunoglobulin IG may be indicated.\"\n }\n ]\n },\n {\n \"Term\": \"Prophylaxis\",\n \"MEDDRACode\": \"10036898\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"prophylactic\",\n \"Probability\": \"2.1075E-06\",\n \"SemanticContext\": \"• Maintenance treatment of asthma as prophylactic therapy in patients aged 4 years and older.\"\n },\n {\n \"VerbatimTerm\": \"prophylactic\",\n \"Probability\": \"6.1038E-06\",\n \"SemanticContext\": \"1 INDICATIONS AND USAGE Flovent DISKUS is indicated for the maintenance treatment of asthma as prophylactic therapy in patients aged 4 years and older.\"\n }\n ]\n },\n {\n \"Term\": \"Varicella zoster virus infection\",\n \"MEDDRACode\": \"10075611\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"varicella zoster\",\n \"Probability\": \"0.0003611147\",\n \"SemanticContext\": \"If a patient is exposed to chickenpox, prophylaxis with varicella zoster immune globulin VZIG may be indicated.\"\n }\n ]\n },\n {\n \"Term\": \"Wheezing\",\n \"MEDDRACode\": \"10047924\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"wheezing\",\n \"Probability\": \"0.5071380734\",\n \"SemanticContext\": \"5.10 Paradoxical Bronchospasm As with other inhaled medicines, bronchospasm may occur with an immediate increase in wheezing after dosing.\"\n }\n ]\n },\n {\n \"Term\": \"Blood ethanol\",\n \"MEDDRACode\": \"10005513\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"ethanol\",\n \"Probability\": \"0.0036768913\",\n \"SemanticContext\": \"It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol.\"\n }\n ]\n },\n {\n \"Term\": \"Urticaria\",\n \"MEDDRACode\": \"10046735\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"urticaria\",\n \"Probability\": \"0.679050684\",\n \"SemanticContext\": \"Immediate Hypersensitivity Reactions Advise patients that immediate hypersensitivity reactions e.g., urticaria, angioedema, rash, bronchospasm, hypotension , including anaphylaxis, may occur after administration of FLOVENT DISKUS.\"\n },\n {\n \"VerbatimTerm\": \"urticaria\",\n \"Probability\": \"0.9106481075\",\n \"SemanticContext\": \"5.6 Immediate Hypersensitivity Reactions Immediate hypersensitivity reactions e.g., urticaria, angioedema, rash, bronchospasm, hypotension , including anaphylaxis, may occur after administration of FLOVENT DISKUS.\"\n }\n ]\n },\n {\n \"Term\": \"Discomfort\",\n \"MEDDRACode\": \"10013082\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"pressure\",\n \"Probability\": \"0.7891979218\",\n \"SemanticContext\": \"Additional Adverse Reactions Other adverse reactions not previously listed, whether considered drug-related or not by the investigators, that were reported more frequently by subjects with asthma treated with FLOVENT DISKUS compared with subjects treated with placebo include the following: palpitations; soft tissue injuries; contusions and hematomas; wounds and lacerations; burns; poisoning and toxicity; pressure-induced disorders; hoarseness/dysphonia; epistaxis; ear, nose, throat, and tonsil signs and symptoms; ear, nose, and throat polyps; allergic ear, nose, and throat disorders; throat constriction; fluid disturbances; weight gain; appetite disturbances; keratitis and conjunctivitis; blepharoconjunctivitis; gastrointestinal signs and symptoms; oral ulcerations; dental discomfort and pain; oral erythema and rashes; mouth and tongue disorders; oral discomfort and pain; tooth decay; cholecystitis; arthralgia and articular rheumatism; muscle cramps and spasms; musculoskeletal inflammation; dizziness; sleep disorders; migraines; paralysis of cranial nerves; edema and swelling; bacterial infections; fungal infections; mobility disorders; mood disorders; bacterial reproductive infections; photodermatitis; dermatitis and dermatosis; viral skin infections; eczema; pruritus; acne and folliculitis; urinary infections.\"\n }\n ]\n },\n {\n \"Term\": \"Congenital anomaly\",\n \"MEDDRACode\": \"10010356\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"birth defects\",\n \"Probability\": \"0.3070732355\",\n \"SemanticContext\": \"The estimated risk of major birth defects and miscarriage for the indicated population is unknown.\"\n },\n {\n \"VerbatimTerm\": \"birth defects\",\n \"Probability\": \"0.2702220082\",\n \"SemanticContext\": \"In the U.S. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.\"\n }\n ]\n },\n {\n \"Term\": \"Lipids\",\n \"MEDDRACode\": \"10024587\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"lipid\",\n \"Probability\": \"0.0001305342\",\n \"SemanticContext\": \"Distribution Following intravenous administration, the initial disposition phase for fluticasone propionate was rapid and consistent with its high lipid solubility and tissue binding.\"\n }\n ]\n },\n {\n \"Term\": \"Herpes ophthalmic\",\n \"MEDDRACode\": \"10062004\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"ocular herpes\",\n \"Probability\": \"0.0047121048\",\n \"SemanticContext\": \"5.1 • Potential worsening of infections e.g., existing tuberculosis; fungal, bacterial, viral, or parasitic infection; ocular herpes simplex .\"\n },\n {\n \"VerbatimTerm\": \"ocular herpes\",\n \"Probability\": \"0.0016393363\",\n \"SemanticContext\": \"Inform patients of potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex.\"\n },\n {\n \"VerbatimTerm\": \"ocular herpes\",\n \"Probability\": \"0.0026061833\",\n \"SemanticContext\": \"ICS should be used with caution, if at all, in patients with active or quiescent tuberculosis infections of the respiratory tract; systemic fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex.\"\n }\n ]\n },\n {\n \"Term\": \"Intraocular pressure increased\",\n \"MEDDRACode\": \"10022806\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"increased intraocular pressure\",\n \"Probability\": \"0.7071456313\",\n \"SemanticContext\": \"5.9 Glaucoma and Cataracts Glaucoma, increased intraocular pressure, and cataracts have been reported in patients following the long-term administration of ICS, including fluticasone propionate.\"\n }\n ]\n },\n {\n \"Term\": \"Herpes simplex\",\n \"MEDDRACode\": \"10019948\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"herpes simplex\",\n \"Probability\": \"0.0285899043\",\n \"SemanticContext\": \"5.1 • Potential worsening of infections e.g., existing tuberculosis; fungal, bacterial, viral, or parasitic infection; ocular herpes simplex .\"\n },\n {\n \"VerbatimTerm\": \"herpes simplex\",\n \"Probability\": \"0.012403816\",\n \"SemanticContext\": \"Inform patients of potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex.\"\n },\n {\n \"VerbatimTerm\": \"herpes simplex\",\n \"Probability\": \"0.0156823695\",\n \"SemanticContext\": \"ICS should be used with caution, if at all, in patients with active or quiescent tuberculosis infections of the respiratory tract; systemic fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex.\"\n }\n ]\n },\n {\n \"Term\": \"Tuberculosis\",\n \"MEDDRACode\": \"10044755\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"tuberculosis infections\",\n \"Probability\": \"0.0003423393\",\n \"SemanticContext\": \"ICS should be used with caution, if at all, in patients with active or quiescent tuberculosis infections of the respiratory tract; systemic fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex.\"\n }\n ]\n },\n {\n \"Term\": \"Hypotension\",\n \"MEDDRACode\": \"10021097\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hypotension\",\n \"Probability\": \"0.9638268948\",\n \"SemanticContext\": \"Immediate Hypersensitivity Reactions Advise patients that immediate hypersensitivity reactions e.g., urticaria, angioedema, rash, bronchospasm, hypotension , including anaphylaxis, may occur after administration of FLOVENT DISKUS.\"\n },\n {\n \"VerbatimTerm\": \"hypotension\",\n \"Probability\": \"0.0324771702\",\n \"SemanticContext\": \"In addition, patients should be observed for signs and symptoms of adrenal insufficiency, such as fatigue, lassitude, weakness, nausea and vomiting, and hypotension.\"\n },\n {\n \"VerbatimTerm\": \"hypotension\",\n \"Probability\": \"0.9898777008\",\n \"SemanticContext\": \"5.6 Immediate Hypersensitivity Reactions Immediate hypersensitivity reactions e.g., urticaria, angioedema, rash, bronchospasm, hypotension , including anaphylaxis, may occur after administration of FLOVENT DISKUS.\"\n }\n ]\n },\n {\n \"Term\": \"Vomiting\",\n \"MEDDRACode\": \"10047700\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"nausea and vomiting\",\n \"Probability\": \"0.9987546206\",\n \"SemanticContext\": \"5.9 ADVERSE REACTIONS Most common adverse reactions incidence >3% include upper respiratory tract infection or inflammation, throat irritation, sinusitis, rhinitis, oral candidiasis, nausea and vomiting, gastrointestinal discomfort, fever, cough, bronchitis, and headache.\"\n },\n {\n \"VerbatimTerm\": \"nausea and vomiting\",\n \"Probability\": \"0.020047605\",\n \"SemanticContext\": \"In addition, patients should be observed for signs and symptoms of adrenal insufficiency, such as fatigue, lassitude, weakness, nausea and vomiting, and hypotension.\"\n },\n {\n \"VerbatimTerm\": \"Nausea and vomiting\",\n \"Probability\": \"0.9995729923\",\n \"SemanticContext\": \"Adverse Reactions with FLOVENT DISKUS with >3% Incidence and More Common than Placebo in Subjects with Asthma Adverse Event FLOVENT DISKUS 50 mcg Twice Daily n = 178 % FLOVENT DISKUS 100 mcg Twice Daily n = 305 % FLOVENT DISKUS 250 mcg Twice Daily n = 86 % FLOVENT DISKUS 500 mcg Twice Daily n = 64 % Placebo n = 543 % Ear, nose, and throat Upper respiratory tract infection 20 18 21 14 16 Throat irritation 13 13 3 22 8 Sinusitis/sinus infection 9 10 6 6 6 Upper respiratory inflammation 5 5 0 5 3 Rhinitis 4 3 1 2 2 Oral candidiasis undefined<1 9 6 5 7 Gastrointestinal Nausea and vomiting 8 4 1 2 4 Gastrointestinal discomfort and pain 4 3 2 2 3 Viral gastrointestinal infection 4 3 3 5 1 Non-site specific Fever 7 7 1 2 4 Viral infection 2 2 0 5 2 Lower respiratory Viral respiratory infection 4 5 1 2 4 Cough 3 5 1 5 4 Bronchitis 2 3 0 8 1 Neurological Headache 12 12 2 14 7 Musculoskeletal and trauma Muscle injury 2 0 1 5 1 Musculoskeletal pain 4 3 2 5 2 Injury 2 undefined<1 0 5 undefined<1 .\"\n },\n {\n \"VerbatimTerm\": \"Nausea and vomiting\",\n \"Probability\": \"0.9997804761\",\n \"SemanticContext\": \"Gastrointestinal: Nausea and vomiting 9% and 0% .\"\n }\n ]\n },\n {\n \"Term\": \"Pregnancy\",\n \"MEDDRACode\": \"10036556\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Pregnancy\",\n \"Probability\": \"0.0035857856\",\n \"SemanticContext\": \"8.1 Pregnancy Risk Summary There are insufficient data on the use of FLOVENT DISKUS in pregnant women.\"\n },\n {\n \"VerbatimTerm\": \"pregnancies\",\n \"Probability\": \"0.1019026041\",\n \"SemanticContext\": \"In the U.S. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.\"\n }\n ]\n },\n {\n \"Term\": \"Adrenal insufficiency\",\n \"MEDDRACode\": \"10001367\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"adrenal insufficiency\",\n \"Probability\": \"0.9292387962\",\n \"SemanticContext\": \"Additionally, inform patients that deaths due to adrenal insufficiency have occurred during and after transfer from systemic corticosteroids.\"\n },\n {\n \"VerbatimTerm\": \"adrenal insufficiency\",\n \"Probability\": \"0.4054490924\",\n \"SemanticContext\": \"5.4 Transferring Patients from Systemic Corticosteroid Therapy Particular care is needed for patients who have been transferred from systemically active corticosteroids to ICS because deaths due to adrenal insufficiency have occurred in patients with asthma during and after transfer from systemic corticosteroids to less systemically available ICS.\"\n },\n {\n \"VerbatimTerm\": \"adrenal insufficiency\",\n \"Probability\": \"0.597563684\",\n \"SemanticContext\": \"During this period of HPA suppression, patients may exhibit signs and symptoms of adrenal insufficiency when exposed to trauma, surgery, or infection particularly gastroenteritis or other conditions associated with severe electrolyte loss.\"\n },\n {\n \"VerbatimTerm\": \"adrenal insufficiency\",\n \"Probability\": \"0.4318218231\",\n \"SemanticContext\": \"In addition, patients should be observed for signs and symptoms of adrenal insufficiency, such as fatigue, lassitude, weakness, nausea and vomiting, and hypotension.\"\n }\n ]\n },\n {\n \"Term\": \"Type I hypersensitivity\",\n \"MEDDRACode\": \"10045240\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"immediate hypersensitivity reactions\",\n \"Probability\": \"0.0183199346\",\n \"SemanticContext\": \"Immediate Hypersensitivity Reactions Advise patients that immediate hypersensitivity reactions e.g., urticaria, angioedema, rash, bronchospasm, hypotension , including anaphylaxis, may occur after administration of FLOVENT DISKUS.\"\n },\n {\n \"VerbatimTerm\": \"Immediate Hypersensitivity Reactions\",\n \"Probability\": \"0.3997601867\",\n \"SemanticContext\": \"Immediate Hypersensitivity Reactions Advise patients that immediate hypersensitivity reactions e.g., urticaria, angioedema, rash, bronchospasm, hypotension , including anaphylaxis, may occur after administration of FLOVENT DISKUS.\"\n },\n {\n \"VerbatimTerm\": \"Immediate Hypersensitivity Reactions\",\n \"Probability\": \"0.2915607095\",\n \"SemanticContext\": \"5.6 Immediate Hypersensitivity Reactions Immediate hypersensitivity reactions e.g., urticaria, angioedema, rash, bronchospasm, hypotension , including anaphylaxis, may occur after administration of FLOVENT DISKUS.\"\n },\n {\n \"VerbatimTerm\": \"Immediate hypersensitivity reactions\",\n \"Probability\": \"0.5230267644\",\n \"SemanticContext\": \"5.6 Immediate Hypersensitivity Reactions Immediate hypersensitivity reactions e.g., urticaria, angioedema, rash, bronchospasm, hypotension , including anaphylaxis, may occur after administration of FLOVENT DISKUS.\"\n },\n {\n \"VerbatimTerm\": \"Reactions Immediate hypersensitivity\",\n \"Probability\": \"0.4304712415\",\n \"SemanticContext\": \"5.6 Immediate Hypersensitivity Reactions Immediate hypersensitivity reactions e.g., urticaria, angioedema, rash, bronchospasm, hypotension , including anaphylaxis, may occur after administration of FLOVENT DISKUS.\"\n },\n {\n \"VerbatimTerm\": \"Hypersensitivity Reactions Immediate\",\n \"Probability\": \"0.1831894517\",\n \"SemanticContext\": \"5.6 Immediate Hypersensitivity Reactions Immediate hypersensitivity reactions e.g., urticaria, angioedema, rash, bronchospasm, hypotension , including anaphylaxis, may occur after administration of FLOVENT DISKUS.\"\n }\n ]\n },\n {\n \"Term\": \"Cortisol increased\",\n \"MEDDRACode\": \"10011207\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"increase cortisol\",\n \"Probability\": \"0.0278916955\",\n \"SemanticContext\": \"For most subjects, the ability to increase cortisol production in response to stress, as assessed by 6-hour cosyntropin stimulation, remained intact with inhaled fluticasone propionate treatment.\"\n }\n ]\n },\n {\n \"Term\": \"Drug level\",\n \"MEDDRACode\": \"10061823\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"pharmacokinetic studies\",\n \"Probability\": \"0.0029532313\",\n \"SemanticContext\": \"Patients with Hepatic and Renal Impairment: Formal pharmacokinetic studies using FLOVENT DISKUS have not been conducted in patients with hepatic or renal impairment.\"\n }\n ]\n },\n {\n \"Term\": \"Premature baby\",\n \"MEDDRACode\": \"10036590\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"prematurity\",\n \"Probability\": \"0.0257898867\",\n \"SemanticContext\": \"Clinical Considerations Disease-Associated Maternal and/or Embryofetal Risk: In women with poorly or moderately controlled asthma, there is an increased risk of several perinatal outcomes such as pre-eclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate.\"\n }\n ]\n },\n {\n \"Term\": \"Asthenia\",\n \"MEDDRACode\": \"10003549\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"weakness\",\n \"Probability\": \"0.0917788744\",\n \"SemanticContext\": \"In addition, patients should be observed for signs and symptoms of adrenal insufficiency, such as fatigue, lassitude, weakness, nausea and vomiting, and hypotension.\"\n }\n ]\n },\n {\n \"Term\": \"Fatigue\",\n \"MEDDRACode\": \"10016256\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"fatigue\",\n \"Probability\": \"0.1973601878\",\n \"SemanticContext\": \"In addition, patients should be observed for signs and symptoms of adrenal insufficiency, such as fatigue, lassitude, weakness, nausea and vomiting, and hypotension.\"\n }\n ]\n },\n {\n \"Term\": \"Adrenocortical insufficiency acute\",\n \"MEDDRACode\": \"10001389\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"adrenal crisis\",\n \"Probability\": \"0.5946388245\",\n \"SemanticContext\": \"It is possible that systemic corticosteroid effects such as hypercorticism and adrenal suppression including adrenal crisis may appear in a small number of patients who are sensitive to these effects.\"\n }\n ]\n },\n {\n \"Term\": \"Culture\",\n \"MEDDRACode\": \"10061447\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"cultured\",\n \"Probability\": \"0.0009693801\",\n \"SemanticContext\": \"Other metabolites detected in vitro using cultured human hepatoma cells have not been detected in man.\"\n },\n {\n \"VerbatimTerm\": \"cultured\",\n \"Probability\": \"0.000654906\",\n \"SemanticContext\": \"No significant clastogenic effect was seen in cultured human peripheral lymphocytes in vitro or in the in vivo mouse micronucleus test.\"\n }\n ]\n },\n {\n \"Term\": \"Stress\",\n \"MEDDRACode\": \"10042209\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"stress\",\n \"Probability\": \"0.0064235032\",\n \"SemanticContext\": \"For most subjects, the ability to increase cortisol production in response to stress, as assessed by 6-hour cosyntropin stimulation, remained intact with inhaled fluticasone propionate treatment.\"\n },\n {\n \"VerbatimTerm\": \"stress\",\n \"Probability\": \"7.11736E-05\",\n \"SemanticContext\": \"During periods of stress or a severe asthma attack, patients who have been withdrawn from systemic corticosteroids should be instructed to resume oral corticosteroids in large doses immediately and to contact their physicians for further instruction.\"\n },\n {\n \"VerbatimTerm\": \"stress\",\n \"Probability\": \"5.7791E-06\",\n \"SemanticContext\": \"These patients should also be instructed to carry a warning card indicating that they may need supplementary systemic corticosteroids during periods of stress or a severe asthma attack.\"\n },\n {\n \"VerbatimTerm\": \"stress\",\n \"Probability\": \"1.2587E-06\",\n \"SemanticContext\": \"Particular care should be taken in observing patients postoperatively or during periods of stress for evidence of inadequate adrenal response.\"\n }\n ]\n },\n {\n \"Term\": \"Immobilisation prolonged\",\n \"MEDDRACode\": \"10066112\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"prolonged immobilization\",\n \"Probability\": \"0.0012049377\",\n \"SemanticContext\": \"Patients with major risk factors for decreased bone mineral content, such as prolonged immobilization, family history of osteoporosis, postmenopausal status, tobacco use, advanced age, poor nutrition, or chronic use of drugs that can reduce bone mass e.g., anticonvulsants, oral corticosteroids , should be monitored and treated with established standards of care.\"\n }\n ]\n },\n {\n \"Term\": \"Social avoidant behaviour\",\n \"MEDDRACode\": \"10041243\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"withdrawn\",\n \"Probability\": \"0.0049997866\",\n \"SemanticContext\": \"Patients who have been previously maintained on 20 mg or more of prednisone or its equivalent may be most susceptible, particularly when their systemic corticosteroids have been almost completely withdrawn.\"\n },\n {\n \"VerbatimTerm\": \"withdrawn\",\n \"Probability\": \"1.08828E-05\",\n \"SemanticContext\": \"During periods of stress or a severe asthma attack, patients who have been withdrawn from systemic corticosteroids should be instructed to resume oral corticosteroids in large doses immediately and to contact their physicians for further instruction.\"\n }\n ]\n },\n {\n \"Term\": \"Puberty\",\n \"MEDDRACode\": \"10037280\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"puberty\",\n \"Probability\": \"0.0024958849\",\n \"SemanticContext\": \"An imbalance in the proportion of children entering puberty between groups and a higher dropout rate in the placebo group due to poorly controlled asthma may be confounding factors in interpreting these data.\"\n }\n ]\n },\n {\n \"Term\": \"Axillary web syndrome\",\n \"MEDDRACode\": \"10074387\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"cord\",\n \"Probability\": \"0.067755878\",\n \"SemanticContext\": \"Data Human Data: Following inhaled administration, fluticasone propionate was detected in the neonatal cord blood after delivery.\"\n }\n ]\n },\n {\n \"Term\": \"Mass\",\n \"MEDDRACode\": \"10026865\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"mass\",\n \"Probability\": \"3.48144E-05\",\n \"SemanticContext\": \"Patients with major risk factors for decreased bone mineral content, such as prolonged immobilization, family history of osteoporosis, postmenopausal status, tobacco use, advanced age, poor nutrition, or chronic use of drugs that can reduce bone mass e.g., anticonvulsants, oral corticosteroids , should be monitored and treated with established standards of care.\"\n }\n ]\n },\n {\n \"Term\": \"Bone densitometry\",\n \"MEDDRACode\": \"10050973\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"dual-energy x-ray absorptiometry\",\n \"Probability\": \"0.0003011823\",\n \"SemanticContext\": \"A 2-year trial in 160 subjects females aged 18 to 40 years, males 18 to 50 with asthma receiving chlorofluorocarbon CFC -propelled fluticasone propionate inhalation aerosol 88 or 440 mcg twice daily demonstrated no statistically significant changes in BMD at any time point 24, 52, 76, and 104 weeks of double-blind treatment as assessed by dual-energy x-ray absorptiometry at lumbar regions L1 through L4.\"\n }\n ]\n },\n {\n \"Term\": \"Abdominal discomfort\",\n \"MEDDRACode\": \"10000059\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"gastrointestinal discomfort\",\n \"Probability\": \"0.9746567011\",\n \"SemanticContext\": \"5.9 ADVERSE REACTIONS Most common adverse reactions incidence >3% include upper respiratory tract infection or inflammation, throat irritation, sinusitis, rhinitis, oral candidiasis, nausea and vomiting, gastrointestinal discomfort, fever, cough, bronchitis, and headache.\"\n },\n {\n \"VerbatimTerm\": \"Gastrointestinal discomfort\",\n \"Probability\": \"0.9892160892\",\n \"SemanticContext\": \"Adverse Reactions with FLOVENT DISKUS with >3% Incidence and More Common than Placebo in Subjects with Asthma Adverse Event FLOVENT DISKUS 50 mcg Twice Daily n = 178 % FLOVENT DISKUS 100 mcg Twice Daily n = 305 % FLOVENT DISKUS 250 mcg Twice Daily n = 86 % FLOVENT DISKUS 500 mcg Twice Daily n = 64 % Placebo n = 543 % Ear, nose, and throat Upper respiratory tract infection 20 18 21 14 16 Throat irritation 13 13 3 22 8 Sinusitis/sinus infection 9 10 6 6 6 Upper respiratory inflammation 5 5 0 5 3 Rhinitis 4 3 1 2 2 Oral candidiasis undefined<1 9 6 5 7 Gastrointestinal Nausea and vomiting 8 4 1 2 4 Gastrointestinal discomfort and pain 4 3 2 2 3 Viral gastrointestinal infection 4 3 3 5 1 Non-site specific Fever 7 7 1 2 4 Viral infection 2 2 0 5 2 Lower respiratory Viral respiratory infection 4 5 1 2 4 Cough 3 5 1 5 4 Bronchitis 2 3 0 8 1 Neurological Headache 12 12 2 14 7 Musculoskeletal and trauma Muscle injury 2 0 1 5 1 Musculoskeletal pain 4 3 2 5 2 Injury 2 undefined<1 0 5 undefined<1 .\"\n }\n ]\n },\n {\n \"Term\": \"Cough\",\n \"MEDDRACode\": \"10011224\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"cough\",\n \"Probability\": \"0.9941369295\",\n \"SemanticContext\": \"5.9 ADVERSE REACTIONS Most common adverse reactions incidence >3% include upper respiratory tract infection or inflammation, throat irritation, sinusitis, rhinitis, oral candidiasis, nausea and vomiting, gastrointestinal discomfort, fever, cough, bronchitis, and headache.\"\n },\n {\n \"VerbatimTerm\": \"Cough\",\n \"Probability\": \"0.9997348189\",\n \"SemanticContext\": \"Adverse Reactions with FLOVENT DISKUS with >3% Incidence and More Common than Placebo in Subjects with Asthma Adverse Event FLOVENT DISKUS 50 mcg Twice Daily n = 178 % FLOVENT DISKUS 100 mcg Twice Daily n = 305 % FLOVENT DISKUS 250 mcg Twice Daily n = 86 % FLOVENT DISKUS 500 mcg Twice Daily n = 64 % Placebo n = 543 % Ear, nose, and throat Upper respiratory tract infection 20 18 21 14 16 Throat irritation 13 13 3 22 8 Sinusitis/sinus infection 9 10 6 6 6 Upper respiratory inflammation 5 5 0 5 3 Rhinitis 4 3 1 2 2 Oral candidiasis undefined<1 9 6 5 7 Gastrointestinal Nausea and vomiting 8 4 1 2 4 Gastrointestinal discomfort and pain 4 3 2 2 3 Viral gastrointestinal infection 4 3 3 5 1 Non-site specific Fever 7 7 1 2 4 Viral infection 2 2 0 5 2 Lower respiratory Viral respiratory infection 4 5 1 2 4 Cough 3 5 1 5 4 Bronchitis 2 3 0 8 1 Neurological Headache 12 12 2 14 7 Musculoskeletal and trauma Muscle injury 2 0 1 5 1 Musculoskeletal pain 4 3 2 5 2 Injury 2 undefined<1 0 5 undefined<1 .\"\n },\n {\n \"VerbatimTerm\": \"Cough\",\n \"Probability\": \"0.9998969436\",\n \"SemanticContext\": \"Lower Respiratory: Cough 9% and 3% and viral respiratory infections 9% and 6% .\"\n }\n ]\n },\n {\n \"Term\": \"Vasculitic rash\",\n \"MEDDRACode\": \"10047111\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"vasculitic rash\",\n \"Probability\": \"0.0222259164\",\n \"SemanticContext\": \"Physicians should be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients.\"\n }\n ]\n },\n {\n \"Term\": \"Condition aggravated\",\n \"MEDDRACode\": \"10010264\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"condition worsens\",\n \"Probability\": \"0.0001969337\",\n \"SemanticContext\": \"Patients should not increase the prescribed dosage but should contact their physicians if symptoms do not improve or if the condition worsens.\"\n }\n ]\n },\n {\n \"Term\": \"Becker's muscular dystrophy\",\n \"MEDDRACode\": \"10059117\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"BMD\",\n \"Probability\": \"6.04154E-05\",\n \"SemanticContext\": \"Reduction in Bone Mineral Density Advise patients who are at an increased risk for decreased BMD that the use of corticosteroids may pose an additional risk.\"\n },\n {\n \"VerbatimTerm\": \"BMD\",\n \"Probability\": \"0.0111394525\",\n \"SemanticContext\": \"5.7 Reduction in Bone Mineral Density Decreases in bone mineral density BMD have been observed with long-term administration of products containing ICS.\"\n },\n {\n \"VerbatimTerm\": \"BMD\",\n \"Probability\": \"0.0001160756\",\n \"SemanticContext\": \"The clinical significance of small changes in BMD with regard to long-term consequences such as fracture is unknown.\"\n },\n {\n \"VerbatimTerm\": \"BMD\",\n \"Probability\": \"8.36532E-05\",\n \"SemanticContext\": \"A 2-year trial in 160 subjects females aged 18 to 40 years, males 18 to 50 with asthma receiving chlorofluorocarbon CFC -propelled fluticasone propionate inhalation aerosol 88 or 440 mcg twice daily demonstrated no statistically significant changes in BMD at any time point 24, 52, 76, and 104 weeks of double-blind treatment as assessed by dual-energy x-ray absorptiometry at lumbar regions L1 through L4.\"\n }\n ]\n },\n {\n \"Term\": \"Inflammation\",\n \"MEDDRACode\": \"10061218\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"inflammation\",\n \"Probability\": \"0.9750931859\",\n \"SemanticContext\": \"5.9 ADVERSE REACTIONS Most common adverse reactions incidence >3% include upper respiratory tract infection or inflammation, throat irritation, sinusitis, rhinitis, oral candidiasis, nausea and vomiting, gastrointestinal discomfort, fever, cough, bronchitis, and headache.\"\n },\n {\n \"VerbatimTerm\": \"inflammation\",\n \"Probability\": \"0.9988005161\",\n \"SemanticContext\": \"Adverse Reactions with FLOVENT DISKUS with >3% Incidence and More Common than Placebo in Subjects with Asthma Adverse Event FLOVENT DISKUS 50 mcg Twice Daily n = 178 % FLOVENT DISKUS 100 mcg Twice Daily n = 305 % FLOVENT DISKUS 250 mcg Twice Daily n = 86 % FLOVENT DISKUS 500 mcg Twice Daily n = 64 % Placebo n = 543 % Ear, nose, and throat Upper respiratory tract infection 20 18 21 14 16 Throat irritation 13 13 3 22 8 Sinusitis/sinus infection 9 10 6 6 6 Upper respiratory inflammation 5 5 0 5 3 Rhinitis 4 3 1 2 2 Oral candidiasis undefined<1 9 6 5 7 Gastrointestinal Nausea and vomiting 8 4 1 2 4 Gastrointestinal discomfort and pain 4 3 2 2 3 Viral gastrointestinal infection 4 3 3 5 1 Non-site specific Fever 7 7 1 2 4 Viral infection 2 2 0 5 2 Lower respiratory Viral respiratory infection 4 5 1 2 4 Cough 3 5 1 5 4 Bronchitis 2 3 0 8 1 Neurological Headache 12 12 2 14 7 Musculoskeletal and trauma Muscle injury 2 0 1 5 1 Musculoskeletal pain 4 3 2 5 2 Injury 2 undefined<1 0 5 undefined<1 .\"\n },\n {\n \"VerbatimTerm\": \"inflammation\",\n \"Probability\": \"0.778014183\",\n \"SemanticContext\": \"Additional Adverse Reactions Other adverse reactions not previously listed, whether considered drug-related or not by the investigators, that were reported more frequently by subjects with asthma treated with FLOVENT DISKUS compared with subjects treated with placebo include the following: palpitations; soft tissue injuries; contusions and hematomas; wounds and lacerations; burns; poisoning and toxicity; pressure-induced disorders; hoarseness/dysphonia; epistaxis; ear, nose, throat, and tonsil signs and symptoms; ear, nose, and throat polyps; allergic ear, nose, and throat disorders; throat constriction; fluid disturbances; weight gain; appetite disturbances; keratitis and conjunctivitis; blepharoconjunctivitis; gastrointestinal signs and symptoms; oral ulcerations; dental discomfort and pain; oral erythema and rashes; mouth and tongue disorders; oral discomfort and pain; tooth decay; cholecystitis; arthralgia and articular rheumatism; muscle cramps and spasms; musculoskeletal inflammation; dizziness; sleep disorders; migraines; paralysis of cranial nerves; edema and swelling; bacterial infections; fungal infections; mobility disorders; mood disorders; bacterial reproductive infections; photodermatitis; dermatitis and dermatosis; viral skin infections; eczema; pruritus; acne and folliculitis; urinary infections.\"\n },\n {\n \"VerbatimTerm\": \"inflammation\",\n \"Probability\": \"0.0026698112\",\n \"SemanticContext\": \"Corticosteroids have been shown to have a wide range of actions on multiple cell types e.g., mast cells, eosinophils, neutrophils, macrophages, lymphocytes and mediators e.g., histamine, eicosanoids, leukotrienes, cytokines involved in inflammation.\"\n },\n {\n \"VerbatimTerm\": \"Inflammation\",\n \"Probability\": \"0.0279160142\",\n \"SemanticContext\": \"Inflammation is an important component in the pathogenesis of asthma.\"\n }\n ]\n },\n {\n \"Term\": \"Infusion\",\n \"MEDDRACode\": \"10060345\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"infusion\",\n \"Probability\": \"5.20678E-05\",\n \"SemanticContext\": \"In a 2-year trial carried out with the DISKHALER inhalation device in 64 subjects with mild, persistent asthma mean FEV 1 91% of predicted randomized to fluticasone propionate 500 mcg twice daily or placebo, no subject receiving fluticasone propionate had an abnormal response to 6-hour cosyntropin infusion peak serum cortisol undefined<18 mcg/dL .\"\n }\n ]\n },\n {\n \"Term\": \"Upper respiratory tract infection\",\n \"MEDDRACode\": \"10046306\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"upper respiratory tract infection\",\n \"Probability\": \"0.9957290888\",\n \"SemanticContext\": \"5.9 ADVERSE REACTIONS Most common adverse reactions incidence >3% include upper respiratory tract infection or inflammation, throat irritation, sinusitis, rhinitis, oral candidiasis, nausea and vomiting, gastrointestinal discomfort, fever, cough, bronchitis, and headache.\"\n },\n {\n \"VerbatimTerm\": \"upper respiratory tract infection\",\n \"Probability\": \"0.9985198975\",\n \"SemanticContext\": \"Ear, Nose, and Throat: Hoarseness/dysphonia 9% and 0% , nasal congestion/blockage 16% and 0% , oral candidiasis 31% and 21% , rhinitis 13% and 9% , sinusitis/sinus infection 33% and 12% , throat irritation 10% and 9% , and upper respiratory tract infection 31% and 24% .\"\n },\n {\n \"VerbatimTerm\": \"Upper respiratory tract infection\",\n \"Probability\": \"0.9976547956\",\n \"SemanticContext\": \"Adverse Reactions with FLOVENT DISKUS with >3% Incidence and More Common than Placebo in Subjects with Asthma Adverse Event FLOVENT DISKUS 50 mcg Twice Daily n = 178 % FLOVENT DISKUS 100 mcg Twice Daily n = 305 % FLOVENT DISKUS 250 mcg Twice Daily n = 86 % FLOVENT DISKUS 500 mcg Twice Daily n = 64 % Placebo n = 543 % Ear, nose, and throat Upper respiratory tract infection 20 18 21 14 16 Throat irritation 13 13 3 22 8 Sinusitis/sinus infection 9 10 6 6 6 Upper respiratory inflammation 5 5 0 5 3 Rhinitis 4 3 1 2 2 Oral candidiasis undefined<1 9 6 5 7 Gastrointestinal Nausea and vomiting 8 4 1 2 4 Gastrointestinal discomfort and pain 4 3 2 2 3 Viral gastrointestinal infection 4 3 3 5 1 Non-site specific Fever 7 7 1 2 4 Viral infection 2 2 0 5 2 Lower respiratory Viral respiratory infection 4 5 1 2 4 Cough 3 5 1 5 4 Bronchitis 2 3 0 8 1 Neurological Headache 12 12 2 14 7 Musculoskeletal and trauma Muscle injury 2 0 1 5 1 Musculoskeletal pain 4 3 2 5 2 Injury 2 undefined<1 0 5 undefined<1 .\"\n }\n ]\n },\n {\n \"Term\": \"Irritable bowel syndrome\",\n \"MEDDRACode\": \"10023003\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"ICS\",\n \"Probability\": \"0.0371358693\",\n \"SemanticContext\": \"FLOVENT DISKUS fluticasone propionate inhalation powder , for oral inhalation use Initial U.S. Approval: 1994 INDICATIONS AND USAGE FLOVENT DISKUS is an inhaled corticosteroid ICS indicated for: .\"\n },\n {\n \"VerbatimTerm\": \"ICS\",\n \"Probability\": \"0.3359710872\",\n \"SemanticContext\": \"5.8 • Glaucoma and cataracts may occur with long-term use of ICS.\"\n },\n {\n \"VerbatimTerm\": \"ICS\",\n \"Probability\": \"0.0075316131\",\n \"SemanticContext\": \"The incidence of common adverse reactions in Table 1 is based upon 7 placebo-controlled U.S. clinical trials in which 1,176 pediatric, adolescent, and adult subjects 466 females and 710 males previously treated with as-needed bronchodilators and/or ICS were treated twice daily for up to 12 weeks with FLOVENT DISKUS doses of 50 to 500 mcg or placebo.\"\n },\n {\n \"VerbatimTerm\": \"ICS\",\n \"Probability\": \"0.0016358495\",\n \"SemanticContext\": \"Subjects in these trials included those inadequately controlled with bronchodilators alone and those already maintained on daily ICS.\"\n },\n {\n \"VerbatimTerm\": \"ICS\",\n \"Probability\": \"0.6502251625\",\n \"SemanticContext\": \"A 12-Week Clinical Trial Evaluating FLOVENT DISKUS 500 mcg Twice Daily in Adults and Adolescents Receiving Inhaled Corticosteroids or Bronchodilators Alone 14.2 Pediatric Subjects Aged 4 to 11 Years A 12-week, placebo-controlled clinical trial was conducted in 437 pediatric subjects 177 received FLOVENT DISKUS , approximately half of whom were receiving ICS at baseline.\"\n },\n {\n \"VerbatimTerm\": \"ICS\",\n \"Probability\": \"0.6518317461\",\n \"SemanticContext\": \"Two other 12-week placebo-controlled clinical trials were conducted in 504 pediatric subjects with asthma, approximately half of whom were receiving ICS at baseline.\"\n },\n {\n \"VerbatimTerm\": \"ICS\",\n \"Probability\": \"9.35867E-05\",\n \"SemanticContext\": \"The recommended starting dosage for patients aged 12 years and older who are not on an inhaled corticosteroid ICS is 100 mcg twice daily, approximately 12 hours apart.\"\n },\n {\n \"VerbatimTerm\": \"ICS\",\n \"Probability\": \"0.002346158\",\n \"SemanticContext\": \"For patients aged 4 to 11 years not on an ICS, the recommended starting dosage is 50 mcg twice daily, approximately 12 hours apart.\"\n },\n {\n \"VerbatimTerm\": \"ICS\",\n \"Probability\": \"0.0014580786\",\n \"SemanticContext\": \"If a dosage regimen fails to provide adequate control of asthma, the therapeutic regimen should be re-evaluated and additional therapeutic options, e.g., replacing the current strength with a higher strength, initiating an ICS and long-acting beta2-agonist LABA combination product, or initiating oral corticosteroids, should be considered.\"\n },\n {\n \"VerbatimTerm\": \"ICS\",\n \"Probability\": \"0.009306699\",\n \"SemanticContext\": \"Glaucoma and Cataracts Advise patients that long-term use of ICS may increase the risk of some eye problems cataracts or glaucoma ; consider regular eye examinations.\"\n },\n {\n \"VerbatimTerm\": \"ICS\",\n \"Probability\": \"0.0749792755\",\n \"SemanticContext\": \"ICS should be used with caution, if at all, in patients with active or quiescent tuberculosis infections of the respiratory tract; systemic fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex.\"\n },\n {\n \"VerbatimTerm\": \"ICS\",\n \"Probability\": \"0.1109933257\",\n \"SemanticContext\": \"5.4 Transferring Patients from Systemic Corticosteroid Therapy Particular care is needed for patients who have been transferred from systemically active corticosteroids to ICS because deaths due to adrenal insufficiency have occurred in patients with asthma during and after transfer from systemic corticosteroids to less systemically available ICS.\"\n },\n {\n \"VerbatimTerm\": \"ICS\",\n \"Probability\": \"0.0283521712\",\n \"SemanticContext\": \"5.4 Transferring Patients from Systemic Corticosteroid Therapy Particular care is needed for patients who have been transferred from systemically active corticosteroids to ICS because deaths due to adrenal insufficiency have occurred in patients with asthma during and after transfer from systemic corticosteroids to less systemically available ICS.\"\n },\n {\n \"VerbatimTerm\": \"ICS\",\n \"Probability\": \"0.0314073265\",\n \"SemanticContext\": \"Because of the possibility of significant systemic absorption of ICS in sensitive patients, patients treated with FLOVENT DISKUS should be observed carefully for any evidence of systemic corticosteroid effects.\"\n },\n {\n \"VerbatimTerm\": \"ICS\",\n \"Probability\": \"0.4428220391\",\n \"SemanticContext\": \"5.7 Reduction in Bone Mineral Density Decreases in bone mineral density BMD have been observed with long-term administration of products containing ICS.\"\n },\n {\n \"VerbatimTerm\": \"ICS\",\n \"Probability\": \"0.557782948\",\n \"SemanticContext\": \"5.9 Glaucoma and Cataracts Glaucoma, increased intraocular pressure, and cataracts have been reported in patients following the long-term administration of ICS, including fluticasone propionate.\"\n },\n {\n \"VerbatimTerm\": \"ICS\",\n \"Probability\": \"0.5863746405\",\n \"SemanticContext\": \"Cases of serious eosinophilic conditions have also been reported with other ICS in this clinical setting.\"\n },\n {\n \"VerbatimTerm\": \"ICS\",\n \"Probability\": \"0.0693159401\",\n \"SemanticContext\": \"A reduction of growth velocity in children or teenagers may occur as a result of poorly controlled asthma or from use of corticosteroids, including ICS.\"\n },\n {\n \"VerbatimTerm\": \"ICS\",\n \"Probability\": \"0.0024684072\",\n \"SemanticContext\": \"The effects of long-term treatment of children and adolescents with ICS, including fluticasone propionate, on final adult height are not known.\"\n },\n {\n \"VerbatimTerm\": \"ICS\",\n \"Probability\": \"0.4312343299\",\n \"SemanticContext\": \"Controlled clinical trials have shown that ICS may cause a reduction in growth in pediatric patients.\"\n }\n ]\n },\n {\n \"Term\": \"Eosinophilic granulomatosis with polyangiitis\",\n \"MEDDRACode\": \"10078117\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Churg-Strauss Syndrome\",\n \"Probability\": \"0.7607616186\",\n \"SemanticContext\": \"5.12 Eosinophilic Conditions and Churg-Strauss Syndrome In rare cases, patients on inhaled fluticasone propionate may present with systemic eosinophilic conditions.\"\n },\n {\n \"VerbatimTerm\": \"Churg-Strauss syndrome\",\n \"Probability\": \"0.4005865455\",\n \"SemanticContext\": \"Some of these patients have clinical features of vasculitis consistent with Churg-Strauss syndrome, a condition that is often treated with systemic corticosteroid therapy.\"\n }\n ]\n },\n {\n \"Term\": \"Neuropathy peripheral\",\n \"MEDDRACode\": \"10029331\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"neuropathy\",\n \"Probability\": \"0.0870198607\",\n \"SemanticContext\": \"Physicians should be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients.\"\n }\n ]\n },\n {\n \"Term\": \"Elderly\",\n \"MEDDRACode\": \"10014348\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": true\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"elderly\",\n \"Probability\": \"0.0010638237\",\n \"SemanticContext\": \"No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger subjects, but greater sensitivity of some older individuals cannot be ruled out.\"\n }\n ]\n },\n {\n \"Term\": \"Infection parasitic\",\n \"MEDDRACode\": \"10021857\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"parasitic infection\",\n \"Probability\": \"0.0050912797\",\n \"SemanticContext\": \"5.1 • Potential worsening of infections e.g., existing tuberculosis; fungal, bacterial, viral, or parasitic infection; ocular herpes simplex .\"\n },\n {\n \"VerbatimTerm\": \"parasitic infections\",\n \"Probability\": \"0.0015230179\",\n \"SemanticContext\": \"Inform patients of potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex.\"\n },\n {\n \"VerbatimTerm\": \"parasitic infections\",\n \"Probability\": \"0.0055085123\",\n \"SemanticContext\": \"ICS should be used with caution, if at all, in patients with active or quiescent tuberculosis infections of the respiratory tract; systemic fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex.\"\n }\n ]\n },\n {\n \"Term\": \"Abortion spontaneous\",\n \"MEDDRACode\": \"10000234\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"miscarriage\",\n \"Probability\": \"0.395837605\",\n \"SemanticContext\": \"The estimated risk of major birth defects and miscarriage for the indicated population is unknown.\"\n },\n {\n \"VerbatimTerm\": \"miscarriage\",\n \"Probability\": \"0.8493605256\",\n \"SemanticContext\": \"In the U.S. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.\"\n }\n ]\n },\n {\n \"Term\": \"Small for dates baby\",\n \"MEDDRACode\": \"10041092\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"small for gestational age\",\n \"Probability\": \"0.0017664135\",\n \"SemanticContext\": \"Clinical Considerations Disease-Associated Maternal and/or Embryofetal Risk: In women with poorly or moderately controlled asthma, there is an increased risk of several perinatal outcomes such as pre-eclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate.\"\n }\n ]\n },\n {\n \"Term\": \"Infection\",\n \"MEDDRACode\": \"10021789\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"infection\",\n \"Probability\": \"0.0031248033\",\n \"SemanticContext\": \"When such an infection develops, it should be treated with appropriate local or systemic i.e., oral antifungal therapy while treatment with FLOVENT DISKUS continues, but at times therapy with FLOVENT DISKUS may need to be interrupted.\"\n },\n {\n \"VerbatimTerm\": \"infection\",\n \"Probability\": \"0.0086285174\",\n \"SemanticContext\": \"How the dose, route, and duration of corticosteroid administration affect the risk of developing a disseminated infection is not known.\"\n },\n {\n \"VerbatimTerm\": \"infection\",\n \"Probability\": \"0.1799666584\",\n \"SemanticContext\": \"During this period of HPA suppression, patients may exhibit signs and symptoms of adrenal insufficiency when exposed to trauma, surgery, or infection particularly gastroenteritis or other conditions associated with severe electrolyte loss.\"\n },\n {\n \"VerbatimTerm\": \"infections\",\n \"Probability\": \"0.057025671\",\n \"SemanticContext\": \"5.1 • Potential worsening of infections e.g., existing tuberculosis; fungal, bacterial, viral, or parasitic infection; ocular herpes simplex .\"\n },\n {\n \"VerbatimTerm\": \"infections\",\n \"Probability\": \"0.0002279878\",\n \"SemanticContext\": \"Use with caution in patients with these infections.\"\n },\n {\n \"VerbatimTerm\": \"infections\",\n \"Probability\": \"0.9364598393\",\n \"SemanticContext\": \"Additional Adverse Reactions Other adverse reactions not previously listed, whether considered drug-related or not by the investigators, that were reported more frequently by subjects with asthma treated with FLOVENT DISKUS compared with subjects treated with placebo include the following: palpitations; soft tissue injuries; contusions and hematomas; wounds and lacerations; burns; poisoning and toxicity; pressure-induced disorders; hoarseness/dysphonia; epistaxis; ear, nose, throat, and tonsil signs and symptoms; ear, nose, and throat polyps; allergic ear, nose, and throat disorders; throat constriction; fluid disturbances; weight gain; appetite disturbances; keratitis and conjunctivitis; blepharoconjunctivitis; gastrointestinal signs and symptoms; oral ulcerations; dental discomfort and pain; oral erythema and rashes; mouth and tongue disorders; oral discomfort and pain; tooth decay; cholecystitis; arthralgia and articular rheumatism; muscle cramps and spasms; musculoskeletal inflammation; dizziness; sleep disorders; migraines; paralysis of cranial nerves; edema and swelling; bacterial infections; fungal infections; mobility disorders; mood disorders; bacterial reproductive infections; photodermatitis; dermatitis and dermatosis; viral skin infections; eczema; pruritus; acne and folliculitis; urinary infections.\"\n },\n {\n \"VerbatimTerm\": \"infections\",\n \"Probability\": \"0.2181164026\",\n \"SemanticContext\": \"5.3 Immunosuppression Persons who are using drugs that suppress the immune system are more susceptible to infections than healthy individuals.\"\n },\n {\n \"VerbatimTerm\": \"Infections\",\n \"Probability\": \"0.9077472091\",\n \"SemanticContext\": \"Infections and Infestations Esophageal candidiasis.\"\n }\n ]\n },\n {\n \"Term\": \"Varicella\",\n \"MEDDRACode\": \"10046980\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"chickenpox\",\n \"Probability\": \"0.3536573052\",\n \"SemanticContext\": \"More serious or even fatal course of chickenpox or measles can occur in susceptible patients.\"\n },\n {\n \"VerbatimTerm\": \"chickenpox\",\n \"Probability\": \"1.59154E-05\",\n \"SemanticContext\": \"Immunosuppression Warn patients who are on immunosuppressant doses of corticosteroids to avoid exposure to chickenpox or measles and, if exposed, to consult their physicians without delay.\"\n },\n {\n \"VerbatimTerm\": \"chickenpox\",\n \"Probability\": \"0.0074231923\",\n \"SemanticContext\": \"If a patient is exposed to chickenpox, prophylaxis with varicella zoster immune globulin VZIG may be indicated.\"\n },\n {\n \"VerbatimTerm\": \"chickenpox\",\n \"Probability\": \"5.21257E-05\",\n \"SemanticContext\": \"If chickenpox develops, treatment with antiviral agents may be considered.\"\n },\n {\n \"VerbatimTerm\": \"Chickenpox\",\n \"Probability\": \"0.2448189557\",\n \"SemanticContext\": \"Chickenpox and measles, for example, can have a more serious or even fatal course in susceptible children or adults using corticosteroids.\"\n }\n ]\n },\n {\n \"Term\": \"Eosinophilia\",\n \"MEDDRACode\": \"10014950\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"eosinophilia\",\n \"Probability\": \"0.040312618\",\n \"SemanticContext\": \"Physicians should be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients.\"\n }\n ]\n },\n {\n \"Term\": \"Vasculitis\",\n \"MEDDRACode\": \"10047115\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"vasculitis\",\n \"Probability\": \"0.5471679568\",\n \"SemanticContext\": \"Some of these patients have clinical features of vasculitis consistent with Churg-Strauss syndrome, a condition that is often treated with systemic corticosteroid therapy.\"\n }\n ]\n },\n {\n \"Term\": \"Cleft palate\",\n \"MEDDRACode\": \"10009269\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Cleft palate\",\n \"Probability\": \"0.0923573375\",\n \"SemanticContext\": \"Cleft palate and fetal skeletal variations were observed in mouse fetuses at a dose approximately 0.1 times the MRHDID on a mcg/m 2 basis with a maternal subcutaneous dose of 45 mcg/kg/day .\"\n },\n {\n \"VerbatimTerm\": \"cleft palate\",\n \"Probability\": \"0.0004657507\",\n \"SemanticContext\": \"Teratogenicity was evident based upon a finding of cleft palate for 1 fetus at a dose approximately 0.04 times the MRHDID on a mcg/m 2 basis with a maternal subcutaneous dose of 4 mcg/kg/day .\"\n }\n ]\n },\n {\n \"Term\": \"Infant\",\n \"MEDDRACode\": \"10021731\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"neonate\",\n \"Probability\": \"0.0045728683000000004\",\n \"SemanticContext\": \"Clinical Considerations Disease-Associated Maternal and/or Embryofetal Risk: In women with poorly or moderately controlled asthma, there is an increased risk of several perinatal outcomes such as pre-eclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate.\"\n }\n ]\n },\n {\n \"Term\": \"Measles\",\n \"MEDDRACode\": \"10027011\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"measles\",\n \"Probability\": \"0.3388572931\",\n \"SemanticContext\": \"More serious or even fatal course of chickenpox or measles can occur in susceptible patients.\"\n },\n {\n \"VerbatimTerm\": \"measles\",\n \"Probability\": \"1.13378E-05\",\n \"SemanticContext\": \"Immunosuppression Warn patients who are on immunosuppressant doses of corticosteroids to avoid exposure to chickenpox or measles and, if exposed, to consult their physicians without delay.\"\n },\n {\n \"VerbatimTerm\": \"measles\",\n \"Probability\": \"0.6687312126\",\n \"SemanticContext\": \"Chickenpox and measles, for example, can have a more serious or even fatal course in susceptible children or adults using corticosteroids.\"\n },\n {\n \"VerbatimTerm\": \"measles\",\n \"Probability\": \"0.0018402338\",\n \"SemanticContext\": \"If a patient is exposed to measles, prophylaxis with pooled intramuscular immunoglobulin IG may be indicated.\"\n }\n ]\n },\n {\n \"Term\": \"Milk allergy\",\n \"MEDDRACode\": \"10027633\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"milk protein allergy\",\n \"Probability\": \"0.4090306163\",\n \"SemanticContext\": \"Anaphylactic reactions in patients with severe milk protein allergy have been reported.\"\n },\n {\n \"VerbatimTerm\": \"milk protein allergy\",\n \"Probability\": \"0.0001417994\",\n \"SemanticContext\": \"There have been reports of anaphylactic reactions in patients with severe milk protein allergy after inhalation of powder products containing lactose; therefore, patients with severe milk protein allergy should not take FLOVENT DISKUS.\"\n },\n {\n \"VerbatimTerm\": \"milk protein allergy\",\n \"Probability\": \"5.6794999999999996E-06\",\n \"SemanticContext\": \"There have been reports of anaphylactic reactions in patients with severe milk protein allergy after inhalation of powder products containing lactose; therefore, patients with severe milk protein allergy should not take FLOVENT DISKUS.\"\n },\n {\n \"VerbatimTerm\": \"milk protein allergy\",\n \"Probability\": \"0.0001407266\",\n \"SemanticContext\": \"There have been reports of anaphylactic reactions in patients with severe milk protein allergy after inhalation of powder products containing lactose; therefore, patients with severe milk protein allergy should not use FLOVENT DISKUS [see Contraindications 4 ] .\"\n },\n {\n \"VerbatimTerm\": \"milk protein allergy\",\n \"Probability\": \"4.9882E-06\",\n \"SemanticContext\": \"There have been reports of anaphylactic reactions in patients with severe milk protein allergy after inhalation of powder products containing lactose; therefore, patients with severe milk protein allergy should not use FLOVENT DISKUS [see Contraindications 4 ] .\"\n }\n ]\n },\n {\n \"Term\": \"Liver disorder\",\n \"MEDDRACode\": \"10024670\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hepatic disease\",\n \"Probability\": \"0.0003906786\",\n \"SemanticContext\": \"Therefore, patients with hepatic disease should be closely monitored.\"\n }\n ]\n },\n {\n \"Term\": \"Renal impairment\",\n \"MEDDRACode\": \"10062237\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Renal Impairment\",\n \"Probability\": \"0.0091104805\",\n \"SemanticContext\": \"Patients with Hepatic and Renal Impairment: Formal pharmacokinetic studies using FLOVENT DISKUS have not been conducted in patients with hepatic or renal impairment.\"\n },\n {\n \"VerbatimTerm\": \"renal impairment\",\n \"Probability\": \"0.0032004416\",\n \"SemanticContext\": \"Patients with Hepatic and Renal Impairment: Formal pharmacokinetic studies using FLOVENT DISKUS have not been conducted in patients with hepatic or renal impairment.\"\n }\n ]\n },\n {\n \"Term\": \"Blindness\",\n \"MEDDRACode\": \"10005169\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"blind\",\n \"Probability\": \"0.0019028783\",\n \"SemanticContext\": \"14 CLINICAL STUDIES 14.1 Adult and Adolescent Subjects Aged 12 Years and Older Four randomized, double-blind, parallel-group, placebo-controlled, U.S. clinical trials were conducted in 1,036 adult and adolescent subjects aged 12 years and older with asthma to assess the efficacy and safety of FLOVENT DISKUS in the treatment of asthma.\"\n },\n {\n \"VerbatimTerm\": \"blind\",\n \"Probability\": \"0.0020107031\",\n \"SemanticContext\": \"A 2-year trial in 160 subjects females aged 18 to 40 years, males 18 to 50 with asthma receiving chlorofluorocarbon CFC -propelled fluticasone propionate inhalation aerosol 88 or 440 mcg twice daily demonstrated no statistically significant changes in BMD at any time point 24, 52, 76, and 104 weeks of double-blind treatment as assessed by dual-energy x-ray absorptiometry at lumbar regions L1 through L4.\"\n }\n ]\n },\n {\n \"Term\": \"Ultrasound scan\",\n \"MEDDRACode\": \"10045434\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": true\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"U.S.\",\n \"Probability\": \"2.68828E-05\",\n \"SemanticContext\": \"FLOVENT DISKUS fluticasone propionate inhalation powder , for oral inhalation use Initial U.S. Approval: 1994 INDICATIONS AND USAGE FLOVENT DISKUS is an inhaled corticosteroid ICS indicated for: .\"\n },\n {\n \"VerbatimTerm\": \"U.S.\",\n \"Probability\": \"0.0001345873\",\n \"SemanticContext\": \"The incidence of common adverse reactions in Table 1 is based upon 7 placebo-controlled U.S. clinical trials in which 1,176 pediatric, adolescent, and adult subjects 466 females and 710 males previously treated with as-needed bronchodilators and/or ICS were treated twice daily for up to 12 weeks with FLOVENT DISKUS doses of 50 to 500 mcg or placebo.\"\n },\n {\n \"VerbatimTerm\": \"U.S.\",\n \"Probability\": \"0.0002687275\",\n \"SemanticContext\": \"Three 3 of the 7 placebo-controlled U.S. clinical trials were pediatric trials.\"\n },\n {\n \"VerbatimTerm\": \"U.S.\",\n \"Probability\": \"0.0002858937\",\n \"SemanticContext\": \"14 CLINICAL STUDIES 14.1 Adult and Adolescent Subjects Aged 12 Years and Older Four randomized, double-blind, parallel-group, placebo-controlled, U.S. clinical trials were conducted in 1,036 adult and adolescent subjects aged 12 years and older with asthma to assess the efficacy and safety of FLOVENT DISKUS in the treatment of asthma.\"\n },\n {\n \"VerbatimTerm\": \"U.S.\",\n \"Probability\": \"0.0003204942\",\n \"SemanticContext\": \"In the U.S. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.\"\n },\n {\n \"VerbatimTerm\": \"U.S.\",\n \"Probability\": \"0.0001127064\",\n \"SemanticContext\": \"A 52-week placebo-controlled trial to assess the potential growth effects of fluticasone propionate inhalation powder FLOVENT ROTADISK at 50 and 100 mcg twice daily was conducted in the U.S. in 325 prepubescent children 244 males and 81 females aged 4 to 11 years.\"\n },\n {\n \"VerbatimTerm\": \"U.S.\",\n \"Probability\": \"0.0011291206\",\n \"SemanticContext\": \"8.5 Geriatric Use Safety data have been collected on 280 subjects FLOVENT DISKUS n = 83, FLOVENT Rotadisk n = 197 aged 65 years and older and 33 subjects FLOVENT DISKUS n = 14, FLOVENT ROTADISK n = 19 aged 75 years and older who have been treated with fluticasone propionate inhalation powder in U.S. and non-U.S. clinical trials.\"\n },\n {\n \"VerbatimTerm\": \"U.S.\",\n \"Probability\": \"7.32103E-05\",\n \"SemanticContext\": \"8.5 Geriatric Use Safety data have been collected on 280 subjects FLOVENT DISKUS n = 83, FLOVENT Rotadisk n = 197 aged 65 years and older and 33 subjects FLOVENT DISKUS n = 14, FLOVENT ROTADISK n = 19 aged 75 years and older who have been treated with fluticasone propionate inhalation powder in U.S. and non-U.S. clinical trials.\"\n }\n ]\n },\n {\n \"Term\": \"Therapeutic response changed\",\n \"MEDDRACode\": \"10074941\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Best Effect\",\n \"Probability\": \"4.8863E-06\",\n \"SemanticContext\": \"Use Daily for Best Effect Patients should use Flovent DISKUS at regular intervals as directed.\"\n }\n ]\n },\n {\n \"Term\": \"Gene mutation\",\n \"MEDDRACode\": \"10064571\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"gene mutation\",\n \"Probability\": \"0.0245318115\",\n \"SemanticContext\": \"Fluticasone propionate did not induce gene mutation in prokaryotic or eukaryotic cells in vitro.\"\n }\n ]\n },\n {\n \"Term\": \"Low birth weight baby\",\n \"MEDDRACode\": \"10067508\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"low birth weight\",\n \"Probability\": \"0.0087366104\",\n \"SemanticContext\": \"Clinical Considerations Disease-Associated Maternal and/or Embryofetal Risk: In women with poorly or moderately controlled asthma, there is an increased risk of several perinatal outcomes such as pre-eclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate.\"\n }\n ]\n }\n ],\n \"IndicationTerms\": []\n }\n ]\n },\n {\n \"GenericName\": \"nitisinone\",\n \"MeddraVersion\": \"24.0\",\n \"Labels\": [\n {\n \"Id\": \"US4a1790ec-5f28-45f5-bed4-007f281d1091\",\n \"NDCCode\": \"66658-204\",\n \"UpdatedDate\": \"May 30, 2019\",\n \"LabelSource\": {\n \"Country\": \"us\",\n \"ProductId\": \"00307f42-748d-4227-8c6f-ed5f0a89ae0a\",\n \"FileId\": \"4a1790ec-5f28-45f5-bed4-007f281d1091\",\n \"Version\": \"9\"\n },\n \"AdverseEventTerms\": [\n {\n \"Term\": \"Bronchitis\",\n \"MEDDRACode\": \"10006451\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"bronchitis\",\n \"Probability\": \"0.9891864061\",\n \"SemanticContext\": \"Adverse reactions reported in less than 1% of the patients, included death, seizure, brain tumor, encephalopathy, hyperkinesia, cyanosis, abdominal pain, diarrhea, enanthema, gastrointestinal hemorrhage, melena, elevated hepatic enzymes, liver enlargement, hypoglycemia, septicemia, and bronchitis.\"\n }\n ]\n },\n {\n \"Term\": \"Benign hepatic neoplasm\",\n \"MEDDRACode\": \"10004269\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"benign hepatic neoplasms\",\n \"Probability\": \"0.4218782783\",\n \"SemanticContext\": \"These complications of HT-1 were observed in patients treated with nitisinone for a median of 22 months during the clinical trial liver transplantation 13%, liver failure 7%, malignant hepatic neoplasms 5%, benign hepatic neoplasms 3%, porphyria 1% .\"\n }\n ]\n },\n {\n \"Term\": \"Cyanosis\",\n \"MEDDRACode\": \"10011703\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"cyanosis\",\n \"Probability\": \"0.9976474643\",\n \"SemanticContext\": \"Adverse reactions reported in less than 1% of the patients, included death, seizure, brain tumor, encephalopathy, hyperkinesia, cyanosis, abdominal pain, diarrhea, enanthema, gastrointestinal hemorrhage, melena, elevated hepatic enzymes, liver enlargement, hypoglycemia, septicemia, and bronchitis.\"\n }\n ]\n },\n {\n \"Term\": \"Brain neoplasm\",\n \"MEDDRACode\": \"10061019\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"brain tumor\",\n \"Probability\": \"0.8771100044\",\n \"SemanticContext\": \"Adverse reactions reported in less than 1% of the patients, included death, seizure, brain tumor, encephalopathy, hyperkinesia, cyanosis, abdominal pain, diarrhea, enanthema, gastrointestinal hemorrhage, melena, elevated hepatic enzymes, liver enlargement, hypoglycemia, septicemia, and bronchitis.\"\n }\n ]\n },\n {\n \"Term\": \"Abdominal pain\",\n \"MEDDRACode\": \"10000081\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"abdominal pain\",\n \"Probability\": \"0.9962461591\",\n \"SemanticContext\": \"Adverse reactions reported in less than 1% of the patients, included death, seizure, brain tumor, encephalopathy, hyperkinesia, cyanosis, abdominal pain, diarrhea, enanthema, gastrointestinal hemorrhage, melena, elevated hepatic enzymes, liver enlargement, hypoglycemia, septicemia, and bronchitis.\"\n }\n ]\n },\n {\n \"Term\": \"Hypoglycaemia\",\n \"MEDDRACode\": \"10020993\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hypoglycemia\",\n \"Probability\": \"0.9911644459\",\n \"SemanticContext\": \"Adverse reactions reported in less than 1% of the patients, included death, seizure, brain tumor, encephalopathy, hyperkinesia, cyanosis, abdominal pain, diarrhea, enanthema, gastrointestinal hemorrhage, melena, elevated hepatic enzymes, liver enlargement, hypoglycemia, septicemia, and bronchitis.\"\n }\n ]\n },\n {\n \"Term\": \"Hepatic failure\",\n \"MEDDRACode\": \"10019663\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"liver failure\",\n \"Probability\": \"0.7190163136\",\n \"SemanticContext\": \"Patients with HT- 1 are at increased risk of developing porphyric crises, hepatic neoplasms, and liver failure requiring liver transplantation.\"\n },\n {\n \"VerbatimTerm\": \"liver failure\",\n \"Probability\": \"0.9500896931\",\n \"SemanticContext\": \"These complications of HT-1 were observed in patients treated with nitisinone for a median of 22 months during the clinical trial liver transplantation 13%, liver failure 7%, malignant hepatic neoplasms 5%, benign hepatic neoplasms 3%, porphyria 1% .\"\n }\n ]\n },\n {\n \"Term\": \"Hepatomegaly\",\n \"MEDDRACode\": \"10019842\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"liver enlargement\",\n \"Probability\": \"0.9987573624\",\n \"SemanticContext\": \"Adverse reactions reported in less than 1% of the patients, included death, seizure, brain tumor, encephalopathy, hyperkinesia, cyanosis, abdominal pain, diarrhea, enanthema, gastrointestinal hemorrhage, melena, elevated hepatic enzymes, liver enlargement, hypoglycemia, septicemia, and bronchitis.\"\n }\n ]\n },\n {\n \"Term\": \"Melaena\",\n \"MEDDRACode\": \"10027141\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"melena\",\n \"Probability\": \"0.9774267673\",\n \"SemanticContext\": \"Adverse reactions reported in less than 1% of the patients, included death, seizure, brain tumor, encephalopathy, hyperkinesia, cyanosis, abdominal pain, diarrhea, enanthema, gastrointestinal hemorrhage, melena, elevated hepatic enzymes, liver enlargement, hypoglycemia, septicemia, and bronchitis.\"\n }\n ]\n },\n {\n \"Term\": \"Hepatic enzyme\",\n \"MEDDRACode\": \"10060793\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hepatic enzymes\",\n \"Probability\": \"0.8880999088\",\n \"SemanticContext\": \"Adverse reactions reported in less than 1% of the patients, included death, seizure, brain tumor, encephalopathy, hyperkinesia, cyanosis, abdominal pain, diarrhea, enanthema, gastrointestinal hemorrhage, melena, elevated hepatic enzymes, liver enlargement, hypoglycemia, septicemia, and bronchitis.\"\n }\n ]\n },\n {\n \"Term\": \"Gastrointestinal haemorrhage\",\n \"MEDDRACode\": \"10017955\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"gastrointestinal hemorrhage\",\n \"Probability\": \"0.9887012839\",\n \"SemanticContext\": \"Adverse reactions reported in less than 1% of the patients, included death, seizure, brain tumor, encephalopathy, hyperkinesia, cyanosis, abdominal pain, diarrhea, enanthema, gastrointestinal hemorrhage, melena, elevated hepatic enzymes, liver enlargement, hypoglycemia, septicemia, and bronchitis.\"\n }\n ]\n },\n {\n \"Term\": \"Liver transplant\",\n \"MEDDRACode\": \"10024714\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"liver transplantation\",\n \"Probability\": \"0.2586750388\",\n \"SemanticContext\": \"Patients with HT- 1 are at increased risk of developing porphyric crises, hepatic neoplasms, and liver failure requiring liver transplantation.\"\n },\n {\n \"VerbatimTerm\": \"liver transplantation\",\n \"Probability\": \"0.1030919254\",\n \"SemanticContext\": \"These complications of HT-1 were observed in patients treated with nitisinone for a median of 22 months during the clinical trial liver transplantation 13%, liver failure 7%, malignant hepatic neoplasms 5%, benign hepatic neoplasms 3%, porphyria 1% .\"\n }\n ]\n },\n {\n \"Term\": \"Platelet count\",\n \"MEDDRACode\": \"10035525\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"platelet counts\",\n \"Probability\": \"0.0238853097\",\n \"SemanticContext\": \"Six patients had thrombocytopenia, three of which had platelet counts 30,000/microL or lower.\"\n },\n {\n \"VerbatimTerm\": \"platelet counts\",\n \"Probability\": \"0.0017426908\",\n \"SemanticContext\": \"In 4 patients with thrombocytopenia, platelet counts gradually returned to normal duration up to 47 days without change in ORFADIN dose.\"\n },\n {\n \"VerbatimTerm\": \"platelet count\",\n \"Probability\": \"6.14E-05\",\n \"SemanticContext\": \"All patients were treated with ORFADIN at a starting dose of 0.3 to 0.5 mg/kg twice daily, and the dose was increased in some patients to 1 mg/kg twice daily based on weight, liver and kidney function tests, platelet count, serum amino acids, urinary phenolic acid, plasma and urine succinylacetone, erythrocyte PBG-synthase, and urine 5-ALA..\"\n }\n ]\n },\n {\n \"Term\": \"Alpha 1 foetoprotein\",\n \"MEDDRACode\": \"10001772\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"alpha-fetoprotein\",\n \"Probability\": \"7.41528E-05\",\n \"SemanticContext\": \"Monitor plasma and/or urine succinylacetone concentrations, liver function parameters and alpha-fetoprotein levels.\"\n }\n ]\n },\n {\n \"Term\": \"Cataract\",\n \"MEDDRACode\": \"10007739\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"cataracts\",\n \"Probability\": \"0.9976519346\",\n \"SemanticContext\": \"ADVERSE REACTIONS Most common adverse reactions >1% are elevated tyrosine levels, thrombocytopenia, leukopenia, conjunctivitis, corneal opacity, keratitis, photophobia, eye pain, blepharitis, cataracts, granulocytopenia, epistaxis, pruritus, exfoliative dermatitis, dry skin, maculopapular rash and alopecia.\"\n },\n {\n \"VerbatimTerm\": \"Cataracts\",\n \"Probability\": \"0.215233624\",\n \"SemanticContext\": \"TABLE 1 *reported in at least 1% of patients Most Common Adverse Reactions in Patients with HT-1 Treated with Nitisinone* Elevated tyrosine levels Leukopenia Thrombocytopenia Conjunctivitis Corneal opacity Keratitis Photophobia Eye pain Blepharitis Cataracts Granulocytopenia Epistaxis Pruritus Exfoliative dermatitis Dry skin Maculopapular rash Alopecia >10% 3% 3% 2% 2% 2% 2% 1% 1% 1% 1% 1% 1% 1% 1% 1% 1% .\"\n }\n ]\n },\n {\n \"Term\": \"Pruritus\",\n \"MEDDRACode\": \"10037087\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"pruritus\",\n \"Probability\": \"0.9994251728\",\n \"SemanticContext\": \"ADVERSE REACTIONS Most common adverse reactions >1% are elevated tyrosine levels, thrombocytopenia, leukopenia, conjunctivitis, corneal opacity, keratitis, photophobia, eye pain, blepharitis, cataracts, granulocytopenia, epistaxis, pruritus, exfoliative dermatitis, dry skin, maculopapular rash and alopecia.\"\n },\n {\n \"VerbatimTerm\": \"Pruritus\",\n \"Probability\": \"0.9525622725\",\n \"SemanticContext\": \"TABLE 1 *reported in at least 1% of patients Most Common Adverse Reactions in Patients with HT-1 Treated with Nitisinone* Elevated tyrosine levels Leukopenia Thrombocytopenia Conjunctivitis Corneal opacity Keratitis Photophobia Eye pain Blepharitis Cataracts Granulocytopenia Epistaxis Pruritus Exfoliative dermatitis Dry skin Maculopapular rash Alopecia >10% 3% 3% 2% 2% 2% 2% 1% 1% 1% 1% 1% 1% 1% 1% 1% 1% .\"\n }\n ]\n },\n {\n \"Term\": \"Seizure\",\n \"MEDDRACode\": \"10039906\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"seizure\",\n \"Probability\": \"0.9971814156\",\n \"SemanticContext\": \"Adverse reactions reported in less than 1% of the patients, included death, seizure, brain tumor, encephalopathy, hyperkinesia, cyanosis, abdominal pain, diarrhea, enanthema, gastrointestinal hemorrhage, melena, elevated hepatic enzymes, liver enlargement, hypoglycemia, septicemia, and bronchitis.\"\n }\n ]\n },\n {\n \"Term\": \"Hepatic neoplasm\",\n \"MEDDRACode\": \"10019695\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hepatic neoplasms\",\n \"Probability\": \"0.5599882007\",\n \"SemanticContext\": \"Patients with HT- 1 are at increased risk of developing porphyric crises, hepatic neoplasms, and liver failure requiring liver transplantation.\"\n }\n ]\n },\n {\n \"Term\": \"Sepsis\",\n \"MEDDRACode\": \"10040047\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"septicemia\",\n \"Probability\": \"0.9948012233\",\n \"SemanticContext\": \"Adverse reactions reported in less than 1% of the patients, included death, seizure, brain tumor, encephalopathy, hyperkinesia, cyanosis, abdominal pain, diarrhea, enanthema, gastrointestinal hemorrhage, melena, elevated hepatic enzymes, liver enlargement, hypoglycemia, septicemia, and bronchitis.\"\n }\n ]\n },\n {\n \"Term\": \"Corneal opacity\",\n \"MEDDRACode\": \"10011035\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"corneal opacity\",\n \"Probability\": \"0.9986885786\",\n \"SemanticContext\": \"ADVERSE REACTIONS Most common adverse reactions >1% are elevated tyrosine levels, thrombocytopenia, leukopenia, conjunctivitis, corneal opacity, keratitis, photophobia, eye pain, blepharitis, cataracts, granulocytopenia, epistaxis, pruritus, exfoliative dermatitis, dry skin, maculopapular rash and alopecia.\"\n },\n {\n \"VerbatimTerm\": \"Corneal opacity\",\n \"Probability\": \"0.8703866005\",\n \"SemanticContext\": \"TABLE 1 *reported in at least 1% of patients Most Common Adverse Reactions in Patients with HT-1 Treated with Nitisinone* Elevated tyrosine levels Leukopenia Thrombocytopenia Conjunctivitis Corneal opacity Keratitis Photophobia Eye pain Blepharitis Cataracts Granulocytopenia Epistaxis Pruritus Exfoliative dermatitis Dry skin Maculopapular rash Alopecia >10% 3% 3% 2% 2% 2% 2% 1% 1% 1% 1% 1% 1% 1% 1% 1% 1% .\"\n },\n {\n \"VerbatimTerm\": \"corneal opacities\",\n \"Probability\": \"0.4033246636\",\n \"SemanticContext\": \"Maintain plasma tyrosine levels below 500 micromol/L. Inadequate restriction of tyrosine and phenylalanine intake can lead to elevations in plasma tyrosine levels and levels greater than 500 micromol/L may lead to the following: Ocular signs and symptoms including corneal ulcers, corneal opacities, keratitis, conjunctivitis, eye pain, and photophobia have been reported in patients treated with ORFADIN [see Adverse Reactions 6.1 ] .\"\n }\n ]\n },\n {\n \"Term\": \"Blood creatinine\",\n \"MEDDRACode\": \"10005480\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"creatinine\",\n \"Probability\": \"4.66506E-05\",\n \"SemanticContext\": \"In all 186 patients whose urine succinylacetone was measured, the urinary succinylacetone concentration decreased to less than 1 mmol/mol creatinine, the lower limit of quantitation.\"\n },\n {\n \"VerbatimTerm\": \"creatinine\",\n \"Probability\": \"0.000847578\",\n \"SemanticContext\": \"The overall median pretreatment level was 4.3 grams/mol creatinine.\"\n },\n {\n \"VerbatimTerm\": \"creatinine\",\n \"Probability\": \"0.0006886423\",\n \"SemanticContext\": \"After one year of treatment in a subgroup of patients N=100 , overall median alpha-1-microglobulin decreased by 1.5 grams/mol creatinine.\"\n },\n {\n \"VerbatimTerm\": \"creatinine\",\n \"Probability\": \"1.47403E-05\",\n \"SemanticContext\": \"In patients 24 months of age and younger in whom multiple values were available N=65 , median alpha-1-microglobulin levels decreased from 5.0 to 3.0 grams/mol creatinine reference value for age less than or equal to 12 grams/mol creatinine .\"\n },\n {\n \"VerbatimTerm\": \"creatinine\",\n \"Probability\": \"0.0037973523\",\n \"SemanticContext\": \"In patients 24 months of age and younger in whom multiple values were available N=65 , median alpha-1-microglobulin levels decreased from 5.0 to 3.0 grams/mol creatinine reference value for age less than or equal to 12 grams/mol creatinine .\"\n },\n {\n \"VerbatimTerm\": \"creatinine\",\n \"Probability\": \"2.48817E-05\",\n \"SemanticContext\": \"In patients older than 24 months in whom multiple values were available N=35 , median alpha-1-microglobulin levels decreased from 2.8 to 2.0 grams/mol creatinine reference for age less than or equal to 6 grams/mol creatinine .\"\n },\n {\n \"VerbatimTerm\": \"creatinine\",\n \"Probability\": \"0.0049907565\",\n \"SemanticContext\": \"In patients older than 24 months in whom multiple values were available N=35 , median alpha-1-microglobulin levels decreased from 2.8 to 2.0 grams/mol creatinine reference for age less than or equal to 6 grams/mol creatinine .\"\n }\n ]\n },\n {\n \"Term\": \"Hepatic cancer\",\n \"MEDDRACode\": \"10073069\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"malignant hepatic neoplasms\",\n \"Probability\": \"0.919803679\",\n \"SemanticContext\": \"These complications of HT-1 were observed in patients treated with nitisinone for a median of 22 months during the clinical trial liver transplantation 13%, liver failure 7%, malignant hepatic neoplasms 5%, benign hepatic neoplasms 3%, porphyria 1% .\"\n }\n ]\n },\n {\n \"Term\": \"Hyperkinesia\",\n \"MEDDRACode\": \"10020651\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hyperkinesia\",\n \"Probability\": \"0.9861875176\",\n \"SemanticContext\": \"Adverse reactions reported in less than 1% of the patients, included death, seizure, brain tumor, encephalopathy, hyperkinesia, cyanosis, abdominal pain, diarrhea, enanthema, gastrointestinal hemorrhage, melena, elevated hepatic enzymes, liver enlargement, hypoglycemia, septicemia, and bronchitis.\"\n }\n ]\n },\n {\n \"Term\": \"Blood sodium\",\n \"MEDDRACode\": \"10005799\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"5.85578E-05\",\n \"SemanticContext\": \"It is practically insoluble in water, soluble in 2M sodium hydroxide and in methanol, and sparingly soluble in alcohol.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0001761317\",\n \"SemanticContext\": \"The inactive ingredients are hydroxypropyl methylcellulose, glycerol, polysorbate 80, sodium benzoate, citric acid monohydrate, trisodium citrate dihydrate, strawberry aroma artificial and purified water.\"\n },\n {\n \"VerbatimTerm\": \"Sodium\",\n \"Probability\": \"0.0011365116\",\n \"SemanticContext\": \"Sodium: Each mL contains 0.7 mg 0.03 mEq .\"\n }\n ]\n },\n {\n \"Term\": \"Weight\",\n \"MEDDRACode\": \"10047890\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": true,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"weight\",\n \"Probability\": \"0.000936538\",\n \"SemanticContext\": \"The starting dose of ORFADIN was 0.3 to 0.5 mg/kg twice daily, and the dose was increased in some patients to 1 mg/kg twice daily based on weight, biochemical, and enzyme markers.\"\n },\n {\n \"VerbatimTerm\": \"weight\",\n \"Probability\": \"0.0001813769\",\n \"SemanticContext\": \"All patients were treated with ORFADIN at a starting dose of 0.3 to 0.5 mg/kg twice daily, and the dose was increased in some patients to 1 mg/kg twice daily based on weight, liver and kidney function tests, platelet count, serum amino acids, urinary phenolic acid, plasma and urine succinylacetone, erythrocyte PBG-synthase, and urine 5-ALA..\"\n },\n {\n \"VerbatimTerm\": \"weight\",\n \"Probability\": \"0.0165419877\",\n \"SemanticContext\": \"In a single dose-group study in rats given 100 mg/kg 16.2 times the recommended initial dose of 1 mg/kg/day on a body surface area basis , reduced litter size, decreased pup weight at birth, and decreased survival of pups after birth was demonstrated.\"\n },\n {\n \"VerbatimTerm\": \"weight\",\n \"Probability\": \"0.0037819743\",\n \"SemanticContext\": \"Data suggest that nitisinone is present in rat milk due to findings of ocular toxicity and lower body weight seen in drug naive nursing rat pups.\"\n }\n ]\n },\n {\n \"Term\": \"Hepatic amoebiasis\",\n \"MEDDRACode\": \"10063741\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"ALA\",\n \"Probability\": \"0.0444850028\",\n \"SemanticContext\": \"All patients were treated with ORFADIN at a starting dose of 0.3 to 0.5 mg/kg twice daily, and the dose was increased in some patients to 1 mg/kg twice daily based on weight, liver and kidney function tests, platelet count, serum amino acids, urinary phenolic acid, plasma and urine succinylacetone, erythrocyte PBG-synthase, and urine 5-ALA..\"\n },\n {\n \"VerbatimTerm\": \"ALA\",\n \"Probability\": \"0.0062949657\",\n \"SemanticContext\": \"During initiation of therapy, when switching from twice daily to once daily dosing, or if there is a deterioration in the patient's condition, it may be necessary to follow all available biochemical parameters more closely i.e. plasma and/or urine succinylacetone, urine 5-aminolevulinate ALA and erythrocyte porphobilinogen PBG -synthase activity .\"\n }\n ]\n },\n {\n \"Term\": \"Carcinogenicity\",\n \"MEDDRACode\": \"10007269\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"carcinogenicity\",\n \"Probability\": \"1.22723E-05\",\n \"SemanticContext\": \"13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility The carcinogenic potential of nitisinone was assessed in a 26-week oral gavage carcinogenicity study in Tg.rasH2 mice.\"\n }\n ]\n },\n {\n \"Term\": \"Blood pyruvic acid\",\n \"MEDDRACode\": \"10005784\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"pyruvate\",\n \"Probability\": \"5.68696E-05\",\n \"SemanticContext\": \"11 DESCRIPTION ORFADIN contains nitisinone, which is a hydroxyphenyl-pyruvate dioxygenase inhibitor indicated as an adjunct to dietary restriction of tyrosine and phenylalanine in the treatment of hereditary tyrosinemia type 1 HT-1 .\"\n },\n {\n \"VerbatimTerm\": \"pyruvate\",\n \"Probability\": \"4.26792E-05\",\n \"SemanticContext\": \"Figure 1 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Nitisinone is a competitive inhibitor of 4-hydroxyphenyl-pyruvate dioxygenase, an enzyme upstream of fumarylacetoacetate hydrolase FAH in the tyrosine catabolic pathway.\"\n },\n {\n \"VerbatimTerm\": \"pyruvate\",\n \"Probability\": \"8.98209E-05\",\n \"SemanticContext\": \"5 WARNINGS AND PRECAUTIONS 5.1 Elevated Plasma Tyrosine Levels, Ocular Symptoms, Developmental Delay and Hyperkeratotic Plaques Nitisinone is an inhibitor of 4-hydroxyphenyl-pyruvate dioxygenase, an enzyme in the tyrosine metabolic pathway [see Clinical Pharmacology 12.1 ] .\"\n }\n ]\n },\n {\n \"Term\": \"Drug interaction\",\n \"MEDDRACode\": \"10013710\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Interactions\",\n \"Probability\": \"0.0001559556\",\n \"SemanticContext\": \"Table 2: Clinically Relevant Interactions Affecting Co-Administered Drugs Sensitive CYP2C9 Substrates e.g., celecoxib, tolbutamide or CYP2C9 Substrates with a Narrow Therapeutic Index e.g., phenytoin, warfarin Clinical Impact Increased exposure of the co-administered drugs metabolized by CYP2C9.\"\n }\n ]\n },\n {\n \"Term\": \"Alopecia\",\n \"MEDDRACode\": \"10001760\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"alopecia\",\n \"Probability\": \"0.9942157269\",\n \"SemanticContext\": \"ADVERSE REACTIONS Most common adverse reactions >1% are elevated tyrosine levels, thrombocytopenia, leukopenia, conjunctivitis, corneal opacity, keratitis, photophobia, eye pain, blepharitis, cataracts, granulocytopenia, epistaxis, pruritus, exfoliative dermatitis, dry skin, maculopapular rash and alopecia.\"\n },\n {\n \"VerbatimTerm\": \"Alopecia\",\n \"Probability\": \"0.9884082079\",\n \"SemanticContext\": \"TABLE 1 *reported in at least 1% of patients Most Common Adverse Reactions in Patients with HT-1 Treated with Nitisinone* Elevated tyrosine levels Leukopenia Thrombocytopenia Conjunctivitis Corneal opacity Keratitis Photophobia Eye pain Blepharitis Cataracts Granulocytopenia Epistaxis Pruritus Exfoliative dermatitis Dry skin Maculopapular rash Alopecia >10% 3% 3% 2% 2% 2% 2% 1% 1% 1% 1% 1% 1% 1% 1% 1% 1% .\"\n }\n ]\n },\n {\n \"Term\": \"Tremor\",\n \"MEDDRACode\": \"10044565\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Shake\",\n \"Probability\": \"0.0056815147\",\n \"SemanticContext\": \"Shake the bottle vigorously for at least 20 seconds until the solid cake at the bottom of the bottle is completely dispersed.\"\n },\n {\n \"VerbatimTerm\": \"Shake\",\n \"Probability\": \"0.0009354055\",\n \"SemanticContext\": \"Preparing a Bottle With the Adapter Inserted: Shake the bottle vigorously for at least 5 seconds.\"\n },\n {\n \"VerbatimTerm\": \"Shake\",\n \"Probability\": \"0.0056815147\",\n \"SemanticContext\": \"Shake the bottle vigorously for at least 20 seconds until the solid cake at the bottom of the bottle is completely dispersed.\"\n },\n {\n \"VerbatimTerm\": \"Shake\",\n \"Probability\": \"0.0009354055\",\n \"SemanticContext\": \"Preparing a Bottle With the Adapter Inserted: Shake the bottle vigorously for at least 5 seconds.\"\n }\n ]\n },\n {\n \"Term\": \"Elderly\",\n \"MEDDRACode\": \"10014348\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": true\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"elderly\",\n \"Probability\": \"5.21771E-05\",\n \"SemanticContext\": \"In general, dose selection for an elderly patient should be cautious reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and concomitant disease or other drug therapy in this patient population.\"\n }\n ]\n },\n {\n \"Term\": \"Dry skin\",\n \"MEDDRACode\": \"10013786\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"dry skin\",\n \"Probability\": \"0.9936286211\",\n \"SemanticContext\": \"ADVERSE REACTIONS Most common adverse reactions >1% are elevated tyrosine levels, thrombocytopenia, leukopenia, conjunctivitis, corneal opacity, keratitis, photophobia, eye pain, blepharitis, cataracts, granulocytopenia, epistaxis, pruritus, exfoliative dermatitis, dry skin, maculopapular rash and alopecia.\"\n }\n ]\n },\n {\n \"Term\": \"Enanthema\",\n \"MEDDRACode\": \"10014579\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"enanthema\",\n \"Probability\": \"0.9956310391\",\n \"SemanticContext\": \"Adverse reactions reported in less than 1% of the patients, included death, seizure, brain tumor, encephalopathy, hyperkinesia, cyanosis, abdominal pain, diarrhea, enanthema, gastrointestinal hemorrhage, melena, elevated hepatic enzymes, liver enlargement, hypoglycemia, septicemia, and bronchitis.\"\n }\n ]\n },\n {\n \"Term\": \"Encephalopathy\",\n \"MEDDRACode\": \"10014625\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"encephalopathy\",\n \"Probability\": \"0.9914292097\",\n \"SemanticContext\": \"Adverse reactions reported in less than 1% of the patients, included death, seizure, brain tumor, encephalopathy, hyperkinesia, cyanosis, abdominal pain, diarrhea, enanthema, gastrointestinal hemorrhage, melena, elevated hepatic enzymes, liver enlargement, hypoglycemia, septicemia, and bronchitis.\"\n }\n ]\n },\n {\n \"Term\": \"Rash maculo-papular\",\n \"MEDDRACode\": \"10037868\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"maculopapular rash\",\n \"Probability\": \"0.9827212095\",\n \"SemanticContext\": \"ADVERSE REACTIONS Most common adverse reactions >1% are elevated tyrosine levels, thrombocytopenia, leukopenia, conjunctivitis, corneal opacity, keratitis, photophobia, eye pain, blepharitis, cataracts, granulocytopenia, epistaxis, pruritus, exfoliative dermatitis, dry skin, maculopapular rash and alopecia.\"\n },\n {\n \"VerbatimTerm\": \"Maculopapular rash\",\n \"Probability\": \"0.5909456015\",\n \"SemanticContext\": \"TABLE 1 *reported in at least 1% of patients Most Common Adverse Reactions in Patients with HT-1 Treated with Nitisinone* Elevated tyrosine levels Leukopenia Thrombocytopenia Conjunctivitis Corneal opacity Keratitis Photophobia Eye pain Blepharitis Cataracts Granulocytopenia Epistaxis Pruritus Exfoliative dermatitis Dry skin Maculopapular rash Alopecia >10% 3% 3% 2% 2% 2% 2% 1% 1% 1% 1% 1% 1% 1% 1% 1% 1% .\"\n }\n ]\n },\n {\n \"Term\": \"Eye pain\",\n \"MEDDRACode\": \"10015958\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"eye pain\",\n \"Probability\": \"0.9916943312\",\n \"SemanticContext\": \"ADVERSE REACTIONS Most common adverse reactions >1% are elevated tyrosine levels, thrombocytopenia, leukopenia, conjunctivitis, corneal opacity, keratitis, photophobia, eye pain, blepharitis, cataracts, granulocytopenia, epistaxis, pruritus, exfoliative dermatitis, dry skin, maculopapular rash and alopecia.\"\n },\n {\n \"VerbatimTerm\": \"eye pain\",\n \"Probability\": \"0.2711836994\",\n \"SemanticContext\": \"Maintain plasma tyrosine levels below 500 micromol/L. Inadequate restriction of tyrosine and phenylalanine intake can lead to elevations in plasma tyrosine levels and levels greater than 500 micromol/L may lead to the following: Ocular signs and symptoms including corneal ulcers, corneal opacities, keratitis, conjunctivitis, eye pain, and photophobia have been reported in patients treated with ORFADIN [see Adverse Reactions 6.1 ] .\"\n },\n {\n \"VerbatimTerm\": \"eye pain\",\n \"Probability\": \"0.0017451048\",\n \"SemanticContext\": \"Patients who develop photophobia, eye pain, or signs of inflammation such as redness, swelling, or burning of the eyes or tyrosine levels are > 500 micromol/L during treatment with ORFADIN should undergo slit-lamp reexamination and immediate measurement of the plasma tyrosine concentration.\"\n },\n {\n \"VerbatimTerm\": \"Eye pain\",\n \"Probability\": \"0.1005108058\",\n \"SemanticContext\": \"TABLE 1 *reported in at least 1% of patients Most Common Adverse Reactions in Patients with HT-1 Treated with Nitisinone* Elevated tyrosine levels Leukopenia Thrombocytopenia Conjunctivitis Corneal opacity Keratitis Photophobia Eye pain Blepharitis Cataracts Granulocytopenia Epistaxis Pruritus Exfoliative dermatitis Dry skin Maculopapular rash Alopecia >10% 3% 3% 2% 2% 2% 2% 1% 1% 1% 1% 1% 1% 1% 1% 1% 1% .\"\n }\n ]\n },\n {\n \"Term\": \"Haemorrhage\",\n \"MEDDRACode\": \"10055798\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"bleeding\",\n \"Probability\": \"0.8598805666\",\n \"SemanticContext\": \"No patients developed infections or bleeding as a result of the episodes of leukopenia and thrombocytopenia.\"\n },\n {\n \"VerbatimTerm\": \"bleeding\",\n \"Probability\": \"0.9498426914\",\n \"SemanticContext\": \"No patients developed infections or bleeding as a result of the episodes of leukopenia and thrombocytopenia.\"\n }\n ]\n },\n {\n \"Term\": \"Leukopenia\",\n \"MEDDRACode\": \"10024384\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Leukopenia\",\n \"Probability\": \"0.7761819363\",\n \"SemanticContext\": \"Leukopenia and Severe Thrombocytopenia : Monitor platelet and white blood cell counts.\"\n },\n {\n \"VerbatimTerm\": \"Leukopenia\",\n \"Probability\": \"0.7124200463\",\n \"SemanticContext\": \"TABLE 1 *reported in at least 1% of patients Most Common Adverse Reactions in Patients with HT-1 Treated with Nitisinone* Elevated tyrosine levels Leukopenia Thrombocytopenia Conjunctivitis Corneal opacity Keratitis Photophobia Eye pain Blepharitis Cataracts Granulocytopenia Epistaxis Pruritus Exfoliative dermatitis Dry skin Maculopapular rash Alopecia >10% 3% 3% 2% 2% 2% 2% 1% 1% 1% 1% 1% 1% 1% 1% 1% 1% .\"\n },\n {\n \"VerbatimTerm\": \"Leukopenia\",\n \"Probability\": \"0.8749364614\",\n \"SemanticContext\": \"5.2 Leukopenia and Severe Thrombocytopenia In clinical trials, patients treated with ORFADIN and dietary restriction developed transient leukopenia 3% , thrombocytopenia 3% , or both 1.5% [see Adverse Reactions 6.1 ] .\"\n },\n {\n \"VerbatimTerm\": \"leukopenia\",\n \"Probability\": \"0.9993851185\",\n \"SemanticContext\": \"ADVERSE REACTIONS Most common adverse reactions >1% are elevated tyrosine levels, thrombocytopenia, leukopenia, conjunctivitis, corneal opacity, keratitis, photophobia, eye pain, blepharitis, cataracts, granulocytopenia, epistaxis, pruritus, exfoliative dermatitis, dry skin, maculopapular rash and alopecia.\"\n },\n {\n \"VerbatimTerm\": \"leukopenia\",\n \"Probability\": \"0.9991173148\",\n \"SemanticContext\": \"The most serious adverse reactions reported during ORFADIN treatment were thrombocytopenia, leukopenia, porphyria, and ocular/visual complaints associated with elevated tyrosine levels [see Warnings and Precautions 5.1 , 5.2 ] .\"\n },\n {\n \"VerbatimTerm\": \"leukopenia\",\n \"Probability\": \"0.6738170981\",\n \"SemanticContext\": \"No patients developed infections or bleeding as a result of the episodes of leukopenia and thrombocytopenia.\"\n },\n {\n \"VerbatimTerm\": \"leukopenia\",\n \"Probability\": \"0.9998116493\",\n \"SemanticContext\": \"5.2 Leukopenia and Severe Thrombocytopenia In clinical trials, patients treated with ORFADIN and dietary restriction developed transient leukopenia 3% , thrombocytopenia 3% , or both 1.5% [see Adverse Reactions 6.1 ] .\"\n },\n {\n \"VerbatimTerm\": \"leukopenia\",\n \"Probability\": \"0.9786258936\",\n \"SemanticContext\": \"No patients developed infections or bleeding as a result of the episodes of leukopenia and thrombocytopenia.\"\n }\n ]\n },\n {\n \"Term\": \"Diarrhoea\",\n \"MEDDRACode\": \"10012735\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"diarrhea\",\n \"Probability\": \"0.0247995853\",\n \"SemanticContext\": \"Risk of Adverse Reactions Due to Glycerol Content of ORFADIN Oral Suspension : Doses of 20 mL of ORFADIN oral suspension may cause headache, upset stomach and diarrhea due to the glycerol content.\"\n },\n {\n \"VerbatimTerm\": \"diarrhea\",\n \"Probability\": \"0.9970415831\",\n \"SemanticContext\": \"Adverse reactions reported in less than 1% of the patients, included death, seizure, brain tumor, encephalopathy, hyperkinesia, cyanosis, abdominal pain, diarrhea, enanthema, gastrointestinal hemorrhage, melena, elevated hepatic enzymes, liver enlargement, hypoglycemia, septicemia, and bronchitis.\"\n },\n {\n \"VerbatimTerm\": \"diarrhea\",\n \"Probability\": \"0.0075250864\",\n \"SemanticContext\": \"Risk of Adverse Reactions Due to Glycerol Content of ORFADIN Oral Suspension Advise patients receiving doses of greater than 20 mL of ORFADIN oral suspension that they may experience headache, upset stomach and diarrhea due to the glycerol component of the formulation and if they develop symptoms to report these to their healthcare provider [see Warnings and Precautions 5.3 ].\"\n },\n {\n \"VerbatimTerm\": \"diarrhea\",\n \"Probability\": \"0.384547472\",\n \"SemanticContext\": \"5.3 Risk of Adverse Reactions Due to Glycerol Content of ORFADIN Oral Suspension Oral doses of glycerol of 10 grams or more have been reported to cause headache, upset stomach and diarrhea.\"\n }\n ]\n },\n {\n \"Term\": \"Porphyria\",\n \"MEDDRACode\": \"10036181\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"porphyria\",\n \"Probability\": \"0.9968924522\",\n \"SemanticContext\": \"The most serious adverse reactions reported during ORFADIN treatment were thrombocytopenia, leukopenia, porphyria, and ocular/visual complaints associated with elevated tyrosine levels [see Warnings and Precautions 5.1 , 5.2 ] .\"\n },\n {\n \"VerbatimTerm\": \"porphyria\",\n \"Probability\": \"0.9637761116\",\n \"SemanticContext\": \"These complications of HT-1 were observed in patients treated with nitisinone for a median of 22 months during the clinical trial liver transplantation 13%, liver failure 7%, malignant hepatic neoplasms 5%, benign hepatic neoplasms 3%, porphyria 1% .\"\n },\n {\n \"VerbatimTerm\": \"porphyria\",\n \"Probability\": \"0.0874952972\",\n \"SemanticContext\": \"An assessment of porphyria-like crises was performed because these events are commonly reported in patients with HT-1 who are not treated with nitisinone.\"\n },\n {\n \"VerbatimTerm\": \"Porphyria\",\n \"Probability\": \"0.8103244305\",\n \"SemanticContext\": \"Porphyria-like crisis were reported in 3 patients 0.3% of cases per year during the clinical study.\"\n }\n ]\n },\n {\n \"Term\": \"Alpha 1 microglobulin decreased\",\n \"MEDDRACode\": \"10070644\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"alpha-1-microglobulin decreased\",\n \"Probability\": \"0.016581893\",\n \"SemanticContext\": \"After one year of treatment in a subgroup of patients N=100 , overall median alpha-1-microglobulin decreased by 1.5 grams/mol creatinine.\"\n }\n ]\n },\n {\n \"Term\": \"Blood iron\",\n \"MEDDRACode\": \"10005616\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"iron\",\n \"Probability\": \"0.0018297732\",\n \"SemanticContext\": \"The capsule shell is gelatin and titanium dioxide and the imprint is an iron oxide.\"\n }\n ]\n },\n {\n \"Term\": \"Euphoric mood\",\n \"MEDDRACode\": \"10015535\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"high\",\n \"Probability\": \"9.19497E-05\",\n \"SemanticContext\": \"For ORFADIN oral suspension, a high calorie 800 to 1000 calories and high fat meal approximately 50% of total caloric content did not affect nitisinone total exposure AUC 72h , but decreased the C max by approximately 20% [see Dosage and Administration 2.2 ] .\"\n },\n {\n \"VerbatimTerm\": \"high\",\n \"Probability\": \"0.0003393888\",\n \"SemanticContext\": \"For ORFADIN oral suspension, a high calorie 800 to 1000 calories and high fat meal approximately 50% of total caloric content did not affect nitisinone total exposure AUC 72h , but decreased the C max by approximately 20% [see Dosage and Administration 2.2 ] .\"\n }\n ]\n },\n {\n \"Term\": \"Tyrosinaemia\",\n \"MEDDRACode\": \"10063443\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"tyrosinemia\",\n \"Probability\": \"0.4226971865\",\n \"SemanticContext\": \"Hyper-tyrosinemia has been reported with ORFADIN treatment [see Warnings and Precautions 5.1 ] .\"\n }\n ]\n },\n {\n \"Term\": \"Ultrasound scan\",\n \"MEDDRACode\": \"10045434\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"U.S.\",\n \"Probability\": \"0.0001526177\",\n \"SemanticContext\": \"ORFADIN ® nitisinone capsules, for oral use ORFADIN ® nitisinone oral suspension Initial U.S. Approval: 2002 RECENT MAJOR CHANGES Warnings and Precautions 5.1 05/2019 .\"\n },\n {\n \"VerbatimTerm\": \"U.S.\",\n \"Probability\": \"0.0001934171\",\n \"SemanticContext\": \"In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.\"\n }\n ]\n },\n {\n \"Term\": \"Headache\",\n \"MEDDRACode\": \"10019211\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"headache\",\n \"Probability\": \"0.7621808052\",\n \"SemanticContext\": \"Risk of Adverse Reactions Due to Glycerol Content of ORFADIN Oral Suspension : Doses of 20 mL of ORFADIN oral suspension may cause headache, upset stomach and diarrhea due to the glycerol content.\"\n },\n {\n \"VerbatimTerm\": \"headache\",\n \"Probability\": \"0.3868203163\",\n \"SemanticContext\": \"Risk of Adverse Reactions Due to Glycerol Content of ORFADIN Oral Suspension Advise patients receiving doses of greater than 20 mL of ORFADIN oral suspension that they may experience headache, upset stomach and diarrhea due to the glycerol component of the formulation and if they develop symptoms to report these to their healthcare provider [see Warnings and Precautions 5.3 ].\"\n },\n {\n \"VerbatimTerm\": \"headache\",\n \"Probability\": \"0.9787971973\",\n \"SemanticContext\": \"5.3 Risk of Adverse Reactions Due to Glycerol Content of ORFADIN Oral Suspension Oral doses of glycerol of 10 grams or more have been reported to cause headache, upset stomach and diarrhea.\"\n }\n ]\n },\n {\n \"Term\": \"Psychomotor hyperactivity\",\n \"MEDDRACode\": \"10037211\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Hyper\",\n \"Probability\": \"0.1422747374\",\n \"SemanticContext\": \"Hyper-tyrosinemia has been reported with ORFADIN treatment [see Warnings and Precautions 5.1 ] .\"\n }\n ]\n },\n {\n \"Term\": \"Abortion spontaneous\",\n \"MEDDRACode\": \"10000234\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"miscarriage\",\n \"Probability\": \"0.3019028306\",\n \"SemanticContext\": \"The background risk of major birth defects and miscarriage for the indicated population are unknown.\"\n },\n {\n \"VerbatimTerm\": \"miscarriage\",\n \"Probability\": \"0.7700802088\",\n \"SemanticContext\": \"In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.\"\n }\n ]\n },\n {\n \"Term\": \"Infant\",\n \"MEDDRACode\": \"10021731\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": true,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"infant\",\n \"Probability\": \"0.0004216433\",\n \"SemanticContext\": \"8.2 Lactation Risk Summary There are no data on the presence of nitisinone in human milk, the effects on the breastfed infant, or the effects on milk production.\"\n },\n {\n \"VerbatimTerm\": \"infant\",\n \"Probability\": \"0.0001218643\",\n \"SemanticContext\": \"The development and health benefits of breastfeeding should be considered along with the mother's clinical need for ORFADIN and any potential adverse effects on the breastfed infant from ORFADIN or from the underlying maternal condition.\"\n }\n ]\n },\n {\n \"Term\": \"Keratopathy\",\n \"MEDDRACode\": \"10023365\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"keratopathies\",\n \"Probability\": \"0.0114008486\",\n \"SemanticContext\": \"In a clinical study in a non HT-1 population without dietary restriction and reported tyrosine levels >500 micromol/l both symptomatic and asymptomatic keratopathies have been observed.\"\n }\n ]\n },\n {\n \"Term\": \"Weight increased\",\n \"MEDDRACode\": \"10047899\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"weight gain\",\n \"Probability\": \"0.0102035403\",\n \"SemanticContext\": \"If the biochemical response is satisfactory undetectable blood and/or urine succinylacetone , the dosage should be adjusted only according to body weight gain and not according to plasma tyrosine levels.\"\n }\n ]\n },\n {\n \"Term\": \"Drug therapy\",\n \"MEDDRACode\": \"10063370\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": true\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"drug therapy\",\n \"Probability\": \"0.0001880527\",\n \"SemanticContext\": \"In general, dose selection for an elderly patient should be cautious reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and concomitant disease or other drug therapy in this patient population.\"\n }\n ]\n },\n {\n \"Term\": \"Blepharitis\",\n \"MEDDRACode\": \"10005148\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"blepharitis\",\n \"Probability\": \"0.9968597889\",\n \"SemanticContext\": \"ADVERSE REACTIONS Most common adverse reactions >1% are elevated tyrosine levels, thrombocytopenia, leukopenia, conjunctivitis, corneal opacity, keratitis, photophobia, eye pain, blepharitis, cataracts, granulocytopenia, epistaxis, pruritus, exfoliative dermatitis, dry skin, maculopapular rash and alopecia.\"\n },\n {\n \"VerbatimTerm\": \"Blepharitis\",\n \"Probability\": \"0.1342070997\",\n \"SemanticContext\": \"TABLE 1 *reported in at least 1% of patients Most Common Adverse Reactions in Patients with HT-1 Treated with Nitisinone* Elevated tyrosine levels Leukopenia Thrombocytopenia Conjunctivitis Corneal opacity Keratitis Photophobia Eye pain Blepharitis Cataracts Granulocytopenia Epistaxis Pruritus Exfoliative dermatitis Dry skin Maculopapular rash Alopecia >10% 3% 3% 2% 2% 2% 2% 1% 1% 1% 1% 1% 1% 1% 1% 1% 1% .\"\n }\n ]\n },\n {\n \"Term\": \"Epistaxis\",\n \"MEDDRACode\": \"10015090\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"epistaxis\",\n \"Probability\": \"0.9993944168\",\n \"SemanticContext\": \"ADVERSE REACTIONS Most common adverse reactions >1% are elevated tyrosine levels, thrombocytopenia, leukopenia, conjunctivitis, corneal opacity, keratitis, photophobia, eye pain, blepharitis, cataracts, granulocytopenia, epistaxis, pruritus, exfoliative dermatitis, dry skin, maculopapular rash and alopecia.\"\n },\n {\n \"VerbatimTerm\": \"Epistaxis\",\n \"Probability\": \"0.9180063009\",\n \"SemanticContext\": \"TABLE 1 *reported in at least 1% of patients Most Common Adverse Reactions in Patients with HT-1 Treated with Nitisinone* Elevated tyrosine levels Leukopenia Thrombocytopenia Conjunctivitis Corneal opacity Keratitis Photophobia Eye pain Blepharitis Cataracts Granulocytopenia Epistaxis Pruritus Exfoliative dermatitis Dry skin Maculopapular rash Alopecia >10% 3% 3% 2% 2% 2% 2% 1% 1% 1% 1% 1% 1% 1% 1% 1% 1% .\"\n }\n ]\n },\n {\n \"Term\": \"Slit-lamp examination\",\n \"MEDDRACode\": \"10041031\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"slit-lamp examination\",\n \"Probability\": \"0.0001762211\",\n \"SemanticContext\": \"Obtain slit-lamp examination prior to treatment, regularly during treatment; Reexamine patients if symptoms develop or tyrosine levels are > 500 micromol/L. Assess plasma tyrosine levels in patients with an abrupt change in neurologic status.\"\n },\n {\n \"VerbatimTerm\": \"slit-lamp examination\",\n \"Probability\": \"1.44788E-05\",\n \"SemanticContext\": \"Therefore, perform a baseline ophthalmologic examination including slit-lamp examination prior to initiating ORFADIN treatment and regularly thereafter.\"\n }\n ]\n },\n {\n \"Term\": \"Drug level\",\n \"MEDDRACode\": \"10061823\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": true\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"pharmacokinetic studies\",\n \"Probability\": \"0.0004348457\",\n \"SemanticContext\": \"No pharmacokinetic studies of nitisinone have been performed in geriatric patients.\"\n }\n ]\n },\n {\n \"Term\": \"Granulocytopenia\",\n \"MEDDRACode\": \"10018687\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"granulocytopenia\",\n \"Probability\": \"0.9953953028\",\n \"SemanticContext\": \"ADVERSE REACTIONS Most common adverse reactions >1% are elevated tyrosine levels, thrombocytopenia, leukopenia, conjunctivitis, corneal opacity, keratitis, photophobia, eye pain, blepharitis, cataracts, granulocytopenia, epistaxis, pruritus, exfoliative dermatitis, dry skin, maculopapular rash and alopecia.\"\n },\n {\n \"VerbatimTerm\": \"Granulocytopenia\",\n \"Probability\": \"0.3235375285\",\n \"SemanticContext\": \"TABLE 1 *reported in at least 1% of patients Most Common Adverse Reactions in Patients with HT-1 Treated with Nitisinone* Elevated tyrosine levels Leukopenia Thrombocytopenia Conjunctivitis Corneal opacity Keratitis Photophobia Eye pain Blepharitis Cataracts Granulocytopenia Epistaxis Pruritus Exfoliative dermatitis Dry skin Maculopapular rash Alopecia >10% 3% 3% 2% 2% 2% 2% 1% 1% 1% 1% 1% 1% 1% 1% 1% 1% .\"\n }\n ]\n },\n {\n \"Term\": \"Dermatitis exfoliative\",\n \"MEDDRACode\": \"10012455\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"exfoliative dermatitis\",\n \"Probability\": \"0.9974045753\",\n \"SemanticContext\": \"ADVERSE REACTIONS Most common adverse reactions >1% are elevated tyrosine levels, thrombocytopenia, leukopenia, conjunctivitis, corneal opacity, keratitis, photophobia, eye pain, blepharitis, cataracts, granulocytopenia, epistaxis, pruritus, exfoliative dermatitis, dry skin, maculopapular rash and alopecia.\"\n },\n {\n \"VerbatimTerm\": \"Exfoliative dermatitis\",\n \"Probability\": \"0.8740289211\",\n \"SemanticContext\": \"TABLE 1 *reported in at least 1% of patients Most Common Adverse Reactions in Patients with HT-1 Treated with Nitisinone* Elevated tyrosine levels Leukopenia Thrombocytopenia Conjunctivitis Corneal opacity Keratitis Photophobia Eye pain Blepharitis Cataracts Granulocytopenia Epistaxis Pruritus Exfoliative dermatitis Dry skin Maculopapular rash Alopecia >10% 3% 3% 2% 2% 2% 2% 1% 1% 1% 1% 1% 1% 1% 1% 1% 1% .\"\n }\n ]\n },\n {\n \"Term\": \"Drug screen\",\n \"MEDDRACode\": \"10050837\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"UDS\",\n \"Probability\": \"5.30194E-05\",\n \"SemanticContext\": \"Nitisinone was not genotoxic in the Ames test and the in vivo mouse liver unscheduled DNA synthesis UDS test.\"\n }\n ]\n },\n {\n \"Term\": \"Abdominal discomfort\",\n \"MEDDRACode\": \"10000059\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"upset stomach\",\n \"Probability\": \"0.3690083623\",\n \"SemanticContext\": \"Risk of Adverse Reactions Due to Glycerol Content of ORFADIN Oral Suspension : Doses of 20 mL of ORFADIN oral suspension may cause headache, upset stomach and diarrhea due to the glycerol content.\"\n },\n {\n \"VerbatimTerm\": \"upset stomach\",\n \"Probability\": \"0.0547213256\",\n \"SemanticContext\": \"Risk of Adverse Reactions Due to Glycerol Content of ORFADIN Oral Suspension Advise patients receiving doses of greater than 20 mL of ORFADIN oral suspension that they may experience headache, upset stomach and diarrhea due to the glycerol component of the formulation and if they develop symptoms to report these to their healthcare provider [see Warnings and Precautions 5.3 ].\"\n },\n {\n \"VerbatimTerm\": \"upset stomach\",\n \"Probability\": \"0.8519128561\",\n \"SemanticContext\": \"5.3 Risk of Adverse Reactions Due to Glycerol Content of ORFADIN Oral Suspension Oral doses of glycerol of 10 grams or more have been reported to cause headache, upset stomach and diarrhea.\"\n }\n ]\n },\n {\n \"Term\": \"Mass\",\n \"MEDDRACode\": \"10026865\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"mass\",\n \"Probability\": \"0.0007213652\",\n \"SemanticContext\": \"The molecular formula is C 14 H 10 F 3 NO 5 with a relative mass of 329.23 Capsules: Hard, white-opaque capsule, marked as 2 mg, 5 mg, 10 mg or 20 mg strengths of nitisinone, intended for oral administration.\"\n }\n ]\n },\n {\n \"Term\": \"Protein total\",\n \"MEDDRACode\": \"10050537\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"plasma proteins\",\n \"Probability\": \"0.0001487434\",\n \"SemanticContext\": \"Distribution In vitro binding of nitisinone to human plasma proteins is greater than 95% at 50 micromolar concentration.\"\n }\n ]\n },\n {\n \"Term\": \"Drug tolerance decreased\",\n \"MEDDRACode\": \"10052805\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"intolerant\",\n \"Probability\": \"3.10848E-05\",\n \"SemanticContext\": \"For patients who have difficulties swallowing capsules and who are intolerant to the oral suspension, the capsules may be opened and the contents suspended in a small amount of water, formula or apple sauce immediately before use.\"\n },\n {\n \"VerbatimTerm\": \"intolerant\",\n \"Probability\": \"9.1146E-05\",\n \"SemanticContext\": \"For patients who have difficulty swallowing the capsules and who are intolerant to the oral suspension [see Warnings and Precautions 5.3 ] , the capsules may be opened and the contents suspended in a small amount of water, formula or apple sauce immediately before use.\"\n }\n ]\n },\n {\n \"Term\": \"Blood methanol\",\n \"MEDDRACode\": \"10005663\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"methanol\",\n \"Probability\": \"0.0001478791\",\n \"SemanticContext\": \"It is practically insoluble in water, soluble in 2M sodium hydroxide and in methanol, and sparingly soluble in alcohol.\"\n }\n ]\n },\n {\n \"Term\": \"Swelling\",\n \"MEDDRACode\": \"10042674\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"swelling\",\n \"Probability\": \"8.48678E-05\",\n \"SemanticContext\": \"Patients who develop photophobia, eye pain, or signs of inflammation such as redness, swelling, or burning of the eyes or tyrosine levels are > 500 micromol/L during treatment with ORFADIN should undergo slit-lamp reexamination and immediate measurement of the plasma tyrosine concentration.\"\n }\n ]\n },\n {\n \"Term\": \"Thermal burn\",\n \"MEDDRACode\": \"10053615\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"burning\",\n \"Probability\": \"2.43257E-05\",\n \"SemanticContext\": \"Patients who develop photophobia, eye pain, or signs of inflammation such as redness, swelling, or burning of the eyes or tyrosine levels are > 500 micromol/L during treatment with ORFADIN should undergo slit-lamp reexamination and immediate measurement of the plasma tyrosine concentration.\"\n }\n ]\n },\n {\n \"Term\": \"Fasting\",\n \"MEDDRACode\": \"10068315\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"fasting\",\n \"Probability\": \"3.4477E-05\",\n \"SemanticContext\": \"Absorption The pharmacokinetic characteristics following single oral administration of ORFADIN 30 mg under fasting conditions are shown in Table 3 .\"\n },\n {\n \"VerbatimTerm\": \"Fasting\",\n \"Probability\": \"2.0264E-06\",\n \"SemanticContext\": \"TABLE 3 Nitisinone Arithmetic Mean CV% Pharmacokinetic Parameters in Healthy Subjects Following a Single Oral 30 mg Dose of ORFADIN Under Fasting Conditions Treatment C max micromol/L [range] t max * h [range] AUC 0-72h micromol·h/L [range] * presented as median [range] ORFADIN capsule n=12 10.5 26 3.5 406 13 [0.8 to 8.0] ORFADIN oral suspension n=12 10.1 34 0.4 350 17 [0.2 to 4.0] .\"\n },\n {\n \"VerbatimTerm\": \"Fasting\",\n \"Probability\": \"2.64254E-05\",\n \"SemanticContext\": \"TABLE 4 Nitisinone Arithmetic Mean CV% Pharmacokinetic Parameters in Healthy Subjects Following Repeated Once Daily Administration of 80 mg ORFADIN Under Fasting Conditions.\"\n },\n {\n \"VerbatimTerm\": \"Fasted\",\n \"Probability\": \"1.52327E-05\",\n \"SemanticContext\": \"After a washout period of 14 days, the mean value of plasma tyrosine was still 808 micromol/L. Fasted follow-up samples obtained from volunteers several weeks later showed tyrosine values back to normal.\"\n }\n ]\n },\n {\n \"Term\": \"Photophobia\",\n \"MEDDRACode\": \"10034960\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"photophobia\",\n \"Probability\": \"0.9966070652\",\n \"SemanticContext\": \"ADVERSE REACTIONS Most common adverse reactions >1% are elevated tyrosine levels, thrombocytopenia, leukopenia, conjunctivitis, corneal opacity, keratitis, photophobia, eye pain, blepharitis, cataracts, granulocytopenia, epistaxis, pruritus, exfoliative dermatitis, dry skin, maculopapular rash and alopecia.\"\n },\n {\n \"VerbatimTerm\": \"photophobia\",\n \"Probability\": \"0.1171221137\",\n \"SemanticContext\": \"Maintain plasma tyrosine levels below 500 micromol/L. Inadequate restriction of tyrosine and phenylalanine intake can lead to elevations in plasma tyrosine levels and levels greater than 500 micromol/L may lead to the following: Ocular signs and symptoms including corneal ulcers, corneal opacities, keratitis, conjunctivitis, eye pain, and photophobia have been reported in patients treated with ORFADIN [see Adverse Reactions 6.1 ] .\"\n },\n {\n \"VerbatimTerm\": \"photophobia\",\n \"Probability\": \"0.0017881989\",\n \"SemanticContext\": \"Patients who develop photophobia, eye pain, or signs of inflammation such as redness, swelling, or burning of the eyes or tyrosine levels are > 500 micromol/L during treatment with ORFADIN should undergo slit-lamp reexamination and immediate measurement of the plasma tyrosine concentration.\"\n },\n {\n \"VerbatimTerm\": \"Photophobia\",\n \"Probability\": \"0.6423541307\",\n \"SemanticContext\": \"TABLE 1 *reported in at least 1% of patients Most Common Adverse Reactions in Patients with HT-1 Treated with Nitisinone* Elevated tyrosine levels Leukopenia Thrombocytopenia Conjunctivitis Corneal opacity Keratitis Photophobia Eye pain Blepharitis Cataracts Granulocytopenia Epistaxis Pruritus Exfoliative dermatitis Dry skin Maculopapular rash Alopecia >10% 3% 3% 2% 2% 2% 2% 1% 1% 1% 1% 1% 1% 1% 1% 1% 1% .\"\n }\n ]\n },\n {\n \"Term\": \"Thrombocytopenia\",\n \"MEDDRACode\": \"10043554\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Thrombocytopenia\",\n \"Probability\": \"0.9478439093\",\n \"SemanticContext\": \"Leukopenia and Severe Thrombocytopenia : Monitor platelet and white blood cell counts.\"\n },\n {\n \"VerbatimTerm\": \"Thrombocytopenia\",\n \"Probability\": \"0.8742595911\",\n \"SemanticContext\": \"TABLE 1 *reported in at least 1% of patients Most Common Adverse Reactions in Patients with HT-1 Treated with Nitisinone* Elevated tyrosine levels Leukopenia Thrombocytopenia Conjunctivitis Corneal opacity Keratitis Photophobia Eye pain Blepharitis Cataracts Granulocytopenia Epistaxis Pruritus Exfoliative dermatitis Dry skin Maculopapular rash Alopecia >10% 3% 3% 2% 2% 2% 2% 1% 1% 1% 1% 1% 1% 1% 1% 1% 1% .\"\n },\n {\n \"VerbatimTerm\": \"Thrombocytopenia\",\n \"Probability\": \"0.8326134682\",\n \"SemanticContext\": \"5.2 Leukopenia and Severe Thrombocytopenia In clinical trials, patients treated with ORFADIN and dietary restriction developed transient leukopenia 3% , thrombocytopenia 3% , or both 1.5% [see Adverse Reactions 6.1 ] .\"\n },\n {\n \"VerbatimTerm\": \"thrombocytopenia\",\n \"Probability\": \"0.9986987114\",\n \"SemanticContext\": \"ADVERSE REACTIONS Most common adverse reactions >1% are elevated tyrosine levels, thrombocytopenia, leukopenia, conjunctivitis, corneal opacity, keratitis, photophobia, eye pain, blepharitis, cataracts, granulocytopenia, epistaxis, pruritus, exfoliative dermatitis, dry skin, maculopapular rash and alopecia.\"\n },\n {\n \"VerbatimTerm\": \"thrombocytopenia\",\n \"Probability\": \"0.9991803169\",\n \"SemanticContext\": \"The most serious adverse reactions reported during ORFADIN treatment were thrombocytopenia, leukopenia, porphyria, and ocular/visual complaints associated with elevated tyrosine levels [see Warnings and Precautions 5.1 , 5.2 ] .\"\n },\n {\n \"VerbatimTerm\": \"thrombocytopenia\",\n \"Probability\": \"0.957967639\",\n \"SemanticContext\": \"Six patients had thrombocytopenia, three of which had platelet counts 30,000/microL or lower.\"\n },\n {\n \"VerbatimTerm\": \"thrombocytopenia\",\n \"Probability\": \"0.0308576524\",\n \"SemanticContext\": \"In 4 patients with thrombocytopenia, platelet counts gradually returned to normal duration up to 47 days without change in ORFADIN dose.\"\n },\n {\n \"VerbatimTerm\": \"thrombocytopenia\",\n \"Probability\": \"0.5318838954\",\n \"SemanticContext\": \"No patients developed infections or bleeding as a result of the episodes of leukopenia and thrombocytopenia.\"\n },\n {\n \"VerbatimTerm\": \"thrombocytopenia\",\n \"Probability\": \"0.9998414516\",\n \"SemanticContext\": \"5.2 Leukopenia and Severe Thrombocytopenia In clinical trials, patients treated with ORFADIN and dietary restriction developed transient leukopenia 3% , thrombocytopenia 3% , or both 1.5% [see Adverse Reactions 6.1 ] .\"\n },\n {\n \"VerbatimTerm\": \"thrombocytopenia\",\n \"Probability\": \"0.9889774323\",\n \"SemanticContext\": \"No patients developed infections or bleeding as a result of the episodes of leukopenia and thrombocytopenia.\"\n }\n ]\n },\n {\n \"Term\": \"Ulcerative keratitis\",\n \"MEDDRACode\": \"10064996\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"corneal ulcers\",\n \"Probability\": \"0.8502650857\",\n \"SemanticContext\": \"Maintain plasma tyrosine levels below 500 micromol/L. Inadequate restriction of tyrosine and phenylalanine intake can lead to elevations in plasma tyrosine levels and levels greater than 500 micromol/L may lead to the following: Ocular signs and symptoms including corneal ulcers, corneal opacities, keratitis, conjunctivitis, eye pain, and photophobia have been reported in patients treated with ORFADIN [see Adverse Reactions 6.1 ] .\"\n }\n ]\n },\n {\n \"Term\": \"Caregiver\",\n \"MEDDRACode\": \"10007664\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"caregivers\",\n \"Probability\": \"6.1072E-06\",\n \"SemanticContext\": \"Advise patients and caregivers of the need to maintain dietary restriction of tyrosine and phenylalanine and to report any unexplained ocular, neurologic, or other symptoms promptly to their healthcare provider [see Warnings and Precautions 5.1 ].\"\n }\n ]\n },\n {\n \"Term\": \"Ocular toxicity\",\n \"MEDDRACode\": \"10061137\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": true,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"ocular toxicity\",\n \"Probability\": \"0.0252822936\",\n \"SemanticContext\": \"Data suggest that nitisinone is present in rat milk due to findings of ocular toxicity and lower body weight seen in drug naive nursing rat pups.\"\n }\n ]\n },\n {\n \"Term\": \"Orphan\",\n \"MEDDRACode\": \"10031120\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Orphan\",\n \"Probability\": \"0.0002202988\",\n \"SemanticContext\": \"To report SUSPECTED ADVERSE REACTIONS, contact Swedish Orphan Biovitrum at 1-866-773-5274 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.\"\n }\n ]\n },\n {\n \"Term\": \"Pregnancy\",\n \"MEDDRACode\": \"10036556\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Pregnancy\",\n \"Probability\": \"0.0080613792\",\n \"SemanticContext\": \"8.1 Pregnancy Risk Summary Limited available data with nitisinone use in pregnant women are not sufficient to determine a drug-associated risk of adverse developmental outcomes.\"\n },\n {\n \"VerbatimTerm\": \"pregnancies\",\n \"Probability\": \"0.0507256091\",\n \"SemanticContext\": \"In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.\"\n }\n ]\n },\n {\n \"Term\": \"Inflammation\",\n \"MEDDRACode\": \"10061218\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"inflammation\",\n \"Probability\": \"0.0001537502\",\n \"SemanticContext\": \"Patients who develop photophobia, eye pain, or signs of inflammation such as redness, swelling, or burning of the eyes or tyrosine levels are > 500 micromol/L during treatment with ORFADIN should undergo slit-lamp reexamination and immediate measurement of the plasma tyrosine concentration.\"\n }\n ]\n },\n {\n \"Term\": \"Intellectual disability\",\n \"MEDDRACode\": \"10067989\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"intellectual disability\",\n \"Probability\": \"0.0347716808\",\n \"SemanticContext\": \"WARNINGS AND PRECAUTIONS Elevated Plasma Tyrosine Levels, Ocular Symptoms, Developmental Delay and Hyperkeratotic Plaques : Inadequate restriction of tyrosine and phenylalanine intake can lead to elevations in plasma tyrosine, which at levels above 500 micromol/L can result in symptoms, intellectual disability and developmental delay or painful hyperkeratotic plaques on the soles and palms; do not adjust ORFADIN dosage in order to lower the plasma tyrosine concentration.\"\n },\n {\n \"VerbatimTerm\": \"intellectual disability\",\n \"Probability\": \"0.0783258975\",\n \"SemanticContext\": \"Elevated Plasma Tyrosine Levels, Ocular Symptoms, Developmental Delay and Hyperkeratotic Plaques Inform patients that inadequate restriction may be associated with ocular signs and symptoms, intellectual disability and developmental delay, and painful hyperkeratotic plaques on the soles and palms.\"\n },\n {\n \"VerbatimTerm\": \"intellectual disability\",\n \"Probability\": \"0.0340760648\",\n \"SemanticContext\": \"Variable degrees of intellectual disability and developmental delay.\"\n }\n ]\n },\n {\n \"Term\": \"White blood cell count\",\n \"MEDDRACode\": \"10047939\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"white blood cell counts\",\n \"Probability\": \"0.0055644512\",\n \"SemanticContext\": \"Leukopenia and Severe Thrombocytopenia : Monitor platelet and white blood cell counts.\"\n },\n {\n \"VerbatimTerm\": \"white blood cell counts\",\n \"Probability\": \"0.0090078115\",\n \"SemanticContext\": \"Monitor platelet and white blood cell counts during ORFADIN therapy.\"\n }\n ]\n },\n {\n \"Term\": \"Lymphoma\",\n \"MEDDRACode\": \"10025310\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"lymphoma\",\n \"Probability\": \"0.0030130744\",\n \"SemanticContext\": \"Nitisinone was mutagenic in the mouse lymphoma cell L5178Y/TK +/- forward mutation test and in an in vivo mouse bone marrow micronucleus test.\"\n }\n ]\n },\n {\n \"Term\": \"Conjunctivitis\",\n \"MEDDRACode\": \"10010741\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"conjunctivitis\",\n \"Probability\": \"0.9998996258\",\n \"SemanticContext\": \"ADVERSE REACTIONS Most common adverse reactions >1% are elevated tyrosine levels, thrombocytopenia, leukopenia, conjunctivitis, corneal opacity, keratitis, photophobia, eye pain, blepharitis, cataracts, granulocytopenia, epistaxis, pruritus, exfoliative dermatitis, dry skin, maculopapular rash and alopecia.\"\n },\n {\n \"VerbatimTerm\": \"conjunctivitis\",\n \"Probability\": \"0.4542601109\",\n \"SemanticContext\": \"Maintain plasma tyrosine levels below 500 micromol/L. Inadequate restriction of tyrosine and phenylalanine intake can lead to elevations in plasma tyrosine levels and levels greater than 500 micromol/L may lead to the following: Ocular signs and symptoms including corneal ulcers, corneal opacities, keratitis, conjunctivitis, eye pain, and photophobia have been reported in patients treated with ORFADIN [see Adverse Reactions 6.1 ] .\"\n },\n {\n \"VerbatimTerm\": \"Conjunctivitis\",\n \"Probability\": \"0.9833356142\",\n \"SemanticContext\": \"TABLE 1 *reported in at least 1% of patients Most Common Adverse Reactions in Patients with HT-1 Treated with Nitisinone* Elevated tyrosine levels Leukopenia Thrombocytopenia Conjunctivitis Corneal opacity Keratitis Photophobia Eye pain Blepharitis Cataracts Granulocytopenia Epistaxis Pruritus Exfoliative dermatitis Dry skin Maculopapular rash Alopecia >10% 3% 3% 2% 2% 2% 2% 1% 1% 1% 1% 1% 1% 1% 1% 1% 1% .\"\n }\n ]\n },\n {\n \"Term\": \"Keratitis\",\n \"MEDDRACode\": \"10023332\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"keratitis\",\n \"Probability\": \"0.9960250854\",\n \"SemanticContext\": \"ADVERSE REACTIONS Most common adverse reactions >1% are elevated tyrosine levels, thrombocytopenia, leukopenia, conjunctivitis, corneal opacity, keratitis, photophobia, eye pain, blepharitis, cataracts, granulocytopenia, epistaxis, pruritus, exfoliative dermatitis, dry skin, maculopapular rash and alopecia.\"\n },\n {\n \"VerbatimTerm\": \"keratitis\",\n \"Probability\": \"0.3952653408\",\n \"SemanticContext\": \"Maintain plasma tyrosine levels below 500 micromol/L. Inadequate restriction of tyrosine and phenylalanine intake can lead to elevations in plasma tyrosine levels and levels greater than 500 micromol/L may lead to the following: Ocular signs and symptoms including corneal ulcers, corneal opacities, keratitis, conjunctivitis, eye pain, and photophobia have been reported in patients treated with ORFADIN [see Adverse Reactions 6.1 ] .\"\n },\n {\n \"VerbatimTerm\": \"Keratitis\",\n \"Probability\": \"0.8308622241\",\n \"SemanticContext\": \"TABLE 1 *reported in at least 1% of patients Most Common Adverse Reactions in Patients with HT-1 Treated with Nitisinone* Elevated tyrosine levels Leukopenia Thrombocytopenia Conjunctivitis Corneal opacity Keratitis Photophobia Eye pain Blepharitis Cataracts Granulocytopenia Epistaxis Pruritus Exfoliative dermatitis Dry skin Maculopapular rash Alopecia >10% 3% 3% 2% 2% 2% 2% 1% 1% 1% 1% 1% 1% 1% 1% 1% 1% .\"\n }\n ]\n },\n {\n \"Term\": \"Congenital anomaly\",\n \"MEDDRACode\": \"10010356\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"birth defects\",\n \"Probability\": \"0.114944756\",\n \"SemanticContext\": \"The background risk of major birth defects and miscarriage for the indicated population are unknown.\"\n },\n {\n \"VerbatimTerm\": \"birth defects\",\n \"Probability\": \"0.0714996159\",\n \"SemanticContext\": \"In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.\"\n }\n ]\n },\n {\n \"Term\": \"Erythema\",\n \"MEDDRACode\": \"10015150\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"redness\",\n \"Probability\": \"0.0009494126\",\n \"SemanticContext\": \"Patients who develop photophobia, eye pain, or signs of inflammation such as redness, swelling, or burning of the eyes or tyrosine levels are > 500 micromol/L during treatment with ORFADIN should undergo slit-lamp reexamination and immediate measurement of the plasma tyrosine concentration.\"\n }\n ]\n },\n {\n \"Term\": \"Succinylacetone\",\n \"MEDDRACode\": \"10069456\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"succinylacetone\",\n \"Probability\": \"7.11323E-05\",\n \"SemanticContext\": \"In patients 5 years of age and older who have undetectable serum and urine succinylacetone concentrations after a minimum of 4 weeks on a stable dosage of nitisinone, the total daily dose may be given once daily.\"\n },\n {\n \"VerbatimTerm\": \"succinylacetone\",\n \"Probability\": \"0.0037440956\",\n \"SemanticContext\": \"ORFADIN was studied in one open-label, uncontrolled study of 207 patients with HT-1, ages 0 to 22 years at enrollment median age 9 months , who were diagnosed with HT-1 by the presence of succinylacetone in the urine or plasma.\"\n },\n {\n \"VerbatimTerm\": \"succinylacetone\",\n \"Probability\": \"0.0440132916\",\n \"SemanticContext\": \"In patients with HT-1, these catabolic intermediates are converted to the toxic metabolites succinylacetone and succinylacetoacetate, which are responsible for the observed liver and kidney toxicity.\"\n },\n {\n \"VerbatimTerm\": \"succinylacetone\",\n \"Probability\": \"0.0031031072\",\n \"SemanticContext\": \"12.2 Pharmacodynamics In a clinical study, patients with HT-1 were diagnosed by the presence of succinylacetone in urine or plasma and treated with ORFADIN [see Clinical Studies 14 ] .\"\n },\n {\n \"VerbatimTerm\": \"succinylacetone\",\n \"Probability\": \"0.0052025318\",\n \"SemanticContext\": \"In all 186 patients whose urine succinylacetone was measured, the urinary succinylacetone concentration decreased to less than 1 mmol/mol creatinine, the lower limit of quantitation.\"\n },\n {\n \"VerbatimTerm\": \"succinylacetone\",\n \"Probability\": \"0.0007870793\",\n \"SemanticContext\": \"In all 186 patients whose urine succinylacetone was measured, the urinary succinylacetone concentration decreased to less than 1 mmol/mol creatinine, the lower limit of quantitation.\"\n },\n {\n \"VerbatimTerm\": \"succinylacetone\",\n \"Probability\": \"0.0037432015\",\n \"SemanticContext\": \"The median time to normalization of urine succinylacetone was 0.3 months.\"\n },\n {\n \"VerbatimTerm\": \"succinylacetone\",\n \"Probability\": \"0.004845202\",\n \"SemanticContext\": \"The probability of recurrence of abnormal values of urine succinylacetone was 1% at a nitisinone concentration of 37 micromol/L 95% confidence interval: 23, 51 micromol/L .\"\n },\n {\n \"VerbatimTerm\": \"succinylacetone\",\n \"Probability\": \"0.0041420758\",\n \"SemanticContext\": \"In 87% 150/172 of patients whose plasma succinylacetone was measured, the plasma succinylacetone concentration decreased to less than 0.1 micromol/L, the lower limit of quantitation.\"\n },\n {\n \"VerbatimTerm\": \"succinylacetone\",\n \"Probability\": \"0.0002055466\",\n \"SemanticContext\": \"In 87% 150/172 of patients whose plasma succinylacetone was measured, the plasma succinylacetone concentration decreased to less than 0.1 micromol/L, the lower limit of quantitation.\"\n },\n {\n \"VerbatimTerm\": \"succinylacetone\",\n \"Probability\": \"0.0011715889\",\n \"SemanticContext\": \"The median time to normalization of plasma succinylacetone was 3.9 months.\"\n },\n {\n \"VerbatimTerm\": \"succinylacetone\",\n \"Probability\": \"0.0273558497\",\n \"SemanticContext\": \"In another study, comparing two dosing regimens, succinylacetone was measured in urine and/or blood in 16 patients with HT-1 aged 5 years to 24 years.\"\n },\n {\n \"VerbatimTerm\": \"succinylacetone\",\n \"Probability\": \"0.0001654029\",\n \"SemanticContext\": \"After at least 4 weeks of twice daily dosing with ORFADIN, both the urine and/or blood succinylacetone concentrations were below the limit of quantitation for the assay.\"\n },\n {\n \"VerbatimTerm\": \"succinylacetone\",\n \"Probability\": \"0.0001511276\",\n \"SemanticContext\": \"Patients were then switched to once daily dosing with the same total daily dosage of ORFADIN and blood and/or urine succinylacetone concentrations remained undetectable when measured following at least 4 weeks of treatment with once daily dosing.\"\n },\n {\n \"VerbatimTerm\": \"succinylacetone\",\n \"Probability\": \"0.0019976795\",\n \"SemanticContext\": \"Patients were diagnosed with HT-1 by the presence of succinylacetone in the urine or plasma.\"\n },\n {\n \"VerbatimTerm\": \"succinylacetone\",\n \"Probability\": \"0.0025373399\",\n \"SemanticContext\": \"All patients were treated with ORFADIN at a starting dose of 0.3 to 0.5 mg/kg twice daily, and the dose was increased in some patients to 1 mg/kg twice daily based on weight, liver and kidney function tests, platelet count, serum amino acids, urinary phenolic acid, plasma and urine succinylacetone, erythrocyte PBG-synthase, and urine 5-ALA..\"\n },\n {\n \"VerbatimTerm\": \"succinylacetone\",\n \"Probability\": \"5.2801E-05\",\n \"SemanticContext\": \"The effects of nitisinone on urine and plasma succinylacetone, porphyrin metabolism, and urinary alpha-1-microglobulin were also assessed in this clinical study.\"\n },\n {\n \"VerbatimTerm\": \"succinylacetone\",\n \"Probability\": \"4.7873E-05\",\n \"SemanticContext\": \"2 DOSAGE AND ADMINISTRATION 2.1 Dosage Starting Dosage The recommended starting dosage of ORFADIN is 0.5 mg/kg administered orally twice daily Maintenance Regimen In patients 5 years of age and older who have undetectable serum and urine succinylacetone concentrations after a minimum of 4 weeks on a stable dosage of nitisinone, the total daily dose of ORFADIN may be given once daily e.g., 1 to 2 mg/kg once daily [see Clinical Pharmacology 12.2 ] .\"\n },\n {\n \"VerbatimTerm\": \"succinylacetone\",\n \"Probability\": \"3.82128E-05\",\n \"SemanticContext\": \"Monitor plasma and/or urine succinylacetone concentrations, liver function parameters and alpha-fetoprotein levels.\"\n },\n {\n \"VerbatimTerm\": \"succinylacetone\",\n \"Probability\": \"0.000112591\",\n \"SemanticContext\": \"If succinylacetone is still detectable in blood or urine 4 weeks after the start of nitisinone treatment, increase the nitisinone dosage to 0.75 mg/kg twice daily.\"\n },\n {\n \"VerbatimTerm\": \"succinylacetone\",\n \"Probability\": \"1.38249E-05\",\n \"SemanticContext\": \"If the biochemical response is satisfactory undetectable blood and/or urine succinylacetone , the dosage should be adjusted only according to body weight gain and not according to plasma tyrosine levels.\"\n },\n {\n \"VerbatimTerm\": \"succinylacetone\",\n \"Probability\": \"0.001109153\",\n \"SemanticContext\": \"During initiation of therapy, when switching from twice daily to once daily dosing, or if there is a deterioration in the patient's condition, it may be necessary to follow all available biochemical parameters more closely i.e. plasma and/or urine succinylacetone, urine 5-aminolevulinate ALA and erythrocyte porphobilinogen PBG -synthase activity .\"\n },\n {\n \"VerbatimTerm\": \"Succinylacetone\",\n \"Probability\": \"0.0578671098\",\n \"SemanticContext\": \"Succinylacetone can also inhibit the porphyrin synthesis pathway leading to the accumulation of 5-aminolevulinate, a neurotoxin responsible for the porphyric crises characteristic of HT-1.\"\n }\n ]\n },\n {\n \"Term\": \"Accidental exposure to product\",\n \"MEDDRACode\": \"10073317\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Accidental ingestion\",\n \"Probability\": \"0.0006572902\",\n \"SemanticContext\": \"10 OVERDOSAGE Accidental ingestion of ORFADIN by individuals eating normal diets not restricted in tyrosine and phenylalanine will result in elevated tyrosine levels.\"\n }\n ]\n },\n {\n \"Term\": \"Enteral nutrition\",\n \"MEDDRACode\": \"10052591\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"gavage\",\n \"Probability\": \"4.0678E-06\",\n \"SemanticContext\": \"13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility The carcinogenic potential of nitisinone was assessed in a 26-week oral gavage carcinogenicity study in Tg.rasH2 mice.\"\n }\n ]\n },\n {\n \"Term\": \"Breast feeding\",\n \"MEDDRACode\": \"10006247\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": true,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"breastfed\",\n \"Probability\": \"0.0002129078\",\n \"SemanticContext\": \"8.2 Lactation Risk Summary There are no data on the presence of nitisinone in human milk, the effects on the breastfed infant, or the effects on milk production.\"\n },\n {\n \"VerbatimTerm\": \"breastfed\",\n \"Probability\": \"6.09255E-05\",\n \"SemanticContext\": \"The development and health benefits of breastfeeding should be considered along with the mother's clinical need for ORFADIN and any potential adverse effects on the breastfed infant from ORFADIN or from the underlying maternal condition.\"\n },\n {\n \"VerbatimTerm\": \"breastfeeding\",\n \"Probability\": \"4.39781E-05\",\n \"SemanticContext\": \"The development and health benefits of breastfeeding should be considered along with the mother's clinical need for ORFADIN and any potential adverse effects on the breastfed infant from ORFADIN or from the underlying maternal condition.\"\n }\n ]\n },\n {\n \"Term\": \"Infection\",\n \"MEDDRACode\": \"10021789\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"infections\",\n \"Probability\": \"0.2515147328\",\n \"SemanticContext\": \"No patients developed infections or bleeding as a result of the episodes of leukopenia and thrombocytopenia.\"\n },\n {\n \"VerbatimTerm\": \"infections\",\n \"Probability\": \"0.4437446594\",\n \"SemanticContext\": \"No patients developed infections or bleeding as a result of the episodes of leukopenia and thrombocytopenia.\"\n }\n ]\n },\n {\n \"Term\": \"Syringomyelia\",\n \"MEDDRACode\": \"10042928\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0001253486\",\n \"SemanticContext\": \"2.2 Preparation and Administration Instructions Preparation of the Oral Suspension The oral suspension will be dispensed with an oral syringe of appropriate size and a bottle adaptor provided by a pharmacist or other healthcare provider.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"1.90638E-05\",\n \"SemanticContext\": \"Measuring and Administering the Dose Once the bottle is prepared with the adapter: Use the oral syringe to measure the dose.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"8.30263E-05\",\n \"SemanticContext\": \"Keep the bottle upright and insert the oral syringe into the adapter.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0006102324\",\n \"SemanticContext\": \"Carefully turn the bottle upside down with the oral syringe in place.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0028539896\",\n \"SemanticContext\": \"Pull back on the syringe plunger to withdraw the dose.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0005148649\",\n \"SemanticContext\": \"Leave the syringe in the adapter and turn the bottle upright.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0001553297\",\n \"SemanticContext\": \"Remove the syringe from the adapter by gently twisting it out of the bottle.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0001311004\",\n \"SemanticContext\": \"Preparation and Administration Instructions [see Dosage and Administration 2.2 ] Preparation of the Oral Suspension The oral suspension will be dispensed with an oral syringe of appropriate size and a bottle adaptor provided by a pharmacist or other healthcare provider.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"1.90638E-05\",\n \"SemanticContext\": \"Measuring and Administering the Dose Once the bottle is prepared with the adapter: Use the oral syringe to measure the dose.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"8.30263E-05\",\n \"SemanticContext\": \"Keep the bottle upright and insert the oral syringe into the adapter.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0006102324\",\n \"SemanticContext\": \"Carefully turn the bottle upside down with the oral syringe in place.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0028539896\",\n \"SemanticContext\": \"Pull back on the syringe plunger to withdraw the dose.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0005148649\",\n \"SemanticContext\": \"Leave the syringe in the adapter and turn the bottle upright.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0001553297\",\n \"SemanticContext\": \"Remove the syringe from the adapter by gently twisting it out of the bottle.\"\n }\n ]\n },\n {\n \"Term\": \"Developmental delay\",\n \"MEDDRACode\": \"10012559\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"developmental delay\",\n \"Probability\": \"0.0149621367\",\n \"SemanticContext\": \"WARNINGS AND PRECAUTIONS Elevated Plasma Tyrosine Levels, Ocular Symptoms, Developmental Delay and Hyperkeratotic Plaques : Inadequate restriction of tyrosine and phenylalanine intake can lead to elevations in plasma tyrosine, which at levels above 500 micromol/L can result in symptoms, intellectual disability and developmental delay or painful hyperkeratotic plaques on the soles and palms; do not adjust ORFADIN dosage in order to lower the plasma tyrosine concentration.\"\n },\n {\n \"VerbatimTerm\": \"developmental delay\",\n \"Probability\": \"0.1440420449\",\n \"SemanticContext\": \"Elevated Plasma Tyrosine Levels, Ocular Symptoms, Developmental Delay and Hyperkeratotic Plaques Inform patients that inadequate restriction may be associated with ocular signs and symptoms, intellectual disability and developmental delay, and painful hyperkeratotic plaques on the soles and palms.\"\n },\n {\n \"VerbatimTerm\": \"developmental delay\",\n \"Probability\": \"0.0457898378\",\n \"SemanticContext\": \"Variable degrees of intellectual disability and developmental delay.\"\n },\n {\n \"VerbatimTerm\": \"Developmental Delay\",\n \"Probability\": \"0.1722911298\",\n \"SemanticContext\": \"WARNINGS AND PRECAUTIONS Elevated Plasma Tyrosine Levels, Ocular Symptoms, Developmental Delay and Hyperkeratotic Plaques : Inadequate restriction of tyrosine and phenylalanine intake can lead to elevations in plasma tyrosine, which at levels above 500 micromol/L can result in symptoms, intellectual disability and developmental delay or painful hyperkeratotic plaques on the soles and palms; do not adjust ORFADIN dosage in order to lower the plasma tyrosine concentration.\"\n },\n {\n \"VerbatimTerm\": \"Developmental Delay\",\n \"Probability\": \"0.0108775198\",\n \"SemanticContext\": \"Elevated Plasma Tyrosine Levels, Ocular Symptoms, Developmental Delay and Hyperkeratotic Plaques Inform patients that inadequate restriction may be associated with ocular signs and symptoms, intellectual disability and developmental delay, and painful hyperkeratotic plaques on the soles and palms.\"\n },\n {\n \"VerbatimTerm\": \"Developmental Delay\",\n \"Probability\": \"0.0481026173\",\n \"SemanticContext\": \"5 WARNINGS AND PRECAUTIONS 5.1 Elevated Plasma Tyrosine Levels, Ocular Symptoms, Developmental Delay and Hyperkeratotic Plaques Nitisinone is an inhibitor of 4-hydroxyphenyl-pyruvate dioxygenase, an enzyme in the tyrosine metabolic pathway [see Clinical Pharmacology 12.1 ] .\"\n }\n ]\n }\n ],\n \"IndicationTerms\": []\n }\n ]\n },\n {\n \"GenericName\": \"cattle epithelium\",\n \"MeddraVersion\": \"24.0\",\n \"Labels\": [\n {\n \"Id\": \"US8f2b01b8-e712-4107-b824-e1f07faa2a41\",\n \"NDCCode\": \"36987-1003\",\n \"UpdatedDate\": \"Jun 18, 2012\",\n \"LabelSource\": {\n \"Country\": \"us\",\n \"ProductId\": \"001dcaf3-5838-4fb0-a4b8-d65ae2eb009e\",\n \"FileId\": \"8f2b01b8-e712-4107-b824-e1f07faa2a41\",\n \"Version\": \"1\"\n },\n \"AdverseEventTerms\": [\n {\n \"Term\": \"Abdominal pain\",\n \"MEDDRACode\": \"10000081\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"abdominal cramps\",\n \"Probability\": \"0.997418642\",\n \"SemanticContext\": \"Less commonly, nausea, emesis, abdominal cramps, diarrhea and uterine contractions may occur.\"\n }\n ]\n },\n {\n \"Term\": \"Diarrhoea\",\n \"MEDDRACode\": \"10012735\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"diarrhea\",\n \"Probability\": \"0.91641891\",\n \"SemanticContext\": \"Less commonly, nausea, emesis, abdominal cramps, diarrhea and uterine contractions may occur.\"\n }\n ]\n },\n {\n \"Term\": \"Cough\",\n \"MEDDRACode\": \"10011224\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"coughing\",\n \"Probability\": \"0.9987183809\",\n \"SemanticContext\": \"ADVERSE REACTIONS Adverse systemic reactions usually occur within minutes and consist primarily of allergic symptoms such as: generalized skin erythema, urticaria, pruritus, angioedema, rhinitis, wheezing, laryngeal edema, itching of nose and throat, breathlessness, dyspnea, coughing, hypotension and marked perspiration.\"\n }\n ]\n },\n {\n \"Term\": \"Angioedema\",\n \"MEDDRACode\": \"10002424\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"angioedema\",\n \"Probability\": \"0.9980547428\",\n \"SemanticContext\": \"ADVERSE REACTIONS Adverse systemic reactions usually occur within minutes and consist primarily of allergic symptoms such as: generalized skin erythema, urticaria, pruritus, angioedema, rhinitis, wheezing, laryngeal edema, itching of nose and throat, breathlessness, dyspnea, coughing, hypotension and marked perspiration.\"\n }\n ]\n },\n {\n \"Term\": \"Hypersensitivity\",\n \"MEDDRACode\": \"10020751\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Allergy\",\n \"Probability\": \"0.0871276557\",\n \"SemanticContext\": \"Standardized extracts are designated in Bioequivalent Allergy Units BAU or Allergy Units AU .\"\n },\n {\n \"VerbatimTerm\": \"Allergy\",\n \"Probability\": \"0.1738342047\",\n \"SemanticContext\": \"Standardized extracts are designated in Bioequivalent Allergy Units BAU or Allergy Units AU .\"\n },\n {\n \"VerbatimTerm\": \"allergy\",\n \"Probability\": \"0.0016205737\",\n \"SemanticContext\": \"INDICATIONS AND USAGE Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity.\"\n }\n ]\n },\n {\n \"Term\": \"Dyspnoea\",\n \"MEDDRACode\": \"10013968\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"breathlessness\",\n \"Probability\": \"0.9983370304\",\n \"SemanticContext\": \"ADVERSE REACTIONS Adverse systemic reactions usually occur within minutes and consist primarily of allergic symptoms such as: generalized skin erythema, urticaria, pruritus, angioedema, rhinitis, wheezing, laryngeal edema, itching of nose and throat, breathlessness, dyspnea, coughing, hypotension and marked perspiration.\"\n }\n ]\n },\n {\n \"Term\": \"Nasopharyngitis\",\n \"MEDDRACode\": \"10028810\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"cold\",\n \"Probability\": \"0.0250076037\",\n \"SemanticContext\": \"Local cold applications and oral antihistamines may be effective treatment.\"\n }\n ]\n },\n {\n \"Term\": \"Vomiting\",\n \"MEDDRACode\": \"10047700\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"emesis\",\n \"Probability\": \"0.9997094274\",\n \"SemanticContext\": \"Less commonly, nausea, emesis, abdominal cramps, diarrhea and uterine contractions may occur.\"\n }\n ]\n },\n {\n \"Term\": \"Injection\",\n \"MEDDRACode\": \"10052995\",\n \"Overdose\": true,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"injection\",\n \"Probability\": \"0.0564363822\",\n \"SemanticContext\": \"See Overdose section Local Reactions consisting of erythema, itching, swelling tenderness and sometimes pain may occur at the injection site.\"\n },\n {\n \"VerbatimTerm\": \"injection\",\n \"Probability\": \"0.0008574529\",\n \"SemanticContext\": \"6 REACTION SYMBOL CRITERIA Negative - No increase in size of bleb since injection.\"\n },\n {\n \"VerbatimTerm\": \"injection\",\n \"Probability\": \"0.0007896586\",\n \"SemanticContext\": \"Assess the patient's physical and emotional status prior to giving as injection.\"\n },\n {\n \"VerbatimTerm\": \"injection\",\n \"Probability\": \"0.0002599747\",\n \"SemanticContext\": \"Dosage of allergenic extracts is a highly individualized matter and varies according to the degree of sensitivity of the patient, his clinical response and tolerance to the extract administered during the early phases of an injection regimen.\"\n },\n {\n \"VerbatimTerm\": \"injection\",\n \"Probability\": \"0.0020262636\",\n \"SemanticContext\": \"The amount of allergenic extract is increased at each injection by not more than 50%-100% of the previous amount and the next increment is governed by the response to the last injection.\"\n },\n {\n \"VerbatimTerm\": \"injection\",\n \"Probability\": \"0.0227029622\",\n \"SemanticContext\": \"The amount of allergenic extract is increased at each injection by not more than 50%-100% of the previous amount and the next increment is governed by the response to the last injection.\"\n },\n {\n \"VerbatimTerm\": \"injection\",\n \"Probability\": \"0.0034703906\",\n \"SemanticContext\": \"A period of two or three years of injection therapy constitutes an average minimum course of treatment.\"\n },\n {\n \"VerbatimTerm\": \"injection\",\n \"Probability\": \"5.19149E-05\",\n \"SemanticContext\": \"An overdose may be prevented by careful observation and questioning of the patient about the previous injection.\"\n },\n {\n \"VerbatimTerm\": \"injection\",\n \"Probability\": \"0.0001184208\",\n \"SemanticContext\": \"If systemic or anaphylactic reaction, does occur, apply a tourniquet above the site of injection and inject intramuscularly or subcutaneously 0.3 to 0.5ml of 1:1000 Epinephrine Hydrochloride into the opposite arm.\"\n },\n {\n \"VerbatimTerm\": \"injection\",\n \"Probability\": \"0.0012606088\",\n \"SemanticContext\": \"4 See Adverse Reactions An allergenic extract should be temporarily withheld from patients or the dose of the extract adjusted downward if any of the following conditions exist: 1 Severe symptoms of rhinitis and/or asthma 2 Infections or flu accompanied by fever and 3 Exposure to excessive amounts of clinically relevant allergen prior to a scheduled injection.\"\n },\n {\n \"VerbatimTerm\": \"injection\",\n \"Probability\": \"8.30978E-05\",\n \"SemanticContext\": \"For safe and effective use of allergenic extracts, sterile diluents, sterile vials, sterile syringes should be used and aseptic precautions observed when making a dilution and/or administering the allergenic extract injection.\"\n },\n {\n \"VerbatimTerm\": \"injection\",\n \"Probability\": \"0.0046193842\",\n \"SemanticContext\": \"Epinephrine injection inhibits the immediate skin test reactions for several hours.\"\n },\n {\n \"VerbatimTerm\": \"injections\",\n \"Probability\": \"4.7088E-06\",\n \"SemanticContext\": \"Allergenic extracts are administered subcutaneously for immunotherapy injections.\"\n },\n {\n \"VerbatimTerm\": \"injections\",\n \"Probability\": \"2.43221E-05\",\n \"SemanticContext\": \"Do not give injections to patients who are in acute distress.\"\n },\n {\n \"VerbatimTerm\": \"injections\",\n \"Probability\": \"0.0006443706\",\n \"SemanticContext\": \"After therapeutic injections patients should be observed for at least 20 minutes for reaction symptoms.\"\n },\n {\n \"VerbatimTerm\": \"injections\",\n \"Probability\": \"0.0001037807\",\n \"SemanticContext\": \"This is followed by an intensive schedule of therapy i.e. injections given 2 to 3 times per week .\"\n },\n {\n \"VerbatimTerm\": \"injections\",\n \"Probability\": \"0.0003167517\",\n \"SemanticContext\": \"The allergen is administered twice weekly or weekly for about 20 injections to achieve the maximum tolerated dose.\"\n },\n {\n \"VerbatimTerm\": \"injections\",\n \"Probability\": \"1.12745E-05\",\n \"SemanticContext\": \"Allergenic Extracts are not intended for intravenous injections.\"\n },\n {\n \"VerbatimTerm\": \"injections\",\n \"Probability\": \"7.10655E-05\",\n \"SemanticContext\": \"Patients should be instructed to remain in the office for 30 minutes during testing using allergenic extracts and at least 30 minutes after therapeutic injections using allergenic extracts.\"\n },\n {\n \"VerbatimTerm\": \"Injections\",\n \"Probability\": \"0.0119986758\",\n \"SemanticContext\": \"Injections discontinued during and following season until next year.\"\n }\n ]\n },\n {\n \"Term\": \"Overdose\",\n \"MEDDRACode\": \"10033295\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Overdose\",\n \"Probability\": \"0.3325219154\",\n \"SemanticContext\": \"See Overdose section Local Reactions consisting of erythema, itching, swelling tenderness and sometimes pain may occur at the injection site.\"\n },\n {\n \"VerbatimTerm\": \"Overdose\",\n \"Probability\": \"0.5323621631\",\n \"SemanticContext\": \"OVERDOSAGE Overdose can cause both local and systemic reactions.\"\n },\n {\n \"VerbatimTerm\": \"overdose\",\n \"Probability\": \"0.1312918663\",\n \"SemanticContext\": \"An overdose may be prevented by careful observation and questioning of the patient about the previous injection.\"\n }\n ]\n },\n {\n \"Term\": \"Laryngeal oedema\",\n \"MEDDRACode\": \"10023845\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"laryngeal edema\",\n \"Probability\": \"0.998510778\",\n \"SemanticContext\": \"ADVERSE REACTIONS Adverse systemic reactions usually occur within minutes and consist primarily of allergic symptoms such as: generalized skin erythema, urticaria, pruritus, angioedema, rhinitis, wheezing, laryngeal edema, itching of nose and throat, breathlessness, dyspnea, coughing, hypotension and marked perspiration.\"\n }\n ]\n },\n {\n \"Term\": \"Uterine contractions during pregnancy\",\n \"MEDDRACode\": \"10049975\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"uterine contractions\",\n \"Probability\": \"0.5294265151\",\n \"SemanticContext\": \"Less commonly, nausea, emesis, abdominal cramps, diarrhea and uterine contractions may occur.\"\n }\n ]\n },\n {\n \"Term\": \"Erythema\",\n \"MEDDRACode\": \"10015150\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"skin erythema\",\n \"Probability\": \"0.9703795314\",\n \"SemanticContext\": \"ADVERSE REACTIONS Adverse systemic reactions usually occur within minutes and consist primarily of allergic symptoms such as: generalized skin erythema, urticaria, pruritus, angioedema, rhinitis, wheezing, laryngeal edema, itching of nose and throat, breathlessness, dyspnea, coughing, hypotension and marked perspiration.\"\n }\n ]\n },\n {\n \"Term\": \"Oedema\",\n \"MEDDRACode\": \"10030095\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Edema\",\n \"Probability\": \"0.1452978551\",\n \"SemanticContext\": \"Edema, erythema and presence of pseudopods, pain and itching may be observed in 4 plus reactions.\"\n }\n ]\n },\n {\n \"Term\": \"Pain\",\n \"MEDDRACode\": \"10033371\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"pain\",\n \"Probability\": \"0.408577919\",\n \"SemanticContext\": \"See Overdose section Local Reactions consisting of erythema, itching, swelling tenderness and sometimes pain may occur at the injection site.\"\n },\n {\n \"VerbatimTerm\": \"pain\",\n \"Probability\": \"0.8186588883\",\n \"SemanticContext\": \"Four Plus ++++ A larger reaction with itching and pain.\"\n },\n {\n \"VerbatimTerm\": \"pain\",\n \"Probability\": \"0.1090065315\",\n \"SemanticContext\": \"Edema, erythema and presence of pseudopods, pain and itching may be observed in 4 plus reactions.\"\n },\n {\n \"VerbatimTerm\": \"pain\",\n \"Probability\": \"0.1107611135\",\n \"SemanticContext\": \"Three Plus +++ Wheal between 8mm and 12mm diameter with erythema and possible pseudopodia and itching or pain.\"\n },\n {\n \"VerbatimTerm\": \"pain\",\n \"Probability\": \"0.2130132914\",\n \"SemanticContext\": \"Four Plus ++++ Any larger reaction with itch and pain, and possible diffuse blush of the skin surrounding the reaction area.\"\n }\n ]\n },\n {\n \"Term\": \"Protein total\",\n \"MEDDRACode\": \"10050537\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"protein\",\n \"Probability\": \"7.67699E-05\",\n \"SemanticContext\": \"Allergenic Extracts are supplied as concentrations designated as protein nitrogen units PNU or weight/volume w/v ratio.\"\n }\n ]\n },\n {\n \"Term\": \"Skin reaction\",\n \"MEDDRACode\": \"10040914\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"skin reactions\",\n \"Probability\": \"0.0303393565\",\n \"SemanticContext\": \"Antihistamines may offer relief of recurrent urticaria, associated skin reactions and gastrointestinal symptoms.\"\n }\n ]\n },\n {\n \"Term\": \"Haemorrhage\",\n \"MEDDRACode\": \"10055798\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": true,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"bleeding\",\n \"Probability\": \"0.0002716468\",\n \"SemanticContext\": \"CONTRAINDICATIONS Allergenic extracts should not be used if the patient has asthma, cardiovascular disease, emphysema, diabetes, bleeding diathesis or pregnancy, unless a specific diagnosis of type 1 allergic disease is made based on skin testing and the benefits of treatment outweigh the risks of an adverse reaction during testing or treatment.\"\n }\n ]\n },\n {\n \"Term\": \"Pregnancy\",\n \"MEDDRACode\": \"10036556\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": true,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"pregnant\",\n \"Probability\": \"0.0002960048\",\n \"SemanticContext\": \"It is not known whether allergenic extracts can cause fetal harm when administered to pregnant women or can affect reproduction capacity.\"\n },\n {\n \"VerbatimTerm\": \"pregnant\",\n \"Probability\": \"4.28656E-05\",\n \"SemanticContext\": \"Allergenic extracts should be given to pregnant women only if clearly needed.\"\n }\n ]\n },\n {\n \"Term\": \"Anaphylactic reaction\",\n \"MEDDRACode\": \"10002198\",\n \"Overdose\": true,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"anaphylactic reaction\",\n \"Probability\": \"0.0178496912\",\n \"SemanticContext\": \"If systemic or anaphylactic reaction, does occur, apply a tourniquet above the site of injection and inject intramuscularly or subcutaneously 0.3 to 0.5ml of 1:1000 Epinephrine Hydrochloride into the opposite arm.\"\n },\n {\n \"VerbatimTerm\": \"anaphylactic reactions\",\n \"Probability\": \"0.6984348893\",\n \"SemanticContext\": \"Sensitive patients may experience severe anaphylactic reactions resulting in respiratory obstruction, shock, coma and /or death.\"\n }\n ]\n },\n {\n \"Term\": \"Local reaction\",\n \"MEDDRACode\": \"10024769\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Local Reactions\",\n \"Probability\": \"0.2527912855\",\n \"SemanticContext\": \"See Overdose section Local Reactions consisting of erythema, itching, swelling tenderness and sometimes pain may occur at the injection site.\"\n },\n {\n \"VerbatimTerm\": \"local reactions\",\n \"Probability\": \"0.0001990043\",\n \"SemanticContext\": \"For marked and prolonged local reactions the use of antihistamines or anti-inflammatory medications may be dictated.\"\n }\n ]\n },\n {\n \"Term\": \"Rhinitis\",\n \"MEDDRACode\": \"10039083\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"rhinitis\",\n \"Probability\": \"0.9971750975\",\n \"SemanticContext\": \"ADVERSE REACTIONS Adverse systemic reactions usually occur within minutes and consist primarily of allergic symptoms such as: generalized skin erythema, urticaria, pruritus, angioedema, rhinitis, wheezing, laryngeal edema, itching of nose and throat, breathlessness, dyspnea, coughing, hypotension and marked perspiration.\"\n },\n {\n \"VerbatimTerm\": \"rhinitis\",\n \"Probability\": \"0.0019544591\",\n \"SemanticContext\": \"4 See Adverse Reactions An allergenic extract should be temporarily withheld from patients or the dose of the extract adjusted downward if any of the following conditions exist: 1 Severe symptoms of rhinitis and/or asthma 2 Infections or flu accompanied by fever and 3 Exposure to excessive amounts of clinically relevant allergen prior to a scheduled injection.\"\n }\n ]\n },\n {\n \"Term\": \"Endotracheal intubation\",\n \"MEDDRACode\": \"10067450\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"intubation\",\n \"Probability\": \"0.0003468759\",\n \"SemanticContext\": \"Respiratory obstruction not responding to parenteral or inhaled bronchodilators may require oxygen, intubation and the use of life support systems.\"\n }\n ]\n },\n {\n \"Term\": \"Wheezing\",\n \"MEDDRACode\": \"10047924\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"wheezing\",\n \"Probability\": \"0.999617219\",\n \"SemanticContext\": \"ADVERSE REACTIONS Adverse systemic reactions usually occur within minutes and consist primarily of allergic symptoms such as: generalized skin erythema, urticaria, pruritus, angioedema, rhinitis, wheezing, laryngeal edema, itching of nose and throat, breathlessness, dyspnea, coughing, hypotension and marked perspiration.\"\n }\n ]\n },\n {\n \"Term\": \"Pruritus\",\n \"MEDDRACode\": \"10037087\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"pruritus\",\n \"Probability\": \"0.9975171089\",\n \"SemanticContext\": \"ADVERSE REACTIONS Adverse systemic reactions usually occur within minutes and consist primarily of allergic symptoms such as: generalized skin erythema, urticaria, pruritus, angioedema, rhinitis, wheezing, laryngeal edema, itching of nose and throat, breathlessness, dyspnea, coughing, hypotension and marked perspiration.\"\n }\n ]\n },\n {\n \"Term\": \"Nausea\",\n \"MEDDRACode\": \"10028813\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"nausea\",\n \"Probability\": \"0.9995443225\",\n \"SemanticContext\": \"Less commonly, nausea, emesis, abdominal cramps, diarrhea and uterine contractions may occur.\"\n }\n ]\n },\n {\n \"Term\": \"Blood immunoglobulin G\",\n \"MEDDRACode\": \"10005593\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"IgG\",\n \"Probability\": \"8.64474E-05\",\n \"SemanticContext\": \"When allergenic extracts are used for immunotherapy, the effect is an increase in immunoglobulin G IgG and an increased T suppresser lymphocyte which interferes with the allergic response.\"\n },\n {\n \"VerbatimTerm\": \"IgG\",\n \"Probability\": \"1.10131E-05\",\n \"SemanticContext\": \"2 With repeated administration of allergenic extracts changes develop in regards to IgG and IgE production and mediator-releasing cells.\"\n }\n ]\n },\n {\n \"Term\": \"Coma\",\n \"MEDDRACode\": \"10010071\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"coma\",\n \"Probability\": \"0.0893443376\",\n \"SemanticContext\": \"Sensitive patients may experience severe anaphylactic reactions resulting in respiratory obstruction, shock, coma and /or death.\"\n }\n ]\n },\n {\n \"Term\": \"Drug interaction\",\n \"MEDDRACode\": \"10013710\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"DRUG INTERACTIONS\",\n \"Probability\": \"0.0027354469\",\n \"SemanticContext\": \"DRUG INTERACTIONS: Some drugs may affect the reactivity of the skin; patients should be instructed to avoid medications, particularly antihistamines and sympathomimetic drugs, for at least 24 hours prior to skin testing.\"\n }\n ]\n },\n {\n \"Term\": \"Syringomyelia\",\n \"MEDDRACode\": \"10042928\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0002168211\",\n \"SemanticContext\": \"Clean test area with alcohol, place sites 5 cm apart using separate sterile tuberculin syringe and a 25 gauge needle for each allergen.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.000118119\",\n \"SemanticContext\": \"Avoid injecting into blood vessel, pull back gently on syringe plunger, if blood enters syringe change position of needle.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"1.71767E-05\",\n \"SemanticContext\": \"Avoid injecting into blood vessel, pull back gently on syringe plunger, if blood enters syringe change position of needle.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.00031411950000000003\",\n \"SemanticContext\": \"A sterile tuberculin syringe graduated in 0.1 ml units to measure each dose for the prescribed dilution should be used.\"\n },\n {\n \"VerbatimTerm\": \"syringes\",\n \"Probability\": \"0.0005180706\",\n \"SemanticContext\": \"For safe and effective use of allergenic extracts, sterile diluents, sterile vials, sterile syringes should be used and aseptic precautions observed when making a dilution and/or administering the allergenic extract injection.\"\n }\n ]\n },\n {\n \"Term\": \"Weight\",\n \"MEDDRACode\": \"10047890\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"weight\",\n \"Probability\": \"5.19867E-05\",\n \"SemanticContext\": \"Allergenic Extracts are supplied as concentrations designated as protein nitrogen units PNU or weight/volume w/v ratio.\"\n }\n ]\n },\n {\n \"Term\": \"Infection\",\n \"MEDDRACode\": \"10021789\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Infections\",\n \"Probability\": \"0.0003758092\",\n \"SemanticContext\": \"4 See Adverse Reactions An allergenic extract should be temporarily withheld from patients or the dose of the extract adjusted downward if any of the following conditions exist: 1 Severe symptoms of rhinitis and/or asthma 2 Infections or flu accompanied by fever and 3 Exposure to excessive amounts of clinically relevant allergen prior to a scheduled injection.\"\n }\n ]\n },\n {\n \"Term\": \"Scratch\",\n \"MEDDRACode\": \"10039737\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"scratch\",\n \"Probability\": \"0.0019248779\",\n \"SemanticContext\": \"Two methods commonly used are scratch testing and intradermal testing.\"\n },\n {\n \"VerbatimTerm\": \"scratch\",\n \"Probability\": \"6.60913E-05\",\n \"SemanticContext\": \"Allergenic extracts for diagnostic use are to be administered in the following manner: To scratch surface of skin, use a circular scarifier.\"\n },\n {\n \"VerbatimTerm\": \"scratch\",\n \"Probability\": \"0.0004561781\",\n \"SemanticContext\": \"1-30 scratch tests may be done at a time.\"\n },\n {\n \"VerbatimTerm\": \"scratch\",\n \"Probability\": \"0.0039084083\",\n \"SemanticContext\": \"A separate sterile scratch instrument is to be used on each patient to prevent transmission of homologous serum hepatitis or other infectious agents from one patient to another.\"\n },\n {\n \"VerbatimTerm\": \"scratch\",\n \"Probability\": \"0.0031726949\",\n \"SemanticContext\": \"The recommended usual dosage for Scratch testing is one drop of allergen applied to each scratch site.\"\n },\n {\n \"VerbatimTerm\": \"scratch\",\n \"Probability\": \"0.000103763\",\n \"SemanticContext\": \"Always apply a control scratch with each test set.\"\n },\n {\n \"VerbatimTerm\": \"scratch\",\n \"Probability\": \"5.39484E-05\",\n \"SemanticContext\": \"Confirm your findings with scratch or intradermal skin testing.\"\n }\n ]\n },\n {\n \"Term\": \"Emotional distress\",\n \"MEDDRACode\": \"10049119\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"distress\",\n \"Probability\": \"0.000876879\",\n \"SemanticContext\": \"Do not give injections to patients who are in acute distress.\"\n }\n ]\n },\n {\n \"Term\": \"Hypotension\",\n \"MEDDRACode\": \"10021097\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hypotension\",\n \"Probability\": \"0.9976927042\",\n \"SemanticContext\": \"ADVERSE REACTIONS Adverse systemic reactions usually occur within minutes and consist primarily of allergic symptoms such as: generalized skin erythema, urticaria, pruritus, angioedema, rhinitis, wheezing, laryngeal edema, itching of nose and throat, breathlessness, dyspnea, coughing, hypotension and marked perspiration.\"\n }\n ]\n },\n {\n \"Term\": \"Hepatitis B\",\n \"MEDDRACode\": \"10019731\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"serum hepatitis\",\n \"Probability\": \"0.0083749751\",\n \"SemanticContext\": \"A separate sterile scratch instrument is to be used on each patient to prevent transmission of homologous serum hepatitis or other infectious agents from one patient to another.\"\n }\n ]\n },\n {\n \"Term\": \"Loss of consciousness\",\n \"MEDDRACode\": \"10024855\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"loss of consciousness\",\n \"Probability\": \"0.9059562683\",\n \"SemanticContext\": \"Severe reactions may cause anaphylaxis or shock and loss of consciousness and rarely death.\"\n }\n ]\n },\n {\n \"Term\": \"Swelling\",\n \"MEDDRACode\": \"10042674\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"swelling\",\n \"Probability\": \"0.3940608501\",\n \"SemanticContext\": \"See Overdose section Local Reactions consisting of erythema, itching, swelling tenderness and sometimes pain may occur at the injection site.\"\n }\n ]\n },\n {\n \"Term\": \"Shock\",\n \"MEDDRACode\": \"10040560\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"shock\",\n \"Probability\": \"0.9884600639\",\n \"SemanticContext\": \"Severe reactions may cause anaphylaxis or shock and loss of consciousness and rarely death.\"\n },\n {\n \"VerbatimTerm\": \"shock\",\n \"Probability\": \"0.4044965208\",\n \"SemanticContext\": \"Sensitive patients may experience severe anaphylactic reactions resulting in respiratory obstruction, shock, coma and /or death.\"\n }\n ]\n },\n {\n \"Term\": \"Emphysema\",\n \"MEDDRACode\": \"10014561\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": true,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"emphysema\",\n \"Probability\": \"6.08589E-05\",\n \"SemanticContext\": \"CONTRAINDICATIONS Allergenic extracts should not be used if the patient has asthma, cardiovascular disease, emphysema, diabetes, bleeding diathesis or pregnancy, unless a specific diagnosis of type 1 allergic disease is made based on skin testing and the benefits of treatment outweigh the risks of an adverse reaction during testing or treatment.\"\n }\n ]\n },\n {\n \"Term\": \"Blood immunoglobulin E\",\n \"MEDDRACode\": \"10005588\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"IgE\",\n \"Probability\": \"2.59591E-05\",\n \"SemanticContext\": \"CLINICAL PHARMACOLOGY The pharmacological action of allergenic extracts used diagnostically is based on the liberation of histamine and other substances when the allergen reacts with IgE antibodies attached to the mast cells.\"\n },\n {\n \"VerbatimTerm\": \"IgE\",\n \"Probability\": \"9.13988E-05\",\n \"SemanticContext\": \"2 With repeated administration of allergenic extracts changes develop in regards to IgG and IgE production and mediator-releasing cells.\"\n }\n ]\n },\n {\n \"Term\": \"Carcinogenicity\",\n \"MEDDRACode\": \"10007269\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"carcinogenicity\",\n \"Probability\": \"0.0001195719\",\n \"SemanticContext\": \"Carcinogenesis, mutagenesis, impairment of fertility: Long term studies in animals have not been conducted with allergenic extracts to determine their potential carcinogenicity, mutagenicity or impairment of fertility.\"\n }\n ]\n },\n {\n \"Term\": \"Urticaria\",\n \"MEDDRACode\": \"10046735\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"wheal\",\n \"Probability\": \"0.8740984797\",\n \"SemanticContext\": \"Both types of tests result in a wheal and flare response at the site of the test which usually develops rapidly and may be read in 20-30 minutes.\"\n },\n {\n \"VerbatimTerm\": \"wheal\",\n \"Probability\": \"0.033331953\",\n \"SemanticContext\": \"Tests sites should be 4 cm apart to allow for wheal and flare reaction.\"\n },\n {\n \"VerbatimTerm\": \"wheal\",\n \"Probability\": \"0.5972542763\",\n \"SemanticContext\": \"To prevent excessive absorption, wipe off antigens producing large reactions as soon as the wheal appears.\"\n },\n {\n \"VerbatimTerm\": \"wheal\",\n \"Probability\": \"0.924597621\",\n \"SemanticContext\": \"Interpretation of Scratch Test Skin tests are graded in terms of the wheal and erythema response noted at 10 to 20 minutes.\"\n },\n {\n \"VerbatimTerm\": \"wheal\",\n \"Probability\": \"0.9067932963\",\n \"SemanticContext\": \"6 REACTION SYMBOL CRITERIA Negative - No wheal.\"\n },\n {\n \"VerbatimTerm\": \"wheal\",\n \"Probability\": \"0.6465527415\",\n \"SemanticContext\": \"Interpretation of Intradermal Test: The patient's reaction is graded on the basis of size of wheal and flare as compared to control.\"\n },\n {\n \"VerbatimTerm\": \"wheal\",\n \"Probability\": \"0.0999630764\",\n \"SemanticContext\": \"One Plus + An increase in size of bleb to a wheal not more than 5mm diameter, with associated erythema.\"\n },\n {\n \"VerbatimTerm\": \"Wheal\",\n \"Probability\": \"0.9145724177\",\n \"SemanticContext\": \"Wheal and erythema size may be recorded by actual measurement as compared with positive and negative controls.\"\n },\n {\n \"VerbatimTerm\": \"Wheal\",\n \"Probability\": \"0.6359077692\",\n \"SemanticContext\": \"One Plus + Wheal absent or very slight erythema present not more than 3 mm diameter .\"\n },\n {\n \"VerbatimTerm\": \"Wheal\",\n \"Probability\": \"0.1068236232\",\n \"SemanticContext\": \"Two Plus ++ Wheal not more than 3mm or erythema not more than 5mm diameter.\"\n },\n {\n \"VerbatimTerm\": \"Wheal\",\n \"Probability\": \"0.2320696861\",\n \"SemanticContext\": \"Three Plus +++ Wheal between 3mm and 5mm diameter, with erythema.\"\n },\n {\n \"VerbatimTerm\": \"Wheal\",\n \"Probability\": \"0.0737953484\",\n \"SemanticContext\": \"Two Plus ++ Wheal between 5mm and 8mm diameter with erythema.\"\n },\n {\n \"VerbatimTerm\": \"Wheal\",\n \"Probability\": \"0.0404487886\",\n \"SemanticContext\": \"Three Plus +++ Wheal between 8mm and 12mm diameter with erythema and possible pseudopodia and itching or pain.\"\n }\n ]\n },\n {\n \"Term\": \"Tenderness\",\n \"MEDDRACode\": \"10043224\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"tenderness\",\n \"Probability\": \"0.530181706\",\n \"SemanticContext\": \"See Overdose section Local Reactions consisting of erythema, itching, swelling tenderness and sometimes pain may occur at the injection site.\"\n }\n ]\n },\n {\n \"Term\": \"Skin test\",\n \"MEDDRACode\": \"10040929\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": true,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"intradermal testing\",\n \"Probability\": \"0.0005679782\",\n \"SemanticContext\": \"Two methods commonly used are scratch testing and intradermal testing.\"\n },\n {\n \"VerbatimTerm\": \"intradermal testing\",\n \"Probability\": \"8.35865E-05\",\n \"SemanticContext\": \"The recommended dosage and range for intradermal testing is 0.05 ml of not more than 100 pnu/ml or 1:1000 w/v only if puncture test is negative of allergenic extract.\"\n },\n {\n \"VerbatimTerm\": \"intradermal testing\",\n \"Probability\": \"2.21959E-05\",\n \"SemanticContext\": \"Concentrated extracts must be diluted with sterile diluent prior to first use on a patient for treatment or intradermal testing.\"\n },\n {\n \"VerbatimTerm\": \"intradermal test\",\n \"Probability\": \"0.0009305679\",\n \"SemanticContext\": \"Diagnostic Use : Scratch Testing Method Scratch testing is considered a simple and safe method although less sensitive than the intradermal test.\"\n },\n {\n \"VerbatimTerm\": \"intradermal test\",\n \"Probability\": \"0.0001747945\",\n \"SemanticContext\": \"Scratch testing can be used to determine the degree of sensitivity to a suspected allergen before using the intradermal test.\"\n },\n {\n \"VerbatimTerm\": \"intradermal test\",\n \"Probability\": \"1.08164E-05\",\n \"SemanticContext\": \"Diagnostic Use: Intradermal Skin Testing Method Do not perform intradermal test with allergens which have evoked a 2+ or greater response to a Scratch test.\"\n },\n {\n \"VerbatimTerm\": \"Intradermal Test\",\n \"Probability\": \"0.0024094067\",\n \"SemanticContext\": \"Interpretation of Intradermal Test: The patient's reaction is graded on the basis of size of wheal and flare as compared to control.\"\n }\n ]\n },\n {\n \"Term\": \"Lymphocyte count\",\n \"MEDDRACode\": \"10025251\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"lymphocyte\",\n \"Probability\": \"0.0009048738\",\n \"SemanticContext\": \"When allergenic extracts are used for immunotherapy, the effect is an increase in immunoglobulin G IgG and an increased T suppresser lymphocyte which interferes with the allergic response.\"\n }\n ]\n },\n {\n \"Term\": \"Epinephrine\",\n \"MEDDRACode\": \"10015060\",\n \"Overdose\": true,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Epinephrine\",\n \"Probability\": \"0.0004442891\",\n \"SemanticContext\": \"If systemic or anaphylactic reaction, does occur, apply a tourniquet above the site of injection and inject intramuscularly or subcutaneously 0.3 to 0.5ml of 1:1000 Epinephrine Hydrochloride into the opposite arm.\"\n },\n {\n \"VerbatimTerm\": \"Epinephrine\",\n \"Probability\": \"0.0008083382\",\n \"SemanticContext\": \"The Epinephrine Hydrochloride 1:1000 dose for infants to 2 years is 0.05 to 0.1 ml, for children 2 to 6 years it is 0.15 ml, for children 6-12 years it is 0.2 ml.\"\n },\n {\n \"VerbatimTerm\": \"Epinephrine\",\n \"Probability\": \"0.0026915043\",\n \"SemanticContext\": \"Patients unresponsive to Epinephrine may be treated with Theophylline.\"\n },\n {\n \"VerbatimTerm\": \"Epinephrine\",\n \"Probability\": \"0.162281245\",\n \"SemanticContext\": \"Epinephrine 1:1000 should be available.\"\n },\n {\n \"VerbatimTerm\": \"Epinephrine\",\n \"Probability\": \"0.378033638\",\n \"SemanticContext\": \"PRECAUTIONS GENERAL: Epinephrine 1:1000 should be available as well as personnel trained in administering emergency treatment.\"\n },\n {\n \"VerbatimTerm\": \"Epinephrine\",\n \"Probability\": \"0.0150145441\",\n \"SemanticContext\": \"Epinephrine injection inhibits the immediate skin test reactions for several hours.\"\n },\n {\n \"VerbatimTerm\": \"epinephrine\",\n \"Probability\": \"2.03643E-05\",\n \"SemanticContext\": \"Patients on non-selective beta blockers may be more reactive to allergens given for testing or treatment and may be unresponsive to the usual doses of epinephrine used to treat allergic reactions.\"\n }\n ]\n },\n {\n \"Term\": \"Infant\",\n \"MEDDRACode\": \"10021731\",\n \"Overdose\": true,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"infants\",\n \"Probability\": \"0.0057532298\",\n \"SemanticContext\": \"The Epinephrine Hydrochloride 1:1000 dose for infants to 2 years is 0.05 to 0.1 ml, for children 2 to 6 years it is 0.15 ml, for children 6-12 years it is 0.2 ml.\"\n },\n {\n \"VerbatimTerm\": \"infant\",\n \"Probability\": \"0.0001657833\",\n \"SemanticContext\": \"There are no current studies on extract components in human milk, or their effect on the nursing infant.\"\n }\n ]\n },\n {\n \"Term\": \"Diabetes mellitus\",\n \"MEDDRACode\": \"10012601\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": true,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"diabetes\",\n \"Probability\": \"5.37186E-05\",\n \"SemanticContext\": \"CONTRAINDICATIONS Allergenic extracts should not be used if the patient has asthma, cardiovascular disease, emphysema, diabetes, bleeding diathesis or pregnancy, unless a specific diagnosis of type 1 allergic disease is made based on skin testing and the benefits of treatment outweigh the risks of an adverse reaction during testing or treatment.\"\n }\n ]\n },\n {\n \"Term\": \"Asthma\",\n \"MEDDRACode\": \"10003553\",\n \"Overdose\": true,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": true,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"asthma\",\n \"Probability\": \"7.56192E-05\",\n \"SemanticContext\": \"CONTRAINDICATIONS Allergenic extracts should not be used if the patient has asthma, cardiovascular disease, emphysema, diabetes, bleeding diathesis or pregnancy, unless a specific diagnosis of type 1 allergic disease is made based on skin testing and the benefits of treatment outweigh the risks of an adverse reaction during testing or treatment.\"\n },\n {\n \"VerbatimTerm\": \"asthma\",\n \"Probability\": \"0.0001133015\",\n \"SemanticContext\": \"The usual dose to relieve broncho-constriction in asthma is 0.5 ml of the 0.5% solution for Isoproterenol HCl.\"\n },\n {\n \"VerbatimTerm\": \"asthma\",\n \"Probability\": \"0.0008843569\",\n \"SemanticContext\": \"4 See Adverse Reactions An allergenic extract should be temporarily withheld from patients or the dose of the extract adjusted downward if any of the following conditions exist: 1 Severe symptoms of rhinitis and/or asthma 2 Infections or flu accompanied by fever and 3 Exposure to excessive amounts of clinically relevant allergen prior to a scheduled injection.\"\n }\n ]\n },\n {\n \"Term\": \"Bronchospasm\",\n \"MEDDRACode\": \"10006482\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"broncho-constriction\",\n \"Probability\": \"0.0035922814\",\n \"SemanticContext\": \"The usual dose to relieve broncho-constriction in asthma is 0.5 ml of the 0.5% solution for Isoproterenol HCl.\"\n }\n ]\n },\n {\n \"Term\": \"Pyrexia\",\n \"MEDDRACode\": \"10037660\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"fever\",\n \"Probability\": \"0.0538895503\",\n \"SemanticContext\": \"4 See Adverse Reactions An allergenic extract should be temporarily withheld from patients or the dose of the extract adjusted downward if any of the following conditions exist: 1 Severe symptoms of rhinitis and/or asthma 2 Infections or flu accompanied by fever and 3 Exposure to excessive amounts of clinically relevant allergen prior to a scheduled injection.\"\n }\n ]\n },\n {\n \"Term\": \"Exercise adequate\",\n \"MEDDRACode\": \"10015636\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"exercised\",\n \"Probability\": \"3.3577E-06\",\n \"SemanticContext\": \"Because many drugs are detected in human milk, caution should be exercised when Allergenic Extracts are administered to a nursing woman.\"\n }\n ]\n },\n {\n \"Term\": \"Therapeutic response changed\",\n \"MEDDRACode\": \"10074941\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"good effect\",\n \"Probability\": \"8.84534E-05\",\n \"SemanticContext\": \"Because of biological differences in individuals and because allergenic extracts are manufactured to be potent and because we have no control over the conditions of use, we cannot and do not warrant either a good effect or against an ill effect following use.\"\n }\n ]\n },\n {\n \"Term\": \"Influenza\",\n \"MEDDRACode\": \"10022000\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"flu\",\n \"Probability\": \"0.0015164389\",\n \"SemanticContext\": \"4 See Adverse Reactions An allergenic extract should be temporarily withheld from patients or the dose of the extract adjusted downward if any of the following conditions exist: 1 Severe symptoms of rhinitis and/or asthma 2 Infections or flu accompanied by fever and 3 Exposure to excessive amounts of clinically relevant allergen prior to a scheduled injection.\"\n }\n ]\n },\n {\n \"Term\": \"Life support\",\n \"MEDDRACode\": \"10024447\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"life support\",\n \"Probability\": \"3.17349E-05\",\n \"SemanticContext\": \"Respiratory obstruction not responding to parenteral or inhaled bronchodilators may require oxygen, intubation and the use of life support systems.\"\n }\n ]\n },\n {\n \"Term\": \"Obstruction\",\n \"MEDDRACode\": \"10061876\",\n \"Overdose\": true,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"obstruction\",\n \"Probability\": \"0.0280609597\",\n \"SemanticContext\": \"Respiratory obstruction not responding to parenteral or inhaled bronchodilators may require oxygen, intubation and the use of life support systems.\"\n },\n {\n \"VerbatimTerm\": \"obstruction\",\n \"Probability\": \"0.2843200266\",\n \"SemanticContext\": \"Sensitive patients may experience severe anaphylactic reactions resulting in respiratory obstruction, shock, coma and /or death.\"\n }\n ]\n },\n {\n \"Term\": \"Drug tolerance\",\n \"MEDDRACode\": \"10052804\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"tolerance\",\n \"Probability\": \"0.0003236024\",\n \"SemanticContext\": \"Dosage of allergenic extracts is a highly individualized matter and varies according to the degree of sensitivity of the patient, his clinical response and tolerance to the extract administered during the early phases of an injection regimen.\"\n }\n ]\n },\n {\n \"Term\": \"Skin test positive\",\n \"MEDDRACode\": \"10040934\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"skin test reactions\",\n \"Probability\": \"0.0005567555\",\n \"SemanticContext\": \"Antihistamines and Hydroxyzine can significantly inhibit the immediate skin test reactions as they tend to neutralize or antagonize the action of histamine.\"\n },\n {\n \"VerbatimTerm\": \"skin test reactions\",\n \"Probability\": \"0.0023002001\",\n \"SemanticContext\": \"Epinephrine injection inhibits the immediate skin test reactions for several hours.\"\n },\n {\n \"VerbatimTerm\": \"skin test reaction\",\n \"Probability\": \"0.1925375909\",\n \"SemanticContext\": \"Partial inhibition of the skin test reaction had been observed for longer periods.\"\n }\n ]\n }\n ],\n \"IndicationTerms\": []\n }\n ]\n },\n {\n \"GenericName\": \"ascorbic acid, sodium fluoride, vitamin a and vitamin d\",\n \"MeddraVersion\": \"24.0\",\n \"Labels\": [\n {\n \"Id\": \"US9e51b11a-386c-2f1d-e053-2995a90a5a9e\",\n \"NDCCode\": \"58657-323\",\n \"UpdatedDate\": \"Feb 13, 2020\",\n \"LabelSource\": {\n \"Country\": \"us\",\n \"ProductId\": \"003181d4-5412-4ffe-b99d-880f2010e3ad\",\n \"FileId\": \"9e51b11a-386c-2f1d-e053-2995a90a5a9e\",\n \"Version\": \"2\"\n },\n \"AdverseEventTerms\": [\n {\n \"Term\": \"Dermatitis allergic\",\n \"MEDDRACode\": \"10012434\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Allergic rash\",\n \"Probability\": \"0.6918789744\",\n \"SemanticContext\": \"undefinedADVERSE REACTIONS Allergic rash and other idiosyncrasies have been rarely reported.\"\n }\n ]\n },\n {\n \"Term\": \"Dental caries\",\n \"MEDDRACode\": \"10012318\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"dental caries\",\n \"Probability\": \"0.4232213497\",\n \"SemanticContext\": \"undefinedCLINICAL PHARMACOLOGY It is well established that fluoridation of the water supply 1 ppm fluoride during the period of tooth development leads to a significant decrease in the incidence of dental caries.\"\n }\n ]\n },\n {\n \"Term\": \"Euphoric mood\",\n \"MEDDRACode\": \"10015535\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"higher\",\n \"Probability\": \"0.0005237162\",\n \"SemanticContext\": \"• Ingestion of higher than recommended levels of fluoride by children has been associated with an increase in mild dental fluorosis in developing, unerupted teeth.\"\n }\n ]\n },\n {\n \"Term\": \"Prophylaxis\",\n \"MEDDRACode\": \"10036898\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"prophylaxis\",\n \"Probability\": \"0.0040636659\",\n \"SemanticContext\": \"undefinedINDICATIONS AND USAGE Supplementation of the diet with vitamins A, C and D. Tri-Vite Drops with Fluoride 0.25 mg also provides fluoride for caries prophylaxis.\"\n }\n ]\n },\n {\n \"Term\": \"Vitamin A\",\n \"MEDDRACode\": \"10050712\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"vitamins A\",\n \"Probability\": \"0.0012074709\",\n \"SemanticContext\": \"undefinedINDICATIONS AND USAGE Supplementation of the diet with vitamins A, C and D. Tri-Vite Drops with Fluoride 0.25 mg also provides fluoride for caries prophylaxis.\"\n },\n {\n \"VerbatimTerm\": \"vitamins A\",\n \"Probability\": \"0.0001556873\",\n \"SemanticContext\": \"Tri-Vite Drops with Fluoride 0.25 mg supply significant amounts of vitamins A, C and D to supplement the diet, and to help assure that nutritional deficiencies of these vitamins will not develop.\"\n }\n ]\n },\n {\n \"Term\": \"Vitamin E\",\n \"MEDDRACode\": \"10058765\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"vitamins\",\n \"Probability\": \"0.0007412732\",\n \"SemanticContext\": \"Tri-Vite Drops with Fluoride 0.25 mg supply significant amounts of vitamins A, C and D to supplement the diet, and to help assure that nutritional deficiencies of these vitamins will not develop.\"\n },\n {\n \"VerbatimTerm\": \"vitamins\",\n \"Probability\": \"1.5087E-05\",\n \"SemanticContext\": \"Thus, in a single easy-to-use preparation, children obtain essential vitamins and fluoride.\"\n },\n {\n \"VerbatimTerm\": \"vitamin\",\n \"Probability\": \"4.8183E-06\",\n \"SemanticContext\": \"When prescribing vitamin fluoride products: 1.\"\n }\n ]\n },\n {\n \"Term\": \"Blood sodium\",\n \"MEDDRACode\": \"10005799\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"5.7017E-05\",\n \"SemanticContext\": \"The amount of sodium fluoride in the 50 mL size is well below the maximum to be dispensed at one time according to recommendations of the American Dental Association.\"\n }\n ]\n },\n {\n \"Term\": \"Fluorosis dental\",\n \"MEDDRACode\": \"10016819\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"dental fluorosis\",\n \"Probability\": \"0.0017783344\",\n \"SemanticContext\": \"undefinedPRECAUTIONS The suggested dose should not be exceeded since dental fluorosis may result from continued ingestion of large amounts of fluoride.\"\n },\n {\n \"VerbatimTerm\": \"dental fluorosis\",\n \"Probability\": \"0.0001504719\",\n \"SemanticContext\": \"Periodically check to make sure that the child does not develop significant dental fluorosis.\"\n },\n {\n \"VerbatimTerm\": \"dental fluorosis\",\n \"Probability\": \"0.012367934\",\n \"SemanticContext\": \"• Ingestion of higher than recommended levels of fluoride by children has been associated with an increase in mild dental fluorosis in developing, unerupted teeth.\"\n }\n ]\n },\n {\n \"Term\": \"Rash\",\n \"MEDDRACode\": \"10037844\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"eruption\",\n \"Probability\": \"0.0634059012\",\n \"SemanticContext\": \"After eruption, the surface enamel acquires fluoride from water, food, supplementary fluoride and smaller amounts from saliva.\"\n }\n ]\n },\n {\n \"Term\": \"Infant\",\n \"MEDDRACode\": \"10021731\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"infants\",\n \"Probability\": \"0.001165688\",\n \"SemanticContext\": \"The American Academy of Pediatrics recommend that infants and young children 6 months to 3 years of age, in areas where the drinking water contains less than 0.3 ppm of fluoride, and children 3-6 years of age, in areas where the drinking water contains 0.3 through 0.6 ppm of fluoride, receive 0.25 mg of supplemental fluoride daily which is provided in a dose of 1 mL of Tri-Vite Drops with Fluoride 0.25 mg See Dosage and Administration .\"\n }\n ]\n }\n ],\n \"IndicationTerms\": []\n }\n ]\n },\n {\n \"GenericName\": \"sacubitril and valsartan\",\n \"MeddraVersion\": \"24.0\",\n \"Labels\": [\n {\n \"Id\": \"USe31ba75d-6df4-420a-9918-092ef89d987b\",\n \"NDCCode\": \"0078-0659\",\n \"UpdatedDate\": \"Jul 14, 2021\",\n \"LabelSource\": {\n \"Country\": \"us\",\n \"ProductId\": \"000dc81d-ab91-450c-8eae-8eb74e72296f\",\n \"FileId\": \"e31ba75d-6df4-420a-9918-092ef89d987b\",\n \"Version\": \"13\"\n },\n \"AdverseEventTerms\": [\n {\n \"Term\": \"Haemoglobin\",\n \"MEDDRACode\": \"10018876\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Hemoglobin\",\n \"Probability\": \"0.0006746948\",\n \"SemanticContext\": \"Laboratory Abnormalities Hemoglobin and Hematocrit Decreases in hemoglobin/hematocrit of > 20% were observed in approximately 5% of both ENTRESTO- and enalapril-treated patients in the double-blind period in PARADIGM-HF.\"\n }\n ]\n },\n {\n \"Term\": \"Haematocrit decreased\",\n \"MEDDRACode\": \"10018838\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Hematocrit Decreases\",\n \"Probability\": \"0.4315832853\",\n \"SemanticContext\": \"Laboratory Abnormalities Hemoglobin and Hematocrit Decreases in hemoglobin/hematocrit of > 20% were observed in approximately 5% of both ENTRESTO- and enalapril-treated patients in the double-blind period in PARADIGM-HF.\"\n }\n ]\n },\n {\n \"Term\": \"Pruritus\",\n \"MEDDRACode\": \"10037087\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"pruritus\",\n \"Probability\": \"0.9524453878\",\n \"SemanticContext\": \"Hypersensitivity including rash, pruritus, and anaphylactic reaction\"\n }\n ]\n },\n {\n \"Term\": \"Haematocrit\",\n \"MEDDRACode\": \"10018837\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hematocrit\",\n \"Probability\": \"0.0010715425\",\n \"SemanticContext\": \"Laboratory Abnormalities Hemoglobin and Hematocrit Decreases in hemoglobin/hematocrit of > 20% were observed in approximately 5% of both ENTRESTO- and enalapril-treated patients in the double-blind period in PARADIGM-HF.\"\n },\n {\n \"VerbatimTerm\": \"hematocrit\",\n \"Probability\": \"0.0003770888\",\n \"SemanticContext\": \"Decreases in hemoglobin/hematocrit of >20% were observed in approximately 7% of ENTRESTO-treated patients and 9% of valsartan-treated patients in the double-blind period in PARAGON-HF.\"\n }\n ]\n },\n {\n \"Term\": \"Haemoglobin S\",\n \"MEDDRACode\": \"10051600\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Hemoglobin\",\n \"Probability\": \"0.0006746948\",\n \"SemanticContext\": \"Laboratory Abnormalities Hemoglobin and Hematocrit Decreases in hemoglobin/hematocrit of > 20% were observed in approximately 5% of both ENTRESTO- and enalapril-treated patients in the double-blind period in PARADIGM-HF.\"\n }\n ]\n },\n {\n \"Term\": \"Fall\",\n \"MEDDRACode\": \"10016173\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Falls\",\n \"Probability\": \"0.5033583641\",\n \"SemanticContext\": \"Falls were reported in 1.9% of patients treated with ENTRESTO compared to 1.3% of patients treated with enalapril.\"\n }\n ]\n },\n {\n \"Term\": \"Hypotension\",\n \"MEDDRACode\": \"10021097\",\n \"Overdose\": true,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"symptomatic hypotension\",\n \"Probability\": \"0.6976981163\",\n \"SemanticContext\": \"5.3 Hypotension ENTRESTO lowers blood pressure and may cause symptomatic hypotension [see Adverse Reactions 6.1 ] .\"\n }\n ]\n },\n {\n \"Term\": \"Euphoric mood\",\n \"MEDDRACode\": \"10015535\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"higher\",\n \"Probability\": \"0.0072290003\",\n \"SemanticContext\": \"In the double-blind period, the incidence of angioedema was higher in patients treated with ENTRESTO than enalapril 0.5% and 0.2%, respectively .\"\n },\n {\n \"VerbatimTerm\": \"higher\",\n \"Probability\": \"0.0011095703\",\n \"SemanticContext\": \"ENTRESTO has been associated with a higher rate of angioedema in Black than in non-Black patients.\"\n },\n {\n \"VerbatimTerm\": \"high\",\n \"Probability\": \"0.0001572967\",\n \"SemanticContext\": \"ENTRESTO is unlikely to be removed by hemodialysis because of high protein binding.\"\n },\n {\n \"VerbatimTerm\": \"high\",\n \"Probability\": \"3.62051E-05\",\n \"SemanticContext\": \"The LBQ657 C max at the high dose HD of 1200 mg/kg/day in male and female mice was, respectively, 14 and 16 times that in humans at the MRHD.\"\n },\n {\n \"VerbatimTerm\": \"high\",\n \"Probability\": \"0.0002788007\",\n \"SemanticContext\": \"The doses of valsartan studied high dose of 160 and 200 mg/kg/day in mice and rats, respectively were about 4 and 10 times, respectively, the MRHD on a mg/m 2 basis.\"\n },\n {\n \"VerbatimTerm\": \"high\",\n \"Probability\": \"0.0002910495\",\n \"SemanticContext\": \"Patients with an activated renin-angiotensin system, such as volume- and/or salt-depleted patients e.g., those being treated with high doses of diuretics , are at greater risk.\"\n }\n ]\n },\n {\n \"Term\": \"Endothelin\",\n \"MEDDRACode\": \"10053401\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"endothelin\",\n \"Probability\": \"0.0002107322\",\n \"SemanticContext\": \"In a 21-day study in HFrEF patients, ENTRESTO significantly increased urine ANP and cGMP and plasma cGMP, and decreased plasma NT-proBNP, aldosterone and endothelin-1.\"\n }\n ]\n },\n {\n \"Term\": \"Myocardial infarction\",\n \"MEDDRACode\": \"10028596\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"myocardial infarction\",\n \"Probability\": \"0.5897655487\",\n \"SemanticContext\": \"The underlying cause of heart failure was coronary artery disease in 60% of patients; 71% had a history of hypertension, 43% had a history of myocardial infarction, 37% had an eGFR< 60 mL/min/1.73m 2 , and 35% had diabetes mellitus.\"\n },\n {\n \"VerbatimTerm\": \"myocardial infarction\",\n \"Probability\": \"0.5838177204\",\n \"SemanticContext\": \"Furthermore, 96% had a history of hypertension, 23% had a history of myocardial infarction, 46% had an eGFR < 60 mL/min/1.73 m 2 , and 43% had diabetes mellitus.\"\n }\n ]\n },\n {\n \"Term\": \"Blindness\",\n \"MEDDRACode\": \"10005169\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"blind\",\n \"Probability\": \"0.0112668574\",\n \"SemanticContext\": \"Adult Heart Failure In PARADIGM-HF, patients were required to complete sequential enalapril and ENTRESTO run-in periods of median 15 and 29 days, respectively, prior to entering the randomized double-blind period comparing ENTRESTO and enalapril.\"\n },\n {\n \"VerbatimTerm\": \"blind\",\n \"Probability\": \"0.0056586564\",\n \"SemanticContext\": \"In the double-blind period, safety was evaluated in 4,203 patients treated with ENTRESTO and 4,229 treated with enalapril.\"\n },\n {\n \"VerbatimTerm\": \"blind\",\n \"Probability\": \"0.3353865445\",\n \"SemanticContext\": \"Discontinuation of therapy because of an adverse event during the double-blind period occurred in 450 10.7% of ENTRESTO treated patients and 516 12.2% of patients receiving enalapril.\"\n },\n {\n \"VerbatimTerm\": \"blind\",\n \"Probability\": \"0.0386224687\",\n \"SemanticContext\": \"Adverse reactions occurring at an incidence of = 5% in patients who were treated with ENTRESTO in the double-blind period of PARADIGM-HF are shown in Table 2.\"\n },\n {\n \"VerbatimTerm\": \"blind\",\n \"Probability\": \"0.0942946374\",\n \"SemanticContext\": \"In the double-blind period, the incidence of angioedema was higher in patients treated with ENTRESTO than enalapril 0.5% and 0.2%, respectively .\"\n },\n {\n \"VerbatimTerm\": \"blind\",\n \"Probability\": \"0.0318712592\",\n \"SemanticContext\": \"Orthostasis was reported in 2.1% of patients treated with ENTRESTO compared to 1.1% of patients treated with enalapril during the double-blind period of PARADIGM-HF.\"\n },\n {\n \"VerbatimTerm\": \"blind\",\n \"Probability\": \"0.0394700766\",\n \"SemanticContext\": \"Laboratory Abnormalities Hemoglobin and Hematocrit Decreases in hemoglobin/hematocrit of > 20% were observed in approximately 5% of both ENTRESTO- and enalapril-treated patients in the double-blind period in PARADIGM-HF.\"\n },\n {\n \"VerbatimTerm\": \"blind\",\n \"Probability\": \"0.0581258237\",\n \"SemanticContext\": \"Decreases in hemoglobin/hematocrit of >20% were observed in approximately 7% of ENTRESTO-treated patients and 9% of valsartan-treated patients in the double-blind period in PARAGON-HF.\"\n },\n {\n \"VerbatimTerm\": \"blind\",\n \"Probability\": \"0.0031373203\",\n \"SemanticContext\": \"Serum Creatinine During the double-blind period in PARADIGM-HF, approximately 16% of both ENTRESTO- and enalapril-treated patients had increases in serum creatinine of > 50%.\"\n },\n {\n \"VerbatimTerm\": \"blind\",\n \"Probability\": \"0.0017570257\",\n \"SemanticContext\": \"During the double-blind period in PARAGON-HF, approximately 17% of ENTRESTO-treated patients and 21% of valsartan-treated patients had increases in serum creatinine of > 50%.\"\n },\n {\n \"VerbatimTerm\": \"blind\",\n \"Probability\": \"0.0012573898\",\n \"SemanticContext\": \"Serum Potassium During the double-blind period of PARADIGM-HF, approximately 16% of both ENTRESTO- and enalapril-treated patients had potassium concentrations > 5.5 mEq/L.\"\n },\n {\n \"VerbatimTerm\": \"blind\",\n \"Probability\": \"0.0011849999\",\n \"SemanticContext\": \"During the double-blind period of PARAGON-HF, approximately 18% of ENTRESTO-treated patients and 20% of valsartan-treated patients had potassium concentrations > 5.5 mEq/L. 6.2 Postmarketing Experience The following additional adverse reactions have been reported in postmarketing experience.\"\n },\n {\n \"VerbatimTerm\": \"blind\",\n \"Probability\": \"0.0175574422\",\n \"SemanticContext\": \"In PARAMOUNT, a randomized, double-blind, 36-week study in patients with heart failure with LVEF = 45% comparing 97/103 mg of ENTRESTO n=149 to 160 mg of valsartan n =152 twice-daily, ENTRESTO decreased NT-proBNP by 17% while valsartan increased NT-proBNP by 8% at Week 12 p = 0.005 .\"\n },\n {\n \"VerbatimTerm\": \"blind\",\n \"Probability\": \"0.0055876076\",\n \"SemanticContext\": \"14.1 Adult Heart Failure PARADIGM-HF PARADIGM-HF was a multinational, randomized, double-blind trial comparing ENTRESTO and enalapril in 8,442 adult patients with symptomatic chronic heart failure NYHA class II--IV and systolic dysfunction left ventricular ejection fraction = 40% .\"\n },\n {\n \"VerbatimTerm\": \"blind\",\n \"Probability\": \"0.0026428103\",\n \"SemanticContext\": \"After discontinuing their existing ACE inhibitor or ARB therapy, patients entered sequential single-blind run-in periods during which they received enalapril 10 mg twice-daily, followed by ENTRESTO 100 mg twice-daily, increasing to 200 mg twice-daily.\"\n },\n {\n \"VerbatimTerm\": \"blind\",\n \"Probability\": \"0.005133003\",\n \"SemanticContext\": \"PARAGON-HF PARAGON-HF, was a multicenter, randomized, double-blind trial comparing ENTRESTO and valsartan in 4,796 adult patients with symptomatic heart failure with left ventricular ejection fraction = 45%, and structural heart disease [either left atrial enlargement LAE or left ventricular hypertrophy LVH ].\"\n },\n {\n \"VerbatimTerm\": \"blind\",\n \"Probability\": \"0.003893435\",\n \"SemanticContext\": \"After discontinuing their existing ACE inhibitor or ARB therapy, patients entered sequential single-blind run-in periods during which they received valsartan 80 mg twice-daily, followed by ENTRESTO 100 mg twice-daily.\"\n },\n {\n \"VerbatimTerm\": \"blind\",\n \"Probability\": \"0.004016161\",\n \"SemanticContext\": \"Figure 7: Treatment Effect for the Composite Endpoint of Time to First HF Hospitalization or CV Death by LVEF in PARADIGM-HF and PARAGON-HF Figure 3: Kaplan-Meier Curves for the Primary Composite Endpoint A , Cardiovascular Death B , and Heart Failure Hospitalization C Figure 4: Primary Composite Endpoint CV Death or HF Hospitalization - Subgroup Analysis Figure 5: Mean Number of Events Over Time for the Primary Composite Endpoint of Total HF Hospitalizations and CV Death Figure 6: Primary Composite Endpoint of Total HF Hospitalizations and CV Death -- Subgroup Analysis PARAGON-HF Figure 7: Treatment Effect for the Composite Endpoint of Time to First HF Hospitalization or CV Death by LVEF in PARADIGM-HF and PARAGON-HF 14.2 Pediatric Heart Failure PANORAMA-HF The efficacy of ENTRESTO was evaluated in a multinational, randomized, double-blind trial comparing ENTRESTO and enalapril based on an analysis in 110 pediatric patients 1 to < 18 years old with heart failure NYHA/Ross class II-IV due to systemic left ventricular systolic dysfunction LVEF = 40% .\"\n },\n {\n \"VerbatimTerm\": \"blind\",\n \"Probability\": \"0.0029983819\",\n \"SemanticContext\": \"8.4 Pediatric Use The safety and effectiveness of ENTRESTO in pediatric heart failure patients 1 to < 18 years old are supported by the reduction from baseline to 12 weeks in NT-proBNP in a randomized, double-blind clinical study [see Clinical Studies 14.2 ] .\"\n },\n {\n \"VerbatimTerm\": \"Blind\",\n \"Probability\": \"0.0049355328\",\n \"SemanticContext\": \"Table 2: Adverse Reactions Reported in = 5% of Patients Treated with ENTRESTO in the Double-Blind Period of PARADIGM-HF ENTRESTO n = 4,203 % Enalapril n = 4,229 % Hypotension 18 12 Hyperkalemia 12 14 Cough 9 13 Dizziness 6 5 Renal failure/acute renal failure 5 5 .\"\n }\n ]\n },\n {\n \"Term\": \"Blood magnesium\",\n \"MEDDRACode\": \"10005651\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"magnesium\",\n \"Probability\": \"0.0001792014\",\n \"SemanticContext\": \"The tablet inactive ingredients are microcrystalline cellulose, low-substituted hydroxypropylcellulose, crospovidone, magnesium stearate vegetable origin , talc, and colloidal silicon dioxide.\"\n }\n ]\n },\n {\n \"Term\": \"Electrocardiogram QT interval\",\n \"MEDDRACode\": \"10014385\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"QTc\",\n \"Probability\": \"2.35464E-05\",\n \"SemanticContext\": \"QT Prolongation: In a thorough QTc clinical study in healthy male subjects, single doses of ENTRESTO 194 mg sacubitril/206 mg valsartan and 583 mg sacubitril/617 mg valsartan had no effect on cardiac repolarization.\"\n }\n ]\n },\n {\n \"Term\": \"Rash\",\n \"MEDDRACode\": \"10037844\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"rash\",\n \"Probability\": \"0.9858818054\",\n \"SemanticContext\": \"Hypersensitivity including rash, pruritus, and anaphylactic reaction\"\n }\n ]\n },\n {\n \"Term\": \"Elderly\",\n \"MEDDRACode\": \"10014348\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": true\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"elderly\",\n \"Probability\": \"0.0002468824\",\n \"SemanticContext\": \"7.3 Nonsteroidal Anti-Inflammatory Drugs NSAIDs Including Selective Cyclooxygenase-2 Inhibitors COX-2 Inhibitors In patients who are elderly, volume-depleted including those on diuretic therapy , or with compromised renal function, concomitant use of NSAIDs, including COX-2 inhibitors, with ENTRESTO may result in worsening of renal function, including possible acute renal failure.\"\n },\n {\n \"VerbatimTerm\": \"elderly\",\n \"Probability\": \"0.0023521185\",\n \"SemanticContext\": \"8.5 Geriatric Use No relevant pharmacokinetic differences have been observed in elderly = 65 years or very elderly = 75 years patients compared to the overall population [see Clinical Pharmacology 12.3 ] .\"\n },\n {\n \"VerbatimTerm\": \"elderly\",\n \"Probability\": \"0.0022372603\",\n \"SemanticContext\": \"8.5 Geriatric Use No relevant pharmacokinetic differences have been observed in elderly = 65 years or very elderly = 75 years patients compared to the overall population [see Clinical Pharmacology 12.3 ] .\"\n }\n ]\n },\n {\n \"Term\": \"Left ventricular hypertrophy\",\n \"MEDDRACode\": \"10049773\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"LVH\",\n \"Probability\": \"0.8518795967\",\n \"SemanticContext\": \"PARAGON-HF PARAGON-HF, was a multicenter, randomized, double-blind trial comparing ENTRESTO and valsartan in 4,796 adult patients with symptomatic heart failure with left ventricular ejection fraction = 45%, and structural heart disease [either left atrial enlargement LAE or left ventricular hypertrophy LVH ].\"\n }\n ]\n },\n {\n \"Term\": \"Sudden death\",\n \"MEDDRACode\": \"10042434\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Sudden death\",\n \"Probability\": \"0.9553558826\",\n \"SemanticContext\": \"Sudden death accounted for 45% of cardiovascular deaths, followed by pump failure, which accounted for 26%.\"\n }\n ]\n },\n {\n \"Term\": \"Brain natriuretic peptide\",\n \"MEDDRACode\": \"10053406\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"BNP\",\n \"Probability\": \"1.2784E-05\",\n \"SemanticContext\": \"In PARADIGM-HF, ENTRESTO decreased plasma NT-proBNP not a neprilysin substrate and increased plasma BNP a neprilysin substrate and urine cGMP compared with enalapril.\"\n }\n ]\n },\n {\n \"Term\": \"Intrauterine contraception\",\n \"MEDDRACode\": \"10082352\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"ICD\",\n \"Probability\": \"0.0009714067\",\n \"SemanticContext\": \"Few patients had an implantable cardioverter-defibrillator ICD or cardiac resynchronization therapy-defibrillator CRT-D 15% .\"\n }\n ]\n },\n {\n \"Term\": \"N-terminal prohormone brain natriuretic peptide increased\",\n \"MEDDRACode\": \"10071662\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"increased NT-proBNP\",\n \"Probability\": \"0.1026400924\",\n \"SemanticContext\": \"In PARAMOUNT, a randomized, double-blind, 36-week study in patients with heart failure with LVEF = 45% comparing 97/103 mg of ENTRESTO n=149 to 160 mg of valsartan n =152 twice-daily, ENTRESTO decreased NT-proBNP by 17% while valsartan increased NT-proBNP by 8% at Week 12 p = 0.005 .\"\n }\n ]\n },\n {\n \"Term\": \"Protein total\",\n \"MEDDRACode\": \"10050537\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"protein\",\n \"Probability\": \"9.02413E-05\",\n \"SemanticContext\": \"ENTRESTO is unlikely to be removed by hemodialysis because of high protein binding.\"\n }\n ]\n },\n {\n \"Term\": \"Acute kidney injury\",\n \"MEDDRACode\": \"10069339\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"acute renal failure\",\n \"Probability\": \"0.6130424738\",\n \"SemanticContext\": \"Table 2: Adverse Reactions Reported in = 5% of Patients Treated with ENTRESTO in the Double-Blind Period of PARADIGM-HF ENTRESTO n = 4,203 % Enalapril n = 4,229 % Hypotension 18 12 Hyperkalemia 12 14 Cough 9 13 Dizziness 6 5 Renal failure/acute renal failure 5 5 .\"\n },\n {\n \"VerbatimTerm\": \"acute renal failure\",\n \"Probability\": \"0.2023137808\",\n \"SemanticContext\": \"7.3 Nonsteroidal Anti-Inflammatory Drugs NSAIDs Including Selective Cyclooxygenase-2 Inhibitors COX-2 Inhibitors In patients who are elderly, volume-depleted including those on diuretic therapy , or with compromised renal function, concomitant use of NSAIDs, including COX-2 inhibitors, with ENTRESTO may result in worsening of renal function, including possible acute renal failure.\"\n },\n {\n \"VerbatimTerm\": \"acute renal failure\",\n \"Probability\": \"0.0932332575\",\n \"SemanticContext\": \"In patients whose renal function depends upon the activity of the renin-angiotensin-aldosterone system e.g., patients with severe congestive heart failure , treatment with ACE inhibitors and angiotensin receptor antagonists has been associated with oliguria, progressive azotemia and, rarely, acute renal failure and death.\"\n }\n ]\n },\n {\n \"Term\": \"Hypertension\",\n \"MEDDRACode\": \"10020772\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hypertension\",\n \"Probability\": \"0.0359680653\",\n \"SemanticContext\": \"Blood Pressure: Addition of a 50 mg single dose of sildenafil to ENTRESTO at steady state 194 mg sacubitril/206 mg valsartan once daily for 5 days in patients with hypertension was associated with additional blood pressure BP reduction ~ 5/4 mmHg, systolic/diastolic BP compared to administration of ENTRESTO alone.\"\n },\n {\n \"VerbatimTerm\": \"hypertension\",\n \"Probability\": \"0.0953121483\",\n \"SemanticContext\": \"The underlying cause of heart failure was coronary artery disease in 60% of patients; 71% had a history of hypertension, 43% had a history of myocardial infarction, 37% had an eGFR < 60 mL/min/1.73m 2 , and 35% had diabetes mellitus.\"\n },\n {\n \"VerbatimTerm\": \"hypertension\",\n \"Probability\": \"0.0353775918\",\n \"SemanticContext\": \"Furthermore, 96% had a history of hypertension, 23% had a history of myocardial infarction, 46% had an eGFR < 60 mL/min/1.73 m 2 , and 43% had diabetes mellitus.\"\n }\n ]\n },\n {\n \"Term\": \"Mass\",\n \"MEDDRACode\": \"10026865\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"mass\",\n \"Probability\": \"0.000305891\",\n \"SemanticContext\": \"Its empirical formula hemipentahydrate is C 48 H 55 N 6 O 8 Na 3 2.5 H 2 O. Its molecular mass is 957.99 and its schematic structural formula is: ENTRESTO is available as film-coated tablets for oral administration, containing 24 mg of sacubitril and 26 mg of valsartan; 49 mg of sacubitril and 51 mg of valsartan; and 97 mg of sacubitril and 103 mg of valsartan.\"\n },\n {\n \"VerbatimTerm\": \"mass\",\n \"Probability\": \"0.0008742213\",\n \"SemanticContext\": \"Animal Data Sacubitril given orally to juvenile rats from postnatal day PND 7 to PND 35 or PND 70 an age approximately equivalent to neonatal through pre-pubertal development or adulthood in humans at doses = 400 mg/kg/day approximately 2-fold the AUC exposure to the active metabolite of sacubitril, LBQ657, at an ENTRESTO pediatric clinical dose of 3.1 mg/kg twice daily resulted in decreases in body weight, bone length, and bone mass.\"\n }\n ]\n },\n {\n \"Term\": \"Pre-eclampsia\",\n \"MEDDRACode\": \"10036485\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"PET\",\n \"Probability\": \"0.0005914867\",\n \"SemanticContext\": \"Transfer the entire contents from the mortar into a clean 200 mL amber colored PET or glass bottle.\"\n }\n ]\n },\n {\n \"Term\": \"Angiotensin converting enzyme\",\n \"MEDDRACode\": \"10050289\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"angiotensin-converting enzyme\",\n \"Probability\": \"0.0001386106\",\n \"SemanticContext\": \"undefined2 DOSAGE AND ADMINISTRATION 2.1 General Considerations ENTRESTO is contraindicated with concomitant use of an angiotensin-converting enzyme ACE inhibitor.\"\n }\n ]\n },\n {\n \"Term\": \"Coronary artery disease\",\n \"MEDDRACode\": \"10011078\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"coronary artery disease\",\n \"Probability\": \"0.1048850119\",\n \"SemanticContext\": \"The underlying cause of heart failure was coronary artery disease in 60% of patients; 71% had a history of hypertension, 43% had a history of myocardial infarction, 37% had an eGFR< 60 mL/min/1.73m 2 , and 35% had diabetes mellitus.\"\n }\n ]\n },\n {\n \"Term\": \"Restrictive allograft syndrome\",\n \"MEDDRACode\": \"10077506\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"RAS\",\n \"Probability\": \"0.0240430236\",\n \"SemanticContext\": \"The primary objective of PARADIGM-HF was to determine whether ENTRESTO, a combination of sacubitril and a RAS inhibitor valsartan , was superior to a RAS inhibitor enalapril alone in reducing the risk of the combined endpoint of cardiovascular CV death or hospitalization for heart failure HF .\"\n },\n {\n \"VerbatimTerm\": \"RAS\",\n \"Probability\": \"0.008209914\",\n \"SemanticContext\": \"The primary objective of PARADIGM-HF was to determine whether ENTRESTO, a combination of sacubitril and a RAS inhibitor valsartan , was superior to a RAS inhibitor enalapril alone in reducing the risk of the combined endpoint of cardiovascular CV death or hospitalization for heart failure HF .\"\n },\n {\n \"VerbatimTerm\": \"RAS\",\n \"Probability\": \"0.0738016665\",\n \"SemanticContext\": \"PARADIGM-HF demonstrated that ENTRESTO, a combination of sacubitril and a RAS inhibitor valsartan , was superior to a RAS inhibitor enalapril , in reducing the risk of the combined endpoint of cardiovascular death or hospitalization for heart failure, based on a time-to-event analysis hazard ratio [HR] 0.80; 95% confidence interval [CI], 0.73, 0.87, p < 0.0001 .\"\n },\n {\n \"VerbatimTerm\": \"RAS\",\n \"Probability\": \"0.0215521157\",\n \"SemanticContext\": \"PARADIGM-HF demonstrated that ENTRESTO, a combination of sacubitril and a RAS inhibitor valsartan , was superior to a RAS inhibitor enalapril , in reducing the risk of the combined endpoint of cardiovascular death or hospitalization for heart failure, based on a time-to-event analysis hazard ratio [HR] 0.80; 95% confidence interval [CI], 0.73, 0.87, p < 0.0001 .\"\n }\n ]\n },\n {\n \"Term\": \"Blood pressure measurement\",\n \"MEDDRACode\": \"10076581\",\n \"Overdose\": true,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Blood Pressure\",\n \"Probability\": \"5.21739E-05\",\n \"SemanticContext\": \"Blood Pressure: Addition of a 50 mg single dose of sildenafil to ENTRESTO at steady state 194 mg sacubitril/206 mg valsartan once daily for 5 days in patients with hypertension was associated with additional blood pressure BP reduction ~ 5/4 mmHg, systolic/diastolic BP compared to administration of ENTRESTO alone.\"\n },\n {\n \"VerbatimTerm\": \"blood pressure\",\n \"Probability\": \"0.0006788671\",\n \"SemanticContext\": \"Blood Pressure: Addition of a 50 mg single dose of sildenafil to ENTRESTO at steady state 194 mg sacubitril/206 mg valsartan once daily for 5 days in patients with hypertension was associated with additional blood pressure BP reduction ~ 5/4 mmHg, systolic/diastolic BP compared to administration of ENTRESTO alone.\"\n },\n {\n \"VerbatimTerm\": \"blood pressure\",\n \"Probability\": \"0.0003552139\",\n \"SemanticContext\": \"In neonates with a history of in utero exposure to ENTRESTO, if oliguria or hypotension occurs, support blood pressure and renal perfusion.\"\n }\n ]\n },\n {\n \"Term\": \"Impulse-control disorder\",\n \"MEDDRACode\": \"10061215\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"ICD\",\n \"Probability\": \"0.0009714067\",\n \"SemanticContext\": \"Few patients had an implantable cardioverter-defibrillator ICD or cardiac resynchronization therapy-defibrillator CRT-D 15% .\"\n }\n ]\n },\n {\n \"Term\": \"Diuretic therapy\",\n \"MEDDRACode\": \"10053073\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"diuretic therapy\",\n \"Probability\": \"0.0001545846\",\n \"SemanticContext\": \"7.3 Nonsteroidal Anti-Inflammatory Drugs NSAIDs Including Selective Cyclooxygenase-2 Inhibitors COX-2 Inhibitors In patients who are elderly, volume-depleted including those on diuretic therapy , or with compromised renal function, concomitant use of NSAIDs, including COX-2 inhibitors, with ENTRESTO may result in worsening of renal function, including possible acute renal failure.\"\n }\n ]\n },\n {\n \"Term\": \"Anaphylactic reaction\",\n \"MEDDRACode\": \"10002198\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"anaphylactic reaction\",\n \"Probability\": \"0.4642142653\",\n \"SemanticContext\": \"Hypersensitivity including rash, pruritus, and anaphylactic reaction\"\n }\n ]\n },\n {\n \"Term\": \"Blood pressure decreased\",\n \"MEDDRACode\": \"10005734\",\n \"Overdose\": true,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"blood pressure lowering\",\n \"Probability\": \"0.3499842584\",\n \"SemanticContext\": \"Hypotension is the most likely result of overdosage due to the blood pressure lowering effects of ENTRESTO.\"\n },\n {\n \"VerbatimTerm\": \"lowers blood pressure\",\n \"Probability\": \"0.4033680558\",\n \"SemanticContext\": \"5.3 Hypotension ENTRESTO lowers blood pressure and may cause symptomatic hypotension [see Adverse Reactions 6.1 ] .\"\n }\n ]\n },\n {\n \"Term\": \"Cardiac failure\",\n \"MEDDRACode\": \"10007554\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Heart Failure\",\n \"Probability\": \"0.0435394645\",\n \"SemanticContext\": \"RECENT MAJOR CHANGES Indications and Usage, Adult Heart Failure 1.1 2/2021 .\"\n },\n {\n \"VerbatimTerm\": \"Heart Failure\",\n \"Probability\": \"0.004365027\",\n \"SemanticContext\": \"DOSAGE AND ADMINISTRATION Indication Titration Step Dose twice daily Starting Second Final Adult Heart Failure 49/51 mg 97/103 mg Pediatric Heart Failure Patients less than 40 kg 1.6 mg/kg 2.3 mg/kg 3.1 mg/kg Pediatric Heart Failure Patients at least 40 kg, less than 50 kg 24/26 mg 49/51 mg 72/78 mg Pediatric Heart Failure Patients at least 50 kg 49/51 mg 72/78 mg 97/103 mg .\"\n },\n {\n \"VerbatimTerm\": \"Heart Failure\",\n \"Probability\": \"0.0061392486\",\n \"SemanticContext\": \"DOSAGE AND ADMINISTRATION Indication Titration Step Dose twice daily Starting Second Final Adult Heart Failure 49/51 mg 97/103 mg Pediatric Heart Failure Patients less than 40 kg 1.6 mg/kg 2.3 mg/kg 3.1 mg/kg Pediatric Heart Failure Patients at least 40 kg, less than 50 kg 24/26 mg 49/51 mg 72/78 mg Pediatric Heart Failure Patients at least 50 kg 49/51 mg 72/78 mg 97/103 mg .\"\n },\n {\n \"VerbatimTerm\": \"Heart Failure\",\n \"Probability\": \"0.0004841089\",\n \"SemanticContext\": \"DOSAGE AND ADMINISTRATION Indication Titration Step Dose twice daily Starting Second Final Adult Heart Failure 49/51 mg 97/103 mg Pediatric Heart Failure Patients less than 40 kg 1.6 mg/kg 2.3 mg/kg 3.1 mg/kg Pediatric Heart Failure Patients at least 40 kg, less than 50 kg 24/26 mg 49/51 mg 72/78 mg Pediatric Heart Failure Patients at least 50 kg 49/51 mg 72/78 mg 97/103 mg .\"\n },\n {\n \"VerbatimTerm\": \"Heart Failure\",\n \"Probability\": \"0.0208270848\",\n \"SemanticContext\": \"DOSAGE AND ADMINISTRATION Indication Titration Step Dose twice daily Starting Second Final Adult Heart Failure 49/51 mg 97/103 mg Pediatric Heart Failure Patients less than 40 kg 1.6 mg/kg 2.3 mg/kg 3.1 mg/kg Pediatric Heart Failure Patients at least 40 kg, less than 50 kg 24/26 mg 49/51 mg 72/78 mg Pediatric Heart Failure Patients at least 50 kg 49/51 mg 72/78 mg 97/103 mg .\"\n },\n {\n \"VerbatimTerm\": \"Heart Failure\",\n \"Probability\": \"0.0014349818\",\n \"SemanticContext\": \"Adult Heart Failure In PARADIGM-HF, patients were required to complete sequential enalapril and ENTRESTO run-in periods of median 15 and 29 days, respectively, prior to entering the randomized double-blind period comparing ENTRESTO and enalapril.\"\n },\n {\n \"VerbatimTerm\": \"Heart Failure\",\n \"Probability\": \"0.0203329325\",\n \"SemanticContext\": \"Pediatric Heart Failure The adverse reactions observed in pediatric patients 1 to < 18 years old who received treatment with ENTRESTO were consistent with those observed in adult patients.\"\n },\n {\n \"VerbatimTerm\": \"Heart Failure\",\n \"Probability\": \"0.0003466606\",\n \"SemanticContext\": \"14.1 Adult Heart Failure PARADIGM-HF PARADIGM-HF was a multinational, randomized, double-blind trial comparing ENTRESTO and enalapril in 8,442 adult patients with symptomatic chronic heart failure NYHA class II--IV and systolic dysfunction left ventricular ejection fraction = 40% .\"\n },\n {\n \"VerbatimTerm\": \"Heart Failure\",\n \"Probability\": \"0.0016563535\",\n \"SemanticContext\": \"Figure 3: Kaplan-Meier Curves for the Primary Composite Endpoint A , Cardiovascular Death B , and Heart Failure Hospitalization C A wide range of demographic characteristics, baseline disease characteristics, and baseline concomitant medications were examined for their influence on outcomes.\"\n },\n {\n \"VerbatimTerm\": \"Heart Failure\",\n \"Probability\": \"0.1514662206\",\n \"SemanticContext\": \"Figure 7: Treatment Effect for the Composite Endpoint of Time to First HF Hospitalization or CV Death by LVEF in PARADIGM-HF and PARAGON-HF Figure 3: Kaplan-Meier Curves for the Primary Composite Endpoint A , Cardiovascular Death B , and Heart Failure Hospitalization C Figure 4: Primary Composite Endpoint CV Death or HF Hospitalization - Subgroup Analysis Figure 5: Mean Number of Events Over Time for the Primary Composite Endpoint of Total HF Hospitalizations and CV Death Figure 6: Primary Composite Endpoint of Total HF Hospitalizations and CV Death -- Subgroup Analysis PARAGON-HF Figure 7: Treatment Effect for the Composite Endpoint of Time to First HF Hospitalization or CV Death by LVEF in PARADIGM-HF and PARAGON-HF 14.2 Pediatric Heart Failure PANORAMA-HF The efficacy of ENTRESTO was evaluated in a multinational, randomized, double-blind trial comparing ENTRESTO and enalapril based on an analysis in 110 pediatric patients 1 to < 18 years old with heart failure NYHA/Ross class II-IV due to systemic left ventricular systolic dysfunction LVEF = 40% .\"\n },\n {\n \"VerbatimTerm\": \"Heart Failure\",\n \"Probability\": \"0.0018772483\",\n \"SemanticContext\": \"Figure 7: Treatment Effect for the Composite Endpoint of Time to First HF Hospitalization or CV Death by LVEF in PARADIGM-HF and PARAGON-HF Figure 3: Kaplan-Meier Curves for the Primary Composite Endpoint A , Cardiovascular Death B , and Heart Failure Hospitalization C Figure 4: Primary Composite Endpoint CV Death or HF Hospitalization - Subgroup Analysis Figure 5: Mean Number of Events Over Time for the Primary Composite Endpoint of Total HF Hospitalizations and CV Death Figure 6: Primary Composite Endpoint of Total HF Hospitalizations and CV Death -- Subgroup Analysis PARAGON-HF Figure 7: Treatment Effect for the Composite Endpoint of Time to First HF Hospitalization or CV Death by LVEF in PARADIGM-HF and PARAGON-HF 14.2 Pediatric Heart Failure PANORAMA-HF The efficacy of ENTRESTO was evaluated in a multinational, randomized, double-blind trial comparing ENTRESTO and enalapril based on an analysis in 110 pediatric patients 1 to < 18 years old with heart failure NYHA/Ross class II-IV due to systemic left ventricular systolic dysfunction LVEF = 40% .\"\n },\n {\n \"VerbatimTerm\": \"Heart Failure\",\n \"Probability\": \"0.0001475513\",\n \"SemanticContext\": \"2.2 Adult Heart Failure The recommended starting dose of ENTRESTO is 49/51 mg orally twice-daily.\"\n },\n {\n \"VerbatimTerm\": \"Heart Failure\",\n \"Probability\": \"0.0206190646\",\n \"SemanticContext\": \"2.3 Pediatric Heart Failure Refer to Table 1 for the recommended dose for pediatric patients aged one year and older.\"\n },\n {\n \"VerbatimTerm\": \"Heart Failure\",\n \"Probability\": \"0.0172035098\",\n \"SemanticContext\": \"undefined1 INDICATIONS AND USAGE 1.1 Adult Heart Failure ENTRESTO is indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure.\"\n },\n {\n \"VerbatimTerm\": \"Heart Failure\",\n \"Probability\": \"0.0064969063\",\n \"SemanticContext\": \"1.2 Pediatric Heart Failure ENTRESTO is indicated for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older.\"\n },\n {\n \"VerbatimTerm\": \"heart failure\",\n \"Probability\": \"0.1512141228\",\n \"SemanticContext\": \"to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure.\"\n },\n {\n \"VerbatimTerm\": \"heart failure\",\n \"Probability\": \"0.0556843281\",\n \"SemanticContext\": \"for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older.\"\n },\n {\n \"VerbatimTerm\": \"heart failure\",\n \"Probability\": \"0.0185587406\",\n \"SemanticContext\": \"A total of 6,622 heart failure patients were treated with ENTRESTO in the PARADIGM-HF vs. enalapril and PARAGON-HF vs. valsartan clinical trials.\"\n },\n {\n \"VerbatimTerm\": \"heart failure\",\n \"Probability\": \"0.0069746077\",\n \"SemanticContext\": \"The cardiovascular and renal effects of ENTRESTO in heart failure patients are attributed to the increased levels of peptides that are degraded by neprilysin, such as natriuretic peptides, by LBQ657, and the simultaneous inhibition of the effects of angiotensin II by valsartan.\"\n },\n {\n \"VerbatimTerm\": \"heart failure\",\n \"Probability\": \"0.0186216533\",\n \"SemanticContext\": \"12.2 Pharmacodynamics The pharmacodynamic effects of ENTRESTO were evaluated after single and multiple dose administrations in healthy subjects and in patients with heart failure, and are consistent with simultaneous neprilysin inhibition and renin-angiotensin system blockade.\"\n },\n {\n \"VerbatimTerm\": \"heart failure\",\n \"Probability\": \"0.0056989193\",\n \"SemanticContext\": \"In PARAMOUNT, a randomized, double-blind, 36-week study in patients with heart failure with LVEF = 45% comparing 97/103 mg of ENTRESTO n=149 to 160 mg of valsartan n =152 twice-daily, ENTRESTO decreased NT-proBNP by 17% while valsartan increased NT-proBNP by 8% at Week 12 p = 0.005 .\"\n },\n {\n \"VerbatimTerm\": \"heart failure\",\n \"Probability\": \"0.0014955401\",\n \"SemanticContext\": \"Pediatric Patients: The pharmacokinetics of ENTRESTO were evaluated in pediatric heart failure patients 1 to< 18 years old administered oral doses of 0.8 mg/kg and 3.1 mg/kg of ENTRESTO.\"\n },\n {\n \"VerbatimTerm\": \"heart failure\",\n \"Probability\": \"0.070230186\",\n \"SemanticContext\": \"The primary objective of PARADIGM-HF was to determine whether ENTRESTO, a combination of sacubitril and a RAS inhibitor valsartan , was superior to a RAS inhibitor enalapril alone in reducing the risk of the combined endpoint of cardiovascular CV death or hospitalization for heart failure HF .\"\n },\n {\n \"VerbatimTerm\": \"heart failure\",\n \"Probability\": \"0.7972712517\",\n \"SemanticContext\": \"The underlying cause of heart failure was coronary artery disease in 60% of patients; 71% had a history of hypertension, 43% had a history of myocardial infarction, 37% had an eGFR < 60 mL/min/1.73m 2 , and 35% had diabetes mellitus.\"\n },\n {\n \"VerbatimTerm\": \"heart failure\",\n \"Probability\": \"0.1473268569\",\n \"SemanticContext\": \"PARADIGM-HF demonstrated that ENTRESTO, a combination of sacubitril and a RAS inhibitor valsartan , was superior to a RAS inhibitor enalapril , in reducing the risk of the combined endpoint of cardiovascular death or hospitalization for heart failure, based on a time-to-event analysis hazard ratio [HR] 0.80; 95% confidence interval [CI], 0.73, 0.87, p < 0.0001 .\"\n },\n {\n \"VerbatimTerm\": \"heart failure\",\n \"Probability\": \"0.2093319893\",\n \"SemanticContext\": \"The treatment effect reflected a reduction in both cardiovascular death and heart failure hospitalization; see Table 3 and Figure 3.\"\n },\n {\n \"VerbatimTerm\": \"heart failure\",\n \"Probability\": \"0.0188558102\",\n \"SemanticContext\": \"** Includes patients who had heart failure hospitalization prior to death.\"\n },\n {\n \"VerbatimTerm\": \"heart failure\",\n \"Probability\": \"0.0672160089\",\n \"SemanticContext\": \"ENTRESTO N = 4,187 n % Enalapril N = 4,212 n % Hazard Ratio 95% CI p -value Primary composite endpoint of cardiovascular death or heart failure hospitalization 914 21.8 1,117 26.5 0.80 0.73, 0.87 < 0.0001 Cardiovascular death as first event 377 9.0 459 10.9 Heart failure hospitalization as first event 537 12.8 658 15.6 Number of patients with events: * Cardiovascular death ** 558 13.3 693 16.5 0.80 0.71, 0.89 Heart failure hospitalizations 537 12.8 658 15.6 0.79 0.71, 0.89 All-cause mortality 711 17.0 835 19.8 0.84 0.76, 0.93 0.0009 .\"\n },\n {\n \"VerbatimTerm\": \"heart failure\",\n \"Probability\": \"0.0520744622\",\n \"SemanticContext\": \"The Kaplan-Meier curves presented below Figure 3 show time to first occurrence of the primary composite endpoint 3A , and time to occurrence of cardiovascular death at any time 3B and first heart failure hospitalization 3C .\"\n },\n {\n \"VerbatimTerm\": \"heart failure\",\n \"Probability\": \"0.1775787771\",\n \"SemanticContext\": \"PARAGON-HF PARAGON-HF, was a multicenter, randomized, double-blind trial comparing ENTRESTO and valsartan in 4,796 adult patients with symptomatic heart failure with left ventricular ejection fraction = 45%, and structural heart disease [either left atrial enlargement LAE or left ventricular hypertrophy LVH ].\"\n },\n {\n \"VerbatimTerm\": \"heart failure\",\n \"Probability\": \"0.0096086562\",\n \"SemanticContext\": \"The primary objective of PARAGON-HF was to determine whether ENTRESTO reduced the rate of the composite endpoint of total first and recurrent heart failure HF hospitalizations and cardiovascular CV death.\"\n },\n {\n \"VerbatimTerm\": \"heart failure\",\n \"Probability\": \"0.6532661915\",\n \"SemanticContext\": \"The underlying cause of heart failure was of ischemic etiology in 36% of patients.\"\n },\n {\n \"VerbatimTerm\": \"heart failure\",\n \"Probability\": \"0.004036963\",\n \"SemanticContext\": \"Figure 7: Treatment Effect for the Composite Endpoint of Time to First HF Hospitalization or CV Death by LVEF in PARADIGM-HF and PARAGON-HF Figure 3: Kaplan-Meier Curves for the Primary Composite Endpoint A , Cardiovascular Death B , and Heart Failure Hospitalization C Figure 4: Primary Composite Endpoint CV Death or HF Hospitalization - Subgroup Analysis Figure 5: Mean Number of Events Over Time for the Primary Composite Endpoint of Total HF Hospitalizations and CV Death Figure 6: Primary Composite Endpoint of Total HF Hospitalizations and CV Death -- Subgroup Analysis PARAGON-HF Figure 7: Treatment Effect for the Composite Endpoint of Time to First HF Hospitalization or CV Death by LVEF in PARADIGM-HF and PARAGON-HF 14.2 Pediatric Heart Failure PANORAMA-HF The efficacy of ENTRESTO was evaluated in a multinational, randomized, double-blind trial comparing ENTRESTO and enalapril based on an analysis in 110 pediatric patients 1 to < 18 years old with heart failure NYHA/Ross class II-IV due to systemic left ventricular systolic dysfunction LVEF = 40% .\"\n },\n {\n \"VerbatimTerm\": \"heart failure\",\n \"Probability\": \"0.2585010529\",\n \"SemanticContext\": \"undefined1 INDICATIONS AND USAGE 1.1 Adult Heart Failure ENTRESTO is indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure.\"\n },\n {\n \"VerbatimTerm\": \"heart failure\",\n \"Probability\": \"0.0864062905\",\n \"SemanticContext\": \"1.2 Pediatric Heart Failure ENTRESTO is indicated for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older.\"\n },\n {\n \"VerbatimTerm\": \"heart failure\",\n \"Probability\": \"0.0007191598\",\n \"SemanticContext\": \"8.4 Pediatric Use The safety and effectiveness of ENTRESTO in pediatric heart failure patients 1 to< 18 years old are supported by the reduction from baseline to 12 weeks in NT-proBNP in a randomized, double-blind clinical study [see Clinical Studies 14.2 ] .\"\n },\n {\n \"VerbatimTerm\": \"Heart failure\",\n \"Probability\": \"0.614628315\",\n \"SemanticContext\": \"ENTRESTO N = 4,187 n % Enalapril N = 4,212 n % Hazard Ratio 95% CI p -value Primary composite endpoint of cardiovascular death or heart failure hospitalization 914 21.8 1,117 26.5 0.80 0.73, 0.87 < 0.0001 Cardiovascular death as first event 377 9.0 459 10.9 Heart failure hospitalization as first event 537 12.8 658 15.6 Number of patients with events: * Cardiovascular death ** 558 13.3 693 16.5 0.80 0.71, 0.89 Heart failure hospitalizations 537 12.8 658 15.6 0.79 0.71, 0.89 All-cause mortality 711 17.0 835 19.8 0.84 0.76, 0.93 0.0009 .\"\n },\n {\n \"VerbatimTerm\": \"Heart failure\",\n \"Probability\": \"0.4307456315\",\n \"SemanticContext\": \"ENTRESTO N = 4,187 n % Enalapril N = 4,212 n % Hazard Ratio 95% CI p -value Primary composite endpoint of cardiovascular death or heart failure hospitalization 914 21.8 1,117 26.5 0.80 0.73, 0.87 < 0.0001 Cardiovascular death as first event 377 9.0 459 10.9 Heart failure hospitalization as first event 537 12.8 658 15.6 Number of patients with events: * Cardiovascular death ** 558 13.3 693 16.5 0.80 0.71, 0.89 Heart failure hospitalizations 537 12.8 658 15.6 0.79 0.71, 0.89 All-cause mortality 711 17.0 835 19.8 0.84 0.76, 0.93 0.0009 .\"\n }\n ]\n },\n {\n \"Term\": \"N-terminal prohormone brain natriuretic peptide\",\n \"MEDDRACode\": \"10067803\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"NT-proBNP\",\n \"Probability\": \"0.0002346635\",\n \"SemanticContext\": \"ENTRESTO reduces NT-proBNP and is expected to improve cardiovascular outcomes.\"\n },\n {\n \"VerbatimTerm\": \"NT-proBNP\",\n \"Probability\": \"0.0001230859\",\n \"SemanticContext\": \"In a 7-day valsartan-controlled study in patients with reduced ejection fraction HFrEF , administration of ENTRESTO resulted in a significant non-sustained increase in natriuresis, increased urine cGMP, and decreased plasma MR-proANP and NT-proBNP compared to valsartan.\"\n },\n {\n \"VerbatimTerm\": \"NT-proBNP\",\n \"Probability\": \"5.95785E-05\",\n \"SemanticContext\": \"In a 21-day study in HFrEF patients, ENTRESTO significantly increased urine ANP and cGMP and plasma cGMP, and decreased plasma NT-proBNP, aldosterone and endothelin-1.\"\n },\n {\n \"VerbatimTerm\": \"NT-proBNP\",\n \"Probability\": \"1.95798E-05\",\n \"SemanticContext\": \"In PARADIGM-HF, ENTRESTO decreased plasma NT-proBNP not a neprilysin substrate and increased plasma BNP a neprilysin substrate and urine cGMP compared with enalapril.\"\n },\n {\n \"VerbatimTerm\": \"NT-proBNP\",\n \"Probability\": \"0.0015756786\",\n \"SemanticContext\": \"In PARAMOUNT, a randomized, double-blind, 36-week study in patients with heart failure with LVEF = 45% comparing 97/103 mg of ENTRESTO n=149 to 160 mg of valsartan n =152 twice-daily, ENTRESTO decreased NT-proBNP by 17% while valsartan increased NT-proBNP by 8% at Week 12 p = 0.005 .\"\n },\n {\n \"VerbatimTerm\": \"NT-proBNP\",\n \"Probability\": \"0.0007931292\",\n \"SemanticContext\": \"In PARAGON-HF, ENTRESTO decreased NT-proBNP by 24% Week 16 and 19% Week 48 compared to 6% and 3% reductions on valsartan, respectively.\"\n },\n {\n \"VerbatimTerm\": \"NT-proBNP\",\n \"Probability\": \"3.44313E-05\",\n \"SemanticContext\": \"The endpoint was the between-group difference in the change in plasma NT-proBNP from baseline to 12 weeks.\"\n },\n {\n \"VerbatimTerm\": \"NT-proBNP\",\n \"Probability\": \"8.026E-05\",\n \"SemanticContext\": \"The reduction from baseline in NT-proBNP was 44% and 33% in the ENTRESTO and enalapril groups, respectively.\"\n },\n {\n \"VerbatimTerm\": \"NT-proBNP\",\n \"Probability\": \"2.15251E-05\",\n \"SemanticContext\": \"Because ENTRESTO improved outcomes and reduced NT-proBNP in PARADIGM-HF, the effect on NT-proBNP was considered a reasonable basis to infer improved cardiovascular outcomes in pediatric patients.\"\n },\n {\n \"VerbatimTerm\": \"NT-proBNP\",\n \"Probability\": \"2.87623E-05\",\n \"SemanticContext\": \"Because ENTRESTO improved outcomes and reduced NT-proBNP in PARADIGM-HF, the effect on NT-proBNP was considered a reasonable basis to infer improved cardiovascular outcomes in pediatric patients.\"\n },\n {\n \"VerbatimTerm\": \"NT-proBNP\",\n \"Probability\": \"0.0001285672\",\n \"SemanticContext\": \"ENTRESTO reduces NT-proBNP and is expected to improve cardiovascular outcomes.\"\n },\n {\n \"VerbatimTerm\": \"NT-proBNP\",\n \"Probability\": \"5.6519E-06\",\n \"SemanticContext\": \"8.4 Pediatric Use The safety and effectiveness of ENTRESTO in pediatric heart failure patients 1 to < 18 years old are supported by the reduction from baseline to 12 weeks in NT-proBNP in a randomized, double-blind clinical study [see Clinical Studies 14.2 ] .\"\n },\n {\n \"VerbatimTerm\": \"NT-proBNP\",\n \"Probability\": \"0.0001370311\",\n \"SemanticContext\": \"The analysis of NT-proBNP included 90 patients age 6 to 18 years and 20 patients age 1 to 6 years.\"\n }\n ]\n },\n {\n \"Term\": \"Hyperkalaemia\",\n \"MEDDRACode\": \"10020646\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hyperkalemia\",\n \"Probability\": \"0.9966822863\",\n \"SemanticContext\": \"ADVERSE REACTIONS Adverse reactions occurring = 5% are hypotension, hyperkalemia, cough, dizziness, and renal failure.\"\n },\n {\n \"VerbatimTerm\": \"hyperkalemia\",\n \"Probability\": \"0.9997469187\",\n \"SemanticContext\": \"During the enalapril run-in period, 1,102 patients 10.5% were permanently discontinued from the study, 5.6% because of an adverse event, most commonly renal dysfunction 1.7% , hyperkalemia 1.7% and hypotension 1.4% .\"\n },\n {\n \"VerbatimTerm\": \"hyperkalemia\",\n \"Probability\": \"0.9976707697\",\n \"SemanticContext\": \"During the ENTRESTO run-in period, an additional 10.4% of patients permanently discontinued treatment, 5.9% because of an adverse event, most commonly renal dysfunction 1.8% , hypotension 1.7% and hyperkalemia 1.3% .\"\n },\n {\n \"VerbatimTerm\": \"hyperkalemia\",\n \"Probability\": \"0.0036262572\",\n \"SemanticContext\": \"Closely observe neonates with histories of in utero exposure to ENTRESTO for hypotension, oliguria, and hyperkalemia.\"\n },\n {\n \"VerbatimTerm\": \"hyperkalemia\",\n \"Probability\": \"0.3021903932\",\n \"SemanticContext\": \"5.5 Hyperkalemia Through its actions on the RAAS, hyperkalemia may occur with ENTRESTO [see Adverse Reactions 6.1 ] .\"\n },\n {\n \"VerbatimTerm\": \"hyperkalemia\",\n \"Probability\": \"0.0092568398\",\n \"SemanticContext\": \"Monitor serum potassium periodically and treat appropriately, especially in patients with risk factors for hyperkalemia such as severe renal impairment, diabetes, hypoaldosteronism, or a high potassium diet.\"\n },\n {\n \"VerbatimTerm\": \"Hyperkalemia\",\n \"Probability\": \"0.987498641\",\n \"SemanticContext\": \"undefined6 ADVERSE REACTIONS Clinically significant adverse reactions that appear in other sections of the labeling include: Angioedema [see Warnings and Precautions 5.2 ] Hypotension [see Warnings and Precautions 5.3 ] Impaired Renal Function [see Warnings and Precautions 5.4 ] Hyperkalemia [see Warnings and Precautions 5.5 ] 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.\"\n },\n {\n \"VerbatimTerm\": \"Hyperkalemia\",\n \"Probability\": \"0.9995377064\",\n \"SemanticContext\": \"Table 2: Adverse Reactions Reported in = 5% of Patients Treated with ENTRESTO in the Double-Blind Period of PARADIGM-HF ENTRESTO n = 4,203 % Enalapril n = 4,229 % Hypotension 18 12 Hyperkalemia 12 14 Cough 9 13 Dizziness 6 5 Renal failure/acute renal failure 5 5 .\"\n },\n {\n \"VerbatimTerm\": \"Hyperkalemia\",\n \"Probability\": \"0.1275221109\",\n \"SemanticContext\": \"5.5 Hyperkalemia Through its actions on the RAAS, hyperkalemia may occur with ENTRESTO [see Adverse Reactions 6.1 ] .\"\n }\n ]\n },\n {\n \"Term\": \"Diabetes mellitus\",\n \"MEDDRACode\": \"10012601\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": true,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"diabetes\",\n \"Probability\": \"0.0004902482\",\n \"SemanticContext\": \"Concomitant use with aliskiren in patients with diabetes.\"\n },\n {\n \"VerbatimTerm\": \"diabetes\",\n \"Probability\": \"0.0003626347\",\n \"SemanticContext\": \"Do not administer within 36 hours of switching from or to an ACE inhibitor [see Drug Interactions 7.1 ] with concomitant use of aliskiren in patients with diabetes [see Drug Interactions 7.1 ]\"\n },\n {\n \"VerbatimTerm\": \"diabetes\",\n \"Probability\": \"3.99219E-05\",\n \"SemanticContext\": \"The concomitant use of ENTRESTO with aliskiren is contraindicated in patients with diabetes [see Contraindications 4 ] .\"\n },\n {\n \"VerbatimTerm\": \"diabetes\",\n \"Probability\": \"0.0587316453\",\n \"SemanticContext\": \"Monitor serum potassium periodically and treat appropriately, especially in patients with risk factors for hyperkalemia such as severe renal impairment, diabetes, hypoaldosteronism, or a high potassium diet.\"\n }\n ]\n },\n {\n \"Term\": \"Cardiac failure chronic\",\n \"MEDDRACode\": \"10007558\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"chronic heart failure\",\n \"Probability\": \"0.0033559799\",\n \"SemanticContext\": \"to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure.\"\n },\n {\n \"VerbatimTerm\": \"chronic heart failure\",\n \"Probability\": \"0.0166277885\",\n \"SemanticContext\": \"14.1 Adult Heart Failure PARADIGM-HF PARADIGM-HF was a multinational, randomized, double-blind trial comparing ENTRESTO and enalapril in 8,442 adult patients with symptomatic chronic heart failure NYHA class II--IV and systolic dysfunction left ventricular ejection fraction = 40% .\"\n },\n {\n \"VerbatimTerm\": \"chronic heart failure\",\n \"Probability\": \"0.0096755028\",\n \"SemanticContext\": \"undefined1 INDICATIONS AND USAGE 1.1 Adult Heart Failure ENTRESTO is indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure.\"\n }\n ]\n },\n {\n \"Term\": \"Atrial natriuretic peptide\",\n \"MEDDRACode\": \"10050734\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"ANP\",\n \"Probability\": \"0.0034817755\",\n \"SemanticContext\": \"In a 21-day study in HFrEF patients, ENTRESTO significantly increased urine ANP and cGMP and plasma cGMP, and decreased plasma NT-proBNP, aldosterone and endothelin-1.\"\n }\n ]\n },\n {\n \"Term\": \"Renal failure\",\n \"MEDDRACode\": \"10038435\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"renal failure\",\n \"Probability\": \"0.9910707474\",\n \"SemanticContext\": \"ADVERSE REACTIONS Adverse reactions occurring = 5% are hypotension, hyperkalemia, cough, dizziness, and renal failure.\"\n },\n {\n \"VerbatimTerm\": \"renal failure\",\n \"Probability\": \"0.8414125443\",\n \"SemanticContext\": \"Clinical Considerations Fetal/Neonatal Adverse Reactions Oligohydramnios in pregnant women who use drugs affecting the renin-angiotensin system in the second and third trimesters of pregnancy can result in the following: reduced fetal renal function leading to anuria and renal failure, fetal lung hypoplasia, skeletal deformations, including skull hypoplasia, hypotension, and death.\"\n },\n {\n \"VerbatimTerm\": \"Renal failure\",\n \"Probability\": \"0.8244662285\",\n \"SemanticContext\": \"Table 2: Adverse Reactions Reported in = 5% of Patients Treated with ENTRESTO in the Double-Blind Period of PARADIGM-HF ENTRESTO n = 4,203 % Enalapril n = 4,229 % Hypotension 18 12 Hyperkalemia 12 14 Cough 9 13 Dizziness 6 5 Renal failure/acute renal failure 5 5 .\"\n }\n ]\n },\n {\n \"Term\": \"Cardiac resynchronisation therapy\",\n \"MEDDRACode\": \"10059862\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"cardiac resynchronization therapy\",\n \"Probability\": \"2.93315E-05\",\n \"SemanticContext\": \"Few patients had an implantable cardioverter-defibrillator ICD or cardiac resynchronization therapy-defibrillator CRT-D 15% .\"\n }\n ]\n },\n {\n \"Term\": \"Oestradiol\",\n \"MEDDRACode\": \"10030227\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"estradiol\",\n \"Probability\": \"0.0001847446\",\n \"SemanticContext\": \"Dedicated drug interaction studies demonstrated that coadministration of furosemide, warfarin, digoxin, carvedilol, a combination of levonorgestrel/ethinyl estradiol, amlodipine, omeprazole, hydrochlorothiazide HCTZ , metformin, atorvastatin, and sildenafil, did not alter the systemic exposure to sacubitril, LBQ657 or valsartan.\"\n }\n ]\n },\n {\n \"Term\": \"Blood iron\",\n \"MEDDRACode\": \"10005616\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"iron\",\n \"Probability\": \"0.2064819038\",\n \"SemanticContext\": \"The film-coat inactive ingredients are hypromellose, titanium dioxide E 171 , Macrogol 4000, talc, and iron oxide red E 172 .\"\n },\n {\n \"VerbatimTerm\": \"iron\",\n \"Probability\": \"0.0707624257\",\n \"SemanticContext\": \"The film-coat for the 24 mg of sacubitril and 26 mg of valsartan tablet and the 97 mg of sacubitril and 103 mg of valsartan tablet also contains iron oxide black E 172 .\"\n },\n {\n \"VerbatimTerm\": \"iron\",\n \"Probability\": \"0.0538579524\",\n \"SemanticContext\": \"The film-coat for the 49 mg of sacubitril and 51 mg of valsartan tablet contains iron oxide yellow E 172 .\"\n }\n ]\n },\n {\n \"Term\": \"Blood pressure systolic\",\n \"MEDDRACode\": \"10005756\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"systolic blood pressure\",\n \"Probability\": \"6.33042E-05\",\n \"SemanticContext\": \"Patients with a systolic blood pressure of< 100 mmHg at screening were excluded.\"\n },\n {\n \"VerbatimTerm\": \"systolic blood pressure\",\n \"Probability\": \"0.0003316402\",\n \"SemanticContext\": \"Patients with a systolic blood pressure of < 110 mmHg and patients with any prior echocardiographic LVEF < 40% at screening were excluded.\"\n }\n ]\n },\n {\n \"Term\": \"Blood sodium\",\n \"MEDDRACode\": \"10005799\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0013027787\",\n \"SemanticContext\": \"ENTRESTO contains a complex comprised of anionic forms of sacubitril and valsartan, sodium cations, and water molecules in the molar ratio of 1:1:3:2.5, respectively.\"\n }\n ]\n },\n {\n \"Term\": \"Left ventricular dysfunction\",\n \"MEDDRACode\": \"10049694\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"left ventricular systolic dysfunction\",\n \"Probability\": \"0.0177028477\",\n \"SemanticContext\": \"for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older.\"\n },\n {\n \"VerbatimTerm\": \"left ventricular systolic dysfunction\",\n \"Probability\": \"0.0277014673\",\n \"SemanticContext\": \"Figure 7: Treatment Effect for the Composite Endpoint of Time to First HF Hospitalization or CV Death by LVEF in PARADIGM-HF and PARAGON-HF Figure 3: Kaplan-Meier Curves for the Primary Composite Endpoint A , Cardiovascular Death B , and Heart Failure Hospitalization C Figure 4: Primary Composite Endpoint CV Death or HF Hospitalization - Subgroup Analysis Figure 5: Mean Number of Events Over Time for the Primary Composite Endpoint of Total HF Hospitalizations and CV Death Figure 6: Primary Composite Endpoint of Total HF Hospitalizations and CV Death -- Subgroup Analysis PARAGON-HF Figure 7: Treatment Effect for the Composite Endpoint of Time to First HF Hospitalization or CV Death by LVEF in PARADIGM-HF and PARAGON-HF 14.2 Pediatric Heart Failure PANORAMA-HF The efficacy of ENTRESTO was evaluated in a multinational, randomized, double-blind trial comparing ENTRESTO and enalapril based on an analysis in 110 pediatric patients 1 to < 18 years old with heart failure NYHA/Ross class II-IV due to systemic left ventricular systolic dysfunction LVEF = 40% .\"\n },\n {\n \"VerbatimTerm\": \"left ventricular systolic dysfunction\",\n \"Probability\": \"0.1870474815\",\n \"SemanticContext\": \"1.2 Pediatric Heart Failure ENTRESTO is indicated for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older.\"\n },\n {\n \"VerbatimTerm\": \"systolic dysfunction left ventricular\",\n \"Probability\": \"0.3379301131\",\n \"SemanticContext\": \"14.1 Adult Heart Failure PARADIGM-HF PARADIGM-HF was a multinational, randomized, double-blind trial comparing ENTRESTO and enalapril in 8,442 adult patients with symptomatic chronic heart failure NYHA class II--IV and systolic dysfunction left ventricular ejection fraction = 40% .\"\n }\n ]\n },\n {\n \"Term\": \"Systemic right ventricle\",\n \"MEDDRACode\": \"10083204\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"systemic right ventricles\",\n \"Probability\": \"0.0070889294\",\n \"SemanticContext\": \"Patients with systemic right ventricles and single ventricles were excluded from the trial.\"\n }\n ]\n },\n {\n \"Term\": \"Hospitalisation\",\n \"MEDDRACode\": \"10054112\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hospitalization\",\n \"Probability\": \"0.0079711378\",\n \"SemanticContext\": \"to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure.\"\n },\n {\n \"VerbatimTerm\": \"hospitalization\",\n \"Probability\": \"0.003831327\",\n \"SemanticContext\": \"The primary objective of PARADIGM-HF was to determine whether ENTRESTO, a combination of sacubitril and a RAS inhibitor valsartan , was superior to a RAS inhibitor enalapril alone in reducing the risk of the combined endpoint of cardiovascular CV death or hospitalization for heart failure HF .\"\n },\n {\n \"VerbatimTerm\": \"hospitalization\",\n \"Probability\": \"0.0387027264\",\n \"SemanticContext\": \"The primary endpoint was the first event in the composite of CV death or hospitalization for HF.\"\n },\n {\n \"VerbatimTerm\": \"hospitalization\",\n \"Probability\": \"0.0046045184\",\n \"SemanticContext\": \"PARADIGM-HF demonstrated that ENTRESTO, a combination of sacubitril and a RAS inhibitor valsartan , was superior to a RAS inhibitor enalapril , in reducing the risk of the combined endpoint of cardiovascular death or hospitalization for heart failure, based on a time-to-event analysis hazard ratio [HR] 0.80; 95% confidence interval [CI], 0.73, 0.87, p < 0.0001 .\"\n },\n {\n \"VerbatimTerm\": \"hospitalization\",\n \"Probability\": \"0.0372165143\",\n \"SemanticContext\": \"The treatment effect reflected a reduction in both cardiovascular death and heart failure hospitalization; see Table 3 and Figure 3.\"\n },\n {\n \"VerbatimTerm\": \"hospitalization\",\n \"Probability\": \"0.0016628206\",\n \"SemanticContext\": \"** Includes patients who had heart failure hospitalization prior to death.\"\n },\n {\n \"VerbatimTerm\": \"hospitalization\",\n \"Probability\": \"0.2542505264\",\n \"SemanticContext\": \"ENTRESTO N = 4,187 n % Enalapril N = 4,212 n % Hazard Ratio 95% CI p -value Primary composite endpoint of cardiovascular death or heart failure hospitalization 914 21.8 1,117 26.5 0.80 0.73, 0.87 < 0.0001 Cardiovascular death as first event 377 9.0 459 10.9 Heart failure hospitalization as first event 537 12.8 658 15.6 Number of patients with events: * Cardiovascular death ** 558 13.3 693 16.5 0.80 0.71, 0.89 Heart failure hospitalizations 537 12.8 658 15.6 0.79 0.71, 0.89 All-cause mortality 711 17.0 835 19.8 0.84 0.76, 0.93 0.0009 .\"\n },\n {\n \"VerbatimTerm\": \"hospitalization\",\n \"Probability\": \"0.156404078\",\n \"SemanticContext\": \"ENTRESTO N = 4,187 n % Enalapril N = 4,212 n % Hazard Ratio 95% CI p -value Primary composite endpoint of cardiovascular death or heart failure hospitalization 914 21.8 1,117 26.5 0.80 0.73, 0.87 < 0.0001 Cardiovascular death as first event 377 9.0 459 10.9 Heart failure hospitalization as first event 537 12.8 658 15.6 Number of patients with events: * Cardiovascular death ** 558 13.3 693 16.5 0.80 0.71, 0.89 Heart failure hospitalizations 537 12.8 658 15.6 0.79 0.71, 0.89 All-cause mortality 711 17.0 835 19.8 0.84 0.76, 0.93 0.0009 .\"\n },\n {\n \"VerbatimTerm\": \"hospitalization\",\n \"Probability\": \"0.0099368393\",\n \"SemanticContext\": \"The Kaplan-Meier curves presented below Figure 3 show time to first occurrence of the primary composite endpoint 3A , and time to occurrence of cardiovascular death at any time 3B and first heart failure hospitalization 3C .\"\n },\n {\n \"VerbatimTerm\": \"hospitalization\",\n \"Probability\": \"0.0174474716\",\n \"SemanticContext\": \"b Includes patients who had CV death following HF hospitalization event.\"\n },\n {\n \"VerbatimTerm\": \"hospitalization\",\n \"Probability\": \"0.0148082972\",\n \"SemanticContext\": \"undefined1 INDICATIONS AND USAGE 1.1 Adult Heart Failure ENTRESTO is indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure.\"\n },\n {\n \"VerbatimTerm\": \"hospitalizations\",\n \"Probability\": \"0.4475217164\",\n \"SemanticContext\": \"ENTRESTO N = 4,187 n % Enalapril N = 4,212 n % Hazard Ratio 95% CI p -value Primary composite endpoint of cardiovascular death or heart failure hospitalization 914 21.8 1,117 26.5 0.80 0.73, 0.87< 0.0001 Cardiovascular death as first event 377 9.0 459 10.9 Heart failure hospitalization as first event 537 12.8 658 15.6 Number of patients with events: * Cardiovascular death ** 558 13.3 693 16.5 0.80 0.71, 0.89 Heart failure hospitalizations 537 12.8 658 15.6 0.79 0.71, 0.89 All-cause mortality 711 17.0 835 19.8 0.84 0.76, 0.93 0.0009 .\"\n },\n {\n \"VerbatimTerm\": \"hospitalizations\",\n \"Probability\": \"0.0009565353\",\n \"SemanticContext\": \"The primary objective of PARAGON-HF was to determine whether ENTRESTO reduced the rate of the composite endpoint of total first and recurrent heart failure HF hospitalizations and cardiovascular CV death.\"\n },\n {\n \"VerbatimTerm\": \"hospitalizations\",\n \"Probability\": \"0.0118823946\",\n \"SemanticContext\": \"PARAGON-HF demonstrated that ENTRESTO had a numerical reduction in the rate of the composite endpoint of total first and recurrent HF hospitalizations and CV death, based on an analysis using a proportional rates model rate ratio [RR] 0.87; 95% CI [0.75, 1.01], p = 0.06 ; see Table 4.\"\n },\n {\n \"VerbatimTerm\": \"hospitalizations\",\n \"Probability\": \"0.0002851188\",\n \"SemanticContext\": \"The treatment effect was primarily driven by the reduction in total HF hospitalizations in patients randomized to ENTRESTO RR 0.85; 95% CI [0.72, 1.00] .\"\n },\n {\n \"VerbatimTerm\": \"hospitalizations\",\n \"Probability\": \"0.0131110549\",\n \"SemanticContext\": \"ENTRESTO N = 2,407 Valsartan N = 2,389 Effect Size 95% CI Efficacy Endpoints n Event Rate a n Event Rate a Composite of total first and recurrent HF hospitalizations and CV death 894 12.8 1,009 14.6 RR = 0.87 0.75, 1.01 p -value 0.06 Total HF Hospitalizations 690 9.9 797 11.6 RR = 0.85 0.72, 1.00 CV Death b 204 2.9 212 3.1 HR = 0.95 0.79, 1.16 .\"\n },\n {\n \"VerbatimTerm\": \"hospitalizations\",\n \"Probability\": \"0.0087746084\",\n \"SemanticContext\": \"Figure 5 shows the mean number of composite endpoint events of total HF hospitalizations and CV death over time.\"\n },\n {\n \"VerbatimTerm\": \"Hospitalization\",\n \"Probability\": \"0.0004169345\",\n \"SemanticContext\": \"Figure 3: Kaplan-Meier Curves for the Primary Composite Endpoint A , Cardiovascular Death B , and Heart Failure Hospitalization C A wide range of demographic characteristics, baseline disease characteristics, and baseline concomitant medications were examined for their influence on outcomes.\"\n },\n {\n \"VerbatimTerm\": \"Hospitalization\",\n \"Probability\": \"0.0016177297\",\n \"SemanticContext\": \"Figure 4: Primary Composite Endpoint CV Death or HF Hospitalization - Subgroup Analysis PARADIGM-HF Note: The figure above presents effects in various subgroups, all of which are baseline characteristics.\"\n },\n {\n \"VerbatimTerm\": \"Hospitalization\",\n \"Probability\": \"0.000187993\",\n \"SemanticContext\": \"Figure 7: Treatment Effect for the Composite Endpoint of Time to First HF Hospitalization or CV Death by LVEF in PARADIGM-HF and PARAGON-HF Figure 3: Kaplan-Meier Curves for the Primary Composite Endpoint A , Cardiovascular Death B , and Heart Failure Hospitalization C Figure 4: Primary Composite Endpoint CV Death or HF Hospitalization - Subgroup Analysis Figure 5: Mean Number of Events Over Time for the Primary Composite Endpoint of Total HF Hospitalizations and CV Death Figure 6: Primary Composite Endpoint of Total HF Hospitalizations and CV Death -- Subgroup Analysis PARAGON-HF Figure 7: Treatment Effect for the Composite Endpoint of Time to First HF Hospitalization or CV Death by LVEF in PARADIGM-HF and PARAGON-HF 14.2 Pediatric Heart Failure PANORAMA-HF The efficacy of ENTRESTO was evaluated in a multinational, randomized, double-blind trial comparing ENTRESTO and enalapril based on an analysis in 110 pediatric patients 1 to < 18 years old with heart failure NYHA/Ross class II-IV due to systemic left ventricular systolic dysfunction LVEF = 40% .\"\n },\n {\n \"VerbatimTerm\": \"Hospitalization\",\n \"Probability\": \"0.0262895525\",\n \"SemanticContext\": \"Figure 7: Treatment Effect for the Composite Endpoint of Time to First HF Hospitalization or CV Death by LVEF in PARADIGM-HF and PARAGON-HF Figure 3: Kaplan-Meier Curves for the Primary Composite Endpoint A , Cardiovascular Death B , and Heart Failure Hospitalization C Figure 4: Primary Composite Endpoint CV Death or HF Hospitalization - Subgroup Analysis Figure 5: Mean Number of Events Over Time for the Primary Composite Endpoint of Total HF Hospitalizations and CV Death Figure 6: Primary Composite Endpoint of Total HF Hospitalizations and CV Death -- Subgroup Analysis PARAGON-HF Figure 7: Treatment Effect for the Composite Endpoint of Time to First HF Hospitalization or CV Death by LVEF in PARADIGM-HF and PARAGON-HF 14.2 Pediatric Heart Failure PANORAMA-HF The efficacy of ENTRESTO was evaluated in a multinational, randomized, double-blind trial comparing ENTRESTO and enalapril based on an analysis in 110 pediatric patients 1 to < 18 years old with heart failure NYHA/Ross class II-IV due to systemic left ventricular systolic dysfunction LVEF = 40% .\"\n },\n {\n \"VerbatimTerm\": \"Hospitalization\",\n \"Probability\": \"0.0049089491\",\n \"SemanticContext\": \"Figure 7: Treatment Effect for the Composite Endpoint of Time to First HF Hospitalization or CV Death by LVEF in PARADIGM-HF and PARAGON-HF Figure 3: Kaplan-Meier Curves for the Primary Composite Endpoint A , Cardiovascular Death B , and Heart Failure Hospitalization C Figure 4: Primary Composite Endpoint CV Death or HF Hospitalization - Subgroup Analysis Figure 5: Mean Number of Events Over Time for the Primary Composite Endpoint of Total HF Hospitalizations and CV Death Figure 6: Primary Composite Endpoint of Total HF Hospitalizations and CV Death -- Subgroup Analysis PARAGON-HF Figure 7: Treatment Effect for the Composite Endpoint of Time to First HF Hospitalization or CV Death by LVEF in PARADIGM-HF and PARAGON-HF 14.2 Pediatric Heart Failure PANORAMA-HF The efficacy of ENTRESTO was evaluated in a multinational, randomized, double-blind trial comparing ENTRESTO and enalapril based on an analysis in 110 pediatric patients 1 to < 18 years old with heart failure NYHA/Ross class II-IV due to systemic left ventricular systolic dysfunction LVEF = 40% .\"\n },\n {\n \"VerbatimTerm\": \"Hospitalization\",\n \"Probability\": \"0.0001484752\",\n \"SemanticContext\": \"Figure 7: Treatment Effect for the Composite Endpoint of Time to First HF Hospitalization or CV Death by LVEF in PARADIGM-HF and PARAGON-HF Figure 3: Kaplan-Meier Curves for the Primary Composite Endpoint A , Cardiovascular Death B , and Heart Failure Hospitalization C Figure 4: Primary Composite Endpoint CV Death or HF Hospitalization - Subgroup Analysis Figure 5: Mean Number of Events Over Time for the Primary Composite Endpoint of Total HF Hospitalizations and CV Death Figure 6: Primary Composite Endpoint of Total HF Hospitalizations and CV Death -- Subgroup Analysis PARAGON-HF Figure 7: Treatment Effect for the Composite Endpoint of Time to First HF Hospitalization or CV Death by LVEF in PARADIGM-HF and PARAGON-HF 14.2 Pediatric Heart Failure PANORAMA-HF The efficacy of ENTRESTO was evaluated in a multinational, randomized, double-blind trial comparing ENTRESTO and enalapril based on an analysis in 110 pediatric patients 1 to < 18 years old with heart failure NYHA/Ross class II-IV due to systemic left ventricular systolic dysfunction LVEF = 40% .\"\n },\n {\n \"VerbatimTerm\": \"Hospitalizations\",\n \"Probability\": \"0.0479264557\",\n \"SemanticContext\": \"ENTRESTO N = 2,407 Valsartan N = 2,389 Effect Size 95% CI Efficacy Endpoints n Event Rate a n Event Rate a Composite of total first and recurrent HF hospitalizations and CV death 894 12.8 1,009 14.6 RR = 0.87 0.75, 1.01 p -value 0.06 Total HF Hospitalizations 690 9.9 797 11.6 RR = 0.85 0.72, 1.00 CV Death b 204 2.9 212 3.1 HR = 0.95 0.79, 1.16 .\"\n },\n {\n \"VerbatimTerm\": \"Hospitalizations\",\n \"Probability\": \"0.0001463592\",\n \"SemanticContext\": \"Figure 5: Mean Number of Events Over Time for the Primary Composite Endpoint of Total HF Hospitalizations and CV Death A wide range of demographic characteristics, baseline disease characteristics, and baseline concomitant medications were examined for their influence on outcomes Figure 6 .\"\n },\n {\n \"VerbatimTerm\": \"Hospitalizations\",\n \"Probability\": \"0.001683265\",\n \"SemanticContext\": \"Figure 6: Primary Composite Endpoint of Total HF Hospitalizations and CV Death -- Subgroup Analysis PARAGON-HF Note: The figure above presents effects in various subgroups, all of which are baseline characteristics.\"\n },\n {\n \"VerbatimTerm\": \"Hospitalizations\",\n \"Probability\": \"0.0047215521\",\n \"SemanticContext\": \"Figure 7: Treatment Effect for the Composite Endpoint of Time to First HF Hospitalization or CV Death by LVEF in PARADIGM-HF and PARAGON-HF Figure 3: Kaplan-Meier Curves for the Primary Composite Endpoint A , Cardiovascular Death B , and Heart Failure Hospitalization C Figure 4: Primary Composite Endpoint CV Death or HF Hospitalization - Subgroup Analysis Figure 5: Mean Number of Events Over Time for the Primary Composite Endpoint of Total HF Hospitalizations and CV Death Figure 6: Primary Composite Endpoint of Total HF Hospitalizations and CV Death -- Subgroup Analysis PARAGON-HF Figure 7: Treatment Effect for the Composite Endpoint of Time to First HF Hospitalization or CV Death by LVEF in PARADIGM-HF and PARAGON-HF 14.2 Pediatric Heart Failure PANORAMA-HF The efficacy of ENTRESTO was evaluated in a multinational, randomized, double-blind trial comparing ENTRESTO and enalapril based on an analysis in 110 pediatric patients 1 to < 18 years old with heart failure NYHA/Ross class II-IV due to systemic left ventricular systolic dysfunction LVEF = 40% .\"\n },\n {\n \"VerbatimTerm\": \"Hospitalizations\",\n \"Probability\": \"0.0044625103\",\n \"SemanticContext\": \"Figure 7: Treatment Effect for the Composite Endpoint of Time to First HF Hospitalization or CV Death by LVEF in PARADIGM-HF and PARAGON-HF Figure 3: Kaplan-Meier Curves for the Primary Composite Endpoint A , Cardiovascular Death B , and Heart Failure Hospitalization C Figure 4: Primary Composite Endpoint CV Death or HF Hospitalization - Subgroup Analysis Figure 5: Mean Number of Events Over Time for the Primary Composite Endpoint of Total HF Hospitalizations and CV Death Figure 6: Primary Composite Endpoint of Total HF Hospitalizations and CV Death -- Subgroup Analysis PARAGON-HF Figure 7: Treatment Effect for the Composite Endpoint of Time to First HF Hospitalization or CV Death by LVEF in PARADIGM-HF and PARAGON-HF 14.2 Pediatric Heart Failure PANORAMA-HF The efficacy of ENTRESTO was evaluated in a multinational, randomized, double-blind trial comparing ENTRESTO and enalapril based on an analysis in 110 pediatric patients 1 to < 18 years old with heart failure NYHA/Ross class II-IV due to systemic left ventricular systolic dysfunction LVEF = 40% .\"\n }\n ]\n },\n {\n \"Term\": \"Drug interaction\",\n \"MEDDRACode\": \"10013710\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": true,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"DRUG INTERACTIONS\",\n \"Probability\": \"0.0002338886\",\n \"SemanticContext\": \"DRUG INTERACTIONS Avoid concomitant use with aliskiren in patients with eGFR < 60.\"\n },\n {\n \"VerbatimTerm\": \"DRUG INTERACTIONS\",\n \"Probability\": \"0.0020399392\",\n \"SemanticContext\": \"7 DRUG INTERACTIONS 7.1 Dual Blockade of the Renin-Angiotensin-Aldosterone System Concomitant use of ENTRESTO with an ACE inhibitor is contraindicated because of the increased risk of angioedema [see Contraindications 4 ] .\"\n },\n {\n \"VerbatimTerm\": \"Drug Interactions\",\n \"Probability\": \"0.0002914369\",\n \"SemanticContext\": \"Drug Interactions: Effect of Co-administered Drugs on ENTRESTO: Because CYP450 enzyme-mediated metabolism of sacubitril and valsartan is minimal, coadministration with drugs that impact CYP450 enzymes is not expected to affect the pharmacokinetics of ENTRESTO.\"\n },\n {\n \"VerbatimTerm\": \"Drug Interactions\",\n \"Probability\": \"0.0003542006\",\n \"SemanticContext\": \"Do not administer within 36 hours of switching from or to an ACE inhibitor [see Drug Interactions 7.1 ] with concomitant use of aliskiren in patients with diabetes [see Drug Interactions 7.1 ]\"\n },\n {\n \"VerbatimTerm\": \"Drug Interactions\",\n \"Probability\": \"0.0002714097\",\n \"SemanticContext\": \"Do not administer within 36 hours of switching from or to an ACE inhibitor [see Drug Interactions 7.1 ] with concomitant use of aliskiren in patients with diabetes [see Drug Interactions 7.1 ]\"\n },\n {\n \"VerbatimTerm\": \"Drug Interactions\",\n \"Probability\": \"0.0005121827\",\n \"SemanticContext\": \"If switching from an ACE inhibitor to ENTRESTO allow a washout period of 36 hours between administration of the two drugs [see Contraindications 4 and Drug Interactions 7.1 ] .\"\n },\n {\n \"VerbatimTerm\": \"drug interaction\",\n \"Probability\": \"0.0001884103\",\n \"SemanticContext\": \"Dedicated drug interaction studies demonstrated that coadministration of furosemide, warfarin, digoxin, carvedilol, a combination of levonorgestrel/ethinyl estradiol, amlodipine, omeprazole, hydrochlorothiazide HCTZ , metformin, atorvastatin, and sildenafil, did not alter the systemic exposure to sacubitril, LBQ657 or valsartan.\"\n }\n ]\n },\n {\n \"Term\": \"Pregnancy\",\n \"MEDDRACode\": \"10036556\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"pregnancy\",\n \"Probability\": \"0.0161731839\",\n \"SemanticContext\": \"When pregnancy is detected, discontinue ENTRESTO as soon as possible.\"\n },\n {\n \"VerbatimTerm\": \"pregnancy\",\n \"Probability\": \"0.0004371703\",\n \"SemanticContext\": \"Pregnancy: Advise female patients of childbearing age about the consequences of exposure to ENTRESTO during pregnancy.\"\n },\n {\n \"VerbatimTerm\": \"pregnancy\",\n \"Probability\": \"0.0022804439\",\n \"SemanticContext\": \"Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death.\"\n },\n {\n \"VerbatimTerm\": \"pregnancy\",\n \"Probability\": \"0.0001852214\",\n \"SemanticContext\": \"When pregnancy is detected, consider alternative drug treatment and discontinue ENTRESTO.\"\n },\n {\n \"VerbatimTerm\": \"pregnancy\",\n \"Probability\": \"0.0273528993\",\n \"SemanticContext\": \"Clinical Considerations Fetal/Neonatal Adverse Reactions Oligohydramnios in pregnant women who use drugs affecting the renin-angiotensin system in the second and third trimesters of pregnancy can result in the following: reduced fetal renal function leading to anuria and renal failure, fetal lung hypoplasia, skeletal deformations, including skull hypoplasia, hypotension, and death.\"\n },\n {\n \"VerbatimTerm\": \"pregnancy\",\n \"Probability\": \"0.0022804439\",\n \"SemanticContext\": \"Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death.\"\n },\n {\n \"VerbatimTerm\": \"pregnancy\",\n \"Probability\": \"0.0017968416\",\n \"SemanticContext\": \"When pregnancy is detected, consider alternative drug treatment and discontinue ENTRESTO.\"\n },\n {\n \"VerbatimTerm\": \"Pregnancy\",\n \"Probability\": \"0.0614420474\",\n \"SemanticContext\": \"Pregnancy: Advise female patients of childbearing age about the consequences of exposure to ENTRESTO during pregnancy.\"\n },\n {\n \"VerbatimTerm\": \"Pregnancy\",\n \"Probability\": \"0.0145212412\",\n \"SemanticContext\": \"8.1 Pregnancy Risk Summary ENTRESTO can cause fetal harm when administered to a pregnant woman.\"\n },\n {\n \"VerbatimTerm\": \"pregnancies\",\n \"Probability\": \"0.000228405\",\n \"SemanticContext\": \"Ask patients to report pregnancies to their physicians as soon as possible [see Warnings and Precautions 5.1 and Use in Specific Populations 8.1 ] .\"\n },\n {\n \"VerbatimTerm\": \"pregnancies\",\n \"Probability\": \"0.0937973261\",\n \"SemanticContext\": \"In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.\"\n }\n ]\n },\n {\n \"Term\": \"Transfusion\",\n \"MEDDRACode\": \"10066152\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"transfusions\",\n \"Probability\": \"1.56276E-05\",\n \"SemanticContext\": \"Exchange transfusions or dialysis may be required as a means of reversing hypotension and replacing renal function.\"\n }\n ]\n },\n {\n \"Term\": \"Ejection fraction\",\n \"MEDDRACode\": \"10050527\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"ejection fraction\",\n \"Probability\": \"0.0007583499\",\n \"SemanticContext\": \"In a 7-day valsartan-controlled study in patients with reduced ejection fraction HFrEF , administration of ENTRESTO resulted in a significant non-sustained increase in natriuresis, increased urine cGMP, and decreased plasma MR-proANP and NT-proBNP compared to valsartan.\"\n }\n ]\n },\n {\n \"Term\": \"Blood potassium increased\",\n \"MEDDRACode\": \"10005725\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"increased serum potassium\",\n \"Probability\": \"0.1358798742\",\n \"SemanticContext\": \"Potassium-sparing diuretics: May lead to increased serum potassium.\"\n }\n ]\n },\n {\n \"Term\": \"Cough\",\n \"MEDDRACode\": \"10011224\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"cough\",\n \"Probability\": \"0.998965919\",\n \"SemanticContext\": \"ADVERSE REACTIONS Adverse reactions occurring = 5% are hypotension, hyperkalemia, cough, dizziness, and renal failure.\"\n },\n {\n \"VerbatimTerm\": \"Cough\",\n \"Probability\": \"0.9997550249\",\n \"SemanticContext\": \"Table 2: Adverse Reactions Reported in = 5% of Patients Treated with ENTRESTO in the Double-Blind Period of PARADIGM-HF ENTRESTO n = 4,203 % Enalapril n = 4,229 % Hypotension 18 12 Hyperkalemia 12 14 Cough 9 13 Dizziness 6 5 Renal failure/acute renal failure 5 5 .\"\n }\n ]\n },\n {\n \"Term\": \"Epinephrine\",\n \"MEDDRACode\": \"10015060\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"epinephrine\",\n \"Probability\": \"1.85311E-05\",\n \"SemanticContext\": \"Where there is involvement of the tongue, glottis or larynx, likely to cause airway obstruction, administer appropriate therapy, e.g., subcutaneous epinephrine/adrenaline solution 1:1000 0.3 mL to 0.5 mL and take measures necessary to ensure maintenance of a patent airway.\"\n }\n ]\n },\n {\n \"Term\": \"Renal impairment\",\n \"MEDDRACode\": \"10062237\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"renal impairment\",\n \"Probability\": \"0.1053782701\",\n \"SemanticContext\": \"Reduce starting dose to half the usually recommended starting dosage for: - patients not currently taking an ACE inhibitor or ARB or previously taking a low dose of these agents 2.5 - patients with severe renal impairment 2.6 - patients with moderate hepatic impairment 2.7 .\"\n },\n {\n \"VerbatimTerm\": \"renal impairment\",\n \"Probability\": \"0.8274530172\",\n \"SemanticContext\": \"NSAIDs: May lead to increased risk of renal impairment.\"\n },\n {\n \"VerbatimTerm\": \"renal impairment\",\n \"Probability\": \"1.30013E-05\",\n \"SemanticContext\": \"Avoid use with aliskiren in patients with renal impairment eGFR < 60 mL/min/1.73 m 2 .\"\n },\n {\n \"VerbatimTerm\": \"renal impairment\",\n \"Probability\": \"0.0008538961\",\n \"SemanticContext\": \"2.6 Dose Adjustment for Severe Renal Impairment In adults and pediatric patients with severe renal impairment eGFR < 30 mL/min/1.73 m 2 , start ENTRESTO at half the usually recommended starting dose.\"\n },\n {\n \"VerbatimTerm\": \"renal impairment\",\n \"Probability\": \"0.0001527369\",\n \"SemanticContext\": \"No starting dose adjustment is needed for mild or moderate renal impairment.\"\n },\n {\n \"VerbatimTerm\": \"renal impairment\",\n \"Probability\": \"0.1105166078\",\n \"SemanticContext\": \"Monitor serum potassium periodically and treat appropriately, especially in patients with risk factors for hyperkalemia such as severe renal impairment, diabetes, hypoaldosteronism, or a high potassium diet.\"\n },\n {\n \"VerbatimTerm\": \"Renal Impairment\",\n \"Probability\": \"0.0058254302\",\n \"SemanticContext\": \"2.6 Dose Adjustment for Severe Renal Impairment In adults and pediatric patients with severe renal impairment eGFR < 30 mL/min/1.73 m 2 , start ENTRESTO at half the usually recommended starting dose.\"\n }\n ]\n },\n {\n \"Term\": \"Peritoneal equilibration test\",\n \"MEDDRACode\": \"10064772\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"PET\",\n \"Probability\": \"0.0005914867\",\n \"SemanticContext\": \"Transfer the entire contents from the mortar into a clean 200 mL amber colored PET or glass bottle.\"\n }\n ]\n },\n {\n \"Term\": \"Angioedema\",\n \"MEDDRACode\": \"10002424\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": true,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"angioedema\",\n \"Probability\": \"0.1606844664\",\n \"SemanticContext\": \"History of angioedema related to previous ACEi or ARB therapy.\"\n },\n {\n \"VerbatimTerm\": \"angioedema\",\n \"Probability\": \"0.170959264\",\n \"SemanticContext\": \"WARNINGS AND PRECAUTIONS Observe for signs and symptoms of angioedema and hypotension.\"\n },\n {\n \"VerbatimTerm\": \"angioedema\",\n \"Probability\": \"0.8044259548\",\n \"SemanticContext\": \"In PARADIGM-HF, the incidence of angioedema was 0.1% in both the enalapril and ENTRESTO run-in periods.\"\n },\n {\n \"VerbatimTerm\": \"angioedema\",\n \"Probability\": \"0.929672718\",\n \"SemanticContext\": \"In the double-blind period, the incidence of angioedema was higher in patients treated with ENTRESTO than enalapril 0.5% and 0.2%, respectively .\"\n },\n {\n \"VerbatimTerm\": \"angioedema\",\n \"Probability\": \"0.9164919853\",\n \"SemanticContext\": \"The incidence of angioedema in Black patients was 2.4% with ENTRESTO and 0.5% with enalapril [see Warnings and Precautions 5.2 ] .\"\n },\n {\n \"VerbatimTerm\": \"angioedema\",\n \"Probability\": \"0.013499409\",\n \"SemanticContext\": \"undefined4 CONTRAINDICATIONS ENTRESTO is contraindicated: in patients with hypersensitivity to any component in patients with a history of angioedema related to previous ACE inhibitor or ARB therapy [see Warnings and Precautions 5.2 ] with concomitant use of ACE inhibitors.\"\n },\n {\n \"VerbatimTerm\": \"angioedema\",\n \"Probability\": \"0.2631254196\",\n \"SemanticContext\": \"7 DRUG INTERACTIONS 7.1 Dual Blockade of the Renin-Angiotensin-Aldosterone System Concomitant use of ENTRESTO with an ACE inhibitor is contraindicated because of the increased risk of angioedema [see Contraindications 4 ] .\"\n },\n {\n \"VerbatimTerm\": \"angioedema\",\n \"Probability\": \"0.90774858\",\n \"SemanticContext\": \"5.2 Angioedema ENTRESTO may cause angioedema [see Adverse Reactions 6.1 ] .\"\n },\n {\n \"VerbatimTerm\": \"angioedema\",\n \"Probability\": \"0.0284106731\",\n \"SemanticContext\": \"If angioedema occurs, discontinue ENTRESTO immediately, provide appropriate therapy, and monitor for airway compromise.\"\n },\n {\n \"VerbatimTerm\": \"angioedema\",\n \"Probability\": \"0.5259882212\",\n \"SemanticContext\": \"In cases of confirmed angioedema where swelling has been confined to the face and lips, the condition has generally resolved without treatment, although antihistamines have been useful in relieving symptoms.\"\n },\n {\n \"VerbatimTerm\": \"angioedema\",\n \"Probability\": \"0.886305809\",\n \"SemanticContext\": \"ENTRESTO has been associated with a higher rate of angioedema in Black than in non-Black patients.\"\n },\n {\n \"VerbatimTerm\": \"angioedema\",\n \"Probability\": \"0.0118951797\",\n \"SemanticContext\": \"Patients with a prior history of angioedema may be at increased risk of angioedema with ENTRESTO [see Adverse Reactions 6.1 ] .\"\n },\n {\n \"VerbatimTerm\": \"angioedema\",\n \"Probability\": \"0.4535813332\",\n \"SemanticContext\": \"Patients with a prior history of angioedema may be at increased risk of angioedema with ENTRESTO [see Adverse Reactions 6.1 ] .\"\n },\n {\n \"VerbatimTerm\": \"angioedema\",\n \"Probability\": \"0.0014428794\",\n \"SemanticContext\": \"ENTRESTO must not be used in patients with a known history of angioedema related to previous ACE inhibitor or ARB therapy [see Contraindications 4 ] .\"\n },\n {\n \"VerbatimTerm\": \"Angioedema\",\n \"Probability\": \"0.9966206551\",\n \"SemanticContext\": \"undefined6 ADVERSE REACTIONS Clinically significant adverse reactions that appear in other sections of the labeling include: Angioedema [see Warnings and Precautions 5.2 ] Hypotension [see Warnings and Precautions 5.3 ] Impaired Renal Function [see Warnings and Precautions 5.4 ] Hyperkalemia [see Warnings and Precautions 5.5 ] 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.\"\n },\n {\n \"VerbatimTerm\": \"Angioedema\",\n \"Probability\": \"0.2056887746\",\n \"SemanticContext\": \"Angioedema: Advise patients to discontinue use of their previous ACE inhibitor or ARB.\"\n },\n {\n \"VerbatimTerm\": \"Angioedema\",\n \"Probability\": \"0.2216739357\",\n \"SemanticContext\": \"5.2 Angioedema ENTRESTO may cause angioedema [see Adverse Reactions 6.1 ] .\"\n },\n {\n \"VerbatimTerm\": \"Angioedema\",\n \"Probability\": \"0.0367594361\",\n \"SemanticContext\": \"Angioedema associated with laryngeal edema may be fatal.\"\n }\n ]\n },\n {\n \"Term\": \"Univentricular heart\",\n \"MEDDRACode\": \"10045545\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"single ventricles\",\n \"Probability\": \"0.0512121022\",\n \"SemanticContext\": \"Patients with systemic right ventricles and single ventricles were excluded from the trial.\"\n }\n ]\n },\n {\n \"Term\": \"Blood aldosterone\",\n \"MEDDRACode\": \"10005293\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"aldosterone\",\n \"Probability\": \"0.0011973083\",\n \"SemanticContext\": \"Valsartan inhibits the effects of angiotensin II by selectively blocking the AT 1 receptor, and also inhibits angiotensin II-dependent aldosterone release.\"\n },\n {\n \"VerbatimTerm\": \"aldosterone\",\n \"Probability\": \"0.0007507205\",\n \"SemanticContext\": \"In a 21-day study in HFrEF patients, ENTRESTO significantly increased urine ANP and cGMP and plasma cGMP, and decreased plasma NT-proBNP, aldosterone and endothelin-1.\"\n },\n {\n \"VerbatimTerm\": \"aldosterone\",\n \"Probability\": \"0.000300467\",\n \"SemanticContext\": \"5.4 Impaired Renal Function As a consequence of inhibiting the renin-angiotensin-aldosterone system RAAS , decreases in renal function may be anticipated in susceptible individuals treated with ENTRESTO [see Adverse Reactions 6.1 ] .\"\n },\n {\n \"VerbatimTerm\": \"aldosterone\",\n \"Probability\": \"7.56205E-05\",\n \"SemanticContext\": \"In patients whose renal function depends upon the activity of the renin-angiotensin-aldosterone system e.g., patients with severe congestive heart failure , treatment with ACE inhibitors and angiotensin receptor antagonists has been associated with oliguria, progressive azotemia and, rarely, acute renal failure and death.\"\n },\n {\n \"VerbatimTerm\": \"Aldosterone\",\n \"Probability\": \"0.0002729297\",\n \"SemanticContext\": \"7 DRUG INTERACTIONS 7.1 Dual Blockade of the Renin-Angiotensin-Aldosterone System Concomitant use of ENTRESTO with an ACE inhibitor is contraindicated because of the increased risk of angioedema [see Contraindications 4 ] .\"\n }\n ]\n },\n {\n \"Term\": \"Blood lactic acid\",\n \"MEDDRACode\": \"10005632\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": true,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"lactating\",\n \"Probability\": \"0.0002166927\",\n \"SemanticContext\": \"Data Following an oral dose 15 mg sacubitril/15 mg valsartan/kg of [ 14 C] ENTRESTO to lactating rats, transfer of LBQ657 into milk was observed.\"\n },\n {\n \"VerbatimTerm\": \"lactating\",\n \"Probability\": \"0.0003025234\",\n \"SemanticContext\": \"After a single oral administration of 3 mg/kg [ 14 C] valsartan to lactating rats, transfer of valsartan into milk was observed.\"\n }\n ]\n },\n {\n \"Term\": \"Blood creatinine\",\n \"MEDDRACode\": \"10005480\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Serum Creatinine\",\n \"Probability\": \"3.70371E-05\",\n \"SemanticContext\": \"Serum Creatinine During the double-blind period in PARADIGM-HF, approximately 16% of both ENTRESTO- and enalapril-treated patients had increases in serum creatinine of > 50%.\"\n },\n {\n \"VerbatimTerm\": \"serum creatinine\",\n \"Probability\": \"4.1474E-06\",\n \"SemanticContext\": \"Closely monitor serum creatinine, and down-titrate or interrupt ENTRESTO in patients who develop a clinically significant decrease in renal function [see Use in Specific Populations 8.7 and Clinical Pharmacology 12.3 ] .\"\n },\n {\n \"VerbatimTerm\": \"serum creatinine\",\n \"Probability\": \"5.50777E-05\",\n \"SemanticContext\": \"As with all drugs that affect the RAAS, ENTRESTO may increase blood urea and serum creatinine levels in patients with bilateral or unilateral renal artery stenosis.\"\n }\n ]\n },\n {\n \"Term\": \"Oligohydramnios\",\n \"MEDDRACode\": \"10030289\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Oligohydramnios\",\n \"Probability\": \"0.0472896993\",\n \"SemanticContext\": \"Clinical Considerations Fetal/Neonatal Adverse Reactions Oligohydramnios in pregnant women who use drugs affecting the renin-angiotensin system in the second and third trimesters of pregnancy can result in the following: reduced fetal renal function leading to anuria and renal failure, fetal lung hypoplasia, skeletal deformations, including skull hypoplasia, hypotension, and death.\"\n },\n {\n \"VerbatimTerm\": \"oligohydramnios\",\n \"Probability\": \"0.0028528571\",\n \"SemanticContext\": \"Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury.\"\n },\n {\n \"VerbatimTerm\": \"oligohydramnios\",\n \"Probability\": \"0.0069398582\",\n \"SemanticContext\": \"If oligohydramnios is observed, consider alternative drug treatment.\"\n }\n ]\n },\n {\n \"Term\": \"Left atrial enlargement\",\n \"MEDDRACode\": \"10051860\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"left atrial enlargement\",\n \"Probability\": \"0.7112764716\",\n \"SemanticContext\": \"PARAGON-HF PARAGON-HF, was a multicenter, randomized, double-blind trial comparing ENTRESTO and valsartan in 4,796 adult patients with symptomatic heart failure with left ventricular ejection fraction = 45%, and structural heart disease [either left atrial enlargement LAE or left ventricular hypertrophy LVH ].\"\n },\n {\n \"VerbatimTerm\": \"LAE\",\n \"Probability\": \"0.8480798006\",\n \"SemanticContext\": \"PARAGON-HF PARAGON-HF, was a multicenter, randomized, double-blind trial comparing ENTRESTO and valsartan in 4,796 adult patients with symptomatic heart failure with left ventricular ejection fraction = 45%, and structural heart disease [either left atrial enlargement LAE or left ventricular hypertrophy LVH ].\"\n }\n ]\n },\n {\n \"Term\": \"Cardiac failure congestive\",\n \"MEDDRACode\": \"10007559\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"congestive heart failure ,\",\n \"Probability\": \"0.0001826882\",\n \"SemanticContext\": \"In patients whose renal function depends upon the activity of the renin-angiotensin-aldosterone system e.g., patients with severe congestive heart failure , treatment with ACE inhibitors and angiotensin receptor antagonists has been associated with oliguria, progressive azotemia and, rarely, acute renal failure and death.\"\n }\n ]\n },\n {\n \"Term\": \"Hepatic function abnormal\",\n \"MEDDRACode\": \"10019670\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hepatic impairment\",\n \"Probability\": \"0.1366409361\",\n \"SemanticContext\": \"Reduce starting dose to half the usually recommended starting dosage for: - patients not currently taking an ACE inhibitor or ARB or previously taking a low dose of these agents 2.5 - patients with severe renal impairment 2.6 - patients with moderate hepatic impairment 2.7 .\"\n },\n {\n \"VerbatimTerm\": \"hepatic impairment\",\n \"Probability\": \"0.4078194499\",\n \"SemanticContext\": \"Figure 2: Pharmacokinetics of ENTRESTO in Specific Populations Note: Child-Pugh Classification was used for hepatic impairment.\"\n },\n {\n \"VerbatimTerm\": \"hepatic impairment\",\n \"Probability\": \"0.0035891533\",\n \"SemanticContext\": \"2.7 Dose Adjustment for Hepatic Impairment In adults and pediatric patients with moderate hepatic impairment Child-Pugh B classification , start ENTRESTO at half the usually recommended starting dose.\"\n },\n {\n \"VerbatimTerm\": \"hepatic impairment\",\n \"Probability\": \"0.0008800924\",\n \"SemanticContext\": \"No starting dose adjustment is needed for mild hepatic impairment.\"\n },\n {\n \"VerbatimTerm\": \"hepatic impairment\",\n \"Probability\": \"0.0005635619\",\n \"SemanticContext\": \"Use in patients with severe hepatic impairment is not recommended.\"\n },\n {\n \"VerbatimTerm\": \"Hepatic Impairment\",\n \"Probability\": \"0.4417148232\",\n \"SemanticContext\": \"Severe Hepatic Impairment: Use not recommended.\"\n },\n {\n \"VerbatimTerm\": \"Hepatic Impairment\",\n \"Probability\": \"0.0229950845\",\n \"SemanticContext\": \"2.7 Dose Adjustment for Hepatic Impairment In adults and pediatric patients with moderate hepatic impairment Child-Pugh B classification , start ENTRESTO at half the usually recommended starting dose.\"\n }\n ]\n },\n {\n \"Term\": \"Dizziness\",\n \"MEDDRACode\": \"10013573\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"dizziness\",\n \"Probability\": \"0.9991669059\",\n \"SemanticContext\": \"ADVERSE REACTIONS Adverse reactions occurring = 5% are hypotension, hyperkalemia, cough, dizziness, and renal failure.\"\n },\n {\n \"VerbatimTerm\": \"Dizziness\",\n \"Probability\": \"0.9995245934\",\n \"SemanticContext\": \"Table 2: Adverse Reactions Reported in = 5% of Patients Treated with ENTRESTO in the Double-Blind Period of PARADIGM-HF ENTRESTO n = 4,203 % Enalapril n = 4,229 % Hypotension 18 12 Hyperkalemia 12 14 Cough 9 13 Dizziness 6 5 Renal failure/acute renal failure 5 5 .\"\n }\n ]\n },\n {\n \"Term\": \"Blood potassium\",\n \"MEDDRACode\": \"10005721\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"potassium\",\n \"Probability\": \"0.0001569092\",\n \"SemanticContext\": \"Monitor renal function and potassium in susceptible patients.\"\n },\n {\n \"VerbatimTerm\": \"potassium\",\n \"Probability\": \"0.0015260875\",\n \"SemanticContext\": \"Serum Potassium During the double-blind period of PARADIGM-HF, approximately 16% of both ENTRESTO- and enalapril-treated patients had potassium concentrations > 5.5 mEq/L.\"\n },\n {\n \"VerbatimTerm\": \"potassium\",\n \"Probability\": \"0.0041038692\",\n \"SemanticContext\": \"During the double-blind period of PARAGON-HF, approximately 18% of ENTRESTO-treated patients and 20% of valsartan-treated patients had potassium concentrations > 5.5 mEq/L. 6.2 Postmarketing Experience The following additional adverse reactions have been reported in postmarketing experience.\"\n },\n {\n \"VerbatimTerm\": \"potassium\",\n \"Probability\": \"4.19231E-05\",\n \"SemanticContext\": \"7.2 Potassium-Sparing Diuretics As with other drugs that block angiotensin II or its effects, concomitant use of potassium-sparing diuretics e.g., spironolactone, triamterene, amiloride , potassium supplements, or salt substitutes containing potassium may lead to increases in serum potassium [see Warnings and Precautions 5.5 ] .\"\n },\n {\n \"VerbatimTerm\": \"potassium\",\n \"Probability\": \"1.48112E-05\",\n \"SemanticContext\": \"7.2 Potassium-Sparing Diuretics As with other drugs that block angiotensin II or its effects, concomitant use of potassium-sparing diuretics e.g., spironolactone, triamterene, amiloride , potassium supplements, or salt substitutes containing potassium may lead to increases in serum potassium [see Warnings and Precautions 5.5 ] .\"\n },\n {\n \"VerbatimTerm\": \"potassium\",\n \"Probability\": \"5.22649E-05\",\n \"SemanticContext\": \"7.2 Potassium-Sparing Diuretics As with other drugs that block angiotensin II or its effects, concomitant use of potassium-sparing diuretics e.g., spironolactone, triamterene, amiloride , potassium supplements, or salt substitutes containing potassium may lead to increases in serum potassium [see Warnings and Precautions 5.5 ] .\"\n },\n {\n \"VerbatimTerm\": \"Potassium\",\n \"Probability\": \"6.78721E-05\",\n \"SemanticContext\": \"Potassium-sparing diuretics: May lead to increased serum potassium.\"\n },\n {\n \"VerbatimTerm\": \"Potassium\",\n \"Probability\": \"0.0001627207\",\n \"SemanticContext\": \"7.2 Potassium-Sparing Diuretics As with other drugs that block angiotensin II or its effects, concomitant use of potassium-sparing diuretics e.g., spironolactone, triamterene, amiloride , potassium supplements, or salt substitutes containing potassium may lead to increases in serum potassium [see Warnings and Precautions 5.5 ] .\"\n }\n ]\n },\n {\n \"Term\": \"Ultrasound scan\",\n \"MEDDRACode\": \"10045434\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"ultrasound examinations\",\n \"Probability\": \"3.85155E-05\",\n \"SemanticContext\": \"Perform serial ultrasound examinations to assess the intra-amniotic environment.\"\n }\n ]\n },\n {\n \"Term\": \"Haemodialysis\",\n \"MEDDRACode\": \"10018875\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hemodialysis\",\n \"Probability\": \"0.0004598498\",\n \"SemanticContext\": \"ENTRESTO is unlikely to be removed by hemodialysis because of high protein binding.\"\n }\n ]\n },\n {\n \"Term\": \"Teratogenicity\",\n \"MEDDRACode\": \"10043275\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"teratogenicity\",\n \"Probability\": \"0.0011942387\",\n \"SemanticContext\": \"In animal reproduction studies, ENTRESTO treatment during organogenesis resulted in increased embryo-fetal lethality in rats and rabbits and teratogenicity in rabbits.\"\n }\n ]\n },\n {\n \"Term\": \"Dyspnoea paroxysmal nocturnal\",\n \"MEDDRACode\": \"10013974\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"PND\",\n \"Probability\": \"0.0512821376\",\n \"SemanticContext\": \"Animal Data Sacubitril given orally to juvenile rats from postnatal day PND 7 to PND 35 or PND 70 an age approximately equivalent to neonatal through pre-pubertal development or adulthood in humans at doses = 400 mg/kg/day approximately 2-fold the AUC exposure to the active metabolite of sacubitril, LBQ657, at an ENTRESTO pediatric clinical dose of 3.1 mg/kg twice daily resulted in decreases in body weight, bone length, and bone mass.\"\n },\n {\n \"VerbatimTerm\": \"PND\",\n \"Probability\": \"0.1512623727\",\n \"SemanticContext\": \"Animal Data Sacubitril given orally to juvenile rats from postnatal day PND 7 to PND 35 or PND 70 an age approximately equivalent to neonatal through pre-pubertal development or adulthood in humans at doses = 400 mg/kg/day approximately 2-fold the AUC exposure to the active metabolite of sacubitril, LBQ657, at an ENTRESTO pediatric clinical dose of 3.1 mg/kg twice daily resulted in decreases in body weight, bone length, and bone mass.\"\n },\n {\n \"VerbatimTerm\": \"PND\",\n \"Probability\": \"0.2018271089\",\n \"SemanticContext\": \"Animal Data Sacubitril given orally to juvenile rats from postnatal day PND 7 to PND 35 or PND 70 an age approximately equivalent to neonatal through pre-pubertal development or adulthood in humans at doses = 400 mg/kg/day approximately 2-fold the AUC exposure to the active metabolite of sacubitril, LBQ657, at an ENTRESTO pediatric clinical dose of 3.1 mg/kg twice daily resulted in decreases in body weight, bone length, and bone mass.\"\n },\n {\n \"VerbatimTerm\": \"PND\",\n \"Probability\": \"0.8077288866\",\n \"SemanticContext\": \"The decrease in body weight was transient from PND 10 to PND 20 and the effects for most bone parameters were reversible after treatment stopped.\"\n },\n {\n \"VerbatimTerm\": \"PND\",\n \"Probability\": \"0.5689792633\",\n \"SemanticContext\": \"The decrease in body weight was transient from PND 10 to PND 20 and the effects for most bone parameters were reversible after treatment stopped.\"\n },\n {\n \"VerbatimTerm\": \"PND\",\n \"Probability\": \"0.0263926089\",\n \"SemanticContext\": \"Valsartan given orally to juvenile rats from PND 7 to PND 70 an age approximately equivalent to neonatal through adulthood in humans produced persistent, irreversible kidney damage at all dose levels.\"\n },\n {\n \"VerbatimTerm\": \"PND\",\n \"Probability\": \"0.093349874\",\n \"SemanticContext\": \"Valsartan given orally to juvenile rats from PND 7 to PND 70 an age approximately equivalent to neonatal through adulthood in humans produced persistent, irreversible kidney damage at all dose levels.\"\n }\n ]\n },\n {\n \"Term\": \"Laryngeal oedema\",\n \"MEDDRACode\": \"10023845\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"laryngeal edema\",\n \"Probability\": \"0.0357260406\",\n \"SemanticContext\": \"Angioedema associated with laryngeal edema may be fatal.\"\n }\n ]\n },\n {\n \"Term\": \"Hyponatraemia\",\n \"MEDDRACode\": \"10021036\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"salt depletion\",\n \"Probability\": \"0.0007889867\",\n \"SemanticContext\": \"Correct volume or salt depletion prior to administration of ENTRESTO or start at a lower dose.\"\n }\n ]\n },\n {\n \"Term\": \"Hypovolaemia\",\n \"MEDDRACode\": \"10021137\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hypovolemia\",\n \"Probability\": \"0.0491985679\",\n \"SemanticContext\": \"If hypotension occurs, consider dose adjustment of diuretics, concomitant antihypertensive drugs, and treatment of other causes of hypotension e.g., hypovolemia .\"\n }\n ]\n },\n {\n \"Term\": \"Carcinogenicity\",\n \"MEDDRACode\": \"10007269\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Carcinogenicity\",\n \"Probability\": \"9.18397E-05\",\n \"SemanticContext\": \"undefined13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis and Mutagenesis Carcinogenicity studies conducted in mice and rats with sacubitril and valsartan did not identify any carcinogenic potential for ENTRESTO.\"\n }\n ]\n },\n {\n \"Term\": \"Infant\",\n \"MEDDRACode\": \"10021731\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"infant\",\n \"Probability\": \"0.0002875924\",\n \"SemanticContext\": \"8.2 Lactation Risk Summary There is no information regarding the presence of sacubitril/valsartan in human milk, the effects on the breastfed infant, or the effects on milk production.\"\n },\n {\n \"VerbatimTerm\": \"infants\",\n \"Probability\": \"0.0009127557\",\n \"SemanticContext\": \"Because of the potential for serious adverse reactions in breastfed infants from exposure to sacubitril/valsartan, advise a nursing woman that breastfeeding is not recommended during treatment with ENTRESTO.\"\n }\n ]\n },\n {\n \"Term\": \"Obstructive airways disorder\",\n \"MEDDRACode\": \"10061877\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"airway obstruction\",\n \"Probability\": \"0.0010028183\",\n \"SemanticContext\": \"Where there is involvement of the tongue, glottis or larynx, likely to cause airway obstruction, administer appropriate therapy, e.g., subcutaneous epinephrine/adrenaline solution 1:1000 0.3 mL to 0.5 mL and take measures necessary to ensure maintenance of a patent airway.\"\n }\n ]\n },\n {\n \"Term\": \"Renal artery stenosis\",\n \"MEDDRACode\": \"10038378\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"unilateral renal artery stenosis\",\n \"Probability\": \"0.0014502406\",\n \"SemanticContext\": \"As with all drugs that affect the RAAS, ENTRESTO may increase blood urea and serum creatinine levels in patients with bilateral or unilateral renal artery stenosis.\"\n }\n ]\n },\n {\n \"Term\": \"Azotaemia\",\n \"MEDDRACode\": \"10003885\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"progressive azotemia\",\n \"Probability\": \"0.0906439722\",\n \"SemanticContext\": \"In patients whose renal function depends upon the activity of the renin-angiotensin-aldosterone system e.g., patients with severe congestive heart failure , treatment with ACE inhibitors and angiotensin receptor antagonists has been associated with oliguria, progressive azotemia and, rarely, acute renal failure and death.\"\n }\n ]\n },\n {\n \"Term\": \"Toxicity to various agents\",\n \"MEDDRACode\": \"10070863\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"lithium toxicity\",\n \"Probability\": \"0.022584945\",\n \"SemanticContext\": \"Lithium: Increased risk of lithium toxicity.\"\n },\n {\n \"VerbatimTerm\": \"lithium toxicity\",\n \"Probability\": \"0.0023825169\",\n \"SemanticContext\": \"7.4 Lithium Increases in serum lithium concentrations and lithium toxicity have been reported during concomitant administration of lithium with angiotensin II receptor antagonists.\"\n }\n ]\n },\n {\n \"Term\": \"Hypersensitivity\",\n \"MEDDRACode\": \"10020751\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": true,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Hypersensitivity\",\n \"Probability\": \"0.2328553498\",\n \"SemanticContext\": \"CONTRAINDICATIONS Hypersensitivity to any component.\"\n },\n {\n \"VerbatimTerm\": \"Hypersensitivity\",\n \"Probability\": \"0.9445102811\",\n \"SemanticContext\": \"Hypersensitivity including rash, pruritus, and anaphylactic reaction\"\n },\n {\n \"VerbatimTerm\": \"hypersensitivity\",\n \"Probability\": \"0.0056717992\",\n \"SemanticContext\": \"undefined4 CONTRAINDICATIONS ENTRESTO is contraindicated: in patients with hypersensitivity to any component in patients with a history of angioedema related to previous ACE inhibitor or ARB therapy [see Warnings and Precautions 5.2 ] with concomitant use of ACE inhibitors.\"\n }\n ]\n },\n {\n \"Term\": \"Weight\",\n \"MEDDRACode\": \"10047890\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"weight\",\n \"Probability\": \"0.0006760657\",\n \"SemanticContext\": \"Animal Data Sacubitril given orally to juvenile rats from postnatal day PND 7 to PND 35 or PND 70 an age approximately equivalent to neonatal through pre-pubertal development or adulthood in humans at doses = 400 mg/kg/day approximately 2-fold the AUC exposure to the active metabolite of sacubitril, LBQ657, at an ENTRESTO pediatric clinical dose of 3.1 mg/kg twice daily resulted in decreases in body weight, bone length, and bone mass.\"\n },\n {\n \"VerbatimTerm\": \"weight\",\n \"Probability\": \"0.0028544664\",\n \"SemanticContext\": \"The decrease in body weight was transient from PND 10 to PND 20 and the effects for most bone parameters were reversible after treatment stopped.\"\n }\n ]\n },\n {\n \"Term\": \"Abortion spontaneous\",\n \"MEDDRACode\": \"10000234\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"miscarriage\",\n \"Probability\": \"0.1440780163\",\n \"SemanticContext\": \"The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.\"\n },\n {\n \"VerbatimTerm\": \"miscarriage\",\n \"Probability\": \"0.8080263138\",\n \"SemanticContext\": \"In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.\"\n }\n ]\n },\n {\n \"Term\": \"Tremor\",\n \"MEDDRACode\": \"10044565\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Shake\",\n \"Probability\": \"0.0288407207\",\n \"SemanticContext\": \"Shake before each use.\"\n }\n ]\n },\n {\n \"Term\": \"Hereditary angioedema\",\n \"MEDDRACode\": \"10019860\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hereditary angioedema\",\n \"Probability\": \"0.0105123818\",\n \"SemanticContext\": \"ENTRESTO should not be used in patients with hereditary angioedema.\"\n }\n ]\n },\n {\n \"Term\": \"Gait disturbance\",\n \"MEDDRACode\": \"10017577\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Step\",\n \"Probability\": \"0.1524640322\",\n \"SemanticContext\": \"DOSAGE AND ADMINISTRATION Indication Titration Step Dose twice daily Starting Second Final Adult Heart Failure 49/51 mg 97/103 mg Pediatric Heart Failure Patients less than 40 kg 1.6 mg/kg 2.3 mg/kg 3.1 mg/kg Pediatric Heart Failure Patients at least 40 kg, less than 50 kg 24/26 mg 49/51 mg 72/78 mg Pediatric Heart Failure Patients at least 50 kg 49/51 mg 72/78 mg 97/103 mg .\"\n },\n {\n \"VerbatimTerm\": \"Step\",\n \"Probability\": \"0.0159031153\",\n \"SemanticContext\": \"Titration Step Dose twice daily Starting Second Final Pediatric Patients Less than 40 kg † 1.6 mg/kg 2.3 mg/kg 3.1 mg/kg Pediatric Patients At least 40 kg, less than 50 kg 24/26 mg 49/51 mg 72/78 mg ‡ Pediatric Patients At least 50 kg 49/51 mg 72/78 mg ‡ 97/103 mg .\"\n }\n ]\n },\n {\n \"Term\": \"Breast feeding\",\n \"MEDDRACode\": \"10006247\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": true,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Breastfeeding\",\n \"Probability\": \"0.7617154121\",\n \"SemanticContext\": \"USE IN SPECIFIC POPULATIONS Lactation: Breastfeeding or drug should be discontinued.\"\n },\n {\n \"VerbatimTerm\": \"breastfed\",\n \"Probability\": \"0.000143826\",\n \"SemanticContext\": \"8.2 Lactation Risk Summary There is no information regarding the presence of sacubitril/valsartan in human milk, the effects on the breastfed infant, or the effects on milk production.\"\n },\n {\n \"VerbatimTerm\": \"breastfed\",\n \"Probability\": \"0.0001499653\",\n \"SemanticContext\": \"Because of the potential for serious adverse reactions in breastfed infants from exposure to sacubitril/valsartan, advise a nursing woman that breastfeeding is not recommended during treatment with ENTRESTO.\"\n },\n {\n \"VerbatimTerm\": \"breastfeeding\",\n \"Probability\": \"7.6376E-06\",\n \"SemanticContext\": \"Because of the potential for serious adverse reactions in breastfed infants from exposure to sacubitril/valsartan, advise a nursing woman that breastfeeding is not recommended during treatment with ENTRESTO.\"\n }\n ]\n },\n {\n \"Term\": \"Upper-airway cough syndrome\",\n \"MEDDRACode\": \"10070488\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"PND\",\n \"Probability\": \"0.0512821376\",\n \"SemanticContext\": \"Animal Data Sacubitril given orally to juvenile rats from postnatal day PND 7 to PND 35 or PND 70 an age approximately equivalent to neonatal through pre-pubertal development or adulthood in humans at doses = 400 mg/kg/day approximately 2-fold the AUC exposure to the active metabolite of sacubitril, LBQ657, at an ENTRESTO pediatric clinical dose of 3.1 mg/kg twice daily resulted in decreases in body weight, bone length, and bone mass.\"\n },\n {\n \"VerbatimTerm\": \"PND\",\n \"Probability\": \"0.1512623727\",\n \"SemanticContext\": \"Animal Data Sacubitril given orally to juvenile rats from postnatal day PND 7 to PND 35 or PND 70 an age approximately equivalent to neonatal through pre-pubertal development or adulthood in humans at doses = 400 mg/kg/day approximately 2-fold the AUC exposure to the active metabolite of sacubitril, LBQ657, at an ENTRESTO pediatric clinical dose of 3.1 mg/kg twice daily resulted in decreases in body weight, bone length, and bone mass.\"\n },\n {\n \"VerbatimTerm\": \"PND\",\n \"Probability\": \"0.2018271089\",\n \"SemanticContext\": \"Animal Data Sacubitril given orally to juvenile rats from postnatal day PND 7 to PND 35 or PND 70 an age approximately equivalent to neonatal through pre-pubertal development or adulthood in humans at doses = 400 mg/kg/day approximately 2-fold the AUC exposure to the active metabolite of sacubitril, LBQ657, at an ENTRESTO pediatric clinical dose of 3.1 mg/kg twice daily resulted in decreases in body weight, bone length, and bone mass.\"\n },\n {\n \"VerbatimTerm\": \"PND\",\n \"Probability\": \"0.8077288866\",\n \"SemanticContext\": \"The decrease in body weight was transient from PND 10 to PND 20 and the effects for most bone parameters were reversible after treatment stopped.\"\n },\n {\n \"VerbatimTerm\": \"PND\",\n \"Probability\": \"0.5689792633\",\n \"SemanticContext\": \"The decrease in body weight was transient from PND 10 to PND 20 and the effects for most bone parameters were reversible after treatment stopped.\"\n },\n {\n \"VerbatimTerm\": \"PND\",\n \"Probability\": \"0.0263926089\",\n \"SemanticContext\": \"Valsartan given orally to juvenile rats from PND 7 to PND 70 an age approximately equivalent to neonatal through adulthood in humans produced persistent, irreversible kidney damage at all dose levels.\"\n },\n {\n \"VerbatimTerm\": \"PND\",\n \"Probability\": \"0.093349874\",\n \"SemanticContext\": \"Valsartan given orally to juvenile rats from PND 7 to PND 70 an age approximately equivalent to neonatal through adulthood in humans produced persistent, irreversible kidney damage at all dose levels.\"\n }\n ]\n },\n {\n \"Term\": \"Congenital anomaly\",\n \"MEDDRACode\": \"10010356\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"birth defects\",\n \"Probability\": \"0.0536800623\",\n \"SemanticContext\": \"The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.\"\n },\n {\n \"VerbatimTerm\": \"birth defects\",\n \"Probability\": \"0.0874367952\",\n \"SemanticContext\": \"In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.\"\n }\n ]\n },\n {\n \"Term\": \"Anuria\",\n \"MEDDRACode\": \"10002847\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"anuria\",\n \"Probability\": \"0.8839309216\",\n \"SemanticContext\": \"Clinical Considerations Fetal/Neonatal Adverse Reactions Oligohydramnios in pregnant women who use drugs affecting the renin-angiotensin system in the second and third trimesters of pregnancy can result in the following: reduced fetal renal function leading to anuria and renal failure, fetal lung hypoplasia, skeletal deformations, including skull hypoplasia, hypotension, and death.\"\n }\n ]\n },\n {\n \"Term\": \"Hydrocephalus\",\n \"MEDDRACode\": \"10020508\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hydrocephaly\",\n \"Probability\": \"0.0060585141\",\n \"SemanticContext\": \"ENTRESTO is teratogenic based on a low incidence of fetal hydrocephaly, associated with maternally toxic doses, which was observed in rabbits at an ENTRESTO dose of = 5 mg sacubitril/5 mg valsartan/kg/day.\"\n }\n ]\n },\n {\n \"Term\": \"Swelling\",\n \"MEDDRACode\": \"10042674\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"swelling\",\n \"Probability\": \"0.1814213693\",\n \"SemanticContext\": \"In cases of confirmed angioedema where swelling has been confined to the face and lips, the condition has generally resolved without treatment, although antihistamines have been useful in relieving symptoms.\"\n }\n ]\n },\n {\n \"Term\": \"Angiotensin II\",\n \"MEDDRACode\": \"10002491\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"angiotensin II\",\n \"Probability\": \"0.0006088912\",\n \"SemanticContext\": \"undefined11 DESCRIPTION ENTRESTO sacubitril and valsartan is a combination of a neprilysin inhibitor and an angiotensin II receptor blocker.\"\n },\n {\n \"VerbatimTerm\": \"angiotensin II\",\n \"Probability\": \"0.0008485913\",\n \"SemanticContext\": \"ENTRESTO inhibits neprilysin neutral endopeptidase; NEP via LBQ657, the active metabolite of the prodrug sacubitril, and blocks the angiotensin II type-1 AT 1 receptor via valsartan.\"\n },\n {\n \"VerbatimTerm\": \"angiotensin II\",\n \"Probability\": \"0.0005801916\",\n \"SemanticContext\": \"The cardiovascular and renal effects of ENTRESTO in heart failure patients are attributed to the increased levels of peptides that are degraded by neprilysin, such as natriuretic peptides, by LBQ657, and the simultaneous inhibition of the effects of angiotensin II by valsartan.\"\n },\n {\n \"VerbatimTerm\": \"angiotensin II\",\n \"Probability\": \"0.0002393425\",\n \"SemanticContext\": \"Valsartan inhibits the effects of angiotensin II by selectively blocking the AT 1 receptor, and also inhibits angiotensin II-dependent aldosterone release.\"\n },\n {\n \"VerbatimTerm\": \"angiotensin II\",\n \"Probability\": \"0.0005828142\",\n \"SemanticContext\": \"Avoid use of ENTRESTO with an ARB, because ENTRESTO contains the angiotensin II receptor blocker valsartan.\"\n },\n {\n \"VerbatimTerm\": \"angiotensin II\",\n \"Probability\": \"4.11002E-05\",\n \"SemanticContext\": \"7.2 Potassium-Sparing Diuretics As with other drugs that block angiotensin II or its effects, concomitant use of potassium-sparing diuretics e.g., spironolactone, triamterene, amiloride , potassium supplements, or salt substitutes containing potassium may lead to increases in serum potassium [see Warnings and Precautions 5.5 ] .\"\n },\n {\n \"VerbatimTerm\": \"angiotensin II\",\n \"Probability\": \"3.23497E-05\",\n \"SemanticContext\": \"7.4 Lithium Increases in serum lithium concentrations and lithium toxicity have been reported during concomitant administration of lithium with angiotensin II receptor antagonists.\"\n },\n {\n \"VerbatimTerm\": \"angiotensin II\",\n \"Probability\": \"6.858E-06\",\n \"SemanticContext\": \"* Ora-Sweet SF ® and Ora-Plus ® are registered trademarks of Paddock Laboratories, Inc. 2.5 Dose Adjustment for Patients Not Taking an ACE inhibitor or ARB or Previously Taking Low Doses of These Agents In patients not currently taking an ACE inhibitor or an angiotensin II receptor blocker ARB and for patients previously taking low doses of these agents, start ENTRESTO at half the usually recommended starting dose.\"\n },\n {\n \"VerbatimTerm\": \"angiotensin II-\",\n \"Probability\": \"0.0015488267\",\n \"SemanticContext\": \"Valsartan inhibits the effects of angiotensin II by selectively blocking the AT 1 receptor, and also inhibits angiotensin II-dependent aldosterone release.\"\n }\n ]\n },\n {\n \"Term\": \"Injury\",\n \"MEDDRACode\": \"10022116\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"injury\",\n \"Probability\": \"0.0035071075\",\n \"SemanticContext\": \"Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.\"\n },\n {\n \"VerbatimTerm\": \"injury\",\n \"Probability\": \"0.0022551715\",\n \"SemanticContext\": \"Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury.\"\n }\n ]\n },\n {\n \"Term\": \"Renin\",\n \"MEDDRACode\": \"10038555\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"renin\",\n \"Probability\": \"0.0010442436\",\n \"SemanticContext\": \"Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.\"\n },\n {\n \"VerbatimTerm\": \"renin\",\n \"Probability\": \"0.0027699471\",\n \"SemanticContext\": \"12.2 Pharmacodynamics The pharmacodynamic effects of ENTRESTO were evaluated after single and multiple dose administrations in healthy subjects and in patients with heart failure, and are consistent with simultaneous neprilysin inhibition and renin-angiotensin system blockade.\"\n },\n {\n \"VerbatimTerm\": \"renin\",\n \"Probability\": \"0.0011363626\",\n \"SemanticContext\": \"ENTRESTO also blocked the AT 1 -receptor as evidenced by increased plasma renin activity and plasma renin concentrations.\"\n },\n {\n \"VerbatimTerm\": \"renin\",\n \"Probability\": \"0.0006325841\",\n \"SemanticContext\": \"ENTRESTO also blocked the AT 1 -receptor as evidenced by increased plasma renin activity and plasma renin concentrations.\"\n },\n {\n \"VerbatimTerm\": \"renin\",\n \"Probability\": \"3.64444E-05\",\n \"SemanticContext\": \"Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death.\"\n },\n {\n \"VerbatimTerm\": \"renin\",\n \"Probability\": \"0.0009186864\",\n \"SemanticContext\": \"Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents.\"\n },\n {\n \"VerbatimTerm\": \"renin\",\n \"Probability\": \"1.70625E-05\",\n \"SemanticContext\": \"However, if there is no appropriate alternative to therapy with drugs affecting the renin-angiotensin system, and if the drug is considered lifesaving for the mother, advise a pregnant woman of the potential risk to the fetus.\"\n },\n {\n \"VerbatimTerm\": \"renin\",\n \"Probability\": \"0.0022264719\",\n \"SemanticContext\": \"Clinical Considerations Fetal/Neonatal Adverse Reactions Oligohydramnios in pregnant women who use drugs affecting the renin-angiotensin system in the second and third trimesters of pregnancy can result in the following: reduced fetal renal function leading to anuria and renal failure, fetal lung hypoplasia, skeletal deformations, including skull hypoplasia, hypotension, and death.\"\n },\n {\n \"VerbatimTerm\": \"renin\",\n \"Probability\": \"3.64444E-05\",\n \"SemanticContext\": \"Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death.\"\n },\n {\n \"VerbatimTerm\": \"renin\",\n \"Probability\": \"1.50169E-05\",\n \"SemanticContext\": \"However, if there is no appropriate alternative to therapy with drugs affecting the renin-angiotensin system, and if the drug is considered lifesaving for the mother, advise a pregnant woman of the potential risk to the fetus [see Use in Specific Populations 8.1 ] .\"\n },\n {\n \"VerbatimTerm\": \"renin\",\n \"Probability\": \"3.05344E-05\",\n \"SemanticContext\": \"Patients with an activated renin-angiotensin system, such as volume- and/or salt-depleted patients e.g., those being treated with high doses of diuretics , are at greater risk.\"\n },\n {\n \"VerbatimTerm\": \"renin\",\n \"Probability\": \"0.0022082627\",\n \"SemanticContext\": \"5.4 Impaired Renal Function As a consequence of inhibiting the renin-angiotensin-aldosterone system RAAS , decreases in renal function may be anticipated in susceptible individuals treated with ENTRESTO [see Adverse Reactions 6.1 ] .\"\n },\n {\n \"VerbatimTerm\": \"renin\",\n \"Probability\": \"7.96807E-05\",\n \"SemanticContext\": \"In patients whose renal function depends upon the activity of the renin-angiotensin-aldosterone system e.g., patients with severe congestive heart failure , treatment with ACE inhibitors and angiotensin receptor antagonists has been associated with oliguria, progressive azotemia and, rarely, acute renal failure and death.\"\n },\n {\n \"VerbatimTerm\": \"Renin\",\n \"Probability\": \"0.0031959414\",\n \"SemanticContext\": \"7 DRUG INTERACTIONS 7.1 Dual Blockade of the Renin-Angiotensin-Aldosterone System Concomitant use of ENTRESTO with an ACE inhibitor is contraindicated because of the increased risk of angioedema [see Contraindications 4 ] .\"\n }\n ]\n },\n {\n \"Term\": \"Planning to become pregnant\",\n \"MEDDRACode\": \"10076056\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"planning to become pregnant\",\n \"Probability\": \"5.27216E-05\",\n \"SemanticContext\": \"Discuss treatment options with women planning to become pregnant.\"\n }\n ]\n },\n {\n \"Term\": \"Dialysis\",\n \"MEDDRACode\": \"10061105\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"dialysis\",\n \"Probability\": \"4.24038E-05\",\n \"SemanticContext\": \"Exchange transfusions or dialysis may be required as a means of reversing hypotension and replacing renal function.\"\n }\n ]\n },\n {\n \"Term\": \"Microcephaly\",\n \"MEDDRACode\": \"10027534\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"skull hypoplasia\",\n \"Probability\": \"0.5449838042\",\n \"SemanticContext\": \"Clinical Considerations Fetal/Neonatal Adverse Reactions Oligohydramnios in pregnant women who use drugs affecting the renin-angiotensin system in the second and third trimesters of pregnancy can result in the following: reduced fetal renal function leading to anuria and renal failure, fetal lung hypoplasia, skeletal deformations, including skull hypoplasia, hypotension, and death.\"\n }\n ]\n },\n {\n \"Term\": \"Oliguria\",\n \"MEDDRACode\": \"10030302\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"oliguria\",\n \"Probability\": \"0.0054986775\",\n \"SemanticContext\": \"Closely observe neonates with histories of in utero exposure to ENTRESTO for hypotension, oliguria, and hyperkalemia.\"\n },\n {\n \"VerbatimTerm\": \"oliguria\",\n \"Probability\": \"0.503377676\",\n \"SemanticContext\": \"In neonates with a history of in utero exposure to ENTRESTO, if oliguria or hypotension occurs, support blood pressure and renal perfusion.\"\n },\n {\n \"VerbatimTerm\": \"oliguria\",\n \"Probability\": \"0.7345627546\",\n \"SemanticContext\": \"In patients whose renal function depends upon the activity of the renin-angiotensin-aldosterone system e.g., patients with severe congestive heart failure , treatment with ACE inhibitors and angiotensin receptor antagonists has been associated with oliguria, progressive azotemia and, rarely, acute renal failure and death.\"\n }\n ]\n },\n {\n \"Term\": \"Blood urea increased\",\n \"MEDDRACode\": \"10005851\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"increase blood urea\",\n \"Probability\": \"0.09696275\",\n \"SemanticContext\": \"As with all drugs that affect the RAAS, ENTRESTO may increase blood urea and serum creatinine levels in patients with bilateral or unilateral renal artery stenosis.\"\n }\n ]\n },\n {\n \"Term\": \"Hypoaldosteronism\",\n \"MEDDRACode\": \"10020944\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hypoaldosteronism\",\n \"Probability\": \"0.2553078532\",\n \"SemanticContext\": \"Monitor serum potassium periodically and treat appropriately, especially in patients with risk factors for hyperkalemia such as severe renal impairment, diabetes, hypoaldosteronism, or a high potassium diet.\"\n }\n ]\n }\n ],\n \"IndicationTerms\": [\n {\n \"Term\": \"Adult Heart Failure\",\n \"MEDDRACode\": \"\"\n },\n {\n \"Term\": \"Pediatric Heart Failure\",\n \"MEDDRACode\": \"\"\n }\n ]\n },\n {\n \"Id\": \"US4ab35376-38ac-4b17-9c18-78bdbe23992a\",\n \"NDCCode\": \"0078-0659\",\n \"UpdatedDate\": \"Jul 14, 2021\",\n \"LabelSource\": {\n \"Country\": \"us\",\n \"ProductId\": \"000dc81d-ab91-450c-8eae-8eb74e72296f\",\n \"FileId\": \"4ab35376-38ac-4b17-9c18-78bdbe23992a\",\n \"Version\": \"13\"\n },\n \"AdverseEventTerms\": [\n {\n \"Term\": \"Haemoglobin\",\n \"MEDDRACode\": \"10018876\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Hemoglobin\",\n \"Probability\": \"0.0006746948\",\n \"SemanticContext\": \"Laboratory Abnormalities Hemoglobin and Hematocrit Decreases in hemoglobin/hematocrit of > 20% were observed in approximately 5% of both ENTRESTO- and enalapril-treated patients in the double-blind period in PARADIGM-HF.\"\n }\n ]\n },\n {\n \"Term\": \"Anaphylactic reaction\",\n \"MEDDRACode\": \"10002198\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"anaphylactic reaction\",\n \"Probability\": \"0.4642142653\",\n \"SemanticContext\": \"Hypersensitivity including rash, pruritus, and anaphylactic reaction\"\n }\n ]\n },\n {\n \"Term\": \"Haematocrit\",\n \"MEDDRACode\": \"10018837\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hematocrit\",\n \"Probability\": \"0.0010715425\",\n \"SemanticContext\": \"Laboratory Abnormalities Hemoglobin and Hematocrit Decreases in hemoglobin/hematocrit of > 20% were observed in approximately 5% of both ENTRESTO- and enalapril-treated patients in the double-blind period in PARADIGM-HF.\"\n },\n {\n \"VerbatimTerm\": \"hematocrit\",\n \"Probability\": \"0.0003770888\",\n \"SemanticContext\": \"Decreases in hemoglobin/hematocrit of >20% were observed in approximately 7% of ENTRESTO-treated patients and 9% of valsartan-treated patients in the double-blind period in PARAGON-HF.\"\n }\n ]\n },\n {\n \"Term\": \"Fall\",\n \"MEDDRACode\": \"10016173\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Falls\",\n \"Probability\": \"0.5033583641\",\n \"SemanticContext\": \"Falls were reported in 1.9% of patients treated with ENTRESTO compared to 1.3% of patients treated with enalapril.\"\n }\n ]\n },\n {\n \"Term\": \"Haemoglobin S\",\n \"MEDDRACode\": \"10051600\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Hemoglobin\",\n \"Probability\": \"0.0006746948\",\n \"SemanticContext\": \"Laboratory Abnormalities Hemoglobin and Hematocrit Decreases in hemoglobin/hematocrit of > 20% were observed in approximately 5% of both ENTRESTO- and enalapril-treated patients in the double-blind period in PARADIGM-HF.\"\n }\n ]\n },\n {\n \"Term\": \"Blood pressure systolic\",\n \"MEDDRACode\": \"10005756\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"systolic blood pressure\",\n \"Probability\": \"6.33042E-05\",\n \"SemanticContext\": \"Patients with a systolic blood pressure of< 100 mmHg at screening were excluded.\"\n },\n {\n \"VerbatimTerm\": \"systolic blood pressure\",\n \"Probability\": \"0.0003316402\",\n \"SemanticContext\": \"Patients with a systolic blood pressure of < 110 mmHg and patients with any prior echocardiographic LVEF < 40% at screening were excluded.\"\n }\n ]\n },\n {\n \"Term\": \"Cardiac failure chronic\",\n \"MEDDRACode\": \"10007558\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"chronic heart failure\",\n \"Probability\": \"0.0033559799\",\n \"SemanticContext\": \"to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure.\"\n },\n {\n \"VerbatimTerm\": \"chronic heart failure\",\n \"Probability\": \"0.0166277885\",\n \"SemanticContext\": \"14.1 Adult Heart Failure PARADIGM-HF PARADIGM-HF was a multinational, randomized, double-blind trial comparing ENTRESTO and enalapril in 8,442 adult patients with symptomatic chronic heart failure NYHA class II--IV and systolic dysfunction left ventricular ejection fraction = 40% .\"\n },\n {\n \"VerbatimTerm\": \"chronic heart failure\",\n \"Probability\": \"0.0096755028\",\n \"SemanticContext\": \"undefined1 INDICATIONS AND USAGE 1.1 Adult Heart Failure ENTRESTO is indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure.\"\n }\n ]\n },\n {\n \"Term\": \"Rash\",\n \"MEDDRACode\": \"10037844\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"rash\",\n \"Probability\": \"0.9858818054\",\n \"SemanticContext\": \"Hypersensitivity including rash, pruritus, and anaphylactic reaction\"\n }\n ]\n },\n {\n \"Term\": \"Blood magnesium\",\n \"MEDDRACode\": \"10005651\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"magnesium\",\n \"Probability\": \"0.0001792014\",\n \"SemanticContext\": \"The tablet inactive ingredients are microcrystalline cellulose, low-substituted hydroxypropylcellulose, crospovidone, magnesium stearate vegetable origin , talc, and colloidal silicon dioxide.\"\n }\n ]\n },\n {\n \"Term\": \"Brain natriuretic peptide\",\n \"MEDDRACode\": \"10053406\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"BNP\",\n \"Probability\": \"1.2784E-05\",\n \"SemanticContext\": \"In PARADIGM-HF, ENTRESTO decreased plasma NT-proBNP not a neprilysin substrate and increased plasma BNP a neprilysin substrate and urine cGMP compared with enalapril.\"\n }\n ]\n },\n {\n \"Term\": \"Pruritus\",\n \"MEDDRACode\": \"10037087\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"pruritus\",\n \"Probability\": \"0.9524453878\",\n \"SemanticContext\": \"Hypersensitivity including rash, pruritus, and anaphylactic reaction\"\n }\n ]\n },\n {\n \"Term\": \"Blindness\",\n \"MEDDRACode\": \"10005169\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"blind\",\n \"Probability\": \"0.0112668574\",\n \"SemanticContext\": \"Adult Heart Failure In PARADIGM-HF, patients were required to complete sequential enalapril and ENTRESTO run-in periods of median 15 and 29 days, respectively, prior to entering the randomized double-blind period comparing ENTRESTO and enalapril.\"\n },\n {\n \"VerbatimTerm\": \"blind\",\n \"Probability\": \"0.0056586564\",\n \"SemanticContext\": \"In the double-blind period, safety was evaluated in 4,203 patients treated with ENTRESTO and 4,229 treated with enalapril.\"\n },\n {\n \"VerbatimTerm\": \"blind\",\n \"Probability\": \"0.3353865445\",\n \"SemanticContext\": \"Discontinuation of therapy because of an adverse event during the double-blind period occurred in 450 10.7% of ENTRESTO treated patients and 516 12.2% of patients receiving enalapril.\"\n },\n {\n \"VerbatimTerm\": \"blind\",\n \"Probability\": \"0.0386224687\",\n \"SemanticContext\": \"Adverse reactions occurring at an incidence of = 5% in patients who were treated with ENTRESTO in the double-blind period of PARADIGM-HF are shown in Table 2.\"\n },\n {\n \"VerbatimTerm\": \"blind\",\n \"Probability\": \"0.0942946374\",\n \"SemanticContext\": \"In the double-blind period, the incidence of angioedema was higher in patients treated with ENTRESTO than enalapril 0.5% and 0.2%, respectively .\"\n },\n {\n \"VerbatimTerm\": \"blind\",\n \"Probability\": \"0.0318712592\",\n \"SemanticContext\": \"Orthostasis was reported in 2.1% of patients treated with ENTRESTO compared to 1.1% of patients treated with enalapril during the double-blind period of PARADIGM-HF.\"\n },\n {\n \"VerbatimTerm\": \"blind\",\n \"Probability\": \"0.0394700766\",\n \"SemanticContext\": \"Laboratory Abnormalities Hemoglobin and Hematocrit Decreases in hemoglobin/hematocrit of > 20% were observed in approximately 5% of both ENTRESTO- and enalapril-treated patients in the double-blind period in PARADIGM-HF.\"\n },\n {\n \"VerbatimTerm\": \"blind\",\n \"Probability\": \"0.0581258237\",\n \"SemanticContext\": \"Decreases in hemoglobin/hematocrit of >20% were observed in approximately 7% of ENTRESTO-treated patients and 9% of valsartan-treated patients in the double-blind period in PARAGON-HF.\"\n },\n {\n \"VerbatimTerm\": \"blind\",\n \"Probability\": \"0.0031373203\",\n \"SemanticContext\": \"Serum Creatinine During the double-blind period in PARADIGM-HF, approximately 16% of both ENTRESTO- and enalapril-treated patients had increases in serum creatinine of > 50%.\"\n },\n {\n \"VerbatimTerm\": \"blind\",\n \"Probability\": \"0.0017570257\",\n \"SemanticContext\": \"During the double-blind period in PARAGON-HF, approximately 17% of ENTRESTO-treated patients and 21% of valsartan-treated patients had increases in serum creatinine of > 50%.\"\n },\n {\n \"VerbatimTerm\": \"blind\",\n \"Probability\": \"0.0012573898\",\n \"SemanticContext\": \"Serum Potassium During the double-blind period of PARADIGM-HF, approximately 16% of both ENTRESTO- and enalapril-treated patients had potassium concentrations > 5.5 mEq/L.\"\n },\n {\n \"VerbatimTerm\": \"blind\",\n \"Probability\": \"0.0011849999\",\n \"SemanticContext\": \"During the double-blind period of PARAGON-HF, approximately 18% of ENTRESTO-treated patients and 20% of valsartan-treated patients had potassium concentrations > 5.5 mEq/L. 6.2 Postmarketing Experience The following additional adverse reactions have been reported in postmarketing experience.\"\n },\n {\n \"VerbatimTerm\": \"blind\",\n \"Probability\": \"0.0175574422\",\n \"SemanticContext\": \"In PARAMOUNT, a randomized, double-blind, 36-week study in patients with heart failure with LVEF = 45% comparing 97/103 mg of ENTRESTO n=149 to 160 mg of valsartan n =152 twice-daily, ENTRESTO decreased NT-proBNP by 17% while valsartan increased NT-proBNP by 8% at Week 12 p = 0.005 .\"\n },\n {\n \"VerbatimTerm\": \"blind\",\n \"Probability\": \"0.0055876076\",\n \"SemanticContext\": \"14.1 Adult Heart Failure PARADIGM-HF PARADIGM-HF was a multinational, randomized, double-blind trial comparing ENTRESTO and enalapril in 8,442 adult patients with symptomatic chronic heart failure NYHA class II--IV and systolic dysfunction left ventricular ejection fraction = 40% .\"\n },\n {\n \"VerbatimTerm\": \"blind\",\n \"Probability\": \"0.0026428103\",\n \"SemanticContext\": \"After discontinuing their existing ACE inhibitor or ARB therapy, patients entered sequential single-blind run-in periods during which they received enalapril 10 mg twice-daily, followed by ENTRESTO 100 mg twice-daily, increasing to 200 mg twice-daily.\"\n },\n {\n \"VerbatimTerm\": \"blind\",\n \"Probability\": \"0.005133003\",\n \"SemanticContext\": \"PARAGON-HF PARAGON-HF, was a multicenter, randomized, double-blind trial comparing ENTRESTO and valsartan in 4,796 adult patients with symptomatic heart failure with left ventricular ejection fraction = 45%, and structural heart disease [either left atrial enlargement LAE or left ventricular hypertrophy LVH ].\"\n },\n {\n \"VerbatimTerm\": \"blind\",\n \"Probability\": \"0.003893435\",\n \"SemanticContext\": \"After discontinuing their existing ACE inhibitor or ARB therapy, patients entered sequential single-blind run-in periods during which they received valsartan 80 mg twice-daily, followed by ENTRESTO 100 mg twice-daily.\"\n },\n {\n \"VerbatimTerm\": \"blind\",\n \"Probability\": \"0.004016161\",\n \"SemanticContext\": \"Figure 7: Treatment Effect for the Composite Endpoint of Time to First HF Hospitalization or CV Death by LVEF in PARADIGM-HF and PARAGON-HF Figure 3: Kaplan-Meier Curves for the Primary Composite Endpoint A , Cardiovascular Death B , and Heart Failure Hospitalization C Figure 4: Primary Composite Endpoint CV Death or HF Hospitalization - Subgroup Analysis Figure 5: Mean Number of Events Over Time for the Primary Composite Endpoint of Total HF Hospitalizations and CV Death Figure 6: Primary Composite Endpoint of Total HF Hospitalizations and CV Death -- Subgroup Analysis PARAGON-HF Figure 7: Treatment Effect for the Composite Endpoint of Time to First HF Hospitalization or CV Death by LVEF in PARADIGM-HF and PARAGON-HF 14.2 Pediatric Heart Failure PANORAMA-HF The efficacy of ENTRESTO was evaluated in a multinational, randomized, double-blind trial comparing ENTRESTO and enalapril based on an analysis in 110 pediatric patients 1 to< 18 years old with heart failure NYHA/Ross class II-IV due to systemic left ventricular systolic dysfunction LVEF = 40% .\"\n },\n {\n \"VerbatimTerm\": \"blind\",\n \"Probability\": \"0.0029983819\",\n \"SemanticContext\": \"8.4 Pediatric Use The safety and effectiveness of ENTRESTO in pediatric heart failure patients 1 to < 18 years old are supported by the reduction from baseline to 12 weeks in NT-proBNP in a randomized, double-blind clinical study [see Clinical Studies 14.2 ] .\"\n },\n {\n \"VerbatimTerm\": \"Blind\",\n \"Probability\": \"0.0049355328\",\n \"SemanticContext\": \"Table 2: Adverse Reactions Reported in = 5% of Patients Treated with ENTRESTO in the Double-Blind Period of PARADIGM-HF ENTRESTO n = 4,203 % Enalapril n = 4,229 % Hypotension 18 12 Hyperkalemia 12 14 Cough 9 13 Dizziness 6 5 Renal failure/acute renal failure 5 5 .\"\n }\n ]\n },\n {\n \"Term\": \"Impulse-control disorder\",\n \"MEDDRACode\": \"10061215\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"ICD\",\n \"Probability\": \"0.0009714067\",\n \"SemanticContext\": \"Few patients had an implantable cardioverter-defibrillator ICD or cardiac resynchronization therapy-defibrillator CRT-D 15% .\"\n }\n ]\n },\n {\n \"Term\": \"Left atrial enlargement\",\n \"MEDDRACode\": \"10051860\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"left atrial enlargement\",\n \"Probability\": \"0.7112764716\",\n \"SemanticContext\": \"PARAGON-HF PARAGON-HF, was a multicenter, randomized, double-blind trial comparing ENTRESTO and valsartan in 4,796 adult patients with symptomatic heart failure with left ventricular ejection fraction = 45%, and structural heart disease [either left atrial enlargement LAE or left ventricular hypertrophy LVH ].\"\n },\n {\n \"VerbatimTerm\": \"LAE\",\n \"Probability\": \"0.8480798006\",\n \"SemanticContext\": \"PARAGON-HF PARAGON-HF, was a multicenter, randomized, double-blind trial comparing ENTRESTO and valsartan in 4,796 adult patients with symptomatic heart failure with left ventricular ejection fraction = 45%, and structural heart disease [either left atrial enlargement LAE or left ventricular hypertrophy LVH ].\"\n }\n ]\n },\n {\n \"Term\": \"Left ventricular hypertrophy\",\n \"MEDDRACode\": \"10049773\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"LVH\",\n \"Probability\": \"0.8518795967\",\n \"SemanticContext\": \"PARAGON-HF PARAGON-HF, was a multicenter, randomized, double-blind trial comparing ENTRESTO and valsartan in 4,796 adult patients with symptomatic heart failure with left ventricular ejection fraction = 45%, and structural heart disease [either left atrial enlargement LAE or left ventricular hypertrophy LVH ].\"\n }\n ]\n },\n {\n \"Term\": \"Haematocrit decreased\",\n \"MEDDRACode\": \"10018838\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Hematocrit Decreases\",\n \"Probability\": \"0.4315832853\",\n \"SemanticContext\": \"Laboratory Abnormalities Hemoglobin and Hematocrit Decreases in hemoglobin/hematocrit of > 20% were observed in approximately 5% of both ENTRESTO- and enalapril-treated patients in the double-blind period in PARADIGM-HF.\"\n }\n ]\n },\n {\n \"Term\": \"Planning to become pregnant\",\n \"MEDDRACode\": \"10076056\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"planning to become pregnant\",\n \"Probability\": \"5.27216E-05\",\n \"SemanticContext\": \"Discuss treatment options with women planning to become pregnant.\"\n }\n ]\n },\n {\n \"Term\": \"Upper-airway cough syndrome\",\n \"MEDDRACode\": \"10070488\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"PND\",\n \"Probability\": \"0.0512821376\",\n \"SemanticContext\": \"Animal Data Sacubitril given orally to juvenile rats from postnatal day PND 7 to PND 35 or PND 70 an age approximately equivalent to neonatal through pre-pubertal development or adulthood in humans at doses = 400 mg/kg/day approximately 2-fold the AUC exposure to the active metabolite of sacubitril, LBQ657, at an ENTRESTO pediatric clinical dose of 3.1 mg/kg twice daily resulted in decreases in body weight, bone length, and bone mass.\"\n },\n {\n \"VerbatimTerm\": \"PND\",\n \"Probability\": \"0.1512623727\",\n \"SemanticContext\": \"Animal Data Sacubitril given orally to juvenile rats from postnatal day PND 7 to PND 35 or PND 70 an age approximately equivalent to neonatal through pre-pubertal development or adulthood in humans at doses = 400 mg/kg/day approximately 2-fold the AUC exposure to the active metabolite of sacubitril, LBQ657, at an ENTRESTO pediatric clinical dose of 3.1 mg/kg twice daily resulted in decreases in body weight, bone length, and bone mass.\"\n },\n {\n \"VerbatimTerm\": \"PND\",\n \"Probability\": \"0.2018271089\",\n \"SemanticContext\": \"Animal Data Sacubitril given orally to juvenile rats from postnatal day PND 7 to PND 35 or PND 70 an age approximately equivalent to neonatal through pre-pubertal development or adulthood in humans at doses = 400 mg/kg/day approximately 2-fold the AUC exposure to the active metabolite of sacubitril, LBQ657, at an ENTRESTO pediatric clinical dose of 3.1 mg/kg twice daily resulted in decreases in body weight, bone length, and bone mass.\"\n },\n {\n \"VerbatimTerm\": \"PND\",\n \"Probability\": \"0.8077288866\",\n \"SemanticContext\": \"The decrease in body weight was transient from PND 10 to PND 20 and the effects for most bone parameters were reversible after treatment stopped.\"\n },\n {\n \"VerbatimTerm\": \"PND\",\n \"Probability\": \"0.5689792633\",\n \"SemanticContext\": \"The decrease in body weight was transient from PND 10 to PND 20 and the effects for most bone parameters were reversible after treatment stopped.\"\n },\n {\n \"VerbatimTerm\": \"PND\",\n \"Probability\": \"0.0263926089\",\n \"SemanticContext\": \"Valsartan given orally to juvenile rats from PND 7 to PND 70 an age approximately equivalent to neonatal through adulthood in humans produced persistent, irreversible kidney damage at all dose levels.\"\n },\n {\n \"VerbatimTerm\": \"PND\",\n \"Probability\": \"0.093349874\",\n \"SemanticContext\": \"Valsartan given orally to juvenile rats from PND 7 to PND 70 an age approximately equivalent to neonatal through adulthood in humans produced persistent, irreversible kidney damage at all dose levels.\"\n }\n ]\n },\n {\n \"Term\": \"Oestradiol\",\n \"MEDDRACode\": \"10030227\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"estradiol\",\n \"Probability\": \"0.0001847446\",\n \"SemanticContext\": \"Dedicated drug interaction studies demonstrated that coadministration of furosemide, warfarin, digoxin, carvedilol, a combination of levonorgestrel/ethinyl estradiol, amlodipine, omeprazole, hydrochlorothiazide HCTZ , metformin, atorvastatin, and sildenafil, did not alter the systemic exposure to sacubitril, LBQ657 or valsartan.\"\n }\n ]\n },\n {\n \"Term\": \"Blood pressure measurement\",\n \"MEDDRACode\": \"10076581\",\n \"Overdose\": true,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Blood Pressure\",\n \"Probability\": \"5.21739E-05\",\n \"SemanticContext\": \"Blood Pressure: Addition of a 50 mg single dose of sildenafil to ENTRESTO at steady state 194 mg sacubitril/206 mg valsartan once daily for 5 days in patients with hypertension was associated with additional blood pressure BP reduction ~ 5/4 mmHg, systolic/diastolic BP compared to administration of ENTRESTO alone.\"\n },\n {\n \"VerbatimTerm\": \"blood pressure\",\n \"Probability\": \"0.0006788671\",\n \"SemanticContext\": \"Blood Pressure: Addition of a 50 mg single dose of sildenafil to ENTRESTO at steady state 194 mg sacubitril/206 mg valsartan once daily for 5 days in patients with hypertension was associated with additional blood pressure BP reduction ~ 5/4 mmHg, systolic/diastolic BP compared to administration of ENTRESTO alone.\"\n },\n {\n \"VerbatimTerm\": \"blood pressure\",\n \"Probability\": \"0.0003552139\",\n \"SemanticContext\": \"In neonates with a history of in utero exposure to ENTRESTO, if oliguria or hypotension occurs, support blood pressure and renal perfusion.\"\n }\n ]\n },\n {\n \"Term\": \"Atrial natriuretic peptide\",\n \"MEDDRACode\": \"10050734\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"ANP\",\n \"Probability\": \"0.0034817755\",\n \"SemanticContext\": \"In a 21-day study in HFrEF patients, ENTRESTO significantly increased urine ANP and cGMP and plasma cGMP, and decreased plasma NT-proBNP, aldosterone and endothelin-1.\"\n }\n ]\n },\n {\n \"Term\": \"Coronary artery disease\",\n \"MEDDRACode\": \"10011078\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"coronary artery disease\",\n \"Probability\": \"0.1048850119\",\n \"SemanticContext\": \"The underlying cause of heart failure was coronary artery disease in 60% of patients; 71% had a history of hypertension, 43% had a history of myocardial infarction, 37% had an eGFR < 60 mL/min/1.73m 2 , and 35% had diabetes mellitus.\"\n }\n ]\n },\n {\n \"Term\": \"Hypertension\",\n \"MEDDRACode\": \"10020772\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hypertension\",\n \"Probability\": \"0.0359680653\",\n \"SemanticContext\": \"Blood Pressure: Addition of a 50 mg single dose of sildenafil to ENTRESTO at steady state 194 mg sacubitril/206 mg valsartan once daily for 5 days in patients with hypertension was associated with additional blood pressure BP reduction ~ 5/4 mmHg, systolic/diastolic BP compared to administration of ENTRESTO alone.\"\n },\n {\n \"VerbatimTerm\": \"hypertension\",\n \"Probability\": \"0.0953121483\",\n \"SemanticContext\": \"The underlying cause of heart failure was coronary artery disease in 60% of patients; 71% had a history of hypertension, 43% had a history of myocardial infarction, 37% had an eGFR < 60 mL/min/1.73m 2 , and 35% had diabetes mellitus.\"\n },\n {\n \"VerbatimTerm\": \"hypertension\",\n \"Probability\": \"0.0353775918\",\n \"SemanticContext\": \"Furthermore, 96% had a history of hypertension, 23% had a history of myocardial infarction, 46% had an eGFR < 60 mL/min/1.73 m 2 , and 43% had diabetes mellitus.\"\n }\n ]\n },\n {\n \"Term\": \"N-terminal prohormone brain natriuretic peptide increased\",\n \"MEDDRACode\": \"10071662\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"increased NT-proBNP\",\n \"Probability\": \"0.1026400924\",\n \"SemanticContext\": \"In PARAMOUNT, a randomized, double-blind, 36-week study in patients with heart failure with LVEF = 45% comparing 97/103 mg of ENTRESTO n=149 to 160 mg of valsartan n =152 twice-daily, ENTRESTO decreased NT-proBNP by 17% while valsartan increased NT-proBNP by 8% at Week 12 p = 0.005 .\"\n }\n ]\n },\n {\n \"Term\": \"Blood aldosterone\",\n \"MEDDRACode\": \"10005293\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"aldosterone\",\n \"Probability\": \"0.0011973083\",\n \"SemanticContext\": \"Valsartan inhibits the effects of angiotensin II by selectively blocking the AT 1 receptor, and also inhibits angiotensin II-dependent aldosterone release.\"\n },\n {\n \"VerbatimTerm\": \"aldosterone\",\n \"Probability\": \"0.0007507205\",\n \"SemanticContext\": \"In a 21-day study in HFrEF patients, ENTRESTO significantly increased urine ANP and cGMP and plasma cGMP, and decreased plasma NT-proBNP, aldosterone and endothelin-1.\"\n },\n {\n \"VerbatimTerm\": \"aldosterone\",\n \"Probability\": \"0.000300467\",\n \"SemanticContext\": \"5.4 Impaired Renal Function As a consequence of inhibiting the renin-angiotensin-aldosterone system RAAS , decreases in renal function may be anticipated in susceptible individuals treated with ENTRESTO [see Adverse Reactions 6.1 ] .\"\n },\n {\n \"VerbatimTerm\": \"aldosterone\",\n \"Probability\": \"7.56205E-05\",\n \"SemanticContext\": \"In patients whose renal function depends upon the activity of the renin-angiotensin-aldosterone system e.g., patients with severe congestive heart failure , treatment with ACE inhibitors and angiotensin receptor antagonists has been associated with oliguria, progressive azotemia and, rarely, acute renal failure and death.\"\n },\n {\n \"VerbatimTerm\": \"Aldosterone\",\n \"Probability\": \"0.0002729297\",\n \"SemanticContext\": \"7 DRUG INTERACTIONS 7.1 Dual Blockade of the Renin-Angiotensin-Aldosterone System Concomitant use of ENTRESTO with an ACE inhibitor is contraindicated because of the increased risk of angioedema [see Contraindications 4 ] .\"\n }\n ]\n },\n {\n \"Term\": \"Blood creatinine\",\n \"MEDDRACode\": \"10005480\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Serum Creatinine\",\n \"Probability\": \"3.70371E-05\",\n \"SemanticContext\": \"Serum Creatinine During the double-blind period in PARADIGM-HF, approximately 16% of both ENTRESTO- and enalapril-treated patients had increases in serum creatinine of > 50%.\"\n },\n {\n \"VerbatimTerm\": \"serum creatinine\",\n \"Probability\": \"4.1474E-06\",\n \"SemanticContext\": \"Closely monitor serum creatinine, and down-titrate or interrupt ENTRESTO in patients who develop a clinically significant decrease in renal function [see Use in Specific Populations 8.7 and Clinical Pharmacology 12.3 ] .\"\n },\n {\n \"VerbatimTerm\": \"serum creatinine\",\n \"Probability\": \"5.50777E-05\",\n \"SemanticContext\": \"As with all drugs that affect the RAAS, ENTRESTO may increase blood urea and serum creatinine levels in patients with bilateral or unilateral renal artery stenosis.\"\n }\n ]\n },\n {\n \"Term\": \"Mass\",\n \"MEDDRACode\": \"10026865\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"mass\",\n \"Probability\": \"0.000305891\",\n \"SemanticContext\": \"Its empirical formula hemipentahydrate is C 48 H 55 N 6 O 8 Na 3 2.5 H 2 O. Its molecular mass is 957.99 and its schematic structural formula is: ENTRESTO is available as film-coated tablets for oral administration, containing 24 mg of sacubitril and 26 mg of valsartan; 49 mg of sacubitril and 51 mg of valsartan; and 97 mg of sacubitril and 103 mg of valsartan.\"\n },\n {\n \"VerbatimTerm\": \"mass\",\n \"Probability\": \"0.0008742213\",\n \"SemanticContext\": \"Animal Data Sacubitril given orally to juvenile rats from postnatal day PND 7 to PND 35 or PND 70 an age approximately equivalent to neonatal through pre-pubertal development or adulthood in humans at doses = 400 mg/kg/day approximately 2-fold the AUC exposure to the active metabolite of sacubitril, LBQ657, at an ENTRESTO pediatric clinical dose of 3.1 mg/kg twice daily resulted in decreases in body weight, bone length, and bone mass.\"\n }\n ]\n },\n {\n \"Term\": \"Diuretic therapy\",\n \"MEDDRACode\": \"10053073\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"diuretic therapy\",\n \"Probability\": \"0.0001545846\",\n \"SemanticContext\": \"7.3 Nonsteroidal Anti-Inflammatory Drugs NSAIDs Including Selective Cyclooxygenase-2 Inhibitors COX-2 Inhibitors In patients who are elderly, volume-depleted including those on diuretic therapy , or with compromised renal function, concomitant use of NSAIDs, including COX-2 inhibitors, with ENTRESTO may result in worsening of renal function, including possible acute renal failure.\"\n }\n ]\n },\n {\n \"Term\": \"Electrocardiogram QT interval\",\n \"MEDDRACode\": \"10014385\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"QTc\",\n \"Probability\": \"2.35464E-05\",\n \"SemanticContext\": \"QT Prolongation: In a thorough QTc clinical study in healthy male subjects, single doses of ENTRESTO 194 mg sacubitril/206 mg valsartan and 583 mg sacubitril/617 mg valsartan had no effect on cardiac repolarization.\"\n }\n ]\n },\n {\n \"Term\": \"Hypersensitivity\",\n \"MEDDRACode\": \"10020751\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": true,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Hypersensitivity\",\n \"Probability\": \"0.2328553498\",\n \"SemanticContext\": \"CONTRAINDICATIONS Hypersensitivity to any component.\"\n },\n {\n \"VerbatimTerm\": \"Hypersensitivity\",\n \"Probability\": \"0.9445102811\",\n \"SemanticContext\": \"Hypersensitivity including rash, pruritus, and anaphylactic reaction\"\n },\n {\n \"VerbatimTerm\": \"hypersensitivity\",\n \"Probability\": \"0.0056717992\",\n \"SemanticContext\": \"undefined4 CONTRAINDICATIONS ENTRESTO is contraindicated: in patients with hypersensitivity to any component in patients with a history of angioedema related to previous ACE inhibitor or ARB therapy [see Warnings and Precautions 5.2 ] with concomitant use of ACE inhibitors.\"\n }\n ]\n },\n {\n \"Term\": \"Angiotensin converting enzyme\",\n \"MEDDRACode\": \"10050289\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"angiotensin-converting enzyme\",\n \"Probability\": \"0.0001386106\",\n \"SemanticContext\": \"undefined2 DOSAGE AND ADMINISTRATION 2.1 General Considerations ENTRESTO is contraindicated with concomitant use of an angiotensin-converting enzyme ACE inhibitor.\"\n }\n ]\n },\n {\n \"Term\": \"Renal impairment\",\n \"MEDDRACode\": \"10062237\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"renal impairment\",\n \"Probability\": \"0.1053782701\",\n \"SemanticContext\": \"Reduce starting dose to half the usually recommended starting dosage for: - patients not currently taking an ACE inhibitor or ARB or previously taking a low dose of these agents 2.5 - patients with severe renal impairment 2.6 - patients with moderate hepatic impairment 2.7 .\"\n },\n {\n \"VerbatimTerm\": \"renal impairment\",\n \"Probability\": \"0.8274530172\",\n \"SemanticContext\": \"NSAIDs: May lead to increased risk of renal impairment.\"\n },\n {\n \"VerbatimTerm\": \"renal impairment\",\n \"Probability\": \"1.30013E-05\",\n \"SemanticContext\": \"Avoid use with aliskiren in patients with renal impairment eGFR< 60 mL/min/1.73 m 2 .\"\n },\n {\n \"VerbatimTerm\": \"renal impairment\",\n \"Probability\": \"0.0008538961\",\n \"SemanticContext\": \"2.6 Dose Adjustment for Severe Renal Impairment In adults and pediatric patients with severe renal impairment eGFR < 30 mL/min/1.73 m 2 , start ENTRESTO at half the usually recommended starting dose.\"\n },\n {\n \"VerbatimTerm\": \"renal impairment\",\n \"Probability\": \"0.0001527369\",\n \"SemanticContext\": \"No starting dose adjustment is needed for mild or moderate renal impairment.\"\n },\n {\n \"VerbatimTerm\": \"renal impairment\",\n \"Probability\": \"0.1105166078\",\n \"SemanticContext\": \"Monitor serum potassium periodically and treat appropriately, especially in patients with risk factors for hyperkalemia such as severe renal impairment, diabetes, hypoaldosteronism, or a high potassium diet.\"\n },\n {\n \"VerbatimTerm\": \"Renal Impairment\",\n \"Probability\": \"0.0058254302\",\n \"SemanticContext\": \"2.6 Dose Adjustment for Severe Renal Impairment In adults and pediatric patients with severe renal impairment eGFR < 30 mL/min/1.73 m 2 , start ENTRESTO at half the usually recommended starting dose.\"\n }\n ]\n },\n {\n \"Term\": \"Euphoric mood\",\n \"MEDDRACode\": \"10015535\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"higher\",\n \"Probability\": \"0.0072290003\",\n \"SemanticContext\": \"In the double-blind period, the incidence of angioedema was higher in patients treated with ENTRESTO than enalapril 0.5% and 0.2%, respectively .\"\n },\n {\n \"VerbatimTerm\": \"higher\",\n \"Probability\": \"0.0011095703\",\n \"SemanticContext\": \"ENTRESTO has been associated with a higher rate of angioedema in Black than in non-Black patients.\"\n },\n {\n \"VerbatimTerm\": \"high\",\n \"Probability\": \"0.0001572967\",\n \"SemanticContext\": \"ENTRESTO is unlikely to be removed by hemodialysis because of high protein binding.\"\n },\n {\n \"VerbatimTerm\": \"high\",\n \"Probability\": \"3.62051E-05\",\n \"SemanticContext\": \"The LBQ657 C max at the high dose HD of 1200 mg/kg/day in male and female mice was, respectively, 14 and 16 times that in humans at the MRHD.\"\n },\n {\n \"VerbatimTerm\": \"high\",\n \"Probability\": \"0.0002788007\",\n \"SemanticContext\": \"The doses of valsartan studied high dose of 160 and 200 mg/kg/day in mice and rats, respectively were about 4 and 10 times, respectively, the MRHD on a mg/m 2 basis.\"\n },\n {\n \"VerbatimTerm\": \"high\",\n \"Probability\": \"0.0002910495\",\n \"SemanticContext\": \"Patients with an activated renin-angiotensin system, such as volume- and/or salt-depleted patients e.g., those being treated with high doses of diuretics , are at greater risk.\"\n }\n ]\n },\n {\n \"Term\": \"Hypotension\",\n \"MEDDRACode\": \"10021097\",\n \"Overdose\": true,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"symptomatic hypotension\",\n \"Probability\": \"0.6976981163\",\n \"SemanticContext\": \"5.3 Hypotension ENTRESTO lowers blood pressure and may cause symptomatic hypotension [see Adverse Reactions 6.1 ] .\"\n }\n ]\n },\n {\n \"Term\": \"Cardiac failure\",\n \"MEDDRACode\": \"10007554\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Heart Failure\",\n \"Probability\": \"0.0435394645\",\n \"SemanticContext\": \"RECENT MAJOR CHANGES Indications and Usage, Adult Heart Failure 1.1 2/2021 .\"\n },\n {\n \"VerbatimTerm\": \"Heart Failure\",\n \"Probability\": \"0.004365027\",\n \"SemanticContext\": \"DOSAGE AND ADMINISTRATION Indication Titration Step Dose twice daily Starting Second Final Adult Heart Failure 49/51 mg 97/103 mg Pediatric Heart Failure Patients less than 40 kg 1.6 mg/kg 2.3 mg/kg 3.1 mg/kg Pediatric Heart Failure Patients at least 40 kg, less than 50 kg 24/26 mg 49/51 mg 72/78 mg Pediatric Heart Failure Patients at least 50 kg 49/51 mg 72/78 mg 97/103 mg .\"\n },\n {\n \"VerbatimTerm\": \"Heart Failure\",\n \"Probability\": \"0.0061392486\",\n \"SemanticContext\": \"DOSAGE AND ADMINISTRATION Indication Titration Step Dose twice daily Starting Second Final Adult Heart Failure 49/51 mg 97/103 mg Pediatric Heart Failure Patients less than 40 kg 1.6 mg/kg 2.3 mg/kg 3.1 mg/kg Pediatric Heart Failure Patients at least 40 kg, less than 50 kg 24/26 mg 49/51 mg 72/78 mg Pediatric Heart Failure Patients at least 50 kg 49/51 mg 72/78 mg 97/103 mg .\"\n },\n {\n \"VerbatimTerm\": \"Heart Failure\",\n \"Probability\": \"0.0004841089\",\n \"SemanticContext\": \"DOSAGE AND ADMINISTRATION Indication Titration Step Dose twice daily Starting Second Final Adult Heart Failure 49/51 mg 97/103 mg Pediatric Heart Failure Patients less than 40 kg 1.6 mg/kg 2.3 mg/kg 3.1 mg/kg Pediatric Heart Failure Patients at least 40 kg, less than 50 kg 24/26 mg 49/51 mg 72/78 mg Pediatric Heart Failure Patients at least 50 kg 49/51 mg 72/78 mg 97/103 mg .\"\n },\n {\n \"VerbatimTerm\": \"Heart Failure\",\n \"Probability\": \"0.0208270848\",\n \"SemanticContext\": \"DOSAGE AND ADMINISTRATION Indication Titration Step Dose twice daily Starting Second Final Adult Heart Failure 49/51 mg 97/103 mg Pediatric Heart Failure Patients less than 40 kg 1.6 mg/kg 2.3 mg/kg 3.1 mg/kg Pediatric Heart Failure Patients at least 40 kg, less than 50 kg 24/26 mg 49/51 mg 72/78 mg Pediatric Heart Failure Patients at least 50 kg 49/51 mg 72/78 mg 97/103 mg .\"\n },\n {\n \"VerbatimTerm\": \"Heart Failure\",\n \"Probability\": \"0.0014349818\",\n \"SemanticContext\": \"Adult Heart Failure In PARADIGM-HF, patients were required to complete sequential enalapril and ENTRESTO run-in periods of median 15 and 29 days, respectively, prior to entering the randomized double-blind period comparing ENTRESTO and enalapril.\"\n },\n {\n \"VerbatimTerm\": \"Heart Failure\",\n \"Probability\": \"0.0203329325\",\n \"SemanticContext\": \"Pediatric Heart Failure The adverse reactions observed in pediatric patients 1 to < 18 years old who received treatment with ENTRESTO were consistent with those observed in adult patients.\"\n },\n {\n \"VerbatimTerm\": \"Heart Failure\",\n \"Probability\": \"0.0003466606\",\n \"SemanticContext\": \"14.1 Adult Heart Failure PARADIGM-HF PARADIGM-HF was a multinational, randomized, double-blind trial comparing ENTRESTO and enalapril in 8,442 adult patients with symptomatic chronic heart failure NYHA class II--IV and systolic dysfunction left ventricular ejection fraction = 40% .\"\n },\n {\n \"VerbatimTerm\": \"Heart Failure\",\n \"Probability\": \"0.0016563535\",\n \"SemanticContext\": \"Figure 3: Kaplan-Meier Curves for the Primary Composite Endpoint A , Cardiovascular Death B , and Heart Failure Hospitalization C A wide range of demographic characteristics, baseline disease characteristics, and baseline concomitant medications were examined for their influence on outcomes.\"\n },\n {\n \"VerbatimTerm\": \"Heart Failure\",\n \"Probability\": \"0.1514662206\",\n \"SemanticContext\": \"Figure 7: Treatment Effect for the Composite Endpoint of Time to First HF Hospitalization or CV Death by LVEF in PARADIGM-HF and PARAGON-HF Figure 3: Kaplan-Meier Curves for the Primary Composite Endpoint A , Cardiovascular Death B , and Heart Failure Hospitalization C Figure 4: Primary Composite Endpoint CV Death or HF Hospitalization - Subgroup Analysis Figure 5: Mean Number of Events Over Time for the Primary Composite Endpoint of Total HF Hospitalizations and CV Death Figure 6: Primary Composite Endpoint of Total HF Hospitalizations and CV Death -- Subgroup Analysis PARAGON-HF Figure 7: Treatment Effect for the Composite Endpoint of Time to First HF Hospitalization or CV Death by LVEF in PARADIGM-HF and PARAGON-HF 14.2 Pediatric Heart Failure PANORAMA-HF The efficacy of ENTRESTO was evaluated in a multinational, randomized, double-blind trial comparing ENTRESTO and enalapril based on an analysis in 110 pediatric patients 1 to < 18 years old with heart failure NYHA/Ross class II-IV due to systemic left ventricular systolic dysfunction LVEF = 40% .\"\n },\n {\n \"VerbatimTerm\": \"Heart Failure\",\n \"Probability\": \"0.0018772483\",\n \"SemanticContext\": \"Figure 7: Treatment Effect for the Composite Endpoint of Time to First HF Hospitalization or CV Death by LVEF in PARADIGM-HF and PARAGON-HF Figure 3: Kaplan-Meier Curves for the Primary Composite Endpoint A , Cardiovascular Death B , and Heart Failure Hospitalization C Figure 4: Primary Composite Endpoint CV Death or HF Hospitalization - Subgroup Analysis Figure 5: Mean Number of Events Over Time for the Primary Composite Endpoint of Total HF Hospitalizations and CV Death Figure 6: Primary Composite Endpoint of Total HF Hospitalizations and CV Death -- Subgroup Analysis PARAGON-HF Figure 7: Treatment Effect for the Composite Endpoint of Time to First HF Hospitalization or CV Death by LVEF in PARADIGM-HF and PARAGON-HF 14.2 Pediatric Heart Failure PANORAMA-HF The efficacy of ENTRESTO was evaluated in a multinational, randomized, double-blind trial comparing ENTRESTO and enalapril based on an analysis in 110 pediatric patients 1 to < 18 years old with heart failure NYHA/Ross class II-IV due to systemic left ventricular systolic dysfunction LVEF = 40% .\"\n },\n {\n \"VerbatimTerm\": \"Heart Failure\",\n \"Probability\": \"0.0001475513\",\n \"SemanticContext\": \"2.2 Adult Heart Failure The recommended starting dose of ENTRESTO is 49/51 mg orally twice-daily.\"\n },\n {\n \"VerbatimTerm\": \"Heart Failure\",\n \"Probability\": \"0.0206190646\",\n \"SemanticContext\": \"2.3 Pediatric Heart Failure Refer to Table 1 for the recommended dose for pediatric patients aged one year and older.\"\n },\n {\n \"VerbatimTerm\": \"Heart Failure\",\n \"Probability\": \"0.0172035098\",\n \"SemanticContext\": \"undefined1 INDICATIONS AND USAGE 1.1 Adult Heart Failure ENTRESTO is indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure.\"\n },\n {\n \"VerbatimTerm\": \"Heart Failure\",\n \"Probability\": \"0.0064969063\",\n \"SemanticContext\": \"1.2 Pediatric Heart Failure ENTRESTO is indicated for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older.\"\n },\n {\n \"VerbatimTerm\": \"heart failure\",\n \"Probability\": \"0.1512141228\",\n \"SemanticContext\": \"to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure.\"\n },\n {\n \"VerbatimTerm\": \"heart failure\",\n \"Probability\": \"0.0556843281\",\n \"SemanticContext\": \"for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older.\"\n },\n {\n \"VerbatimTerm\": \"heart failure\",\n \"Probability\": \"0.0185587406\",\n \"SemanticContext\": \"A total of 6,622 heart failure patients were treated with ENTRESTO in the PARADIGM-HF vs. enalapril and PARAGON-HF vs. valsartan clinical trials.\"\n },\n {\n \"VerbatimTerm\": \"heart failure\",\n \"Probability\": \"0.0069746077\",\n \"SemanticContext\": \"The cardiovascular and renal effects of ENTRESTO in heart failure patients are attributed to the increased levels of peptides that are degraded by neprilysin, such as natriuretic peptides, by LBQ657, and the simultaneous inhibition of the effects of angiotensin II by valsartan.\"\n },\n {\n \"VerbatimTerm\": \"heart failure\",\n \"Probability\": \"0.0186216533\",\n \"SemanticContext\": \"12.2 Pharmacodynamics The pharmacodynamic effects of ENTRESTO were evaluated after single and multiple dose administrations in healthy subjects and in patients with heart failure, and are consistent with simultaneous neprilysin inhibition and renin-angiotensin system blockade.\"\n },\n {\n \"VerbatimTerm\": \"heart failure\",\n \"Probability\": \"0.0056989193\",\n \"SemanticContext\": \"In PARAMOUNT, a randomized, double-blind, 36-week study in patients with heart failure with LVEF = 45% comparing 97/103 mg of ENTRESTO n=149 to 160 mg of valsartan n =152 twice-daily, ENTRESTO decreased NT-proBNP by 17% while valsartan increased NT-proBNP by 8% at Week 12 p = 0.005 .\"\n },\n {\n \"VerbatimTerm\": \"heart failure\",\n \"Probability\": \"0.0014955401\",\n \"SemanticContext\": \"Pediatric Patients: The pharmacokinetics of ENTRESTO were evaluated in pediatric heart failure patients 1 to< 18 years old administered oral doses of 0.8 mg/kg and 3.1 mg/kg of ENTRESTO.\"\n },\n {\n \"VerbatimTerm\": \"heart failure\",\n \"Probability\": \"0.070230186\",\n \"SemanticContext\": \"The primary objective of PARADIGM-HF was to determine whether ENTRESTO, a combination of sacubitril and a RAS inhibitor valsartan , was superior to a RAS inhibitor enalapril alone in reducing the risk of the combined endpoint of cardiovascular CV death or hospitalization for heart failure HF .\"\n },\n {\n \"VerbatimTerm\": \"heart failure\",\n \"Probability\": \"0.7972712517\",\n \"SemanticContext\": \"The underlying cause of heart failure was coronary artery disease in 60% of patients; 71% had a history of hypertension, 43% had a history of myocardial infarction, 37% had an eGFR < 60 mL/min/1.73m 2 , and 35% had diabetes mellitus.\"\n },\n {\n \"VerbatimTerm\": \"heart failure\",\n \"Probability\": \"0.1473268569\",\n \"SemanticContext\": \"PARADIGM-HF demonstrated that ENTRESTO, a combination of sacubitril and a RAS inhibitor valsartan , was superior to a RAS inhibitor enalapril , in reducing the risk of the combined endpoint of cardiovascular death or hospitalization for heart failure, based on a time-to-event analysis hazard ratio [HR] 0.80; 95% confidence interval [CI], 0.73, 0.87, p < 0.0001 .\"\n },\n {\n \"VerbatimTerm\": \"heart failure\",\n \"Probability\": \"0.2093319893\",\n \"SemanticContext\": \"The treatment effect reflected a reduction in both cardiovascular death and heart failure hospitalization; see Table 3 and Figure 3.\"\n },\n {\n \"VerbatimTerm\": \"heart failure\",\n \"Probability\": \"0.0188558102\",\n \"SemanticContext\": \"** Includes patients who had heart failure hospitalization prior to death.\"\n },\n {\n \"VerbatimTerm\": \"heart failure\",\n \"Probability\": \"0.0672160089\",\n \"SemanticContext\": \"ENTRESTO N = 4,187 n % Enalapril N = 4,212 n % Hazard Ratio 95% CI p -value Primary composite endpoint of cardiovascular death or heart failure hospitalization 914 21.8 1,117 26.5 0.80 0.73, 0.87 < 0.0001 Cardiovascular death as first event 377 9.0 459 10.9 Heart failure hospitalization as first event 537 12.8 658 15.6 Number of patients with events: * Cardiovascular death ** 558 13.3 693 16.5 0.80 0.71, 0.89 Heart failure hospitalizations 537 12.8 658 15.6 0.79 0.71, 0.89 All-cause mortality 711 17.0 835 19.8 0.84 0.76, 0.93 0.0009 .\"\n },\n {\n \"VerbatimTerm\": \"heart failure\",\n \"Probability\": \"0.0520744622\",\n \"SemanticContext\": \"The Kaplan-Meier curves presented below Figure 3 show time to first occurrence of the primary composite endpoint 3A , and time to occurrence of cardiovascular death at any time 3B and first heart failure hospitalization 3C .\"\n },\n {\n \"VerbatimTerm\": \"heart failure\",\n \"Probability\": \"0.1775787771\",\n \"SemanticContext\": \"PARAGON-HF PARAGON-HF, was a multicenter, randomized, double-blind trial comparing ENTRESTO and valsartan in 4,796 adult patients with symptomatic heart failure with left ventricular ejection fraction = 45%, and structural heart disease [either left atrial enlargement LAE or left ventricular hypertrophy LVH ].\"\n },\n {\n \"VerbatimTerm\": \"heart failure\",\n \"Probability\": \"0.0096086562\",\n \"SemanticContext\": \"The primary objective of PARAGON-HF was to determine whether ENTRESTO reduced the rate of the composite endpoint of total first and recurrent heart failure HF hospitalizations and cardiovascular CV death.\"\n },\n {\n \"VerbatimTerm\": \"heart failure\",\n \"Probability\": \"0.6532661915\",\n \"SemanticContext\": \"The underlying cause of heart failure was of ischemic etiology in 36% of patients.\"\n },\n {\n \"VerbatimTerm\": \"heart failure\",\n \"Probability\": \"0.004036963\",\n \"SemanticContext\": \"Figure 7: Treatment Effect for the Composite Endpoint of Time to First HF Hospitalization or CV Death by LVEF in PARADIGM-HF and PARAGON-HF Figure 3: Kaplan-Meier Curves for the Primary Composite Endpoint A , Cardiovascular Death B , and Heart Failure Hospitalization C Figure 4: Primary Composite Endpoint CV Death or HF Hospitalization - Subgroup Analysis Figure 5: Mean Number of Events Over Time for the Primary Composite Endpoint of Total HF Hospitalizations and CV Death Figure 6: Primary Composite Endpoint of Total HF Hospitalizations and CV Death -- Subgroup Analysis PARAGON-HF Figure 7: Treatment Effect for the Composite Endpoint of Time to First HF Hospitalization or CV Death by LVEF in PARADIGM-HF and PARAGON-HF 14.2 Pediatric Heart Failure PANORAMA-HF The efficacy of ENTRESTO was evaluated in a multinational, randomized, double-blind trial comparing ENTRESTO and enalapril based on an analysis in 110 pediatric patients 1 to < 18 years old with heart failure NYHA/Ross class II-IV due to systemic left ventricular systolic dysfunction LVEF = 40% .\"\n },\n {\n \"VerbatimTerm\": \"heart failure\",\n \"Probability\": \"0.2585010529\",\n \"SemanticContext\": \"undefined1 INDICATIONS AND USAGE 1.1 Adult Heart Failure ENTRESTO is indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure.\"\n },\n {\n \"VerbatimTerm\": \"heart failure\",\n \"Probability\": \"0.0864062905\",\n \"SemanticContext\": \"1.2 Pediatric Heart Failure ENTRESTO is indicated for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older.\"\n },\n {\n \"VerbatimTerm\": \"heart failure\",\n \"Probability\": \"0.0007191598\",\n \"SemanticContext\": \"8.4 Pediatric Use The safety and effectiveness of ENTRESTO in pediatric heart failure patients 1 to< 18 years old are supported by the reduction from baseline to 12 weeks in NT-proBNP in a randomized, double-blind clinical study [see Clinical Studies 14.2 ] .\"\n },\n {\n \"VerbatimTerm\": \"Heart failure\",\n \"Probability\": \"0.614628315\",\n \"SemanticContext\": \"ENTRESTO N = 4,187 n % Enalapril N = 4,212 n % Hazard Ratio 95% CI p -value Primary composite endpoint of cardiovascular death or heart failure hospitalization 914 21.8 1,117 26.5 0.80 0.73, 0.87 < 0.0001 Cardiovascular death as first event 377 9.0 459 10.9 Heart failure hospitalization as first event 537 12.8 658 15.6 Number of patients with events: * Cardiovascular death ** 558 13.3 693 16.5 0.80 0.71, 0.89 Heart failure hospitalizations 537 12.8 658 15.6 0.79 0.71, 0.89 All-cause mortality 711 17.0 835 19.8 0.84 0.76, 0.93 0.0009 .\"\n },\n {\n \"VerbatimTerm\": \"Heart failure\",\n \"Probability\": \"0.4307456315\",\n \"SemanticContext\": \"ENTRESTO N = 4,187 n % Enalapril N = 4,212 n % Hazard Ratio 95% CI p -value Primary composite endpoint of cardiovascular death or heart failure hospitalization 914 21.8 1,117 26.5 0.80 0.73, 0.87 < 0.0001 Cardiovascular death as first event 377 9.0 459 10.9 Heart failure hospitalization as first event 537 12.8 658 15.6 Number of patients with events: * Cardiovascular death ** 558 13.3 693 16.5 0.80 0.71, 0.89 Heart failure hospitalizations 537 12.8 658 15.6 0.79 0.71, 0.89 All-cause mortality 711 17.0 835 19.8 0.84 0.76, 0.93 0.0009 .\"\n }\n ]\n },\n {\n \"Term\": \"Hyperkalaemia\",\n \"MEDDRACode\": \"10020646\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hyperkalemia\",\n \"Probability\": \"0.9966822863\",\n \"SemanticContext\": \"ADVERSE REACTIONS Adverse reactions occurring = 5% are hypotension, hyperkalemia, cough, dizziness, and renal failure.\"\n },\n {\n \"VerbatimTerm\": \"hyperkalemia\",\n \"Probability\": \"0.9997469187\",\n \"SemanticContext\": \"During the enalapril run-in period, 1,102 patients 10.5% were permanently discontinued from the study, 5.6% because of an adverse event, most commonly renal dysfunction 1.7% , hyperkalemia 1.7% and hypotension 1.4% .\"\n },\n {\n \"VerbatimTerm\": \"hyperkalemia\",\n \"Probability\": \"0.9976707697\",\n \"SemanticContext\": \"During the ENTRESTO run-in period, an additional 10.4% of patients permanently discontinued treatment, 5.9% because of an adverse event, most commonly renal dysfunction 1.8% , hypotension 1.7% and hyperkalemia 1.3% .\"\n },\n {\n \"VerbatimTerm\": \"hyperkalemia\",\n \"Probability\": \"0.0036262572\",\n \"SemanticContext\": \"Closely observe neonates with histories of in utero exposure to ENTRESTO for hypotension, oliguria, and hyperkalemia.\"\n },\n {\n \"VerbatimTerm\": \"hyperkalemia\",\n \"Probability\": \"0.3021903932\",\n \"SemanticContext\": \"5.5 Hyperkalemia Through its actions on the RAAS, hyperkalemia may occur with ENTRESTO [see Adverse Reactions 6.1 ] .\"\n },\n {\n \"VerbatimTerm\": \"hyperkalemia\",\n \"Probability\": \"0.0092568398\",\n \"SemanticContext\": \"Monitor serum potassium periodically and treat appropriately, especially in patients with risk factors for hyperkalemia such as severe renal impairment, diabetes, hypoaldosteronism, or a high potassium diet.\"\n },\n {\n \"VerbatimTerm\": \"Hyperkalemia\",\n \"Probability\": \"0.987498641\",\n \"SemanticContext\": \"undefined6 ADVERSE REACTIONS Clinically significant adverse reactions that appear in other sections of the labeling include: Angioedema [see Warnings and Precautions 5.2 ] Hypotension [see Warnings and Precautions 5.3 ] Impaired Renal Function [see Warnings and Precautions 5.4 ] Hyperkalemia [see Warnings and Precautions 5.5 ] 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.\"\n },\n {\n \"VerbatimTerm\": \"Hyperkalemia\",\n \"Probability\": \"0.9995377064\",\n \"SemanticContext\": \"Table 2: Adverse Reactions Reported in = 5% of Patients Treated with ENTRESTO in the Double-Blind Period of PARADIGM-HF ENTRESTO n = 4,203 % Enalapril n = 4,229 % Hypotension 18 12 Hyperkalemia 12 14 Cough 9 13 Dizziness 6 5 Renal failure/acute renal failure 5 5 .\"\n },\n {\n \"VerbatimTerm\": \"Hyperkalemia\",\n \"Probability\": \"0.1275221109\",\n \"SemanticContext\": \"5.5 Hyperkalemia Through its actions on the RAAS, hyperkalemia may occur with ENTRESTO [see Adverse Reactions 6.1 ] .\"\n }\n ]\n },\n {\n \"Term\": \"Hepatic function abnormal\",\n \"MEDDRACode\": \"10019670\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hepatic impairment\",\n \"Probability\": \"0.1366409361\",\n \"SemanticContext\": \"Reduce starting dose to half the usually recommended starting dosage for: - patients not currently taking an ACE inhibitor or ARB or previously taking a low dose of these agents 2.5 - patients with severe renal impairment 2.6 - patients with moderate hepatic impairment 2.7 .\"\n },\n {\n \"VerbatimTerm\": \"hepatic impairment\",\n \"Probability\": \"0.4078194499\",\n \"SemanticContext\": \"Figure 2: Pharmacokinetics of ENTRESTO in Specific Populations Note: Child-Pugh Classification was used for hepatic impairment.\"\n },\n {\n \"VerbatimTerm\": \"hepatic impairment\",\n \"Probability\": \"0.0035891533\",\n \"SemanticContext\": \"2.7 Dose Adjustment for Hepatic Impairment In adults and pediatric patients with moderate hepatic impairment Child-Pugh B classification , start ENTRESTO at half the usually recommended starting dose.\"\n },\n {\n \"VerbatimTerm\": \"hepatic impairment\",\n \"Probability\": \"0.0008800924\",\n \"SemanticContext\": \"No starting dose adjustment is needed for mild hepatic impairment.\"\n },\n {\n \"VerbatimTerm\": \"hepatic impairment\",\n \"Probability\": \"0.0005635619\",\n \"SemanticContext\": \"Use in patients with severe hepatic impairment is not recommended.\"\n },\n {\n \"VerbatimTerm\": \"Hepatic Impairment\",\n \"Probability\": \"0.4417148232\",\n \"SemanticContext\": \"Severe Hepatic Impairment: Use not recommended.\"\n },\n {\n \"VerbatimTerm\": \"Hepatic Impairment\",\n \"Probability\": \"0.0229950845\",\n \"SemanticContext\": \"2.7 Dose Adjustment for Hepatic Impairment In adults and pediatric patients with moderate hepatic impairment Child-Pugh B classification , start ENTRESTO at half the usually recommended starting dose.\"\n }\n ]\n },\n {\n \"Term\": \"Diabetes mellitus\",\n \"MEDDRACode\": \"10012601\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": true,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"diabetes\",\n \"Probability\": \"0.0004902482\",\n \"SemanticContext\": \"Concomitant use with aliskiren in patients with diabetes.\"\n },\n {\n \"VerbatimTerm\": \"diabetes\",\n \"Probability\": \"0.0003626347\",\n \"SemanticContext\": \"Do not administer within 36 hours of switching from or to an ACE inhibitor [see Drug Interactions 7.1 ] with concomitant use of aliskiren in patients with diabetes [see Drug Interactions 7.1 ]\"\n },\n {\n \"VerbatimTerm\": \"diabetes\",\n \"Probability\": \"3.99219E-05\",\n \"SemanticContext\": \"The concomitant use of ENTRESTO with aliskiren is contraindicated in patients with diabetes [see Contraindications 4 ] .\"\n },\n {\n \"VerbatimTerm\": \"diabetes\",\n \"Probability\": \"0.0587316453\",\n \"SemanticContext\": \"Monitor serum potassium periodically and treat appropriately, especially in patients with risk factors for hyperkalemia such as severe renal impairment, diabetes, hypoaldosteronism, or a high potassium diet.\"\n }\n ]\n },\n {\n \"Term\": \"Protein total\",\n \"MEDDRACode\": \"10050537\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"protein\",\n \"Probability\": \"9.02413E-05\",\n \"SemanticContext\": \"ENTRESTO is unlikely to be removed by hemodialysis because of high protein binding.\"\n }\n ]\n },\n {\n \"Term\": \"Blood iron\",\n \"MEDDRACode\": \"10005616\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"iron\",\n \"Probability\": \"0.2064819038\",\n \"SemanticContext\": \"The film-coat inactive ingredients are hypromellose, titanium dioxide E 171 , Macrogol 4000, talc, and iron oxide red E 172 .\"\n },\n {\n \"VerbatimTerm\": \"iron\",\n \"Probability\": \"0.0707624257\",\n \"SemanticContext\": \"The film-coat for the 24 mg of sacubitril and 26 mg of valsartan tablet and the 97 mg of sacubitril and 103 mg of valsartan tablet also contains iron oxide black E 172 .\"\n },\n {\n \"VerbatimTerm\": \"iron\",\n \"Probability\": \"0.0538579524\",\n \"SemanticContext\": \"The film-coat for the 49 mg of sacubitril and 51 mg of valsartan tablet contains iron oxide yellow E 172 .\"\n }\n ]\n },\n {\n \"Term\": \"Intrauterine contraception\",\n \"MEDDRACode\": \"10082352\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"ICD\",\n \"Probability\": \"0.0009714067\",\n \"SemanticContext\": \"Few patients had an implantable cardioverter-defibrillator ICD or cardiac resynchronization therapy-defibrillator CRT-D 15% .\"\n }\n ]\n },\n {\n \"Term\": \"Acute kidney injury\",\n \"MEDDRACode\": \"10069339\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"acute renal failure\",\n \"Probability\": \"0.6130424738\",\n \"SemanticContext\": \"Table 2: Adverse Reactions Reported in = 5% of Patients Treated with ENTRESTO in the Double-Blind Period of PARADIGM-HF ENTRESTO n = 4,203 % Enalapril n = 4,229 % Hypotension 18 12 Hyperkalemia 12 14 Cough 9 13 Dizziness 6 5 Renal failure/acute renal failure 5 5 .\"\n },\n {\n \"VerbatimTerm\": \"acute renal failure\",\n \"Probability\": \"0.2023137808\",\n \"SemanticContext\": \"7.3 Nonsteroidal Anti-Inflammatory Drugs NSAIDs Including Selective Cyclooxygenase-2 Inhibitors COX-2 Inhibitors In patients who are elderly, volume-depleted including those on diuretic therapy , or with compromised renal function, concomitant use of NSAIDs, including COX-2 inhibitors, with ENTRESTO may result in worsening of renal function, including possible acute renal failure.\"\n },\n {\n \"VerbatimTerm\": \"acute renal failure\",\n \"Probability\": \"0.0932332575\",\n \"SemanticContext\": \"In patients whose renal function depends upon the activity of the renin-angiotensin-aldosterone system e.g., patients with severe congestive heart failure , treatment with ACE inhibitors and angiotensin receptor antagonists has been associated with oliguria, progressive azotemia and, rarely, acute renal failure and death.\"\n }\n ]\n },\n {\n \"Term\": \"Angioedema\",\n \"MEDDRACode\": \"10002424\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": true,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"angioedema\",\n \"Probability\": \"0.1606844664\",\n \"SemanticContext\": \"History of angioedema related to previous ACEi or ARB therapy.\"\n },\n {\n \"VerbatimTerm\": \"angioedema\",\n \"Probability\": \"0.170959264\",\n \"SemanticContext\": \"WARNINGS AND PRECAUTIONS Observe for signs and symptoms of angioedema and hypotension.\"\n },\n {\n \"VerbatimTerm\": \"angioedema\",\n \"Probability\": \"0.8044259548\",\n \"SemanticContext\": \"In PARADIGM-HF, the incidence of angioedema was 0.1% in both the enalapril and ENTRESTO run-in periods.\"\n },\n {\n \"VerbatimTerm\": \"angioedema\",\n \"Probability\": \"0.929672718\",\n \"SemanticContext\": \"In the double-blind period, the incidence of angioedema was higher in patients treated with ENTRESTO than enalapril 0.5% and 0.2%, respectively .\"\n },\n {\n \"VerbatimTerm\": \"angioedema\",\n \"Probability\": \"0.9164919853\",\n \"SemanticContext\": \"The incidence of angioedema in Black patients was 2.4% with ENTRESTO and 0.5% with enalapril [see Warnings and Precautions 5.2 ] .\"\n },\n {\n \"VerbatimTerm\": \"angioedema\",\n \"Probability\": \"0.013499409\",\n \"SemanticContext\": \"undefined4 CONTRAINDICATIONS ENTRESTO is contraindicated: in patients with hypersensitivity to any component in patients with a history of angioedema related to previous ACE inhibitor or ARB therapy [see Warnings and Precautions 5.2 ] with concomitant use of ACE inhibitors.\"\n },\n {\n \"VerbatimTerm\": \"angioedema\",\n \"Probability\": \"0.2631254196\",\n \"SemanticContext\": \"7 DRUG INTERACTIONS 7.1 Dual Blockade of the Renin-Angiotensin-Aldosterone System Concomitant use of ENTRESTO with an ACE inhibitor is contraindicated because of the increased risk of angioedema [see Contraindications 4 ] .\"\n },\n {\n \"VerbatimTerm\": \"angioedema\",\n \"Probability\": \"0.90774858\",\n \"SemanticContext\": \"5.2 Angioedema ENTRESTO may cause angioedema [see Adverse Reactions 6.1 ] .\"\n },\n {\n \"VerbatimTerm\": \"angioedema\",\n \"Probability\": \"0.0284106731\",\n \"SemanticContext\": \"If angioedema occurs, discontinue ENTRESTO immediately, provide appropriate therapy, and monitor for airway compromise.\"\n },\n {\n \"VerbatimTerm\": \"angioedema\",\n \"Probability\": \"0.5259882212\",\n \"SemanticContext\": \"In cases of confirmed angioedema where swelling has been confined to the face and lips, the condition has generally resolved without treatment, although antihistamines have been useful in relieving symptoms.\"\n },\n {\n \"VerbatimTerm\": \"angioedema\",\n \"Probability\": \"0.886305809\",\n \"SemanticContext\": \"ENTRESTO has been associated with a higher rate of angioedema in Black than in non-Black patients.\"\n },\n {\n \"VerbatimTerm\": \"angioedema\",\n \"Probability\": \"0.0118951797\",\n \"SemanticContext\": \"Patients with a prior history of angioedema may be at increased risk of angioedema with ENTRESTO [see Adverse Reactions 6.1 ] .\"\n },\n {\n \"VerbatimTerm\": \"angioedema\",\n \"Probability\": \"0.4535813332\",\n \"SemanticContext\": \"Patients with a prior history of angioedema may be at increased risk of angioedema with ENTRESTO [see Adverse Reactions 6.1 ] .\"\n },\n {\n \"VerbatimTerm\": \"angioedema\",\n \"Probability\": \"0.0014428794\",\n \"SemanticContext\": \"ENTRESTO must not be used in patients with a known history of angioedema related to previous ACE inhibitor or ARB therapy [see Contraindications 4 ] .\"\n },\n {\n \"VerbatimTerm\": \"Angioedema\",\n \"Probability\": \"0.9966206551\",\n \"SemanticContext\": \"undefined6 ADVERSE REACTIONS Clinically significant adverse reactions that appear in other sections of the labeling include: Angioedema [see Warnings and Precautions 5.2 ] Hypotension [see Warnings and Precautions 5.3 ] Impaired Renal Function [see Warnings and Precautions 5.4 ] Hyperkalemia [see Warnings and Precautions 5.5 ] 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.\"\n },\n {\n \"VerbatimTerm\": \"Angioedema\",\n \"Probability\": \"0.2056887746\",\n \"SemanticContext\": \"Angioedema: Advise patients to discontinue use of their previous ACE inhibitor or ARB.\"\n },\n {\n \"VerbatimTerm\": \"Angioedema\",\n \"Probability\": \"0.2216739357\",\n \"SemanticContext\": \"5.2 Angioedema ENTRESTO may cause angioedema [see Adverse Reactions 6.1 ] .\"\n },\n {\n \"VerbatimTerm\": \"Angioedema\",\n \"Probability\": \"0.0367594361\",\n \"SemanticContext\": \"Angioedema associated with laryngeal edema may be fatal.\"\n }\n ]\n },\n {\n \"Term\": \"Toxicity to various agents\",\n \"MEDDRACode\": \"10070863\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"lithium toxicity\",\n \"Probability\": \"0.022584945\",\n \"SemanticContext\": \"Lithium: Increased risk of lithium toxicity.\"\n },\n {\n \"VerbatimTerm\": \"lithium toxicity\",\n \"Probability\": \"0.0023825169\",\n \"SemanticContext\": \"7.4 Lithium Increases in serum lithium concentrations and lithium toxicity have been reported during concomitant administration of lithium with angiotensin II receptor antagonists.\"\n }\n ]\n },\n {\n \"Term\": \"Pregnancy\",\n \"MEDDRACode\": \"10036556\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"pregnancy\",\n \"Probability\": \"0.0161731839\",\n \"SemanticContext\": \"When pregnancy is detected, discontinue ENTRESTO as soon as possible.\"\n },\n {\n \"VerbatimTerm\": \"pregnancy\",\n \"Probability\": \"0.0004371703\",\n \"SemanticContext\": \"Pregnancy: Advise female patients of childbearing age about the consequences of exposure to ENTRESTO during pregnancy.\"\n },\n {\n \"VerbatimTerm\": \"pregnancy\",\n \"Probability\": \"0.0022804439\",\n \"SemanticContext\": \"Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death.\"\n },\n {\n \"VerbatimTerm\": \"pregnancy\",\n \"Probability\": \"0.0001852214\",\n \"SemanticContext\": \"When pregnancy is detected, consider alternative drug treatment and discontinue ENTRESTO.\"\n },\n {\n \"VerbatimTerm\": \"pregnancy\",\n \"Probability\": \"0.0273528993\",\n \"SemanticContext\": \"Clinical Considerations Fetal/Neonatal Adverse Reactions Oligohydramnios in pregnant women who use drugs affecting the renin-angiotensin system in the second and third trimesters of pregnancy can result in the following: reduced fetal renal function leading to anuria and renal failure, fetal lung hypoplasia, skeletal deformations, including skull hypoplasia, hypotension, and death.\"\n },\n {\n \"VerbatimTerm\": \"pregnancy\",\n \"Probability\": \"0.0022804439\",\n \"SemanticContext\": \"Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death.\"\n },\n {\n \"VerbatimTerm\": \"pregnancy\",\n \"Probability\": \"0.0017968416\",\n \"SemanticContext\": \"When pregnancy is detected, consider alternative drug treatment and discontinue ENTRESTO.\"\n },\n {\n \"VerbatimTerm\": \"Pregnancy\",\n \"Probability\": \"0.0614420474\",\n \"SemanticContext\": \"Pregnancy: Advise female patients of childbearing age about the consequences of exposure to ENTRESTO during pregnancy.\"\n },\n {\n \"VerbatimTerm\": \"Pregnancy\",\n \"Probability\": \"0.0145212412\",\n \"SemanticContext\": \"8.1 Pregnancy Risk Summary ENTRESTO can cause fetal harm when administered to a pregnant woman.\"\n },\n {\n \"VerbatimTerm\": \"pregnancies\",\n \"Probability\": \"0.000228405\",\n \"SemanticContext\": \"Ask patients to report pregnancies to their physicians as soon as possible [see Warnings and Precautions 5.1 and Use in Specific Populations 8.1 ] .\"\n },\n {\n \"VerbatimTerm\": \"pregnancies\",\n \"Probability\": \"0.0937973261\",\n \"SemanticContext\": \"In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.\"\n }\n ]\n },\n {\n \"Term\": \"Gait disturbance\",\n \"MEDDRACode\": \"10017577\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Step\",\n \"Probability\": \"0.1524640322\",\n \"SemanticContext\": \"DOSAGE AND ADMINISTRATION Indication Titration Step Dose twice daily Starting Second Final Adult Heart Failure 49/51 mg 97/103 mg Pediatric Heart Failure Patients less than 40 kg 1.6 mg/kg 2.3 mg/kg 3.1 mg/kg Pediatric Heart Failure Patients at least 40 kg, less than 50 kg 24/26 mg 49/51 mg 72/78 mg Pediatric Heart Failure Patients at least 50 kg 49/51 mg 72/78 mg 97/103 mg .\"\n },\n {\n \"VerbatimTerm\": \"Step\",\n \"Probability\": \"0.0159031153\",\n \"SemanticContext\": \"Titration Step Dose twice daily Starting Second Final Pediatric Patients Less than 40 kg † 1.6 mg/kg 2.3 mg/kg 3.1 mg/kg Pediatric Patients At least 40 kg, less than 50 kg 24/26 mg 49/51 mg 72/78 mg ‡ Pediatric Patients At least 50 kg 49/51 mg 72/78 mg ‡ 97/103 mg .\"\n }\n ]\n },\n {\n \"Term\": \"Elderly\",\n \"MEDDRACode\": \"10014348\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": true\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"elderly\",\n \"Probability\": \"0.0002468824\",\n \"SemanticContext\": \"7.3 Nonsteroidal Anti-Inflammatory Drugs NSAIDs Including Selective Cyclooxygenase-2 Inhibitors COX-2 Inhibitors In patients who are elderly, volume-depleted including those on diuretic therapy , or with compromised renal function, concomitant use of NSAIDs, including COX-2 inhibitors, with ENTRESTO may result in worsening of renal function, including possible acute renal failure.\"\n },\n {\n \"VerbatimTerm\": \"elderly\",\n \"Probability\": \"0.0023521185\",\n \"SemanticContext\": \"8.5 Geriatric Use No relevant pharmacokinetic differences have been observed in elderly = 65 years or very elderly = 75 years patients compared to the overall population [see Clinical Pharmacology 12.3 ] .\"\n },\n {\n \"VerbatimTerm\": \"elderly\",\n \"Probability\": \"0.0022372603\",\n \"SemanticContext\": \"8.5 Geriatric Use No relevant pharmacokinetic differences have been observed in elderly = 65 years or very elderly = 75 years patients compared to the overall population [see Clinical Pharmacology 12.3 ] .\"\n }\n ]\n },\n {\n \"Term\": \"Abortion spontaneous\",\n \"MEDDRACode\": \"10000234\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"miscarriage\",\n \"Probability\": \"0.1440780163\",\n \"SemanticContext\": \"The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.\"\n },\n {\n \"VerbatimTerm\": \"miscarriage\",\n \"Probability\": \"0.8080263138\",\n \"SemanticContext\": \"In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.\"\n }\n ]\n },\n {\n \"Term\": \"Blood potassium increased\",\n \"MEDDRACode\": \"10005725\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"high potassium\",\n \"Probability\": \"0.0245267749\",\n \"SemanticContext\": \"Monitor serum potassium periodically and treat appropriately, especially in patients with risk factors for hyperkalemia such as severe renal impairment, diabetes, hypoaldosteronism, or a high potassium diet.\"\n }\n ]\n },\n {\n \"Term\": \"Microcephaly\",\n \"MEDDRACode\": \"10027534\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"skull hypoplasia\",\n \"Probability\": \"0.5449838042\",\n \"SemanticContext\": \"Clinical Considerations Fetal/Neonatal Adverse Reactions Oligohydramnios in pregnant women who use drugs affecting the renin-angiotensin system in the second and third trimesters of pregnancy can result in the following: reduced fetal renal function leading to anuria and renal failure, fetal lung hypoplasia, skeletal deformations, including skull hypoplasia, hypotension, and death.\"\n }\n ]\n },\n {\n \"Term\": \"Oligohydramnios\",\n \"MEDDRACode\": \"10030289\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Oligohydramnios\",\n \"Probability\": \"0.0472896993\",\n \"SemanticContext\": \"Clinical Considerations Fetal/Neonatal Adverse Reactions Oligohydramnios in pregnant women who use drugs affecting the renin-angiotensin system in the second and third trimesters of pregnancy can result in the following: reduced fetal renal function leading to anuria and renal failure, fetal lung hypoplasia, skeletal deformations, including skull hypoplasia, hypotension, and death.\"\n },\n {\n \"VerbatimTerm\": \"oligohydramnios\",\n \"Probability\": \"0.0028528571\",\n \"SemanticContext\": \"Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury.\"\n },\n {\n \"VerbatimTerm\": \"oligohydramnios\",\n \"Probability\": \"0.0069398582\",\n \"SemanticContext\": \"If oligohydramnios is observed, consider alternative drug treatment.\"\n }\n ]\n },\n {\n \"Term\": \"Laryngeal oedema\",\n \"MEDDRACode\": \"10023845\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"laryngeal edema\",\n \"Probability\": \"0.0357260406\",\n \"SemanticContext\": \"Angioedema associated with laryngeal edema may be fatal.\"\n }\n ]\n },\n {\n \"Term\": \"Hyponatraemia\",\n \"MEDDRACode\": \"10021036\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"salt depletion\",\n \"Probability\": \"0.0007889867\",\n \"SemanticContext\": \"Correct volume or salt depletion prior to administration of ENTRESTO or start at a lower dose.\"\n }\n ]\n },\n {\n \"Term\": \"Blood sodium\",\n \"MEDDRACode\": \"10005799\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0013027787\",\n \"SemanticContext\": \"ENTRESTO contains a complex comprised of anionic forms of sacubitril and valsartan, sodium cations, and water molecules in the molar ratio of 1:1:3:2.5, respectively.\"\n }\n ]\n },\n {\n \"Term\": \"Positron emission tomogram\",\n \"MEDDRACode\": \"10036220\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"PET\",\n \"Probability\": \"0.0005914867\",\n \"SemanticContext\": \"Transfer the entire contents from the mortar into a clean 200 mL amber colored PET or glass bottle.\"\n }\n ]\n },\n {\n \"Term\": \"Sudden death\",\n \"MEDDRACode\": \"10042434\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Sudden death\",\n \"Probability\": \"0.9553558826\",\n \"SemanticContext\": \"Sudden death accounted for 45% of cardiovascular deaths, followed by pump failure, which accounted for 26%.\"\n }\n ]\n },\n {\n \"Term\": \"Renin\",\n \"MEDDRACode\": \"10038555\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"renin\",\n \"Probability\": \"0.0010442436\",\n \"SemanticContext\": \"Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.\"\n },\n {\n \"VerbatimTerm\": \"renin\",\n \"Probability\": \"0.0027699471\",\n \"SemanticContext\": \"12.2 Pharmacodynamics The pharmacodynamic effects of ENTRESTO were evaluated after single and multiple dose administrations in healthy subjects and in patients with heart failure, and are consistent with simultaneous neprilysin inhibition and renin-angiotensin system blockade.\"\n },\n {\n \"VerbatimTerm\": \"renin\",\n \"Probability\": \"0.0011363626\",\n \"SemanticContext\": \"ENTRESTO also blocked the AT 1 -receptor as evidenced by increased plasma renin activity and plasma renin concentrations.\"\n },\n {\n \"VerbatimTerm\": \"renin\",\n \"Probability\": \"0.0006325841\",\n \"SemanticContext\": \"ENTRESTO also blocked the AT 1 -receptor as evidenced by increased plasma renin activity and plasma renin concentrations.\"\n },\n {\n \"VerbatimTerm\": \"renin\",\n \"Probability\": \"3.64444E-05\",\n \"SemanticContext\": \"Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death.\"\n },\n {\n \"VerbatimTerm\": \"renin\",\n \"Probability\": \"0.0009186864\",\n \"SemanticContext\": \"Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents.\"\n },\n {\n \"VerbatimTerm\": \"renin\",\n \"Probability\": \"1.70625E-05\",\n \"SemanticContext\": \"However, if there is no appropriate alternative to therapy with drugs affecting the renin-angiotensin system, and if the drug is considered lifesaving for the mother, advise a pregnant woman of the potential risk to the fetus.\"\n },\n {\n \"VerbatimTerm\": \"renin\",\n \"Probability\": \"0.0022264719\",\n \"SemanticContext\": \"Clinical Considerations Fetal/Neonatal Adverse Reactions Oligohydramnios in pregnant women who use drugs affecting the renin-angiotensin system in the second and third trimesters of pregnancy can result in the following: reduced fetal renal function leading to anuria and renal failure, fetal lung hypoplasia, skeletal deformations, including skull hypoplasia, hypotension, and death.\"\n },\n {\n \"VerbatimTerm\": \"renin\",\n \"Probability\": \"3.64444E-05\",\n \"SemanticContext\": \"Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death.\"\n },\n {\n \"VerbatimTerm\": \"renin\",\n \"Probability\": \"1.50169E-05\",\n \"SemanticContext\": \"However, if there is no appropriate alternative to therapy with drugs affecting the renin-angiotensin system, and if the drug is considered lifesaving for the mother, advise a pregnant woman of the potential risk to the fetus [see Use in Specific Populations 8.1 ] .\"\n },\n {\n \"VerbatimTerm\": \"renin\",\n \"Probability\": \"3.05344E-05\",\n \"SemanticContext\": \"Patients with an activated renin-angiotensin system, such as volume- and/or salt-depleted patients e.g., those being treated with high doses of diuretics , are at greater risk.\"\n },\n {\n \"VerbatimTerm\": \"renin\",\n \"Probability\": \"0.0022082627\",\n \"SemanticContext\": \"5.4 Impaired Renal Function As a consequence of inhibiting the renin-angiotensin-aldosterone system RAAS , decreases in renal function may be anticipated in susceptible individuals treated with ENTRESTO [see Adverse Reactions 6.1 ] .\"\n },\n {\n \"VerbatimTerm\": \"renin\",\n \"Probability\": \"7.96807E-05\",\n \"SemanticContext\": \"In patients whose renal function depends upon the activity of the renin-angiotensin-aldosterone system e.g., patients with severe congestive heart failure , treatment with ACE inhibitors and angiotensin receptor antagonists has been associated with oliguria, progressive azotemia and, rarely, acute renal failure and death.\"\n },\n {\n \"VerbatimTerm\": \"Renin\",\n \"Probability\": \"0.0031959414\",\n \"SemanticContext\": \"7 DRUG INTERACTIONS 7.1 Dual Blockade of the Renin-Angiotensin-Aldosterone System Concomitant use of ENTRESTO with an ACE inhibitor is contraindicated because of the increased risk of angioedema [see Contraindications 4 ] .\"\n }\n ]\n },\n {\n \"Term\": \"Cardiac resynchronisation therapy\",\n \"MEDDRACode\": \"10059862\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"cardiac resynchronization therapy\",\n \"Probability\": \"2.93315E-05\",\n \"SemanticContext\": \"Few patients had an implantable cardioverter-defibrillator ICD or cardiac resynchronization therapy-defibrillator CRT-D 15% .\"\n }\n ]\n },\n {\n \"Term\": \"Blood potassium\",\n \"MEDDRACode\": \"10005721\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"serum potassium\",\n \"Probability\": \"1.69533E-05\",\n \"SemanticContext\": \"Monitor serum potassium periodically and treat appropriately, especially in patients with risk factors for hyperkalemia such as severe renal impairment, diabetes, hypoaldosteronism, or a high potassium diet.\"\n },\n {\n \"VerbatimTerm\": \"Serum Potassium\",\n \"Probability\": \"5.4055E-05\",\n \"SemanticContext\": \"Serum Potassium During the double-blind period of PARADIGM-HF, approximately 16% of both ENTRESTO- and enalapril-treated patients had potassium concentrations > 5.5 mEq/L.\"\n }\n ]\n },\n {\n \"Term\": \"Dialysis\",\n \"MEDDRACode\": \"10061105\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"dialysis\",\n \"Probability\": \"4.24038E-05\",\n \"SemanticContext\": \"Exchange transfusions or dialysis may be required as a means of reversing hypotension and replacing renal function.\"\n }\n ]\n },\n {\n \"Term\": \"Restrictive allograft syndrome\",\n \"MEDDRACode\": \"10077506\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"RAS\",\n \"Probability\": \"0.0240430236\",\n \"SemanticContext\": \"The primary objective of PARADIGM-HF was to determine whether ENTRESTO, a combination of sacubitril and a RAS inhibitor valsartan , was superior to a RAS inhibitor enalapril alone in reducing the risk of the combined endpoint of cardiovascular CV death or hospitalization for heart failure HF .\"\n },\n {\n \"VerbatimTerm\": \"RAS\",\n \"Probability\": \"0.008209914\",\n \"SemanticContext\": \"The primary objective of PARADIGM-HF was to determine whether ENTRESTO, a combination of sacubitril and a RAS inhibitor valsartan , was superior to a RAS inhibitor enalapril alone in reducing the risk of the combined endpoint of cardiovascular CV death or hospitalization for heart failure HF .\"\n },\n {\n \"VerbatimTerm\": \"RAS\",\n \"Probability\": \"0.0738016665\",\n \"SemanticContext\": \"PARADIGM-HF demonstrated that ENTRESTO, a combination of sacubitril and a RAS inhibitor valsartan , was superior to a RAS inhibitor enalapril , in reducing the risk of the combined endpoint of cardiovascular death or hospitalization for heart failure, based on a time-to-event analysis hazard ratio [HR] 0.80; 95% confidence interval [CI], 0.73, 0.87, p< 0.0001 .\"\n },\n {\n \"VerbatimTerm\": \"RAS\",\n \"Probability\": \"0.0215521157\",\n \"SemanticContext\": \"PARADIGM-HF demonstrated that ENTRESTO, a combination of sacubitril and a RAS inhibitor valsartan , was superior to a RAS inhibitor enalapril , in reducing the risk of the combined endpoint of cardiovascular death or hospitalization for heart failure, based on a time-to-event analysis hazard ratio [HR] 0.80; 95% confidence interval [CI], 0.73, 0.87, p < 0.0001 .\"\n }\n ]\n },\n {\n \"Term\": \"Univentricular heart\",\n \"MEDDRACode\": \"10045545\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"single ventricles\",\n \"Probability\": \"0.0512121022\",\n \"SemanticContext\": \"Patients with systemic right ventricles and single ventricles were excluded from the trial.\"\n }\n ]\n },\n {\n \"Term\": \"Drug interaction\",\n \"MEDDRACode\": \"10013710\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": true,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"DRUG INTERACTIONS\",\n \"Probability\": \"0.0002338886\",\n \"SemanticContext\": \"DRUG INTERACTIONS Avoid concomitant use with aliskiren in patients with eGFR < 60.\"\n },\n {\n \"VerbatimTerm\": \"DRUG INTERACTIONS\",\n \"Probability\": \"0.0020399392\",\n \"SemanticContext\": \"7 DRUG INTERACTIONS 7.1 Dual Blockade of the Renin-Angiotensin-Aldosterone System Concomitant use of ENTRESTO with an ACE inhibitor is contraindicated because of the increased risk of angioedema [see Contraindications 4 ] .\"\n },\n {\n \"VerbatimTerm\": \"Drug Interactions\",\n \"Probability\": \"0.0002914369\",\n \"SemanticContext\": \"Drug Interactions: Effect of Co-administered Drugs on ENTRESTO: Because CYP450 enzyme-mediated metabolism of sacubitril and valsartan is minimal, coadministration with drugs that impact CYP450 enzymes is not expected to affect the pharmacokinetics of ENTRESTO.\"\n },\n {\n \"VerbatimTerm\": \"Drug Interactions\",\n \"Probability\": \"0.0003542006\",\n \"SemanticContext\": \"Do not administer within 36 hours of switching from or to an ACE inhibitor [see Drug Interactions 7.1 ] with concomitant use of aliskiren in patients with diabetes [see Drug Interactions 7.1 ]\"\n },\n {\n \"VerbatimTerm\": \"Drug Interactions\",\n \"Probability\": \"0.0002714097\",\n \"SemanticContext\": \"Do not administer within 36 hours of switching from or to an ACE inhibitor [see Drug Interactions 7.1 ] with concomitant use of aliskiren in patients with diabetes [see Drug Interactions 7.1 ]\"\n },\n {\n \"VerbatimTerm\": \"Drug Interactions\",\n \"Probability\": \"0.0005121827\",\n \"SemanticContext\": \"If switching from an ACE inhibitor to ENTRESTO allow a washout period of 36 hours between administration of the two drugs [see Contraindications 4 and Drug Interactions 7.1 ] .\"\n },\n {\n \"VerbatimTerm\": \"drug interaction\",\n \"Probability\": \"0.0001884103\",\n \"SemanticContext\": \"Dedicated drug interaction studies demonstrated that coadministration of furosemide, warfarin, digoxin, carvedilol, a combination of levonorgestrel/ethinyl estradiol, amlodipine, omeprazole, hydrochlorothiazide HCTZ , metformin, atorvastatin, and sildenafil, did not alter the systemic exposure to sacubitril, LBQ657 or valsartan.\"\n }\n ]\n },\n {\n \"Term\": \"Renal failure\",\n \"MEDDRACode\": \"10038435\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"renal failure\",\n \"Probability\": \"0.9910707474\",\n \"SemanticContext\": \"ADVERSE REACTIONS Adverse reactions occurring = 5% are hypotension, hyperkalemia, cough, dizziness, and renal failure.\"\n },\n {\n \"VerbatimTerm\": \"renal failure\",\n \"Probability\": \"0.8414125443\",\n \"SemanticContext\": \"Clinical Considerations Fetal/Neonatal Adverse Reactions Oligohydramnios in pregnant women who use drugs affecting the renin-angiotensin system in the second and third trimesters of pregnancy can result in the following: reduced fetal renal function leading to anuria and renal failure, fetal lung hypoplasia, skeletal deformations, including skull hypoplasia, hypotension, and death.\"\n },\n {\n \"VerbatimTerm\": \"Renal failure\",\n \"Probability\": \"0.8244662285\",\n \"SemanticContext\": \"Table 2: Adverse Reactions Reported in = 5% of Patients Treated with ENTRESTO in the Double-Blind Period of PARADIGM-HF ENTRESTO n = 4,203 % Enalapril n = 4,229 % Hypotension 18 12 Hyperkalemia 12 14 Cough 9 13 Dizziness 6 5 Renal failure/acute renal failure 5 5 .\"\n }\n ]\n },\n {\n \"Term\": \"N-terminal prohormone brain natriuretic peptide\",\n \"MEDDRACode\": \"10067803\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"NT-proBNP\",\n \"Probability\": \"0.0002346635\",\n \"SemanticContext\": \"ENTRESTO reduces NT-proBNP and is expected to improve cardiovascular outcomes.\"\n },\n {\n \"VerbatimTerm\": \"NT-proBNP\",\n \"Probability\": \"0.0001230859\",\n \"SemanticContext\": \"In a 7-day valsartan-controlled study in patients with reduced ejection fraction HFrEF , administration of ENTRESTO resulted in a significant non-sustained increase in natriuresis, increased urine cGMP, and decreased plasma MR-proANP and NT-proBNP compared to valsartan.\"\n },\n {\n \"VerbatimTerm\": \"NT-proBNP\",\n \"Probability\": \"5.95785E-05\",\n \"SemanticContext\": \"In a 21-day study in HFrEF patients, ENTRESTO significantly increased urine ANP and cGMP and plasma cGMP, and decreased plasma NT-proBNP, aldosterone and endothelin-1.\"\n },\n {\n \"VerbatimTerm\": \"NT-proBNP\",\n \"Probability\": \"1.95798E-05\",\n \"SemanticContext\": \"In PARADIGM-HF, ENTRESTO decreased plasma NT-proBNP not a neprilysin substrate and increased plasma BNP a neprilysin substrate and urine cGMP compared with enalapril.\"\n },\n {\n \"VerbatimTerm\": \"NT-proBNP\",\n \"Probability\": \"0.0015756786\",\n \"SemanticContext\": \"In PARAMOUNT, a randomized, double-blind, 36-week study in patients with heart failure with LVEF = 45% comparing 97/103 mg of ENTRESTO n=149 to 160 mg of valsartan n =152 twice-daily, ENTRESTO decreased NT-proBNP by 17% while valsartan increased NT-proBNP by 8% at Week 12 p = 0.005 .\"\n },\n {\n \"VerbatimTerm\": \"NT-proBNP\",\n \"Probability\": \"0.0007931292\",\n \"SemanticContext\": \"In PARAGON-HF, ENTRESTO decreased NT-proBNP by 24% Week 16 and 19% Week 48 compared to 6% and 3% reductions on valsartan, respectively.\"\n },\n {\n \"VerbatimTerm\": \"NT-proBNP\",\n \"Probability\": \"3.44313E-05\",\n \"SemanticContext\": \"The endpoint was the between-group difference in the change in plasma NT-proBNP from baseline to 12 weeks.\"\n },\n {\n \"VerbatimTerm\": \"NT-proBNP\",\n \"Probability\": \"8.026E-05\",\n \"SemanticContext\": \"The reduction from baseline in NT-proBNP was 44% and 33% in the ENTRESTO and enalapril groups, respectively.\"\n },\n {\n \"VerbatimTerm\": \"NT-proBNP\",\n \"Probability\": \"2.15251E-05\",\n \"SemanticContext\": \"Because ENTRESTO improved outcomes and reduced NT-proBNP in PARADIGM-HF, the effect on NT-proBNP was considered a reasonable basis to infer improved cardiovascular outcomes in pediatric patients.\"\n },\n {\n \"VerbatimTerm\": \"NT-proBNP\",\n \"Probability\": \"2.87623E-05\",\n \"SemanticContext\": \"Because ENTRESTO improved outcomes and reduced NT-proBNP in PARADIGM-HF, the effect on NT-proBNP was considered a reasonable basis to infer improved cardiovascular outcomes in pediatric patients.\"\n },\n {\n \"VerbatimTerm\": \"NT-proBNP\",\n \"Probability\": \"0.0001285672\",\n \"SemanticContext\": \"ENTRESTO reduces NT-proBNP and is expected to improve cardiovascular outcomes.\"\n },\n {\n \"VerbatimTerm\": \"NT-proBNP\",\n \"Probability\": \"5.6519E-06\",\n \"SemanticContext\": \"8.4 Pediatric Use The safety and effectiveness of ENTRESTO in pediatric heart failure patients 1 to < 18 years old are supported by the reduction from baseline to 12 weeks in NT-proBNP in a randomized, double-blind clinical study [see Clinical Studies 14.2 ] .\"\n },\n {\n \"VerbatimTerm\": \"NT-proBNP\",\n \"Probability\": \"0.0001370311\",\n \"SemanticContext\": \"The analysis of NT-proBNP included 90 patients age 6 to 18 years and 20 patients age 1 to 6 years.\"\n }\n ]\n },\n {\n \"Term\": \"Dizziness\",\n \"MEDDRACode\": \"10013573\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"dizziness\",\n \"Probability\": \"0.9991669059\",\n \"SemanticContext\": \"ADVERSE REACTIONS Adverse reactions occurring = 5% are hypotension, hyperkalemia, cough, dizziness, and renal failure.\"\n },\n {\n \"VerbatimTerm\": \"Dizziness\",\n \"Probability\": \"0.9995245934\",\n \"SemanticContext\": \"Table 2: Adverse Reactions Reported in = 5% of Patients Treated with ENTRESTO in the Double-Blind Period of PARADIGM-HF ENTRESTO n = 4,203 % Enalapril n = 4,229 % Hypotension 18 12 Hyperkalemia 12 14 Cough 9 13 Dizziness 6 5 Renal failure/acute renal failure 5 5 .\"\n }\n ]\n },\n {\n \"Term\": \"Breast feeding\",\n \"MEDDRACode\": \"10006247\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": true,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Breastfeeding\",\n \"Probability\": \"0.7617154121\",\n \"SemanticContext\": \"USE IN SPECIFIC POPULATIONS Lactation: Breastfeeding or drug should be discontinued.\"\n },\n {\n \"VerbatimTerm\": \"breastfed\",\n \"Probability\": \"0.000143826\",\n \"SemanticContext\": \"8.2 Lactation Risk Summary There is no information regarding the presence of sacubitril/valsartan in human milk, the effects on the breastfed infant, or the effects on milk production.\"\n },\n {\n \"VerbatimTerm\": \"breastfed\",\n \"Probability\": \"0.0001499653\",\n \"SemanticContext\": \"Because of the potential for serious adverse reactions in breastfed infants from exposure to sacubitril/valsartan, advise a nursing woman that breastfeeding is not recommended during treatment with ENTRESTO.\"\n },\n {\n \"VerbatimTerm\": \"breastfeeding\",\n \"Probability\": \"7.6376E-06\",\n \"SemanticContext\": \"Because of the potential for serious adverse reactions in breastfed infants from exposure to sacubitril/valsartan, advise a nursing woman that breastfeeding is not recommended during treatment with ENTRESTO.\"\n }\n ]\n },\n {\n \"Term\": \"Congenital anomaly\",\n \"MEDDRACode\": \"10010356\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"birth defects\",\n \"Probability\": \"0.0536800623\",\n \"SemanticContext\": \"The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.\"\n },\n {\n \"VerbatimTerm\": \"birth defects\",\n \"Probability\": \"0.0874367952\",\n \"SemanticContext\": \"In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.\"\n }\n ]\n },\n {\n \"Term\": \"Haemodialysis\",\n \"MEDDRACode\": \"10018875\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hemodialysis\",\n \"Probability\": \"0.0004598498\",\n \"SemanticContext\": \"ENTRESTO is unlikely to be removed by hemodialysis because of high protein binding.\"\n }\n ]\n },\n {\n \"Term\": \"Dyspnoea paroxysmal nocturnal\",\n \"MEDDRACode\": \"10013974\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"PND\",\n \"Probability\": \"0.0512821376\",\n \"SemanticContext\": \"Animal Data Sacubitril given orally to juvenile rats from postnatal day PND 7 to PND 35 or PND 70 an age approximately equivalent to neonatal through pre-pubertal development or adulthood in humans at doses = 400 mg/kg/day approximately 2-fold the AUC exposure to the active metabolite of sacubitril, LBQ657, at an ENTRESTO pediatric clinical dose of 3.1 mg/kg twice daily resulted in decreases in body weight, bone length, and bone mass.\"\n },\n {\n \"VerbatimTerm\": \"PND\",\n \"Probability\": \"0.1512623727\",\n \"SemanticContext\": \"Animal Data Sacubitril given orally to juvenile rats from postnatal day PND 7 to PND 35 or PND 70 an age approximately equivalent to neonatal through pre-pubertal development or adulthood in humans at doses = 400 mg/kg/day approximately 2-fold the AUC exposure to the active metabolite of sacubitril, LBQ657, at an ENTRESTO pediatric clinical dose of 3.1 mg/kg twice daily resulted in decreases in body weight, bone length, and bone mass.\"\n },\n {\n \"VerbatimTerm\": \"PND\",\n \"Probability\": \"0.2018271089\",\n \"SemanticContext\": \"Animal Data Sacubitril given orally to juvenile rats from postnatal day PND 7 to PND 35 or PND 70 an age approximately equivalent to neonatal through pre-pubertal development or adulthood in humans at doses = 400 mg/kg/day approximately 2-fold the AUC exposure to the active metabolite of sacubitril, LBQ657, at an ENTRESTO pediatric clinical dose of 3.1 mg/kg twice daily resulted in decreases in body weight, bone length, and bone mass.\"\n },\n {\n \"VerbatimTerm\": \"PND\",\n \"Probability\": \"0.8077288866\",\n \"SemanticContext\": \"The decrease in body weight was transient from PND 10 to PND 20 and the effects for most bone parameters were reversible after treatment stopped.\"\n },\n {\n \"VerbatimTerm\": \"PND\",\n \"Probability\": \"0.5689792633\",\n \"SemanticContext\": \"The decrease in body weight was transient from PND 10 to PND 20 and the effects for most bone parameters were reversible after treatment stopped.\"\n },\n {\n \"VerbatimTerm\": \"PND\",\n \"Probability\": \"0.0263926089\",\n \"SemanticContext\": \"Valsartan given orally to juvenile rats from PND 7 to PND 70 an age approximately equivalent to neonatal through adulthood in humans produced persistent, irreversible kidney damage at all dose levels.\"\n },\n {\n \"VerbatimTerm\": \"PND\",\n \"Probability\": \"0.093349874\",\n \"SemanticContext\": \"Valsartan given orally to juvenile rats from PND 7 to PND 70 an age approximately equivalent to neonatal through adulthood in humans produced persistent, irreversible kidney damage at all dose levels.\"\n }\n ]\n },\n {\n \"Term\": \"Ultrasound scan\",\n \"MEDDRACode\": \"10045434\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"ultrasound examinations\",\n \"Probability\": \"3.85155E-05\",\n \"SemanticContext\": \"Perform serial ultrasound examinations to assess the intra-amniotic environment.\"\n }\n ]\n },\n {\n \"Term\": \"Injury\",\n \"MEDDRACode\": \"10022116\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"injury\",\n \"Probability\": \"0.0035071075\",\n \"SemanticContext\": \"Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.\"\n },\n {\n \"VerbatimTerm\": \"injury\",\n \"Probability\": \"0.0022551715\",\n \"SemanticContext\": \"Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury.\"\n }\n ]\n },\n {\n \"Term\": \"Myocardial infarction\",\n \"MEDDRACode\": \"10028596\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"myocardial infarction\",\n \"Probability\": \"0.5897655487\",\n \"SemanticContext\": \"The underlying cause of heart failure was coronary artery disease in 60% of patients; 71% had a history of hypertension, 43% had a history of myocardial infarction, 37% had an eGFR < 60 mL/min/1.73m 2 , and 35% had diabetes mellitus.\"\n },\n {\n \"VerbatimTerm\": \"myocardial infarction\",\n \"Probability\": \"0.5838177204\",\n \"SemanticContext\": \"Furthermore, 96% had a history of hypertension, 23% had a history of myocardial infarction, 46% had an eGFR < 60 mL/min/1.73 m 2 , and 43% had diabetes mellitus.\"\n }\n ]\n },\n {\n \"Term\": \"Obstructive airways disorder\",\n \"MEDDRACode\": \"10061877\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"airway obstruction\",\n \"Probability\": \"0.0010028183\",\n \"SemanticContext\": \"Where there is involvement of the tongue, glottis or larynx, likely to cause airway obstruction, administer appropriate therapy, e.g., subcutaneous epinephrine/adrenaline solution 1:1000 0.3 mL to 0.5 mL and take measures necessary to ensure maintenance of a patent airway.\"\n }\n ]\n },\n {\n \"Term\": \"Renal artery stenosis\",\n \"MEDDRACode\": \"10038378\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"unilateral renal artery stenosis\",\n \"Probability\": \"0.0014502406\",\n \"SemanticContext\": \"As with all drugs that affect the RAAS, ENTRESTO may increase blood urea and serum creatinine levels in patients with bilateral or unilateral renal artery stenosis.\"\n }\n ]\n },\n {\n \"Term\": \"Angiotensin II\",\n \"MEDDRACode\": \"10002491\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"angiotensin II\",\n \"Probability\": \"0.0006088912\",\n \"SemanticContext\": \"undefined11 DESCRIPTION ENTRESTO sacubitril and valsartan is a combination of a neprilysin inhibitor and an angiotensin II receptor blocker.\"\n },\n {\n \"VerbatimTerm\": \"angiotensin II\",\n \"Probability\": \"0.0008485913\",\n \"SemanticContext\": \"ENTRESTO inhibits neprilysin neutral endopeptidase; NEP via LBQ657, the active metabolite of the prodrug sacubitril, and blocks the angiotensin II type-1 AT 1 receptor via valsartan.\"\n },\n {\n \"VerbatimTerm\": \"angiotensin II\",\n \"Probability\": \"0.0005801916\",\n \"SemanticContext\": \"The cardiovascular and renal effects of ENTRESTO in heart failure patients are attributed to the increased levels of peptides that are degraded by neprilysin, such as natriuretic peptides, by LBQ657, and the simultaneous inhibition of the effects of angiotensin II by valsartan.\"\n },\n {\n \"VerbatimTerm\": \"angiotensin II\",\n \"Probability\": \"0.0002393425\",\n \"SemanticContext\": \"Valsartan inhibits the effects of angiotensin II by selectively blocking the AT 1 receptor, and also inhibits angiotensin II-dependent aldosterone release.\"\n },\n {\n \"VerbatimTerm\": \"angiotensin II\",\n \"Probability\": \"0.0005828142\",\n \"SemanticContext\": \"Avoid use of ENTRESTO with an ARB, because ENTRESTO contains the angiotensin II receptor blocker valsartan.\"\n },\n {\n \"VerbatimTerm\": \"angiotensin II\",\n \"Probability\": \"4.11002E-05\",\n \"SemanticContext\": \"7.2 Potassium-Sparing Diuretics As with other drugs that block angiotensin II or its effects, concomitant use of potassium-sparing diuretics e.g., spironolactone, triamterene, amiloride , potassium supplements, or salt substitutes containing potassium may lead to increases in serum potassium [see Warnings and Precautions 5.5 ] .\"\n },\n {\n \"VerbatimTerm\": \"angiotensin II\",\n \"Probability\": \"3.23497E-05\",\n \"SemanticContext\": \"7.4 Lithium Increases in serum lithium concentrations and lithium toxicity have been reported during concomitant administration of lithium with angiotensin II receptor antagonists.\"\n },\n {\n \"VerbatimTerm\": \"angiotensin II\",\n \"Probability\": \"6.858E-06\",\n \"SemanticContext\": \"* Ora-Sweet SF ® and Ora-Plus ® are registered trademarks of Paddock Laboratories, Inc. 2.5 Dose Adjustment for Patients Not Taking an ACE inhibitor or ARB or Previously Taking Low Doses of These Agents In patients not currently taking an ACE inhibitor or an angiotensin II receptor blocker ARB and for patients previously taking low doses of these agents, start ENTRESTO at half the usually recommended starting dose.\"\n },\n {\n \"VerbatimTerm\": \"angiotensin II-\",\n \"Probability\": \"0.0015488267\",\n \"SemanticContext\": \"Valsartan inhibits the effects of angiotensin II by selectively blocking the AT 1 receptor, and also inhibits angiotensin II-dependent aldosterone release.\"\n }\n ]\n },\n {\n \"Term\": \"Infant\",\n \"MEDDRACode\": \"10021731\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"infant\",\n \"Probability\": \"0.0002875924\",\n \"SemanticContext\": \"8.2 Lactation Risk Summary There is no information regarding the presence of sacubitril/valsartan in human milk, the effects on the breastfed infant, or the effects on milk production.\"\n },\n {\n \"VerbatimTerm\": \"infants\",\n \"Probability\": \"0.0009127557\",\n \"SemanticContext\": \"Because of the potential for serious adverse reactions in breastfed infants from exposure to sacubitril/valsartan, advise a nursing woman that breastfeeding is not recommended during treatment with ENTRESTO.\"\n }\n ]\n },\n {\n \"Term\": \"Pre-eclampsia\",\n \"MEDDRACode\": \"10036485\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"PET\",\n \"Probability\": \"0.0005914867\",\n \"SemanticContext\": \"Transfer the entire contents from the mortar into a clean 200 mL amber colored PET or glass bottle.\"\n }\n ]\n },\n {\n \"Term\": \"Tremor\",\n \"MEDDRACode\": \"10044565\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Shake\",\n \"Probability\": \"0.0288407207\",\n \"SemanticContext\": \"Shake before each use.\"\n }\n ]\n },\n {\n \"Term\": \"Oliguria\",\n \"MEDDRACode\": \"10030302\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"oliguria\",\n \"Probability\": \"0.0054986775\",\n \"SemanticContext\": \"Closely observe neonates with histories of in utero exposure to ENTRESTO for hypotension, oliguria, and hyperkalemia.\"\n },\n {\n \"VerbatimTerm\": \"oliguria\",\n \"Probability\": \"0.503377676\",\n \"SemanticContext\": \"In neonates with a history of in utero exposure to ENTRESTO, if oliguria or hypotension occurs, support blood pressure and renal perfusion.\"\n },\n {\n \"VerbatimTerm\": \"oliguria\",\n \"Probability\": \"0.7345627546\",\n \"SemanticContext\": \"In patients whose renal function depends upon the activity of the renin-angiotensin-aldosterone system e.g., patients with severe congestive heart failure , treatment with ACE inhibitors and angiotensin receptor antagonists has been associated with oliguria, progressive azotemia and, rarely, acute renal failure and death.\"\n }\n ]\n },\n {\n \"Term\": \"Hereditary angioedema\",\n \"MEDDRACode\": \"10019860\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hereditary angioedema\",\n \"Probability\": \"0.0105123818\",\n \"SemanticContext\": \"ENTRESTO should not be used in patients with hereditary angioedema.\"\n }\n ]\n },\n {\n \"Term\": \"Cough\",\n \"MEDDRACode\": \"10011224\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"cough\",\n \"Probability\": \"0.998965919\",\n \"SemanticContext\": \"ADVERSE REACTIONS Adverse reactions occurring = 5% are hypotension, hyperkalemia, cough, dizziness, and renal failure.\"\n },\n {\n \"VerbatimTerm\": \"Cough\",\n \"Probability\": \"0.9997550249\",\n \"SemanticContext\": \"Table 2: Adverse Reactions Reported in = 5% of Patients Treated with ENTRESTO in the Double-Blind Period of PARADIGM-HF ENTRESTO n = 4,203 % Enalapril n = 4,229 % Hypotension 18 12 Hyperkalemia 12 14 Cough 9 13 Dizziness 6 5 Renal failure/acute renal failure 5 5 .\"\n }\n ]\n },\n {\n \"Term\": \"Swelling\",\n \"MEDDRACode\": \"10042674\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"swelling\",\n \"Probability\": \"0.1814213693\",\n \"SemanticContext\": \"In cases of confirmed angioedema where swelling has been confined to the face and lips, the condition has generally resolved without treatment, although antihistamines have been useful in relieving symptoms.\"\n }\n ]\n },\n {\n \"Term\": \"Hydrocephalus\",\n \"MEDDRACode\": \"10020508\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hydrocephaly\",\n \"Probability\": \"0.0060585141\",\n \"SemanticContext\": \"ENTRESTO is teratogenic based on a low incidence of fetal hydrocephaly, associated with maternally toxic doses, which was observed in rabbits at an ENTRESTO dose of = 5 mg sacubitril/5 mg valsartan/kg/day.\"\n }\n ]\n },\n {\n \"Term\": \"Azotaemia\",\n \"MEDDRACode\": \"10003885\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"progressive azotemia\",\n \"Probability\": \"0.0906439722\",\n \"SemanticContext\": \"In patients whose renal function depends upon the activity of the renin-angiotensin-aldosterone system e.g., patients with severe congestive heart failure , treatment with ACE inhibitors and angiotensin receptor antagonists has been associated with oliguria, progressive azotemia and, rarely, acute renal failure and death.\"\n }\n ]\n },\n {\n \"Term\": \"Blood urea increased\",\n \"MEDDRACode\": \"10005851\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"increase blood urea\",\n \"Probability\": \"0.09696275\",\n \"SemanticContext\": \"As with all drugs that affect the RAAS, ENTRESTO may increase blood urea and serum creatinine levels in patients with bilateral or unilateral renal artery stenosis.\"\n }\n ]\n },\n {\n \"Term\": \"Weight\",\n \"MEDDRACode\": \"10047890\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"weight\",\n \"Probability\": \"0.0006760657\",\n \"SemanticContext\": \"Animal Data Sacubitril given orally to juvenile rats from postnatal day PND 7 to PND 35 or PND 70 an age approximately equivalent to neonatal through pre-pubertal development or adulthood in humans at doses = 400 mg/kg/day approximately 2-fold the AUC exposure to the active metabolite of sacubitril, LBQ657, at an ENTRESTO pediatric clinical dose of 3.1 mg/kg twice daily resulted in decreases in body weight, bone length, and bone mass.\"\n },\n {\n \"VerbatimTerm\": \"weight\",\n \"Probability\": \"0.0028544664\",\n \"SemanticContext\": \"The decrease in body weight was transient from PND 10 to PND 20 and the effects for most bone parameters were reversible after treatment stopped.\"\n }\n ]\n },\n {\n \"Term\": \"Hospitalisation\",\n \"MEDDRACode\": \"10054112\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hospitalization\",\n \"Probability\": \"0.0079711378\",\n \"SemanticContext\": \"to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure.\"\n },\n {\n \"VerbatimTerm\": \"hospitalization\",\n \"Probability\": \"0.003831327\",\n \"SemanticContext\": \"The primary objective of PARADIGM-HF was to determine whether ENTRESTO, a combination of sacubitril and a RAS inhibitor valsartan , was superior to a RAS inhibitor enalapril alone in reducing the risk of the combined endpoint of cardiovascular CV death or hospitalization for heart failure HF .\"\n },\n {\n \"VerbatimTerm\": \"hospitalization\",\n \"Probability\": \"0.0387027264\",\n \"SemanticContext\": \"The primary endpoint was the first event in the composite of CV death or hospitalization for HF.\"\n },\n {\n \"VerbatimTerm\": \"hospitalization\",\n \"Probability\": \"0.0046045184\",\n \"SemanticContext\": \"PARADIGM-HF demonstrated that ENTRESTO, a combination of sacubitril and a RAS inhibitor valsartan , was superior to a RAS inhibitor enalapril , in reducing the risk of the combined endpoint of cardiovascular death or hospitalization for heart failure, based on a time-to-event analysis hazard ratio [HR] 0.80; 95% confidence interval [CI], 0.73, 0.87, p< 0.0001 .\"\n },\n {\n \"VerbatimTerm\": \"hospitalization\",\n \"Probability\": \"0.0372165143\",\n \"SemanticContext\": \"The treatment effect reflected a reduction in both cardiovascular death and heart failure hospitalization; see Table 3 and Figure 3.\"\n },\n {\n \"VerbatimTerm\": \"hospitalization\",\n \"Probability\": \"0.0016628206\",\n \"SemanticContext\": \"** Includes patients who had heart failure hospitalization prior to death.\"\n },\n {\n \"VerbatimTerm\": \"hospitalization\",\n \"Probability\": \"0.2542505264\",\n \"SemanticContext\": \"ENTRESTO N = 4,187 n % Enalapril N = 4,212 n % Hazard Ratio 95% CI p -value Primary composite endpoint of cardiovascular death or heart failure hospitalization 914 21.8 1,117 26.5 0.80 0.73, 0.87 < 0.0001 Cardiovascular death as first event 377 9.0 459 10.9 Heart failure hospitalization as first event 537 12.8 658 15.6 Number of patients with events: * Cardiovascular death ** 558 13.3 693 16.5 0.80 0.71, 0.89 Heart failure hospitalizations 537 12.8 658 15.6 0.79 0.71, 0.89 All-cause mortality 711 17.0 835 19.8 0.84 0.76, 0.93 0.0009 .\"\n },\n {\n \"VerbatimTerm\": \"hospitalization\",\n \"Probability\": \"0.156404078\",\n \"SemanticContext\": \"ENTRESTO N = 4,187 n % Enalapril N = 4,212 n % Hazard Ratio 95% CI p -value Primary composite endpoint of cardiovascular death or heart failure hospitalization 914 21.8 1,117 26.5 0.80 0.73, 0.87 < 0.0001 Cardiovascular death as first event 377 9.0 459 10.9 Heart failure hospitalization as first event 537 12.8 658 15.6 Number of patients with events: * Cardiovascular death ** 558 13.3 693 16.5 0.80 0.71, 0.89 Heart failure hospitalizations 537 12.8 658 15.6 0.79 0.71, 0.89 All-cause mortality 711 17.0 835 19.8 0.84 0.76, 0.93 0.0009 .\"\n },\n {\n \"VerbatimTerm\": \"hospitalization\",\n \"Probability\": \"0.0099368393\",\n \"SemanticContext\": \"The Kaplan-Meier curves presented below Figure 3 show time to first occurrence of the primary composite endpoint 3A , and time to occurrence of cardiovascular death at any time 3B and first heart failure hospitalization 3C .\"\n },\n {\n \"VerbatimTerm\": \"hospitalization\",\n \"Probability\": \"0.0174474716\",\n \"SemanticContext\": \"b Includes patients who had CV death following HF hospitalization event.\"\n },\n {\n \"VerbatimTerm\": \"hospitalization\",\n \"Probability\": \"0.0148082972\",\n \"SemanticContext\": \"undefined1 INDICATIONS AND USAGE 1.1 Adult Heart Failure ENTRESTO is indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure.\"\n },\n {\n \"VerbatimTerm\": \"hospitalizations\",\n \"Probability\": \"0.4475217164\",\n \"SemanticContext\": \"ENTRESTO N = 4,187 n % Enalapril N = 4,212 n % Hazard Ratio 95% CI p -value Primary composite endpoint of cardiovascular death or heart failure hospitalization 914 21.8 1,117 26.5 0.80 0.73, 0.87< 0.0001 Cardiovascular death as first event 377 9.0 459 10.9 Heart failure hospitalization as first event 537 12.8 658 15.6 Number of patients with events: * Cardiovascular death ** 558 13.3 693 16.5 0.80 0.71, 0.89 Heart failure hospitalizations 537 12.8 658 15.6 0.79 0.71, 0.89 All-cause mortality 711 17.0 835 19.8 0.84 0.76, 0.93 0.0009 .\"\n },\n {\n \"VerbatimTerm\": \"hospitalizations\",\n \"Probability\": \"0.0009565353\",\n \"SemanticContext\": \"The primary objective of PARAGON-HF was to determine whether ENTRESTO reduced the rate of the composite endpoint of total first and recurrent heart failure HF hospitalizations and cardiovascular CV death.\"\n },\n {\n \"VerbatimTerm\": \"hospitalizations\",\n \"Probability\": \"0.0118823946\",\n \"SemanticContext\": \"PARAGON-HF demonstrated that ENTRESTO had a numerical reduction in the rate of the composite endpoint of total first and recurrent HF hospitalizations and CV death, based on an analysis using a proportional rates model rate ratio [RR] 0.87; 95% CI [0.75, 1.01], p = 0.06 ; see Table 4.\"\n },\n {\n \"VerbatimTerm\": \"hospitalizations\",\n \"Probability\": \"0.0002851188\",\n \"SemanticContext\": \"The treatment effect was primarily driven by the reduction in total HF hospitalizations in patients randomized to ENTRESTO RR 0.85; 95% CI [0.72, 1.00] .\"\n },\n {\n \"VerbatimTerm\": \"hospitalizations\",\n \"Probability\": \"0.0131110549\",\n \"SemanticContext\": \"ENTRESTO N = 2,407 Valsartan N = 2,389 Effect Size 95% CI Efficacy Endpoints n Event Rate a n Event Rate a Composite of total first and recurrent HF hospitalizations and CV death 894 12.8 1,009 14.6 RR = 0.87 0.75, 1.01 p -value 0.06 Total HF Hospitalizations 690 9.9 797 11.6 RR = 0.85 0.72, 1.00 CV Death b 204 2.9 212 3.1 HR = 0.95 0.79, 1.16 .\"\n },\n {\n \"VerbatimTerm\": \"hospitalizations\",\n \"Probability\": \"0.0087746084\",\n \"SemanticContext\": \"Figure 5 shows the mean number of composite endpoint events of total HF hospitalizations and CV death over time.\"\n },\n {\n \"VerbatimTerm\": \"Hospitalization\",\n \"Probability\": \"0.0004169345\",\n \"SemanticContext\": \"Figure 3: Kaplan-Meier Curves for the Primary Composite Endpoint A , Cardiovascular Death B , and Heart Failure Hospitalization C A wide range of demographic characteristics, baseline disease characteristics, and baseline concomitant medications were examined for their influence on outcomes.\"\n },\n {\n \"VerbatimTerm\": \"Hospitalization\",\n \"Probability\": \"0.0016177297\",\n \"SemanticContext\": \"Figure 4: Primary Composite Endpoint CV Death or HF Hospitalization - Subgroup Analysis PARADIGM-HF Note: The figure above presents effects in various subgroups, all of which are baseline characteristics.\"\n },\n {\n \"VerbatimTerm\": \"Hospitalization\",\n \"Probability\": \"0.000187993\",\n \"SemanticContext\": \"Figure 7: Treatment Effect for the Composite Endpoint of Time to First HF Hospitalization or CV Death by LVEF in PARADIGM-HF and PARAGON-HF Figure 3: Kaplan-Meier Curves for the Primary Composite Endpoint A , Cardiovascular Death B , and Heart Failure Hospitalization C Figure 4: Primary Composite Endpoint CV Death or HF Hospitalization - Subgroup Analysis Figure 5: Mean Number of Events Over Time for the Primary Composite Endpoint of Total HF Hospitalizations and CV Death Figure 6: Primary Composite Endpoint of Total HF Hospitalizations and CV Death -- Subgroup Analysis PARAGON-HF Figure 7: Treatment Effect for the Composite Endpoint of Time to First HF Hospitalization or CV Death by LVEF in PARADIGM-HF and PARAGON-HF 14.2 Pediatric Heart Failure PANORAMA-HF The efficacy of ENTRESTO was evaluated in a multinational, randomized, double-blind trial comparing ENTRESTO and enalapril based on an analysis in 110 pediatric patients 1 to < 18 years old with heart failure NYHA/Ross class II-IV due to systemic left ventricular systolic dysfunction LVEF = 40% .\"\n },\n {\n \"VerbatimTerm\": \"Hospitalization\",\n \"Probability\": \"0.0262895525\",\n \"SemanticContext\": \"Figure 7: Treatment Effect for the Composite Endpoint of Time to First HF Hospitalization or CV Death by LVEF in PARADIGM-HF and PARAGON-HF Figure 3: Kaplan-Meier Curves for the Primary Composite Endpoint A , Cardiovascular Death B , and Heart Failure Hospitalization C Figure 4: Primary Composite Endpoint CV Death or HF Hospitalization - Subgroup Analysis Figure 5: Mean Number of Events Over Time for the Primary Composite Endpoint of Total HF Hospitalizations and CV Death Figure 6: Primary Composite Endpoint of Total HF Hospitalizations and CV Death -- Subgroup Analysis PARAGON-HF Figure 7: Treatment Effect for the Composite Endpoint of Time to First HF Hospitalization or CV Death by LVEF in PARADIGM-HF and PARAGON-HF 14.2 Pediatric Heart Failure PANORAMA-HF The efficacy of ENTRESTO was evaluated in a multinational, randomized, double-blind trial comparing ENTRESTO and enalapril based on an analysis in 110 pediatric patients 1 to < 18 years old with heart failure NYHA/Ross class II-IV due to systemic left ventricular systolic dysfunction LVEF = 40% .\"\n },\n {\n \"VerbatimTerm\": \"Hospitalization\",\n \"Probability\": \"0.0049089491\",\n \"SemanticContext\": \"Figure 7: Treatment Effect for the Composite Endpoint of Time to First HF Hospitalization or CV Death by LVEF in PARADIGM-HF and PARAGON-HF Figure 3: Kaplan-Meier Curves for the Primary Composite Endpoint A , Cardiovascular Death B , and Heart Failure Hospitalization C Figure 4: Primary Composite Endpoint CV Death or HF Hospitalization - Subgroup Analysis Figure 5: Mean Number of Events Over Time for the Primary Composite Endpoint of Total HF Hospitalizations and CV Death Figure 6: Primary Composite Endpoint of Total HF Hospitalizations and CV Death -- Subgroup Analysis PARAGON-HF Figure 7: Treatment Effect for the Composite Endpoint of Time to First HF Hospitalization or CV Death by LVEF in PARADIGM-HF and PARAGON-HF 14.2 Pediatric Heart Failure PANORAMA-HF The efficacy of ENTRESTO was evaluated in a multinational, randomized, double-blind trial comparing ENTRESTO and enalapril based on an analysis in 110 pediatric patients 1 to < 18 years old with heart failure NYHA/Ross class II-IV due to systemic left ventricular systolic dysfunction LVEF = 40% .\"\n },\n {\n \"VerbatimTerm\": \"Hospitalization\",\n \"Probability\": \"0.0001484752\",\n \"SemanticContext\": \"Figure 7: Treatment Effect for the Composite Endpoint of Time to First HF Hospitalization or CV Death by LVEF in PARADIGM-HF and PARAGON-HF Figure 3: Kaplan-Meier Curves for the Primary Composite Endpoint A , Cardiovascular Death B , and Heart Failure Hospitalization C Figure 4: Primary Composite Endpoint CV Death or HF Hospitalization - Subgroup Analysis Figure 5: Mean Number of Events Over Time for the Primary Composite Endpoint of Total HF Hospitalizations and CV Death Figure 6: Primary Composite Endpoint of Total HF Hospitalizations and CV Death -- Subgroup Analysis PARAGON-HF Figure 7: Treatment Effect for the Composite Endpoint of Time to First HF Hospitalization or CV Death by LVEF in PARADIGM-HF and PARAGON-HF 14.2 Pediatric Heart Failure PANORAMA-HF The efficacy of ENTRESTO was evaluated in a multinational, randomized, double-blind trial comparing ENTRESTO and enalapril based on an analysis in 110 pediatric patients 1 to < 18 years old with heart failure NYHA/Ross class II-IV due to systemic left ventricular systolic dysfunction LVEF = 40% .\"\n },\n {\n \"VerbatimTerm\": \"Hospitalizations\",\n \"Probability\": \"0.0479264557\",\n \"SemanticContext\": \"ENTRESTO N = 2,407 Valsartan N = 2,389 Effect Size 95% CI Efficacy Endpoints n Event Rate a n Event Rate a Composite of total first and recurrent HF hospitalizations and CV death 894 12.8 1,009 14.6 RR = 0.87 0.75, 1.01 p -value 0.06 Total HF Hospitalizations 690 9.9 797 11.6 RR = 0.85 0.72, 1.00 CV Death b 204 2.9 212 3.1 HR = 0.95 0.79, 1.16 .\"\n },\n {\n \"VerbatimTerm\": \"Hospitalizations\",\n \"Probability\": \"0.0001463592\",\n \"SemanticContext\": \"Figure 5: Mean Number of Events Over Time for the Primary Composite Endpoint of Total HF Hospitalizations and CV Death A wide range of demographic characteristics, baseline disease characteristics, and baseline concomitant medications were examined for their influence on outcomes Figure 6 .\"\n },\n {\n \"VerbatimTerm\": \"Hospitalizations\",\n \"Probability\": \"0.001683265\",\n \"SemanticContext\": \"Figure 6: Primary Composite Endpoint of Total HF Hospitalizations and CV Death -- Subgroup Analysis PARAGON-HF Note: The figure above presents effects in various subgroups, all of which are baseline characteristics.\"\n },\n {\n \"VerbatimTerm\": \"Hospitalizations\",\n \"Probability\": \"0.0047215521\",\n \"SemanticContext\": \"Figure 7: Treatment Effect for the Composite Endpoint of Time to First HF Hospitalization or CV Death by LVEF in PARADIGM-HF and PARAGON-HF Figure 3: Kaplan-Meier Curves for the Primary Composite Endpoint A , Cardiovascular Death B , and Heart Failure Hospitalization C Figure 4: Primary Composite Endpoint CV Death or HF Hospitalization - Subgroup Analysis Figure 5: Mean Number of Events Over Time for the Primary Composite Endpoint of Total HF Hospitalizations and CV Death Figure 6: Primary Composite Endpoint of Total HF Hospitalizations and CV Death -- Subgroup Analysis PARAGON-HF Figure 7: Treatment Effect for the Composite Endpoint of Time to First HF Hospitalization or CV Death by LVEF in PARADIGM-HF and PARAGON-HF 14.2 Pediatric Heart Failure PANORAMA-HF The efficacy of ENTRESTO was evaluated in a multinational, randomized, double-blind trial comparing ENTRESTO and enalapril based on an analysis in 110 pediatric patients 1 to < 18 years old with heart failure NYHA/Ross class II-IV due to systemic left ventricular systolic dysfunction LVEF = 40% .\"\n },\n {\n \"VerbatimTerm\": \"Hospitalizations\",\n \"Probability\": \"0.0044625103\",\n \"SemanticContext\": \"Figure 7: Treatment Effect for the Composite Endpoint of Time to First HF Hospitalization or CV Death by LVEF in PARADIGM-HF and PARAGON-HF Figure 3: Kaplan-Meier Curves for the Primary Composite Endpoint A , Cardiovascular Death B , and Heart Failure Hospitalization C Figure 4: Primary Composite Endpoint CV Death or HF Hospitalization - Subgroup Analysis Figure 5: Mean Number of Events Over Time for the Primary Composite Endpoint of Total HF Hospitalizations and CV Death Figure 6: Primary Composite Endpoint of Total HF Hospitalizations and CV Death -- Subgroup Analysis PARAGON-HF Figure 7: Treatment Effect for the Composite Endpoint of Time to First HF Hospitalization or CV Death by LVEF in PARADIGM-HF and PARAGON-HF 14.2 Pediatric Heart Failure PANORAMA-HF The efficacy of ENTRESTO was evaluated in a multinational, randomized, double-blind trial comparing ENTRESTO and enalapril based on an analysis in 110 pediatric patients 1 to < 18 years old with heart failure NYHA/Ross class II-IV due to systemic left ventricular systolic dysfunction LVEF = 40% .\"\n }\n ]\n },\n {\n \"Term\": \"Teratogenicity\",\n \"MEDDRACode\": \"10043275\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"teratogenicity\",\n \"Probability\": \"0.0011942387\",\n \"SemanticContext\": \"In animal reproduction studies, ENTRESTO treatment during organogenesis resulted in increased embryo-fetal lethality in rats and rabbits and teratogenicity in rabbits.\"\n }\n ]\n },\n {\n \"Term\": \"Transfusion\",\n \"MEDDRACode\": \"10066152\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"transfusions\",\n \"Probability\": \"1.56276E-05\",\n \"SemanticContext\": \"Exchange transfusions or dialysis may be required as a means of reversing hypotension and replacing renal function.\"\n }\n ]\n },\n {\n \"Term\": \"Left ventricular dysfunction\",\n \"MEDDRACode\": \"10049694\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"left ventricular systolic dysfunction\",\n \"Probability\": \"0.0177028477\",\n \"SemanticContext\": \"for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older.\"\n },\n {\n \"VerbatimTerm\": \"left ventricular systolic dysfunction\",\n \"Probability\": \"0.0277014673\",\n \"SemanticContext\": \"Figure 7: Treatment Effect for the Composite Endpoint of Time to First HF Hospitalization or CV Death by LVEF in PARADIGM-HF and PARAGON-HF Figure 3: Kaplan-Meier Curves for the Primary Composite Endpoint A , Cardiovascular Death B , and Heart Failure Hospitalization C Figure 4: Primary Composite Endpoint CV Death or HF Hospitalization - Subgroup Analysis Figure 5: Mean Number of Events Over Time for the Primary Composite Endpoint of Total HF Hospitalizations and CV Death Figure 6: Primary Composite Endpoint of Total HF Hospitalizations and CV Death -- Subgroup Analysis PARAGON-HF Figure 7: Treatment Effect for the Composite Endpoint of Time to First HF Hospitalization or CV Death by LVEF in PARADIGM-HF and PARAGON-HF 14.2 Pediatric Heart Failure PANORAMA-HF The efficacy of ENTRESTO was evaluated in a multinational, randomized, double-blind trial comparing ENTRESTO and enalapril based on an analysis in 110 pediatric patients 1 to < 18 years old with heart failure NYHA/Ross class II-IV due to systemic left ventricular systolic dysfunction LVEF = 40% .\"\n },\n {\n \"VerbatimTerm\": \"left ventricular systolic dysfunction\",\n \"Probability\": \"0.1870474815\",\n \"SemanticContext\": \"1.2 Pediatric Heart Failure ENTRESTO is indicated for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older.\"\n },\n {\n \"VerbatimTerm\": \"systolic dysfunction left ventricular\",\n \"Probability\": \"0.3379301131\",\n \"SemanticContext\": \"14.1 Adult Heart Failure PARADIGM-HF PARADIGM-HF was a multinational, randomized, double-blind trial comparing ENTRESTO and enalapril in 8,442 adult patients with symptomatic chronic heart failure NYHA class II--IV and systolic dysfunction left ventricular ejection fraction = 40% .\"\n }\n ]\n },\n {\n \"Term\": \"Carcinogenicity\",\n \"MEDDRACode\": \"10007269\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Carcinogenicity\",\n \"Probability\": \"9.18397E-05\",\n \"SemanticContext\": \"undefined13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis and Mutagenesis Carcinogenicity studies conducted in mice and rats with sacubitril and valsartan did not identify any carcinogenic potential for ENTRESTO.\"\n }\n ]\n },\n {\n \"Term\": \"Ejection fraction\",\n \"MEDDRACode\": \"10050527\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"left ventricular ejection fraction\",\n \"Probability\": \"7.4423E-05\",\n \"SemanticContext\": \"Benefits are most clearly evident in patients with left ventricular ejection fraction LVEF below normal.\"\n },\n {\n \"VerbatimTerm\": \"left ventricular ejection fraction\",\n \"Probability\": \"0.0080160499\",\n \"SemanticContext\": \"14.1 Adult Heart Failure PARADIGM-HF PARADIGM-HF was a multinational, randomized, double-blind trial comparing ENTRESTO and enalapril in 8,442 adult patients with symptomatic chronic heart failure NYHA class II--IV and systolic dysfunction left ventricular ejection fraction = 40% .\"\n },\n {\n \"VerbatimTerm\": \"left ventricular ejection fraction\",\n \"Probability\": \"0.0063023269\",\n \"SemanticContext\": \"The mean left ventricular ejection fraction was 29%.\"\n },\n {\n \"VerbatimTerm\": \"left ventricular ejection fraction\",\n \"Probability\": \"0.0204381645\",\n \"SemanticContext\": \"PARAGON-HF PARAGON-HF, was a multicenter, randomized, double-blind trial comparing ENTRESTO and valsartan in 4,796 adult patients with symptomatic heart failure with left ventricular ejection fraction = 45%, and structural heart disease [either left atrial enlargement LAE or left ventricular hypertrophy LVH ].\"\n },\n {\n \"VerbatimTerm\": \"left ventricular ejection fraction\",\n \"Probability\": \"0.0029089153\",\n \"SemanticContext\": \"The median left ventricular ejection fraction was 57%.\"\n },\n {\n \"VerbatimTerm\": \"left ventricular ejection fraction\",\n \"Probability\": \"4.50567E-05\",\n \"SemanticContext\": \"Benefits are most clearly evident in patients with left ventricular ejection fraction LVEF below normal.\"\n },\n {\n \"VerbatimTerm\": \"LVEF\",\n \"Probability\": \"0.000123769\",\n \"SemanticContext\": \"Benefits are most clearly evident in patients with left ventricular ejection fraction LVEF below normal.\"\n },\n {\n \"VerbatimTerm\": \"LVEF\",\n \"Probability\": \"0.0004310012\",\n \"SemanticContext\": \"In PARAMOUNT, a randomized, double-blind, 36-week study in patients with heart failure with LVEF = 45% comparing 97/103 mg of ENTRESTO n=149 to 160 mg of valsartan n =152 twice-daily, ENTRESTO decreased NT-proBNP by 17% while valsartan increased NT-proBNP by 8% at Week 12 p = 0.005 .\"\n },\n {\n \"VerbatimTerm\": \"LVEF\",\n \"Probability\": \"0.0009112656\",\n \"SemanticContext\": \"Patients with a systolic blood pressure of< 110 mmHg and patients with any prior echocardiographic LVEF < 40% at screening were excluded.\"\n },\n {\n \"VerbatimTerm\": \"LVEF\",\n \"Probability\": \"0.0005043745\",\n \"SemanticContext\": \"In an analysis of the relationship between LVEF and outcome in PARADIGM-HF and PARAGON-HF, patients with LVEF below normal treated with ENTRESTO experienced greater risk reduction Figure 7 .\"\n },\n {\n \"VerbatimTerm\": \"LVEF\",\n \"Probability\": \"0.0012643933\",\n \"SemanticContext\": \"In an analysis of the relationship between LVEF and outcome in PARADIGM-HF and PARAGON-HF, patients with LVEF below normal treated with ENTRESTO experienced greater risk reduction Figure 7 .\"\n },\n {\n \"VerbatimTerm\": \"LVEF\",\n \"Probability\": \"0.0033538342\",\n \"SemanticContext\": \"Figure 7: Treatment Effect for the Composite Endpoint of Time to First HF Hospitalization or CV Death by LVEF in PARADIGM-HF and PARAGON-HF Figure 3: Kaplan-Meier Curves for the Primary Composite Endpoint A , Cardiovascular Death B , and Heart Failure Hospitalization C Figure 4: Primary Composite Endpoint CV Death or HF Hospitalization - Subgroup Analysis Figure 5: Mean Number of Events Over Time for the Primary Composite Endpoint of Total HF Hospitalizations and CV Death Figure 6: Primary Composite Endpoint of Total HF Hospitalizations and CV Death -- Subgroup Analysis PARAGON-HF Figure 7: Treatment Effect for the Composite Endpoint of Time to First HF Hospitalization or CV Death by LVEF in PARADIGM-HF and PARAGON-HF 14.2 Pediatric Heart Failure PANORAMA-HF The efficacy of ENTRESTO was evaluated in a multinational, randomized, double-blind trial comparing ENTRESTO and enalapril based on an analysis in 110 pediatric patients 1 to < 18 years old with heart failure NYHA/Ross class II-IV due to systemic left ventricular systolic dysfunction LVEF = 40% .\"\n },\n {\n \"VerbatimTerm\": \"LVEF\",\n \"Probability\": \"0.0004678965\",\n \"SemanticContext\": \"Figure 7: Treatment Effect for the Composite Endpoint of Time to First HF Hospitalization or CV Death by LVEF in PARADIGM-HF and PARAGON-HF Figure 3: Kaplan-Meier Curves for the Primary Composite Endpoint A , Cardiovascular Death B , and Heart Failure Hospitalization C Figure 4: Primary Composite Endpoint CV Death or HF Hospitalization - Subgroup Analysis Figure 5: Mean Number of Events Over Time for the Primary Composite Endpoint of Total HF Hospitalizations and CV Death Figure 6: Primary Composite Endpoint of Total HF Hospitalizations and CV Death -- Subgroup Analysis PARAGON-HF Figure 7: Treatment Effect for the Composite Endpoint of Time to First HF Hospitalization or CV Death by LVEF in PARADIGM-HF and PARAGON-HF 14.2 Pediatric Heart Failure PANORAMA-HF The efficacy of ENTRESTO was evaluated in a multinational, randomized, double-blind trial comparing ENTRESTO and enalapril based on an analysis in 110 pediatric patients 1 to < 18 years old with heart failure NYHA/Ross class II-IV due to systemic left ventricular systolic dysfunction LVEF = 40% .\"\n },\n {\n \"VerbatimTerm\": \"LVEF\",\n \"Probability\": \"0.007358849\",\n \"SemanticContext\": \"Figure 7: Treatment Effect for the Composite Endpoint of Time to First HF Hospitalization or CV Death by LVEF in PARADIGM-HF and PARAGON-HF Figure 3: Kaplan-Meier Curves for the Primary Composite Endpoint A , Cardiovascular Death B , and Heart Failure Hospitalization C Figure 4: Primary Composite Endpoint CV Death or HF Hospitalization - Subgroup Analysis Figure 5: Mean Number of Events Over Time for the Primary Composite Endpoint of Total HF Hospitalizations and CV Death Figure 6: Primary Composite Endpoint of Total HF Hospitalizations and CV Death -- Subgroup Analysis PARAGON-HF Figure 7: Treatment Effect for the Composite Endpoint of Time to First HF Hospitalization or CV Death by LVEF in PARADIGM-HF and PARAGON-HF 14.2 Pediatric Heart Failure PANORAMA-HF The efficacy of ENTRESTO was evaluated in a multinational, randomized, double-blind trial comparing ENTRESTO and enalapril based on an analysis in 110 pediatric patients 1 to < 18 years old with heart failure NYHA/Ross class II-IV due to systemic left ventricular systolic dysfunction LVEF = 40% .\"\n },\n {\n \"VerbatimTerm\": \"LVEF\",\n \"Probability\": \"4.84301E-05\",\n \"SemanticContext\": \"Benefits are most clearly evident in patients with left ventricular ejection fraction LVEF below normal.\"\n },\n {\n \"VerbatimTerm\": \"LVEF\",\n \"Probability\": \"0.0010620356\",\n \"SemanticContext\": \"LVEF is a variable measure, so use clinical judgment in deciding whom to treat [see Clinical Studies 14.1 ] .\"\n }\n ]\n },\n {\n \"Term\": \"Epinephrine\",\n \"MEDDRACode\": \"10015060\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"epinephrine\",\n \"Probability\": \"1.85311E-05\",\n \"SemanticContext\": \"Where there is involvement of the tongue, glottis or larynx, likely to cause airway obstruction, administer appropriate therapy, e.g., subcutaneous epinephrine/adrenaline solution 1:1000 0.3 mL to 0.5 mL and take measures necessary to ensure maintenance of a patent airway.\"\n }\n ]\n },\n {\n \"Term\": \"Anuria\",\n \"MEDDRACode\": \"10002847\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"anuria\",\n \"Probability\": \"0.8839309216\",\n \"SemanticContext\": \"Clinical Considerations Fetal/Neonatal Adverse Reactions Oligohydramnios in pregnant women who use drugs affecting the renin-angiotensin system in the second and third trimesters of pregnancy can result in the following: reduced fetal renal function leading to anuria and renal failure, fetal lung hypoplasia, skeletal deformations, including skull hypoplasia, hypotension, and death.\"\n }\n ]\n },\n {\n \"Term\": \"Hypoaldosteronism\",\n \"MEDDRACode\": \"10020944\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hypoaldosteronism\",\n \"Probability\": \"0.2553078532\",\n \"SemanticContext\": \"Monitor serum potassium periodically and treat appropriately, especially in patients with risk factors for hyperkalemia such as severe renal impairment, diabetes, hypoaldosteronism, or a high potassium diet.\"\n }\n ]\n },\n {\n \"Term\": \"Blood lactic acid\",\n \"MEDDRACode\": \"10005632\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": true,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"lactating\",\n \"Probability\": \"0.0002166927\",\n \"SemanticContext\": \"Data Following an oral dose 15 mg sacubitril/15 mg valsartan/kg of [ 14 C] ENTRESTO to lactating rats, transfer of LBQ657 into milk was observed.\"\n },\n {\n \"VerbatimTerm\": \"lactating\",\n \"Probability\": \"0.0003025234\",\n \"SemanticContext\": \"After a single oral administration of 3 mg/kg [ 14 C] valsartan to lactating rats, transfer of valsartan into milk was observed.\"\n }\n ]\n },\n {\n \"Term\": \"Cardiac failure congestive\",\n \"MEDDRACode\": \"10007559\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"congestive heart failure ,\",\n \"Probability\": \"0.0001826882\",\n \"SemanticContext\": \"In patients whose renal function depends upon the activity of the renin-angiotensin-aldosterone system e.g., patients with severe congestive heart failure , treatment with ACE inhibitors and angiotensin receptor antagonists has been associated with oliguria, progressive azotemia and, rarely, acute renal failure and death.\"\n }\n ]\n },\n {\n \"Term\": \"Hypovolaemia\",\n \"MEDDRACode\": \"10021137\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hypovolemia\",\n \"Probability\": \"0.0491985679\",\n \"SemanticContext\": \"If hypotension occurs, consider dose adjustment of diuretics, concomitant antihypertensive drugs, and treatment of other causes of hypotension e.g., hypovolemia .\"\n }\n ]\n },\n {\n \"Term\": \"Blood pressure decreased\",\n \"MEDDRACode\": \"10005734\",\n \"Overdose\": true,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"blood pressure lowering\",\n \"Probability\": \"0.3499842584\",\n \"SemanticContext\": \"Hypotension is the most likely result of overdosage due to the blood pressure lowering effects of ENTRESTO.\"\n },\n {\n \"VerbatimTerm\": \"lowers blood pressure\",\n \"Probability\": \"0.4033680558\",\n \"SemanticContext\": \"5.3 Hypotension ENTRESTO lowers blood pressure and may cause symptomatic hypotension [see Adverse Reactions 6.1 ] .\"\n }\n ]\n },\n {\n \"Term\": \"Endothelin\",\n \"MEDDRACode\": \"10053401\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"endothelin\",\n \"Probability\": \"0.0002107322\",\n \"SemanticContext\": \"In a 21-day study in HFrEF patients, ENTRESTO significantly increased urine ANP and cGMP and plasma cGMP, and decreased plasma NT-proBNP, aldosterone and endothelin-1.\"\n }\n ]\n },\n {\n \"Term\": \"Systemic right ventricle\",\n \"MEDDRACode\": \"10083204\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"systemic right ventricles\",\n \"Probability\": \"0.0070889294\",\n \"SemanticContext\": \"Patients with systemic right ventricles and single ventricles were excluded from the trial.\"\n }\n ]\n },\n {\n \"Term\": \"Peritoneal equilibration test\",\n \"MEDDRACode\": \"10064772\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"PET\",\n \"Probability\": \"0.0005914867\",\n \"SemanticContext\": \"Transfer the entire contents from the mortar into a clean 200 mL amber colored PET or glass bottle.\"\n }\n ]\n }\n ],\n \"IndicationTerms\": []\n }\n ]\n },\n {\n \"GenericName\": \"levothyroxine, liothyronine\",\n \"MeddraVersion\": \"24.0\",\n \"Labels\": [\n {\n \"Id\": \"US8cdcf814-f5ee-43b6-bf09-68eab5e5befe\",\n \"NDCCode\": \"42192-328\",\n \"UpdatedDate\": \"Nov 16, 2018\",\n \"LabelSource\": {\n \"Country\": \"us\",\n \"ProductId\": \"00046231-8fab-44a0-b986-9a9dd450881d\",\n \"FileId\": \"8cdcf814-f5ee-43b6-bf09-68eab5e5befe\",\n \"Version\": \"4\"\n },\n \"AdverseEventTerms\": [\n {\n \"Term\": \"Protein total\",\n \"MEDDRACode\": \"10050537\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"proteins\",\n \"Probability\": \"0.0008095491\",\n \"SemanticContext\": \"These hormones enhance oxygen consumption by most tissues of the body, increase the basal metabolic rate, and the metabolism of carbohydrates, lipids, and proteins.\"\n }\n ]\n },\n {\n \"Term\": \"Gait disturbance\",\n \"MEDDRACode\": \"10017577\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"steps\",\n \"Probability\": \"0.3979978263\",\n \"SemanticContext\": \"CLINICAL PHARMACOLOGY: The steps in the synthesis of the thyroid hormones are controlled by thyrotropin Thyroid Stimulating Hormone, TSH secreted by the anterior pituitary.\"\n }\n ]\n },\n {\n \"Term\": \"Tri-iodothyronine\",\n \"MEDDRACode\": \"10044591\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"triiodothyronine\",\n \"Probability\": \"9.64919E-05\",\n \"SemanticContext\": \"They contain both tetraiodothyronine sodium T4 levothyroxine and triiodothyronine sodium T3 liothyronine providing 38 mcg levothyroxine T4 and 9 mcg liothyronine T3 per grain of thyroid.\"\n },\n {\n \"VerbatimTerm\": \"triiodothyronine\",\n \"Probability\": \"9.69602E-05\",\n \"SemanticContext\": \"The ratio of these two hormones in the circulation does not represent the ratio in the thyroid gland, since about 80 percent of peripheral triiodothyronine comes from monodeiodination of levothyroxine.\"\n },\n {\n \"VerbatimTerm\": \"triiodothyronine\",\n \"Probability\": \"0.0003259208\",\n \"SemanticContext\": \"Maintenance dosages 60 to 120 mg/day usually result in normal serum levothyroxine T4 and triiodothyronine T3 levels.\"\n },\n {\n \"VerbatimTerm\": \"Triiodothyronine\",\n \"Probability\": \"0.0003667706\",\n \"SemanticContext\": \"Triiodothyronine T3 levels are low in the fetus and newborn, in old age, in chronic caloric deprivation, hepatic cirrhosis, renal failure, surgical stress, and chronic illnesses representing what has been called the “T3 thyronine syndrome.”\"\n }\n ]\n },\n {\n \"Term\": \"Blood thyroid stimulating hormone\",\n \"MEDDRACode\": \"10005829\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"TSH\",\n \"Probability\": \"0.0003246203\",\n \"SemanticContext\": \"CLINICAL PHARMACOLOGY: The steps in the synthesis of the thyroid hormones are controlled by thyrotropin Thyroid Stimulating Hormone, TSH secreted by the anterior pituitary.\"\n },\n {\n \"VerbatimTerm\": \"TSH\",\n \"Probability\": \"5.24614E-05\",\n \"SemanticContext\": \"Adequate therapy usually results in normal TSH and T4 levels after 2 to 3 weeks of therapy.\"\n },\n {\n \"VerbatimTerm\": \"TSH\",\n \"Probability\": \"0.0050452584\",\n \"SemanticContext\": \"Readjustment of thyroid hormone dosage should be made within the first four weeks of therapy, after proper clinical and laboratory evaluations, including serum levels of T4, bound and free, and TSH.\"\n },\n {\n \"VerbatimTerm\": \"TSH\",\n \"Probability\": \"0.0009340714\",\n \"SemanticContext\": \"TSH should be suppressed to low or undetectable levels.\"\n },\n {\n \"VerbatimTerm\": \"TSH\",\n \"Probability\": \"0.0012988942\",\n \"SemanticContext\": \"These doses usually yield normal serum T4 and T3 levels and lack of response to TSH.\"\n },\n {\n \"VerbatimTerm\": \"TSH\",\n \"Probability\": \"0.0006005524\",\n \"SemanticContext\": \"As pituitary TSH suppressants, in the treatment or prevention of various types of euthyroid goiters, including thyroid nodules, subacute or chronic Iymphocytic thyroiditis Hashimoto’s , multinodular goiter, and in the management of thyroid cancer.\"\n },\n {\n \"VerbatimTerm\": \"TSH\",\n \"Probability\": \"8.67526E-05\",\n \"SemanticContext\": \"Routine determinations of serum T4 and/or TSH is strongly advised in neonates in view of the deleterious effects of thyroid deficiency on growth and development.\"\n },\n {\n \"VerbatimTerm\": \"TSH\",\n \"Probability\": \"0.0001418302\",\n \"SemanticContext\": \"Cessation of therapy is justified in patients who have maintained a normal TSH during those 2 to 8 weeks.\"\n }\n ]\n },\n {\n \"Term\": \"Toxic nodular goitre\",\n \"MEDDRACode\": \"10044242\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"thyroid gland autonomy\",\n \"Probability\": \"0.0434112288\",\n \"SemanticContext\": \"This is the basis for the thyroid suppression test and is used as an aid in the diagnosis of patients with signs of mild hyperthyroidism in whom base line laboratory tests appear normal, or to demonstrate thyroid gland autonomy in patients with Grave’s ophthalmopathy.\"\n },\n {\n \"VerbatimTerm\": \"thyroid gland autonomy\",\n \"Probability\": \"0.613892138\",\n \"SemanticContext\": \"A 50 percent or greater suppression of uptake indicates a normal thyroid-pituitary axis and thus rules out thyroid gland autonomy.\"\n },\n {\n \"VerbatimTerm\": \"of thyroid gland autonomy\",\n \"Probability\": \"3.81505E-05\",\n \"SemanticContext\": \"Thyroid hormones should be administered cautiously to patients in whom there is strong suspicion of thyroid gland autonomy, in view of the fact that the exogenous hormone effects will be additive to the endogenous source.\"\n }\n ]\n },\n {\n \"Term\": \"Congenital hypothyroidism\",\n \"MEDDRACode\": \"10010510\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"cretinism\",\n \"Probability\": \"0.9477028847\",\n \"SemanticContext\": \"This category includes cretinism, myxedema, and ordinary hypothyroidism in patients of any age children, adults, the elderly , or state including pregnancy ; primary hypothyroidism resulting from functional deficiency, primary atrophy, partial or total absence of thyroid gland, or the effects of surgery, radiation, or drugs, with or without the presence of goiter; and secondary pituitary , or tertiary hypothalamic hypothyroidism See WARNINGS .\"\n }\n ]\n },\n {\n \"Term\": \"Drug interaction\",\n \"MEDDRACode\": \"10013710\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Drug Interactions\",\n \"Probability\": \"0.0010239693\",\n \"SemanticContext\": \"Drug Interactions--Oral Anticoagulants--Thyroid hormones appear to increase catabolism of vitamin K-dependent clotting factors.\"\n }\n ]\n },\n {\n \"Term\": \"Blood insulin\",\n \"MEDDRACode\": \"10005605\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Insulin\",\n \"Probability\": \"1.36089E-05\",\n \"SemanticContext\": \"Insulin or Oral Hypoglycemics--Initiating thyroid replacement therapy may cause increases in insulin or oral hypoglycemic requirements.\"\n },\n {\n \"VerbatimTerm\": \"insulin\",\n \"Probability\": \"3.68673E-05\",\n \"SemanticContext\": \"Patients receiving insulin or oral hypoglycemics should be closely watched during initiation of thyroid replacement therapy.\"\n },\n {\n \"VerbatimTerm\": \"insulin\",\n \"Probability\": \"1.588E-06\",\n \"SemanticContext\": \"If thyroid medication is stopped, a downward readjustment of the dosage of insulin or oral hypoglycemic agent may be necessary to avoid hypoglycemia.\"\n }\n ]\n },\n {\n \"Term\": \"Reverse tri-iodothyronine\",\n \"MEDDRACode\": \"10060292\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"reverse triiodothyronine\",\n \"Probability\": \"0.0010273487\",\n \"SemanticContext\": \"Peripheral monodeiodination of levothyroxine at the 5 position inner ring also results in the formation of reverse triiodothyronine T3 , which is calorigenically inactive.\"\n }\n ]\n },\n {\n \"Term\": \"Prothrombin time\",\n \"MEDDRACode\": \"10037056\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"prothrombin time\",\n \"Probability\": \"3.27396E-05\",\n \"SemanticContext\": \"In case of concomitant oral anticoagulant therapy, the prothrombin time should be measured frequently to determine if the dosage of oral anticoagulants is to be readjusted.\"\n },\n {\n \"VerbatimTerm\": \"prothrombin time\",\n \"Probability\": \"8.66991E-05\",\n \"SemanticContext\": \"Prothrombin time should be closely monitored in thyroid-treated patients on oral anticoagulants and dosage of the latter agents adjusted on the basis of frequent prothrombin time determinations.\"\n },\n {\n \"VerbatimTerm\": \"Prothrombin time\",\n \"Probability\": \"0.0032159018\",\n \"SemanticContext\": \"Prothrombin time should be closely monitored in thyroid-treated patients on oral anticoagulants and dosage of the latter agents adjusted on the basis of frequent prothrombin time determinations.\"\n }\n ]\n },\n {\n \"Term\": \"Oxygen consumption\",\n \"MEDDRACode\": \"10059167\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"oxygen consumption\",\n \"Probability\": \"0.0001664435\",\n \"SemanticContext\": \"These hormones enhance oxygen consumption by most tissues of the body, increase the basal metabolic rate, and the metabolism of carbohydrates, lipids, and proteins.\"\n }\n ]\n },\n {\n \"Term\": \"Stress\",\n \"MEDDRACode\": \"10042209\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"stress\",\n \"Probability\": \"0.0001563473\",\n \"SemanticContext\": \"Triiodothyronine T3 levels are low in the fetus and newborn, in old age, in chronic caloric deprivation, hepatic cirrhosis, renal failure, surgical stress, and chronic illnesses representing what has been called the “T3 thyronine syndrome.”\"\n }\n ]\n },\n {\n \"Term\": \"Blood sodium\",\n \"MEDDRACode\": \"10005799\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"7.42633E-05\",\n \"SemanticContext\": \"They contain both tetraiodothyronine sodium T4 levothyroxine and triiodothyronine sodium T3 liothyronine providing 38 mcg levothyroxine T4 and 9 mcg liothyronine T3 per grain of thyroid.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"1.62832E-05\",\n \"SemanticContext\": \"They contain both tetraiodothyronine sodium T4 levothyroxine and triiodothyronine sodium T3 liothyronine providing 38 mcg levothyroxine T4 and 9 mcg liothyronine T3 per grain of thyroid.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0001558358\",\n \"SemanticContext\": \"In acute, emergency conditions, injectable levothyroxine sodium may be given intravenously when oral administration is not feasible or desirable, as in the treatment of myxedema coma, or during total parenteral nutrition.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"1.86784E-05\",\n \"SemanticContext\": \"Levothyroxine sodium T4 is given at starting dose of 400 mcg 100 mcg/mL given rapidly, and is usually well tolerated, even in the elderly.\"\n }\n ]\n },\n {\n \"Term\": \"Myxoedema coma\",\n \"MEDDRACode\": \"10060819\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"myxedema coma\",\n \"Probability\": \"0.0047434974\",\n \"SemanticContext\": \"In acute, emergency conditions, injectable levothyroxine sodium may be given intravenously when oral administration is not feasible or desirable, as in the treatment of myxedema coma, or during total parenteral nutrition.\"\n },\n {\n \"VerbatimTerm\": \"myxedema coma\",\n \"Probability\": \"0.0230175909\",\n \"SemanticContext\": \"The therapy of myxedema coma requires simultaneous administration of glucocorticoids See DOSAGE AND ADMINISTRATION .\"\n },\n {\n \"VerbatimTerm\": \"Myxedema Coma\",\n \"Probability\": \"0.7138081789\",\n \"SemanticContext\": \"Myxedema Coma--Myxedema coma is usually precipitated in the hypothyroid patient of longstanding by intercurrent illness or drugs such as sedatives and anesthetics and should be considered a medical emergency.\"\n },\n {\n \"VerbatimTerm\": \"Myxedema coma\",\n \"Probability\": \"0.6486904621\",\n \"SemanticContext\": \"Myxedema Coma--Myxedema coma is usually precipitated in the hypothyroid patient of longstanding by intercurrent illness or drugs such as sedatives and anesthetics and should be considered a medical emergency.\"\n }\n ]\n },\n {\n \"Term\": \"Angina pectoris\",\n \"MEDDRACode\": \"10002383\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"angina\",\n \"Probability\": \"0.018316377\",\n \"SemanticContext\": \"The appearance of angina is an indication for a reduction in dosage.\"\n }\n ]\n },\n {\n \"Term\": \"Infant\",\n \"MEDDRACode\": \"10021731\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"newborn\",\n \"Probability\": \"0.0003079717\",\n \"SemanticContext\": \"Triiodothyronine T3 levels are low in the fetus and newborn, in old age, in chronic caloric deprivation, hepatic cirrhosis, renal failure, surgical stress, and chronic illnesses representing what has been called the “T3 thyronine syndrome.”\"\n }\n ]\n },\n {\n \"Term\": \"Metastasis\",\n \"MEDDRACode\": \"10062194\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"metastases\",\n \"Probability\": \"0.0154331718\",\n \"SemanticContext\": \"Thyroid Cancer--Exogenous thyroid hormone may produce regression of metastases from follicular and papillary carcinoma of the thyroid and is used as ancillary therapy of these conditions with radioactive iodine.\"\n }\n ]\n },\n {\n \"Term\": \"Analgesic drug level\",\n \"MEDDRACode\": \"10060090\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"salicylates\",\n \"Probability\": \"0.0001714304\",\n \"SemanticContext\": \"Drug/Laboratory Test Interactions--The following drugs or moieties are known to interfere with laboratory tests performed in patients on thyroid hormone therapy: androgens, corticosteroids, estrogens, oral contraceptives containing estrogens, iodine-containing preparations, and the numerous preparations containing salicylates.\"\n },\n {\n \"VerbatimTerm\": \"salicylates\",\n \"Probability\": \"0.0032912723\",\n \"SemanticContext\": \"The binding of levothyroxine by TBPA is inhibited by salicylates.\"\n }\n ]\n },\n {\n \"Term\": \"Hepatic cirrhosis\",\n \"MEDDRACode\": \"10019641\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hepatic cirrhosis\",\n \"Probability\": \"0.0016571142\",\n \"SemanticContext\": \"Triiodothyronine T3 levels are low in the fetus and newborn, in old age, in chronic caloric deprivation, hepatic cirrhosis, renal failure, surgical stress, and chronic illnesses representing what has been called the “T3 thyronine syndrome.”\"\n }\n ]\n },\n {\n \"Term\": \"Hyperthyroidism\",\n \"MEDDRACode\": \"10020850\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": true,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hyperthyroidism\",\n \"Probability\": \"0.1045784578\",\n \"SemanticContext\": \"ADVERSE REACTIONS: Adverse reactions other than those indicative of hyperthyroidism because of therapeutic overdosage, either initially or during the maintenance period, are rare See OVERDOSAGE .\"\n },\n {\n \"VerbatimTerm\": \"hyperthyroidism\",\n \"Probability\": \"0.0001374557\",\n \"SemanticContext\": \"This is the basis for the thyroid suppression test and is used as an aid in the diagnosis of patients with signs of mild hyperthyroidism in whom base line laboratory tests appear normal, or to demonstrate thyroid gland autonomy in patients with Grave’s ophthalmopathy.\"\n },\n {\n \"VerbatimTerm\": \"hyperthyroidism\",\n \"Probability\": \"0.0257308781\",\n \"SemanticContext\": \"Hypothyroidism decreases and hyperthyroidism increases the sensitivity to oral anticoagulants.\"\n }\n ]\n },\n {\n \"Term\": \"Obesity\",\n \"MEDDRACode\": \"10029883\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"obesity\",\n \"Probability\": \"0.0020029861\",\n \"SemanticContext\": \"WARNINGS Drugs with thyroid hormone activity, alone or together with other therapeutic agents, have been used for the treatment of obesity.\"\n },\n {\n \"VerbatimTerm\": \"obesity\",\n \"Probability\": \"0.0001313883\",\n \"SemanticContext\": \"The use of thyroid hormones in the therapy of obesity, alone or combined with other drugs, is unjustified and has been shown to be ineffective.\"\n }\n ]\n },\n {\n \"Term\": \"Hypersensitivity\",\n \"MEDDRACode\": \"10020751\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": true,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hypersensitivity\",\n \"Probability\": \"0.001322482\",\n \"SemanticContext\": \"CONTRAINDICATIONS: Thyroid hormone preparations are generally contraindicated in patients with diagnosed but as yet uncorrected adrenal cortical insufficiency, untreated thyrotoxicosis, and apparent hypersensitivity to any of their active or extraneous constituents.\"\n }\n ]\n },\n {\n \"Term\": \"Infection\",\n \"MEDDRACode\": \"10021789\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"infection\",\n \"Probability\": \"0.0012989332\",\n \"SemanticContext\": \"Therapy should be directed at the correction of electrolyte disturbances and possible infection besides the administration of thyroid hormones.\"\n }\n ]\n },\n {\n \"Term\": \"Oral contraception\",\n \"MEDDRACode\": \"10030970\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Oral Contraceptives\",\n \"Probability\": \"0.0009350232\",\n \"SemanticContext\": \"Estrogen, Oral Contraceptives--Estrogens tend to increase serum thyroxine-binding globulin TBg .\"\n },\n {\n \"VerbatimTerm\": \"oral contraceptives\",\n \"Probability\": \"0.0001473146\",\n \"SemanticContext\": \"Therefore, patients without a functioning thyroid gland who are on thyroid replacement therapy may need to increase their thyroid dose if estrogens or estrogen-containing oral contraceptives are given.\"\n },\n {\n \"VerbatimTerm\": \"oral contraceptives\",\n \"Probability\": \"2.83368E-05\",\n \"SemanticContext\": \"Drug/Laboratory Test Interactions--The following drugs or moieties are known to interfere with laboratory tests performed in patients on thyroid hormone therapy: androgens, corticosteroids, estrogens, oral contraceptives containing estrogens, iodine-containing preparations, and the numerous preparations containing salicylates.\"\n },\n {\n \"VerbatimTerm\": \"oral contraceptives\",\n \"Probability\": \"0.0004184642\",\n \"SemanticContext\": \"Pregnancy, estrogens, and estrogencontaining oral contraceptives increase TBg concentrations.\"\n }\n ]\n },\n {\n \"Term\": \"Vitamin K\",\n \"MEDDRACode\": \"10058768\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"vitamin K\",\n \"Probability\": \"6.49223E-05\",\n \"SemanticContext\": \"Drug Interactions--Oral Anticoagulants--Thyroid hormones appear to increase catabolism of vitamin K-dependent clotting factors.\"\n }\n ]\n },\n {\n \"Term\": \"Blood oestrogen\",\n \"MEDDRACode\": \"10005684\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Estrogen\",\n \"Probability\": \"8.84053E-05\",\n \"SemanticContext\": \"Estrogen, Oral Contraceptives--Estrogens tend to increase serum thyroxine-binding globulin TBg .\"\n },\n {\n \"VerbatimTerm\": \"Estrogens\",\n \"Probability\": \"2.11692E-05\",\n \"SemanticContext\": \"Estrogen, Oral Contraceptives--Estrogens tend to increase serum thyroxine-binding globulin TBg .\"\n },\n {\n \"VerbatimTerm\": \"estrogens\",\n \"Probability\": \"0.00013191\",\n \"SemanticContext\": \"In a patient with a nonfunctioning thyroid gland who is receiving thyroid replacement therapy, free levothyroxine may be decreased when estrogens are started thus increasing thyroid requirements.\"\n },\n {\n \"VerbatimTerm\": \"estrogens\",\n \"Probability\": \"7.0991E-06\",\n \"SemanticContext\": \"Therefore, patients without a functioning thyroid gland who are on thyroid replacement therapy may need to increase their thyroid dose if estrogens or estrogen-containing oral contraceptives are given.\"\n },\n {\n \"VerbatimTerm\": \"estrogens\",\n \"Probability\": \"1.7297E-06\",\n \"SemanticContext\": \"Drug/Laboratory Test Interactions--The following drugs or moieties are known to interfere with laboratory tests performed in patients on thyroid hormone therapy: androgens, corticosteroids, estrogens, oral contraceptives containing estrogens, iodine-containing preparations, and the numerous preparations containing salicylates.\"\n },\n {\n \"VerbatimTerm\": \"estrogens\",\n \"Probability\": \"2.2578E-06\",\n \"SemanticContext\": \"Drug/Laboratory Test Interactions--The following drugs or moieties are known to interfere with laboratory tests performed in patients on thyroid hormone therapy: androgens, corticosteroids, estrogens, oral contraceptives containing estrogens, iodine-containing preparations, and the numerous preparations containing salicylates.\"\n },\n {\n \"VerbatimTerm\": \"estrogens\",\n \"Probability\": \"0.0001355784\",\n \"SemanticContext\": \"Pregnancy, estrogens, and estrogencontaining oral contraceptives increase TBg concentrations.\"\n },\n {\n \"VerbatimTerm\": \"estrogen\",\n \"Probability\": \"7.9124E-06\",\n \"SemanticContext\": \"Therefore, patients without a functioning thyroid gland who are on thyroid replacement therapy may need to increase their thyroid dose if estrogens or estrogen-containing oral contraceptives are given.\"\n }\n ]\n },\n {\n \"Term\": \"Hepatitis A\",\n \"MEDDRACode\": \"10019719\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"infectious hepatitis\",\n \"Probability\": \"0.066685237\",\n \"SemanticContext\": \"TBg may also be increased during infectious hepatitis.\"\n }\n ]\n },\n {\n \"Term\": \"Thyroxin binding globulin\",\n \"MEDDRACode\": \"10051424\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"thyroxine-binding globulin\",\n \"Probability\": \"1.76856E-05\",\n \"SemanticContext\": \"Estrogen, Oral Contraceptives--Estrogens tend to increase serum thyroxine-binding globulin TBg .\"\n }\n ]\n },\n {\n \"Term\": \"Coagulopathy\",\n \"MEDDRACode\": \"10009802\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"clotting\",\n \"Probability\": \"0.003183384\",\n \"SemanticContext\": \"Drug Interactions--Oral Anticoagulants--Thyroid hormones appear to increase catabolism of vitamin K-dependent clotting factors.\"\n },\n {\n \"VerbatimTerm\": \"clotting\",\n \"Probability\": \"0.0043136617\",\n \"SemanticContext\": \"If oral anticoagulants are also being given, compensatory increases in clotting factor synthesis are impaired.\"\n }\n ]\n },\n {\n \"Term\": \"Iodine uptake\",\n \"MEDDRACode\": \"10022917\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"iodine uptake\",\n \"Probability\": \"9.35045E-05\",\n \"SemanticContext\": \"Medicinal or dietary iodine interferes with all in vivo tests of radio-iodine uptake, producing low uptakes which may not be relative of a true decrease in hormone synthesis.\"\n }\n ]\n },\n {\n \"Term\": \"Renal failure\",\n \"MEDDRACode\": \"10038435\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"renal failure\",\n \"Probability\": \"0.0100464765\",\n \"SemanticContext\": \"Triiodothyronine T3 levels are low in the fetus and newborn, in old age, in chronic caloric deprivation, hepatic cirrhosis, renal failure, surgical stress, and chronic illnesses representing what has been called the “T3 thyronine syndrome.”\"\n }\n ]\n },\n {\n \"Term\": \"Lipids\",\n \"MEDDRACode\": \"10024587\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"lipids\",\n \"Probability\": \"0.0002828702\",\n \"SemanticContext\": \"These hormones enhance oxygen consumption by most tissues of the body, increase the basal metabolic rate, and the metabolism of carbohydrates, lipids, and proteins.\"\n }\n ]\n },\n {\n \"Term\": \"Elderly\",\n \"MEDDRACode\": \"10014348\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"elderly\",\n \"Probability\": \"0.0011839484\",\n \"SemanticContext\": \"Levothyroxine sodium T4 is given at starting dose of 400 mcg 100 mcg/mL given rapidly, and is usually well tolerated, even in the elderly.\"\n },\n {\n \"VerbatimTerm\": \"elderly\",\n \"Probability\": \"0.0073802383\",\n \"SemanticContext\": \"This category includes cretinism, myxedema, and ordinary hypothyroidism in patients of any age children, adults, the elderly , or state including pregnancy ; primary hypothyroidism resulting from functional deficiency, primary atrophy, partial or total absence of thyroid gland, or the effects of surgery, radiation, or drugs, with or without the presence of goiter; and secondary pituitary , or tertiary hypothalamic hypothyroidism See WARNINGS .\"\n },\n {\n \"VerbatimTerm\": \"elderly\",\n \"Probability\": \"8.59216E-05\",\n \"SemanticContext\": \"These include patients with angina pectoris or the elderly, in whom there is a greater likelihood of acute cardiac disease.\"\n }\n ]\n },\n {\n \"Term\": \"Myxoedema\",\n \"MEDDRACode\": \"10028665\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"myxedema\",\n \"Probability\": \"6.35665E-05\",\n \"SemanticContext\": \"A lower starting dosage, 15 mg/day, is recommended in patients with long standing myxedema, particularly if cardiovascular impairment is suspected, in which case extreme caution is recommended.\"\n },\n {\n \"VerbatimTerm\": \"myxedema\",\n \"Probability\": \"0.9209269881\",\n \"SemanticContext\": \"This category includes cretinism, myxedema, and ordinary hypothyroidism in patients of any age children, adults, the elderly , or state including pregnancy ; primary hypothyroidism resulting from functional deficiency, primary atrophy, partial or total absence of thyroid gland, or the effects of surgery, radiation, or drugs, with or without the presence of goiter; and secondary pituitary , or tertiary hypothalamic hypothyroidism See WARNINGS .\"\n }\n ]\n },\n {\n \"Term\": \"Exercise adequate\",\n \"MEDDRACode\": \"10015636\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": true,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"exercised\",\n \"Probability\": \"3.08737E-05\",\n \"SemanticContext\": \"However, caution should be exercised when thyroid is administered to a nursing woman.\"\n }\n ]\n },\n {\n \"Term\": \"Dehydration\",\n \"MEDDRACode\": \"10012174\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"fluid loss\",\n \"Probability\": \"0.0018025837\",\n \"SemanticContext\": \"Measures to control fever, hypoglycemia, or fluid loss should be instituted if needed.\"\n }\n ]\n },\n {\n \"Term\": \"Prophylaxis\",\n \"MEDDRACode\": \"10036898\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"prevention\",\n \"Probability\": \"0.0001276798\",\n \"SemanticContext\": \"As pituitary TSH suppressants, in the treatment or prevention of various types of euthyroid goiters, including thyroid nodules, subacute or chronic Iymphocytic thyroiditis Hashimoto’s , multinodular goiter, and in the management of thyroid cancer.\"\n }\n ]\n },\n {\n \"Term\": \"Temperature intolerance\",\n \"MEDDRACode\": \"10057040\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"heat intolerance\",\n \"Probability\": \"0.0239849743\",\n \"SemanticContext\": \"They should immediately report during the course of therapy any signs or symptoms of thyroid hormone toxicity, e.g., chest pain, increased pulse rate, palpitations, excessive sweating, heat intolerance, nervousness, or any other unusual event.\"\n }\n ]\n },\n {\n \"Term\": \"Electrolyte imbalance\",\n \"MEDDRACode\": \"10014418\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"electrolyte disturbances\",\n \"Probability\": \"1.55484E-05\",\n \"SemanticContext\": \"Therapy should be directed at the correction of electrolyte disturbances and possible infection besides the administration of thyroid hormones.\"\n }\n ]\n },\n {\n \"Term\": \"Androgens\",\n \"MEDDRACode\": \"10061633\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"androgens\",\n \"Probability\": \"7.229E-06\",\n \"SemanticContext\": \"Drug/Laboratory Test Interactions--The following drugs or moieties are known to interfere with laboratory tests performed in patients on thyroid hormone therapy: androgens, corticosteroids, estrogens, oral contraceptives containing estrogens, iodine-containing preparations, and the numerous preparations containing salicylates.\"\n },\n {\n \"VerbatimTerm\": \"androgen\",\n \"Probability\": \"0.0062271683\",\n \"SemanticContext\": \"Decreases in TBg concentrations are observed in nephrosis, acromegaly, and after androgen or corticosteroid therapy.\"\n }\n ]\n },\n {\n \"Term\": \"Cardiac failure congestive\",\n \"MEDDRACode\": \"10007559\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"congestive heart failure\",\n \"Probability\": \"0.0042913449\",\n \"SemanticContext\": \"Cardiac glycosides may be indicated if congestive heart failure develops.\"\n }\n ]\n },\n {\n \"Term\": \"Vomiting\",\n \"MEDDRACode\": \"10047700\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Vomiting\",\n \"Probability\": \"0.4640085399\",\n \"SemanticContext\": \"Vomiting may be induced initially if further gastrointestinal absorption can reasonably be prevented and barring contraindications such as coma, convulsions, or loss of the gagging reflex.\"\n }\n ]\n },\n {\n \"Term\": \"Decreased appetite\",\n \"MEDDRACode\": \"10061428\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"anorectic\",\n \"Probability\": \"0.1443664581\",\n \"SemanticContext\": \"Larger doses may produce serious or even life-threatening manifestations of toxicity, particularly when given in association with sympathomimetic amines such as those used for their anorectic effects.\"\n }\n ]\n },\n {\n \"Term\": \"Blood calcium\",\n \"MEDDRACode\": \"10005392\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"calcium\",\n \"Probability\": \"0.0003832079\",\n \"SemanticContext\": \"The inactive ingredients are calcium stearate, dextrose monohydrate, maltodextrin and mineral oil.\"\n }\n ]\n },\n {\n \"Term\": \"Acromegaly\",\n \"MEDDRACode\": \"10000599\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"acromegaly\",\n \"Probability\": \"0.5185831189\",\n \"SemanticContext\": \"Decreases in TBg concentrations are observed in nephrosis, acromegaly, and after androgen or corticosteroid therapy.\"\n }\n ]\n },\n {\n \"Term\": \"Malabsorption\",\n \"MEDDRACode\": \"10025476\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"malabsorption\",\n \"Probability\": \"0.0002174134\",\n \"SemanticContext\": \"Failure to respond to doses of 180 mg suggests lack of compliance or malabsorption.\"\n }\n ]\n },\n {\n \"Term\": \"Hypercatabolism\",\n \"MEDDRACode\": \"10049645\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"increase catabolism\",\n \"Probability\": \"0.0002620599\",\n \"SemanticContext\": \"Drug Interactions--Oral Anticoagulants--Thyroid hormones appear to increase catabolism of vitamin K-dependent clotting factors.\"\n }\n ]\n },\n {\n \"Term\": \"Psychomotor hyperactivity\",\n \"MEDDRACode\": \"10037211\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hyper\",\n \"Probability\": \"0.0592742935\",\n \"SemanticContext\": \"Familial hyper- or hypothyroxine-binding-globulinemias have been described.\"\n }\n ]\n },\n {\n \"Term\": \"Adrenal insufficiency\",\n \"MEDDRACode\": \"10001367\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": true,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"adrenal cortical insufficiency\",\n \"Probability\": \"0.017261954\",\n \"SemanticContext\": \"CONTRAINDICATIONS: Thyroid hormone preparations are generally contraindicated in patients with diagnosed but as yet uncorrected adrenal cortical insufficiency, untreated thyrotoxicosis, and apparent hypersensitivity to any of their active or extraneous constituents.\"\n },\n {\n \"VerbatimTerm\": \"adrenal cortical insufficiency\",\n \"Probability\": \"0.0004305562\",\n \"SemanticContext\": \"Thyroid hormone therapy in patients with concomitant diabetes mellitus or diabetes insipidus or adrenal cortical insufficiency aggravates the intensity of their symptoms.\"\n }\n ]\n },\n {\n \"Term\": \"Parenteral nutrition\",\n \"MEDDRACode\": \"10051284\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"total parenteral nutrition\",\n \"Probability\": \"3.40876E-05\",\n \"SemanticContext\": \"In acute, emergency conditions, injectable levothyroxine sodium may be given intravenously when oral administration is not feasible or desirable, as in the treatment of myxedema coma, or during total parenteral nutrition.\"\n }\n ]\n },\n {\n \"Term\": \"Hyperhidrosis\",\n \"MEDDRACode\": \"10020642\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"sweating\",\n \"Probability\": \"0.0158832837\",\n \"SemanticContext\": \"They should immediately report during the course of therapy any signs or symptoms of thyroid hormone toxicity, e.g., chest pain, increased pulse rate, palpitations, excessive sweating, heat intolerance, nervousness, or any other unusual event.\"\n }\n ]\n },\n {\n \"Term\": \"Coma\",\n \"MEDDRACode\": \"10010071\",\n \"Overdose\": true,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"coma\",\n \"Probability\": \"0.5351128578\",\n \"SemanticContext\": \"Vomiting may be induced initially if further gastrointestinal absorption can reasonably be prevented and barring contraindications such as coma, convulsions, or loss of the gagging reflex.\"\n }\n ]\n },\n {\n \"Term\": \"Laboratory test\",\n \"MEDDRACode\": \"10059938\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"laboratory tests\",\n \"Probability\": \"3.21845E-05\",\n \"SemanticContext\": \"Drug/Laboratory Test Interactions--The following drugs or moieties are known to interfere with laboratory tests performed in patients on thyroid hormone therapy: androgens, corticosteroids, estrogens, oral contraceptives containing estrogens, iodine-containing preparations, and the numerous preparations containing salicylates.\"\n },\n {\n \"VerbatimTerm\": \"laboratory tests\",\n \"Probability\": \"9.7172E-06\",\n \"SemanticContext\": \"This is the basis for the thyroid suppression test and is used as an aid in the diagnosis of patients with signs of mild hyperthyroidism in whom base line laboratory tests appear normal, or to demonstrate thyroid gland autonomy in patients with Grave’s ophthalmopathy.\"\n },\n {\n \"VerbatimTerm\": \"Laboratory Test\",\n \"Probability\": \"1.71102E-05\",\n \"SemanticContext\": \"Drug/Laboratory Test Interactions--The following drugs or moieties are known to interfere with laboratory tests performed in patients on thyroid hormone therapy: androgens, corticosteroids, estrogens, oral contraceptives containing estrogens, iodine-containing preparations, and the numerous preparations containing salicylates.\"\n }\n ]\n },\n {\n \"Term\": \"Illness\",\n \"MEDDRACode\": \"10080284\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"illnesses\",\n \"Probability\": \"0.0082043875\",\n \"SemanticContext\": \"Triiodothyronine T3 levels are low in the fetus and newborn, in old age, in chronic caloric deprivation, hepatic cirrhosis, renal failure, surgical stress, and chronic illnesses representing what has been called the “T3 thyronine syndrome.”\"\n },\n {\n \"VerbatimTerm\": \"illness\",\n \"Probability\": \"0.0752242878\",\n \"SemanticContext\": \"Myxedema Coma--Myxedema coma is usually precipitated in the hypothyroid patient of longstanding by intercurrent illness or drugs such as sedatives and anesthetics and should be considered a medical emergency.\"\n }\n ]\n },\n {\n \"Term\": \"Goitre\",\n \"MEDDRACode\": \"10018498\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"euthyroid goiters\",\n \"Probability\": \"0.0277207512\",\n \"SemanticContext\": \"As pituitary TSH suppressants, in the treatment or prevention of various types of euthyroid goiters, including thyroid nodules, subacute or chronic Iymphocytic thyroiditis Hashimoto’s , multinodular goiter, and in the management of thyroid cancer.\"\n }\n ]\n },\n {\n \"Term\": \"Primary hypothyroidism\",\n \"MEDDRACode\": \"10036697\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"primary hypothyroidism\",\n \"Probability\": \"0.4649939537\",\n \"SemanticContext\": \"This category includes cretinism, myxedema, and ordinary hypothyroidism in patients of any age children, adults, the elderly , or state including pregnancy ; primary hypothyroidism resulting from functional deficiency, primary atrophy, partial or total absence of thyroid gland, or the effects of surgery, radiation, or drugs, with or without the presence of goiter; and secondary pituitary , or tertiary hypothalamic hypothyroidism See WARNINGS .\"\n }\n ]\n },\n {\n \"Term\": \"Chest pain\",\n \"MEDDRACode\": \"10008479\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"chest pain\",\n \"Probability\": \"0.209582448\",\n \"SemanticContext\": \"They should immediately report during the course of therapy any signs or symptoms of thyroid hormone toxicity, e.g., chest pain, increased pulse rate, palpitations, excessive sweating, heat intolerance, nervousness, or any other unusual event.\"\n }\n ]\n },\n {\n \"Term\": \"Hypoglycaemia\",\n \"MEDDRACode\": \"10020993\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hypoglycemia\",\n \"Probability\": \"0.0060033114\",\n \"SemanticContext\": \"If thyroid medication is stopped, a downward readjustment of the dosage of insulin or oral hypoglycemic agent may be necessary to avoid hypoglycemia.\"\n },\n {\n \"VerbatimTerm\": \"hypoglycemia\",\n \"Probability\": \"0.0054774196\",\n \"SemanticContext\": \"Measures to control fever, hypoglycemia, or fluid loss should be instituted if needed.\"\n }\n ]\n },\n {\n \"Term\": \"Seizure\",\n \"MEDDRACode\": \"10039906\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"convulsions\",\n \"Probability\": \"0.6756373644\",\n \"SemanticContext\": \"Vomiting may be induced initially if further gastrointestinal absorption can reasonably be prevented and barring contraindications such as coma, convulsions, or loss of the gagging reflex.\"\n }\n ]\n },\n {\n \"Term\": \"Atrophy\",\n \"MEDDRACode\": \"10003694\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"atrophy\",\n \"Probability\": \"0.0098249698\",\n \"SemanticContext\": \"This category includes cretinism, myxedema, and ordinary hypothyroidism in patients of any age children, adults, the elderly , or state including pregnancy ; primary hypothyroidism resulting from functional deficiency, primary atrophy, partial or total absence of thyroid gland, or the effects of surgery, radiation, or drugs, with or without the presence of goiter; and secondary pituitary , or tertiary hypothalamic hypothyroidism See WARNINGS .\"\n }\n ]\n },\n {\n \"Term\": \"Heart rate increased\",\n \"MEDDRACode\": \"10019303\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"increased pulse rate\",\n \"Probability\": \"0.0300316848\",\n \"SemanticContext\": \"They should immediately report during the course of therapy any signs or symptoms of thyroid hormone toxicity, e.g., chest pain, increased pulse rate, palpitations, excessive sweating, heat intolerance, nervousness, or any other unusual event.\"\n }\n ]\n },\n {\n \"Term\": \"Surgery\",\n \"MEDDRACode\": \"10042609\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"surgery\",\n \"Probability\": \"0.0001674352\",\n \"SemanticContext\": \"This category includes cretinism, myxedema, and ordinary hypothyroidism in patients of any age children, adults, the elderly , or state including pregnancy ; primary hypothyroidism resulting from functional deficiency, primary atrophy, partial or total absence of thyroid gland, or the effects of surgery, radiation, or drugs, with or without the presence of goiter; and secondary pituitary , or tertiary hypothalamic hypothyroidism See WARNINGS .\"\n }\n ]\n },\n {\n \"Term\": \"Thyroid mass\",\n \"MEDDRACode\": \"10058900\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"thyroid nodules\",\n \"Probability\": \"0.1249633208\",\n \"SemanticContext\": \"As pituitary TSH suppressants, in the treatment or prevention of various types of euthyroid goiters, including thyroid nodules, subacute or chronic Iymphocytic thyroiditis Hashimoto’s , multinodular goiter, and in the management of thyroid cancer.\"\n }\n ]\n },\n {\n \"Term\": \"Blood glucose\",\n \"MEDDRACode\": \"10005553\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"glucose\",\n \"Probability\": \"3.723E-07\",\n \"SemanticContext\": \"At all times, close monitoring of urinary glucose levels is mandatory in such patients.\"\n }\n ]\n },\n {\n \"Term\": \"Nervousness\",\n \"MEDDRACode\": \"10029216\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"nervousness\",\n \"Probability\": \"0.0076254918\",\n \"SemanticContext\": \"They should immediately report during the course of therapy any signs or symptoms of thyroid hormone toxicity, e.g., chest pain, increased pulse rate, palpitations, excessive sweating, heat intolerance, nervousness, or any other unusual event.\"\n }\n ]\n },\n {\n \"Term\": \"Endocrine ophthalmopathy\",\n \"MEDDRACode\": \"10060742\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Grave’s ophthalmopathy\",\n \"Probability\": \"0.0029905178\",\n \"SemanticContext\": \"This is the basis for the thyroid suppression test and is used as an aid in the diagnosis of patients with signs of mild hyperthyroidism in whom base line laboratory tests appear normal, or to demonstrate thyroid gland autonomy in patients with Grave’s ophthalmopathy.\"\n }\n ]\n },\n {\n \"Term\": \"Thyroxine normal\",\n \"MEDDRACode\": \"10043820\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Normal T4\",\n \"Probability\": \"0.00018889\",\n \"SemanticContext\": \"Normal T4 levels are achieved in 24 hours followed in 3 days by threefold elevation of T3.\"\n }\n ]\n },\n {\n \"Term\": \"Pregnancy\",\n \"MEDDRACode\": \"10036556\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Pregnancy\",\n \"Probability\": \"0.0050214669\",\n \"SemanticContext\": \"Pregnancy, estrogens, and estrogencontaining oral contraceptives increase TBg concentrations.\"\n },\n {\n \"VerbatimTerm\": \"Pregnancy\",\n \"Probability\": \"0.0115109589\",\n \"SemanticContext\": \"Pregnancy-Category A--Thyroid hormones do not readily cross the placental barrier.\"\n },\n {\n \"VerbatimTerm\": \"pregnancy\",\n \"Probability\": \"0.0272340756\",\n \"SemanticContext\": \"This category includes cretinism, myxedema, and ordinary hypothyroidism in patients of any age children, adults, the elderly , or state including pregnancy ; primary hypothyroidism resulting from functional deficiency, primary atrophy, partial or total absence of thyroid gland, or the effects of surgery, radiation, or drugs, with or without the presence of goiter; and secondary pituitary , or tertiary hypothalamic hypothyroidism See WARNINGS .\"\n },\n {\n \"VerbatimTerm\": \"pregnancy\",\n \"Probability\": \"0.000184223\",\n \"SemanticContext\": \"On the basis of current knowledge, thyroid replacement therapy to hypothyroid women should not be discontinued during pregnancy.\"\n }\n ]\n },\n {\n \"Term\": \"Thyroid therapy\",\n \"MEDDRACode\": \"10065358\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"thyroid therapy\",\n \"Probability\": \"4.50578E-05\",\n \"SemanticContext\": \"Information for the Patient--Patients on thyroid hormone preparations and parents of children on thyroid therapy should be informed that: 1.\"\n },\n {\n \"VerbatimTerm\": \"thyroid therapy\",\n \"Probability\": \"0.0029497449\",\n \"SemanticContext\": \"Partial loss of hair may be experienced by children in the first few months of thyroid therapy, but this is usually a transient phenomenon and later recovery is usually the rule.\"\n }\n ]\n },\n {\n \"Term\": \"Diabetes insipidus\",\n \"MEDDRACode\": \"10012599\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"diabetes insipidus\",\n \"Probability\": \"0.0024348337\",\n \"SemanticContext\": \"Thyroid hormone therapy in patients with concomitant diabetes mellitus or diabetes insipidus or adrenal cortical insufficiency aggravates the intensity of their symptoms.\"\n }\n ]\n },\n {\n \"Term\": \"Induction and maintenance of anaesthesia\",\n \"MEDDRACode\": \"10021723\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"induction\",\n \"Probability\": \"0.0001627718\",\n \"SemanticContext\": \"T3 may be used in preference to levothyroxine T4 during radio-isotope scanning procedures, since induction of hypothyroidism in those cases is more abrupt and can be of shorter duration.\"\n }\n ]\n },\n {\n \"Term\": \"Thyroid cancer\",\n \"MEDDRACode\": \"10066474\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Thyroid Cancer\",\n \"Probability\": \"0.0084470604\",\n \"SemanticContext\": \"Thyroid Cancer--Exogenous thyroid hormone may produce regression of metastases from follicular and papillary carcinoma of the thyroid and is used as ancillary therapy of these conditions with radioactive iodine.\"\n },\n {\n \"VerbatimTerm\": \"thyroid cancer\",\n \"Probability\": \"0.072081469\",\n \"SemanticContext\": \"As pituitary TSH suppressants, in the treatment or prevention of various types of euthyroid goiters, including thyroid nodules, subacute or chronic Iymphocytic thyroiditis Hashimoto’s , multinodular goiter, and in the management of thyroid cancer.\"\n }\n ]\n },\n {\n \"Term\": \"Weight\",\n \"MEDDRACode\": \"10047890\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"weight\",\n \"Probability\": \"2.85141E-05\",\n \"SemanticContext\": \"For adults, the usual suppressive dose of levothyroxine T4 is 1.56 mcg/kg of body weight per day given for 7 to 10 days.\"\n },\n {\n \"VerbatimTerm\": \"weight\",\n \"Probability\": \"0.0068051587\",\n \"SemanticContext\": \"Recommended Pediatric Dosage for Congenital Hypothyroidism NP Thyroid Tablets Age Dose per day Daily dose per kg of body weight 0 - 6 mos.\"\n },\n {\n \"VerbatimTerm\": \"weight\",\n \"Probability\": \"2.19912E-05\",\n \"SemanticContext\": \"In euthyroid patients, doses within the range of daily hormonal requirements are ineffective for weight reduction.\"\n }\n ]\n },\n {\n \"Term\": \"Nephrotic syndrome\",\n \"MEDDRACode\": \"10029164\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"nephrosis\",\n \"Probability\": \"0.9727867842\",\n \"SemanticContext\": \"Decreases in TBg concentrations are observed in nephrosis, acromegaly, and after androgen or corticosteroid therapy.\"\n }\n ]\n },\n {\n \"Term\": \"Thyroxine free decreased\",\n \"MEDDRACode\": \"10055162\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"decreased free thyroxine\",\n \"Probability\": \"0.0346533321\",\n \"SemanticContext\": \"However, if the patient’s thyroid gland has sufficient function, the decreased free thyroxine will result in a compensatory increase in thyroxine output by the thyroid.\"\n }\n ]\n },\n {\n \"Term\": \"Hypothyroidism\",\n \"MEDDRACode\": \"10021114\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hypothyroidism\",\n \"Probability\": \"0.0129303532\",\n \"SemanticContext\": \"The persistence of clinical and laboratory evidence of hypothyroidism in spite of adequate dosage replacement indicates either poor patient compliance, poor absorption, excessive fecal loss, or inactivity of the preparation.\"\n },\n {\n \"VerbatimTerm\": \"hypothyroidism\",\n \"Probability\": \"0.0423145033\",\n \"SemanticContext\": \"T3 may be used in preference to levothyroxine T4 during radio-isotope scanning procedures, since induction of hypothyroidism in those cases is more abrupt and can be of shorter duration.\"\n },\n {\n \"VerbatimTerm\": \"hypothyroidism\",\n \"Probability\": \"0.0001410824\",\n \"SemanticContext\": \"As replacement or supplemental therapy in patients with hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis.\"\n },\n {\n \"VerbatimTerm\": \"hypothyroidism\",\n \"Probability\": \"0.1772571504\",\n \"SemanticContext\": \"As replacement or supplemental therapy in patients with hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis.\"\n },\n {\n \"VerbatimTerm\": \"hypothyroidism\",\n \"Probability\": \"0.6373782158\",\n \"SemanticContext\": \"This category includes cretinism, myxedema, and ordinary hypothyroidism in patients of any age children, adults, the elderly , or state including pregnancy ; primary hypothyroidism resulting from functional deficiency, primary atrophy, partial or total absence of thyroid gland, or the effects of surgery, radiation, or drugs, with or without the presence of goiter; and secondary pituitary , or tertiary hypothalamic hypothyroidism See WARNINGS .\"\n },\n {\n \"VerbatimTerm\": \"hypothyroidism\",\n \"Probability\": \"0.1791256517\",\n \"SemanticContext\": \"This category includes cretinism, myxedema, and ordinary hypothyroidism in patients of any age children, adults, the elderly , or state including pregnancy ; primary hypothyroidism resulting from functional deficiency, primary atrophy, partial or total absence of thyroid gland, or the effects of surgery, radiation, or drugs, with or without the presence of goiter; and secondary pituitary , or tertiary hypothalamic hypothyroidism See WARNINGS .\"\n },\n {\n \"VerbatimTerm\": \"hypothyroidism\",\n \"Probability\": \"0.4443814456\",\n \"SemanticContext\": \"Replacement therapy is to be taken essentially for life, with the exception of cases of transient hypothyroidism, usually associated with thyroiditis, and in those patients receiving a therapeutic trial of the drug.\"\n },\n {\n \"VerbatimTerm\": \"hypothyroidism\",\n \"Probability\": \"0.0103573296\",\n \"SemanticContext\": \"Neither is their use justified for the treatment of male or female infertility unless this condition is accompanied by hypothyroidism.\"\n },\n {\n \"VerbatimTerm\": \"hypothyroidism\",\n \"Probability\": \"0.0024958125\",\n \"SemanticContext\": \"Treatment should be initiated immediately upon diagnosis, and maintained for life, unless transient hypothyroidism is suspected; in which case, therapy may be interrupted for 2 to 8 weeks after the age of 3 years to reassess the condition.\"\n },\n {\n \"VerbatimTerm\": \"Hypothyroidism\",\n \"Probability\": \"0.4244366288\",\n \"SemanticContext\": \"Hypothyroidism--Therapy is usually instituted using low doses, with increments which depend on the cardiovascular status of the patient.\"\n },\n {\n \"VerbatimTerm\": \"Hypothyroidism\",\n \"Probability\": \"0.0719261467\",\n \"SemanticContext\": \"Hypothyroidism decreases and hyperthyroidism increases the sensitivity to oral anticoagulants.\"\n }\n ]\n },\n {\n \"Term\": \"Infertility female\",\n \"MEDDRACode\": \"10021928\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"female infertility\",\n \"Probability\": \"6.4513E-05\",\n \"SemanticContext\": \"Neither is their use justified for the treatment of male or female infertility unless this condition is accompanied by hypothyroidism.\"\n }\n ]\n },\n {\n \"Term\": \"Hormone therapy\",\n \"MEDDRACode\": \"10065646\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hormone therapy\",\n \"Probability\": \"1.19111E-05\",\n \"SemanticContext\": \"Drug/Laboratory Test Interactions--The following drugs or moieties are known to interfere with laboratory tests performed in patients on thyroid hormone therapy: androgens, corticosteroids, estrogens, oral contraceptives containing estrogens, iodine-containing preparations, and the numerous preparations containing salicylates.\"\n },\n {\n \"VerbatimTerm\": \"hormone therapy\",\n \"Probability\": \"0.0001680663\",\n \"SemanticContext\": \"Thyroid hormone therapy in patients with concomitant diabetes mellitus or diabetes insipidus or adrenal cortical insufficiency aggravates the intensity of their symptoms.\"\n }\n ]\n },\n {\n \"Term\": \"Neoplasm malignant\",\n \"MEDDRACode\": \"10028997\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"carcinoma\",\n \"Probability\": \"0.0028671587\",\n \"SemanticContext\": \"Thyroid Cancer--Exogenous thyroid hormone may produce regression of metastases from follicular and papillary carcinoma of the thyroid and is used as ancillary therapy of these conditions with radioactive iodine.\"\n },\n {\n \"VerbatimTerm\": \"carcinoma\",\n \"Probability\": \"0.0044939062\",\n \"SemanticContext\": \"Medullary carcinoma of the thyroid is usually unresponsive to this therapy.\"\n }\n ]\n },\n {\n \"Term\": \"Radioisotope scan\",\n \"MEDDRACode\": \"10061478\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"radio-isotope scanning\",\n \"Probability\": \"4.6773E-06\",\n \"SemanticContext\": \"T3 may be used in preference to levothyroxine T4 during radio-isotope scanning procedures, since induction of hypothyroidism in those cases is more abrupt and can be of shorter duration.\"\n }\n ]\n },\n {\n \"Term\": \"Anticoagulant therapy\",\n \"MEDDRACode\": \"10053468\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"anticoagulant therapy\",\n \"Probability\": \"4.9079E-06\",\n \"SemanticContext\": \"No special precautions appear to be necessary when oral anticoagulant therapy is begun in a patient already stabilized on maintenance thyroid replacement therapy.\"\n },\n {\n \"VerbatimTerm\": \"anticoagulant therapy\",\n \"Probability\": \"8.24854E-05\",\n \"SemanticContext\": \"In case of concomitant oral anticoagulant therapy, the prothrombin time should be measured frequently to determine if the dosage of oral anticoagulants is to be readjusted.\"\n }\n ]\n },\n {\n \"Term\": \"Thyroiditis subacute\",\n \"MEDDRACode\": \"10043784\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"subacute thyroiditis\",\n \"Probability\": \"0.1262662709\",\n \"SemanticContext\": \"As replacement or supplemental therapy in patients with hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis.\"\n }\n ]\n },\n {\n \"Term\": \"Palpitations\",\n \"MEDDRACode\": \"10033557\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"palpitations\",\n \"Probability\": \"0.0306515768\",\n \"SemanticContext\": \"They should immediately report during the course of therapy any signs or symptoms of thyroid hormone toxicity, e.g., chest pain, increased pulse rate, palpitations, excessive sweating, heat intolerance, nervousness, or any other unusual event.\"\n }\n ]\n },\n {\n \"Term\": \"Pyrexia\",\n \"MEDDRACode\": \"10037660\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"fever\",\n \"Probability\": \"0.0121473074\",\n \"SemanticContext\": \"Measures to control fever, hypoglycemia, or fluid loss should be instituted if needed.\"\n }\n ]\n },\n {\n \"Term\": \"Retching\",\n \"MEDDRACode\": \"10038776\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"gagging\",\n \"Probability\": \"0.3845998049\",\n \"SemanticContext\": \"Vomiting may be induced initially if further gastrointestinal absorption can reasonably be prevented and barring contraindications such as coma, convulsions, or loss of the gagging reflex.\"\n }\n ]\n },\n {\n \"Term\": \"Diabetes mellitus\",\n \"MEDDRACode\": \"10012601\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"diabetes mellitus\",\n \"Probability\": \"0.0007376707\",\n \"SemanticContext\": \"In case of concomitant diabetes mellitus, the daily dosage of antidiabetic medication may need readjustment as thyroid hormone replacement is achieved.\"\n },\n {\n \"VerbatimTerm\": \"diabetes mellitus\",\n \"Probability\": \"0.0013852225\",\n \"SemanticContext\": \"Thyroid hormone therapy in patients with concomitant diabetes mellitus or diabetes insipidus or adrenal cortical insufficiency aggravates the intensity of their symptoms.\"\n }\n ]\n },\n {\n \"Term\": \"Thyroiditis\",\n \"MEDDRACode\": \"10043778\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"thyroiditis\",\n \"Probability\": \"0.1294929534\",\n \"SemanticContext\": \"As pituitary TSH suppressants, in the treatment or prevention of various types of euthyroid goiters, including thyroid nodules, subacute or chronic Iymphocytic thyroiditis Hashimoto’s , multinodular goiter, and in the management of thyroid cancer.\"\n },\n {\n \"VerbatimTerm\": \"thyroiditis\",\n \"Probability\": \"0.5507380366\",\n \"SemanticContext\": \"Replacement therapy is to be taken essentially for life, with the exception of cases of transient hypothyroidism, usually associated with thyroiditis, and in those patients receiving a therapeutic trial of the drug.\"\n }\n ]\n },\n {\n \"Term\": \"Craniosynostosis\",\n \"MEDDRACode\": \"10049889\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"craniosynostosis\",\n \"Probability\": \"0.0048106476\",\n \"SemanticContext\": \"In infants, excessive doses of thyroid hormone preparations may produce craniosynostosis.\"\n }\n ]\n }\n ],\n \"IndicationTerms\": []\n }\n ]\n },\n {\n \"GenericName\": \"salicylic acid\",\n \"MeddraVersion\": \"24.0\",\n \"Labels\": [\n {\n \"Id\": \"USfb43c2d8-731b-437c-ba5c-82e7b8dbe712\",\n \"NDCCode\": \"42783-324\",\n \"UpdatedDate\": \"May 01, 2018\",\n \"LabelSource\": {\n \"Country\": \"us\",\n \"ProductId\": \"00350fc0-b8db-47e5-8164-0ab539e1c642\",\n \"FileId\": \"fb43c2d8-731b-437c-ba5c-82e7b8dbe712\",\n \"Version\": \"1\"\n },\n \"AdverseEventTerms\": [\n {\n \"Term\": \"Skin papilloma\",\n \"MEDDRACode\": \"10040907\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": true,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"common warts\",\n \"Probability\": \"0.0043132901\",\n \"SemanticContext\": \"INDICATIONS AND USAGE This Product is indicated for the topical treatment and removal of common warts and plantar warts.\"\n },\n {\n \"VerbatimTerm\": \"common warts\",\n \"Probability\": \"0.000249505\",\n \"SemanticContext\": \"PATIENT INSTRUCTIONS Your health care provider has prescribed this Product, a topical prescription preparation for the treatment of common warts and plantar warts.\"\n }\n ]\n },\n {\n \"Term\": \"Diabetes mellitus\",\n \"MEDDRACode\": \"10012601\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": true,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"diabetes\",\n \"Probability\": \"0.0018152893\",\n \"SemanticContext\": \"CONTRAINDICATIONS Patients with diabetes or impaired blood circulation should not use the Product.\"\n }\n ]\n },\n {\n \"Term\": \"Flushing\",\n \"MEDDRACode\": \"10016825\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"flush\",\n \"Probability\": \"0.00321877\",\n \"SemanticContext\": \"If contact with eyes or mucous membranes occurs, immediately flush with water for 15 minutes.\"\n }\n ]\n },\n {\n \"Term\": \"Gait disturbance\",\n \"MEDDRACode\": \"10017577\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Step\",\n \"Probability\": \"0.0043095946\",\n \"SemanticContext\": \"Repeat Step 1 and Step 2 once or twice daily as advised by the health care provider.\"\n },\n {\n \"VerbatimTerm\": \"Step\",\n \"Probability\": \"0.0240872502\",\n \"SemanticContext\": \"Repeat Step 1 and Step 2 once or twice daily as advised by the health care provider.\"\n }\n ]\n },\n {\n \"Term\": \"Discomfort\",\n \"MEDDRACode\": \"10013082\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n 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\"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"freckles\",\n \"Probability\": \"0.1348685026\",\n \"SemanticContext\": \"Indicated for the gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of hyperpigmentation.\"\n }\n ]\n },\n {\n \"Term\": \"Chloasma\",\n \"MEDDRACode\": \"10008570\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"melasma\",\n \"Probability\": \"0.2460022271\",\n \"SemanticContext\": \"Indicated for the gradual 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\"UpdatedDate\": \"Jun 02, 2021\",\n \"LabelSource\": {\n \"Country\": \"us\",\n \"ProductId\": \"024cd444-04e2-441a-9863-9e5db741e657\",\n \"FileId\": \"304627ab-6caa-40f1-813f-70805bb35b39\",\n \"Version\": \"3\"\n },\n \"AdverseEventTerms\": [\n {\n \"Term\": \"Abdominal distension\",\n \"MEDDRACode\": \"10000060\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Abdominal distention\",\n \"Probability\": \"0.9220182896\",\n \"SemanticContext\": \"Gastrointestinal Abdominal distention, bowel/bladder dysfunction after intrathecal administration , elevation in serum liver enzyme levels usually reversible upon discontinuation , hepatomegaly, increased appetite, nausea, pancreatitis, peptic ulcer with possible perforation and hemorrhage, perforation of the small and large intestine particularly in patients with inflammatory bowel disease , ulcerative esophagitis.\"\n }\n ]\n },\n {\n \"Term\": \"Abscess sterile\",\n \"MEDDRACode\": \"10000317\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"sterile abscess\",\n \"Probability\": \"0.9173126221\",\n \"SemanticContext\": \"Dermatologic Acne, allergic dermatitis, cutaneous and subcutaneous atrophy, dry scaly skin, 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\"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"tolerance\",\n \"Probability\": \"0.0068207681\",\n \"SemanticContext\": \"Endocrine Decreased carbohydrate and glucose tolerance, development of cushingoid state, glucosuria, hirsutism, hypertrichosis, increased requirements for insulin or oral hypoglycemic adrenocortical and pituitary unresponsiveness particularly in times of stress, as in trauma, surgery, or illness , suppression of growth in pediatric patients.\"\n }\n ]\n },\n {\n \"Term\": \"Cardiac arrest\",\n \"MEDDRACode\": \"10007515\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"cardiac arrest\",\n \"Probability\": \"0.9751826525\",\n \"SemanticContext\": \"Cardiovascular Bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure, fat embolism, hypertension, hypertrophic cardiomyopathy in premature infants, myocardial rupture following recent myocardial infarction see WARNINGS , pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis.\"\n }\n ]\n },\n {\n \"Term\": \"Blood insulin\",\n \"MEDDRACode\": \"10005605\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"insulin\",\n \"Probability\": \"0.0001421571\",\n \"SemanticContext\": \"Endocrine Decreased carbohydrate and glucose tolerance, development of cushingoid state, glucosuria, hirsutism, hypertrichosis, increased requirements for insulin or oral hypoglycemic adrenocortical and pituitary unresponsiveness particularly in times of stress, as in trauma, surgery, or illness , suppression of growth in pediatric patients.\"\n }\n ]\n },\n {\n \"Term\": \"Haemorrhage\",\n \"MEDDRACode\": \"10055798\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hemorrhage\",\n \"Probability\": \"0.0100172162\",\n \"SemanticContext\": \"Gastrointestinal Abdominal distention, bowel/bladder dysfunction after intrathecal administration , elevation in serum liver enzyme levels usually reversible upon discontinuation , hepatomegaly, increased appetite, nausea, pancreatitis, peptic ulcer with possible perforation and hemorrhage, perforation of the small and large intestine particularly in patients with inflammatory bowel disease , ulcerative esophagitis.\"\n }\n ]\n },\n {\n \"Term\": \"Cushingoid\",\n \"MEDDRACode\": \"10011655\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"cushingoid\",\n \"Probability\": \"0.1795087159\",\n \"SemanticContext\": \"Endocrine Decreased carbohydrate and glucose tolerance, development of cushingoid state, glucosuria, hirsutism, hypertrichosis, increased requirements for insulin or oral hypoglycemic adrenocortical and pituitary unresponsiveness particularly in times of stress, as in trauma, surgery, or illness , suppression of growth in pediatric patients.\"\n }\n ]\n },\n {\n \"Term\": \"Bladder dysfunction\",\n \"MEDDRACode\": \"10069632\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"bladder dysfunction\",\n \"Probability\": \"0.1721846163\",\n \"SemanticContext\": \"Gastrointestinal Abdominal distention, bowel/bladder dysfunction after intrathecal administration , elevation in serum liver enzyme levels usually reversible upon discontinuation , hepatomegaly, increased appetite, nausea, pancreatitis, peptic ulcer with possible perforation and hemorrhage, perforation of the small and large intestine particularly in patients with inflammatory bowel disease , ulcerative esophagitis.\"\n }\n ]\n },\n {\n \"Term\": \"Exophthalmos\",\n \"MEDDRACode\": \"10015683\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Exophthalmos\",\n \"Probability\": \"0.7306218147\",\n \"SemanticContext\": \"Ophthalmic Exophthalmos, glaucoma, increased intraocular pressure, posterior subcapsular cataracts, rare instances of blindness associated with periocular injections, vision blurred.\"\n }\n ]\n },\n {\n \"Term\": \"Glycosuria\",\n \"MEDDRACode\": \"10018473\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"glucosuria\",\n \"Probability\": \"0.3521543741\",\n \"SemanticContext\": \"Endocrine Decreased carbohydrate and glucose tolerance, development of cushingoid state, glucosuria, hirsutism, hypertrichosis, increased requirements for insulin or oral hypoglycemic adrenocortical and pituitary unresponsiveness particularly in times of stress, as in trauma, surgery, or illness , suppression of growth in pediatric patients.\"\n }\n ]\n },\n {\n \"Term\": \"Electrolyte imbalance\",\n \"MEDDRACode\": \"10014418\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Electrolyte Disturbances\",\n \"Probability\": \"0.0702655315\",\n \"SemanticContext\": \"Fluid and Electrolyte Disturbances Congestive heart failure in susceptible patients, fluid retention, hypokalemic alkalosis, potassium loss, sodium retention.\"\n }\n ]\n },\n {\n \"Term\": \"Hiccups\",\n \"MEDDRACode\": \"10020039\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hiccups\",\n \"Probability\": \"0.9896069765\",\n \"SemanticContext\": \"Other Abnormal fat deposits, decreased resistance to infection, hiccups, increased or decreased motility and number of spermatozoa, malaise, moon face, weight gain.\"\n }\n ]\n },\n {\n \"Term\": \"Arachnoiditis\",\n \"MEDDRACode\": \"10003074\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Arachnoiditis\",\n \"Probability\": \"0.8410742879\",\n \"SemanticContext\": \"Arachnoiditis, meningitis, paraparesis/paraplegia, and sensory disturbances have occurred after intrathecal administration see WARNINGS, Neurologic section .\"\n }\n ]\n },\n {\n \"Term\": \"Angioedema\",\n \"MEDDRACode\": \"10002424\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"angioedema\",\n \"Probability\": \"0.985330224\",\n \"SemanticContext\": \"ADVERSE REACTIONS listed alphabetically, under each subsection Allergic Reactions Anaphylactoid reaction, anaphylaxis, angioedema.\"\n }\n ]\n },\n {\n \"Term\": \"Compression fracture\",\n \"MEDDRACode\": \"10010214\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"compression fractures\",\n \"Probability\": \"0.0764600933\",\n \"SemanticContext\": \"Musculoskeletal Aseptic necrosis of femoral and humeral heads, calcinosis following intra-articular or intralesional use , Charcot-like arthropathy, loss of muscle mass, muscle weakness, osteoporosis, pathologic fracture of long bones, postinjection flare following intra-articular use , steroid myopathy, tendon rupture, vertebral compression fractures.\"\n }\n ]\n },\n {\n \"Term\": \"Headache\",\n \"MEDDRACode\": \"10019211\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"headache\",\n \"Probability\": \"0.9994540215\",\n \"SemanticContext\": \"Neurologic/Psychiatric Convulsions, depression, emotional instability, euphoria, headache, increased intracranial pressure with papilledema pseudotumor cerebri usually following discontinuation of treatment, insomnia, mood swings, neuritis, neuropathy, paresthesia, personality changes, psychic disorders, vertigo.\"\n }\n ]\n },\n {\n \"Term\": \"Hirsutism\",\n \"MEDDRACode\": \"10020112\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hirsutism\",\n \"Probability\": \"0.2953276932\",\n \"SemanticContext\": \"Endocrine Decreased carbohydrate and glucose tolerance, development of cushingoid state, glucosuria, hirsutism, hypertrichosis, increased requirements for insulin or oral hypoglycemic adrenocortical and pituitary unresponsiveness particularly in times of stress, as in trauma, surgery, or illness , suppression of growth in pediatric patients.\"\n }\n ]\n },\n {\n \"Term\": \"Intracranial pressure increased\",\n \"MEDDRACode\": \"10022773\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"increased intracranial pressure\",\n \"Probability\": \"0.9971914887\",\n \"SemanticContext\": \"Neurologic/Psychiatric Convulsions, depression, emotional instability, euphoria, headache, increased intracranial pressure with papilledema pseudotumor cerebri usually following discontinuation of treatment, insomnia, mood swings, neuritis, neuropathy, paresthesia, personality changes, psychic disorders, vertigo.\"\n }\n ]\n },\n {\n \"Term\": \"Muscular weakness\",\n \"MEDDRACode\": \"10028372\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"muscle weakness\",\n \"Probability\": \"0.62056458\",\n \"SemanticContext\": \"Musculoskeletal Aseptic necrosis of femoral and humeral heads, calcinosis following intra-articular or intralesional use , Charcot-like arthropathy, loss of muscle mass, muscle weakness, osteoporosis, pathologic fracture of long bones, postinjection flare following intra-articular use , steroid myopathy, tendon rupture, vertebral compression fractures.\"\n }\n ]\n },\n {\n \"Term\": \"Paraesthesia\",\n \"MEDDRACode\": \"10033775\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"paresthesia\",\n \"Probability\": \"0.991415143\",\n \"SemanticContext\": \"Neurologic/Psychiatric Convulsions, depression, emotional instability, euphoria, headache, increased intracranial pressure with papilledema pseudotumor cerebri usually following discontinuation of treatment, insomnia, mood swings, neuritis, neuropathy, paresthesia, personality changes, psychic disorders, vertigo.\"\n }\n ]\n },\n {\n \"Term\": \"Petechiae\",\n \"MEDDRACode\": \"10034754\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"petechiae\",\n \"Probability\": \"0.9535653591\",\n \"SemanticContext\": \"Dermatologic Acne, allergic dermatitis, cutaneous and subcutaneous atrophy, dry scaly skin, ecchymoses and petechiae, edema, erythema, hyperpigmentation, hypopigmentation, impaired wound healing, increased sweating, rash, sterile abscess, striae, suppressed reactions to skin tests, thin fragile skin, thinning scalp hair, urticaria.\"\n }\n ]\n },\n {\n \"Term\": \"Hypertrichosis\",\n \"MEDDRACode\": \"10020864\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hypertrichosis\",\n \"Probability\": \"0.0435546935\",\n \"SemanticContext\": \"Endocrine Decreased carbohydrate and glucose tolerance, development of cushingoid state, glucosuria, hirsutism, hypertrichosis, increased requirements for insulin or oral hypoglycemic adrenocortical and pituitary unresponsiveness particularly in times of stress, as in trauma, surgery, or illness , suppression of growth in pediatric patients.\"\n }\n ]\n },\n {\n \"Term\": \"Pulmonary oedema\",\n \"MEDDRACode\": \"10037423\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"pulmonary edema\",\n \"Probability\": \"0.9963120222\",\n \"SemanticContext\": \"Cardiovascular Bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure, fat embolism, hypertension, hypertrophic cardiomyopathy in premature infants, myocardial rupture following recent myocardial infarction see WARNINGS , pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis.\"\n }\n ]\n },\n {\n \"Term\": \"Tendon rupture\",\n \"MEDDRACode\": \"10043248\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"tendon rupture\",\n \"Probability\": \"0.462841779\",\n \"SemanticContext\": \"Musculoskeletal Aseptic necrosis of femoral and humeral heads, calcinosis following intra-articular or intralesional use , Charcot-like arthropathy, loss of muscle mass, muscle weakness, osteoporosis, pathologic fracture of long bones, postinjection flare following intra-articular use , steroid myopathy, tendon rupture, vertebral compression fractures.\"\n }\n ]\n },\n {\n \"Term\": \"Weight increased\",\n \"MEDDRACode\": \"10047899\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"weight gain\",\n \"Probability\": \"0.7207409739\",\n \"SemanticContext\": \"Other Abnormal fat deposits, decreased resistance to infection, hiccups, increased or decreased motility and number of spermatozoa, malaise, moon face, weight gain.\"\n }\n ]\n },\n {\n \"Term\": \"Neuropathy peripheral\",\n \"MEDDRACode\": \"10029331\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"neuropathy\",\n \"Probability\": \"0.9886909723\",\n \"SemanticContext\": \"Neurologic/Psychiatric Convulsions, depression, emotional instability, euphoria, headache, increased intracranial pressure with papilledema pseudotumor cerebri usually following discontinuation of treatment, insomnia, mood swings, neuritis, neuropathy, paresthesia, personality changes, psychic disorders, vertigo.\"\n }\n ]\n },\n {\n \"Term\": \"Nitrogen balance negative\",\n \"MEDDRACode\": \"10029425\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Negative nitrogen balance\",\n \"Probability\": \"0.0774745941\",\n \"SemanticContext\": \"Metabolic Negative nitrogen balance due to protein catabolism.\"\n }\n ]\n },\n {\n \"Term\": \"Papilloedema\",\n \"MEDDRACode\": \"10033712\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"papilledema\",\n \"Probability\": \"0.9876710773\",\n \"SemanticContext\": \"Neurologic/Psychiatric Convulsions, depression, emotional instability, euphoria, headache, increased intracranial pressure with papilledema pseudotumor cerebri usually following discontinuation of treatment, insomnia, mood swings, neuritis, neuropathy, paresthesia, personality changes, psychic disorders, vertigo.\"\n }\n ]\n },\n {\n \"Term\": \"Affect lability\",\n \"MEDDRACode\": \"10054196\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"emotional instability\",\n \"Probability\": \"0.9832019806\",\n \"SemanticContext\": \"Neurologic/Psychiatric Convulsions, depression, emotional instability, euphoria, headache, increased intracranial pressure with papilledema pseudotumor cerebri usually following discontinuation of treatment, insomnia, mood swings, neuritis, neuropathy, paresthesia, personality changes, psychic disorders, vertigo.\"\n },\n {\n \"VerbatimTerm\": \"emotional instability\",\n \"Probability\": \"0.0597355664\",\n \"SemanticContext\": \"Also, existing emotional instability or psychotic tendencies may be aggravated by corticosteroids.\"\n }\n ]\n },\n {\n \"Term\": \"Tachycardia\",\n \"MEDDRACode\": \"10043071\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"tachycardia\",\n \"Probability\": \"0.9980987906\",\n \"SemanticContext\": \"Cardiovascular Bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure, fat embolism, hypertension, hypertrophic cardiomyopathy in premature infants, myocardial rupture following recent myocardial infarction see WARNINGS , pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis.\"\n }\n ]\n },\n {\n \"Term\": \"Vision blurred\",\n \"MEDDRACode\": \"10047513\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"vision blurred\",\n \"Probability\": \"0.9673128724\",\n \"SemanticContext\": \"Ophthalmic Exophthalmos, glaucoma, increased intraocular pressure, posterior subcapsular cataracts, rare instances of blindness associated with periocular injections, vision blurred.\"\n }\n ]\n },\n {\n \"Term\": \"Intraocular pressure increased\",\n \"MEDDRACode\": \"10022806\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"increased intraocular pressure\",\n \"Probability\": \"0.9504164457\",\n \"SemanticContext\": \"Ophthalmic Exophthalmos, glaucoma, increased intraocular pressure, posterior subcapsular cataracts, rare instances of blindness associated with periocular injections, vision blurred.\"\n },\n {\n \"VerbatimTerm\": \"increased intraocular pressure\",\n \"Probability\": \"0.0126463771\",\n \"SemanticContext\": \"Ophthalmic Use of corticosteroids may produce posterior subcapsular cataracts, increased intraocular pressure, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to bacteria, fungi, or viruses.\"\n }\n ]\n },\n {\n \"Term\": \"Peptic ulcer\",\n \"MEDDRACode\": \"10034341\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"peptic ulcer\",\n \"Probability\": \"0.3271082044\",\n \"SemanticContext\": \"Gastrointestinal Abdominal distention, bowel/bladder dysfunction after intrathecal administration , elevation in serum liver enzyme levels usually reversible upon discontinuation , hepatomegaly, increased appetite, nausea, pancreatitis, peptic ulcer with possible perforation and hemorrhage, perforation of the small and large intestine particularly in patients with inflammatory bowel disease , ulcerative esophagitis.\"\n },\n {\n \"VerbatimTerm\": \"peptic ulcers\",\n \"Probability\": \"0.0030171871\",\n \"SemanticContext\": \"Gastrointestinal Steroids should be used with caution in active or latent peptic ulcers, diverticulitis, fresh intestinal anastomoses, and nonspecific ulcerative colitis, since they may increase the risk of a perforation.\"\n },\n {\n \"VerbatimTerm\": \"peptic ulcers\",\n \"Probability\": \"0.1322284937\",\n \"SemanticContext\": \"Like adults, pediatric patients should be carefully observed with frequent measurements of blood pressure, weight, height, intraocular pressure, and clinical evaluation for the presence of infection, psychosocial disturbances, thromboembolism, peptic ulcers, cataracts, and osteoporosis.\"\n },\n {\n \"VerbatimTerm\": \"peptic ulcers\",\n \"Probability\": \"0.1322284937\",\n \"SemanticContext\": \"Like adults, pediatric patients should be carefully observed with frequent measurements of blood pressure, weight, height, intraocular pressure, and clinical evaluation for the presence of infection, psychosocial disturbances, thromboembolism, peptic ulcers, cataracts, and osteoporosis.\"\n }\n ]\n },\n {\n \"Term\": \"Myopathy\",\n \"MEDDRACode\": \"10028641\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"steroid myopathy\",\n \"Probability\": \"0.8647968769\",\n \"SemanticContext\": \"Musculoskeletal Aseptic necrosis of femoral and humeral heads, calcinosis following intra-articular or intralesional use , Charcot-like arthropathy, loss of muscle mass, muscle weakness, osteoporosis, pathologic fracture of long bones, postinjection flare following intra-articular use , steroid myopathy, tendon rupture, vertebral compression fractures.\"\n }\n ]\n },\n {\n \"Term\": \"Muscle mass\",\n \"MEDDRACode\": \"10056720\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"muscle mass\",\n \"Probability\": \"0.2707986832\",\n \"SemanticContext\": \"Musculoskeletal Aseptic necrosis of femoral and humeral heads, calcinosis following intra-articular or intralesional use , Charcot-like arthropathy, loss of muscle mass, muscle weakness, osteoporosis, pathologic fracture of long bones, postinjection flare following intra-articular use , steroid myopathy, tendon rupture, vertebral compression fractures.\"\n }\n ]\n },\n {\n \"Term\": \"Gasping syndrome\",\n \"MEDDRACode\": \"10069162\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Gasping Syndrome\",\n \"Probability\": \"0.8540283442\",\n \"SemanticContext\": \"DOSAGE AND ADMINISTRATION Benzyl alcohol as a preservative has been associated with a fatal \\\"Gasping Syndrome\\\" in premature infants and infants of low birth weight.\"\n }\n ]\n },\n {\n \"Term\": \"Tendonitis\",\n \"MEDDRACode\": \"10043255\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"tendinitis\",\n \"Probability\": \"0.0425513685\",\n \"SemanticContext\": \"In tenosynovitis and tendinitis, three or four local injections at intervals of 1 to 2 weeks between injections are given in most cases.\"\n }\n ]\n },\n {\n \"Term\": \"Nausea\",\n \"MEDDRACode\": \"10028813\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"nausea\",\n \"Probability\": \"0.9926043749\",\n \"SemanticContext\": \"Gastrointestinal Abdominal distention, bowel/bladder dysfunction after intrathecal administration , elevation in serum liver enzyme levels usually reversible upon discontinuation , hepatomegaly, increased appetite, nausea, pancreatitis, peptic ulcer with possible perforation and hemorrhage, perforation of the small and large intestine particularly in patients with inflammatory bowel disease , ulcerative esophagitis.\"\n }\n ]\n },\n {\n \"Term\": \"Pancreatitis\",\n \"MEDDRACode\": \"10033645\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"pancreatitis\",\n \"Probability\": \"0.9878380299\",\n \"SemanticContext\": \"Gastrointestinal Abdominal distention, bowel/bladder dysfunction after intrathecal administration , elevation in serum liver enzyme levels usually reversible upon discontinuation , hepatomegaly, increased appetite, nausea, pancreatitis, peptic ulcer with possible perforation and hemorrhage, perforation of the small and large intestine particularly in patients with inflammatory bowel disease , ulcerative esophagitis.\"\n }\n ]\n },\n {\n \"Term\": \"Dermatitis allergic\",\n \"MEDDRACode\": \"10012434\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"allergic dermatitis\",\n \"Probability\": \"0.9705027342\",\n \"SemanticContext\": \"Dermatologic Acne, allergic dermatitis, cutaneous and subcutaneous atrophy, dry scaly skin, ecchymoses and petechiae, edema, erythema, hyperpigmentation, hypopigmentation, impaired wound healing, increased sweating, rash, sterile abscess, striae, suppressed reactions to skin tests, thin fragile skin, thinning scalp hair, urticaria.\"\n }\n ]\n },\n {\n \"Term\": \"Urticaria\",\n \"MEDDRACode\": \"10046735\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"urticaria\",\n \"Probability\": \"0.249610126\",\n \"SemanticContext\": \"Dermatologic Acne, allergic dermatitis, cutaneous and subcutaneous atrophy, dry scaly skin, ecchymoses and petechiae, edema, erythema, hyperpigmentation, hypopigmentation, impaired wound healing, increased sweating, rash, sterile abscess, striae, suppressed reactions to skin tests, thin fragile skin, thinning scalp hair, urticaria.\"\n }\n ]\n },\n {\n \"Term\": \"Oesophagitis ulcerative\",\n \"MEDDRACode\": \"10049098\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"ulcerative esophagitis\",\n \"Probability\": \"0.1189861596\",\n \"SemanticContext\": \"Gastrointestinal Abdominal distention, bowel/bladder dysfunction after intrathecal administration , elevation in serum liver enzyme levels usually reversible upon discontinuation , hepatomegaly, increased appetite, nausea, pancreatitis, peptic ulcer with possible perforation and hemorrhage, perforation of the small and large intestine particularly in patients with inflammatory bowel disease , ulcerative esophagitis.\"\n }\n ]\n },\n {\n \"Term\": \"Cataract subcapsular\",\n \"MEDDRACode\": \"10007764\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"posterior subcapsular cataracts\",\n \"Probability\": \"0.9602507353\",\n \"SemanticContext\": \"Ophthalmic Exophthalmos, glaucoma, increased intraocular pressure, posterior subcapsular cataracts, rare instances of blindness associated with periocular injections, vision blurred.\"\n },\n {\n \"VerbatimTerm\": \"posterior subcapsular cataracts\",\n \"Probability\": \"0.0417295992\",\n \"SemanticContext\": \"Ophthalmic Use of corticosteroids may produce posterior subcapsular cataracts, increased intraocular pressure, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to bacteria, fungi, or viruses.\"\n }\n ]\n },\n {\n \"Term\": \"Dermatitis atopic\",\n \"MEDDRACode\": \"10012438\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"atopic dermatitis\",\n \"Probability\": \"0.1745997667\",\n \"SemanticContext\": \"INDICATIONS AND USAGE When oral therapy is not feasible, the intramuscular use of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is indicated as follows: Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions.\"\n }\n ]\n },\n {\n \"Term\": \"Vasculitis\",\n \"MEDDRACode\": \"10047115\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"vasculitis\",\n \"Probability\": \"0.9850702286\",\n \"SemanticContext\": \"Cardiovascular Bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure, fat embolism, hypertension, hypertrophic cardiomyopathy in premature infants, myocardial rupture following recent myocardial infarction see WARNINGS , pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis.\"\n }\n ]\n },\n {\n \"Term\": \"Personality change\",\n \"MEDDRACode\": \"10034719\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"personality changes\",\n \"Probability\": \"0.8840609789\",\n \"SemanticContext\": \"Neurologic/Psychiatric Convulsions, depression, emotional instability, euphoria, headache, increased intracranial pressure with papilledema pseudotumor cerebri usually following discontinuation of treatment, insomnia, mood swings, neuritis, neuropathy, paresthesia, personality changes, psychic disorders, vertigo.\"\n },\n {\n \"VerbatimTerm\": \"personality changes\",\n \"Probability\": \"0.3702911735\",\n \"SemanticContext\": \"Psychic derangements may appear when corticosteroids are used, ranging from euphoria, insomnia, mood swings, personality changes, and severe depression to frank psychotic manifestations.\"\n }\n ]\n },\n {\n \"Term\": \"Cataract\",\n \"MEDDRACode\": \"10007739\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"cataracts\",\n \"Probability\": \"0.0275354087\",\n \"SemanticContext\": \"Like adults, pediatric patients should be carefully observed with frequent measurements of blood pressure, weight, height, intraocular pressure, and clinical evaluation for the presence of infection, psychosocial disturbances, thromboembolism, peptic ulcers, cataracts, and osteoporosis.\"\n },\n {\n \"VerbatimTerm\": \"cataracts\",\n \"Probability\": \"0.0275354087\",\n \"SemanticContext\": \"Like adults, pediatric patients should be carefully observed with frequent measurements of blood pressure, weight, height, intraocular pressure, and clinical evaluation for the presence of infection, psychosocial disturbances, thromboembolism, peptic ulcers, cataracts, and osteoporosis.\"\n }\n ]\n },\n {\n \"Term\": \"Embolism\",\n \"MEDDRACode\": \"10061169\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"thromboembolism\",\n \"Probability\": \"0.9893396497\",\n \"SemanticContext\": \"Cardiovascular Bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure, fat embolism, hypertension, hypertrophic cardiomyopathy in premature infants, myocardial rupture following recent myocardial infarction see WARNINGS , pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis.\"\n },\n {\n \"VerbatimTerm\": \"thromboembolism\",\n \"Probability\": \"0.2168209255\",\n \"SemanticContext\": \"Like adults, pediatric patients should be carefully observed with frequent measurements of blood pressure, weight, height, intraocular pressure, and clinical evaluation for the presence of infection, psychosocial disturbances, thromboembolism, peptic ulcers, cataracts, and osteoporosis.\"\n },\n {\n \"VerbatimTerm\": \"thromboembolism\",\n \"Probability\": \"0.2168209255\",\n \"SemanticContext\": \"Like adults, pediatric patients should be carefully observed with frequent measurements of blood pressure, weight, height, intraocular pressure, and clinical evaluation for the presence of infection, psychosocial disturbances, thromboembolism, peptic ulcers, cataracts, and osteoporosis.\"\n }\n ]\n },\n {\n \"Term\": \"Sensory disturbance\",\n \"MEDDRACode\": \"10040026\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"sensory disturbances\",\n \"Probability\": \"0.9903715849\",\n \"SemanticContext\": \"Arachnoiditis, meningitis, paraparesis/paraplegia, and sensory disturbances have occurred after intrathecal administration see WARNINGS, Neurologic section .\"\n }\n ]\n },\n {\n \"Term\": \"Wound\",\n \"MEDDRACode\": \"10052428\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"wound\",\n \"Probability\": \"0.7914398909\",\n \"SemanticContext\": \"Dermatologic Acne, allergic dermatitis, cutaneous and subcutaneous atrophy, dry scaly skin, ecchymoses and petechiae, edema, erythema, hyperpigmentation, hypopigmentation, impaired wound healing, increased sweating, rash, sterile abscess, striae, suppressed reactions to skin tests, thin fragile skin, thinning scalp hair, urticaria.\"\n }\n ]\n },\n {\n \"Term\": \"Asthenia\",\n \"MEDDRACode\": \"10003549\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"weakness\",\n \"Probability\": \"0.0763281584\",\n \"SemanticContext\": \"\\nAnticholinesterases Concomitant use of anticholinesterase agents and corticosteroids may produce severe weakness in patients with myasthenia gravis.\"\n },\n {\n \"VerbatimTerm\": \"weakness\",\n \"Probability\": \"0.0763281584\",\n \"SemanticContext\": \"\\nAnticholinesterases Concomitant use of anticholinesterase agents and corticosteroids may produce severe weakness in patients with myasthenia gravis.\"\n }\n ]\n },\n {\n \"Term\": \"Premature baby\",\n \"MEDDRACode\": \"10036590\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"premature infants\",\n \"Probability\": \"0.8951079845\",\n \"SemanticContext\": \"Cardiovascular Bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure, fat embolism, hypertension, hypertrophic cardiomyopathy in premature infants, myocardial rupture following recent myocardial infarction see WARNINGS , pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis.\"\n },\n {\n \"VerbatimTerm\": \"premature infants\",\n \"Probability\": \"0.067655772\",\n \"SemanticContext\": \"DOSAGE AND ADMINISTRATION Benzyl alcohol as a preservative has been associated with a fatal \\\"Gasping Syndrome\\\" in premature infants and infants of low birth weight.\"\n },\n {\n \"VerbatimTerm\": \"premature infant\",\n \"Probability\": \"0.0024376214\",\n \"SemanticContext\": \"Solutions used for further dilution of this product should be preservative-free when used in the neonate, especially the premature infant.\"\n }\n ]\n },\n {\n \"Term\": \"Oedema\",\n \"MEDDRACode\": \"10030095\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"edema\",\n \"Probability\": \"0.9890325069\",\n \"SemanticContext\": \"Dermatologic Acne, allergic dermatitis, cutaneous and subcutaneous atrophy, dry scaly skin, ecchymoses and petechiae, edema, erythema, hyperpigmentation, hypopigmentation, impaired wound healing, increased sweating, rash, sterile abscess, striae, suppressed reactions to skin tests, thin fragile skin, thinning scalp hair, urticaria.\"\n },\n {\n \"VerbatimTerm\": \"edema\",\n \"Probability\": \"0.7782428265\",\n \"SemanticContext\": \"Cardio-renal As sodium retention with resultant edema and potassium loss may occur in patients receiving corticosteroids, these agents should be used with caution in patients with congestive heart failure, hypertension, or renal insufficiency.\"\n }\n ]\n },\n {\n \"Term\": \"Depression\",\n \"MEDDRACode\": \"10012378\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"depression\",\n \"Probability\": \"0.9991014004\",\n \"SemanticContext\": \"Neurologic/Psychiatric Convulsions, depression, emotional instability, euphoria, headache, increased intracranial pressure with papilledema pseudotumor cerebri usually following discontinuation of treatment, insomnia, mood swings, neuritis, neuropathy, paresthesia, personality changes, psychic disorders, vertigo.\"\n },\n {\n \"VerbatimTerm\": \"depression\",\n \"Probability\": \"0.8945868015\",\n \"SemanticContext\": \"Psychic derangements may appear when corticosteroids are used, ranging from euphoria, insomnia, mood swings, personality changes, and severe depression to frank psychotic manifestations.\"\n }\n ]\n },\n {\n \"Term\": \"Osteonecrosis\",\n \"MEDDRACode\": \"10031264\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Aseptic necrosis\",\n \"Probability\": \"0.0380903184\",\n \"SemanticContext\": \"Musculoskeletal Aseptic necrosis of femoral and humeral heads, calcinosis following intra-articular or intralesional use , Charcot-like arthropathy, loss of muscle mass, muscle weakness, osteoporosis, pathologic fracture of long bones, postinjection flare following intra-articular use , steroid myopathy, tendon rupture, vertebral compression fractures.\"\n }\n ]\n },\n {\n \"Term\": \"Blood cortisol\",\n \"MEDDRACode\": \"10005455\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"cortisol plasma\",\n \"Probability\": \"0.0002329946\",\n \"SemanticContext\": \"This negative impact of corticosteroids on growth has been observed at low systemic doses and in the absence of laboratory evidence of HPA axis suppression ie, cosyntropin stimulation and basal cortisol plasma levels .\"\n },\n {\n \"VerbatimTerm\": \"cortisol plasma\",\n \"Probability\": \"0.0002329946\",\n \"SemanticContext\": \"This negative impact of corticosteroids on growth has been observed at low systemic doses and in the absence of laboratory evidence of HPA axis suppression ie, cosyntropin stimulation and basal cortisol plasma levels .\"\n }\n ]\n },\n {\n \"Term\": \"Anaphylactoid reaction\",\n \"MEDDRACode\": \"10002216\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Reactions Anaphylactoid\",\n \"Probability\": \"0.9314328432\",\n \"SemanticContext\": \"ADVERSE REACTIONS listed alphabetically, under each subsection Allergic Reactions Anaphylactoid reaction, anaphylaxis, angioedema.\"\n },\n {\n \"VerbatimTerm\": \"Anaphylactoid reaction\",\n \"Probability\": \"0.9212471247\",\n \"SemanticContext\": \"ADVERSE REACTIONS listed alphabetically, under each subsection Allergic Reactions Anaphylactoid reaction, anaphylaxis, angioedema.\"\n }\n ]\n },\n {\n \"Term\": \"Infant\",\n \"MEDDRACode\": \"10021731\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"infants\",\n \"Probability\": \"0.0330094695\",\n \"SemanticContext\": \"DOSAGE AND ADMINISTRATION Benzyl alcohol as a preservative has been associated with a fatal \\\"Gasping Syndrome\\\" in premature infants and infants of low birth weight.\"\n },\n {\n \"VerbatimTerm\": \"Infants\",\n \"Probability\": \"0.0005888939\",\n \"SemanticContext\": \"Infants born to mothers who have received corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism.\"\n },\n {\n \"VerbatimTerm\": \"Infants\",\n \"Probability\": \"0.0005597472\",\n \"SemanticContext\": \"Infants born to mothers who have received corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism.\"\n }\n ]\n },\n {\n \"Term\": \"Tenosynovitis\",\n \"MEDDRACode\": \"10043261\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Tenosynovitis\",\n \"Probability\": \"0.9132003188\",\n \"SemanticContext\": \"Bursitis, Tenosynovitis, Peritendinitis In acute subdeltoid, subacromial, olecranon, and prepatellar bursitis, one intrabursal injection of 1.0 mL Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension can relieve pain and restore full range of movement.\"\n },\n {\n \"VerbatimTerm\": \"Tenosynovitis\",\n \"Probability\": \"0.868797183\",\n \"SemanticContext\": \"Diagnosis Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension Dose mL Bursitis under heloma durum or heloma molle 0.25-0.5 under calcaneal spur 0.5 over hallux rigidus or digiti quinti varus 0.5 Tenosynovitis, periostitis of cuboid 0.5 Acute gouty arthritis 0.5-1.0 .\"\n },\n {\n \"VerbatimTerm\": \"tenosynovitis\",\n \"Probability\": \"0.4887915254\",\n \"SemanticContext\": \"In tenosynovitis and tendinitis, three or four local injections at intervals of 1 to 2 weeks between injections are given in most cases.\"\n },\n {\n \"VerbatimTerm\": \"tenosynovitis\",\n \"Probability\": \"0.0029706955\",\n \"SemanticContext\": \"The intra-articular or soft tissue administration of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is indicated as adjunctive therapy for short-term administration to tide the patient over an acute episode or exacerbation in acute gouty arthritis, acute and subacute bursitis, acute nonspecific tenosynovitis, epicondylitis, rheumatoid arthritis, synovitis of osteoarthritis.\"\n }\n ]\n },\n {\n \"Term\": \"Tremor\",\n \"MEDDRACode\": \"10044565\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"shaken\",\n \"Probability\": \"0.0258416235\",\n \"SemanticContext\": \"The local anesthetic is then drawn in, and the syringe shaken briefly.\"\n }\n ]\n },\n {\n \"Term\": \"Blood chloride\",\n \"MEDDRACode\": \"10005416\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"chloride\",\n \"Probability\": \"0.0002238452\",\n \"SemanticContext\": \"Inactive ingredients per mL: 8.9 mg dibasic sodium phosphate dihydrate; 3.8 mg monobasic sodium phosphate dihydrate; 0.1 mg edetate disodium; and 0.2 mg benzalkonium chloride as preservative.\"\n }\n ]\n },\n {\n \"Term\": \"Cardiac failure congestive\",\n \"MEDDRACode\": \"10007559\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"congestive heart failure\",\n \"Probability\": \"0.0397903919\",\n \"SemanticContext\": \"There have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure.\"\n },\n {\n \"VerbatimTerm\": \"congestive heart failure\",\n \"Probability\": \"0.0585443377\",\n \"SemanticContext\": \"There have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure see PRECAUTIONS, Drug Interactions, Amphotericin B Injection and Potassium-Depleting Agents section .\"\n },\n {\n \"VerbatimTerm\": \"congestive heart failure\",\n \"Probability\": \"0.0397903919\",\n \"SemanticContext\": \"There have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure.\"\n },\n {\n \"VerbatimTerm\": \"Congestive heart failure\",\n \"Probability\": \"0.6931449175\",\n \"SemanticContext\": \"Fluid and Electrolyte Disturbances Congestive heart failure in susceptible patients, fluid retention, hypokalemic alkalosis, potassium loss, sodium retention.\"\n }\n ]\n },\n {\n \"Term\": \"Fluid retention\",\n \"MEDDRACode\": \"10016807\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"water retention\",\n \"Probability\": \"0.3459350467\",\n \"SemanticContext\": \"Cardio-renal Average and large doses of corticosteroids can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium.\"\n }\n ]\n },\n {\n \"Term\": \"Fracture\",\n \"MEDDRACode\": \"10017076\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"fracture\",\n \"Probability\": \"0.1648706198\",\n \"SemanticContext\": \"Musculoskeletal Aseptic necrosis of femoral and humeral heads, calcinosis following intra-articular or intralesional use , Charcot-like arthropathy, loss of muscle mass, muscle weakness, osteoporosis, pathologic fracture of long bones, postinjection flare following intra-articular use , steroid myopathy, tendon rupture, vertebral compression fractures.\"\n }\n ]\n },\n {\n \"Term\": \"Idiopathic intracranial hypertension\",\n \"MEDDRACode\": \"10078904\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"pseudotumor cerebri\",\n \"Probability\": \"0.9905838966\",\n \"SemanticContext\": \"Neurologic/Psychiatric Convulsions, depression, emotional instability, euphoria, headache, increased intracranial pressure with papilledema pseudotumor cerebri usually following discontinuation of treatment, insomnia, mood swings, neuritis, neuropathy, paresthesia, personality changes, psychic disorders, vertigo.\"\n }\n ]\n },\n {\n \"Term\": \"Rheumatoid arthritis\",\n \"MEDDRACode\": \"10039073\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Rheumatoid Arthritis\",\n \"Probability\": \"0.0207345784\",\n \"SemanticContext\": \"Rheumatoid Arthritis and Osteoarthritis Following intra-articular administration of 0.5 to 2.0 mL of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension, relief of pain, soreness, and stiffness may be experienced.\"\n },\n {\n \"VerbatimTerm\": \"rheumatoid arthritis\",\n \"Probability\": \"0.000122507\",\n \"SemanticContext\": \"Rheumatic Disorders As adjunctive therapy for short-term administration to tide the patient over an acute episode or exacerbation in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis selected cases may require low-dose maintenance therapy .\"\n },\n {\n \"VerbatimTerm\": \"rheumatoid arthritis\",\n \"Probability\": \"0.014891088\",\n \"SemanticContext\": \"The intra-articular or soft tissue administration of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is indicated as adjunctive therapy for short-term administration to tide the patient over an acute episode or exacerbation in acute gouty arthritis, acute and subacute bursitis, acute nonspecific tenosynovitis, epicondylitis, rheumatoid arthritis, synovitis of osteoarthritis.\"\n }\n ]\n },\n {\n \"Term\": \"Illness\",\n \"MEDDRACode\": \"10080284\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"illness\",\n \"Probability\": \"0.0265882611\",\n \"SemanticContext\": \"Endocrine Decreased carbohydrate and glucose tolerance, development of cushingoid state, glucosuria, hirsutism, hypertrichosis, increased requirements for insulin or oral hypoglycemic adrenocortical and pituitary unresponsiveness particularly in times of stress, as in trauma, surgery, or illness , suppression of growth in pediatric patients.\"\n }\n ]\n },\n {\n \"Term\": \"Myocardial rupture\",\n \"MEDDRACode\": \"10028604\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"myocardial rupture\",\n \"Probability\": \"0.9622409344\",\n \"SemanticContext\": \"Cardiovascular Bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure, fat embolism, hypertension, hypertrophic cardiomyopathy in premature infants, myocardial rupture following recent myocardial infarction see WARNINGS , pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis.\"\n }\n ]\n },\n {\n \"Term\": \"Psychomotor hyperactivity\",\n \"MEDDRACode\": \"10037211\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Increased activity\",\n \"Probability\": \"0.0042690933\",\n \"SemanticContext\": \"\\nCyclosporine Increased activity of both cyclosporine and corticosteroids may occur when the two are used concurrently.\"\n },\n {\n \"VerbatimTerm\": \"Increased activity\",\n \"Probability\": \"0.0042690933\",\n \"SemanticContext\": \"\\nCyclosporine Increased activity of both cyclosporine and corticosteroids may occur when the two are used concurrently.\"\n }\n ]\n },\n {\n \"Term\": \"Vertigo\",\n \"MEDDRACode\": \"10047340\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"vertigo\",\n \"Probability\": \"0.9880939722\",\n \"SemanticContext\": \"Neurologic/Psychiatric Convulsions, depression, emotional instability, euphoria, headache, increased intracranial pressure with papilledema pseudotumor cerebri usually following discontinuation of treatment, insomnia, mood swings, neuritis, neuropathy, paresthesia, personality changes, psychic disorders, vertigo.\"\n }\n ]\n },\n {\n \"Term\": \"Blood glucose\",\n \"MEDDRACode\": \"10005553\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"glucose\",\n \"Probability\": \"0.0010493994\",\n \"SemanticContext\": \"Endocrine Decreased carbohydrate and glucose tolerance, development of cushingoid state, glucosuria, hirsutism, hypertrichosis, increased requirements for insulin or oral hypoglycemic adrenocortical and pituitary unresponsiveness particularly in times of stress, as in trauma, surgery, or illness , suppression of growth in pediatric patients.\"\n }\n ]\n },\n {\n \"Term\": \"Ankylosing spondylitis\",\n \"MEDDRACode\": \"10002556\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"ankylosing spondylitis\",\n \"Probability\": \"0.1903775632\",\n \"SemanticContext\": \"Rheumatic Disorders As adjunctive therapy for short-term administration to tide the patient over an acute episode or exacerbation in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis selected cases may require low-dose maintenance therapy .\"\n }\n ]\n },\n {\n \"Term\": \"Autoimmune haemolytic anaemia\",\n \"MEDDRACode\": \"10073785\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"autoimmune hemolytic anemia\",\n \"Probability\": \"0.9908950329\",\n \"SemanticContext\": \"Hematologic Disorders Acquired autoimmune hemolytic anemia, Diamond-Blackfan anemia, pure red cell aplasia, selected cases of secondary thrombocytopenia.\"\n }\n ]\n },\n {\n \"Term\": \"Berylliosis\",\n \"MEDDRACode\": \"10004485\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Berylliosis\",\n \"Probability\": \"0.0167868137\",\n \"SemanticContext\": \"Respiratory Diseases Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis.\"\n }\n ]\n },\n {\n \"Term\": \"Keloid scar\",\n \"MEDDRACode\": \"10023330\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"keloids\",\n \"Probability\": \"0.7265982032\",\n \"SemanticContext\": \"The intralesional administration of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is indicated for alopecia areata; discoid lupus erythematosus; keloids; localized hypertrophic, infiltrated, inflammatory lesions of granuloma annulare, lichen planus, lichen simplex chronicus neurodermatitis , and psoriatic plaques; necrobiosis lipoidica diabeticorum.\"\n }\n ]\n },\n {\n \"Term\": \"Serum sickness\",\n \"MEDDRACode\": \"10040400\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"serum sickness\",\n \"Probability\": \"0.0081218183\",\n \"SemanticContext\": \"INDICATIONS AND USAGE When oral therapy is not feasible, the intramuscular use of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is indicated as follows: Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions.\"\n }\n ]\n },\n {\n \"Term\": \"Systemic lupus erythematosus\",\n \"MEDDRACode\": \"10042945\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"systemic lupus erythematosus\",\n \"Probability\": \"0.8350071311\",\n \"SemanticContext\": \"For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.\"\n }\n ]\n },\n {\n \"Term\": \"Dental caries\",\n \"MEDDRACode\": \"10012318\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"cavity\",\n \"Probability\": \"0.0012502074\",\n \"SemanticContext\": \"Using sterile technique, a 20- to 24-gauge needle on an empty syringe is inserted into the synovial cavity and a few drops of synovial fluid are withdrawn to confirm that the needle is in the joint.\"\n }\n ]\n },\n {\n \"Term\": \"Low birth weight baby\",\n \"MEDDRACode\": \"10067508\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"low birth weight\",\n \"Probability\": \"0.0174386799\",\n \"SemanticContext\": \"DOSAGE AND ADMINISTRATION Benzyl alcohol as a preservative has been associated with a fatal \\\"Gasping Syndrome\\\" in premature infants and infants of low birth weight.\"\n }\n ]\n },\n {\n \"Term\": \"Blood disorder\",\n \"MEDDRACode\": \"10061590\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Hematologic Disorders\",\n \"Probability\": \"0.0125087798\",\n \"SemanticContext\": \"Hematologic Disorders Acquired autoimmune hemolytic anemia, Diamond-Blackfan anemia, pure red cell aplasia, selected cases of secondary thrombocytopenia.\"\n }\n ]\n },\n {\n \"Term\": \"Eosinophilic pneumonia\",\n \"MEDDRACode\": \"10014962\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"eosinophilic pneumonias\",\n \"Probability\": \"0.1809546351\",\n \"SemanticContext\": \"Respiratory Diseases Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis.\"\n }\n ]\n },\n {\n \"Term\": \"Lichen planus\",\n \"MEDDRACode\": \"10024429\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"lichen planus\",\n \"Probability\": \"0.2711394429\",\n \"SemanticContext\": \"The intralesional administration of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is indicated for alopecia areata; discoid lupus erythematosus; keloids; localized hypertrophic, infiltrated, inflammatory lesions of granuloma annulare, lichen planus, lichen simplex chronicus neurodermatitis , and psoriatic plaques; necrobiosis lipoidica diabeticorum.\"\n }\n ]\n },\n {\n \"Term\": \"Pulmonary tuberculosis\",\n \"MEDDRACode\": \"10037440\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"pulmonary tuberculosis\",\n \"Probability\": \"0.1883048713\",\n \"SemanticContext\": \"Respiratory Diseases Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis.\"\n }\n ]\n },\n {\n \"Term\": \"Overdose\",\n \"MEDDRACode\": \"10033295\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"acute overdose\",\n \"Probability\": \"0.0699537098\",\n \"SemanticContext\": \"OVERDOSAGE Treatment of acute overdose is by supportive and symptomatic therapy.\"\n }\n ]\n },\n {\n \"Term\": \"Neuromuscular blockade\",\n \"MEDDRACode\": \"10029315\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"neuromuscular blocking\",\n \"Probability\": \"2.50523E-05\",\n \"SemanticContext\": \"An acute myopathy has been observed with the use of high doses of corticosteroids, most often occurring in patients with disorders of neuromuscular transmission eg, myasthenia gravis , or in patients receiving concomitant therapy with neuromuscular blocking drugs eg, pancuronium .\"\n }\n ]\n },\n {\n \"Term\": \"Myocardial infarction\",\n \"MEDDRACode\": \"10028596\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"myocardial infarction\",\n \"Probability\": \"0.9729269743\",\n \"SemanticContext\": \"Cardiovascular Bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure, fat embolism, hypertension, hypertrophic cardiomyopathy in premature infants, myocardial rupture following recent myocardial infarction see WARNINGS , pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis.\"\n },\n {\n \"VerbatimTerm\": \"myocardial infarction\",\n \"Probability\": \"0.0201148987\",\n \"SemanticContext\": \"Literature reports suggest an apparent association between use of corticosteroids and left ventricular free wall rupture after a recent myocardial infarction; therefore, therapy with corticosteroids should be used with great caution in these patients.\"\n }\n ]\n },\n {\n \"Term\": \"Blood potassium\",\n \"MEDDRACode\": \"10005721\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"potassium\",\n \"Probability\": \"0.5004429221\",\n \"SemanticContext\": \"Fluid and Electrolyte Disturbances Congestive heart failure in susceptible patients, fluid retention, hypokalemic alkalosis, potassium loss, sodium retention.\"\n },\n {\n \"VerbatimTerm\": \"potassium\",\n \"Probability\": \"1.5906E-06\",\n \"SemanticContext\": \"\\nAmphotericin B Injection and Potassium-Depleting Agents When corticosteroids are administered concomitantly with potassium-depleting agents ie, amphotericin B, diuretics , patients should be observed closely for development of hypokalemia.\"\n },\n {\n \"VerbatimTerm\": \"potassium\",\n \"Probability\": \"0.0042815804\",\n \"SemanticContext\": \"Cardio-renal Average and large doses of corticosteroids can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium.\"\n },\n {\n \"VerbatimTerm\": \"potassium\",\n \"Probability\": \"0.0043652952\",\n \"SemanticContext\": \"Cardio-renal As sodium retention with resultant edema and potassium loss may occur in patients receiving corticosteroids, these agents should be used with caution in patients with congestive heart failure, hypertension, or renal insufficiency.\"\n },\n {\n \"VerbatimTerm\": \"potassium\",\n \"Probability\": \"1.5906E-06\",\n \"SemanticContext\": \"\\nAmphotericin B Injection and Potassium-Depleting Agents When corticosteroids are administered concomitantly with potassium-depleting agents ie, amphotericin B, diuretics , patients should be observed closely for development of hypokalemia.\"\n },\n {\n \"VerbatimTerm\": \"Potassium\",\n \"Probability\": \"1.16859E-05\",\n \"SemanticContext\": \"\\nAmphotericin B Injection and Potassium-Depleting Agents When corticosteroids are administered concomitantly with potassium-depleting agents ie, amphotericin B, diuretics , patients should be observed closely for development of hypokalemia.\"\n },\n {\n \"VerbatimTerm\": \"Potassium\",\n \"Probability\": \"0.0005347729\",\n \"SemanticContext\": \"There have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure see PRECAUTIONS, Drug Interactions, Amphotericin B Injection and Potassium-Depleting Agents section .\"\n },\n {\n \"VerbatimTerm\": \"Potassium\",\n \"Probability\": \"1.16859E-05\",\n \"SemanticContext\": \"\\nAmphotericin B Injection and Potassium-Depleting Agents When corticosteroids are administered concomitantly with potassium-depleting agents ie, amphotericin B, diuretics , patients should be observed closely for development of hypokalemia.\"\n }\n ]\n },\n {\n \"Term\": \"Blood methanol\",\n \"MEDDRACode\": \"10005663\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"methanol\",\n \"Probability\": \"0.0001775324\",\n \"SemanticContext\": \"It is freely soluble in water and in methanol, but is practically insoluble in acetone and in chloroform.\"\n }\n ]\n },\n {\n \"Term\": \"Blood pressure measurement\",\n \"MEDDRACode\": \"10076581\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"blood pressure\",\n \"Probability\": \"0.0005681515\",\n \"SemanticContext\": \"Cardio-renal Average and large doses of corticosteroids can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium.\"\n },\n {\n \"VerbatimTerm\": \"blood pressure\",\n \"Probability\": \"1.01429E-05\",\n \"SemanticContext\": \"Like adults, pediatric patients should be carefully observed with frequent measurements of blood pressure, weight, height, intraocular pressure, and clinical evaluation for the presence of infection, psychosocial disturbances, thromboembolism, peptic ulcers, cataracts, and osteoporosis.\"\n },\n {\n \"VerbatimTerm\": \"blood pressure\",\n \"Probability\": \"1.01429E-05\",\n \"SemanticContext\": \"Like adults, pediatric patients should be carefully observed with frequent measurements of blood pressure, weight, height, intraocular pressure, and clinical evaluation for the presence of infection, psychosocial disturbances, thromboembolism, peptic ulcers, cataracts, and osteoporosis.\"\n }\n ]\n },\n {\n \"Term\": \"Bacterial sepsis\",\n \"MEDDRACode\": \"10053840\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"gram-negative septicemia\",\n \"Probability\": \"0.8683134317\",\n \"SemanticContext\": \"In such patients, corticosteroid-induced immunosuppression may lead to Strongyloides hyperinfection and dissemination with widespread larval migration, often accompanied by severe enterocolitis and potentially fatal gram-negative septicemia.\"\n }\n ]\n },\n {\n \"Term\": \"Blood calcium\",\n \"MEDDRACode\": \"10005392\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"calcium\",\n \"Probability\": \"0.0001752377\",\n \"SemanticContext\": \"Musculoskeletal Corticosteroids decrease bone formation and increase bone resorption both through their effect on calcium regulation ie, decreasing absorption and increasing excretion and inhibition of osteoblast function.\"\n }\n ]\n },\n {\n \"Term\": \"Anaphylactic reaction\",\n \"MEDDRACode\": \"10002198\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"anaphylactic reactions\",\n \"Probability\": \"0.9846376181\",\n \"SemanticContext\": \"General Rare instances of anaphylactoid/anaphylactic reactions with a possibility of shock have occurred in patients receiving parenteral corticosteroid therapy see ADVERSE REACTIONS .\"\n }\n ]\n },\n {\n \"Term\": \"Glaucoma\",\n \"MEDDRACode\": \"10018304\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"glaucoma\",\n \"Probability\": \"0.8367315531\",\n \"SemanticContext\": \"Ophthalmic Exophthalmos, glaucoma, increased intraocular pressure, posterior subcapsular cataracts, rare instances of blindness associated with periocular injections, vision blurred.\"\n },\n {\n \"VerbatimTerm\": \"glaucoma\",\n \"Probability\": \"0.0019948184\",\n \"SemanticContext\": \"Ophthalmic Use of corticosteroids may produce posterior subcapsular cataracts, increased intraocular pressure, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to bacteria, fungi, or viruses.\"\n }\n ]\n },\n {\n \"Term\": \"Blood sodium\",\n \"MEDDRACode\": \"10005799\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": true,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"2.97322E-05\",\n \"SemanticContext\": \"DESCRIPTION Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is a sterile aqueous suspension containing 3 mg per milliliter betamethasone, as betamethasone sodium phosphate, and 3 mg per milliliter betamethasone acetate.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0005223453\",\n \"SemanticContext\": \"Inactive ingredients per mL: 8.9 mg dibasic sodium phosphate dihydrate; 3.8 mg monobasic sodium phosphate dihydrate; 0.1 mg edetate disodium; and 0.2 mg benzalkonium chloride as preservative.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.000304848\",\n \"SemanticContext\": \"Inactive ingredients per mL: 8.9 mg dibasic sodium phosphate dihydrate; 3.8 mg monobasic sodium phosphate dihydrate; 0.1 mg edetate disodium; and 0.2 mg benzalkonium chloride as preservative.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"2.55551E-05\",\n \"SemanticContext\": \"The formula for betamethasone sodium phosphate is C 22 H 28 FNa 2 0 8 P and it has a molecular weight of 516.40.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0001307428\",\n \"SemanticContext\": \"The chemical structures for betamethasone sodium phosphate and betamethasone acetate are as follows: Betamethasone sodium phosphate is a white to practically white, odorless powder, and is hygroscopic.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"3.14241E-05\",\n \"SemanticContext\": \"The chemical structures for betamethasone sodium phosphate and betamethasone acetate are as follows: Betamethasone sodium phosphate is a white to practically white, odorless powder, and is hygroscopic.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0001794994\",\n \"SemanticContext\": \"A derivative of prednisolone, betamethasone has a 16ß-methyl group that enhances the anti-inflammatory action of the molecule and reduces the sodium- and water-retaining properties of the fluorine atom bound at carbon 9.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"4.07215E-05\",\n \"SemanticContext\": \"Betamethasone sodium phosphate, a soluble ester, provides prompt activity, while betamethasone acetate is only slightly soluble and affords sustained activity.\"\n },\n {\n \"VerbatimTerm\": \"Sodium\",\n \"Probability\": \"0.0008715093\",\n \"SemanticContext\": \"DESCRIPTION Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is a sterile aqueous suspension containing 3 mg per milliliter betamethasone, as betamethasone sodium phosphate, and 3 mg per milliliter betamethasone acetate.\"\n },\n {\n \"VerbatimTerm\": \"Sodium\",\n \"Probability\": \"0.00126037\",\n \"SemanticContext\": \"CONTRAINDICATIONS Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is contraindicated in patients who are hypersensitive to any components of this product see DESCRIPTION .\"\n },\n {\n \"VerbatimTerm\": \"Sodium\",\n \"Probability\": \"5.12198E-05\",\n \"SemanticContext\": \"The initial dosage of parenterally administered Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension may vary from 0.25 to 9.0 mg per day depending on the specific disease entity being treated.\"\n },\n {\n \"VerbatimTerm\": \"Sodium\",\n \"Probability\": \"2.93331E-05\",\n \"SemanticContext\": \"If coadministration of a local anesthetic is desired, Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension may be mixed with 1% or 2% lidocaine hydrochloride, using the formulations which do not contain parabens.\"\n },\n {\n \"VerbatimTerm\": \"Sodium\",\n \"Probability\": \"0.0004365742\",\n \"SemanticContext\": \"The required dose of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is first withdrawn from the vial into the syringe.\"\n },\n {\n \"VerbatimTerm\": \"Sodium\",\n \"Probability\": \"7.2664E-06\",\n \"SemanticContext\": \"Do not inject local anesthetics into the vial of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension .\"\n },\n {\n \"VerbatimTerm\": \"Sodium\",\n \"Probability\": \"0.0014873147\",\n \"SemanticContext\": \"Bursitis, Tenosynovitis, Peritendinitis In acute subdeltoid, subacromial, olecranon, and prepatellar bursitis, one intrabursal injection of 1.0 mL Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension can relieve pain and restore full range of movement.\"\n },\n {\n \"VerbatimTerm\": \"Sodium\",\n \"Probability\": \"0.0003788769\",\n \"SemanticContext\": \"Rheumatoid Arthritis and Osteoarthritis Following intra-articular administration of 0.5 to 2.0 mL of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension, relief of pain, soreness, and stiffness may be experienced.\"\n },\n {\n \"VerbatimTerm\": \"Sodium\",\n \"Probability\": \"0.0001123659\",\n \"SemanticContext\": \"Intra-articular Injection of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is well tolerated in joints and periarticular tissues.\"\n },\n {\n \"VerbatimTerm\": \"Sodium\",\n \"Probability\": \"0.0003017485\",\n \"SemanticContext\": \"There is virtually no pain on injection, and the \\\"secondary flare\\\" that sometimes occurs a few hours after intra-articular injection of corticosteroids has not been reported with Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension.\"\n },\n {\n \"VerbatimTerm\": \"Sodium\",\n \"Probability\": \"9.2707E-05\",\n \"SemanticContext\": \"The aspirating syringe is replaced by a syringe containing Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension and injection is then made into the joint.\"\n },\n {\n \"VerbatimTerm\": \"Sodium\",\n \"Probability\": \"0.0002496243\",\n \"SemanticContext\": \"A portion of the administered dose of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is absorbed systemically following intra-articular injection.\"\n },\n {\n \"VerbatimTerm\": \"Sodium\",\n \"Probability\": \"0.0006137788\",\n \"SemanticContext\": \"Dermatologic Conditions In intralesional treatment, 0.2 mL/cm 2 of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is injected intradermally not subcutaneously using a tuberculin syringe with a 25-gauge, 1/2-inch needle.\"\n },\n {\n \"VerbatimTerm\": \"Sodium\",\n \"Probability\": \"0.0001061985\",\n \"SemanticContext\": \"Diagnosis Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension Dose mL Bursitis under heloma durum or heloma molle 0.25-0.5 under calcaneal spur 0.5 over hallux rigidus or digiti quinti varus 0.5 Tenosynovitis, periostitis of cuboid 0.5 Acute gouty arthritis 0.5-1.0 .\"\n },\n {\n \"VerbatimTerm\": \"Sodium\",\n \"Probability\": \"3.09731E-05\",\n \"SemanticContext\": \"INDICATIONS AND USAGE When oral therapy is not feasible, the intramuscular use of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is indicated as follows: Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions.\"\n },\n {\n \"VerbatimTerm\": \"Sodium\",\n \"Probability\": \"0.0002723932\",\n \"SemanticContext\": \"The intra-articular or soft tissue administration of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is indicated as adjunctive therapy for short-term administration to tide the patient over an acute episode or exacerbation in acute gouty arthritis, acute and subacute bursitis, acute nonspecific tenosynovitis, epicondylitis, rheumatoid arthritis, synovitis of osteoarthritis.\"\n },\n {\n \"VerbatimTerm\": \"Sodium\",\n \"Probability\": \"0.0001842082\",\n \"SemanticContext\": \"The intralesional administration of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is indicated for alopecia areata; discoid lupus erythematosus; keloids; localized hypertrophic, infiltrated, inflammatory lesions of granuloma annulare, lichen planus, lichen simplex chronicus neurodermatitis , and psoriatic plaques; necrobiosis lipoidica diabeticorum.\"\n },\n {\n \"VerbatimTerm\": \"Sodium\",\n \"Probability\": \"0.0002279878\",\n \"SemanticContext\": \"Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension may also be useful in cystic tumors of an aponeurosis or tendon ganglia .\"\n },\n {\n \"VerbatimTerm\": \"Sodium\",\n \"Probability\": \"0.001940161\",\n \"SemanticContext\": \"WARNINGS Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension should not be administered intravenously.\"\n },\n {\n \"VerbatimTerm\": \"Sodium\",\n \"Probability\": \"3.54269E-05\",\n \"SemanticContext\": \"High doses of corticosteroids, including Betamethasone Sodium Phosphate and Betamethasone Acetate, should not be used for the treatment of traumatic brain injury.\"\n }\n ]\n },\n {\n \"Term\": \"Stress\",\n \"MEDDRACode\": \"10042209\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"stress\",\n \"Probability\": \"0.0246864855\",\n \"SemanticContext\": \"Endocrine Decreased carbohydrate and glucose tolerance, development of cushingoid state, glucosuria, hirsutism, hypertrichosis, increased requirements for insulin or oral hypoglycemic adrenocortical and pituitary unresponsiveness particularly in times of stress, as in trauma, surgery, or illness , suppression of growth in pediatric patients.\"\n },\n {\n \"VerbatimTerm\": \"stress\",\n \"Probability\": \"0.0001570582\",\n \"SemanticContext\": \"In patients on corticosteroid therapy subjected to any unusual stress, hydrocortisone or cortisone is the drug of choice as a supplement during and after the event.\"\n },\n {\n \"VerbatimTerm\": \"stress\",\n \"Probability\": \"7.95044E-05\",\n \"SemanticContext\": \"Therefore, in any situation of stress occurring during that period, naturally occurring glucocorticoids hydrocortisone cortisone , which also have salt-retaining properties, rather than betamethasone, are the appropriate choices as replacement therapy in adrenocortical deficiency states.\"\n }\n ]\n },\n {\n \"Term\": \"Periostitis\",\n \"MEDDRACode\": \"10034551\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"periostitis\",\n \"Probability\": \"0.6446253061\",\n \"SemanticContext\": \"Diagnosis Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension Dose mL Bursitis under heloma durum or heloma molle 0.25-0.5 under calcaneal spur 0.5 over hallux rigidus or digiti quinti varus 0.5 Tenosynovitis, periostitis of cuboid 0.5 Acute gouty arthritis 0.5-1.0 .\"\n }\n ]\n },\n {\n \"Term\": \"Fungal infection\",\n \"MEDDRACode\": \"10017533\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Fungal Infections\",\n \"Probability\": \"0.0591728687\",\n \"SemanticContext\": \"\\nFungal Infections Corticosteroids may exacerbate systemic fungal infections and therefore should not be used in the presence of such infections unless they are needed to control drug reactions.\"\n },\n {\n \"VerbatimTerm\": \"fungal infections\",\n \"Probability\": \"0.0039953887\",\n \"SemanticContext\": \"\\nFungal Infections Corticosteroids may exacerbate systemic fungal infections and therefore should not be used in the presence of such infections unless they are needed to control drug reactions.\"\n }\n ]\n },\n {\n \"Term\": \"Prophylaxis\",\n \"MEDDRACode\": \"10036898\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"prophylaxis\",\n \"Probability\": \"4.42576E-05\",\n \"SemanticContext\": \"If exposed to chickenpox, prophylaxis with varicella zoster immune globulin VZIG may be indicated.\"\n },\n {\n \"VerbatimTerm\": \"prophylaxis\",\n \"Probability\": \"5.9652E-05\",\n \"SemanticContext\": \"If exposed to measles, prophylaxis with immunoglobulin IG may be indicated.\"\n }\n ]\n },\n {\n \"Term\": \"Congenital foot malformation\",\n \"MEDDRACode\": \"10062332\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"digiti quinti varus\",\n \"Probability\": \"0.21388188\",\n \"SemanticContext\": \"Diagnosis Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension Dose mL Bursitis under heloma durum or heloma molle 0.25-0.5 under calcaneal spur 0.5 over hallux rigidus or digiti quinti varus 0.5 Tenosynovitis, periostitis of cuboid 0.5 Acute gouty arthritis 0.5-1.0 .\"\n }\n ]\n },\n {\n \"Term\": \"Musculoskeletal stiffness\",\n \"MEDDRACode\": \"10052904\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"stiffness\",\n \"Probability\": \"0.3236957788\",\n \"SemanticContext\": \"Rheumatoid Arthritis and Osteoarthritis Following intra-articular administration of 0.5 to 2.0 mL of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension, relief of pain, soreness, and stiffness may be experienced.\"\n }\n ]\n },\n {\n \"Term\": \"Syringomyelia\",\n \"MEDDRACode\": \"10042928\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0210611224\",\n \"SemanticContext\": \"The required dose of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is first withdrawn from the vial into the syringe.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0052629709\",\n \"SemanticContext\": \"The local anesthetic is then drawn in, and the syringe shaken briefly.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0006746352\",\n \"SemanticContext\": \"Using sterile technique, a 20- to 24-gauge needle on an empty syringe is inserted into the synovial cavity and a few drops of synovial fluid are withdrawn to confirm that the needle is in the joint.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0279426575\",\n \"SemanticContext\": \"The aspirating syringe is replaced by a syringe containing Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension and injection is then made into the joint.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0108411014\",\n \"SemanticContext\": \"The aspirating syringe is replaced by a syringe containing Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension and injection is then made into the joint.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0007407963\",\n \"SemanticContext\": \"Dermatologic Conditions In intralesional treatment, 0.2 mL/cm 2 of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is injected intradermally not subcutaneously using a tuberculin syringe with a 25-gauge, 1/2-inch needle.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0063966215\",\n \"SemanticContext\": \"Disorders of the Foot A tuberculin syringe with a 25-gauge, 3/4-inch needle is suitable for most injections into the foot.\"\n }\n ]\n },\n {\n \"Term\": \"Viral infection\",\n \"MEDDRACode\": \"10047461\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Viral Infections\",\n \"Probability\": \"0.0239899755\",\n \"SemanticContext\": \"\\nViral Infections Chickenpox and measles can have a more serious or even fatal course in pediatric and adult patients on corticosteroids.\"\n }\n ]\n },\n {\n \"Term\": \"Blood glucose increased\",\n \"MEDDRACode\": \"10005557\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"increase blood glucose\",\n \"Probability\": \"0.0001438558\",\n \"SemanticContext\": \"\\nAntidiabetics Because corticosteroids may increase blood glucose concentrations, dosage adjustments of antidiabetic agents may be required.\"\n },\n {\n \"VerbatimTerm\": \"increase blood glucose\",\n \"Probability\": \"0.0001438558\",\n \"SemanticContext\": \"\\nAntidiabetics Because corticosteroids may increase blood glucose concentrations, dosage adjustments of antidiabetic agents may be required.\"\n }\n ]\n },\n {\n \"Term\": \"Blood oestrogen\",\n \"MEDDRACode\": \"10005684\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Estrogens\",\n \"Probability\": \"0.0003915131\",\n \"SemanticContext\": \"\\nEstrogens, Including Oral Contraceptives Estrogens may decrease the hepatic metabolism of certain corticosteroids, thereby increasing their effect.\"\n },\n {\n \"VerbatimTerm\": \"Estrogens\",\n \"Probability\": \"9.2539E-06\",\n \"SemanticContext\": \"\\nEstrogens, Including Oral Contraceptives Estrogens may decrease the hepatic metabolism of certain corticosteroids, thereby increasing their effect.\"\n },\n {\n \"VerbatimTerm\": \"Estrogens\",\n \"Probability\": \"0.0003915131\",\n \"SemanticContext\": \"\\nEstrogens, Including Oral Contraceptives Estrogens may decrease the hepatic metabolism of certain corticosteroids, thereby increasing their effect.\"\n },\n {\n \"VerbatimTerm\": \"Estrogens\",\n \"Probability\": \"9.2539E-06\",\n \"SemanticContext\": \"\\nEstrogens, Including Oral Contraceptives Estrogens may decrease the hepatic metabolism of certain corticosteroids, thereby increasing their effect.\"\n }\n ]\n },\n {\n \"Term\": \"Joint range of motion decreased\",\n \"MEDDRACode\": \"10048706\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hallux rigidus\",\n \"Probability\": \"0.92116189\",\n \"SemanticContext\": \"Diagnosis Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension Dose mL Bursitis under heloma durum or heloma molle 0.25-0.5 under calcaneal spur 0.5 over hallux rigidus or digiti quinti varus 0.5 Tenosynovitis, periostitis of cuboid 0.5 Acute gouty arthritis 0.5-1.0 .\"\n }\n ]\n },\n {\n \"Term\": \"Synovial cyst\",\n \"MEDDRACode\": \"10042858\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"ganglions of joint\",\n \"Probability\": \"0.0047482252\",\n \"SemanticContext\": \"In ganglions of joint capsules and tendon sheaths, injection of 0.5 mL directly into the ganglion cysts has produced marked reduction in the size of the lesions.\"\n }\n ]\n },\n {\n \"Term\": \"Pain\",\n \"MEDDRACode\": \"10033371\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"pain\",\n \"Probability\": \"0.0262791514\",\n \"SemanticContext\": \"Bursitis, Tenosynovitis, Peritendinitis In acute subdeltoid, subacromial, olecranon, and prepatellar bursitis, one intrabursal injection of 1.0 mL Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension can relieve pain and restore full range of movement.\"\n },\n {\n \"VerbatimTerm\": \"pain\",\n \"Probability\": \"0.1884167194\",\n \"SemanticContext\": \"Partial relief of pain and some increase in mobility can be expected in both conditions after one or two injections.\"\n },\n {\n \"VerbatimTerm\": \"pain\",\n \"Probability\": \"0.6658216715\",\n \"SemanticContext\": \"Rheumatoid Arthritis and Osteoarthritis Following intra-articular administration of 0.5 to 2.0 mL of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension, relief of pain, soreness, and stiffness may be experienced.\"\n },\n {\n \"VerbatimTerm\": \"pain\",\n \"Probability\": \"0.2712846398\",\n \"SemanticContext\": \"There is virtually no pain on injection, and the \\\"secondary flare\\\" that sometimes occurs a few hours after intra-articular injection of corticosteroids has not been reported with Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension.\"\n },\n {\n \"VerbatimTerm\": \"pain\",\n \"Probability\": \"0.2470580935\",\n \"SemanticContext\": \"A marked increase in pain accompanied by local swelling, further restriction of joint motion, fever, and malaise are suggestive of septic arthritis.\"\n }\n ]\n },\n {\n \"Term\": \"Drug interaction\",\n \"MEDDRACode\": \"10013710\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Drug Interactions\",\n \"Probability\": \"0.0041617751\",\n \"SemanticContext\": \"Drug Interactions\\nAminoglutethimide Aminoglutethimide may lead to a loss of corticosteroid-induced adrenal suppression.\"\n },\n {\n \"VerbatimTerm\": \"Drug Interactions\",\n \"Probability\": \"0.003357619\",\n \"SemanticContext\": \"There have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure see PRECAUTIONS, Drug Interactions, Amphotericin B Injection and Potassium-Depleting Agents section .\"\n },\n {\n \"VerbatimTerm\": \"Drug Interactions\",\n \"Probability\": \"2.85905E-05\",\n \"SemanticContext\": \"Drug Interactions\\nAminoglutethimide Aminoglutethimide may lead to a loss of corticosteroid-induced adrenal suppression.\"\n }\n ]\n },\n {\n \"Term\": \"Hypoprothrombinaemia\",\n \"MEDDRACode\": \"10021085\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hypoprothrombinemia\",\n \"Probability\": \"2.90804E-05\",\n \"SemanticContext\": \"Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia.\"\n },\n {\n \"VerbatimTerm\": \"hypoprothrombinemia\",\n \"Probability\": \"2.90804E-05\",\n \"SemanticContext\": \"Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia.\"\n }\n ]\n },\n {\n \"Term\": \"Craniotomy\",\n \"MEDDRACode\": \"10011322\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"craniotomy\",\n \"Probability\": \"0.1861142814\",\n \"SemanticContext\": \"Nervous System Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor or craniotomy.\"\n }\n ]\n },\n {\n \"Term\": \"Osteoarthritis\",\n \"MEDDRACode\": \"10031161\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Osteoarthritis\",\n \"Probability\": \"0.000841707\",\n \"SemanticContext\": \"Rheumatoid Arthritis and Osteoarthritis Following intra-articular administration of 0.5 to 2.0 mL of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension, relief of pain, soreness, and stiffness may be experienced.\"\n },\n {\n \"VerbatimTerm\": \"osteoarthritis\",\n \"Probability\": \"0.1333166361\",\n \"SemanticContext\": \"The intra-articular or soft tissue administration of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is indicated as adjunctive therapy for short-term administration to tide the patient over an acute episode or exacerbation in acute gouty arthritis, acute and subacute bursitis, acute nonspecific tenosynovitis, epicondylitis, rheumatoid arthritis, synovitis of osteoarthritis.\"\n }\n ]\n },\n {\n \"Term\": \"Adrenal suppression\",\n \"MEDDRACode\": \"10001382\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"adrenal suppression\",\n \"Probability\": \"0.2117733359\",\n \"SemanticContext\": \"Drug Interactions\\nAminoglutethimide Aminoglutethimide may lead to a loss of corticosteroid-induced adrenal suppression.\"\n },\n {\n \"VerbatimTerm\": \"adrenal suppression\",\n \"Probability\": \"0.2563617527\",\n \"SemanticContext\": \"Drug Interactions\\nAminoglutethimide Aminoglutethimide may lead to a loss of corticosteroid-induced adrenal suppression.\"\n }\n ]\n },\n {\n \"Term\": \"Meningitis tuberculous\",\n \"MEDDRACode\": \"10027259\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"tuberculous meningitis\",\n \"Probability\": \"0.3902463913\",\n \"SemanticContext\": \"Miscellaneous Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy.\"\n }\n ]\n },\n {\n \"Term\": \"Nephropathy\",\n \"MEDDRACode\": \"10029151\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Renal Diseases\",\n \"Probability\": \"0.0666455328\",\n \"SemanticContext\": \"Renal Diseases To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus.\"\n }\n ]\n },\n {\n \"Term\": \"Unresponsive to stimuli\",\n \"MEDDRACode\": \"10045555\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"unresponsive\",\n \"Probability\": \"0.0376680493\",\n \"SemanticContext\": \"Ophthalmic Diseases Sympathetic ophthalmia, temporal arteritis, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids.\"\n }\n ]\n },\n {\n \"Term\": \"Necrobiosis lipoidica diabeticorum\",\n \"MEDDRACode\": \"10056969\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"necrobiosis lipoidica diabeticorum\",\n \"Probability\": \"0.6191030741\",\n \"SemanticContext\": \"The intralesional administration of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is indicated for alopecia areata; discoid lupus erythematosus; keloids; localized hypertrophic, infiltrated, inflammatory lesions of granuloma annulare, lichen planus, lichen simplex chronicus neurodermatitis , and psoriatic plaques; necrobiosis lipoidica diabeticorum.\"\n }\n ]\n },\n {\n \"Term\": \"Polymyositis\",\n \"MEDDRACode\": \"10036102\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"polymyositis\",\n \"Probability\": \"0.846999824\",\n \"SemanticContext\": \"For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.\"\n }\n ]\n },\n {\n \"Term\": \"Proteinuria\",\n \"MEDDRACode\": \"10037032\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"proteinuria\",\n \"Probability\": \"0.6872887611\",\n \"SemanticContext\": \"Renal Diseases To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus.\"\n }\n ]\n },\n {\n \"Term\": \"Rheumatic disorder\",\n \"MEDDRACode\": \"10072736\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"rheumatic\",\n \"Probability\": \"0.011113435\",\n \"SemanticContext\": \"Rheumatic Disorders As adjunctive therapy for short-term administration to tide the patient over an acute episode or exacerbation in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis selected cases may require low-dose maintenance therapy .\"\n }\n ]\n },\n {\n \"Term\": \"Sarcoidosis\",\n \"MEDDRACode\": \"10039486\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"sarcoidosis\",\n \"Probability\": \"0.4187629521\",\n \"SemanticContext\": \"Respiratory Diseases Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis.\"\n }\n ]\n },\n {\n \"Term\": \"Synovitis\",\n \"MEDDRACode\": \"10042868\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"synovitis\",\n \"Probability\": \"0.0329957306\",\n \"SemanticContext\": \"The intra-articular or soft tissue administration of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is indicated as adjunctive therapy for short-term administration to tide the patient over an acute episode or exacerbation in acute gouty arthritis, acute and subacute bursitis, acute nonspecific tenosynovitis, epicondylitis, rheumatoid arthritis, synovitis of osteoarthritis.\"\n }\n ]\n },\n {\n \"Term\": \"Thyroiditis\",\n \"MEDDRACode\": \"10043778\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"thyroiditis\",\n \"Probability\": \"0.9144436121\",\n \"SemanticContext\": \"Endocrine Disorders Congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis.\"\n }\n ]\n },\n {\n \"Term\": \"Leukaemia\",\n \"MEDDRACode\": \"10024288\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"leukemias\",\n \"Probability\": \"0.0145325661\",\n \"SemanticContext\": \"Neoplastic Diseases For palliative management of leukemias and lymphomas.\"\n },\n {\n \"VerbatimTerm\": \"leukemias\",\n \"Probability\": \"0.0010807216\",\n \"SemanticContext\": \"Published studies provide evidence of efficacy and safety in pediatric patients for the treatment of nephrotic syndrome >2 years of age , and aggressive lymphomas and leukemias >1 month of age .\"\n },\n {\n \"VerbatimTerm\": \"leukemias\",\n \"Probability\": \"0.0010807216\",\n \"SemanticContext\": \"Published studies provide evidence of efficacy and safety in pediatric patients for the treatment of nephrotic syndrome >2 years of age , and aggressive lymphomas and leukemias >1 month of age .\"\n }\n ]\n },\n {\n \"Term\": \"Nephrotic syndrome\",\n \"MEDDRACode\": \"10029164\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"nephrotic syndrome\",\n \"Probability\": \"0.2895687819\",\n \"SemanticContext\": \"Renal Diseases To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus.\"\n },\n {\n \"VerbatimTerm\": \"nephrotic syndrome\",\n \"Probability\": \"0.0101575553\",\n \"SemanticContext\": \"Published studies provide evidence of efficacy and safety in pediatric patients for the treatment of nephrotic syndrome >2 years of age , and aggressive lymphomas and leukemias >1 month of age .\"\n },\n {\n \"VerbatimTerm\": \"nephrotic syndrome\",\n \"Probability\": \"0.0101575553\",\n \"SemanticContext\": \"Published studies provide evidence of efficacy and safety in pediatric patients for the treatment of nephrotic syndrome >2 years of age , and aggressive lymphomas and leukemias >1 month of age .\"\n }\n ]\n },\n {\n \"Term\": \"Adrenal insufficiency\",\n \"MEDDRACode\": \"10001367\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hypoadrenalism\",\n \"Probability\": \"0.0015194118\",\n \"SemanticContext\": \"Infants born to mothers who have received corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism.\"\n },\n {\n \"VerbatimTerm\": \"hypoadrenalism\",\n \"Probability\": \"0.0004232228\",\n \"SemanticContext\": \"Infants born to mothers who have received corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism.\"\n }\n ]\n },\n {\n \"Term\": \"Diverticulitis\",\n \"MEDDRACode\": \"10013538\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"diverticulitis\",\n \"Probability\": \"0.0026333332\",\n \"SemanticContext\": \"Gastrointestinal Steroids should be used with caution in active or latent peptic ulcers, diverticulitis, fresh intestinal anastomoses, and nonspecific ulcerative colitis, since they may increase the risk of a perforation.\"\n }\n ]\n },\n {\n \"Term\": \"Enterobiasis\",\n \"MEDDRACode\": \"10014881\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"threadworm\",\n \"Probability\": \"3.1695E-06\",\n \"SemanticContext\": \"Similarly, corticosteroids should be used with great care in patients with known or suspected Strongyloides threadworm infestation.\"\n }\n ]\n },\n {\n \"Term\": \"Immunisation\",\n \"MEDDRACode\": \"10021430\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Immunization\",\n \"Probability\": \"0.0011593997\",\n \"SemanticContext\": \"Immunization procedures may be undertaken in patients who are receiving corticosteroids as replacement therapy, eg, for Addison's disease.\"\n }\n ]\n },\n {\n \"Term\": \"Immunoglobulins\",\n \"MEDDRACode\": \"10021496\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"immunoglobulin\",\n \"Probability\": \"1.30001E-05\",\n \"SemanticContext\": \"If exposed to measles, prophylaxis with immunoglobulin IG may be indicated.\"\n }\n ]\n },\n {\n \"Term\": \"Latent tuberculosis\",\n \"MEDDRACode\": \"10065048\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"latent tuberculosis\",\n \"Probability\": \"9.3484E-06\",\n \"SemanticContext\": \"If corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity, close observation is necessary as reactivation of the disease may occur.\"\n }\n ]\n },\n {\n \"Term\": \"Dermatitis bullous\",\n \"MEDDRACode\": \"10012441\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Bullous dermatitis\",\n \"Probability\": \"0.9218941927\",\n \"SemanticContext\": \"Dermatologic Diseases Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme Stevens-Johnson syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Dermatitis exfoliative generalised\",\n \"MEDDRACode\": \"10012456\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"erythroderma\",\n \"Probability\": \"0.9552758932\",\n \"SemanticContext\": \"Dermatologic Diseases Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme Stevens-Johnson syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Thrombocytopenia\",\n \"MEDDRACode\": \"10043554\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"secondary thrombocytopenia\",\n \"Probability\": \"0.9785981178\",\n \"SemanticContext\": \"Hematologic Disorders Acquired autoimmune hemolytic anemia, Diamond-Blackfan anemia, pure red cell aplasia, selected cases of secondary thrombocytopenia.\"\n }\n ]\n },\n {\n \"Term\": \"Brain neoplasm\",\n \"MEDDRACode\": \"10061019\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"brain tumor\",\n \"Probability\": \"0.0975262523\",\n \"SemanticContext\": \"Nervous System Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor or craniotomy.\"\n }\n ]\n },\n {\n \"Term\": \"Chemotherapy\",\n \"MEDDRACode\": \"10061758\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"chemotherapy\",\n \"Probability\": \"0.0083633363\",\n \"SemanticContext\": \"Miscellaneous Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy.\"\n },\n {\n \"VerbatimTerm\": \"chemotherapy\",\n \"Probability\": \"0.0070828795\",\n \"SemanticContext\": \"Respiratory Diseases Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis.\"\n }\n ]\n },\n {\n \"Term\": \"Dermatitis contact\",\n \"MEDDRACode\": \"10012442\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"contact dermatitis\",\n \"Probability\": \"0.0338545442\",\n \"SemanticContext\": \"INDICATIONS AND USAGE When oral therapy is not feasible, the intramuscular use of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is indicated as follows: Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions.\"\n }\n ]\n },\n {\n \"Term\": \"Polyuria\",\n \"MEDDRACode\": \"10036142\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"diuresis\",\n \"Probability\": \"0.5409085751\",\n \"SemanticContext\": \"Renal Diseases To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus.\"\n }\n ]\n },\n {\n \"Term\": \"Stevens-Johnson syndrome\",\n \"MEDDRACode\": \"10042033\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Stevens-Johnson syndrome\",\n \"Probability\": \"0.6234071255\",\n \"SemanticContext\": \"Dermatologic Diseases Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme Stevens-Johnson syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Bradycardia\",\n \"MEDDRACode\": \"10006093\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Bradycardia\",\n \"Probability\": \"0.9474010468\",\n \"SemanticContext\": \"Cardiovascular Bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure, fat embolism, hypertension, hypertrophic cardiomyopathy in premature infants, myocardial rupture following recent myocardial infarction see WARNINGS , pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis.\"\n }\n ]\n },\n {\n \"Term\": \"Cleft palate\",\n \"MEDDRACode\": \"10009269\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"cleft palate\",\n \"Probability\": \"0.107471168\",\n \"SemanticContext\": \"Animal studies in which corticosteroids have been given to pregnant mice, rats, and rabbits have yielded an increased incidence of cleft palate in the offspring.\"\n },\n {\n \"VerbatimTerm\": \"cleft palate\",\n \"Probability\": \"0.107471168\",\n \"SemanticContext\": \"Animal studies in which corticosteroids have been given to pregnant mice, rats, and rabbits have yielded an increased incidence of cleft palate in the offspring.\"\n }\n ]\n },\n {\n \"Term\": \"Pregnancy\",\n \"MEDDRACode\": \"10036556\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Pregnancy\",\n \"Probability\": \"0.0036288202\",\n \"SemanticContext\": \"Pregnancy\\nTeratogenic Effects Corticosteroids have been shown to be teratogenic in many species when given in doses equivalent to the human dose.\"\n },\n {\n \"VerbatimTerm\": \"Pregnancy\",\n \"Probability\": \"0.0036288202\",\n \"SemanticContext\": \"Pregnancy\\nTeratogenic Effects Corticosteroids have been shown to be teratogenic in many species when given in doses equivalent to the human dose.\"\n },\n {\n \"VerbatimTerm\": \"pregnancy\",\n \"Probability\": \"3.21595E-05\",\n \"SemanticContext\": \"Corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.\"\n },\n {\n \"VerbatimTerm\": \"pregnancy\",\n \"Probability\": \"3.52198E-05\",\n \"SemanticContext\": \"Infants born to mothers who have received corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism.\"\n },\n {\n \"VerbatimTerm\": \"pregnancy\",\n \"Probability\": \"3.21595E-05\",\n \"SemanticContext\": \"Corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.\"\n },\n {\n \"VerbatimTerm\": \"pregnancy\",\n \"Probability\": \"2.88181E-05\",\n \"SemanticContext\": \"Infants born to mothers who have received corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism.\"\n }\n ]\n },\n {\n \"Term\": \"Amoebiasis\",\n \"MEDDRACode\": \"10001980\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"amebiasis\",\n \"Probability\": \"0.0001121461\",\n \"SemanticContext\": \"It is recommended that latent amebiasis or active amebiasis be ruled out before initiating corticosteroid therapy in any patient who has spent time in the tropics or in any patient with unexplained diarrhea.\"\n },\n {\n \"VerbatimTerm\": \"amebiasis\",\n \"Probability\": \"3.55436E-05\",\n \"SemanticContext\": \"It is recommended that latent amebiasis or active amebiasis be ruled out before initiating corticosteroid therapy in any patient who has spent time in the tropics or in any patient with unexplained diarrhea.\"\n }\n ]\n },\n {\n \"Term\": \"Congenital aplastic anaemia\",\n \"MEDDRACode\": \"10053138\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Diamond-Blackfan anemia\",\n \"Probability\": \"0.9970852733\",\n \"SemanticContext\": \"Hematologic Disorders Acquired autoimmune hemolytic anemia, Diamond-Blackfan anemia, pure red cell aplasia, selected cases of secondary thrombocytopenia.\"\n }\n ]\n },\n {\n \"Term\": \"Drug hypersensitivity\",\n \"MEDDRACode\": \"10013700\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"drug hypersensitivity\",\n \"Probability\": \"0.0465348065\",\n \"SemanticContext\": \"INDICATIONS AND USAGE When oral therapy is not feasible, the intramuscular use of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is indicated as follows: Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions.\"\n }\n ]\n },\n {\n \"Term\": \"Granuloma annulare\",\n \"MEDDRACode\": \"10018692\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"granuloma annulare\",\n \"Probability\": \"0.7087999582\",\n \"SemanticContext\": \"The intralesional administration of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is indicated for alopecia areata; discoid lupus erythematosus; keloids; localized hypertrophic, infiltrated, inflammatory lesions of granuloma annulare, lichen planus, lichen simplex chronicus neurodermatitis , and psoriatic plaques; necrobiosis lipoidica diabeticorum.\"\n }\n ]\n },\n {\n \"Term\": \"Fat embolism\",\n \"MEDDRACode\": \"10016246\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"fat embolism\",\n \"Probability\": \"0.9359493256\",\n \"SemanticContext\": \"Cardiovascular Bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure, fat embolism, hypertension, hypertrophic cardiomyopathy in premature infants, myocardial rupture following recent myocardial infarction see WARNINGS , pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis.\"\n }\n ]\n },\n {\n \"Term\": \"Cerebrovascular accident\",\n \"MEDDRACode\": \"10008190\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"stroke\",\n \"Probability\": \"0.9507777691\",\n \"SemanticContext\": \"Specific events reported include, but are not limited to, spinal cord infarction, paraplegia, quadriplegia, cortical blindness, and stroke.\"\n }\n ]\n },\n {\n \"Term\": \"Disseminated tuberculosis\",\n \"MEDDRACode\": \"10013453\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"disseminated tuberculosis\",\n \"Probability\": \"0.0014456213\",\n \"SemanticContext\": \"\\nTuberculosis The use of corticosteroids in active tuberculosis should be restricted to those cases of fulminating or disseminated tuberculosis in which the corticosteroid is used for the management of the disease in conjunction with an appropriate antituberculous regimen.\"\n }\n ]\n },\n {\n \"Term\": \"Quadriplegia\",\n \"MEDDRACode\": \"10037714\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"quadriplegia\",\n \"Probability\": \"0.7614523768\",\n \"SemanticContext\": \"Specific events reported include, but are not limited to, spinal cord infarction, paraplegia, quadriplegia, cortical blindness, and stroke.\"\n }\n ]\n },\n {\n \"Term\": \"Weight\",\n \"MEDDRACode\": \"10047890\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"weight\",\n \"Probability\": \"0.0043830574\",\n \"SemanticContext\": \"The formula for betamethasone sodium phosphate is C 22 H 28 FNa 2 0 8 P and it has a molecular weight of 516.40.\"\n },\n {\n \"VerbatimTerm\": \"weight\",\n \"Probability\": \"0.0027593374\",\n \"SemanticContext\": \"The formula for betamethasone acetate is C 24 H 31 FO 6 and it has a molecular weight of 434.50.\"\n },\n {\n \"VerbatimTerm\": \"weight\",\n \"Probability\": \"1.75551E-05\",\n \"SemanticContext\": \"Like adults, pediatric patients should be carefully observed with frequent measurements of blood pressure, weight, height, intraocular pressure, and clinical evaluation for the presence of infection, psychosocial disturbances, thromboembolism, peptic ulcers, cataracts, and osteoporosis.\"\n },\n {\n \"VerbatimTerm\": \"weight\",\n \"Probability\": \"1.75551E-05\",\n \"SemanticContext\": \"Like adults, pediatric patients should be carefully observed with frequent measurements of blood pressure, weight, height, intraocular pressure, and clinical evaluation for the presence of infection, psychosocial disturbances, thromboembolism, peptic ulcers, cataracts, and osteoporosis.\"\n }\n ]\n },\n {\n \"Term\": \"Alopecia areata\",\n \"MEDDRACode\": \"10001761\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"alopecia areata\",\n \"Probability\": \"0.9339317083\",\n \"SemanticContext\": \"The intralesional administration of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is indicated for alopecia areata; discoid lupus erythematosus; keloids; localized hypertrophic, infiltrated, inflammatory lesions of granuloma annulare, lichen planus, lichen simplex chronicus neurodermatitis , and psoriatic plaques; necrobiosis lipoidica diabeticorum.\"\n }\n ]\n },\n {\n \"Term\": \"Endocrine disorder\",\n \"MEDDRACode\": \"10014695\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Endocrine Disorders\",\n \"Probability\": \"0.0909818709\",\n \"SemanticContext\": \"Endocrine Disorders Congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis.\"\n }\n ]\n },\n {\n \"Term\": \"Tuberculosis\",\n \"MEDDRACode\": \"10044755\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"active tuberculosis\",\n \"Probability\": \"0.0002934635\",\n \"SemanticContext\": \"\\nTuberculosis The use of corticosteroids in active tuberculosis should be restricted to those cases of fulminating or disseminated tuberculosis in which the corticosteroid is used for the management of the disease in conjunction with an appropriate antituberculous regimen.\"\n }\n ]\n },\n {\n \"Term\": \"Lymphoma\",\n \"MEDDRACode\": \"10025310\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"lymphomas\",\n \"Probability\": \"0.0005052686\",\n \"SemanticContext\": \"Neoplastic Diseases For palliative management of leukemias and lymphomas.\"\n },\n {\n \"VerbatimTerm\": \"lymphomas\",\n \"Probability\": \"0.0014491677\",\n \"SemanticContext\": \"Published studies provide evidence of efficacy and safety in pediatric patients for the treatment of nephrotic syndrome >2 years of age , and aggressive lymphomas and leukemias >1 month of age .\"\n },\n {\n \"VerbatimTerm\": \"lymphomas\",\n \"Probability\": \"0.0014491677\",\n \"SemanticContext\": \"Published studies provide evidence of efficacy and safety in pediatric patients for the treatment of nephrotic syndrome >2 years of age , and aggressive lymphomas and leukemias >1 month of age .\"\n }\n ]\n },\n {\n \"Term\": \"Inflammatory bowel disease\",\n \"MEDDRACode\": \"10021972\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"inflammatory bowel disease\",\n \"Probability\": \"0.1555013657\",\n \"SemanticContext\": \"Gastrointestinal Abdominal distention, bowel/bladder dysfunction after intrathecal administration , elevation in serum liver enzyme levels usually reversible upon discontinuation , hepatomegaly, increased appetite, nausea, pancreatitis, peptic ulcer with possible perforation and hemorrhage, perforation of the small and large intestine particularly in patients with inflammatory bowel disease , ulcerative esophagitis.\"\n }\n ]\n },\n {\n \"Term\": \"Nervousness\",\n \"MEDDRACode\": \"10029216\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Nervous\",\n \"Probability\": \"0.0716812611\",\n \"SemanticContext\": \"Nervous System Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor or craniotomy.\"\n }\n ]\n },\n {\n \"Term\": \"Skin test\",\n \"MEDDRACode\": \"10040929\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"skin tests\",\n \"Probability\": \"0.4890305996\",\n \"SemanticContext\": \"Dermatologic Acne, allergic dermatitis, cutaneous and subcutaneous atrophy, dry scaly skin, ecchymoses and petechiae, edema, erythema, hyperpigmentation, hypopigmentation, impaired wound healing, increased sweating, rash, sterile abscess, striae, suppressed reactions to skin tests, thin fragile skin, thinning scalp hair, urticaria.\"\n },\n {\n \"VerbatimTerm\": \"skin tests\",\n \"Probability\": \"0.0017348826\",\n \"SemanticContext\": \"\\nSkin Tests Corticosteroids may suppress reactions to skin tests.\"\n },\n {\n \"VerbatimTerm\": \"skin tests\",\n \"Probability\": \"0.0017348826\",\n \"SemanticContext\": \"\\nSkin Tests Corticosteroids may suppress reactions to skin tests.\"\n },\n {\n \"VerbatimTerm\": \"Skin Tests\",\n \"Probability\": \"8.4429E-05\",\n \"SemanticContext\": \"\\nSkin Tests Corticosteroids may suppress reactions to skin tests.\"\n },\n {\n \"VerbatimTerm\": \"Skin Tests\",\n \"Probability\": \"8.4429E-05\",\n \"SemanticContext\": \"\\nSkin Tests Corticosteroids may suppress reactions to skin tests.\"\n }\n ]\n },\n {\n \"Term\": \"Paraparesis\",\n \"MEDDRACode\": \"10033885\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"paraparesis\",\n \"Probability\": \"0.9797343016\",\n \"SemanticContext\": \"Arachnoiditis, meningitis, paraparesis/paraplegia, and sensory disturbances have occurred after intrathecal administration see WARNINGS, Neurologic section .\"\n }\n ]\n },\n {\n \"Term\": \"Skin exfoliation\",\n \"MEDDRACode\": \"10040844\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"scaly skin\",\n \"Probability\": \"0.9725744724\",\n \"SemanticContext\": \"Dermatologic Acne, allergic dermatitis, cutaneous and subcutaneous atrophy, dry scaly skin, ecchymoses and petechiae, edema, erythema, hyperpigmentation, hypopigmentation, impaired wound healing, increased sweating, rash, sterile abscess, striae, suppressed reactions to skin tests, thin fragile skin, thinning scalp hair, urticaria.\"\n }\n ]\n },\n {\n \"Term\": \"Blood calcium increased\",\n \"MEDDRACode\": \"10005396\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"increase calcium\",\n \"Probability\": \"0.0015409291\",\n \"SemanticContext\": \"All corticosteroids increase calcium excretion.\"\n }\n ]\n },\n {\n \"Term\": \"Bone formation decreased\",\n \"MEDDRACode\": \"10056809\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"decrease bone formation\",\n \"Probability\": \"0.1900968254\",\n \"SemanticContext\": \"Musculoskeletal Corticosteroids decrease bone formation and increase bone resorption both through their effect on calcium regulation ie, decreasing absorption and increasing excretion and inhibition of osteoblast function.\"\n }\n ]\n },\n {\n \"Term\": \"Cerebral malaria\",\n \"MEDDRACode\": \"10063094\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"cerebral malaria\",\n \"Probability\": \"0.0010203421\",\n \"SemanticContext\": \"Corticosteroids should not be used in cerebral malaria.\"\n }\n ]\n },\n {\n \"Term\": \"Craniocerebral injury\",\n \"MEDDRACode\": \"10070976\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"traumatic brain injury\",\n \"Probability\": \"0.004729569\",\n \"SemanticContext\": \"High doses of corticosteroids, including Betamethasone Sodium Phosphate and Betamethasone Acetate, should not be used for the treatment of traumatic brain injury.\"\n }\n ]\n },\n {\n \"Term\": \"Enterocolitis\",\n \"MEDDRACode\": \"10014893\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"enterocolitis\",\n \"Probability\": \"0.9283791184\",\n \"SemanticContext\": \"In such patients, corticosteroid-induced immunosuppression may lead to Strongyloides hyperinfection and dissemination with widespread larval migration, often accompanied by severe enterocolitis and potentially fatal gram-negative septicemia.\"\n }\n ]\n },\n {\n \"Term\": \"Brain oedema\",\n \"MEDDRACode\": \"10048962\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"cerebral edema\",\n \"Probability\": \"0.848790884\",\n \"SemanticContext\": \"Nervous System Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor or craniotomy.\"\n }\n ]\n },\n {\n \"Term\": \"Dermatitis herpetiformis\",\n \"MEDDRACode\": \"10012468\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"dermatitis herpetiformis\",\n \"Probability\": \"0.7886803746\",\n \"SemanticContext\": \"Dermatologic Diseases Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme Stevens-Johnson syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Dermatomyositis\",\n \"MEDDRACode\": \"10012503\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"dermatomyositis\",\n \"Probability\": \"0.8715889454\",\n \"SemanticContext\": \"For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.\"\n }\n ]\n },\n {\n \"Term\": \"Erythema multiforme\",\n \"MEDDRACode\": \"10015218\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"severe erythema multiforme\",\n \"Probability\": \"0.9751800299\",\n \"SemanticContext\": \"Dermatologic Diseases Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme Stevens-Johnson syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Neoplasm\",\n \"MEDDRACode\": \"10028980\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"tumors\",\n \"Probability\": \"0.000385493\",\n \"SemanticContext\": \"Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension may also be useful in cystic tumors of an aponeurosis or tendon ganglia .\"\n }\n ]\n },\n {\n \"Term\": \"Colitis ulcerative\",\n \"MEDDRACode\": \"10009900\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"ulcerative colitis\",\n \"Probability\": \"0.3862008154\",\n \"SemanticContext\": \"Gastrointestinal Diseases To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis.\"\n },\n {\n \"VerbatimTerm\": \"ulcerative colitis\",\n \"Probability\": \"0.0139125884\",\n \"SemanticContext\": \"Gastrointestinal Steroids should be used with caution in active or latent peptic ulcers, diverticulitis, fresh intestinal anastomoses, and nonspecific ulcerative colitis, since they may increase the risk of a perforation.\"\n }\n ]\n },\n {\n \"Term\": \"Pyrexia\",\n \"MEDDRACode\": \"10037660\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"fever\",\n \"Probability\": \"0.0002241731\",\n \"SemanticContext\": \"Information for Patients Patients should be warned not to discontinue the use of corticosteroids abruptly or without medical supervision, to advise any medical attendants that they are taking corticosteroids and to seek medical advice at once should they develop fever or other signs of infection.\"\n },\n {\n \"VerbatimTerm\": \"fever\",\n \"Probability\": \"0.6035419106\",\n \"SemanticContext\": \"A marked increase in pain accompanied by local swelling, further restriction of joint motion, fever, and malaise are suggestive of septic arthritis.\"\n },\n {\n \"VerbatimTerm\": \"fever\",\n \"Probability\": \"0.0002241731\",\n \"SemanticContext\": \"Information for Patients Patients should be warned not to discontinue the use of corticosteroids abruptly or without medical supervision, to advise any medical attendants that they are taking corticosteroids and to seek medical advice at once should they develop fever or other signs of infection.\"\n }\n ]\n },\n {\n \"Term\": \"Diarrhoea\",\n \"MEDDRACode\": \"10012735\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"diarrhea\",\n \"Probability\": \"0.0157217383\",\n \"SemanticContext\": \"It is recommended that latent amebiasis or active amebiasis be ruled out before initiating corticosteroid therapy in any patient who has spent time in the tropics or in any patient with unexplained diarrhea.\"\n }\n ]\n },\n {\n \"Term\": \"Ecchymosis\",\n \"MEDDRACode\": \"10014080\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"ecchymoses\",\n \"Probability\": \"0.878459692\",\n \"SemanticContext\": \"Dermatologic Acne, allergic dermatitis, cutaneous and subcutaneous atrophy, dry scaly skin, ecchymoses and petechiae, edema, erythema, hyperpigmentation, hypopigmentation, impaired wound healing, increased sweating, rash, sterile abscess, striae, suppressed reactions to skin tests, thin fragile skin, thinning scalp hair, urticaria.\"\n }\n ]\n },\n {\n \"Term\": \"Flatulence\",\n \"MEDDRACode\": \"10016766\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"wound\",\n \"Probability\": \"0.7914398909\",\n \"SemanticContext\": \"Dermatologic Acne, allergic dermatitis, cutaneous and subcutaneous atrophy, dry scaly skin, ecchymoses and petechiae, edema, erythema, hyperpigmentation, hypopigmentation, impaired wound healing, increased sweating, rash, sterile abscess, striae, suppressed reactions to skin tests, thin fragile skin, thinning scalp hair, urticaria.\"\n }\n ]\n },\n {\n \"Term\": \"Hepatomegaly\",\n \"MEDDRACode\": \"10019842\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hepatomegaly\",\n \"Probability\": \"0.9734054804\",\n \"SemanticContext\": \"Gastrointestinal Abdominal distention, bowel/bladder dysfunction after intrathecal administration , elevation in serum liver enzyme levels usually reversible upon discontinuation , hepatomegaly, increased appetite, nausea, pancreatitis, peptic ulcer with possible perforation and hemorrhage, perforation of the small and large intestine particularly in patients with inflammatory bowel disease , ulcerative esophagitis.\"\n }\n ]\n },\n {\n \"Term\": \"Hyperhidrosis\",\n \"MEDDRACode\": \"10020642\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"increased sweating\",\n \"Probability\": \"0.9847165346\",\n \"SemanticContext\": \"Dermatologic Acne, allergic dermatitis, cutaneous and subcutaneous atrophy, dry scaly skin, ecchymoses and petechiae, edema, erythema, hyperpigmentation, hypopigmentation, impaired wound healing, increased sweating, rash, sterile abscess, striae, suppressed reactions to skin tests, thin fragile skin, thinning scalp hair, urticaria.\"\n }\n ]\n },\n {\n \"Term\": \"Addison's disease\",\n \"MEDDRACode\": \"10001130\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Addison's disease\",\n \"Probability\": \"0.0001981854\",\n \"SemanticContext\": \"Immunization procedures may be undertaken in patients who are receiving corticosteroids as replacement therapy, eg, for Addison's disease.\"\n }\n ]\n },\n {\n \"Term\": \"Arthritis bacterial\",\n \"MEDDRACode\": \"10053555\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"septic arthritis\",\n \"Probability\": \"0.0120142698\",\n \"SemanticContext\": \"A marked increase in pain accompanied by local swelling, further restriction of joint motion, fever, and malaise are suggestive of septic arthritis.\"\n }\n ]\n },\n {\n \"Term\": \"Gastrointestinal perforation\",\n \"MEDDRACode\": \"10018001\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"gastrointestinal perforation\",\n \"Probability\": \"0.0660684109\",\n \"SemanticContext\": \"Signs of peritoneal irritation following gastrointestinal perforation in patients receiving corticosteroids may be minimal or absent.\"\n }\n ]\n },\n {\n \"Term\": \"Immunosuppression\",\n \"MEDDRACode\": \"10062016\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"immunosuppression\",\n \"Probability\": \"0.0673691928\",\n \"SemanticContext\": \"In such patients, corticosteroid-induced immunosuppression may lead to Strongyloides hyperinfection and dissemination with widespread larval migration, often accompanied by severe enterocolitis and potentially fatal gram-negative septicemia.\"\n }\n ]\n },\n {\n \"Term\": \"Localised infection\",\n \"MEDDRACode\": \"10024774\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"localize infection\",\n \"Probability\": \"0.0579909086\",\n \"SemanticContext\": \"There may be decreased resistance and inability to localize infection when corticosteroids are used.\"\n }\n ]\n },\n {\n \"Term\": \"Optic neuritis\",\n \"MEDDRACode\": \"10030942\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"optic neuritis\",\n \"Probability\": \"0.0068469644\",\n \"SemanticContext\": \"The use of oral corticosteroids is not recommended in the treatment of optic neuritis and may lead to an increase in the risk of new episodes.\"\n }\n ]\n },\n {\n \"Term\": \"Renal failure\",\n \"MEDDRACode\": \"10038435\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"renal insufficiency\",\n \"Probability\": \"0.0040278435\",\n \"SemanticContext\": \"Cardio-renal As sodium retention with resultant edema and potassium loss may occur in patients receiving corticosteroids, these agents should be used with caution in patients with congestive heart failure, hypertension, or renal insufficiency.\"\n }\n ]\n },\n {\n \"Term\": \"Varicella zoster virus infection\",\n \"MEDDRACode\": \"10075611\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"varicella zoster\",\n \"Probability\": \"0.0005417168\",\n \"SemanticContext\": \"If exposed to chickenpox, prophylaxis with varicella zoster immune globulin VZIG may be indicated.\"\n }\n ]\n },\n {\n \"Term\": \"Wheezing\",\n \"MEDDRACode\": \"10047924\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"wheezing\",\n \"Probability\": \"0.0007653832\",\n \"SemanticContext\": \"Other indications for pediatric use of corticosteroids, eg, severe asthma and wheezing, are based on adequate and well-controlled trials conducted in adults, on the premises that the course of the diseases and their pathophysiology are considered to be substantially similar in both populations.\"\n },\n {\n \"VerbatimTerm\": \"wheezing\",\n \"Probability\": \"0.0007653832\",\n \"SemanticContext\": \"Other indications for pediatric use of corticosteroids, eg, severe asthma and wheezing, are based on adequate and well-controlled trials conducted in adults, on the premises that the course of the diseases and their pathophysiology are considered to be substantially similar in both populations.\"\n }\n ]\n },\n {\n \"Term\": \"Increased appetite\",\n \"MEDDRACode\": \"10021654\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"increased appetite\",\n \"Probability\": \"0.9850496054\",\n \"SemanticContext\": \"Gastrointestinal Abdominal distention, bowel/bladder dysfunction after intrathecal administration , elevation in serum liver enzyme levels usually reversible upon discontinuation , hepatomegaly, increased appetite, nausea, pancreatitis, peptic ulcer with possible perforation and hemorrhage, perforation of the small and large intestine particularly in patients with inflammatory bowel disease , ulcerative esophagitis.\"\n }\n ]\n },\n {\n \"Term\": \"Herpes ophthalmic\",\n \"MEDDRACode\": \"10062004\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"ocular herpes\",\n \"Probability\": \"0.0001932383\",\n \"SemanticContext\": \"Corticosteroids should not be used in active ocular herpes simplex.\"\n }\n ]\n },\n {\n \"Term\": \"Infestation\",\n \"MEDDRACode\": \"10061217\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"infestation\",\n \"Probability\": \"1.85043E-05\",\n \"SemanticContext\": \"Similarly, corticosteroids should be used with great care in patients with known or suspected Strongyloides threadworm infestation.\"\n }\n ]\n },\n {\n \"Term\": \"Intestinal anastomosis\",\n \"MEDDRACode\": \"10057146\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"intestinal anastomoses\",\n \"Probability\": \"0.0007113516\",\n \"SemanticContext\": \"Gastrointestinal Steroids should be used with caution in active or latent peptic ulcers, diverticulitis, fresh intestinal anastomoses, and nonspecific ulcerative colitis, since they may increase the risk of a perforation.\"\n }\n ]\n },\n {\n \"Term\": \"Kaposi's sarcoma\",\n \"MEDDRACode\": \"10023284\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Kaposi's sarcoma\",\n \"Probability\": \"0.6447533965\",\n \"SemanticContext\": \"Kaposi's sarcoma has been reported to occur in patients receiving corticosteroid therapy, most often for chronic conditions.\"\n }\n ]\n },\n {\n \"Term\": \"Seizure\",\n \"MEDDRACode\": \"10039906\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Convulsions\",\n \"Probability\": \"0.9118654132\",\n \"SemanticContext\": \"Neurologic/Psychiatric Convulsions, depression, emotional instability, euphoria, headache, increased intracranial pressure with papilledema pseudotumor cerebri usually following discontinuation of treatment, insomnia, mood swings, neuritis, neuropathy, paresthesia, personality changes, psychic disorders, vertigo.\"\n },\n {\n \"VerbatimTerm\": \"Convulsions\",\n \"Probability\": \"0.28859514000000003\",\n \"SemanticContext\": \"Convulsions have been reported with this concurrent use.\"\n },\n {\n \"VerbatimTerm\": \"Convulsions\",\n \"Probability\": \"0.28859514000000003\",\n \"SemanticContext\": \"Convulsions have been reported with this concurrent use.\"\n }\n ]\n },\n {\n \"Term\": \"Blindness\",\n \"MEDDRACode\": \"10005169\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"blindness\",\n \"Probability\": \"0.943292141\",\n \"SemanticContext\": \"Ophthalmic Exophthalmos, glaucoma, increased intraocular pressure, posterior subcapsular cataracts, rare instances of blindness associated with periocular injections, vision blurred.\"\n }\n ]\n },\n {\n \"Term\": \"Blood creatinine\",\n \"MEDDRACode\": \"10005480\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"creatinine\",\n \"Probability\": \"2.31214E-05\",\n \"SemanticContext\": \"Elevation of creatinine kinase may occur.\"\n }\n ]\n },\n {\n \"Term\": \"Quadriparesis\",\n \"MEDDRACode\": \"10049680\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"quadriparesis\",\n \"Probability\": \"0.0258567631\",\n \"SemanticContext\": \"This acute myopathy is generalized, may involve ocular and respiratory muscles, and may result in quadriparesis.\"\n }\n ]\n },\n {\n \"Term\": \"Shock\",\n \"MEDDRACode\": \"10040560\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"shock\",\n \"Probability\": \"0.9884623289\",\n \"SemanticContext\": \"General Rare instances of anaphylactoid/anaphylactic reactions with a possibility of shock have occurred in patients receiving parenteral corticosteroid therapy see ADVERSE REACTIONS .\"\n }\n ]\n },\n {\n \"Term\": \"Elderly\",\n \"MEDDRACode\": \"10014348\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": true\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"elderly\",\n \"Probability\": \"0.0003065467\",\n \"SemanticContext\": \"Geriatric Use No overall differences in safety or effectiveness were observed between elderly subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and young patients, but greater sensitivity of some older individuals cannot be ruled out.\"\n },\n {\n \"VerbatimTerm\": \"elderly\",\n \"Probability\": \"0.0006117523\",\n \"SemanticContext\": \"Geriatric Use No overall differences in safety or effectiveness were observed between elderly subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and young patients, but greater sensitivity of some older individuals cannot be ruled out.\"\n },\n {\n \"VerbatimTerm\": \"elderly\",\n \"Probability\": \"0.0003065467\",\n \"SemanticContext\": \"Geriatric Use No overall differences in safety or effectiveness were observed between elderly subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and young patients, but greater sensitivity of some older individuals cannot be ruled out.\"\n },\n {\n \"VerbatimTerm\": \"elderly\",\n \"Probability\": \"0.0006117523\",\n \"SemanticContext\": \"Geriatric Use No overall differences in safety or effectiveness were observed between elderly subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and young patients, but greater sensitivity of some older individuals cannot be ruled out.\"\n }\n ]\n },\n {\n \"Term\": \"Syncope\",\n \"MEDDRACode\": \"10042772\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"syncope\",\n \"Probability\": \"0.9975394011\",\n \"SemanticContext\": \"Cardiovascular Bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure, fat embolism, hypertension, hypertrophic cardiomyopathy in premature infants, myocardial rupture following recent myocardial infarction see WARNINGS , pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis.\"\n }\n ]\n },\n {\n \"Term\": \"Hypersensitivity\",\n \"MEDDRACode\": \"10020751\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hypersensitivity reactions\",\n \"Probability\": \"0.5334290266\",\n \"SemanticContext\": \"INDICATIONS AND USAGE When oral therapy is not feasible, the intramuscular use of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is indicated as follows: Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions.\"\n }\n ]\n },\n {\n \"Term\": \"Hypertension\",\n \"MEDDRACode\": \"10020772\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hypertension\",\n \"Probability\": \"0.9820815325\",\n \"SemanticContext\": \"Cardiovascular Bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure, fat embolism, hypertension, hypertrophic cardiomyopathy in premature infants, myocardial rupture following recent myocardial infarction see WARNINGS , pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis.\"\n },\n {\n \"VerbatimTerm\": \"hypertension\",\n \"Probability\": \"0.0003859103\",\n \"SemanticContext\": \"Cardio-renal As sodium retention with resultant edema and potassium loss may occur in patients receiving corticosteroids, these agents should be used with caution in patients with congestive heart failure, hypertension, or renal insufficiency.\"\n }\n ]\n },\n {\n \"Term\": \"Injury\",\n \"MEDDRACode\": \"10022116\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"trauma\",\n \"Probability\": \"0.0567143857\",\n \"SemanticContext\": \"Endocrine Decreased carbohydrate and glucose tolerance, development of cushingoid state, glucosuria, hirsutism, hypertrichosis, increased requirements for insulin or oral hypoglycemic adrenocortical and pituitary unresponsiveness particularly in times of stress, as in trauma, surgery, or illness , suppression of growth in pediatric patients.\"\n },\n {\n \"VerbatimTerm\": \"trauma\",\n \"Probability\": \"0.0063321888\",\n \"SemanticContext\": \"Results from one multicenter, randomized, placebo-controlled study with methylprednisolone hemisuccinate, an IV corticosteroid, showed an increase in early mortality at 2 weeks and late mortality at 6 months in patients with cranial trauma who were determined not to have other clear indications for corticosteroid treatment.\"\n }\n ]\n },\n {\n \"Term\": \"Mood swings\",\n \"MEDDRACode\": \"10027951\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"mood swings\",\n \"Probability\": \"0.8343330622\",\n \"SemanticContext\": \"Neurologic/Psychiatric Convulsions, depression, emotional instability, euphoria, headache, increased intracranial pressure with papilledema pseudotumor cerebri usually following discontinuation of treatment, insomnia, mood swings, neuritis, neuropathy, paresthesia, personality changes, psychic disorders, vertigo.\"\n },\n {\n \"VerbatimTerm\": \"mood swings\",\n \"Probability\": \"0.2920098901\",\n \"SemanticContext\": \"Psychic derangements may appear when corticosteroids are used, ranging from euphoria, insomnia, mood swings, personality changes, and severe depression to frank psychotic manifestations.\"\n }\n ]\n },\n {\n \"Term\": \"Injection\",\n \"MEDDRACode\": \"10052995\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"injections\",\n \"Probability\": \"0.0023337007\",\n \"SemanticContext\": \"Several intrabursal injections of corticosteroids are usually required in recurrent acute bursitis and in acute exacerbations of chronic bursitis.\"\n },\n {\n \"VerbatimTerm\": \"injections\",\n \"Probability\": \"0.0041358471\",\n \"SemanticContext\": \"Partial relief of pain and some increase in mobility can be expected in both conditions after one or two injections.\"\n },\n {\n \"VerbatimTerm\": \"injections\",\n \"Probability\": \"0.0143804252\",\n \"SemanticContext\": \"In tenosynovitis and tendinitis, three or four local injections at intervals of 1 to 2 weeks between injections are given in most cases.\"\n },\n {\n \"VerbatimTerm\": \"injections\",\n \"Probability\": \"0.0100973248\",\n \"SemanticContext\": \"In tenosynovitis and tendinitis, three or four local injections at intervals of 1 to 2 weeks between injections are given in most cases.\"\n },\n {\n \"VerbatimTerm\": \"injections\",\n \"Probability\": \"0.0005225837\",\n \"SemanticContext\": \"Disorders of the Foot A tuberculin syringe with a 25-gauge, 3/4-inch needle is suitable for most injections into the foot.\"\n },\n {\n \"VerbatimTerm\": \"Injection\",\n \"Probability\": \"0.0001057766\",\n \"SemanticContext\": \"\\nAmphotericin B Injection and Potassium-Depleting Agents When corticosteroids are administered concomitantly with potassium-depleting agents ie, amphotericin B, diuretics , patients should be observed closely for development of hypokalemia.\"\n },\n {\n \"VerbatimTerm\": \"Injection\",\n \"Probability\": \"0.0031567216\",\n \"SemanticContext\": \"Intra-articular Injection of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is well tolerated in joints and periarticular tissues.\"\n },\n {\n \"VerbatimTerm\": \"Injection\",\n \"Probability\": \"4.94146E-05\",\n \"SemanticContext\": \"Recommended Doses for Intra-articular Injection Size of joint Location Dose mL Very large Hip 1.0-2.0 Large Knee, ankle, shoulder 1.0 Medium Elbow, wrist 0.5-1.0 Small metacarpophalangeal, interphalangeal sternoclavicular Hand, chest 0.25-0.5 .\"\n },\n {\n \"VerbatimTerm\": \"Injection\",\n \"Probability\": \"0.0023193061\",\n \"SemanticContext\": \"There have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure see PRECAUTIONS, Drug Interactions, Amphotericin B Injection and Potassium-Depleting Agents section .\"\n },\n {\n \"VerbatimTerm\": \"Injection\",\n \"Probability\": \"0.0003004372\",\n \"SemanticContext\": \"Injection of a steroid into an infected site is to be avoided.\"\n },\n {\n \"VerbatimTerm\": \"Injection\",\n \"Probability\": \"0.0001057766\",\n \"SemanticContext\": \"\\nAmphotericin B Injection and Potassium-Depleting Agents When corticosteroids are administered concomitantly with potassium-depleting agents ie, amphotericin B, diuretics , patients should be observed closely for development of hypokalemia.\"\n },\n {\n \"VerbatimTerm\": \"injection\",\n \"Probability\": \"0.4555534422\",\n \"SemanticContext\": \"Bursitis, Tenosynovitis, Peritendinitis In acute subdeltoid, subacromial, olecranon, and prepatellar bursitis, one intrabursal injection of 1.0 mL Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension can relieve pain and restore full range of movement.\"\n },\n {\n \"VerbatimTerm\": \"injection\",\n \"Probability\": \"0.0003508031\",\n \"SemanticContext\": \"In ganglions of joint capsules and tendon sheaths, injection of 0.5 mL directly into the ganglion cysts has produced marked reduction in the size of the lesions.\"\n },\n {\n \"VerbatimTerm\": \"injection\",\n \"Probability\": \"0.1375828981\",\n \"SemanticContext\": \"There is virtually no pain on injection, and the \\\"secondary flare\\\" that sometimes occurs a few hours after intra-articular injection of corticosteroids has not been reported with Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension.\"\n },\n {\n \"VerbatimTerm\": \"injection\",\n \"Probability\": \"0.0096125007\",\n \"SemanticContext\": \"There is virtually no pain on injection, and the \\\"secondary flare\\\" that sometimes occurs a few hours after intra-articular injection of corticosteroids has not been reported with Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension.\"\n },\n {\n \"VerbatimTerm\": \"injection\",\n \"Probability\": \"0.0008165836\",\n \"SemanticContext\": \"The aspirating syringe is replaced by a syringe containing Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension and injection is then made into the joint.\"\n },\n {\n \"VerbatimTerm\": \"injection\",\n \"Probability\": \"0.001773417\",\n \"SemanticContext\": \"A portion of the administered dose of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is absorbed systemically following intra-articular injection.\"\n },\n {\n \"VerbatimTerm\": \"injection\",\n \"Probability\": \"0.0003313422\",\n \"SemanticContext\": \"Local injection of a steroid into a previously injected joint is not usually recommended.\"\n },\n {\n \"VerbatimTerm\": \"injection\",\n \"Probability\": \"0.000412643\",\n \"SemanticContext\": \"Corticosteroid injection into unstable joints is generally not recommended.\"\n },\n {\n \"VerbatimTerm\": \"injection\",\n \"Probability\": \"0.0107664168\",\n \"SemanticContext\": \"Intra-articular injection may result in damage to joint tissues see ADVERSE REACTIONS, Musculoskeletal section .\"\n },\n {\n \"VerbatimTerm\": \"Injections\",\n \"Probability\": \"0.0035157204\",\n \"SemanticContext\": \"Injections should be made into the affected tendon sheaths rather than into the tendons themselves.\"\n }\n ]\n },\n {\n \"Term\": \"Sodium retention\",\n \"MEDDRACode\": \"10041277\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"sodium retention\",\n \"Probability\": \"0.9046910405\",\n \"SemanticContext\": \"Fluid and Electrolyte Disturbances Congestive heart failure in susceptible patients, fluid retention, hypokalemic alkalosis, potassium loss, sodium retention.\"\n },\n {\n \"VerbatimTerm\": \"sodium retention\",\n \"Probability\": \"0.4755086899\",\n \"SemanticContext\": \"Cardio-renal As sodium retention with resultant edema and potassium loss may occur in patients receiving corticosteroids, these agents should be used with caution in patients with congestive heart failure, hypertension, or renal insufficiency.\"\n }\n ]\n },\n {\n \"Term\": \"Erythema\",\n \"MEDDRACode\": \"10015150\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"erythema\",\n \"Probability\": \"0.9973179102\",\n \"SemanticContext\": \"Dermatologic Acne, allergic dermatitis, cutaneous and subcutaneous atrophy, dry scaly skin, ecchymoses and petechiae, edema, erythema, hyperpigmentation, hypopigmentation, impaired wound healing, increased sweating, rash, sterile abscess, striae, suppressed reactions to skin tests, thin fragile skin, thinning scalp hair, urticaria.\"\n }\n ]\n },\n {\n \"Term\": \"Mental disorder\",\n \"MEDDRACode\": \"10061284\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"psychic disorders\",\n \"Probability\": \"0.7727022171\",\n \"SemanticContext\": \"Neurologic/Psychiatric Convulsions, depression, emotional instability, euphoria, headache, increased intracranial pressure with papilledema pseudotumor cerebri usually following discontinuation of treatment, insomnia, mood swings, neuritis, neuropathy, paresthesia, personality changes, psychic disorders, vertigo.\"\n }\n ]\n },\n {\n \"Term\": \"Euphoric mood\",\n \"MEDDRACode\": \"10015535\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"High\",\n \"Probability\": \"0.0023848414\",\n \"SemanticContext\": \"High doses of corticosteroids, including Betamethasone Sodium Phosphate and Betamethasone Acetate, should not be used for the treatment of traumatic brain injury.\"\n },\n {\n \"VerbatimTerm\": \"high\",\n \"Probability\": \"0.000518918\",\n \"SemanticContext\": \"The studies do show that relatively high doses of corticosteroids are necessary to demonstrate a significant effect see DOSAGE AND ADMINISTRATION .\"\n },\n {\n \"VerbatimTerm\": \"high\",\n \"Probability\": \"0.0005062521\",\n \"SemanticContext\": \"An acute myopathy has been observed with the use of high doses of corticosteroids, most often occurring in patients with disorders of neuromuscular transmission eg, myasthenia gravis , or in patients receiving concomitant therapy with neuromuscular blocking drugs eg, pancuronium .\"\n }\n ]\n },\n {\n \"Term\": \"Insomnia\",\n \"MEDDRACode\": \"10022437\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"insomnia\",\n \"Probability\": \"0.9912691712\",\n \"SemanticContext\": \"Neurologic/Psychiatric Convulsions, depression, emotional instability, euphoria, headache, increased intracranial pressure with papilledema pseudotumor cerebri usually following discontinuation of treatment, insomnia, mood swings, neuritis, neuropathy, paresthesia, personality changes, psychic disorders, vertigo.\"\n },\n {\n \"VerbatimTerm\": \"insomnia\",\n \"Probability\": \"0.7756026387\",\n \"SemanticContext\": \"Psychic derangements may appear when corticosteroids are used, ranging from euphoria, insomnia, mood swings, personality changes, and severe depression to frank psychotic manifestations.\"\n }\n ]\n },\n {\n \"Term\": \"Malaise\",\n \"MEDDRACode\": \"10025482\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"malaise\",\n \"Probability\": \"0.4331051707\",\n \"SemanticContext\": \"Other Abnormal fat deposits, decreased resistance to infection, hiccups, increased or decreased motility and number of spermatozoa, malaise, moon face, weight gain.\"\n },\n {\n \"VerbatimTerm\": \"malaise\",\n \"Probability\": \"0.3105759621\",\n \"SemanticContext\": \"A marked increase in pain accompanied by local swelling, further restriction of joint motion, fever, and malaise are suggestive of septic arthritis.\"\n }\n ]\n },\n {\n \"Term\": \"Crohn's disease\",\n \"MEDDRACode\": \"10011401\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"regional enteritis\",\n \"Probability\": \"0.1630475819\",\n \"SemanticContext\": \"Gastrointestinal Diseases To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis.\"\n }\n ]\n },\n {\n \"Term\": \"Cutaneous lupus erythematosus\",\n \"MEDDRACode\": \"10056509\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"discoid lupus erythematosus\",\n \"Probability\": \"0.6132032275\",\n \"SemanticContext\": \"The intralesional administration of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is indicated for alopecia areata; discoid lupus erythematosus; keloids; localized hypertrophic, infiltrated, inflammatory lesions of granuloma annulare, lichen planus, lichen simplex chronicus neurodermatitis , and psoriatic plaques; necrobiosis lipoidica diabeticorum.\"\n }\n ]\n },\n {\n \"Term\": \"Giant cell arteritis\",\n \"MEDDRACode\": \"10018250\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"temporal arteritis\",\n \"Probability\": \"0.1124004126\",\n \"SemanticContext\": \"Ophthalmic Diseases Sympathetic ophthalmia, temporal arteritis, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids.\"\n }\n ]\n },\n {\n \"Term\": \"Juvenile idiopathic arthritis\",\n \"MEDDRACode\": \"10059176\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"juvenile rheumatoid arthritis\",\n \"Probability\": \"0.0017668903\",\n \"SemanticContext\": \"Rheumatic Disorders As adjunctive therapy for short-term administration to tide the patient over an acute episode or exacerbation in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis selected cases may require low-dose maintenance therapy .\"\n }\n ]\n },\n {\n \"Term\": \"Neurodermatitis\",\n \"MEDDRACode\": \"10029263\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"neurodermatitis\",\n \"Probability\": \"0.320153743\",\n \"SemanticContext\": \"The intralesional administration of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is indicated for alopecia areata; discoid lupus erythematosus; keloids; localized hypertrophic, infiltrated, inflammatory lesions of granuloma annulare, lichen planus, lichen simplex chronicus neurodermatitis , and psoriatic plaques; necrobiosis lipoidica diabeticorum.\"\n }\n ]\n },\n {\n \"Term\": \"Skin striae\",\n \"MEDDRACode\": \"10040925\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"striae\",\n \"Probability\": \"0.9901443124\",\n \"SemanticContext\": \"Dermatologic Acne, allergic dermatitis, cutaneous and subcutaneous atrophy, dry scaly skin, ecchymoses and petechiae, edema, erythema, hyperpigmentation, hypopigmentation, impaired wound healing, increased sweating, rash, sterile abscess, striae, suppressed reactions to skin tests, thin fragile skin, thinning scalp hair, urticaria.\"\n }\n ]\n },\n {\n \"Term\": \"Perforation\",\n \"MEDDRACode\": \"10076705\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"perforation\",\n \"Probability\": \"0.00783512\",\n \"SemanticContext\": \"Gastrointestinal Abdominal distention, bowel/bladder dysfunction after intrathecal administration , elevation in serum liver enzyme levels usually reversible upon discontinuation , hepatomegaly, increased appetite, nausea, pancreatitis, peptic ulcer with possible perforation and hemorrhage, perforation of the small and large intestine particularly in patients with inflammatory bowel disease , ulcerative esophagitis.\"\n },\n {\n \"VerbatimTerm\": \"perforation\",\n \"Probability\": \"0.0098355711\",\n \"SemanticContext\": \"Gastrointestinal Abdominal distention, bowel/bladder dysfunction after intrathecal administration , elevation in serum liver enzyme levels usually reversible upon discontinuation , hepatomegaly, increased appetite, nausea, pancreatitis, peptic ulcer with possible perforation and hemorrhage, perforation of the small and large intestine particularly in patients with inflammatory bowel disease , ulcerative esophagitis.\"\n },\n {\n \"VerbatimTerm\": \"perforation\",\n \"Probability\": \"0.3528776169\",\n \"SemanticContext\": \"Gastrointestinal Steroids should be used with caution in active or latent peptic ulcers, diverticulitis, fresh intestinal anastomoses, and nonspecific ulcerative colitis, since they may increase the risk of a perforation.\"\n }\n ]\n },\n {\n \"Term\": \"Epidural injection\",\n \"MEDDRACode\": \"10072041\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"epidural injection\",\n \"Probability\": \"0.0806579888\",\n \"SemanticContext\": \"Serious Neurologic Adverse Reactions with Epidural Administration Serious neurologic events, some resulting in death, have been reported with epidural injection of corticosteroids.\"\n }\n ]\n },\n {\n \"Term\": \"Psychotic disorder\",\n \"MEDDRACode\": \"10061920\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"psychotic\",\n \"Probability\": \"0.1747502387\",\n \"SemanticContext\": \"Psychic derangements may appear when corticosteroids are used, ranging from euphoria, insomnia, mood swings, personality changes, and severe depression to frank psychotic manifestations.\"\n },\n {\n \"VerbatimTerm\": \"psychotic\",\n \"Probability\": \"0.4338344634\",\n \"SemanticContext\": \"Also, existing emotional instability or psychotic tendencies may be aggravated by corticosteroids.\"\n }\n ]\n },\n {\n \"Term\": \"Exercise adequate\",\n \"MEDDRACode\": \"10015636\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": true,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"exercised\",\n \"Probability\": \"3.803E-06\",\n \"SemanticContext\": \"Caution should be exercised when corticosteroids are administered to a nursing woman.\"\n },\n {\n \"VerbatimTerm\": \"exercised\",\n \"Probability\": \"1.04144E-05\",\n \"SemanticContext\": \"Caution should be exercised when corticosteroids are administered to a nursing woman.\"\n }\n ]\n },\n {\n \"Term\": \"Infection\",\n \"MEDDRACode\": \"10021789\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"infection\",\n \"Probability\": \"0.9585197568\",\n \"SemanticContext\": \"Other Abnormal fat deposits, decreased resistance to infection, hiccups, increased or decreased motility and number of spermatozoa, malaise, moon face, weight gain.\"\n },\n {\n \"VerbatimTerm\": \"infection\",\n \"Probability\": \"0.0003484488\",\n \"SemanticContext\": \"Information for Patients Patients should be warned not to discontinue the use of corticosteroids abruptly or without medical supervision, to advise any medical attendants that they are taking corticosteroids and to seek medical advice at once should they develop fever or other signs of infection.\"\n },\n {\n \"VerbatimTerm\": \"infection\",\n \"Probability\": \"0.006968081\",\n \"SemanticContext\": \"Corticosteroids may also mask some signs of current infection.\"\n },\n {\n \"VerbatimTerm\": \"infection\",\n \"Probability\": \"0.0003484488\",\n \"SemanticContext\": \"Information for Patients Patients should be warned not to discontinue the use of corticosteroids abruptly or without medical supervision, to advise any medical attendants that they are taking corticosteroids and to seek medical advice at once should they develop fever or other signs of infection.\"\n },\n {\n \"VerbatimTerm\": \"infection\",\n \"Probability\": \"0.0496386588\",\n \"SemanticContext\": \"Like adults, pediatric patients should be carefully observed with frequent measurements of blood pressure, weight, height, intraocular pressure, and clinical evaluation for the presence of infection, psychosocial disturbances, thromboembolism, peptic ulcers, cataracts, and osteoporosis.\"\n },\n {\n \"VerbatimTerm\": \"infection\",\n \"Probability\": \"0.0496386588\",\n \"SemanticContext\": \"Like adults, pediatric patients should be carefully observed with frequent measurements of blood pressure, weight, height, intraocular pressure, and clinical evaluation for the presence of infection, psychosocial disturbances, thromboembolism, peptic ulcers, cataracts, and osteoporosis.\"\n },\n {\n \"VerbatimTerm\": \"Infections\",\n \"Probability\": \"0.0002012551\",\n \"SemanticContext\": \"Route administration of vaccines or toxoids should be deferred until corticosteroid therapy is discontinued if possible see WARNINGS, Infections, Vaccination section .\"\n },\n {\n \"VerbatimTerm\": \"Infections\",\n \"Probability\": \"0.0199725032\",\n \"SemanticContext\": \"Infections\\nGeneral Patients who are on corticosteroids are more susceptible to infections than are healthy individuals.\"\n },\n {\n \"VerbatimTerm\": \"Infections\",\n \"Probability\": \"0.0002012551\",\n \"SemanticContext\": \"Route administration of vaccines or toxoids should be deferred until corticosteroid therapy is discontinued if possible see WARNINGS, Infections, Vaccination section .\"\n },\n {\n \"VerbatimTerm\": \"infections\",\n \"Probability\": \"0.0062551498\",\n \"SemanticContext\": \"Infections\\nGeneral Patients who are on corticosteroids are more susceptible to infections than are healthy individuals.\"\n },\n {\n \"VerbatimTerm\": \"infections\",\n \"Probability\": \"0.0172864199\",\n \"SemanticContext\": \"These infections may be mild to severe.\"\n },\n {\n \"VerbatimTerm\": \"infections\",\n \"Probability\": \"0.0025751591\",\n \"SemanticContext\": \"\\nFungal Infections Corticosteroids may exacerbate systemic fungal infections and therefore should not be used in the presence of such infections unless they are needed to control drug reactions.\"\n },\n {\n \"VerbatimTerm\": \"infections\",\n \"Probability\": \"0.0399692357\",\n \"SemanticContext\": \"\\nSpecial Pathogens Latent disease may be activated or there may be an exacerbation of intercurrent infections due to pathogens, including those caused by Amoeba, Candida, Cryptococcus, Mycobacterium, Nocardia, Pneumocystis, and Toxoplasma.\"\n },\n {\n \"VerbatimTerm\": \"infections\",\n \"Probability\": \"0.0026830435\",\n \"SemanticContext\": \"Ophthalmic Use of corticosteroids may produce posterior subcapsular cataracts, increased intraocular pressure, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to bacteria, fungi, or viruses.\"\n },\n {\n \"VerbatimTerm\": \"Infection\",\n \"Probability\": \"0.045684129\",\n \"SemanticContext\": \"Infection with any pathogen viral, bacterial, fungal, protozoan, or helminthic in any location of the body may be associated with the use of corticosteroids alone or in combination with other immunosuppressive agents.\"\n }\n ]\n },\n {\n \"Term\": \"Meningitis\",\n \"MEDDRACode\": \"10027199\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"meningitis\",\n \"Probability\": \"0.9676510096\",\n \"SemanticContext\": \"Arachnoiditis, meningitis, paraparesis/paraplegia, and sensory disturbances have occurred after intrathecal administration see WARNINGS, Neurologic section .\"\n }\n ]\n },\n {\n \"Term\": \"Social avoidant behaviour\",\n \"MEDDRACode\": \"10041243\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"withdrawn\",\n \"Probability\": \"7.4647E-06\",\n \"SemanticContext\": \"If possible, anticholinesterase agents should be withdrawn at least 24 hours before initiating corticosteroid therapy.\"\n },\n {\n \"VerbatimTerm\": \"withdrawn\",\n \"Probability\": \"0.0001446605\",\n \"SemanticContext\": \"If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.\"\n },\n {\n \"VerbatimTerm\": \"withdrawn\",\n \"Probability\": \"0.0010358393\",\n \"SemanticContext\": \"The required dose of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is first withdrawn from the vial into the syringe.\"\n },\n {\n \"VerbatimTerm\": \"withdrawn\",\n \"Probability\": \"0.0002759099\",\n \"SemanticContext\": \"Using sterile technique, a 20- to 24-gauge needle on an empty syringe is inserted into the synovial cavity and a few drops of synovial fluid are withdrawn to confirm that the needle is in the joint.\"\n },\n {\n \"VerbatimTerm\": \"withdrawn\",\n \"Probability\": \"7.4647E-06\",\n \"SemanticContext\": \"If possible, anticholinesterase agents should be withdrawn at least 24 hours before initiating corticosteroid therapy.\"\n }\n ]\n },\n {\n \"Term\": \"Hepatic enzyme\",\n \"MEDDRACode\": \"10060793\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Hepatic Enzyme\",\n \"Probability\": \"0.0014983416\",\n \"SemanticContext\": \"\\nHepatic Enzyme Inducers eg, barbiturates, phenytoin, carbamazepine, rifampin Drugs which induce hepatic microsomal drug-metabolizing enzyme activity may enhance the metabolism of corticosteroids and require that the dosage of the corticosteroid be increased.\"\n },\n {\n \"VerbatimTerm\": \"Hepatic Enzyme\",\n \"Probability\": \"0.0014983416\",\n \"SemanticContext\": \"\\nHepatic Enzyme Inducers eg, barbiturates, phenytoin, carbamazepine, rifampin Drugs which induce hepatic microsomal drug-metabolizing enzyme activity may enhance the metabolism of corticosteroids and require that the dosage of the corticosteroid be increased.\"\n }\n ]\n },\n {\n \"Term\": \"Local anaesthesia\",\n \"MEDDRACode\": \"10024758\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"local anesthetic\",\n \"Probability\": \"0.0007935762\",\n \"SemanticContext\": \"If coadministration of a local anesthetic is desired, Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension may be mixed with 1% or 2% lidocaine hydrochloride, using the formulations which do not contain parabens.\"\n },\n {\n \"VerbatimTerm\": \"local anesthetic\",\n \"Probability\": \"0.0004024804\",\n \"SemanticContext\": \"The local anesthetic is then drawn in, and the syringe shaken briefly.\"\n },\n {\n \"VerbatimTerm\": \"local anesthetics\",\n \"Probability\": \"0.0006788969\",\n \"SemanticContext\": \"Similar local anesthetics may also be used.\"\n },\n {\n \"VerbatimTerm\": \"local anesthetics\",\n \"Probability\": \"9.4923E-06\",\n \"SemanticContext\": \"Do not inject local anesthetics into the vial of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension .\"\n }\n ]\n },\n {\n \"Term\": \"Osteoporosis\",\n \"MEDDRACode\": \"10031282\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"osteoporosis\",\n \"Probability\": \"0.221250236\",\n \"SemanticContext\": \"Musculoskeletal Aseptic necrosis of femoral and humeral heads, calcinosis following intra-articular or intralesional use , Charcot-like arthropathy, loss of muscle mass, muscle weakness, osteoporosis, pathologic fracture of long bones, postinjection flare following intra-articular use , steroid myopathy, tendon rupture, vertebral compression fractures.\"\n },\n {\n \"VerbatimTerm\": \"osteoporosis\",\n \"Probability\": \"0.0007471144\",\n \"SemanticContext\": \"This, together with a decrease in the protein matrix of the bone secondary to an increase in protein catabolism, and reduced sex hormone production, may lead to inhibition of bone growth in pediatric patients and the development of osteoporosis at any age.\"\n },\n {\n \"VerbatimTerm\": \"osteoporosis\",\n \"Probability\": \"0.0002445281\",\n \"SemanticContext\": \"Special consideration should be given to patients at increased risk of osteoporosis ie, postmenopausal women before initiating corticosteroid therapy.\"\n },\n {\n \"VerbatimTerm\": \"osteoporosis\",\n \"Probability\": \"0.0227037072\",\n \"SemanticContext\": \"Like adults, pediatric patients should be carefully observed with frequent measurements of blood pressure, weight, height, intraocular pressure, and clinical evaluation for the presence of infection, psychosocial disturbances, thromboembolism, peptic ulcers, cataracts, and osteoporosis.\"\n },\n {\n \"VerbatimTerm\": \"osteoporosis\",\n \"Probability\": \"0.0227037072\",\n \"SemanticContext\": \"Like adults, pediatric patients should be carefully observed with frequent measurements of blood pressure, weight, height, intraocular pressure, and clinical evaluation for the presence of infection, psychosocial disturbances, thromboembolism, peptic ulcers, cataracts, and osteoporosis.\"\n }\n ]\n },\n {\n \"Term\": \"Paraplegia\",\n \"MEDDRACode\": \"10033892\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"paraplegia\",\n \"Probability\": \"0.9867712259\",\n \"SemanticContext\": \"Arachnoiditis, meningitis, paraparesis/paraplegia, and sensory disturbances have occurred after intrathecal administration see WARNINGS, Neurologic section .\"\n },\n {\n \"VerbatimTerm\": \"paraplegia\",\n \"Probability\": \"0.4716084898\",\n \"SemanticContext\": \"Specific events reported include, but are not limited to, spinal cord infarction, paraplegia, quadriplegia, cortical blindness, and stroke.\"\n }\n ]\n },\n {\n \"Term\": \"Bursitis\",\n \"MEDDRACode\": \"10006811\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"prepatellar bursitis\",\n \"Probability\": \"0.4466034174\",\n \"SemanticContext\": \"Bursitis, Tenosynovitis, Peritendinitis In acute subdeltoid, subacromial, olecranon, and prepatellar bursitis, one intrabursal injection of 1.0 mL Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension can relieve pain and restore full range of movement.\"\n }\n ]\n },\n {\n \"Term\": \"Gouty arthritis\",\n \"MEDDRACode\": \"10018634\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"gouty arthritis\",\n \"Probability\": \"0.1532896757\",\n \"SemanticContext\": \"Diagnosis Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension Dose mL Bursitis under heloma durum or heloma molle 0.25-0.5 under calcaneal spur 0.5 over hallux rigidus or digiti quinti varus 0.5 Tenosynovitis, periostitis of cuboid 0.5 Acute gouty arthritis 0.5-1.0 .\"\n },\n {\n \"VerbatimTerm\": \"gouty arthritis\",\n \"Probability\": \"0.0744909942\",\n \"SemanticContext\": \"Rheumatic Disorders As adjunctive therapy for short-term administration to tide the patient over an acute episode or exacerbation in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis selected cases may require low-dose maintenance therapy .\"\n },\n {\n \"VerbatimTerm\": \"gouty arthritis\",\n \"Probability\": \"0.0042401552\",\n \"SemanticContext\": \"The intra-articular or soft tissue administration of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is indicated as adjunctive therapy for short-term administration to tide the patient over an acute episode or exacerbation in acute gouty arthritis, acute and subacute bursitis, acute nonspecific tenosynovitis, epicondylitis, rheumatoid arthritis, synovitis of osteoarthritis.\"\n }\n ]\n },\n {\n \"Term\": \"Multiple sclerosis\",\n \"MEDDRACode\": \"10028245\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"multiple sclerosis\",\n \"Probability\": \"0.0001541376\",\n \"SemanticContext\": \"In the treatment of acute exacerbations of multiple sclerosis, daily doses of 30 mg of betamethasone for a week followed by 12 mg every other day for 1 month are recommended see PRECAUTIONS, Neuro-psychiatric section .\"\n },\n {\n \"VerbatimTerm\": \"multiple sclerosis\",\n \"Probability\": \"0.7853093147\",\n \"SemanticContext\": \"Nervous System Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor or craniotomy.\"\n },\n {\n \"VerbatimTerm\": \"multiple sclerosis\",\n \"Probability\": \"0.0160097182\",\n \"SemanticContext\": \"Neuro-psychiatric Although controlled clinical trials have shown corticosteroids to be effective in speeding the resolution of acute exacerbations of multiple sclerosis, they do not show that they affect the ultimate outcome or natural history of the disease.\"\n }\n ]\n },\n {\n \"Term\": \"Barbiturates\",\n \"MEDDRACode\": \"10063229\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"barbiturates\",\n \"Probability\": \"0.0132356882\",\n \"SemanticContext\": \"\\nHepatic Enzyme Inducers eg, barbiturates, phenytoin, carbamazepine, rifampin Drugs which induce hepatic microsomal drug-metabolizing enzyme activity may enhance the metabolism of corticosteroids and require that the dosage of the corticosteroid be increased.\"\n },\n {\n \"VerbatimTerm\": \"barbiturates\",\n \"Probability\": \"0.0132356882\",\n \"SemanticContext\": \"\\nHepatic Enzyme Inducers eg, barbiturates, phenytoin, carbamazepine, rifampin Drugs which induce hepatic microsomal drug-metabolizing enzyme activity may enhance the metabolism of corticosteroids and require that the dosage of the corticosteroid be increased.\"\n }\n ]\n },\n {\n \"Term\": \"Hypokalaemia\",\n \"MEDDRACode\": \"10021015\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hypokalemia\",\n \"Probability\": \"0.2461926341\",\n \"SemanticContext\": \"\\nAmphotericin B Injection and Potassium-Depleting Agents When corticosteroids are administered concomitantly with potassium-depleting agents ie, amphotericin B, diuretics , patients should be observed closely for development of hypokalemia.\"\n },\n {\n \"VerbatimTerm\": \"hypokalemia\",\n \"Probability\": \"0.3628238142\",\n \"SemanticContext\": \"\\nDigitalis Glycosides Patients on digitalis glycosides may be at increased risk of arrhythmias due to hypokalemia.\"\n },\n {\n \"VerbatimTerm\": \"hypokalemia\",\n \"Probability\": \"0.2461926341\",\n \"SemanticContext\": \"\\nAmphotericin B Injection and Potassium-Depleting Agents When corticosteroids are administered concomitantly with potassium-depleting agents ie, amphotericin B, diuretics , patients should be observed closely for development of hypokalemia.\"\n },\n {\n \"VerbatimTerm\": \"hypokalemia\",\n \"Probability\": \"0.3628238142\",\n \"SemanticContext\": \"\\nDigitalis Glycosides Patients on digitalis glycosides may be at increased risk of arrhythmias due to hypokalemia.\"\n }\n ]\n },\n {\n \"Term\": \"Myasthenia gravis\",\n \"MEDDRACode\": \"10028417\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"myasthenia gravis\",\n \"Probability\": \"0.000156492\",\n \"SemanticContext\": \"\\nAnticholinesterases Concomitant use of anticholinesterase agents and corticosteroids may produce severe weakness in patients with myasthenia gravis.\"\n },\n {\n \"VerbatimTerm\": \"myasthenia gravis\",\n \"Probability\": \"0.0157971382\",\n \"SemanticContext\": \"An acute myopathy has been observed with the use of high doses of corticosteroids, most often occurring in patients with disorders of neuromuscular transmission eg, myasthenia gravis , or in patients receiving concomitant therapy with neuromuscular blocking drugs eg, pancuronium .\"\n },\n {\n \"VerbatimTerm\": \"myasthenia gravis\",\n \"Probability\": \"0.000156492\",\n \"SemanticContext\": \"\\nAnticholinesterases Concomitant use of anticholinesterase agents and corticosteroids may produce severe weakness in patients with myasthenia gravis.\"\n }\n ]\n },\n {\n \"Term\": \"Hypercalcaemia\",\n \"MEDDRACode\": \"10020583\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hypercalcemia\",\n \"Probability\": \"0.9642394185\",\n \"SemanticContext\": \"Endocrine Disorders Congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis.\"\n }\n ]\n },\n {\n \"Term\": \"Metastatic neoplasm\",\n \"MEDDRACode\": \"10061289\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"metastatic\",\n \"Probability\": \"0.2010820806\",\n \"SemanticContext\": \"Nervous System Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor or craniotomy.\"\n }\n ]\n },\n {\n \"Term\": \"Blindness cortical\",\n \"MEDDRACode\": \"10005177\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"cortical blindness\",\n \"Probability\": \"0.9183953404\",\n \"SemanticContext\": \"Specific events reported include, but are not limited to, spinal cord infarction, paraplegia, quadriplegia, cortical blindness, and stroke.\"\n }\n ]\n },\n {\n \"Term\": \"Mineral supplementation\",\n \"MEDDRACode\": \"10053963\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"potassium supplementation\",\n \"Probability\": \"7.20068E-05\",\n \"SemanticContext\": \"Dietary salt restriction and potassium supplementation may be necessary.\"\n }\n ]\n },\n {\n \"Term\": \"Protein total\",\n \"MEDDRACode\": \"10050537\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"protein\",\n \"Probability\": \"0.0006082356\",\n \"SemanticContext\": \"Metabolic Negative nitrogen balance due to protein catabolism.\"\n },\n {\n \"VerbatimTerm\": \"protein\",\n \"Probability\": \"9.80571E-05\",\n \"SemanticContext\": \"This, together with a decrease in the protein matrix of the bone secondary to an increase in protein catabolism, and reduced sex hormone production, may lead to inhibition of bone growth in pediatric patients and the development of osteoporosis at any age.\"\n },\n {\n \"VerbatimTerm\": \"protein\",\n \"Probability\": \"4.50235E-05\",\n \"SemanticContext\": \"This, together with a decrease in the protein matrix of the bone secondary to an increase in protein catabolism, and reduced sex hormone production, may lead to inhibition of bone growth in pediatric patients and the development of osteoporosis at any age.\"\n }\n ]\n },\n {\n \"Term\": \"Blood ketone body\",\n \"MEDDRACode\": \"10057593\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"acetone\",\n \"Probability\": \"0.0002208948\",\n \"SemanticContext\": \"It is freely soluble in water and in methanol, but is practically insoluble in acetone and in chloroform.\"\n },\n {\n \"VerbatimTerm\": \"acetone\",\n \"Probability\": \"6.59293E-05\",\n \"SemanticContext\": \"It is practically insoluble in water, but freely soluble in acetone, and is soluble in alcohol and in chloroform.\"\n }\n ]\n },\n {\n \"Term\": \"Immune thrombocytopenia\",\n \"MEDDRACode\": \"10083842\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": true,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"idiopathic thrombocytopenic purpura\",\n \"Probability\": \"0.0010954142\",\n \"SemanticContext\": \"Intramuscular corticosteroid preparations are contraindicated for idiopathic thrombocytopenic purpura.\"\n }\n ]\n },\n {\n \"Term\": \"Oral contraception\",\n \"MEDDRACode\": \"10030970\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Oral Contraceptives\",\n \"Probability\": \"0.0005377531\",\n \"SemanticContext\": \"\\nEstrogens, Including Oral Contraceptives Estrogens may decrease the hepatic metabolism of certain corticosteroids, thereby increasing their effect.\"\n },\n {\n \"VerbatimTerm\": \"Oral Contraceptives\",\n \"Probability\": \"0.0005377531\",\n \"SemanticContext\": \"\\nEstrogens, Including Oral Contraceptives Estrogens may decrease the hepatic metabolism of certain corticosteroids, thereby increasing their effect.\"\n }\n ]\n },\n {\n \"Term\": \"Sympathetic ophthalmia\",\n \"MEDDRACode\": \"10042742\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Sympathetic ophthalmia\",\n \"Probability\": \"0.1706544161\",\n \"SemanticContext\": \"Ophthalmic Diseases Sympathetic ophthalmia, temporal arteritis, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids.\"\n }\n ]\n },\n {\n \"Term\": \"Steroid therapy\",\n \"MEDDRACode\": \"10062117\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"steroid therapy\",\n \"Probability\": \"1.95673E-05\",\n \"SemanticContext\": \"For chronic overdosage in the face of severe disease requiring continuous steroid therapy, the dosage of the corticosteroid may be reduced only temporarily, or alternate day treatment may be introduced.\"\n }\n ]\n },\n {\n \"Term\": \"Uveitis\",\n \"MEDDRACode\": \"10046851\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"uveitis\",\n \"Probability\": \"0.3520230055\",\n \"SemanticContext\": \"Ophthalmic Diseases Sympathetic ophthalmia, temporal arteritis, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids.\"\n }\n ]\n },\n {\n \"Term\": \"Asthma\",\n \"MEDDRACode\": \"10003553\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"asthma\",\n \"Probability\": \"0.0466814041\",\n \"SemanticContext\": \"INDICATIONS AND USAGE When oral therapy is not feasible, the intramuscular use of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is indicated as follows: Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions.\"\n },\n {\n \"VerbatimTerm\": \"asthma\",\n \"Probability\": \"0.0001035512\",\n \"SemanticContext\": \"Other indications for pediatric use of corticosteroids, eg, severe asthma and wheezing, are based on adequate and well-controlled trials conducted in adults, on the premises that the course of the diseases and their pathophysiology are considered to be substantially similar in both populations.\"\n },\n {\n \"VerbatimTerm\": \"asthma\",\n \"Probability\": \"0.0001035512\",\n \"SemanticContext\": \"Other indications for pediatric use of corticosteroids, eg, severe asthma and wheezing, are based on adequate and well-controlled trials conducted in adults, on the premises that the course of the diseases and their pathophysiology are considered to be substantially similar in both populations.\"\n }\n ]\n },\n {\n \"Term\": \"Measles\",\n \"MEDDRACode\": \"10027011\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"measles\",\n \"Probability\": \"1.31754E-05\",\n \"SemanticContext\": \"Persons who are on corticosteroids should be warned to avoid exposure to chickenpox or measles.\"\n },\n {\n \"VerbatimTerm\": \"measles\",\n \"Probability\": \"0.8368965387\",\n \"SemanticContext\": \"\\nViral Infections Chickenpox and measles can have a more serious or even fatal course in pediatric and adult patients on corticosteroids.\"\n },\n {\n \"VerbatimTerm\": \"measles\",\n \"Probability\": \"0.0004200339\",\n \"SemanticContext\": \"If exposed to measles, prophylaxis with immunoglobulin IG may be indicated.\"\n },\n {\n \"VerbatimTerm\": \"measles\",\n \"Probability\": \"1.39059E-05\",\n \"SemanticContext\": \"Persons who are on corticosteroids should be warned to avoid exposure to chickenpox or measles.\"\n }\n ]\n },\n {\n \"Term\": \"Globulin\",\n \"MEDDRACode\": \"10018342\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"globulin\",\n \"Probability\": \"7.3308E-06\",\n \"SemanticContext\": \"If exposed to chickenpox, prophylaxis with varicella zoster immune globulin VZIG may be indicated.\"\n }\n ]\n },\n {\n \"Term\": \"Spinal cord infarction\",\n \"MEDDRACode\": \"10058571\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"spinal cord infarction\",\n \"Probability\": \"0.8695024252\",\n \"SemanticContext\": \"Specific events reported include, but are not limited to, spinal cord infarction, paraplegia, quadriplegia, cortical blindness, and stroke.\"\n }\n ]\n },\n {\n \"Term\": \"Swelling\",\n \"MEDDRACode\": \"10042674\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"local swelling\",\n \"Probability\": \"0.1138755977\",\n \"SemanticContext\": \"A marked increase in pain accompanied by local swelling, further restriction of joint motion, fever, and malaise are suggestive of septic arthritis.\"\n }\n ]\n },\n {\n \"Term\": \"Aplasia pure red cell\",\n \"MEDDRACode\": \"10002965\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \", pure red cell aplasia\",\n \"Probability\": \"0.9681130648\",\n \"SemanticContext\": \"Hematologic Disorders Acquired autoimmune hemolytic anemia, Diamond-Blackfan anemia, pure red cell aplasia, selected cases of secondary thrombocytopenia.\"\n },\n {\n \"VerbatimTerm\": \"pure red cell aplasia,\",\n \"Probability\": \"0.9838365316\",\n \"SemanticContext\": \"Hematologic Disorders Acquired autoimmune hemolytic anemia, Diamond-Blackfan anemia, pure red cell aplasia, selected cases of secondary thrombocytopenia.\"\n }\n ]\n },\n {\n \"Term\": \"Carditis\",\n \"MEDDRACode\": \"10062746\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"carditis\",\n \"Probability\": \"0.1682180166\",\n \"SemanticContext\": \"Rheumatic Disorders As adjunctive therapy for short-term administration to tide the patient over an acute episode or exacerbation in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis selected cases may require low-dose maintenance therapy .\"\n }\n ]\n },\n {\n \"Term\": \"Pemphigus\",\n \"MEDDRACode\": \"10034280\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"pemphigus\",\n \"Probability\": \"0.7534125447\",\n \"SemanticContext\": \"Dermatologic Diseases Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme Stevens-Johnson syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Psoriasis\",\n \"MEDDRACode\": \"10037153\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"psoriatic plaques\",\n \"Probability\": \"0.9028086662\",\n \"SemanticContext\": \"The intralesional administration of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is indicated for alopecia areata; discoid lupus erythematosus; keloids; localized hypertrophic, infiltrated, inflammatory lesions of granuloma annulare, lichen planus, lichen simplex chronicus neurodermatitis , and psoriatic plaques; necrobiosis lipoidica diabeticorum.\"\n }\n ]\n },\n {\n \"Term\": \"Psoriatic arthropathy\",\n \"MEDDRACode\": \"10037162\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"psoriatic arthritis\",\n \"Probability\": \"9.00042E-05\",\n \"SemanticContext\": \"Rheumatic Disorders As adjunctive therapy for short-term administration to tide the patient over an acute episode or exacerbation in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis selected cases may require low-dose maintenance therapy .\"\n }\n ]\n },\n {\n \"Term\": \"Transfusion reaction\",\n \"MEDDRACode\": \"10044359\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"transfusion reactions\",\n \"Probability\": \"0.001026541\",\n \"SemanticContext\": \"INDICATIONS AND USAGE When oral therapy is not feasible, the intramuscular use of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is indicated as follows: Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions.\"\n }\n ]\n },\n {\n \"Term\": \"Trichiniasis\",\n \"MEDDRACode\": \"10044608\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Trichinosis\",\n \"Probability\": \"0.0454051495\",\n \"SemanticContext\": \"Miscellaneous Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy.\"\n }\n ]\n },\n {\n \"Term\": \"Secondary adrenocortical insufficiency\",\n \"MEDDRACode\": \"10039807\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"secondary adrenocortical insufficiency\",\n \"Probability\": \"0.0055174232\",\n \"SemanticContext\": \"Hydrocortisone or cortisone is the drug of choice in primary or secondary adrenocortical insufficiency.\"\n },\n {\n \"VerbatimTerm\": \"secondary adrenocortical insufficiency\",\n \"Probability\": \"0.0083829165\",\n \"SemanticContext\": \"Endocrine Drug-induced secondary adrenocortical insufficiency may be minimized by gradual reduction of dosage.\"\n }\n ]\n },\n {\n \"Term\": \"Cutaneous T-cell lymphoma\",\n \"MEDDRACode\": \"10011677\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"mycosis fungoides\",\n \"Probability\": \"0.9239732027\",\n \"SemanticContext\": \"Dermatologic Diseases Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme Stevens-Johnson syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Epicondylitis\",\n \"MEDDRACode\": \"10014971\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"epicondylitis\",\n \"Probability\": \"0.0014092624\",\n \"SemanticContext\": \"The intra-articular or soft tissue administration of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is indicated as adjunctive therapy for short-term administration to tide the patient over an acute episode or exacerbation in acute gouty arthritis, acute and subacute bursitis, acute nonspecific tenosynovitis, epicondylitis, rheumatoid arthritis, synovitis of osteoarthritis.\"\n }\n ]\n },\n {\n \"Term\": \"Varicella\",\n \"MEDDRACode\": \"10046980\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"chickenpox\",\n \"Probability\": \"1.87264E-05\",\n \"SemanticContext\": \"Persons who are on corticosteroids should be warned to avoid exposure to chickenpox or measles.\"\n },\n {\n \"VerbatimTerm\": \"chickenpox\",\n \"Probability\": \"0.0142869055\",\n \"SemanticContext\": \"If exposed to chickenpox, prophylaxis with varicella zoster immune globulin VZIG may be indicated.\"\n },\n {\n \"VerbatimTerm\": \"chickenpox\",\n \"Probability\": \"0.0004098415\",\n \"SemanticContext\": \"If chickenpox develops, treatment with antiviral agents should be considered.\"\n },\n {\n \"VerbatimTerm\": \"chickenpox\",\n \"Probability\": \"1.92554E-05\",\n \"SemanticContext\": \"Persons who are on corticosteroids should be warned to avoid exposure to chickenpox or measles.\"\n },\n {\n \"VerbatimTerm\": \"Chickenpox\",\n \"Probability\": \"0.3868080676\",\n \"SemanticContext\": \"\\nViral Infections Chickenpox and measles can have a more serious or even fatal course in pediatric and adult patients on corticosteroids.\"\n }\n ]\n },\n {\n \"Term\": \"Resorption bone increased\",\n \"MEDDRACode\": \"10038642\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"increase bone resorption\",\n \"Probability\": \"0.1071431041\",\n \"SemanticContext\": \"Musculoskeletal Corticosteroids decrease bone formation and increase bone resorption both through their effect on calcium regulation ie, decreasing absorption and increasing excretion and inhibition of osteoblast function.\"\n }\n ]\n },\n {\n \"Term\": \"Hyperphenylalaninaemia\",\n \"MEDDRACode\": \"10084106\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"HPA\",\n \"Probability\": \"0.0368575752\",\n \"SemanticContext\": \"Endocrine Corticosteroids can produce reversible hypothalamic pituitary adrenal HPA axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment.\"\n },\n {\n \"VerbatimTerm\": \"HPA\",\n \"Probability\": \"0.0050438046\",\n \"SemanticContext\": \"This negative impact of corticosteroids on growth has been observed at low systemic doses and in the absence of laboratory evidence of HPA axis suppression ie, cosyntropin stimulation and basal cortisol plasma levels .\"\n },\n {\n \"VerbatimTerm\": \"HPA\",\n \"Probability\": \"0.0018695891\",\n \"SemanticContext\": \"Growth velocity may therefore be a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly used tests of HPA axis function.\"\n },\n {\n \"VerbatimTerm\": \"HPA\",\n \"Probability\": \"0.0050438046\",\n \"SemanticContext\": \"This negative impact of corticosteroids on growth has been observed at low systemic doses and in the absence of laboratory evidence of HPA axis suppression ie, cosyntropin stimulation and basal cortisol plasma levels .\"\n },\n {\n \"VerbatimTerm\": \"HPA\",\n \"Probability\": \"0.0018695891\",\n \"SemanticContext\": \"Growth velocity may therefore be a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly used tests of HPA axis function.\"\n }\n ]\n },\n {\n \"Term\": \"Sepsis\",\n \"MEDDRACode\": \"10040047\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"sepsis\",\n \"Probability\": \"0.0037489235\",\n \"SemanticContext\": \"If this complication occurs and the diagnosis of sepsis is confirmed, appropriate antimicrobial therapy should be instituted.\"\n }\n ]\n },\n {\n \"Term\": \"Hypertrophic cardiomyopathy\",\n \"MEDDRACode\": \"10020871\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hypertrophic cardiomyopathy\",\n \"Probability\": \"0.9198092222\",\n \"SemanticContext\": \"Cardiovascular Bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure, fat embolism, hypertension, hypertrophic cardiomyopathy in premature infants, myocardial rupture following recent myocardial infarction see WARNINGS , pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis.\"\n }\n ]\n },\n {\n \"Term\": \"Periocular injection\",\n \"MEDDRACode\": \"10071199\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"periocular injections\",\n \"Probability\": \"0.8666328192\",\n \"SemanticContext\": \"Ophthalmic Exophthalmos, glaucoma, increased intraocular pressure, posterior subcapsular cataracts, rare instances of blindness associated with periocular injections, vision blurred.\"\n }\n ]\n },\n {\n \"Term\": \"Rash\",\n \"MEDDRACode\": \"10037844\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"rash\",\n \"Probability\": \"0.9927941561\",\n \"SemanticContext\": \"Dermatologic Acne, allergic dermatitis, cutaneous and subcutaneous atrophy, dry scaly skin, ecchymoses and petechiae, edema, erythema, hyperpigmentation, hypopigmentation, impaired wound healing, increased sweating, rash, sterile abscess, striae, suppressed reactions to skin tests, thin fragile skin, thinning scalp hair, urticaria.\"\n }\n ]\n },\n {\n \"Term\": \"Thrombophlebitis\",\n \"MEDDRACode\": \"10043570\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"thrombophlebitis\",\n \"Probability\": \"0.990190506\",\n \"SemanticContext\": \"Cardiovascular Bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure, fat embolism, hypertension, hypertrophic cardiomyopathy in premature infants, myocardial rupture following recent myocardial infarction see WARNINGS , pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis.\"\n }\n ]\n },\n {\n \"Term\": \"Neuritis\",\n \"MEDDRACode\": \"10029240\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"neuritis\",\n \"Probability\": \"0.9945985079\",\n \"SemanticContext\": \"Neurologic/Psychiatric Convulsions, depression, emotional instability, euphoria, headache, increased intracranial pressure with papilledema pseudotumor cerebri usually following discontinuation of treatment, insomnia, mood swings, neuritis, neuropathy, paresthesia, personality changes, psychic disorders, vertigo.\"\n }\n ]\n },\n {\n \"Term\": \"Intraocular pressure test\",\n \"MEDDRACode\": \"10060950\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"intraocular pressure\",\n \"Probability\": \"1.92508E-05\",\n \"SemanticContext\": \"Like adults, pediatric patients should be carefully observed with frequent measurements of blood pressure, weight, height, intraocular pressure, and clinical evaluation for the presence of infection, psychosocial disturbances, thromboembolism, peptic ulcers, cataracts, and osteoporosis.\"\n },\n {\n \"VerbatimTerm\": \"intraocular pressure\",\n \"Probability\": \"1.92508E-05\",\n \"SemanticContext\": \"Like adults, pediatric patients should be carefully observed with frequent measurements of blood pressure, weight, height, intraocular pressure, and clinical evaluation for the presence of infection, psychosocial disturbances, thromboembolism, peptic ulcers, cataracts, and osteoporosis.\"\n }\n ]\n },\n {\n \"Term\": \"Blood phosphorus\",\n \"MEDDRACode\": \"10005717\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": true,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Phosphate\",\n \"Probability\": \"0.0018841326\",\n \"SemanticContext\": \"DESCRIPTION Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is a sterile aqueous suspension containing 3 mg per milliliter betamethasone, as betamethasone sodium phosphate, and 3 mg per milliliter betamethasone acetate.\"\n },\n {\n \"VerbatimTerm\": \"Phosphate\",\n \"Probability\": \"0.0016702712\",\n \"SemanticContext\": \"CONTRAINDICATIONS Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is contraindicated in patients who are hypersensitive to any components of this product see DESCRIPTION .\"\n },\n {\n \"VerbatimTerm\": \"Phosphate\",\n \"Probability\": \"7.84435E-05\",\n \"SemanticContext\": \"The initial dosage of parenterally administered Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension may vary from 0.25 to 9.0 mg per day depending on the specific disease entity being treated.\"\n },\n {\n \"VerbatimTerm\": \"Phosphate\",\n \"Probability\": \"4.62551E-05\",\n \"SemanticContext\": \"If coadministration of a local anesthetic is desired, Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension may be mixed with 1% or 2% lidocaine hydrochloride, using the formulations which do not contain parabens.\"\n },\n {\n \"VerbatimTerm\": \"Phosphate\",\n \"Probability\": \"0.0007407665\",\n \"SemanticContext\": \"The required dose of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is first withdrawn from the vial into the syringe.\"\n },\n {\n \"VerbatimTerm\": \"Phosphate\",\n \"Probability\": \"1.78292E-05\",\n \"SemanticContext\": \"Do not inject local anesthetics into the vial of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension .\"\n },\n {\n \"VerbatimTerm\": \"Phosphate\",\n \"Probability\": \"0.0027849674\",\n \"SemanticContext\": \"Bursitis, Tenosynovitis, Peritendinitis In acute subdeltoid, subacromial, olecranon, and prepatellar bursitis, one intrabursal injection of 1.0 mL Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension can relieve pain and restore full range of movement.\"\n },\n {\n \"VerbatimTerm\": \"Phosphate\",\n \"Probability\": \"0.000951767\",\n \"SemanticContext\": \"Rheumatoid Arthritis and Osteoarthritis Following intra-articular administration of 0.5 to 2.0 mL of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension, relief of pain, soreness, and stiffness may be experienced.\"\n },\n {\n \"VerbatimTerm\": \"Phosphate\",\n \"Probability\": \"0.0001305044\",\n \"SemanticContext\": \"Intra-articular Injection of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is well tolerated in joints and periarticular tissues.\"\n },\n {\n \"VerbatimTerm\": \"Phosphate\",\n \"Probability\": \"0.000316292\",\n \"SemanticContext\": \"There is virtually no pain on injection, and the \\\"secondary flare\\\" that sometimes occurs a few hours after intra-articular injection of corticosteroids has not been reported with Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension.\"\n },\n {\n \"VerbatimTerm\": \"Phosphate\",\n \"Probability\": \"0.0002126098\",\n \"SemanticContext\": \"The aspirating syringe is replaced by a syringe containing Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension and injection is then made into the joint.\"\n },\n {\n \"VerbatimTerm\": \"Phosphate\",\n \"Probability\": \"0.0003962517\",\n \"SemanticContext\": \"A portion of the administered dose of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is absorbed systemically following intra-articular injection.\"\n },\n {\n \"VerbatimTerm\": \"Phosphate\",\n \"Probability\": \"0.0008839667\",\n \"SemanticContext\": \"Dermatologic Conditions In intralesional treatment, 0.2 mL/cm 2 of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is injected intradermally not subcutaneously using a tuberculin syringe with a 25-gauge, 1/2-inch needle.\"\n },\n {\n \"VerbatimTerm\": \"Phosphate\",\n \"Probability\": \"0.0001143761\",\n \"SemanticContext\": \"Diagnosis Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension Dose mL Bursitis under heloma durum or heloma molle 0.25-0.5 under calcaneal spur 0.5 over hallux rigidus or digiti quinti varus 0.5 Tenosynovitis, periostitis of cuboid 0.5 Acute gouty arthritis 0.5-1.0 .\"\n },\n {\n \"VerbatimTerm\": \"Phosphate\",\n \"Probability\": \"5.47399E-05\",\n \"SemanticContext\": \"INDICATIONS AND USAGE When oral therapy is not feasible, the intramuscular use of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is indicated as follows: Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions.\"\n },\n {\n \"VerbatimTerm\": \"Phosphate\",\n \"Probability\": \"0.0005810857\",\n \"SemanticContext\": \"The intra-articular or soft tissue administration of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is indicated as adjunctive therapy for short-term administration to tide the patient over an acute episode or exacerbation in acute gouty arthritis, acute and subacute bursitis, acute nonspecific tenosynovitis, epicondylitis, rheumatoid arthritis, synovitis of osteoarthritis.\"\n },\n {\n \"VerbatimTerm\": \"Phosphate\",\n \"Probability\": \"0.0004518628\",\n \"SemanticContext\": \"The intralesional administration of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is indicated for alopecia areata; discoid lupus erythematosus; keloids; localized hypertrophic, infiltrated, inflammatory lesions of granuloma annulare, lichen planus, lichen simplex chronicus neurodermatitis , and psoriatic plaques; necrobiosis lipoidica diabeticorum.\"\n },\n {\n \"VerbatimTerm\": \"Phosphate\",\n \"Probability\": \"0.0001576841\",\n \"SemanticContext\": \"Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension may also be useful in cystic tumors of an aponeurosis or tendon ganglia .\"\n },\n {\n \"VerbatimTerm\": \"Phosphate\",\n \"Probability\": \"0.0031431615\",\n \"SemanticContext\": \"WARNINGS Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension should not be administered intravenously.\"\n },\n {\n \"VerbatimTerm\": \"Phosphate\",\n \"Probability\": \"3.98965E-05\",\n \"SemanticContext\": \"High doses of corticosteroids, including Betamethasone Sodium Phosphate and Betamethasone Acetate, should not be used for the treatment of traumatic brain injury.\"\n },\n {\n \"VerbatimTerm\": \"phosphate\",\n \"Probability\": \"2.44964E-05\",\n \"SemanticContext\": \"DESCRIPTION Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is a sterile aqueous suspension containing 3 mg per milliliter betamethasone, as betamethasone sodium phosphate, and 3 mg per milliliter betamethasone acetate.\"\n },\n {\n \"VerbatimTerm\": \"phosphate\",\n \"Probability\": \"0.000279963\",\n \"SemanticContext\": \"Inactive ingredients per mL: 8.9 mg dibasic sodium phosphate dihydrate; 3.8 mg monobasic sodium phosphate dihydrate; 0.1 mg edetate disodium; and 0.2 mg benzalkonium chloride as preservative.\"\n },\n {\n \"VerbatimTerm\": \"phosphate\",\n \"Probability\": \"0.0002626181\",\n \"SemanticContext\": \"Inactive ingredients per mL: 8.9 mg dibasic sodium phosphate dihydrate; 3.8 mg monobasic sodium phosphate dihydrate; 0.1 mg edetate disodium; and 0.2 mg benzalkonium chloride as preservative.\"\n },\n {\n \"VerbatimTerm\": \"phosphate\",\n \"Probability\": \"5.19532E-05\",\n \"SemanticContext\": \"The formula for betamethasone sodium phosphate is C 22 H 28 FNa 2 0 8 P and it has a molecular weight of 516.40.\"\n },\n {\n \"VerbatimTerm\": \"phosphate\",\n \"Probability\": \"0.0004613101\",\n \"SemanticContext\": \"Chemically, it is 9-Fluoro-11ß,17,21-trihydroxy-16ß-methylpregna-1,4-diene-3,20-dione 21- disodium phosphate .\"\n },\n {\n \"VerbatimTerm\": \"phosphate\",\n \"Probability\": \"7.94276E-05\",\n \"SemanticContext\": \"The chemical structures for betamethasone sodium phosphate and betamethasone acetate are as follows: Betamethasone sodium phosphate is a white to practically white, odorless powder, and is hygroscopic.\"\n },\n {\n \"VerbatimTerm\": \"phosphate\",\n \"Probability\": \"2.84038E-05\",\n \"SemanticContext\": \"The chemical structures for betamethasone sodium phosphate and betamethasone acetate are as follows: Betamethasone sodium phosphate is a white to practically white, odorless powder, and is hygroscopic.\"\n },\n {\n \"VerbatimTerm\": \"phosphate\",\n \"Probability\": \"2.99046E-05\",\n \"SemanticContext\": \"Betamethasone sodium phosphate, a soluble ester, provides prompt activity, while betamethasone acetate is only slightly soluble and affords sustained activity.\"\n }\n ]\n },\n {\n \"Term\": \"Condom\",\n \"MEDDRACode\": \"10010274\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"sheaths\",\n \"Probability\": \"0.0001238286\",\n \"SemanticContext\": \"Injections should be made into the affected tendon sheaths rather than into the tendons themselves.\"\n },\n {\n \"VerbatimTerm\": \"sheaths\",\n \"Probability\": \"0.0003462434\",\n \"SemanticContext\": \"In ganglions of joint capsules and tendon sheaths, injection of 0.5 mL directly into the ganglion cysts has produced marked reduction in the size of the lesions.\"\n }\n ]\n },\n {\n \"Term\": \"Exostosis\",\n \"MEDDRACode\": \"10015688\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"calcaneal spur\",\n \"Probability\": \"0.8606539965\",\n \"SemanticContext\": \"Diagnosis Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension Dose mL Bursitis under heloma durum or heloma molle 0.25-0.5 under calcaneal spur 0.5 over hallux rigidus or digiti quinti varus 0.5 Tenosynovitis, periostitis of cuboid 0.5 Acute gouty arthritis 0.5-1.0 .\"\n }\n ]\n },\n {\n \"Term\": \"Analgesic drug level\",\n \"MEDDRACode\": \"10060090\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"salicylates\",\n \"Probability\": \"0.0001884699\",\n \"SemanticContext\": \"The clearance of salicylates may be increased with concurrent use of corticosteroids.\"\n },\n {\n \"VerbatimTerm\": \"salicylates\",\n \"Probability\": \"0.0001884699\",\n \"SemanticContext\": \"The clearance of salicylates may be increased with concurrent use of corticosteroids.\"\n }\n ]\n },\n {\n \"Term\": \"Adrenogenital syndrome\",\n \"MEDDRACode\": \"10061630\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Congenital adrenal hyperplasia\",\n \"Probability\": \"0.9850029945\",\n \"SemanticContext\": \"Endocrine Disorders Congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis.\"\n }\n ]\n },\n {\n \"Term\": \"Neoplasm malignant\",\n \"MEDDRACode\": \"10028997\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"cancer\",\n \"Probability\": \"0.3044053316\",\n \"SemanticContext\": \"Endocrine Disorders Congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis.\"\n }\n ]\n },\n {\n \"Term\": \"Seasonal allergy\",\n \"MEDDRACode\": \"10048908\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"seasonal allergic rhinitis\",\n \"Probability\": \"0.0007181764\",\n \"SemanticContext\": \"INDICATIONS AND USAGE When oral therapy is not feasible, the intramuscular use of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is indicated as follows: Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions.\"\n }\n ]\n },\n {\n \"Term\": \"Herpes simplex\",\n \"MEDDRACode\": \"10019948\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"herpes simplex\",\n \"Probability\": \"0.0076557696\",\n \"SemanticContext\": \"Corticosteroids should not be used in active ocular herpes simplex.\"\n }\n ]\n }\n ],\n \"IndicationTerms\": []\n }\n ]\n },\n {\n \"GenericName\": \"nitisinone\",\n \"MeddraVersion\": \"24.0\",\n \"Labels\": [\n {\n \"Id\": \"US666833b3-2e77-4272-bd81-9f785b384b01\",\n \"NDCCode\": \"70709-000\",\n \"UpdatedDate\": \"Jun 24, 2021\",\n \"LabelSource\": {\n \"Country\": \"us\",\n \"ProductId\": \"00fd1905-27e4-420e-8dc5-a69e4ddc1526\",\n \"FileId\": \"666833b3-2e77-4272-bd81-9f785b384b01\",\n \"Version\": \"8\"\n },\n \"AdverseEventTerms\": [\n {\n \"Term\": \"Abdominal pain\",\n \"MEDDRACode\": \"10000081\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"abdominal pain\",\n \"Probability\": \"0.9962461591\",\n \"SemanticContext\": \"Adverse reactions reported in less than 1% of the patients, included death, seizure, brain tumor, encephalopathy, hyperkinesia, cyanosis, abdominal pain, diarrhea, enanthema, gastrointestinal hemorrhage, melena, elevated hepatic enzymes, liver enlargement, hypoglycemia, septicemia, and bronchitis.\"\n }\n ]\n },\n {\n \"Term\": \"Brain neoplasm\",\n \"MEDDRACode\": \"10061019\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"brain tumor\",\n \"Probability\": \"0.8771100044\",\n \"SemanticContext\": \"Adverse reactions reported in less than 1% of the patients, included death, seizure, brain tumor, encephalopathy, hyperkinesia, cyanosis, abdominal pain, diarrhea, enanthema, gastrointestinal hemorrhage, melena, elevated hepatic enzymes, liver enlargement, hypoglycemia, septicemia, and bronchitis.\"\n }\n ]\n },\n {\n \"Term\": \"Benign hepatic neoplasm\",\n \"MEDDRACode\": \"10004269\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"benign hepatic neoplasms\",\n \"Probability\": \"0.4218782783\",\n \"SemanticContext\": \"These complications of HT-1 were observed in patients treated with nitisinone for a median of 22 months during the clinical trial liver transplantation 13%, liver failure 7%, malignant hepatic neoplasms 5%, benign hepatic neoplasms 3%, porphyria 1% .\"\n }\n ]\n },\n {\n \"Term\": \"Gastrointestinal haemorrhage\",\n \"MEDDRACode\": \"10017955\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"gastrointestinal hemorrhage\",\n \"Probability\": \"0.9887012839\",\n \"SemanticContext\": \"Adverse reactions reported in less than 1% of the patients, included death, seizure, brain tumor, encephalopathy, hyperkinesia, cyanosis, abdominal pain, diarrhea, enanthema, gastrointestinal hemorrhage, melena, elevated hepatic enzymes, liver enlargement, hypoglycemia, septicemia, and bronchitis.\"\n }\n ]\n },\n {\n \"Term\": \"Hyperkinesia\",\n \"MEDDRACode\": \"10020651\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hyperkinesia\",\n \"Probability\": \"0.9861875176\",\n \"SemanticContext\": \"Adverse reactions reported in less than 1% of the patients, included death, seizure, brain tumor, encephalopathy, hyperkinesia, cyanosis, abdominal pain, diarrhea, enanthema, gastrointestinal hemorrhage, melena, elevated hepatic enzymes, liver enlargement, hypoglycemia, septicemia, and bronchitis.\"\n }\n ]\n },\n {\n \"Term\": \"Hepatic enzyme\",\n \"MEDDRACode\": \"10060793\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hepatic enzymes\",\n \"Probability\": \"0.8880999088\",\n \"SemanticContext\": \"Adverse reactions reported in less than 1% of the patients, included death, seizure, brain tumor, encephalopathy, hyperkinesia, cyanosis, abdominal pain, diarrhea, enanthema, gastrointestinal hemorrhage, melena, elevated hepatic enzymes, liver enlargement, hypoglycemia, septicemia, and bronchitis.\"\n }\n ]\n },\n {\n \"Term\": \"Diarrhoea\",\n \"MEDDRACode\": \"10012735\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"diarrhea\",\n \"Probability\": \"0.9970415831\",\n \"SemanticContext\": \"Adverse reactions reported in less than 1% of the patients, included death, seizure, brain tumor, encephalopathy, hyperkinesia, cyanosis, abdominal pain, diarrhea, enanthema, gastrointestinal hemorrhage, melena, elevated hepatic enzymes, liver enlargement, hypoglycemia, septicemia, and bronchitis.\"\n }\n ]\n },\n {\n \"Term\": \"Hepatic cancer\",\n \"MEDDRACode\": \"10073069\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"malignant hepatic neoplasms\",\n \"Probability\": \"0.919803679\",\n \"SemanticContext\": \"These complications of HT-1 were observed in patients treated with nitisinone for a median of 22 months during the clinical trial liver transplantation 13%, liver failure 7%, malignant hepatic neoplasms 5%, benign hepatic neoplasms 3%, porphyria 1% .\"\n }\n ]\n },\n {\n \"Term\": \"Bronchitis\",\n \"MEDDRACode\": \"10006451\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"bronchitis\",\n \"Probability\": \"0.9891864061\",\n \"SemanticContext\": \"Adverse reactions reported in less than 1% of the patients, included death, seizure, brain tumor, encephalopathy, hyperkinesia, cyanosis, abdominal pain, diarrhea, enanthema, gastrointestinal hemorrhage, melena, elevated hepatic enzymes, liver enlargement, hypoglycemia, septicemia, and bronchitis.\"\n }\n ]\n },\n {\n \"Term\": \"Melaena\",\n \"MEDDRACode\": \"10027141\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"melena\",\n \"Probability\": \"0.9774267673\",\n \"SemanticContext\": \"Adverse reactions reported in less than 1% of the patients, included death, seizure, brain tumor, encephalopathy, hyperkinesia, cyanosis, abdominal pain, diarrhea, enanthema, gastrointestinal hemorrhage, melena, elevated hepatic enzymes, liver enlargement, hypoglycemia, septicemia, and bronchitis.\"\n }\n ]\n },\n {\n \"Term\": \"Cyanosis\",\n \"MEDDRACode\": \"10011703\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"cyanosis\",\n \"Probability\": \"0.9976474643\",\n \"SemanticContext\": \"Adverse reactions reported in less than 1% of the patients, included death, seizure, brain tumor, encephalopathy, hyperkinesia, cyanosis, abdominal pain, diarrhea, enanthema, gastrointestinal hemorrhage, melena, elevated hepatic enzymes, liver enlargement, hypoglycemia, septicemia, and bronchitis.\"\n }\n ]\n },\n {\n \"Term\": \"Hepatic failure\",\n \"MEDDRACode\": \"10019663\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"liver failure\",\n \"Probability\": \"0.7190163136\",\n \"SemanticContext\": \"Patients with HT-1 are at increased risk of developing porphyric crises, hepatic neoplasms, and liver failure requiring liver transplantation.\"\n },\n {\n \"VerbatimTerm\": \"liver failure\",\n \"Probability\": \"0.9500896931\",\n \"SemanticContext\": \"These complications of HT-1 were observed in patients treated with nitisinone for a median of 22 months during the clinical trial liver transplantation 13%, liver failure 7%, malignant hepatic neoplasms 5%, benign hepatic neoplasms 3%, porphyria 1% .\"\n }\n ]\n },\n {\n \"Term\": \"Hypoglycaemia\",\n \"MEDDRACode\": \"10020993\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hypoglycemia\",\n \"Probability\": \"0.9911644459\",\n \"SemanticContext\": \"Adverse reactions reported in less than 1% of the patients, included death, seizure, brain tumor, encephalopathy, hyperkinesia, cyanosis, abdominal pain, diarrhea, enanthema, gastrointestinal hemorrhage, melena, elevated hepatic enzymes, liver enlargement, hypoglycemia, septicemia, and bronchitis.\"\n }\n ]\n },\n {\n \"Term\": \"Hepatic neoplasm\",\n \"MEDDRACode\": \"10019695\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hepatic neoplasms\",\n \"Probability\": \"0.5599882007\",\n \"SemanticContext\": \"Patients with HT-1 are at increased risk of developing porphyric crises, hepatic neoplasms, and liver failure requiring liver transplantation.\"\n }\n ]\n },\n {\n \"Term\": \"Sepsis\",\n \"MEDDRACode\": \"10040047\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"septicemia\",\n \"Probability\": \"0.9948012233\",\n \"SemanticContext\": \"Adverse reactions reported in less than 1% of the patients, included death, seizure, brain tumor, encephalopathy, hyperkinesia, cyanosis, abdominal pain, diarrhea, enanthema, gastrointestinal hemorrhage, melena, elevated hepatic enzymes, liver enlargement, hypoglycemia, septicemia, and bronchitis.\"\n }\n ]\n },\n {\n \"Term\": \"Alpha 1 foetoprotein\",\n \"MEDDRACode\": \"10001772\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"alphafetoprotein\",\n \"Probability\": \"7.12262E-05\",\n \"SemanticContext\": \"Monitor plasma and/or urine succinylacetone concentrations, liver function parameters and alphafetoprotein levels.\"\n }\n ]\n },\n {\n \"Term\": \"Porphyria\",\n \"MEDDRACode\": \"10036181\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"porphyria\",\n \"Probability\": \"0.9967538118\",\n \"SemanticContext\": \"The most serious adverse reactions reported during nitisinone treatment were thrombocytopenia, leukopenia, porphyria, and ocular/visual complaints associated with elevated tyrosine levels [see Warnings and Precautions 5.1 , 5.2 ] .\"\n },\n {\n \"VerbatimTerm\": \"porphyria\",\n \"Probability\": \"0.9637761116\",\n \"SemanticContext\": \"These complications of HT-1 were observed in patients treated with nitisinone for a median of 22 months during the clinical trial liver transplantation 13%, liver failure 7%, malignant hepatic neoplasms 5%, benign hepatic neoplasms 3%, porphyria 1% .\"\n },\n {\n \"VerbatimTerm\": \"porphyria\",\n \"Probability\": \"0.0874952972\",\n \"SemanticContext\": \"An assessment of porphyria-like crises was performed because these events are commonly reported in patients with HT-1 who are not treated with nitisinone.\"\n },\n {\n \"VerbatimTerm\": \"Porphyria\",\n \"Probability\": \"0.8103244305\",\n \"SemanticContext\": \"Porphyria-like crisis were reported in 3 patients 0.3% of cases per year during the clinical study.\"\n }\n ]\n },\n {\n \"Term\": \"Blood creatinine\",\n \"MEDDRACode\": \"10005480\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"creatinine\",\n \"Probability\": \"4.66506E-05\",\n \"SemanticContext\": \"In all 186 patients whose urine succinylacetone was measured, the urinary succinylacetone concentration decreased to less than 1 mmol/mol creatinine, the lower limit of quantitation.\"\n },\n {\n \"VerbatimTerm\": \"creatinine\",\n \"Probability\": \"0.000847578\",\n \"SemanticContext\": \"The overall median pretreatment level was 4.3 grams/mol creatinine.\"\n },\n {\n \"VerbatimTerm\": \"creatinine\",\n \"Probability\": \"0.0006886423\",\n \"SemanticContext\": \"After one year of treatment in a subgroup of patients N=100 , overall median alpha-1-microglobulin decreased by 1.5 grams/mol creatinine.\"\n },\n {\n \"VerbatimTerm\": \"creatinine\",\n \"Probability\": \"1.33082E-05\",\n \"SemanticContext\": \"In patients 24 months of age and younger in whom multiple values were available N=65 , median alpha-1-microglobulin levels decreased from 5 to 3 grams/mol creatinine reference value for age less than or equal to12 grams/mol creatinine .\"\n },\n {\n \"VerbatimTerm\": \"creatinine\",\n \"Probability\": \"0.0018891096\",\n \"SemanticContext\": \"In patients 24 months of age and younger in whom multiple values were available N=65 , median alpha-1-microglobulin levels decreased from 5 to 3 grams/mol creatinine reference value for age less than or equal to12 grams/mol creatinine .\"\n },\n {\n \"VerbatimTerm\": \"creatinine\",\n \"Probability\": \"2.48817E-05\",\n \"SemanticContext\": \"In patients older than 24 months in whom multiple values were available N=35 , median alpha-1-microglobulin levels decreased from 2.8 to 2 grams/mol creatinine reference for age less than or equal to 6 grams/mol creatinine .\"\n },\n {\n \"VerbatimTerm\": \"creatinine\",\n \"Probability\": \"0.0049907565\",\n \"SemanticContext\": \"In patients older than 24 months in whom multiple values were available N=35 , median alpha-1-microglobulin levels decreased from 2.8 to 2 grams/mol creatinine reference for age less than or equal to 6 grams/mol creatinine .\"\n }\n ]\n },\n {\n \"Term\": \"Leukopenia\",\n \"MEDDRACode\": \"10024384\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Leukopenia\",\n \"Probability\": \"0.7281470299\",\n \"SemanticContext\": \"Leukopenia and Severe Thrombocytopenia: Monitor platelet and white blood cell counts.\"\n },\n {\n \"VerbatimTerm\": \"Leukopenia\",\n \"Probability\": \"0.9958049059\",\n \"SemanticContext\": \"*reported in at least 1% of patients; ** another oral formulation of nitisinone TABLE 1 Most Common Adverse Reactions * in Patients with HT-1 Treated with Nitisinone ** Elevated tyrosine levels >10% Leukopenia 3% Thrombocytopenia 3% Conjunctivitis 2% Corneal Opacity 2% Keratitis 2% Photophobia 2% Eye Pain 1% Blepharitis 1% Cataracts 1% Granulocytopenia 1% Epistaxis 1% Pruritus 1% Exfoliative Dermatitis 1% Dry Skin 1% Maculopapular Rash 1% Alopecia 1% .\"\n },\n {\n \"VerbatimTerm\": \"Leukopenia\",\n \"Probability\": \"0.8428916931\",\n \"SemanticContext\": \"5.2 Leukopenia and Severe Thrombocytopenia In clinical trials, patients treated with another oral formulation of nitisinone and dietary restriction developed transient leukopenia 3% , thrombocytopenia 3% , or both 1.5% [see Adverse Reactions 6.1 ] .\"\n },\n {\n \"VerbatimTerm\": \"leukopenia\",\n \"Probability\": \"0.9993851185\",\n \"SemanticContext\": \"ADVERSE REACTIONS Most common adverse reactions >1% are elevated tyrosine levels, thrombocytopenia, leukopenia, conjunctivitis, corneal opacity, keratitis, photophobia, eye pain, blepharitis, cataracts, granulocytopenia, epistaxis, pruritus, exfoliative dermatitis, dry skin, maculopapular rash and alopecia.\"\n },\n {\n \"VerbatimTerm\": \"leukopenia\",\n \"Probability\": \"0.9986950159\",\n \"SemanticContext\": \"The most serious adverse reactions reported during nitisinone treatment were thrombocytopenia, leukopenia, porphyria, and ocular/visual complaints associated with elevated tyrosine levels [see Warnings and Precautions 5.1 , 5.2 ] .\"\n },\n {\n \"VerbatimTerm\": \"leukopenia\",\n \"Probability\": \"0.5836666226\",\n \"SemanticContext\": \"No patients developed infections or bleeding as a result of the episodes of leukopenia and thrombocytopenia.\"\n },\n {\n \"VerbatimTerm\": \"leukopenia\",\n \"Probability\": \"0.9991931915\",\n \"SemanticContext\": \"5.2 Leukopenia and Severe Thrombocytopenia In clinical trials, patients treated with another oral formulation of nitisinone and dietary restriction developed transient leukopenia 3% , thrombocytopenia 3% , or both 1.5% [see Adverse Reactions 6.1 ] .\"\n },\n {\n \"VerbatimTerm\": \"leukopenia\",\n \"Probability\": \"0.9727530479\",\n \"SemanticContext\": \"No patients developed infections or bleeding as a result of the episodes of leukopenia and thrombocytopenia.\"\n }\n ]\n },\n {\n \"Term\": \"Seizure\",\n \"MEDDRACode\": \"10039906\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"seizure\",\n \"Probability\": \"0.9971814156\",\n \"SemanticContext\": \"Adverse reactions reported in less than 1% of the patients, included death, seizure, brain tumor, encephalopathy, hyperkinesia, cyanosis, abdominal pain, diarrhea, enanthema, gastrointestinal hemorrhage, melena, elevated hepatic enzymes, liver enlargement, hypoglycemia, septicemia, and bronchitis.\"\n }\n ]\n },\n {\n \"Term\": \"Encephalopathy\",\n \"MEDDRACode\": \"10014625\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"encephalopathy\",\n \"Probability\": \"0.9914292097\",\n \"SemanticContext\": \"Adverse reactions reported in less than 1% of the patients, included death, seizure, brain tumor, encephalopathy, hyperkinesia, cyanosis, abdominal pain, diarrhea, enanthema, gastrointestinal hemorrhage, melena, elevated hepatic enzymes, liver enlargement, hypoglycemia, septicemia, and bronchitis.\"\n }\n ]\n },\n {\n \"Term\": \"Liver transplant\",\n \"MEDDRACode\": \"10024714\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"liver transplant\",\n \"Probability\": \"0.0103512406\",\n \"SemanticContext\": \"Efficacy was assessed by comparison of survival and incidence of liver transplant to historical controls.\"\n }\n ]\n },\n {\n \"Term\": \"Platelet count\",\n \"MEDDRACode\": \"10035525\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"platelet counts\",\n \"Probability\": \"0.0200046599\",\n \"SemanticContext\": \"Six patients had thrombocytopenia, three of which had platelet counts 30,000/microL or lower.\"\n },\n {\n \"VerbatimTerm\": \"platelet counts\",\n \"Probability\": \"0.0016482174\",\n \"SemanticContext\": \"In 4 patients with thrombocytopenia, platelet counts gradually returned to normal duration up to 47 days without change in the nitisinone dose.\"\n },\n {\n \"VerbatimTerm\": \"platelet count\",\n \"Probability\": \"6.14E-05\",\n \"SemanticContext\": \"All patients were treated with nitisinone at a starting dose of 0.3 to 0.5 mg/kg twice daily, and the dose was increased in some patients to 1 mg/kg twice daily based on weight, liver and kidney function tests, platelet count, serum amino acids, urinary phenolic acid, plasma and urine succinylacetone, erythrocyte PBG- synthase, and urine 5-ALA..\"\n }\n ]\n },\n {\n \"Term\": \"Infection\",\n \"MEDDRACode\": \"10021789\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"infections\",\n \"Probability\": \"0.1618879437\",\n \"SemanticContext\": \"No patients developed infections or bleeding as a result of the episodes of leukopenia and thrombocytopenia.\"\n },\n {\n \"VerbatimTerm\": \"infections\",\n \"Probability\": \"0.4100490808\",\n \"SemanticContext\": \"No patients developed infections or bleeding as a result of the episodes of leukopenia and thrombocytopenia.\"\n }\n ]\n },\n {\n \"Term\": \"Blood sodium\",\n \"MEDDRACode\": \"10005799\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"5.85578E-05\",\n \"SemanticContext\": \"It is practically insoluble in water, soluble in 2M sodium hydroxide and in methanol, and sparingly soluble in alcohol.\"\n }\n ]\n },\n {\n \"Term\": \"Mass\",\n \"MEDDRACode\": \"10026865\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"mass\",\n \"Probability\": \"0.0002525449\",\n \"SemanticContext\": \"The molecular formula is C 14 H 10 F 3 NO 5 with a relative mass of 329.23.\"\n }\n ]\n },\n {\n \"Term\": \"Rash maculo-papular\",\n \"MEDDRACode\": \"10037868\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"maculopapular rash\",\n \"Probability\": \"0.9827212095\",\n \"SemanticContext\": \"ADVERSE REACTIONS Most common adverse reactions >1% are elevated tyrosine levels, thrombocytopenia, leukopenia, conjunctivitis, corneal opacity, keratitis, photophobia, eye pain, blepharitis, cataracts, granulocytopenia, epistaxis, pruritus, exfoliative dermatitis, dry skin, maculopapular rash and alopecia.\"\n },\n {\n \"VerbatimTerm\": \"Maculopapular Rash\",\n \"Probability\": \"0.9966608286\",\n \"SemanticContext\": \"*reported in at least 1% of patients; ** another oral formulation of nitisinone TABLE 1 Most Common Adverse Reactions * in Patients with HT-1 Treated with Nitisinone ** Elevated tyrosine levels >10% Leukopenia 3% Thrombocytopenia 3% Conjunctivitis 2% Corneal Opacity 2% Keratitis 2% Photophobia 2% Eye Pain 1% Blepharitis 1% Cataracts 1% Granulocytopenia 1% Epistaxis 1% Pruritus 1% Exfoliative Dermatitis 1% Dry Skin 1% Maculopapular Rash 1% Alopecia 1% .\"\n }\n ]\n },\n {\n \"Term\": \"Elderly\",\n \"MEDDRACode\": \"10014348\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": true\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"elderly\",\n \"Probability\": \"5.21771E-05\",\n \"SemanticContext\": \"In general, dose selection for an elderly patient should be cautious reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and concomitant disease or other drug therapy in this patient population.\"\n }\n ]\n },\n {\n \"Term\": \"Weight\",\n \"MEDDRACode\": \"10047890\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": true,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"weight\",\n \"Probability\": \"0.0008899271\",\n \"SemanticContext\": \"The starting dose of nitisinone was 0.3 to 0.5 mg/kg twice daily, and the dose was increased in some patients to 1 mg/kg twice daily based on weight, biochemical, and enzyme markers.\"\n },\n {\n \"VerbatimTerm\": \"weight\",\n \"Probability\": \"0.0001813769\",\n \"SemanticContext\": \"All patients were treated with nitisinone at a starting dose of 0.3 to 0.5 mg/kg twice daily, and the dose was increased in some patients to 1 mg/kg twice daily based on weight, liver and kidney function tests, platelet count, serum amino acids, urinary phenolic acid, plasma and urine succinylacetone, erythrocyte PBG- synthase, and urine 5-ALA..\"\n },\n {\n \"VerbatimTerm\": \"weight\",\n \"Probability\": \"0.0165419877\",\n \"SemanticContext\": \"In a single dose-group study in rats given 100 mg/kg 16.2 times the recommended initial dose of 1 mg/kg/day on a body surface area basis , reduced litter size, decreased pup weight at birth, and decreased survival of pups after birth was demonstrated.\"\n },\n {\n \"VerbatimTerm\": \"weight\",\n \"Probability\": \"0.0037819743\",\n \"SemanticContext\": \"Data suggest that nitisinone is present in rat milk due to findings of ocular toxicity and lower body weight seen in drug naive nursing rat pups.\"\n }\n ]\n },\n {\n \"Term\": \"Drug therapy\",\n \"MEDDRACode\": \"10063370\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": true\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"drug therapy\",\n \"Probability\": \"0.0001880527\",\n \"SemanticContext\": \"In general, dose selection for an elderly patient should be cautious reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and concomitant disease or other drug therapy in this patient population.\"\n }\n ]\n },\n {\n \"Term\": \"Epistaxis\",\n \"MEDDRACode\": \"10015090\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"epistaxis\",\n \"Probability\": \"0.9993944168\",\n \"SemanticContext\": \"ADVERSE REACTIONS Most common adverse reactions >1% are elevated tyrosine levels, thrombocytopenia, leukopenia, conjunctivitis, corneal opacity, keratitis, photophobia, eye pain, blepharitis, cataracts, granulocytopenia, epistaxis, pruritus, exfoliative dermatitis, dry skin, maculopapular rash and alopecia.\"\n },\n {\n \"VerbatimTerm\": \"Epistaxis\",\n \"Probability\": \"0.9998600483\",\n \"SemanticContext\": \"*reported in at least 1% of patients; ** another oral formulation of nitisinone TABLE 1 Most Common Adverse Reactions * in Patients with HT-1 Treated with Nitisinone ** Elevated tyrosine levels >10% Leukopenia 3% Thrombocytopenia 3% Conjunctivitis 2% Corneal Opacity 2% Keratitis 2% Photophobia 2% Eye Pain 1% Blepharitis 1% Cataracts 1% Granulocytopenia 1% Epistaxis 1% Pruritus 1% Exfoliative Dermatitis 1% Dry Skin 1% Maculopapular Rash 1% Alopecia 1% .\"\n }\n ]\n },\n {\n \"Term\": \"Pregnancy\",\n \"MEDDRACode\": \"10036556\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Pregnancy\",\n \"Probability\": \"0.0080613792\",\n \"SemanticContext\": \"8.1 Pregnancy Risk Summary Limited available data with nitisinone use in pregnant women are not sufficient to determine a drug-associated risk of adverse developmental outcomes.\"\n },\n {\n \"VerbatimTerm\": \"pregnancies\",\n \"Probability\": \"0.0507256091\",\n \"SemanticContext\": \"In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.\"\n }\n ]\n },\n {\n \"Term\": \"Haemorrhage\",\n \"MEDDRACode\": \"10055798\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"bleeding\",\n \"Probability\": \"0.7405520678\",\n \"SemanticContext\": \"No patients developed infections or bleeding as a result of the episodes of leukopenia and thrombocytopenia.\"\n },\n {\n \"VerbatimTerm\": \"bleeding\",\n \"Probability\": \"0.9396822453\",\n \"SemanticContext\": \"No patients developed infections or bleeding as a result of the episodes of leukopenia and thrombocytopenia.\"\n }\n ]\n },\n {\n \"Term\": \"Gait disturbance\",\n \"MEDDRACode\": \"10017577\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"steps\",\n \"Probability\": \"0.0004326999\",\n \"SemanticContext\": \"If patient’s dosage requires more than two tablets, follow the steps below using multiple oral syringes to achieve the required dose.\"\n },\n {\n \"VerbatimTerm\": \"steps\",\n \"Probability\": \"0.0104697645\",\n \"SemanticContext\": \"If particles are still present in the syringe, repeat steps 9-10.\"\n },\n {\n \"VerbatimTerm\": \"steps\",\n \"Probability\": \"0.0015802085\",\n \"SemanticContext\": \"If particles are still present in the syringe, repeat steps 9-10.\"\n },\n {\n \"VerbatimTerm\": \"Step\",\n \"Probability\": \"0.0007086098\",\n \"SemanticContext\": \"If more than one tablet is needed, repeat the procedure starting from Step 2 and collect all the resulting powder together in the applesauce container.\"\n }\n ]\n },\n {\n \"Term\": \"Keratopathy\",\n \"MEDDRACode\": \"10023365\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"keratopathies\",\n \"Probability\": \"0.0316928327\",\n \"SemanticContext\": \"In a clinical study in a non HT-1 population without dietary restriction and reported tyrosine levels > 500 micromol/L both symptomatic and asymptomatic keratopathies have been observed.\"\n }\n ]\n },\n {\n \"Term\": \"Ulcerative keratitis\",\n \"MEDDRACode\": \"10064996\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"corneal ulcers\",\n \"Probability\": \"0.8493527174\",\n \"SemanticContext\": \"Maintain plasma tyrosine levels below 500 micromol/L. Inadequate restriction of tyrosine and phenylalanine intake can lead to elevations in plasma tyrosine levels and levels greater than 500 micromol/L may lead to the following: Ocular signs and symptoms including corneal ulcers, corneal opacities, keratitis, conjunctivitis, eye pain, and photophobia have been reported in patients treated with nitisinone [see Adverse Reactions 6.1 ] .\"\n }\n ]\n },\n {\n \"Term\": \"Drug level\",\n \"MEDDRACode\": \"10061823\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": true\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"pharmacokinetic studies\",\n \"Probability\": \"0.0004348457\",\n \"SemanticContext\": \"No pharmacokinetic studies of nitisinone have been performed in geriatric patients.\"\n }\n ]\n },\n {\n \"Term\": \"Hepatic amoebiasis\",\n \"MEDDRACode\": \"10063741\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"ALA\",\n \"Probability\": \"0.0444850028\",\n \"SemanticContext\": \"All patients were treated with nitisinone at a starting dose of 0.3 to 0.5 mg/kg twice daily, and the dose was increased in some patients to 1 mg/kg twice daily based on weight, liver and kidney function tests, platelet count, serum amino acids, urinary phenolic acid, plasma and urine succinylacetone, erythrocyte PBG- synthase, and urine 5-ALA..\"\n },\n {\n \"VerbatimTerm\": \"ALA\",\n \"Probability\": \"0.0074394345\",\n \"SemanticContext\": \"During initiation of therapy, when switching from twice daily to once daily dosing, or if there is a deterioration in the patient’s condition, it may be necessary to follow all available biochemical parameters more closely i.e. plasma and/or urine succinylacetone, urine 5-aminolevulinate ALA and erythrocyte porphobilinogen PBG -synthase activity .\"\n }\n ]\n },\n {\n \"Term\": \"Drug interaction\",\n \"MEDDRACode\": \"10013710\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"DRUG INTERACTIONS\",\n \"Probability\": \"4.24696E-05\",\n \"SemanticContext\": \"DRUG INTERACTIONS CYP2C9 Substrates: Increased systemic exposure of these co-administered drugs; reduce the dosage.\"\n },\n {\n \"VerbatimTerm\": \"DRUG INTERACTIONS\",\n \"Probability\": \"0.0015628934\",\n \"SemanticContext\": \"7 DRUG INTERACTIONS\"\n },\n {\n \"VerbatimTerm\": \"Drug Interaction\",\n \"Probability\": \"0.0001656711\",\n \"SemanticContext\": \"Drug Interaction Studies Nitisinone does not inhibit CYP2D6.\"\n },\n {\n \"VerbatimTerm\": \"Drug Interaction\",\n \"Probability\": \"1.09566E-05\",\n \"SemanticContext\": \"In Vitro Studies Where Drug Interaction Potential Was Not Further Evaluated Clinically In vitro studies showed that nitisinone does not inhibit CYP1A2, 2C19, or 3A4.\"\n }\n ]\n },\n {\n \"Term\": \"Fasting\",\n \"MEDDRACode\": \"10068315\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"fasting\",\n \"Probability\": \"2.2028E-05\",\n \"SemanticContext\": \"Absorption The pharmacokinetic characteristics following single oral administration of 10 mg NITYR under fasting conditions are shown in TABLE 3.\"\n },\n {\n \"VerbatimTerm\": \"Fasting\",\n \"Probability\": \"2.06E-06\",\n \"SemanticContext\": \"Geometric Mean Pharmacokinetic Parameters in Healthy Subjects Following a Single Oral 10 mg Dose of NITYR Under Fasting Conditions Treatment C max ng/mL [range] T max * h [range] AUC 0-120h ng•h/mL [range] * presented as median [range] Single 10 mg NITYR Tablet fasted n=23 1278 [780 to 1649] 3.5 [1.0 to 4.0] 77874 [42335 to 104211] .\"\n },\n {\n \"VerbatimTerm\": \"fasted\",\n \"Probability\": \"0.0005966723\",\n \"SemanticContext\": \"Geometric Mean Pharmacokinetic Parameters in Healthy Subjects Following a Single Oral 10 mg Dose of NITYR Under Fasting Conditions Treatment C max ng/mL [range] T max * h [range] AUC 0-120h ng•h/mL [range] * presented as median [range] Single 10 mg NITYR Tablet fasted n=23 1278 [780 to 1649] 3.5 [1.0 to 4.0] 77874 [42335 to 104211] .\"\n },\n {\n \"VerbatimTerm\": \"Fasted\",\n \"Probability\": \"1.52327E-05\",\n \"SemanticContext\": \"After a washout period of 14 days, the mean value of plasma tyrosine was still 808 micromol/L. Fasted follow-up samples obtained from volunteers several weeks later showed tyrosine values back to normal.\"\n }\n ]\n },\n {\n \"Term\": \"Syringomyelia\",\n \"MEDDRACode\": \"10042928\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0004400611\",\n \"SemanticContext\": \"For patients who have difficulties swallowing intact tablets, including pediatric patients, the tablets can be disintegrated in water and administered using an oral syringe.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0002626181\",\n \"SemanticContext\": \"For patients, including pediatric patients, who have difficulty swallowing intact tablets, NITYR can be disintegrated in water and administered using an oral syringe.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0044604242\",\n \"SemanticContext\": \"Preparation and Administration of NITYR with Water in an Oral Syringe: A 5-mL oral syringe with a cap will be provided by a pharmacist.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"6.45052E-05\",\n \"SemanticContext\": \"Do not prepare more than two tablets at once within the same oral syringe.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0003437698\",\n \"SemanticContext\": \"One Tablet Remove the plunger from the 5-mL oral syringe and insert a single, intact tablet.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0192509592\",\n \"SemanticContext\": \"Cap the oral syringe and leave the oral syringe for at least 60 minutes.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0026107728\",\n \"SemanticContext\": \"Cap the oral syringe and leave the oral syringe for at least 60 minutes.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.003290683\",\n \"SemanticContext\": \"After 60 minutes, turn the oral syringe up and down for at least 30 seconds to suspend the material.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0024821162\",\n \"SemanticContext\": \"Inspect the syringe to ensure the tablet has disintegrated prior to administration to the patient.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0007963181\",\n \"SemanticContext\": \"If the tablet is not fully disintegrated, leave the oral syringe for an additional 10 minutes.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0001390278\",\n \"SemanticContext\": \"Before administration of the suspension to the patient, turn the oral syringe up and down for 30 seconds to re-suspend the particles.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0020206571\",\n \"SemanticContext\": \"Inspect the syringe again to ensure the tablet has disintegrated prior to administration to the patient.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"1.52671E-05\",\n \"SemanticContext\": \"However, if this is not possible, the suspension can be stored at room temperature in the capped oral syringe, protected from direct sunlight for up to 24 hours after adding water to the tablets.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0005013347\",\n \"SemanticContext\": \"Uncap the oral syringe and administer the suspension into the patient's mouth.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0010636747\",\n \"SemanticContext\": \"To facilitate full administration, avoid depressing the plunger to the end of the oral syringe and leave a gap between the plunger and the oral syringe.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0081748664\",\n \"SemanticContext\": \"To facilitate full administration, avoid depressing the plunger to the end of the oral syringe and leave a gap between the plunger and the oral syringe.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0017935336\",\n \"SemanticContext\": \"Rinse the oral syringe by drawing up 2 mL of water.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0060437918\",\n \"SemanticContext\": \"Cap the oral syringe and shake well for 10 seconds to suspend any remaining particles.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0010438263\",\n \"SemanticContext\": \"Uncap the oral syringe and administer the suspension into the patient’s mouth, this time fully depressing the plunger.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"8.06156E-05\",\n \"SemanticContext\": \"If particles are still present in the syringe, repeat steps 9-10.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0274252295\",\n \"SemanticContext\": \"Two Tablets Remove the plunger from the 5-mL oral syringe and insert two intact tablets.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0157724321\",\n \"SemanticContext\": \"Cap the oral syringe and leave it for at least 60 minutes.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.003290683\",\n \"SemanticContext\": \"After 60 minutes, turn the oral syringe up and down for at least 30 seconds to suspend the material.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0035707653\",\n \"SemanticContext\": \"Inspect the syringe to ensure the tablets have disintegrated prior to administration to the patient.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0007963181\",\n \"SemanticContext\": \"If the tablet is not fully disintegrated, leave the oral syringe for an additional 10 minutes.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0001390278\",\n \"SemanticContext\": \"Before administration of the suspension to the patient, turn the oral syringe up and down for 30 seconds to re-suspend the particles.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0020206571\",\n \"SemanticContext\": \"Inspect the syringe again to ensure the tablet has disintegrated prior to administration to the patient.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"1.52671E-05\",\n \"SemanticContext\": \"However, if this is not possible, the suspension can be stored at room temperature in the capped oral syringe, protected from direct sunlight for up to 24 hours after adding water to the tablets.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0005013347\",\n \"SemanticContext\": \"Uncap the oral syringe and administer the suspension into the patient's mouth.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0010636747\",\n \"SemanticContext\": \"To facilitate full administration, avoid depressing the plunger to the end of the oral syringe and leave a gap between the plunger and the oral syringe.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0081748664\",\n \"SemanticContext\": \"To facilitate full administration, avoid depressing the plunger to the end of the oral syringe and leave a gap between the plunger and the oral syringe.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0017935336\",\n \"SemanticContext\": \"Rinse the oral syringe by drawing up 2 mL of water.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0060437918\",\n \"SemanticContext\": \"Cap the oral syringe and shake well for 10 seconds to suspend any remaining particles.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0013137758\",\n \"SemanticContext\": \"Uncap the oral syringe and administer the suspension into the patient’s mouth, this time fully depressing the plunger and ensuring the syringe is empty.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0007374883\",\n \"SemanticContext\": \"Uncap the oral syringe and administer the suspension into the patient’s mouth, this time fully depressing the plunger and ensuring the syringe is empty.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"1.19199E-05\",\n \"SemanticContext\": \"If particles are still present in the syringe, repeat steps 9-10.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0002424717\",\n \"SemanticContext\": \"For patients, including pediatric patients, who have difficulty swallowing the intact tablets, the tablets can be disintegrated in water and administered using an oral syringe.\"\n },\n {\n \"VerbatimTerm\": \"Syringe\",\n \"Probability\": \"0.0027284026\",\n \"SemanticContext\": \"Preparation and Administration of NITYR with Water in an Oral Syringe: A 5-mL oral syringe with a cap will be provided by a pharmacist.\"\n },\n {\n \"VerbatimTerm\": \"syringes\",\n \"Probability\": \"9.10204E-05\",\n \"SemanticContext\": \"If patient’s dosage requires more than two tablets, follow the steps below using multiple oral syringes to achieve the required dose.\"\n }\n ]\n },\n {\n \"Term\": \"Euphoric mood\",\n \"MEDDRACode\": \"10015535\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"high\",\n \"Probability\": \"0.0003047287\",\n \"SemanticContext\": \"Food effect: In a food effect study, a high-fat and high-calorie breakfast 973.6 cal distributed in carbohydrate 250.1 cal, proteins 157 cal, fat 566.5 cal did not significantly affect the total exposure AUC 0-120h and C max of nitisinone following single oral administration of 10 mg NITYR.\"\n },\n {\n \"VerbatimTerm\": \"high\",\n \"Probability\": \"0.0001479089\",\n \"SemanticContext\": \"Food effect: In a food effect study, a high-fat and high-calorie breakfast 973.6 cal distributed in carbohydrate 250.1 cal, proteins 157 cal, fat 566.5 cal did not significantly affect the total exposure AUC 0-120h and C max of nitisinone following single oral administration of 10 mg NITYR.\"\n }\n ]\n },\n {\n \"Term\": \"Granulocytopenia\",\n \"MEDDRACode\": \"10018687\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"granulocytopenia\",\n \"Probability\": \"0.9953953028\",\n \"SemanticContext\": \"ADVERSE REACTIONS Most common adverse reactions >1% are elevated tyrosine levels, thrombocytopenia, leukopenia, conjunctivitis, corneal opacity, keratitis, photophobia, eye pain, blepharitis, cataracts, granulocytopenia, epistaxis, pruritus, exfoliative dermatitis, dry skin, maculopapular rash and alopecia.\"\n },\n {\n \"VerbatimTerm\": \"Granulocytopenia\",\n \"Probability\": \"0.9989602566\",\n \"SemanticContext\": \"*reported in at least 1% of patients; ** another oral formulation of nitisinone TABLE 1 Most Common Adverse Reactions * in Patients with HT-1 Treated with Nitisinone ** Elevated tyrosine levels >10% Leukopenia 3% Thrombocytopenia 3% Conjunctivitis 2% Corneal Opacity 2% Keratitis 2% Photophobia 2% Eye Pain 1% Blepharitis 1% Cataracts 1% Granulocytopenia 1% Epistaxis 1% Pruritus 1% Exfoliative Dermatitis 1% Dry Skin 1% Maculopapular Rash 1% Alopecia 1% .\"\n }\n ]\n },\n {\n \"Term\": \"Tyrosinaemia\",\n \"MEDDRACode\": \"10063443\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"tyrosinemia\",\n \"Probability\": \"0.3782399297\",\n \"SemanticContext\": \"Hyper-tyrosinemia has been reported with nitisinone treatment [see Warnings and Precautions 5.1 ].\"\n }\n ]\n },\n {\n \"Term\": \"Dry skin\",\n \"MEDDRACode\": \"10013786\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"dry skin\",\n \"Probability\": \"0.9936286211\",\n \"SemanticContext\": \"ADVERSE REACTIONS Most common adverse reactions >1% are elevated tyrosine levels, thrombocytopenia, leukopenia, conjunctivitis, corneal opacity, keratitis, photophobia, eye pain, blepharitis, cataracts, granulocytopenia, epistaxis, pruritus, exfoliative dermatitis, dry skin, maculopapular rash and alopecia.\"\n },\n {\n \"VerbatimTerm\": \"Dry Skin\",\n \"Probability\": \"0.9942692518\",\n \"SemanticContext\": \"*reported in at least 1% of patients; ** another oral formulation of nitisinone TABLE 1 Most Common Adverse Reactions * in Patients with HT-1 Treated with Nitisinone ** Elevated tyrosine levels >10% Leukopenia 3% Thrombocytopenia 3% Conjunctivitis 2% Corneal Opacity 2% Keratitis 2% Photophobia 2% Eye Pain 1% Blepharitis 1% Cataracts 1% Granulocytopenia 1% Epistaxis 1% Pruritus 1% Exfoliative Dermatitis 1% Dry Skin 1% Maculopapular Rash 1% Alopecia 1% .\"\n }\n ]\n },\n {\n \"Term\": \"Cataract\",\n \"MEDDRACode\": \"10007739\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"cataracts\",\n \"Probability\": \"0.9976519346\",\n \"SemanticContext\": \"ADVERSE REACTIONS Most common adverse reactions >1% are elevated tyrosine levels, thrombocytopenia, leukopenia, conjunctivitis, corneal opacity, keratitis, photophobia, eye pain, blepharitis, cataracts, granulocytopenia, epistaxis, pruritus, exfoliative dermatitis, dry skin, maculopapular rash and alopecia.\"\n },\n {\n \"VerbatimTerm\": \"Cataracts\",\n \"Probability\": \"0.9969762564\",\n \"SemanticContext\": \"*reported in at least 1% of patients; ** another oral formulation of nitisinone TABLE 1 Most Common Adverse Reactions * in Patients with HT-1 Treated with Nitisinone ** Elevated tyrosine levels >10% Leukopenia 3% Thrombocytopenia 3% Conjunctivitis 2% Corneal Opacity 2% Keratitis 2% Photophobia 2% Eye Pain 1% Blepharitis 1% Cataracts 1% Granulocytopenia 1% Epistaxis 1% Pruritus 1% Exfoliative Dermatitis 1% Dry Skin 1% Maculopapular Rash 1% Alopecia 1% .\"\n }\n ]\n },\n {\n \"Term\": \"Carcinogenicity\",\n \"MEDDRACode\": \"10007269\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"carcinogenicity\",\n \"Probability\": \"1.22723E-05\",\n \"SemanticContext\": \"13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility The carcinogenic potential of nitisinone was assessed in a 26-week oral gavage carcinogenicity study in Tg.rasH2 mice.\"\n }\n ]\n },\n {\n \"Term\": \"Thrombocytopenia\",\n \"MEDDRACode\": \"10043554\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Thrombocytopenia\",\n \"Probability\": \"0.9437289238\",\n \"SemanticContext\": \"Leukopenia and Severe Thrombocytopenia: Monitor platelet and white blood cell counts.\"\n },\n {\n \"VerbatimTerm\": \"Thrombocytopenia\",\n \"Probability\": \"0.9973372221\",\n \"SemanticContext\": \"*reported in at least 1% of patients; ** another oral formulation of nitisinone TABLE 1 Most Common Adverse Reactions * in Patients with HT-1 Treated with Nitisinone ** Elevated tyrosine levels >10% Leukopenia 3% Thrombocytopenia 3% Conjunctivitis 2% Corneal Opacity 2% Keratitis 2% Photophobia 2% Eye Pain 1% Blepharitis 1% Cataracts 1% Granulocytopenia 1% Epistaxis 1% Pruritus 1% Exfoliative Dermatitis 1% Dry Skin 1% Maculopapular Rash 1% Alopecia 1% .\"\n },\n {\n \"VerbatimTerm\": \"Thrombocytopenia\",\n \"Probability\": \"0.7632495761\",\n \"SemanticContext\": \"5.2 Leukopenia and Severe Thrombocytopenia In clinical trials, patients treated with another oral formulation of nitisinone and dietary restriction developed transient leukopenia 3% , thrombocytopenia 3% , or both 1.5% [see Adverse Reactions 6.1 ] .\"\n },\n {\n \"VerbatimTerm\": \"thrombocytopenia\",\n \"Probability\": \"0.9986987114\",\n \"SemanticContext\": \"ADVERSE REACTIONS Most common adverse reactions >1% are elevated tyrosine levels, thrombocytopenia, leukopenia, conjunctivitis, corneal opacity, keratitis, photophobia, eye pain, blepharitis, cataracts, granulocytopenia, epistaxis, pruritus, exfoliative dermatitis, dry skin, maculopapular rash and alopecia.\"\n },\n {\n \"VerbatimTerm\": \"thrombocytopenia\",\n \"Probability\": \"0.9986166954\",\n \"SemanticContext\": \"The most serious adverse reactions reported during nitisinone treatment were thrombocytopenia, leukopenia, porphyria, and ocular/visual complaints associated with elevated tyrosine levels [see Warnings and Precautions 5.1 , 5.2 ] .\"\n },\n {\n \"VerbatimTerm\": \"thrombocytopenia\",\n \"Probability\": \"0.957967639\",\n \"SemanticContext\": \"Six patients had thrombocytopenia, three of which had platelet counts 30,000/microL or lower.\"\n },\n {\n \"VerbatimTerm\": \"thrombocytopenia\",\n \"Probability\": \"0.0278029442\",\n \"SemanticContext\": \"In 4 patients with thrombocytopenia, platelet counts gradually returned to normal duration up to 47 days without change in the nitisinone dose.\"\n },\n {\n \"VerbatimTerm\": \"thrombocytopenia\",\n \"Probability\": \"0.3529744744\",\n \"SemanticContext\": \"No patients developed infections or bleeding as a result of the episodes of leukopenia and thrombocytopenia.\"\n },\n {\n \"VerbatimTerm\": \"thrombocytopenia\",\n \"Probability\": \"0.999733448\",\n \"SemanticContext\": \"5.2 Leukopenia and Severe Thrombocytopenia In clinical trials, patients treated with another oral formulation of nitisinone and dietary restriction developed transient leukopenia 3% , thrombocytopenia 3% , or both 1.5% [see Adverse Reactions 6.1 ] .\"\n },\n {\n \"VerbatimTerm\": \"thrombocytopenia\",\n \"Probability\": \"0.9845604897\",\n \"SemanticContext\": \"No patients developed infections or bleeding as a result of the episodes of leukopenia and thrombocytopenia.\"\n }\n ]\n },\n {\n \"Term\": \"Developmental delay\",\n \"MEDDRACode\": \"10012559\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"developmental delay\",\n \"Probability\": \"0.0147041678\",\n \"SemanticContext\": \"WARNINGS AND PRECAUTIONS Elevated Plasma Tyrosine Levels, Ocular Symptoms, Developmental Delay and Hyperkeratotic Plaques : Inadequate restriction of tyrosine and phenylalanine intake can lead to elevations in plasma tyrosine, which at levels above 500 micromol/L can result in symptoms, intellectual disability and developmental delay or painful hyperkeratotic plaques on the soles and palms; do not adjust NITYR dosage in order to lower the plasma tyrosine concentration.\"\n },\n {\n \"VerbatimTerm\": \"developmental delay\",\n \"Probability\": \"0.1244806945\",\n \"SemanticContext\": \"Elevated Plasma Tyrosine Levels, Ocular Symptoms, Developmental Delay and Hyperkeratotic Plaques Inform patients that inadequate dietary restriction may be associated with ocular signs and symptoms, intellectual disability and developmental delay, and painful hyperkeratotic plaques on the soles and palms.\"\n },\n {\n \"VerbatimTerm\": \"developmental delay\",\n \"Probability\": \"0.0448462665\",\n \"SemanticContext\": \"Variable degrees of intellectual disability and developmental delay.\"\n },\n {\n \"VerbatimTerm\": \"Developmental Delay\",\n \"Probability\": \"0.1722911298\",\n \"SemanticContext\": \"WARNINGS AND PRECAUTIONS Elevated Plasma Tyrosine Levels, Ocular Symptoms, Developmental Delay and Hyperkeratotic Plaques : Inadequate restriction of tyrosine and phenylalanine intake can lead to elevations in plasma tyrosine, which at levels above 500 micromol/L can result in symptoms, intellectual disability and developmental delay or painful hyperkeratotic plaques on the soles and palms; do not adjust NITYR dosage in order to lower the plasma tyrosine concentration.\"\n },\n {\n \"VerbatimTerm\": \"Developmental Delay\",\n \"Probability\": \"0.0101369023\",\n \"SemanticContext\": \"Elevated Plasma Tyrosine Levels, Ocular Symptoms, Developmental Delay and Hyperkeratotic Plaques Inform patients that inadequate dietary restriction may be associated with ocular signs and symptoms, intellectual disability and developmental delay, and painful hyperkeratotic plaques on the soles and palms.\"\n },\n {\n \"VerbatimTerm\": \"Developmental Delay\",\n \"Probability\": \"0.0481026173\",\n \"SemanticContext\": \"5 WARNINGS AND PRECAUTIONS 5.1 Elevated Plasma Tyrosine Levels, Ocular Symptoms, Developmental Delay and Hyperkeratotic Plaques Nitisinone is an inhibitor of 4-hydroxyphenyl-pyruvate dioxygenase, an enzyme in the tyrosine metabolic pathway [see Clinical Pharmacology 12.1 ] .\"\n }\n ]\n },\n {\n \"Term\": \"Keratitis\",\n \"MEDDRACode\": \"10023332\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"keratitis\",\n \"Probability\": \"0.9960250854\",\n \"SemanticContext\": \"ADVERSE REACTIONS Most common adverse reactions >1% are elevated tyrosine levels, thrombocytopenia, leukopenia, conjunctivitis, corneal opacity, keratitis, photophobia, eye pain, blepharitis, cataracts, granulocytopenia, epistaxis, pruritus, exfoliative dermatitis, dry skin, maculopapular rash and alopecia.\"\n },\n {\n \"VerbatimTerm\": \"keratitis\",\n \"Probability\": \"0.3959064186\",\n \"SemanticContext\": \"Maintain plasma tyrosine levels below 500 micromol/L. Inadequate restriction of tyrosine and phenylalanine intake can lead to elevations in plasma tyrosine levels and levels greater than 500 micromol/L may lead to the following: Ocular signs and symptoms including corneal ulcers, corneal opacities, keratitis, conjunctivitis, eye pain, and photophobia have been reported in patients treated with nitisinone [see Adverse Reactions 6.1 ] .\"\n },\n {\n \"VerbatimTerm\": \"Keratitis\",\n \"Probability\": \"0.9920753241\",\n \"SemanticContext\": \"*reported in at least 1% of patients; ** another oral formulation of nitisinone TABLE 1 Most Common Adverse Reactions * in Patients with HT-1 Treated with Nitisinone ** Elevated tyrosine levels >10% Leukopenia 3% Thrombocytopenia 3% Conjunctivitis 2% Corneal Opacity 2% Keratitis 2% Photophobia 2% Eye Pain 1% Blepharitis 1% Cataracts 1% Granulocytopenia 1% Epistaxis 1% Pruritus 1% Exfoliative Dermatitis 1% Dry Skin 1% Maculopapular Rash 1% Alopecia 1% .\"\n }\n ]\n },\n {\n \"Term\": \"Corneal opacity\",\n \"MEDDRACode\": \"10011035\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"corneal opacity\",\n \"Probability\": \"0.9986885786\",\n \"SemanticContext\": \"ADVERSE REACTIONS Most common adverse reactions >1% are elevated tyrosine levels, thrombocytopenia, leukopenia, conjunctivitis, corneal opacity, keratitis, photophobia, eye pain, blepharitis, cataracts, granulocytopenia, epistaxis, pruritus, exfoliative dermatitis, dry skin, maculopapular rash and alopecia.\"\n },\n {\n \"VerbatimTerm\": \"Corneal Opacity\",\n \"Probability\": \"0.9945774078\",\n \"SemanticContext\": \"*reported in at least 1% of patients; ** another oral formulation of nitisinone TABLE 1 Most Common Adverse Reactions * in Patients with HT-1 Treated with Nitisinone ** Elevated tyrosine levels >10% Leukopenia 3% Thrombocytopenia 3% Conjunctivitis 2% Corneal Opacity 2% Keratitis 2% Photophobia 2% Eye Pain 1% Blepharitis 1% Cataracts 1% Granulocytopenia 1% Epistaxis 1% Pruritus 1% Exfoliative Dermatitis 1% Dry Skin 1% Maculopapular Rash 1% Alopecia 1% .\"\n },\n {\n \"VerbatimTerm\": \"corneal opacities\",\n \"Probability\": \"0.402217567\",\n \"SemanticContext\": \"Maintain plasma tyrosine levels below 500 micromol/L. Inadequate restriction of tyrosine and phenylalanine intake can lead to elevations in plasma tyrosine levels and levels greater than 500 micromol/L may lead to the following: Ocular signs and symptoms including corneal ulcers, corneal opacities, keratitis, conjunctivitis, eye pain, and photophobia have been reported in patients treated with nitisinone [see Adverse Reactions 6.1 ] .\"\n }\n ]\n },\n {\n \"Term\": \"Ultrasound scan\",\n \"MEDDRACode\": \"10045434\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"U.S.\",\n \"Probability\": \"0.0001198693\",\n \"SemanticContext\": \"NITYR ® nitisinone tablets, for oral use Initial U.S. Approval: 2002 RECENT MAJOR CHANGES Dosage 2.1 09/2020 Warnings and Precautions 5.1 09/2020 .\"\n },\n {\n \"VerbatimTerm\": \"U.S.\",\n \"Probability\": \"0.0001934171\",\n \"SemanticContext\": \"In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.\"\n }\n ]\n },\n {\n \"Term\": \"Photophobia\",\n \"MEDDRACode\": \"10034960\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"photophobia\",\n \"Probability\": \"0.9966070652\",\n \"SemanticContext\": \"ADVERSE REACTIONS Most common adverse reactions >1% are elevated tyrosine levels, thrombocytopenia, leukopenia, conjunctivitis, corneal opacity, keratitis, photophobia, eye pain, blepharitis, cataracts, granulocytopenia, epistaxis, pruritus, exfoliative dermatitis, dry skin, maculopapular rash and alopecia.\"\n },\n {\n \"VerbatimTerm\": \"photophobia\",\n \"Probability\": \"0.1020393074\",\n \"SemanticContext\": \"Maintain plasma tyrosine levels below 500 micromol/L. Inadequate restriction of tyrosine and phenylalanine intake can lead to elevations in plasma tyrosine levels and levels greater than 500 micromol/L may lead to the following: Ocular signs and symptoms including corneal ulcers, corneal opacities, keratitis, conjunctivitis, eye pain, and photophobia have been reported in patients treated with nitisinone [see Adverse Reactions 6.1 ] .\"\n },\n {\n \"VerbatimTerm\": \"photophobia\",\n \"Probability\": \"0.0017881989\",\n \"SemanticContext\": \"Patients who develop photophobia, eye pain, or signs of inflammation such as redness, swelling, or burning of the eyes or tyrosine levels are > 500 micromol/L during treatment with NITYR should undergo slit-lamp reexamination and immediate measurement of the plasma tyrosine concentration.\"\n },\n {\n \"VerbatimTerm\": \"Photophobia\",\n \"Probability\": \"0.9932962656\",\n \"SemanticContext\": \"*reported in at least 1% of patients; ** another oral formulation of nitisinone TABLE 1 Most Common Adverse Reactions * in Patients with HT-1 Treated with Nitisinone ** Elevated tyrosine levels >10% Leukopenia 3% Thrombocytopenia 3% Conjunctivitis 2% Corneal Opacity 2% Keratitis 2% Photophobia 2% Eye Pain 1% Blepharitis 1% Cataracts 1% Granulocytopenia 1% Epistaxis 1% Pruritus 1% Exfoliative Dermatitis 1% Dry Skin 1% Maculopapular Rash 1% Alopecia 1% .\"\n }\n ]\n },\n {\n \"Term\": \"Infant\",\n \"MEDDRACode\": \"10021731\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": true,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"infant\",\n \"Probability\": \"0.0004216433\",\n \"SemanticContext\": \"8.2 Lactation Risk Summary There are no data on the presence of nitisinone in human milk, the effects on the breastfed infant, or the effects on milk production.\"\n },\n {\n \"VerbatimTerm\": \"infant\",\n \"Probability\": \"0.0001617074\",\n \"SemanticContext\": \"The development and health benefits of breastfeeding should be considered along with the mother’s clinical need for NITYR and any potential adverse effects on the breastfed infant from NITYR or from the underlying maternal condition.\"\n }\n ]\n },\n {\n \"Term\": \"Drug screen\",\n \"MEDDRACode\": \"10050837\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"UDS\",\n \"Probability\": \"5.30194E-05\",\n \"SemanticContext\": \"Nitisinone was not genotoxic in the Ames test and the in vivo mouse liver unscheduled DNA synthesis UDS test.\"\n }\n ]\n },\n {\n \"Term\": \"Alpha 1 microglobulin decreased\",\n \"MEDDRACode\": \"10070644\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"alpha-1-microglobulin decreased\",\n \"Probability\": \"0.016581893\",\n \"SemanticContext\": \"After one year of treatment in a subgroup of patients N=100 , overall median alpha-1-microglobulin decreased by 1.5 grams/mol creatinine.\"\n }\n ]\n },\n {\n \"Term\": \"Weight increased\",\n \"MEDDRACode\": \"10047899\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"weight gain\",\n \"Probability\": \"0.0102035403\",\n \"SemanticContext\": \"If the biochemical response is satisfactory undetectable blood and/or urine succinylacetone , the dosage should be adjusted only according to body weight gain and not according to plasma tyrosine levels.\"\n }\n ]\n },\n {\n \"Term\": \"Thermal burn\",\n \"MEDDRACode\": \"10053615\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"burning\",\n \"Probability\": \"2.38282E-05\",\n \"SemanticContext\": \"Patients who develop photophobia, eye pain, or signs of inflammation such as redness, swelling, or burning of the eyes or tyrosine levels are > 500 micromol/L during treatment with NITYR should undergo slit-lamp reexamination and immediate measurement of the plasma tyrosine concentration.\"\n }\n ]\n },\n {\n \"Term\": \"Hepatomegaly\",\n \"MEDDRACode\": \"10019842\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"liver enlargement\",\n \"Probability\": \"0.9987573624\",\n \"SemanticContext\": \"Adverse reactions reported in less than 1% of the patients, included death, seizure, brain tumor, encephalopathy, hyperkinesia, cyanosis, abdominal pain, diarrhea, enanthema, gastrointestinal hemorrhage, melena, elevated hepatic enzymes, liver enlargement, hypoglycemia, septicemia, and bronchitis.\"\n }\n ]\n },\n {\n \"Term\": \"Intellectual disability\",\n \"MEDDRACode\": \"10067989\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"intellectual disability\",\n \"Probability\": \"0.0345519185\",\n \"SemanticContext\": \"WARNINGS AND PRECAUTIONS Elevated Plasma Tyrosine Levels, Ocular Symptoms, Developmental Delay and Hyperkeratotic Plaques : Inadequate restriction of tyrosine and phenylalanine intake can lead to elevations in plasma tyrosine, which at levels above 500 micromol/L can result in symptoms, intellectual disability and developmental delay or painful hyperkeratotic plaques on the soles and palms; do not adjust NITYR dosage in order to lower the plasma tyrosine concentration.\"\n },\n {\n \"VerbatimTerm\": \"intellectual disability\",\n \"Probability\": \"0.0740502179\",\n \"SemanticContext\": \"Elevated Plasma Tyrosine Levels, Ocular Symptoms, Developmental Delay and Hyperkeratotic Plaques Inform patients that inadequate dietary restriction may be associated with ocular signs and symptoms, intellectual disability and developmental delay, and painful hyperkeratotic plaques on the soles and palms.\"\n },\n {\n \"VerbatimTerm\": \"intellectual disability\",\n \"Probability\": \"0.0342915356\",\n \"SemanticContext\": \"Variable degrees of intellectual disability and developmental delay.\"\n }\n ]\n },\n {\n \"Term\": \"Abortion spontaneous\",\n \"MEDDRACode\": \"10000234\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"miscarriage\",\n \"Probability\": \"0.3019028306\",\n \"SemanticContext\": \"The background risk of major birth defects and miscarriage for the indicated population are unknown.\"\n },\n {\n \"VerbatimTerm\": \"miscarriage\",\n \"Probability\": \"0.7700802088\",\n \"SemanticContext\": \"In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.\"\n }\n ]\n },\n {\n \"Term\": \"Erythema\",\n \"MEDDRACode\": \"10015150\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"redness\",\n \"Probability\": \"0.0009130239\",\n \"SemanticContext\": \"Patients who develop photophobia, eye pain, or signs of inflammation such as redness, swelling, or burning of the eyes or tyrosine levels are > 500 micromol/L during treatment with NITYR should undergo slit-lamp reexamination and immediate measurement of the plasma tyrosine concentration.\"\n }\n ]\n },\n {\n \"Term\": \"Blood methanol\",\n \"MEDDRACode\": \"10005663\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"methanol\",\n \"Probability\": \"0.0001478791\",\n \"SemanticContext\": \"It is practically insoluble in water, soluble in 2M sodium hydroxide and in methanol, and sparingly soluble in alcohol.\"\n }\n ]\n },\n {\n \"Term\": \"Dermatitis exfoliative\",\n \"MEDDRACode\": \"10012455\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"exfoliative dermatitis\",\n \"Probability\": \"0.9974045753\",\n \"SemanticContext\": \"ADVERSE REACTIONS Most common adverse reactions >1% are elevated tyrosine levels, thrombocytopenia, leukopenia, conjunctivitis, corneal opacity, keratitis, photophobia, eye pain, blepharitis, cataracts, granulocytopenia, epistaxis, pruritus, exfoliative dermatitis, dry skin, maculopapular rash and alopecia.\"\n },\n {\n \"VerbatimTerm\": \"Exfoliative Dermatitis\",\n \"Probability\": \"0.9964780807\",\n \"SemanticContext\": \"*reported in at least 1% of patients; ** another oral formulation of nitisinone TABLE 1 Most Common Adverse Reactions * in Patients with HT-1 Treated with Nitisinone ** Elevated tyrosine levels >10% Leukopenia 3% Thrombocytopenia 3% Conjunctivitis 2% Corneal Opacity 2% Keratitis 2% Photophobia 2% Eye Pain 1% Blepharitis 1% Cataracts 1% Granulocytopenia 1% Epistaxis 1% Pruritus 1% Exfoliative Dermatitis 1% Dry Skin 1% Maculopapular Rash 1% Alopecia 1% .\"\n }\n ]\n },\n {\n \"Term\": \"Blood pyruvic acid\",\n \"MEDDRACode\": \"10005784\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"pyruvate\",\n \"Probability\": \"0.0004402995\",\n \"SemanticContext\": \"INDICATIONS AND USAGE NITYR is a hydroxyphenyl-pyruvate dioxygenase inhibitor indicated for the treatment of adult and pediatric patients with hereditary tyrosinemia type 1 HT-1 in combination with dietary restriction of tyrosine and phenylalanine.\"\n },\n {\n \"VerbatimTerm\": \"pyruvate\",\n \"Probability\": \"6.89497E-05\",\n \"SemanticContext\": \"11 DESCRIPTION NITYR contains nitisinone, which is a hydroxyphenyl-pyruvate dioxygenase inhibitor indicated as an adjunct to dietary restriction of tyrosine and phenylalanine in the treatment of hereditary tyrosinemia type 1 HT-1 .\"\n },\n {\n \"VerbatimTerm\": \"pyruvate\",\n \"Probability\": \"4.35974E-05\",\n \"SemanticContext\": \"Figure 1 Structural Formula 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Nitisinone is a competitive inhibitor of 4-hydroxyphenyl-pyruvate dioxygenase, an enzyme upstream of fumarylacetoacetate hydrolase FAH in the tyrosine catabolic pathway.\"\n },\n {\n \"VerbatimTerm\": \"pyruvate\",\n \"Probability\": \"8.98209E-05\",\n \"SemanticContext\": \"5 WARNINGS AND PRECAUTIONS 5.1 Elevated Plasma Tyrosine Levels, Ocular Symptoms, Developmental Delay and Hyperkeratotic Plaques Nitisinone is an inhibitor of 4-hydroxyphenyl-pyruvate dioxygenase, an enzyme in the tyrosine metabolic pathway [see Clinical Pharmacology 12.1 ] .\"\n }\n ]\n },\n {\n \"Term\": \"Blepharitis\",\n \"MEDDRACode\": \"10005148\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"blepharitis\",\n \"Probability\": \"0.9968597889\",\n \"SemanticContext\": \"ADVERSE REACTIONS Most common adverse reactions >1% are elevated tyrosine levels, thrombocytopenia, leukopenia, conjunctivitis, corneal opacity, keratitis, photophobia, eye pain, blepharitis, cataracts, granulocytopenia, epistaxis, pruritus, exfoliative dermatitis, dry skin, maculopapular rash and alopecia.\"\n },\n {\n \"VerbatimTerm\": \"Blepharitis\",\n \"Probability\": \"0.9916366935\",\n \"SemanticContext\": \"*reported in at least 1% of patients; ** another oral formulation of nitisinone TABLE 1 Most Common Adverse Reactions * in Patients with HT-1 Treated with Nitisinone ** Elevated tyrosine levels >10% Leukopenia 3% Thrombocytopenia 3% Conjunctivitis 2% Corneal Opacity 2% Keratitis 2% Photophobia 2% Eye Pain 1% Blepharitis 1% Cataracts 1% Granulocytopenia 1% Epistaxis 1% Pruritus 1% Exfoliative Dermatitis 1% Dry Skin 1% Maculopapular Rash 1% Alopecia 1% .\"\n }\n ]\n },\n {\n \"Term\": \"Slit-lamp examination\",\n \"MEDDRACode\": \"10041031\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"slit-lamp examination\",\n \"Probability\": \"0.0001762211\",\n \"SemanticContext\": \"Obtain slit-lamp examination prior to treatment, regularly during treatment; Reexamine patients if symptoms develop or tyrosine levels are > 500 micromol/L. Assess plasma tyrosine levels in patients with an abrupt change in neurologic status.\"\n },\n {\n \"VerbatimTerm\": \"slit-lamp examination\",\n \"Probability\": \"1.3375E-05\",\n \"SemanticContext\": \"Therefore, perform a baseline ophthalmologic examination including slit-lamp examination prior to initiating NITYR treatment and regularly thereafter.\"\n }\n ]\n },\n {\n \"Term\": \"White blood cell count\",\n \"MEDDRACode\": \"10047939\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"white blood cell counts\",\n \"Probability\": \"0.0060758591\",\n \"SemanticContext\": \"Leukopenia and Severe Thrombocytopenia: Monitor platelet and white blood cell counts.\"\n },\n {\n \"VerbatimTerm\": \"white blood cell counts\",\n \"Probability\": \"0.00435251\",\n \"SemanticContext\": \"Monitor platelet and white blood cell counts during NITYR therapy.\"\n }\n ]\n },\n {\n \"Term\": \"Eye pain\",\n \"MEDDRACode\": \"10015958\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"eye pain\",\n \"Probability\": \"0.9916943312\",\n \"SemanticContext\": \"ADVERSE REACTIONS Most common adverse reactions >1% are elevated tyrosine levels, thrombocytopenia, leukopenia, conjunctivitis, corneal opacity, keratitis, photophobia, eye pain, blepharitis, cataracts, granulocytopenia, epistaxis, pruritus, exfoliative dermatitis, dry skin, maculopapular rash and alopecia.\"\n },\n {\n \"VerbatimTerm\": \"eye pain\",\n \"Probability\": \"0.2802772522\",\n \"SemanticContext\": \"Maintain plasma tyrosine levels below 500 micromol/L. Inadequate restriction of tyrosine and phenylalanine intake can lead to elevations in plasma tyrosine levels and levels greater than 500 micromol/L may lead to the following: Ocular signs and symptoms including corneal ulcers, corneal opacities, keratitis, conjunctivitis, eye pain, and photophobia have been reported in patients treated with nitisinone [see Adverse Reactions 6.1 ] .\"\n },\n {\n \"VerbatimTerm\": \"eye pain\",\n \"Probability\": \"0.001738131\",\n \"SemanticContext\": \"Patients who develop photophobia, eye pain, or signs of inflammation such as redness, swelling, or burning of the eyes or tyrosine levels are > 500 micromol/L during treatment with NITYR should undergo slit-lamp reexamination and immediate measurement of the plasma tyrosine concentration.\"\n },\n {\n \"VerbatimTerm\": \"Eye Pain\",\n \"Probability\": \"0.9862341881\",\n \"SemanticContext\": \"*reported in at least 1% of patients; ** another oral formulation of nitisinone TABLE 1 Most Common Adverse Reactions * in Patients with HT-1 Treated with Nitisinone ** Elevated tyrosine levels >10% Leukopenia 3% Thrombocytopenia 3% Conjunctivitis 2% Corneal Opacity 2% Keratitis 2% Photophobia 2% Eye Pain 1% Blepharitis 1% Cataracts 1% Granulocytopenia 1% Epistaxis 1% Pruritus 1% Exfoliative Dermatitis 1% Dry Skin 1% Maculopapular Rash 1% Alopecia 1% .\"\n }\n ]\n },\n {\n \"Term\": \"Succinylacetone\",\n \"MEDDRACode\": \"10069456\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"succinylacetone\",\n \"Probability\": \"7.11323E-05\",\n \"SemanticContext\": \"In patients 5 years of age and older who have undetectable serum and urine succinylacetone concentrations after a minimum of 4 weeks on a stable dosage of nitisinone, the total daily dose may be given once daily.\"\n },\n {\n \"VerbatimTerm\": \"succinylacetone\",\n \"Probability\": \"0.0037440956\",\n \"SemanticContext\": \"Nitisinone was studied in one open-label, uncontrolled study of 207 patients with HT-1, ages 0 to 22 years at enrollment median age 9 months , who were diagnosed with HT-1 by the presence of succinylacetone in the urine or plasma.\"\n },\n {\n \"VerbatimTerm\": \"succinylacetone\",\n \"Probability\": \"0.0440132916\",\n \"SemanticContext\": \"In patients with HT-1, these catabolic intermediates are converted to the toxic metabolites succinylacetone and succinylacetoacetate, which are responsible for the observed liver and kidney toxicity.\"\n },\n {\n \"VerbatimTerm\": \"succinylacetone\",\n \"Probability\": \"0.002638191\",\n \"SemanticContext\": \"12.2 Pharmacodynamics In a clinical study, patients with HT-1 were diagnosed by the presence of succinylacetone in urine or plasma and treated with another oral formulation of nitisinone [see Clinical Studies 14 ].\"\n },\n {\n \"VerbatimTerm\": \"succinylacetone\",\n \"Probability\": \"0.0052025318\",\n \"SemanticContext\": \"In all 186 patients whose urine succinylacetone was measured, the urinary succinylacetone concentration decreased to less than 1 mmol/mol creatinine, the lower limit of quantitation.\"\n },\n {\n \"VerbatimTerm\": \"succinylacetone\",\n \"Probability\": \"0.0007870793\",\n \"SemanticContext\": \"In all 186 patients whose urine succinylacetone was measured, the urinary succinylacetone concentration decreased to less than 1 mmol/mol creatinine, the lower limit of quantitation.\"\n },\n {\n \"VerbatimTerm\": \"succinylacetone\",\n \"Probability\": \"0.0037432015\",\n \"SemanticContext\": \"The median time to normalization of urine succinylacetone was 0.3 months.\"\n },\n {\n \"VerbatimTerm\": \"succinylacetone\",\n \"Probability\": \"0.004845202\",\n \"SemanticContext\": \"The probability of recurrence of abnormal values of urine succinylacetone was 1% at a nitisinone concentration of 37 micromol/L 95% confidence interval: 23, 51 micromol/L .\"\n },\n {\n \"VerbatimTerm\": \"succinylacetone\",\n \"Probability\": \"0.0041420758\",\n \"SemanticContext\": \"In 87% 150/172 of patients whose plasma succinylacetone was measured, the plasma succinylacetone concentration decreased to less than 0.1 micromol/L, the lower limit of quantitation.\"\n },\n {\n \"VerbatimTerm\": \"succinylacetone\",\n \"Probability\": \"0.0002055466\",\n \"SemanticContext\": \"In 87% 150/172 of patients whose plasma succinylacetone was measured, the plasma succinylacetone concentration decreased to less than 0.1 micromol/L, the lower limit of quantitation.\"\n },\n {\n \"VerbatimTerm\": \"succinylacetone\",\n \"Probability\": \"0.0004523695\",\n \"SemanticContext\": \"The median time to normalization of plasma succinylacetone was 3.9 months.\"\n },\n {\n \"VerbatimTerm\": \"succinylacetone\",\n \"Probability\": \"0.0100154579\",\n \"SemanticContext\": \"In another study, comparing two dosing regimens of another oral formulation of nitisinone, succinylacetone was measured in urine and/or blood in 16 patients with HT-1 aged 5 years to 24 years.\"\n },\n {\n \"VerbatimTerm\": \"succinylacetone\",\n \"Probability\": \"8.53974E-05\",\n \"SemanticContext\": \"After at least 4 weeks of twice daily dosing with nitisinone, both the urine and/or blood succinylacetone concentrations were below the limit of quantitation for the assay.\"\n },\n {\n \"VerbatimTerm\": \"succinylacetone\",\n \"Probability\": \"5.82679E-05\",\n \"SemanticContext\": \"Patients were then switched to once daily dosing with the same total daily dosage of nitisinone and blood and/or urine succinylacetone concentrations remained undetectable when measured following at least 4 weeks of treatment with once daily dosing.\"\n },\n {\n \"VerbatimTerm\": \"succinylacetone\",\n \"Probability\": \"0.0021595955\",\n \"SemanticContext\": \"Patients were diagnosed with HT-1 by the presence of succinylacetone in the urine or plasma.\"\n },\n {\n \"VerbatimTerm\": \"succinylacetone\",\n \"Probability\": \"0.0025373399\",\n \"SemanticContext\": \"All patients were treated with nitisinone at a starting dose of 0.3 to 0.5 mg/kg twice daily, and the dose was increased in some patients to 1 mg/kg twice daily based on weight, liver and kidney function tests, platelet count, serum amino acids, urinary phenolic acid, plasma and urine succinylacetone, erythrocyte PBG- synthase, and urine 5-ALA..\"\n },\n {\n \"VerbatimTerm\": \"succinylacetone\",\n \"Probability\": \"5.2801E-05\",\n \"SemanticContext\": \"The effects of nitisinone on urine and plasma succinylacetone, porphyrin metabolism, and urinary alpha-1-microglobulin were also assessed in this clinical study.\"\n },\n {\n \"VerbatimTerm\": \"succinylacetone\",\n \"Probability\": \"3.80618E-05\",\n \"SemanticContext\": \"Maintenance Regimen In patients 5 years of age and older who have undetectable serum and urine succinylacetone concentrations after a minimum of 4 weeks on a stable dosage of nitisinone, the total daily dose of NITYR may be given once daily e.g., 1 to 2 mg/kg once daily [see Clinical Pharmacology 12.2 ] .\"\n },\n {\n \"VerbatimTerm\": \"succinylacetone\",\n \"Probability\": \"5.64748E-05\",\n \"SemanticContext\": \"Monitor plasma and/or urine succinylacetone concentrations, liver function parameters and alphafetoprotein levels.\"\n },\n {\n \"VerbatimTerm\": \"succinylacetone\",\n \"Probability\": \"0.0001119899\",\n \"SemanticContext\": \"If succinylacetone is still detectable in blood or urine 4 weeks after the start of nitisinone treatment, increase the NITYR dosage to 0.75 mg/kg twice daily.\"\n },\n {\n \"VerbatimTerm\": \"succinylacetone\",\n \"Probability\": \"1.38249E-05\",\n \"SemanticContext\": \"If the biochemical response is satisfactory undetectable blood and/or urine succinylacetone , the dosage should be adjusted only according to body weight gain and not according to plasma tyrosine levels.\"\n },\n {\n \"VerbatimTerm\": \"succinylacetone\",\n \"Probability\": \"0.0014832914\",\n \"SemanticContext\": \"During initiation of therapy, when switching from twice daily to once daily dosing, or if there is a deterioration in the patient’s condition, it may be necessary to follow all available biochemical parameters more closely i.e. plasma and/or urine succinylacetone, urine 5-aminolevulinate ALA and erythrocyte porphobilinogen PBG -synthase activity .\"\n },\n {\n \"VerbatimTerm\": \"Succinylacetone\",\n \"Probability\": \"0.0578671098\",\n \"SemanticContext\": \"Succinylacetone can also inhibit the porphyrin synthesis pathway leading to the accumulation of 5-aminolevulinate, a neurotoxin responsible for the porphyric crises characteristic of HT-1.\"\n }\n ]\n },\n {\n \"Term\": \"Conjunctivitis\",\n \"MEDDRACode\": \"10010741\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"conjunctivitis\",\n \"Probability\": \"0.9998996258\",\n \"SemanticContext\": \"ADVERSE REACTIONS Most common adverse reactions >1% are elevated tyrosine levels, thrombocytopenia, leukopenia, conjunctivitis, corneal opacity, keratitis, photophobia, eye pain, blepharitis, cataracts, granulocytopenia, epistaxis, pruritus, exfoliative dermatitis, dry skin, maculopapular rash and alopecia.\"\n },\n {\n \"VerbatimTerm\": \"conjunctivitis\",\n \"Probability\": \"0.4590257704\",\n \"SemanticContext\": \"Maintain plasma tyrosine levels below 500 micromol/L. Inadequate restriction of tyrosine and phenylalanine intake can lead to elevations in plasma tyrosine levels and levels greater than 500 micromol/L may lead to the following: Ocular signs and symptoms including corneal ulcers, corneal opacities, keratitis, conjunctivitis, eye pain, and photophobia have been reported in patients treated with nitisinone [see Adverse Reactions 6.1 ] .\"\n },\n {\n \"VerbatimTerm\": \"Conjunctivitis\",\n \"Probability\": \"0.9989107847\",\n \"SemanticContext\": \"*reported in at least 1% of patients; ** another oral formulation of nitisinone TABLE 1 Most Common Adverse Reactions * in Patients with HT-1 Treated with Nitisinone ** Elevated tyrosine levels >10% Leukopenia 3% Thrombocytopenia 3% Conjunctivitis 2% Corneal Opacity 2% Keratitis 2% Photophobia 2% Eye Pain 1% Blepharitis 1% Cataracts 1% Granulocytopenia 1% Epistaxis 1% Pruritus 1% Exfoliative Dermatitis 1% Dry Skin 1% Maculopapular Rash 1% Alopecia 1% .\"\n }\n ]\n },\n {\n \"Term\": \"Alopecia\",\n \"MEDDRACode\": \"10001760\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"alopecia\",\n \"Probability\": \"0.9942157269\",\n \"SemanticContext\": \"ADVERSE REACTIONS Most common adverse reactions >1% are elevated tyrosine levels, thrombocytopenia, leukopenia, conjunctivitis, corneal opacity, keratitis, photophobia, eye pain, blepharitis, cataracts, granulocytopenia, epistaxis, pruritus, exfoliative dermatitis, dry skin, maculopapular rash and alopecia.\"\n },\n {\n \"VerbatimTerm\": \"Alopecia\",\n \"Probability\": \"0.998177886\",\n \"SemanticContext\": \"*reported in at least 1% of patients; ** another oral formulation of nitisinone TABLE 1 Most Common Adverse Reactions * in Patients with HT-1 Treated with Nitisinone ** Elevated tyrosine levels >10% Leukopenia 3% Thrombocytopenia 3% Conjunctivitis 2% Corneal Opacity 2% Keratitis 2% Photophobia 2% Eye Pain 1% Blepharitis 1% Cataracts 1% Granulocytopenia 1% Epistaxis 1% Pruritus 1% Exfoliative Dermatitis 1% Dry Skin 1% Maculopapular Rash 1% Alopecia 1% .\"\n }\n ]\n },\n {\n \"Term\": \"Pruritus\",\n \"MEDDRACode\": \"10037087\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"pruritus\",\n \"Probability\": \"0.9994251728\",\n \"SemanticContext\": \"ADVERSE REACTIONS Most common adverse reactions >1% are elevated tyrosine levels, thrombocytopenia, leukopenia, conjunctivitis, corneal opacity, keratitis, photophobia, eye pain, blepharitis, cataracts, granulocytopenia, epistaxis, pruritus, exfoliative dermatitis, dry skin, maculopapular rash and alopecia.\"\n },\n {\n \"VerbatimTerm\": \"Pruritus\",\n \"Probability\": \"0.9995413423\",\n \"SemanticContext\": \"*reported in at least 1% of patients; ** another oral formulation of nitisinone TABLE 1 Most Common Adverse Reactions * in Patients with HT-1 Treated with Nitisinone ** Elevated tyrosine levels >10% Leukopenia 3% Thrombocytopenia 3% Conjunctivitis 2% Corneal Opacity 2% Keratitis 2% Photophobia 2% Eye Pain 1% Blepharitis 1% Cataracts 1% Granulocytopenia 1% Epistaxis 1% Pruritus 1% Exfoliative Dermatitis 1% Dry Skin 1% Maculopapular Rash 1% Alopecia 1% .\"\n }\n ]\n },\n {\n \"Term\": \"Breast feeding\",\n \"MEDDRACode\": \"10006247\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": true,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"breastfed\",\n \"Probability\": \"0.0002129078\",\n \"SemanticContext\": \"8.2 Lactation Risk Summary There are no data on the presence of nitisinone in human milk, the effects on the breastfed infant, or the effects on milk production.\"\n },\n {\n \"VerbatimTerm\": \"breastfed\",\n \"Probability\": \"6.20559E-05\",\n \"SemanticContext\": \"The development and health benefits of breastfeeding should be considered along with the mother’s clinical need for NITYR and any potential adverse effects on the breastfed infant from NITYR or from the underlying maternal condition.\"\n },\n {\n \"VerbatimTerm\": \"breastfeeding\",\n \"Probability\": \"4.87741E-05\",\n \"SemanticContext\": \"The development and health benefits of breastfeeding should be considered along with the mother’s clinical need for NITYR and any potential adverse effects on the breastfed infant from NITYR or from the underlying maternal condition.\"\n }\n ]\n },\n {\n \"Term\": \"Ocular toxicity\",\n \"MEDDRACode\": \"10061137\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": true,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"ocular toxicity\",\n \"Probability\": \"0.0252822936\",\n \"SemanticContext\": \"Data suggest that nitisinone is present in rat milk due to findings of ocular toxicity and lower body weight seen in drug naive nursing rat pups.\"\n }\n ]\n },\n {\n \"Term\": \"Enteral nutrition\",\n \"MEDDRACode\": \"10052591\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"gavage\",\n \"Probability\": \"4.0678E-06\",\n \"SemanticContext\": \"13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility The carcinogenic potential of nitisinone was assessed in a 26-week oral gavage carcinogenicity study in Tg.rasH2 mice.\"\n }\n ]\n },\n {\n \"Term\": \"Lymphoma\",\n \"MEDDRACode\": \"10025310\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"lymphoma\",\n \"Probability\": \"0.0030130744\",\n \"SemanticContext\": \"Nitisinone was mutagenic in the mouse lymphoma cell L5178Y/TK+/- forward mutation test and in an in vivo mouse bone marrow micronucleus test.\"\n }\n ]\n },\n {\n \"Term\": \"Caregiver\",\n \"MEDDRACode\": \"10007664\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"caregivers\",\n \"Probability\": \"6.1072E-06\",\n \"SemanticContext\": \"Advise patients and caregivers of the need to maintain dietary restriction of tyrosine and phenylalanine and to report any unexplained ocular, neurologic, or other symptoms promptly to their healthcare provider [see Warnings and Precautions 5.1 ] .\"\n }\n ]\n },\n {\n \"Term\": \"Psychomotor hyperactivity\",\n \"MEDDRACode\": \"10037211\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Hyper\",\n \"Probability\": \"0.1314475834\",\n \"SemanticContext\": \"Hyper-tyrosinemia has been reported with nitisinone treatment [see Warnings and Precautions 5.1 ].\"\n }\n ]\n },\n {\n \"Term\": \"Enanthema\",\n \"MEDDRACode\": \"10014579\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"enanthema\",\n \"Probability\": \"0.9956310391\",\n \"SemanticContext\": \"Adverse reactions reported in less than 1% of the patients, included death, seizure, brain tumor, encephalopathy, hyperkinesia, cyanosis, abdominal pain, diarrhea, enanthema, gastrointestinal hemorrhage, melena, elevated hepatic enzymes, liver enlargement, hypoglycemia, septicemia, and bronchitis.\"\n }\n ]\n },\n {\n \"Term\": \"Protein total\",\n \"MEDDRACode\": \"10050537\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"plasma proteins\",\n \"Probability\": \"0.0001487434\",\n \"SemanticContext\": \"Distribution In vitro binding of nitisinone to human plasma proteins is greater than 95% at 50 micromolar concentration.\"\n }\n ]\n },\n {\n \"Term\": \"Discomfort\",\n \"MEDDRACode\": \"10013082\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"pressure\",\n \"Probability\": \"0.0005073547\",\n \"SemanticContext\": \"Position the tablet between two metal teaspoons and apply light pressure on the top spoon.\"\n }\n ]\n },\n {\n \"Term\": \"Accidental exposure to product\",\n \"MEDDRACode\": \"10073317\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Accidental ingestion\",\n \"Probability\": \"0.0006006062\",\n \"SemanticContext\": \"10 OVERDOSAGE Accidental ingestion of nitisinone by individuals eating normal diets not restricted in tyrosine and phenylalanine will result in elevated tyrosine levels.\"\n }\n ]\n },\n {\n \"Term\": \"Congenital anomaly\",\n \"MEDDRACode\": \"10010356\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"birth defects\",\n \"Probability\": \"0.114944756\",\n \"SemanticContext\": \"The background risk of major birth defects and miscarriage for the indicated population are unknown.\"\n },\n {\n \"VerbatimTerm\": \"birth defects\",\n \"Probability\": \"0.0714996159\",\n \"SemanticContext\": \"In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.\"\n }\n ]\n },\n {\n \"Term\": \"Inflammation\",\n \"MEDDRACode\": \"10061218\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"inflammation\",\n \"Probability\": \"0.000151962\",\n \"SemanticContext\": \"Patients who develop photophobia, eye pain, or signs of inflammation such as redness, swelling, or burning of the eyes or tyrosine levels are > 500 micromol/L during treatment with NITYR should undergo slit-lamp reexamination and immediate measurement of the plasma tyrosine concentration.\"\n }\n ]\n },\n {\n \"Term\": \"Swelling\",\n \"MEDDRACode\": \"10042674\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"swelling\",\n \"Probability\": \"8.13479E-05\",\n \"SemanticContext\": \"Patients who develop photophobia, eye pain, or signs of inflammation such as redness, swelling, or burning of the eyes or tyrosine levels are > 500 micromol/L during treatment with NITYR should undergo slit-lamp reexamination and immediate measurement of the plasma tyrosine concentration.\"\n }\n ]\n }\n ],\n \"IndicationTerms\": []\n },\n {\n \"Id\": \"US287a3a70-3548-4cb8-bf81-1c333aac91b1\",\n \"NDCCode\": \"70709-000\",\n \"UpdatedDate\": \"Jun 24, 2021\",\n \"LabelSource\": {\n \"Country\": \"us\",\n \"ProductId\": \"00fd1905-27e4-420e-8dc5-a69e4ddc1526\",\n \"FileId\": \"287a3a70-3548-4cb8-bf81-1c333aac91b1\",\n \"Version\": \"8\"\n },\n \"AdverseEventTerms\": [\n {\n \"Term\": \"Abdominal pain\",\n \"MEDDRACode\": \"10000081\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"abdominal pain\",\n \"Probability\": \"0.9962461591\",\n \"SemanticContext\": \"Adverse reactions reported in less than 1% of the patients, included death, seizure, brain tumor, encephalopathy, hyperkinesia, cyanosis, abdominal pain, diarrhea, enanthema, gastrointestinal hemorrhage, melena, elevated hepatic enzymes, liver enlargement, hypoglycemia, septicemia, and bronchitis.\"\n }\n ]\n },\n {\n \"Term\": \"Brain neoplasm\",\n \"MEDDRACode\": \"10061019\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"brain tumor\",\n \"Probability\": \"0.8771100044\",\n \"SemanticContext\": \"Adverse reactions reported in less than 1% of the patients, included death, seizure, brain tumor, encephalopathy, hyperkinesia, cyanosis, abdominal pain, diarrhea, enanthema, gastrointestinal hemorrhage, melena, elevated hepatic enzymes, liver enlargement, hypoglycemia, septicemia, and bronchitis.\"\n }\n ]\n },\n {\n \"Term\": \"Benign hepatic neoplasm\",\n \"MEDDRACode\": \"10004269\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"benign hepatic neoplasms\",\n \"Probability\": \"0.4218782783\",\n \"SemanticContext\": \"These complications of HT-1 were observed in patients treated with nitisinone for a median of 22 months during the clinical trial liver transplantation 13%, liver failure 7%, malignant hepatic neoplasms 5%, benign hepatic neoplasms 3%, porphyria 1% .\"\n }\n ]\n },\n {\n \"Term\": \"Bronchitis\",\n \"MEDDRACode\": \"10006451\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"bronchitis\",\n \"Probability\": \"0.9891864061\",\n \"SemanticContext\": \"Adverse reactions reported in less than 1% of the patients, included death, seizure, brain tumor, encephalopathy, hyperkinesia, cyanosis, abdominal pain, diarrhea, enanthema, gastrointestinal hemorrhage, melena, elevated hepatic enzymes, liver enlargement, hypoglycemia, septicemia, and bronchitis.\"\n }\n ]\n },\n {\n \"Term\": \"Hepatic cancer\",\n \"MEDDRACode\": \"10073069\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"malignant hepatic neoplasms\",\n \"Probability\": \"0.919803679\",\n \"SemanticContext\": \"These complications of HT-1 were observed in patients treated with nitisinone for a median of 22 months during the clinical trial liver transplantation 13%, liver failure 7%, malignant hepatic neoplasms 5%, benign hepatic neoplasms 3%, porphyria 1% .\"\n }\n ]\n },\n {\n \"Term\": \"Hepatic failure\",\n \"MEDDRACode\": \"10019663\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"liver failure\",\n \"Probability\": \"0.7190163136\",\n \"SemanticContext\": \"Patients with HT-1 are at increased risk of developing porphyric crises, hepatic neoplasms, and liver failure requiring liver transplantation.\"\n },\n {\n \"VerbatimTerm\": \"liver failure\",\n \"Probability\": \"0.9500896931\",\n \"SemanticContext\": \"These complications of HT-1 were observed in patients treated with nitisinone for a median of 22 months during the clinical trial liver transplantation 13%, liver failure 7%, malignant hepatic neoplasms 5%, benign hepatic neoplasms 3%, porphyria 1% .\"\n }\n ]\n },\n {\n \"Term\": \"Encephalopathy\",\n \"MEDDRACode\": \"10014625\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"encephalopathy\",\n \"Probability\": \"0.9914292097\",\n \"SemanticContext\": \"Adverse reactions reported in less than 1% of the patients, included death, seizure, brain tumor, encephalopathy, hyperkinesia, cyanosis, abdominal pain, diarrhea, enanthema, gastrointestinal hemorrhage, melena, elevated hepatic enzymes, liver enlargement, hypoglycemia, septicemia, and bronchitis.\"\n }\n ]\n },\n {\n \"Term\": \"Gastrointestinal haemorrhage\",\n \"MEDDRACode\": \"10017955\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"gastrointestinal hemorrhage\",\n \"Probability\": \"0.9887012839\",\n \"SemanticContext\": \"Adverse reactions reported in less than 1% of the patients, included death, seizure, brain tumor, encephalopathy, hyperkinesia, cyanosis, abdominal pain, diarrhea, enanthema, gastrointestinal hemorrhage, melena, elevated hepatic enzymes, liver enlargement, hypoglycemia, septicemia, and bronchitis.\"\n }\n ]\n },\n {\n \"Term\": \"Enanthema\",\n \"MEDDRACode\": \"10014579\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"enanthema\",\n \"Probability\": \"0.9956310391\",\n \"SemanticContext\": \"Adverse reactions reported in less than 1% of the patients, included death, seizure, brain tumor, encephalopathy, hyperkinesia, cyanosis, abdominal pain, diarrhea, enanthema, gastrointestinal hemorrhage, melena, elevated hepatic enzymes, liver enlargement, hypoglycemia, septicemia, and bronchitis.\"\n }\n ]\n },\n {\n \"Term\": \"Hepatomegaly\",\n \"MEDDRACode\": \"10019842\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"liver enlargement\",\n \"Probability\": \"0.9987573624\",\n \"SemanticContext\": \"Adverse reactions reported in less than 1% of the patients, included death, seizure, brain tumor, encephalopathy, hyperkinesia, cyanosis, abdominal pain, diarrhea, enanthema, gastrointestinal hemorrhage, melena, elevated hepatic enzymes, liver enlargement, hypoglycemia, septicemia, and bronchitis.\"\n }\n ]\n },\n {\n \"Term\": \"Melaena\",\n \"MEDDRACode\": \"10027141\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"melena\",\n \"Probability\": \"0.9774267673\",\n \"SemanticContext\": \"Adverse reactions reported in less than 1% of the patients, included death, seizure, brain tumor, encephalopathy, hyperkinesia, cyanosis, abdominal pain, diarrhea, enanthema, gastrointestinal hemorrhage, melena, elevated hepatic enzymes, liver enlargement, hypoglycemia, septicemia, and bronchitis.\"\n }\n ]\n },\n {\n \"Term\": \"Hypoglycaemia\",\n \"MEDDRACode\": \"10020993\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hypoglycemia\",\n \"Probability\": \"0.9911644459\",\n \"SemanticContext\": \"Adverse reactions reported in less than 1% of the patients, included death, seizure, brain tumor, encephalopathy, hyperkinesia, cyanosis, abdominal pain, diarrhea, enanthema, gastrointestinal hemorrhage, melena, elevated hepatic enzymes, liver enlargement, hypoglycemia, septicemia, and bronchitis.\"\n }\n ]\n },\n {\n \"Term\": \"Hepatic enzyme\",\n \"MEDDRACode\": \"10060793\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hepatic enzymes\",\n \"Probability\": \"0.8880999088\",\n \"SemanticContext\": \"Adverse reactions reported in less than 1% of the patients, included death, seizure, brain tumor, encephalopathy, hyperkinesia, cyanosis, abdominal pain, diarrhea, enanthema, gastrointestinal hemorrhage, melena, elevated hepatic enzymes, liver enlargement, hypoglycemia, septicemia, and bronchitis.\"\n }\n ]\n },\n {\n \"Term\": \"Sepsis\",\n \"MEDDRACode\": \"10040047\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"septicemia\",\n \"Probability\": \"0.9948012233\",\n \"SemanticContext\": \"Adverse reactions reported in less than 1% of the patients, included death, seizure, brain tumor, encephalopathy, hyperkinesia, cyanosis, abdominal pain, diarrhea, enanthema, gastrointestinal hemorrhage, melena, elevated hepatic enzymes, liver enlargement, hypoglycemia, septicemia, and bronchitis.\"\n }\n ]\n },\n {\n \"Term\": \"Weight\",\n \"MEDDRACode\": \"10047890\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": true,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"weight\",\n \"Probability\": \"0.0008899271\",\n \"SemanticContext\": \"The starting dose of nitisinone was 0.3 to 0.5 mg/kg twice daily, and the dose was increased in some patients to 1 mg/kg twice daily based on weight, biochemical, and enzyme markers.\"\n },\n {\n \"VerbatimTerm\": \"weight\",\n \"Probability\": \"0.0001813769\",\n \"SemanticContext\": \"All patients were treated with nitisinone at a starting dose of 0.3 to 0.5 mg/kg twice daily, and the dose was increased in some patients to 1 mg/kg twice daily based on weight, liver and kidney function tests, platelet count, serum amino acids, urinary phenolic acid, plasma and urine succinylacetone, erythrocyte PBG- synthase, and urine 5-ALA..\"\n },\n {\n \"VerbatimTerm\": \"weight\",\n \"Probability\": \"0.0165419877\",\n \"SemanticContext\": \"In a single dose-group study in rats given 100 mg/kg 16.2 times the recommended initial dose of 1 mg/kg/day on a body surface area basis , reduced litter size, decreased pup weight at birth, and decreased survival of pups after birth was demonstrated.\"\n },\n {\n \"VerbatimTerm\": \"weight\",\n \"Probability\": \"0.0037819743\",\n \"SemanticContext\": \"Data suggest that nitisinone is present in rat milk due to findings of ocular toxicity and lower body weight seen in drug naive nursing rat pups.\"\n }\n ]\n },\n {\n \"Term\": \"Blood sodium\",\n \"MEDDRACode\": \"10005799\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"5.85578E-05\",\n \"SemanticContext\": \"It is practically insoluble in water, soluble in 2M sodium hydroxide and in methanol, and sparingly soluble in alcohol.\"\n }\n ]\n },\n {\n \"Term\": \"Seizure\",\n \"MEDDRACode\": \"10039906\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"seizure\",\n \"Probability\": \"0.9971814156\",\n \"SemanticContext\": \"Adverse reactions reported in less than 1% of the patients, included death, seizure, brain tumor, encephalopathy, hyperkinesia, cyanosis, abdominal pain, diarrhea, enanthema, gastrointestinal hemorrhage, melena, elevated hepatic enzymes, liver enlargement, hypoglycemia, septicemia, and bronchitis.\"\n }\n ]\n },\n {\n \"Term\": \"Alpha 1 foetoprotein\",\n \"MEDDRACode\": \"10001772\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"alphafetoprotein\",\n \"Probability\": \"7.12262E-05\",\n \"SemanticContext\": \"Monitor plasma and/or urine succinylacetone concentrations, liver function parameters and alphafetoprotein levels.\"\n }\n ]\n },\n {\n \"Term\": \"Liver transplant\",\n \"MEDDRACode\": \"10024714\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"liver transplantation\",\n \"Probability\": \"0.2586750388\",\n \"SemanticContext\": \"Patients with HT-1 are at increased risk of developing porphyric crises, hepatic neoplasms, and liver failure requiring liver transplantation.\"\n },\n {\n \"VerbatimTerm\": \"liver transplantation\",\n \"Probability\": \"0.1030919254\",\n \"SemanticContext\": \"These complications of HT-1 were observed in patients treated with nitisinone for a median of 22 months during the clinical trial liver transplantation 13%, liver failure 7%, malignant hepatic neoplasms 5%, benign hepatic neoplasms 3%, porphyria 1% .\"\n }\n ]\n },\n {\n \"Term\": \"Porphyria\",\n \"MEDDRACode\": \"10036181\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"porphyria\",\n \"Probability\": \"0.9967538118\",\n \"SemanticContext\": \"The most serious adverse reactions reported during nitisinone treatment were thrombocytopenia, leukopenia, porphyria, and ocular/visual complaints associated with elevated tyrosine levels [see Warnings and Precautions 5.1 , 5.2 ] .\"\n },\n {\n \"VerbatimTerm\": \"porphyria\",\n \"Probability\": \"0.9637761116\",\n \"SemanticContext\": \"These complications of HT-1 were observed in patients treated with nitisinone for a median of 22 months during the clinical trial liver transplantation 13%, liver failure 7%, malignant hepatic neoplasms 5%, benign hepatic neoplasms 3%, porphyria 1% .\"\n },\n {\n \"VerbatimTerm\": \"porphyria\",\n \"Probability\": \"0.0874952972\",\n \"SemanticContext\": \"An assessment of porphyria-like crises was performed because these events are commonly reported in patients with HT-1 who are not treated with nitisinone.\"\n },\n {\n \"VerbatimTerm\": \"Porphyria\",\n \"Probability\": \"0.8103244305\",\n \"SemanticContext\": \"Porphyria-like crisis were reported in 3 patients 0.3% of cases per year during the clinical study.\"\n }\n ]\n },\n {\n \"Term\": \"Infection\",\n \"MEDDRACode\": \"10021789\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"infections\",\n \"Probability\": \"0.1618879437\",\n \"SemanticContext\": \"No patients developed infections or bleeding as a result of the episodes of leukopenia and thrombocytopenia.\"\n },\n {\n \"VerbatimTerm\": \"infections\",\n \"Probability\": \"0.4100490808\",\n \"SemanticContext\": \"No patients developed infections or bleeding as a result of the episodes of leukopenia and thrombocytopenia.\"\n }\n ]\n },\n {\n \"Term\": \"Rash maculo-papular\",\n \"MEDDRACode\": \"10037868\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"maculopapular rash\",\n \"Probability\": \"0.9827212095\",\n \"SemanticContext\": \"ADVERSE REACTIONS Most common adverse reactions >1% are elevated tyrosine levels, thrombocytopenia, leukopenia, conjunctivitis, corneal opacity, keratitis, photophobia, eye pain, blepharitis, cataracts, granulocytopenia, epistaxis, pruritus, exfoliative dermatitis, dry skin, maculopapular rash and alopecia.\"\n },\n {\n \"VerbatimTerm\": \"Maculopapular Rash\",\n \"Probability\": \"0.9966608286\",\n \"SemanticContext\": \"*reported in at least 1% of patients; ** another oral formulation of nitisinone TABLE 1 Most Common Adverse Reactions * in Patients with HT-1 Treated with Nitisinone ** Elevated tyrosine levels >10% Leukopenia 3% Thrombocytopenia 3% Conjunctivitis 2% Corneal Opacity 2% Keratitis 2% Photophobia 2% Eye Pain 1% Blepharitis 1% Cataracts 1% Granulocytopenia 1% Epistaxis 1% Pruritus 1% Exfoliative Dermatitis 1% Dry Skin 1% Maculopapular Rash 1% Alopecia 1% .\"\n }\n ]\n },\n {\n \"Term\": \"Leukopenia\",\n \"MEDDRACode\": \"10024384\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Leukopenia\",\n \"Probability\": \"0.7281470299\",\n \"SemanticContext\": \"Leukopenia and Severe Thrombocytopenia: Monitor platelet and white blood cell counts.\"\n },\n {\n \"VerbatimTerm\": \"Leukopenia\",\n \"Probability\": \"0.9958049059\",\n \"SemanticContext\": \"*reported in at least 1% of patients; ** another oral formulation of nitisinone TABLE 1 Most Common Adverse Reactions * in Patients with HT-1 Treated with Nitisinone ** Elevated tyrosine levels >10% Leukopenia 3% Thrombocytopenia 3% Conjunctivitis 2% Corneal Opacity 2% Keratitis 2% Photophobia 2% Eye Pain 1% Blepharitis 1% Cataracts 1% Granulocytopenia 1% Epistaxis 1% Pruritus 1% Exfoliative Dermatitis 1% Dry Skin 1% Maculopapular Rash 1% Alopecia 1% .\"\n },\n {\n \"VerbatimTerm\": \"Leukopenia\",\n \"Probability\": \"0.8428916931\",\n \"SemanticContext\": \"5.2 Leukopenia and Severe Thrombocytopenia In clinical trials, patients treated with another oral formulation of nitisinone and dietary restriction developed transient leukopenia 3% , thrombocytopenia 3% , or both 1.5% [see Adverse Reactions 6.1 ] .\"\n },\n {\n \"VerbatimTerm\": \"leukopenia\",\n \"Probability\": \"0.9993851185\",\n \"SemanticContext\": \"ADVERSE REACTIONS Most common adverse reactions >1% are elevated tyrosine levels, thrombocytopenia, leukopenia, conjunctivitis, corneal opacity, keratitis, photophobia, eye pain, blepharitis, cataracts, granulocytopenia, epistaxis, pruritus, exfoliative dermatitis, dry skin, maculopapular rash and alopecia.\"\n },\n {\n \"VerbatimTerm\": \"leukopenia\",\n \"Probability\": \"0.9986950159\",\n \"SemanticContext\": \"The most serious adverse reactions reported during nitisinone treatment were thrombocytopenia, leukopenia, porphyria, and ocular/visual complaints associated with elevated tyrosine levels [see Warnings and Precautions 5.1 , 5.2 ] .\"\n },\n {\n \"VerbatimTerm\": \"leukopenia\",\n \"Probability\": \"0.5836666226\",\n \"SemanticContext\": \"No patients developed infections or bleeding as a result of the episodes of leukopenia and thrombocytopenia.\"\n },\n {\n \"VerbatimTerm\": \"leukopenia\",\n \"Probability\": \"0.9991931915\",\n \"SemanticContext\": \"5.2 Leukopenia and Severe Thrombocytopenia In clinical trials, patients treated with another oral formulation of nitisinone and dietary restriction developed transient leukopenia 3% , thrombocytopenia 3% , or both 1.5% [see Adverse Reactions 6.1 ] .\"\n },\n {\n \"VerbatimTerm\": \"leukopenia\",\n \"Probability\": \"0.9727530479\",\n \"SemanticContext\": \"No patients developed infections or bleeding as a result of the episodes of leukopenia and thrombocytopenia.\"\n }\n ]\n },\n {\n \"Term\": \"Haemorrhage\",\n \"MEDDRACode\": \"10055798\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"bleeding\",\n \"Probability\": \"0.7405520678\",\n \"SemanticContext\": \"No patients developed infections or bleeding as a result of the episodes of leukopenia and thrombocytopenia.\"\n },\n {\n \"VerbatimTerm\": \"bleeding\",\n \"Probability\": \"0.9396822453\",\n \"SemanticContext\": \"No patients developed infections or bleeding as a result of the episodes of leukopenia and thrombocytopenia.\"\n }\n ]\n },\n {\n \"Term\": \"Mass\",\n \"MEDDRACode\": \"10026865\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"mass\",\n \"Probability\": \"0.0002525449\",\n \"SemanticContext\": \"The molecular formula is C 14 H 10 F 3 NO 5 with a relative mass of 329.23.\"\n }\n ]\n },\n {\n \"Term\": \"Hyperkinesia\",\n \"MEDDRACode\": \"10020651\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hyperkinesia\",\n \"Probability\": \"0.9861875176\",\n \"SemanticContext\": \"Adverse reactions reported in less than 1% of the patients, included death, seizure, brain tumor, encephalopathy, hyperkinesia, cyanosis, abdominal pain, diarrhea, enanthema, gastrointestinal hemorrhage, melena, elevated hepatic enzymes, liver enlargement, hypoglycemia, septicemia, and bronchitis.\"\n }\n ]\n },\n {\n \"Term\": \"Protein total\",\n \"MEDDRACode\": \"10050537\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"plasma proteins\",\n \"Probability\": \"0.0001487434\",\n \"SemanticContext\": \"Distribution In vitro binding of nitisinone to human plasma proteins is greater than 95% at 50 micromolar concentration.\"\n }\n ]\n },\n {\n \"Term\": \"Tyrosinaemia\",\n \"MEDDRACode\": \"10063443\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"tyrosinemia\",\n \"Probability\": \"0.3782399297\",\n \"SemanticContext\": \"Hyper-tyrosinemia has been reported with nitisinone treatment [see Warnings and Precautions 5.1 ].\"\n }\n ]\n },\n {\n \"Term\": \"Alpha 1 microglobulin decreased\",\n \"MEDDRACode\": \"10070644\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"alpha-1-microglobulin decreased\",\n \"Probability\": \"0.016581893\",\n \"SemanticContext\": \"After one year of treatment in a subgroup of patients N=100 , overall median alpha-1-microglobulin decreased by 1.5 grams/mol creatinine.\"\n }\n ]\n },\n {\n \"Term\": \"Dermatitis exfoliative\",\n \"MEDDRACode\": \"10012455\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"exfoliative dermatitis\",\n \"Probability\": \"0.9974045753\",\n \"SemanticContext\": \"ADVERSE REACTIONS Most common adverse reactions >1% are elevated tyrosine levels, thrombocytopenia, leukopenia, conjunctivitis, corneal opacity, keratitis, photophobia, eye pain, blepharitis, cataracts, granulocytopenia, epistaxis, pruritus, exfoliative dermatitis, dry skin, maculopapular rash and alopecia.\"\n },\n {\n \"VerbatimTerm\": \"Exfoliative Dermatitis\",\n \"Probability\": \"0.9964780807\",\n \"SemanticContext\": \"*reported in at least 1% of patients; ** another oral formulation of nitisinone TABLE 1 Most Common Adverse Reactions * in Patients with HT-1 Treated with Nitisinone ** Elevated tyrosine levels >10% Leukopenia 3% Thrombocytopenia 3% Conjunctivitis 2% Corneal Opacity 2% Keratitis 2% Photophobia 2% Eye Pain 1% Blepharitis 1% Cataracts 1% Granulocytopenia 1% Epistaxis 1% Pruritus 1% Exfoliative Dermatitis 1% Dry Skin 1% Maculopapular Rash 1% Alopecia 1% .\"\n }\n ]\n },\n {\n \"Term\": \"Succinylacetone\",\n \"MEDDRACode\": \"10069456\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"succinylacetone\",\n \"Probability\": \"7.11323E-05\",\n \"SemanticContext\": \"In patients 5 years of age and older who have undetectable serum and urine succinylacetone concentrations after a minimum of 4 weeks on a stable dosage of nitisinone, the total daily dose may be given once daily.\"\n },\n {\n \"VerbatimTerm\": \"succinylacetone\",\n \"Probability\": \"0.0037440956\",\n \"SemanticContext\": \"Nitisinone was studied in one open-label, uncontrolled study of 207 patients with HT-1, ages 0 to 22 years at enrollment median age 9 months , who were diagnosed with HT-1 by the presence of succinylacetone in the urine or plasma.\"\n },\n {\n \"VerbatimTerm\": \"succinylacetone\",\n \"Probability\": \"0.0440132916\",\n \"SemanticContext\": \"In patients with HT-1, these catabolic intermediates are converted to the toxic metabolites succinylacetone and succinylacetoacetate, which are responsible for the observed liver and kidney toxicity.\"\n },\n {\n \"VerbatimTerm\": \"succinylacetone\",\n \"Probability\": \"0.002638191\",\n \"SemanticContext\": \"12.2 Pharmacodynamics In a clinical study, patients with HT-1 were diagnosed by the presence of succinylacetone in urine or plasma and treated with another oral formulation of nitisinone [see Clinical Studies 14 ].\"\n },\n {\n \"VerbatimTerm\": \"succinylacetone\",\n \"Probability\": \"0.0052025318\",\n \"SemanticContext\": \"In all 186 patients whose urine succinylacetone was measured, the urinary succinylacetone concentration decreased to less than 1 mmol/mol creatinine, the lower limit of quantitation.\"\n },\n {\n \"VerbatimTerm\": \"succinylacetone\",\n \"Probability\": \"0.0007870793\",\n \"SemanticContext\": \"In all 186 patients whose urine succinylacetone was measured, the urinary succinylacetone concentration decreased to less than 1 mmol/mol creatinine, the lower limit of quantitation.\"\n },\n {\n \"VerbatimTerm\": \"succinylacetone\",\n \"Probability\": \"0.0037432015\",\n \"SemanticContext\": \"The median time to normalization of urine succinylacetone was 0.3 months.\"\n },\n {\n \"VerbatimTerm\": \"succinylacetone\",\n \"Probability\": \"0.004845202\",\n \"SemanticContext\": \"The probability of recurrence of abnormal values of urine succinylacetone was 1% at a nitisinone concentration of 37 micromol/L 95% confidence interval: 23, 51 micromol/L .\"\n },\n {\n \"VerbatimTerm\": \"succinylacetone\",\n \"Probability\": \"0.0041420758\",\n \"SemanticContext\": \"In 87% 150/172 of patients whose plasma succinylacetone was measured, the plasma succinylacetone concentration decreased to less than 0.1 micromol/L, the lower limit of quantitation.\"\n },\n {\n \"VerbatimTerm\": \"succinylacetone\",\n \"Probability\": \"0.0002055466\",\n \"SemanticContext\": \"In 87% 150/172 of patients whose plasma succinylacetone was measured, the plasma succinylacetone concentration decreased to less than 0.1 micromol/L, the lower limit of quantitation.\"\n },\n {\n \"VerbatimTerm\": \"succinylacetone\",\n \"Probability\": \"0.0004523695\",\n \"SemanticContext\": \"The median time to normalization of plasma succinylacetone was 3.9 months.\"\n },\n {\n \"VerbatimTerm\": \"succinylacetone\",\n \"Probability\": \"0.0100154579\",\n \"SemanticContext\": \"In another study, comparing two dosing regimens of another oral formulation of nitisinone, succinylacetone was measured in urine and/or blood in 16 patients with HT-1 aged 5 years to 24 years.\"\n },\n {\n \"VerbatimTerm\": \"succinylacetone\",\n \"Probability\": \"8.53974E-05\",\n \"SemanticContext\": \"After at least 4 weeks of twice daily dosing with nitisinone, both the urine and/or blood succinylacetone concentrations were below the limit of quantitation for the assay.\"\n },\n {\n \"VerbatimTerm\": \"succinylacetone\",\n \"Probability\": \"5.82679E-05\",\n \"SemanticContext\": \"Patients were then switched to once daily dosing with the same total daily dosage of nitisinone and blood and/or urine succinylacetone concentrations remained undetectable when measured following at least 4 weeks of treatment with once daily dosing.\"\n },\n {\n \"VerbatimTerm\": \"succinylacetone\",\n \"Probability\": \"0.0021595955\",\n \"SemanticContext\": \"Patients were diagnosed with HT-1 by the presence of succinylacetone in the urine or plasma.\"\n },\n {\n \"VerbatimTerm\": \"succinylacetone\",\n \"Probability\": \"0.0025373399\",\n \"SemanticContext\": \"All patients were treated with nitisinone at a starting dose of 0.3 to 0.5 mg/kg twice daily, and the dose was increased in some patients to 1 mg/kg twice daily based on weight, liver and kidney function tests, platelet count, serum amino acids, urinary phenolic acid, plasma and urine succinylacetone, erythrocyte PBG- synthase, and urine 5-ALA..\"\n },\n {\n \"VerbatimTerm\": \"succinylacetone\",\n \"Probability\": \"5.2801E-05\",\n \"SemanticContext\": \"The effects of nitisinone on urine and plasma succinylacetone, porphyrin metabolism, and urinary alpha-1-microglobulin were also assessed in this clinical study.\"\n },\n {\n \"VerbatimTerm\": \"succinylacetone\",\n \"Probability\": \"3.80618E-05\",\n \"SemanticContext\": \"Maintenance Regimen In patients 5 years of age and older who have undetectable serum and urine succinylacetone concentrations after a minimum of 4 weeks on a stable dosage of nitisinone, the total daily dose of NITYR may be given once daily e.g., 1 to 2 mg/kg once daily [see Clinical Pharmacology 12.2 ] .\"\n },\n {\n \"VerbatimTerm\": \"succinylacetone\",\n \"Probability\": \"5.64748E-05\",\n \"SemanticContext\": \"Monitor plasma and/or urine succinylacetone concentrations, liver function parameters and alphafetoprotein levels.\"\n },\n {\n \"VerbatimTerm\": \"succinylacetone\",\n \"Probability\": \"0.0001119899\",\n \"SemanticContext\": \"If succinylacetone is still detectable in blood or urine 4 weeks after the start of nitisinone treatment, increase the NITYR dosage to 0.75 mg/kg twice daily.\"\n },\n {\n \"VerbatimTerm\": \"succinylacetone\",\n \"Probability\": \"1.38249E-05\",\n \"SemanticContext\": \"If the biochemical response is satisfactory undetectable blood and/or urine succinylacetone , the dosage should be adjusted only according to body weight gain and not according to plasma tyrosine levels.\"\n },\n {\n \"VerbatimTerm\": \"succinylacetone\",\n \"Probability\": \"0.0014832914\",\n \"SemanticContext\": \"During initiation of therapy, when switching from twice daily to once daily dosing, or if there is a deterioration in the patient’s condition, it may be necessary to follow all available biochemical parameters more closely i.e. plasma and/or urine succinylacetone, urine 5-aminolevulinate ALA and erythrocyte porphobilinogen PBG -synthase activity .\"\n },\n {\n \"VerbatimTerm\": \"Succinylacetone\",\n \"Probability\": \"0.0578671098\",\n \"SemanticContext\": \"Succinylacetone can also inhibit the porphyrin synthesis pathway leading to the accumulation of 5-aminolevulinate, a neurotoxin responsible for the porphyric crises characteristic of HT-1.\"\n }\n ]\n },\n {\n \"Term\": \"Blepharitis\",\n \"MEDDRACode\": \"10005148\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"blepharitis\",\n \"Probability\": \"0.9968597889\",\n \"SemanticContext\": \"ADVERSE REACTIONS Most common adverse reactions >1% are elevated tyrosine levels, thrombocytopenia, leukopenia, conjunctivitis, corneal opacity, keratitis, photophobia, eye pain, blepharitis, cataracts, granulocytopenia, epistaxis, pruritus, exfoliative dermatitis, dry skin, maculopapular rash and alopecia.\"\n },\n {\n \"VerbatimTerm\": \"Blepharitis\",\n \"Probability\": \"0.9916366935\",\n \"SemanticContext\": \"*reported in at least 1% of patients; ** another oral formulation of nitisinone TABLE 1 Most Common Adverse Reactions * in Patients with HT-1 Treated with Nitisinone ** Elevated tyrosine levels >10% Leukopenia 3% Thrombocytopenia 3% Conjunctivitis 2% Corneal Opacity 2% Keratitis 2% Photophobia 2% Eye Pain 1% Blepharitis 1% Cataracts 1% Granulocytopenia 1% Epistaxis 1% Pruritus 1% Exfoliative Dermatitis 1% Dry Skin 1% Maculopapular Rash 1% Alopecia 1% .\"\n }\n ]\n },\n {\n \"Term\": \"Cataract\",\n \"MEDDRACode\": \"10007739\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"cataracts\",\n \"Probability\": \"0.9976519346\",\n \"SemanticContext\": \"ADVERSE REACTIONS Most common adverse reactions >1% are elevated tyrosine levels, thrombocytopenia, leukopenia, conjunctivitis, corneal opacity, keratitis, photophobia, eye pain, blepharitis, cataracts, granulocytopenia, epistaxis, pruritus, exfoliative dermatitis, dry skin, maculopapular rash and alopecia.\"\n },\n {\n \"VerbatimTerm\": \"Cataracts\",\n \"Probability\": \"0.9969762564\",\n \"SemanticContext\": \"*reported in at least 1% of patients; ** another oral formulation of nitisinone TABLE 1 Most Common Adverse Reactions * in Patients with HT-1 Treated with Nitisinone ** Elevated tyrosine levels >10% Leukopenia 3% Thrombocytopenia 3% Conjunctivitis 2% Corneal Opacity 2% Keratitis 2% Photophobia 2% Eye Pain 1% Blepharitis 1% Cataracts 1% Granulocytopenia 1% Epistaxis 1% Pruritus 1% Exfoliative Dermatitis 1% Dry Skin 1% Maculopapular Rash 1% Alopecia 1% .\"\n }\n ]\n },\n {\n \"Term\": \"Pruritus\",\n \"MEDDRACode\": \"10037087\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"pruritus\",\n \"Probability\": \"0.9994251728\",\n \"SemanticContext\": \"ADVERSE REACTIONS Most common adverse reactions >1% are elevated tyrosine levels, thrombocytopenia, leukopenia, conjunctivitis, corneal opacity, keratitis, photophobia, eye pain, blepharitis, cataracts, granulocytopenia, epistaxis, pruritus, exfoliative dermatitis, dry skin, maculopapular rash and alopecia.\"\n },\n {\n \"VerbatimTerm\": \"Pruritus\",\n \"Probability\": \"0.9995413423\",\n \"SemanticContext\": \"*reported in at least 1% of patients; ** another oral formulation of nitisinone TABLE 1 Most Common Adverse Reactions * in Patients with HT-1 Treated with Nitisinone ** Elevated tyrosine levels >10% Leukopenia 3% Thrombocytopenia 3% Conjunctivitis 2% Corneal Opacity 2% Keratitis 2% Photophobia 2% Eye Pain 1% Blepharitis 1% Cataracts 1% Granulocytopenia 1% Epistaxis 1% Pruritus 1% Exfoliative Dermatitis 1% Dry Skin 1% Maculopapular Rash 1% Alopecia 1% .\"\n }\n ]\n },\n {\n \"Term\": \"Ocular toxicity\",\n \"MEDDRACode\": \"10061137\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": true,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"ocular toxicity\",\n \"Probability\": \"0.0252822936\",\n \"SemanticContext\": \"Data suggest that nitisinone is present in rat milk due to findings of ocular toxicity and lower body weight seen in drug naive nursing rat pups.\"\n }\n ]\n },\n {\n \"Term\": \"Inflammation\",\n \"MEDDRACode\": \"10061218\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"inflammation\",\n \"Probability\": \"0.000151962\",\n \"SemanticContext\": \"Patients who develop photophobia, eye pain, or signs of inflammation such as redness, swelling, or burning of the eyes or tyrosine levels are > 500 micromol/L during treatment with NITYR should undergo slit-lamp reexamination and immediate measurement of the plasma tyrosine concentration.\"\n }\n ]\n },\n {\n \"Term\": \"Blood methanol\",\n \"MEDDRACode\": \"10005663\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"methanol\",\n \"Probability\": \"0.0001478791\",\n \"SemanticContext\": \"It is practically insoluble in water, soluble in 2M sodium hydroxide and in methanol, and sparingly soluble in alcohol.\"\n }\n ]\n },\n {\n \"Term\": \"Pregnancy\",\n \"MEDDRACode\": \"10036556\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"pregnant\",\n \"Probability\": \"0.0002281666\",\n \"SemanticContext\": \"8.1 Pregnancy Risk Summary Limited available data with nitisinone use in pregnant women are not sufficient to determine a drug-associated risk of adverse developmental outcomes.\"\n }\n ]\n },\n {\n \"Term\": \"Blood creatinine\",\n \"MEDDRACode\": \"10005480\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"creatinine\",\n \"Probability\": \"4.66506E-05\",\n \"SemanticContext\": \"In all 186 patients whose urine succinylacetone was measured, the urinary succinylacetone concentration decreased to less than 1 mmol/mol creatinine, the lower limit of quantitation.\"\n },\n {\n \"VerbatimTerm\": \"creatinine\",\n \"Probability\": \"0.000847578\",\n \"SemanticContext\": \"The overall median pretreatment level was 4.3 grams/mol creatinine.\"\n },\n {\n \"VerbatimTerm\": \"creatinine\",\n \"Probability\": \"0.0006886423\",\n \"SemanticContext\": \"After one year of treatment in a subgroup of patients N=100 , overall median alpha-1-microglobulin decreased by 1.5 grams/mol creatinine.\"\n },\n {\n \"VerbatimTerm\": \"creatinine\",\n \"Probability\": \"1.33082E-05\",\n \"SemanticContext\": \"In patients 24 months of age and younger in whom multiple values were available N=65 , median alpha-1-microglobulin levels decreased from 5 to 3 grams/mol creatinine reference value for age less than or equal to12 grams/mol creatinine .\"\n },\n {\n \"VerbatimTerm\": \"creatinine\",\n \"Probability\": \"0.0018891096\",\n \"SemanticContext\": \"In patients 24 months of age and younger in whom multiple values were available N=65 , median alpha-1-microglobulin levels decreased from 5 to 3 grams/mol creatinine reference value for age less than or equal to12 grams/mol creatinine .\"\n },\n {\n \"VerbatimTerm\": \"creatinine\",\n \"Probability\": \"2.48817E-05\",\n \"SemanticContext\": \"In patients older than 24 months in whom multiple values were available N=35 , median alpha-1-microglobulin levels decreased from 2.8 to 2 grams/mol creatinine reference for age less than or equal to 6 grams/mol creatinine .\"\n },\n {\n \"VerbatimTerm\": \"creatinine\",\n \"Probability\": \"0.0049907565\",\n \"SemanticContext\": \"In patients older than 24 months in whom multiple values were available N=35 , median alpha-1-microglobulin levels decreased from 2.8 to 2 grams/mol creatinine reference for age less than or equal to 6 grams/mol creatinine .\"\n }\n ]\n },\n {\n \"Term\": \"Discomfort\",\n \"MEDDRACode\": \"10013082\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"pressure\",\n \"Probability\": \"0.0005073547\",\n \"SemanticContext\": \"Position the tablet between two metal teaspoons and apply light pressure on the top spoon.\"\n }\n ]\n },\n {\n \"Term\": \"Thrombocytopenia\",\n \"MEDDRACode\": \"10043554\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Thrombocytopenia\",\n \"Probability\": \"0.9437289238\",\n \"SemanticContext\": \"Leukopenia and Severe Thrombocytopenia: Monitor platelet and white blood cell counts.\"\n },\n {\n \"VerbatimTerm\": \"Thrombocytopenia\",\n \"Probability\": \"0.9973372221\",\n \"SemanticContext\": \"*reported in at least 1% of patients; ** another oral formulation of nitisinone TABLE 1 Most Common Adverse Reactions * in Patients with HT-1 Treated with Nitisinone ** Elevated tyrosine levels >10% Leukopenia 3% Thrombocytopenia 3% Conjunctivitis 2% Corneal Opacity 2% Keratitis 2% Photophobia 2% Eye Pain 1% Blepharitis 1% Cataracts 1% Granulocytopenia 1% Epistaxis 1% Pruritus 1% Exfoliative Dermatitis 1% Dry Skin 1% Maculopapular Rash 1% Alopecia 1% .\"\n },\n {\n \"VerbatimTerm\": \"Thrombocytopenia\",\n \"Probability\": \"0.7632495761\",\n \"SemanticContext\": \"5.2 Leukopenia and Severe Thrombocytopenia In clinical trials, patients treated with another oral formulation of nitisinone and dietary restriction developed transient leukopenia 3% , thrombocytopenia 3% , or both 1.5% [see Adverse Reactions 6.1 ] .\"\n },\n {\n \"VerbatimTerm\": \"thrombocytopenia\",\n \"Probability\": \"0.9986987114\",\n \"SemanticContext\": \"ADVERSE REACTIONS Most common adverse reactions >1% are elevated tyrosine levels, thrombocytopenia, leukopenia, conjunctivitis, corneal opacity, keratitis, photophobia, eye pain, blepharitis, cataracts, granulocytopenia, epistaxis, pruritus, exfoliative dermatitis, dry skin, maculopapular rash and alopecia.\"\n },\n {\n \"VerbatimTerm\": \"thrombocytopenia\",\n \"Probability\": \"0.9986166954\",\n \"SemanticContext\": \"The most serious adverse reactions reported during nitisinone treatment were thrombocytopenia, leukopenia, porphyria, and ocular/visual complaints associated with elevated tyrosine levels [see Warnings and Precautions 5.1 , 5.2 ] .\"\n },\n {\n \"VerbatimTerm\": \"thrombocytopenia\",\n \"Probability\": \"0.957967639\",\n \"SemanticContext\": \"Six patients had thrombocytopenia, three of which had platelet counts 30,000/microL or lower.\"\n },\n {\n \"VerbatimTerm\": \"thrombocytopenia\",\n \"Probability\": \"0.0278029442\",\n \"SemanticContext\": \"In 4 patients with thrombocytopenia, platelet counts gradually returned to normal duration up to 47 days without change in the nitisinone dose.\"\n },\n {\n \"VerbatimTerm\": \"thrombocytopenia\",\n \"Probability\": \"0.3529744744\",\n \"SemanticContext\": \"No patients developed infections or bleeding as a result of the episodes of leukopenia and thrombocytopenia.\"\n },\n {\n \"VerbatimTerm\": \"thrombocytopenia\",\n \"Probability\": \"0.999733448\",\n \"SemanticContext\": \"5.2 Leukopenia and Severe Thrombocytopenia In clinical trials, patients treated with another oral formulation of nitisinone and dietary restriction developed transient leukopenia 3% , thrombocytopenia 3% , or both 1.5% [see Adverse Reactions 6.1 ] .\"\n },\n {\n \"VerbatimTerm\": \"thrombocytopenia\",\n \"Probability\": \"0.9845604897\",\n \"SemanticContext\": \"No patients developed infections or bleeding as a result of the episodes of leukopenia and thrombocytopenia.\"\n }\n ]\n },\n {\n \"Term\": \"Euphoric mood\",\n \"MEDDRACode\": \"10015535\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"high\",\n \"Probability\": \"0.0003047287\",\n \"SemanticContext\": \"Food effect: In a food effect study, a high-fat and high-calorie breakfast 973.6 cal distributed in carbohydrate 250.1 cal, proteins 157 cal, fat 566.5 cal did not significantly affect the total exposure AUC 0-120h and C max of nitisinone following single oral administration of 10 mg NITYR.\"\n },\n {\n \"VerbatimTerm\": \"high\",\n \"Probability\": \"0.0001479089\",\n \"SemanticContext\": \"Food effect: In a food effect study, a high-fat and high-calorie breakfast 973.6 cal distributed in carbohydrate 250.1 cal, proteins 157 cal, fat 566.5 cal did not significantly affect the total exposure AUC 0-120h and C max of nitisinone following single oral administration of 10 mg NITYR.\"\n }\n ]\n },\n {\n \"Term\": \"Weight increased\",\n \"MEDDRACode\": \"10047899\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"weight gain\",\n \"Probability\": \"0.0102035403\",\n \"SemanticContext\": \"If the biochemical response is satisfactory undetectable blood and/or urine succinylacetone , the dosage should be adjusted only according to body weight gain and not according to plasma tyrosine levels.\"\n }\n ]\n },\n {\n \"Term\": \"Drug therapy\",\n \"MEDDRACode\": \"10063370\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": true\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"drug therapy\",\n \"Probability\": \"0.0001880527\",\n \"SemanticContext\": \"In general, dose selection for an elderly patient should be cautious reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and concomitant disease or other drug therapy in this patient population.\"\n }\n ]\n },\n {\n \"Term\": \"Dry skin\",\n \"MEDDRACode\": \"10013786\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"dry skin\",\n \"Probability\": \"0.9936286211\",\n \"SemanticContext\": \"ADVERSE REACTIONS Most common adverse reactions >1% are elevated tyrosine levels, thrombocytopenia, leukopenia, conjunctivitis, corneal opacity, keratitis, photophobia, eye pain, blepharitis, cataracts, granulocytopenia, epistaxis, pruritus, exfoliative dermatitis, dry skin, maculopapular rash and alopecia.\"\n },\n {\n \"VerbatimTerm\": \"Dry Skin\",\n \"Probability\": \"0.9942692518\",\n \"SemanticContext\": \"*reported in at least 1% of patients; ** another oral formulation of nitisinone TABLE 1 Most Common Adverse Reactions * in Patients with HT-1 Treated with Nitisinone ** Elevated tyrosine levels >10% Leukopenia 3% Thrombocytopenia 3% Conjunctivitis 2% Corneal Opacity 2% Keratitis 2% Photophobia 2% Eye Pain 1% Blepharitis 1% Cataracts 1% Granulocytopenia 1% Epistaxis 1% Pruritus 1% Exfoliative Dermatitis 1% Dry Skin 1% Maculopapular Rash 1% Alopecia 1% .\"\n }\n ]\n },\n {\n \"Term\": \"Elderly\",\n \"MEDDRACode\": \"10014348\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": true\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"elderly\",\n \"Probability\": \"5.21771E-05\",\n \"SemanticContext\": \"In general, dose selection for an elderly patient should be cautious reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and concomitant disease or other drug therapy in this patient population.\"\n }\n ]\n },\n {\n \"Term\": \"Body surface area\",\n \"MEDDRACode\": \"10050311\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"body surface area\",\n \"Probability\": \"0.0002888143\",\n \"SemanticContext\": \"There were no drug-related neoplastic findings in male or female Tg.rasH2 mice at doses up to 100 mg/kg/ day nitisinone approximately 8.1 times the recommended initial dose of 1 mg/kg/day on a body surface area basis .\"\n },\n {\n \"VerbatimTerm\": \"body surface area\",\n \"Probability\": \"0.0001231067\",\n \"SemanticContext\": \"In a single dose-group study in rats given 100 mg/kg 16.2 times the recommended initial dose of 1 mg/kg/day on a body surface area basis , reduced litter size, decreased pup weight at birth, and decreased survival of pups after birth was demonstrated.\"\n },\n {\n \"VerbatimTerm\": \"body surface area\",\n \"Probability\": \"0.0004608333\",\n \"SemanticContext\": \"Data Animal Data Reproduction studies have been performed in mice at oral doses of about 0.4, 4 and 20 times the recommended initial dose 1 mg/kg/day and in rabbits at oral doses of about 1.6, 4 and 8 times the recommended initial dose based on the body surface area.\"\n },\n {\n \"VerbatimTerm\": \"body surface area\",\n \"Probability\": \"0.0005449653\",\n \"SemanticContext\": \"In mice, nitisinone has been shown to cause incomplete skeletal ossification of fetal bones at 0.4, 4 and 20 times the recommended initial dose, increased gestational length at 4 and 20 times the recommended initial dose, and decreased pup survival at 0.4 times the recommended initial dose based on the body surface area.\"\n },\n {\n \"VerbatimTerm\": \"body surface area\",\n \"Probability\": \"0.0009199679\",\n \"SemanticContext\": \"In rabbits, nitisinone caused incomplete skeletal ossification of fetal bones at 1.6, 4 and 8 times the recommended initial dose based on the body surface area.\"\n }\n ]\n },\n {\n \"Term\": \"Blood pyruvic acid\",\n \"MEDDRACode\": \"10005784\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"pyruvate\",\n \"Probability\": \"0.0004402995\",\n \"SemanticContext\": \"INDICATIONS AND USAGE NITYR is a hydroxyphenyl-pyruvate dioxygenase inhibitor indicated for the treatment of adult and pediatric patients with hereditary tyrosinemia type 1 HT-1 in combination with dietary restriction of tyrosine and phenylalanine.\"\n },\n {\n \"VerbatimTerm\": \"pyruvate\",\n \"Probability\": \"6.89497E-05\",\n \"SemanticContext\": \"11 DESCRIPTION NITYR contains nitisinone, which is a hydroxyphenyl-pyruvate dioxygenase inhibitor indicated as an adjunct to dietary restriction of tyrosine and phenylalanine in the treatment of hereditary tyrosinemia type 1 HT-1 .\"\n },\n {\n \"VerbatimTerm\": \"pyruvate\",\n \"Probability\": \"4.35974E-05\",\n \"SemanticContext\": \"Figure 1 Structural Formula 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Nitisinone is a competitive inhibitor of 4-hydroxyphenyl-pyruvate dioxygenase, an enzyme upstream of fumarylacetoacetate hydrolase FAH in the tyrosine catabolic pathway.\"\n },\n {\n \"VerbatimTerm\": \"pyruvate\",\n \"Probability\": \"8.98209E-05\",\n \"SemanticContext\": \"5 WARNINGS AND PRECAUTIONS 5.1 Elevated Plasma Tyrosine Levels, Ocular Symptoms, Developmental Delay and Hyperkeratotic Plaques Nitisinone is an inhibitor of 4-hydroxyphenyl-pyruvate dioxygenase, an enzyme in the tyrosine metabolic pathway [see Clinical Pharmacology 12.1 ] .\"\n }\n ]\n },\n {\n \"Term\": \"Thermal burn\",\n \"MEDDRACode\": \"10053615\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"burning\",\n \"Probability\": \"2.38282E-05\",\n \"SemanticContext\": \"Patients who develop photophobia, eye pain, or signs of inflammation such as redness, swelling, or burning of the eyes or tyrosine levels are > 500 micromol/L during treatment with NITYR should undergo slit-lamp reexamination and immediate measurement of the plasma tyrosine concentration.\"\n }\n ]\n },\n {\n \"Term\": \"Ultrasound scan\",\n \"MEDDRACode\": \"10045434\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"U.S.\",\n \"Probability\": \"0.0001198693\",\n \"SemanticContext\": \"NITYR ® nitisinone tablets, for oral use Initial U.S. Approval: 2002 RECENT MAJOR CHANGES Dosage 2.1 09/2020 Warnings and Precautions 5.1 09/2020 .\"\n },\n {\n \"VerbatimTerm\": \"U.S.\",\n \"Probability\": \"0.0001934171\",\n \"SemanticContext\": \"In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.\"\n }\n ]\n },\n {\n \"Term\": \"Conjunctivitis\",\n \"MEDDRACode\": \"10010741\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"conjunctivitis\",\n \"Probability\": \"0.9998996258\",\n \"SemanticContext\": \"ADVERSE REACTIONS Most common adverse reactions >1% are elevated tyrosine levels, thrombocytopenia, leukopenia, conjunctivitis, corneal opacity, keratitis, photophobia, eye pain, blepharitis, cataracts, granulocytopenia, epistaxis, pruritus, exfoliative dermatitis, dry skin, maculopapular rash and alopecia.\"\n },\n {\n \"VerbatimTerm\": \"conjunctivitis\",\n \"Probability\": \"0.4590257704\",\n \"SemanticContext\": \"Maintain plasma tyrosine levels below 500 micromol/L. Inadequate restriction of tyrosine and phenylalanine intake can lead to elevations in plasma tyrosine levels and levels greater than 500 micromol/L may lead to the following: Ocular signs and symptoms including corneal ulcers, corneal opacities, keratitis, conjunctivitis, eye pain, and photophobia have been reported in patients treated with nitisinone [see Adverse Reactions 6.1 ] .\"\n },\n {\n \"VerbatimTerm\": \"Conjunctivitis\",\n \"Probability\": \"0.9989107847\",\n \"SemanticContext\": \"*reported in at least 1% of patients; ** another oral formulation of nitisinone TABLE 1 Most Common Adverse Reactions * in Patients with HT-1 Treated with Nitisinone ** Elevated tyrosine levels >10% Leukopenia 3% Thrombocytopenia 3% Conjunctivitis 2% Corneal Opacity 2% Keratitis 2% Photophobia 2% Eye Pain 1% Blepharitis 1% Cataracts 1% Granulocytopenia 1% Epistaxis 1% Pruritus 1% Exfoliative Dermatitis 1% Dry Skin 1% Maculopapular Rash 1% Alopecia 1% .\"\n }\n ]\n },\n {\n \"Term\": \"Psychomotor hyperactivity\",\n \"MEDDRACode\": \"10037211\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Hyper\",\n \"Probability\": \"0.1314475834\",\n \"SemanticContext\": \"Hyper-tyrosinemia has been reported with nitisinone treatment [see Warnings and Precautions 5.1 ].\"\n }\n ]\n },\n {\n \"Term\": \"Cyanosis\",\n \"MEDDRACode\": \"10011703\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"cyanosis\",\n \"Probability\": \"0.9976474643\",\n \"SemanticContext\": \"Adverse reactions reported in less than 1% of the patients, included death, seizure, brain tumor, encephalopathy, hyperkinesia, cyanosis, abdominal pain, diarrhea, enanthema, gastrointestinal hemorrhage, melena, elevated hepatic enzymes, liver enlargement, hypoglycemia, septicemia, and bronchitis.\"\n }\n ]\n },\n {\n \"Term\": \"Diarrhoea\",\n \"MEDDRACode\": \"10012735\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"diarrhea\",\n \"Probability\": \"0.9970415831\",\n \"SemanticContext\": \"Adverse reactions reported in less than 1% of the patients, included death, seizure, brain tumor, encephalopathy, hyperkinesia, cyanosis, abdominal pain, diarrhea, enanthema, gastrointestinal hemorrhage, melena, elevated hepatic enzymes, liver enlargement, hypoglycemia, septicemia, and bronchitis.\"\n }\n ]\n },\n {\n \"Term\": \"Corneal opacity\",\n \"MEDDRACode\": \"10011035\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"corneal opacity\",\n \"Probability\": \"0.9986885786\",\n \"SemanticContext\": \"ADVERSE REACTIONS Most common adverse reactions >1% are elevated tyrosine levels, thrombocytopenia, leukopenia, conjunctivitis, corneal opacity, keratitis, photophobia, eye pain, blepharitis, cataracts, granulocytopenia, epistaxis, pruritus, exfoliative dermatitis, dry skin, maculopapular rash and alopecia.\"\n },\n {\n \"VerbatimTerm\": \"Corneal Opacity\",\n \"Probability\": \"0.9945774078\",\n \"SemanticContext\": \"*reported in at least 1% of patients; ** another oral formulation of nitisinone TABLE 1 Most Common Adverse Reactions * in Patients with HT-1 Treated with Nitisinone ** Elevated tyrosine levels >10% Leukopenia 3% Thrombocytopenia 3% Conjunctivitis 2% Corneal Opacity 2% Keratitis 2% Photophobia 2% Eye Pain 1% Blepharitis 1% Cataracts 1% Granulocytopenia 1% Epistaxis 1% Pruritus 1% Exfoliative Dermatitis 1% Dry Skin 1% Maculopapular Rash 1% Alopecia 1% .\"\n },\n {\n \"VerbatimTerm\": \"corneal opacities\",\n \"Probability\": \"0.402217567\",\n \"SemanticContext\": \"Maintain plasma tyrosine levels below 500 micromol/L. Inadequate restriction of tyrosine and phenylalanine intake can lead to elevations in plasma tyrosine levels and levels greater than 500 micromol/L may lead to the following: Ocular signs and symptoms including corneal ulcers, corneal opacities, keratitis, conjunctivitis, eye pain, and photophobia have been reported in patients treated with nitisinone [see Adverse Reactions 6.1 ] .\"\n }\n ]\n },\n {\n \"Term\": \"Photophobia\",\n \"MEDDRACode\": \"10034960\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"photophobia\",\n \"Probability\": \"0.9966070652\",\n \"SemanticContext\": \"ADVERSE REACTIONS Most common adverse reactions >1% are elevated tyrosine levels, thrombocytopenia, leukopenia, conjunctivitis, corneal opacity, keratitis, photophobia, eye pain, blepharitis, cataracts, granulocytopenia, epistaxis, pruritus, exfoliative dermatitis, dry skin, maculopapular rash and alopecia.\"\n },\n {\n \"VerbatimTerm\": \"photophobia\",\n \"Probability\": \"0.1020393074\",\n \"SemanticContext\": \"Maintain plasma tyrosine levels below 500 micromol/L. Inadequate restriction of tyrosine and phenylalanine intake can lead to elevations in plasma tyrosine levels and levels greater than 500 micromol/L may lead to the following: Ocular signs and symptoms including corneal ulcers, corneal opacities, keratitis, conjunctivitis, eye pain, and photophobia have been reported in patients treated with nitisinone [see Adverse Reactions 6.1 ] .\"\n },\n {\n \"VerbatimTerm\": \"photophobia\",\n \"Probability\": \"0.0017881989\",\n \"SemanticContext\": \"Patients who develop photophobia, eye pain, or signs of inflammation such as redness, swelling, or burning of the eyes or tyrosine levels are > 500 micromol/L during treatment with NITYR should undergo slit-lamp reexamination and immediate measurement of the plasma tyrosine concentration.\"\n },\n {\n \"VerbatimTerm\": \"Photophobia\",\n \"Probability\": \"0.9932962656\",\n \"SemanticContext\": \"*reported in at least 1% of patients; ** another oral formulation of nitisinone TABLE 1 Most Common Adverse Reactions * in Patients with HT-1 Treated with Nitisinone ** Elevated tyrosine levels >10% Leukopenia 3% Thrombocytopenia 3% Conjunctivitis 2% Corneal Opacity 2% Keratitis 2% Photophobia 2% Eye Pain 1% Blepharitis 1% Cataracts 1% Granulocytopenia 1% Epistaxis 1% Pruritus 1% Exfoliative Dermatitis 1% Dry Skin 1% Maculopapular Rash 1% Alopecia 1% .\"\n }\n ]\n },\n {\n \"Term\": \"Drug screen\",\n \"MEDDRACode\": \"10050837\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"UDS\",\n \"Probability\": \"5.30194E-05\",\n \"SemanticContext\": \"Nitisinone was not genotoxic in the Ames test and the in vivo mouse liver unscheduled DNA synthesis UDS test.\"\n }\n ]\n },\n {\n \"Term\": \"Enteral nutrition\",\n \"MEDDRACode\": \"10052591\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"gavage\",\n \"Probability\": \"4.0678E-06\",\n \"SemanticContext\": \"13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility The carcinogenic potential of nitisinone was assessed in a 26-week oral gavage carcinogenicity study in Tg.rasH2 mice.\"\n }\n ]\n },\n {\n \"Term\": \"Lymphoma\",\n \"MEDDRACode\": \"10025310\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"lymphoma\",\n \"Probability\": \"0.0030130744\",\n \"SemanticContext\": \"Nitisinone was mutagenic in the mouse lymphoma cell L5178Y/TK+/- forward mutation test and in an in vivo mouse bone marrow micronucleus test.\"\n }\n ]\n },\n {\n \"Term\": \"Infant\",\n \"MEDDRACode\": \"10021731\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": true,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"infant\",\n \"Probability\": \"0.0004216433\",\n \"SemanticContext\": \"8.2 Lactation Risk Summary There are no data on the presence of nitisinone in human milk, the effects on the breastfed infant, or the effects on milk production.\"\n },\n {\n \"VerbatimTerm\": \"infant\",\n \"Probability\": \"0.0001617074\",\n \"SemanticContext\": \"The development and health benefits of breastfeeding should be considered along with the mother’s clinical need for NITYR and any potential adverse effects on the breastfed infant from NITYR or from the underlying maternal condition.\"\n }\n ]\n },\n {\n \"Term\": \"Drug interaction\",\n \"MEDDRACode\": \"10013710\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"DRUG INTERACTIONS\",\n \"Probability\": \"4.24696E-05\",\n \"SemanticContext\": \"DRUG INTERACTIONS CYP2C9 Substrates: Increased systemic exposure of these co-administered drugs; reduce the dosage.\"\n },\n {\n \"VerbatimTerm\": \"DRUG INTERACTIONS\",\n \"Probability\": \"0.0015628934\",\n \"SemanticContext\": \"7 DRUG INTERACTIONS\"\n },\n {\n \"VerbatimTerm\": \"Drug Interaction\",\n \"Probability\": \"0.0001656711\",\n \"SemanticContext\": \"Drug Interaction Studies Nitisinone does not inhibit CYP2D6.\"\n },\n {\n \"VerbatimTerm\": \"Drug Interaction\",\n \"Probability\": \"1.09566E-05\",\n \"SemanticContext\": \"In Vitro Studies Where Drug Interaction Potential Was Not Further Evaluated Clinically In vitro studies showed that nitisinone does not inhibit CYP1A2, 2C19, or 3A4.\"\n }\n ]\n },\n {\n \"Term\": \"Hepatic neoplasm\",\n \"MEDDRACode\": \"10019695\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hepatic neoplasms\",\n \"Probability\": \"0.5599882007\",\n \"SemanticContext\": \"Patients with HT-1 are at increased risk of developing porphyric crises, hepatic neoplasms, and liver failure requiring liver transplantation.\"\n }\n ]\n },\n {\n \"Term\": \"Swelling\",\n \"MEDDRACode\": \"10042674\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"swelling\",\n \"Probability\": \"8.13479E-05\",\n \"SemanticContext\": \"Patients who develop photophobia, eye pain, or signs of inflammation such as redness, swelling, or burning of the eyes or tyrosine levels are > 500 micromol/L during treatment with NITYR should undergo slit-lamp reexamination and immediate measurement of the plasma tyrosine concentration.\"\n }\n ]\n },\n {\n \"Term\": \"Alopecia\",\n \"MEDDRACode\": \"10001760\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"alopecia\",\n \"Probability\": \"0.9942157269\",\n \"SemanticContext\": \"ADVERSE REACTIONS Most common adverse reactions >1% are elevated tyrosine levels, thrombocytopenia, leukopenia, conjunctivitis, corneal opacity, keratitis, photophobia, eye pain, blepharitis, cataracts, granulocytopenia, epistaxis, pruritus, exfoliative dermatitis, dry skin, maculopapular rash and alopecia.\"\n },\n {\n \"VerbatimTerm\": \"Alopecia\",\n \"Probability\": \"0.998177886\",\n \"SemanticContext\": \"*reported in at least 1% of patients; ** another oral formulation of nitisinone TABLE 1 Most Common Adverse Reactions * in Patients with HT-1 Treated with Nitisinone ** Elevated tyrosine levels >10% Leukopenia 3% Thrombocytopenia 3% Conjunctivitis 2% Corneal Opacity 2% Keratitis 2% Photophobia 2% Eye Pain 1% Blepharitis 1% Cataracts 1% Granulocytopenia 1% Epistaxis 1% Pruritus 1% Exfoliative Dermatitis 1% Dry Skin 1% Maculopapular Rash 1% Alopecia 1% .\"\n }\n ]\n },\n {\n \"Term\": \"Developmental delay\",\n \"MEDDRACode\": \"10012559\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"developmental delay\",\n \"Probability\": \"0.0147041678\",\n \"SemanticContext\": \"WARNINGS AND PRECAUTIONS Elevated Plasma Tyrosine Levels, Ocular Symptoms, Developmental Delay and Hyperkeratotic Plaques : Inadequate restriction of tyrosine and phenylalanine intake can lead to elevations in plasma tyrosine, which at levels above 500 micromol/L can result in symptoms, intellectual disability and developmental delay or painful hyperkeratotic plaques on the soles and palms; do not adjust NITYR dosage in order to lower the plasma tyrosine concentration.\"\n },\n {\n \"VerbatimTerm\": \"developmental delay\",\n \"Probability\": \"0.1244806945\",\n \"SemanticContext\": \"Elevated Plasma Tyrosine Levels, Ocular Symptoms, Developmental Delay and Hyperkeratotic Plaques Inform patients that inadequate dietary restriction may be associated with ocular signs and symptoms, intellectual disability and developmental delay, and painful hyperkeratotic plaques on the soles and palms.\"\n },\n {\n \"VerbatimTerm\": \"developmental delay\",\n \"Probability\": \"0.0448462665\",\n \"SemanticContext\": \"Variable degrees of intellectual disability and developmental delay.\"\n },\n {\n \"VerbatimTerm\": \"Developmental Delay\",\n \"Probability\": \"0.1722911298\",\n \"SemanticContext\": \"WARNINGS AND PRECAUTIONS Elevated Plasma Tyrosine Levels, Ocular Symptoms, Developmental Delay and Hyperkeratotic Plaques : Inadequate restriction of tyrosine and phenylalanine intake can lead to elevations in plasma tyrosine, which at levels above 500 micromol/L can result in symptoms, intellectual disability and developmental delay or painful hyperkeratotic plaques on the soles and palms; do not adjust NITYR dosage in order to lower the plasma tyrosine concentration.\"\n },\n {\n \"VerbatimTerm\": \"Developmental Delay\",\n \"Probability\": \"0.0101369023\",\n \"SemanticContext\": \"Elevated Plasma Tyrosine Levels, Ocular Symptoms, Developmental Delay and Hyperkeratotic Plaques Inform patients that inadequate dietary restriction may be associated with ocular signs and symptoms, intellectual disability and developmental delay, and painful hyperkeratotic plaques on the soles and palms.\"\n },\n {\n \"VerbatimTerm\": \"Developmental Delay\",\n \"Probability\": \"0.0481026173\",\n \"SemanticContext\": \"5 WARNINGS AND PRECAUTIONS 5.1 Elevated Plasma Tyrosine Levels, Ocular Symptoms, Developmental Delay and Hyperkeratotic Plaques Nitisinone is an inhibitor of 4-hydroxyphenyl-pyruvate dioxygenase, an enzyme in the tyrosine metabolic pathway [see Clinical Pharmacology 12.1 ] .\"\n }\n ]\n },\n {\n \"Term\": \"Hepatic amoebiasis\",\n \"MEDDRACode\": \"10063741\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"ALA\",\n \"Probability\": \"0.0444850028\",\n \"SemanticContext\": \"All patients were treated with nitisinone at a starting dose of 0.3 to 0.5 mg/kg twice daily, and the dose was increased in some patients to 1 mg/kg twice daily based on weight, liver and kidney function tests, platelet count, serum amino acids, urinary phenolic acid, plasma and urine succinylacetone, erythrocyte PBG- synthase, and urine 5-ALA..\"\n },\n {\n \"VerbatimTerm\": \"ALA\",\n \"Probability\": \"0.0074394345\",\n \"SemanticContext\": \"During initiation of therapy, when switching from twice daily to once daily dosing, or if there is a deterioration in the patient’s condition, it may be necessary to follow all available biochemical parameters more closely i.e. plasma and/or urine succinylacetone, urine 5-aminolevulinate ALA and erythrocyte porphobilinogen PBG -synthase activity .\"\n }\n ]\n },\n {\n \"Term\": \"Accidental exposure to product\",\n \"MEDDRACode\": \"10073317\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Accidental ingestion\",\n \"Probability\": \"0.0006006062\",\n \"SemanticContext\": \"10 OVERDOSAGE Accidental ingestion of nitisinone by individuals eating normal diets not restricted in tyrosine and phenylalanine will result in elevated tyrosine levels.\"\n }\n ]\n },\n {\n \"Term\": \"Syringomyelia\",\n \"MEDDRACode\": \"10042928\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0004400611\",\n \"SemanticContext\": \"For patients who have difficulties swallowing intact tablets, including pediatric patients, the tablets can be disintegrated in water and administered using an oral syringe.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0002626181\",\n \"SemanticContext\": \"For patients, including pediatric patients, who have difficulty swallowing intact tablets, NITYR can be disintegrated in water and administered using an oral syringe.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0044604242\",\n \"SemanticContext\": \"Preparation and Administration of NITYR with Water in an Oral Syringe: A 5-mL oral syringe with a cap will be provided by a pharmacist.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"6.45052E-05\",\n \"SemanticContext\": \"Do not prepare more than two tablets at once within the same oral syringe.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0003437698\",\n \"SemanticContext\": \"One Tablet Remove the plunger from the 5-mL oral syringe and insert a single, intact tablet.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0192509592\",\n \"SemanticContext\": \"Cap the oral syringe and leave the oral syringe for at least 60 minutes.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0026107728\",\n \"SemanticContext\": \"Cap the oral syringe and leave the oral syringe for at least 60 minutes.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.003290683\",\n \"SemanticContext\": \"After 60 minutes, turn the oral syringe up and down for at least 30 seconds to suspend the material.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0024821162\",\n \"SemanticContext\": \"Inspect the syringe to ensure the tablet has disintegrated prior to administration to the patient.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0007963181\",\n \"SemanticContext\": \"If the tablet is not fully disintegrated, leave the oral syringe for an additional 10 minutes.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0001390278\",\n \"SemanticContext\": \"Before administration of the suspension to the patient, turn the oral syringe up and down for 30 seconds to re-suspend the particles.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0020206571\",\n \"SemanticContext\": \"Inspect the syringe again to ensure the tablet has disintegrated prior to administration to the patient.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"1.52671E-05\",\n \"SemanticContext\": \"However, if this is not possible, the suspension can be stored at room temperature in the capped oral syringe, protected from direct sunlight for up to 24 hours after adding water to the tablets.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0005013347\",\n \"SemanticContext\": \"Uncap the oral syringe and administer the suspension into the patient's mouth.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0010636747\",\n \"SemanticContext\": \"To facilitate full administration, avoid depressing the plunger to the end of the oral syringe and leave a gap between the plunger and the oral syringe.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0081748664\",\n \"SemanticContext\": \"To facilitate full administration, avoid depressing the plunger to the end of the oral syringe and leave a gap between the plunger and the oral syringe.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0017935336\",\n \"SemanticContext\": \"Rinse the oral syringe by drawing up 2 mL of water.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0060437918\",\n \"SemanticContext\": \"Cap the oral syringe and shake well for 10 seconds to suspend any remaining particles.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0010438263\",\n \"SemanticContext\": \"Uncap the oral syringe and administer the suspension into the patient’s mouth, this time fully depressing the plunger.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"8.06156E-05\",\n \"SemanticContext\": \"If particles are still present in the syringe, repeat steps 9-10.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0274252295\",\n \"SemanticContext\": \"Two Tablets Remove the plunger from the 5-mL oral syringe and insert two intact tablets.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0157724321\",\n \"SemanticContext\": \"Cap the oral syringe and leave it for at least 60 minutes.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.003290683\",\n \"SemanticContext\": \"After 60 minutes, turn the oral syringe up and down for at least 30 seconds to suspend the material.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0035707653\",\n \"SemanticContext\": \"Inspect the syringe to ensure the tablets have disintegrated prior to administration to the patient.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0007963181\",\n \"SemanticContext\": \"If the tablet is not fully disintegrated, leave the oral syringe for an additional 10 minutes.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0001390278\",\n \"SemanticContext\": \"Before administration of the suspension to the patient, turn the oral syringe up and down for 30 seconds to re-suspend the particles.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0020206571\",\n \"SemanticContext\": \"Inspect the syringe again to ensure the tablet has disintegrated prior to administration to the patient.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"1.52671E-05\",\n \"SemanticContext\": \"However, if this is not possible, the suspension can be stored at room temperature in the capped oral syringe, protected from direct sunlight for up to 24 hours after adding water to the tablets.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0005013347\",\n \"SemanticContext\": \"Uncap the oral syringe and administer the suspension into the patient's mouth.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0010636747\",\n \"SemanticContext\": \"To facilitate full administration, avoid depressing the plunger to the end of the oral syringe and leave a gap between the plunger and the oral syringe.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0081748664\",\n \"SemanticContext\": \"To facilitate full administration, avoid depressing the plunger to the end of the oral syringe and leave a gap between the plunger and the oral syringe.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0017935336\",\n \"SemanticContext\": \"Rinse the oral syringe by drawing up 2 mL of water.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0060437918\",\n \"SemanticContext\": \"Cap the oral syringe and shake well for 10 seconds to suspend any remaining particles.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0013137758\",\n \"SemanticContext\": \"Uncap the oral syringe and administer the suspension into the patient’s mouth, this time fully depressing the plunger and ensuring the syringe is empty.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0007374883\",\n \"SemanticContext\": \"Uncap the oral syringe and administer the suspension into the patient’s mouth, this time fully depressing the plunger and ensuring the syringe is empty.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"1.19199E-05\",\n \"SemanticContext\": \"If particles are still present in the syringe, repeat steps 9-10.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0002424717\",\n \"SemanticContext\": \"For patients, including pediatric patients, who have difficulty swallowing the intact tablets, the tablets can be disintegrated in water and administered using an oral syringe.\"\n },\n {\n \"VerbatimTerm\": \"Syringe\",\n \"Probability\": \"0.0027284026\",\n \"SemanticContext\": \"Preparation and Administration of NITYR with Water in an Oral Syringe: A 5-mL oral syringe with a cap will be provided by a pharmacist.\"\n },\n {\n \"VerbatimTerm\": \"syringes\",\n \"Probability\": \"9.10204E-05\",\n \"SemanticContext\": \"If patient’s dosage requires more than two tablets, follow the steps below using multiple oral syringes to achieve the required dose.\"\n }\n ]\n },\n {\n \"Term\": \"Fasting\",\n \"MEDDRACode\": \"10068315\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"fasting\",\n \"Probability\": \"2.2028E-05\",\n \"SemanticContext\": \"Absorption The pharmacokinetic characteristics following single oral administration of 10 mg NITYR under fasting conditions are shown in TABLE 3.\"\n },\n {\n \"VerbatimTerm\": \"Fasting\",\n \"Probability\": \"2.06E-06\",\n \"SemanticContext\": \"Geometric Mean Pharmacokinetic Parameters in Healthy Subjects Following a Single Oral 10 mg Dose of NITYR Under Fasting Conditions Treatment C max ng/mL [range] T max * h [range] AUC 0-120h ng•h/mL [range] * presented as median [range] Single 10 mg NITYR Tablet fasted n=23 1278 [780 to 1649] 3.5 [1.0 to 4.0] 77874 [42335 to 104211] .\"\n },\n {\n \"VerbatimTerm\": \"fasted\",\n \"Probability\": \"0.0005966723\",\n \"SemanticContext\": \"Geometric Mean Pharmacokinetic Parameters in Healthy Subjects Following a Single Oral 10 mg Dose of NITYR Under Fasting Conditions Treatment C max ng/mL [range] T max * h [range] AUC 0-120h ng•h/mL [range] * presented as median [range] Single 10 mg NITYR Tablet fasted n=23 1278 [780 to 1649] 3.5 [1.0 to 4.0] 77874 [42335 to 104211] .\"\n },\n {\n \"VerbatimTerm\": \"Fasted\",\n \"Probability\": \"1.52327E-05\",\n \"SemanticContext\": \"After a washout period of 14 days, the mean value of plasma tyrosine was still 808 micromol/L. Fasted follow-up samples obtained from volunteers several weeks later showed tyrosine values back to normal.\"\n }\n ]\n },\n {\n \"Term\": \"Epistaxis\",\n \"MEDDRACode\": \"10015090\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"epistaxis\",\n \"Probability\": \"0.9993944168\",\n \"SemanticContext\": \"ADVERSE REACTIONS Most common adverse reactions >1% are elevated tyrosine levels, thrombocytopenia, leukopenia, conjunctivitis, corneal opacity, keratitis, photophobia, eye pain, blepharitis, cataracts, granulocytopenia, epistaxis, pruritus, exfoliative dermatitis, dry skin, maculopapular rash and alopecia.\"\n },\n {\n \"VerbatimTerm\": \"Epistaxis\",\n \"Probability\": \"0.9998600483\",\n \"SemanticContext\": \"*reported in at least 1% of patients; ** another oral formulation of nitisinone TABLE 1 Most Common Adverse Reactions * in Patients with HT-1 Treated with Nitisinone ** Elevated tyrosine levels >10% Leukopenia 3% Thrombocytopenia 3% Conjunctivitis 2% Corneal Opacity 2% Keratitis 2% Photophobia 2% Eye Pain 1% Blepharitis 1% Cataracts 1% Granulocytopenia 1% Epistaxis 1% Pruritus 1% Exfoliative Dermatitis 1% Dry Skin 1% Maculopapular Rash 1% Alopecia 1% .\"\n }\n ]\n },\n {\n \"Term\": \"Granulocytopenia\",\n \"MEDDRACode\": \"10018687\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"granulocytopenia\",\n \"Probability\": \"0.9953953028\",\n \"SemanticContext\": \"ADVERSE REACTIONS Most common adverse reactions >1% are elevated tyrosine levels, thrombocytopenia, leukopenia, conjunctivitis, corneal opacity, keratitis, photophobia, eye pain, blepharitis, cataracts, granulocytopenia, epistaxis, pruritus, exfoliative dermatitis, dry skin, maculopapular rash and alopecia.\"\n },\n {\n \"VerbatimTerm\": \"Granulocytopenia\",\n \"Probability\": \"0.9989602566\",\n \"SemanticContext\": \"*reported in at least 1% of patients; ** another oral formulation of nitisinone TABLE 1 Most Common Adverse Reactions * in Patients with HT-1 Treated with Nitisinone ** Elevated tyrosine levels >10% Leukopenia 3% Thrombocytopenia 3% Conjunctivitis 2% Corneal Opacity 2% Keratitis 2% Photophobia 2% Eye Pain 1% Blepharitis 1% Cataracts 1% Granulocytopenia 1% Epistaxis 1% Pruritus 1% Exfoliative Dermatitis 1% Dry Skin 1% Maculopapular Rash 1% Alopecia 1% .\"\n }\n ]\n },\n {\n \"Term\": \"White blood cell count\",\n \"MEDDRACode\": \"10047939\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"white blood cell counts\",\n \"Probability\": \"0.0060758591\",\n \"SemanticContext\": \"Leukopenia and Severe Thrombocytopenia: Monitor platelet and white blood cell counts.\"\n },\n {\n \"VerbatimTerm\": \"white blood cell counts\",\n \"Probability\": \"0.00435251\",\n \"SemanticContext\": \"Monitor platelet and white blood cell counts during NITYR therapy.\"\n }\n ]\n },\n {\n \"Term\": \"Carcinogenicity\",\n \"MEDDRACode\": \"10007269\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"carcinogenicity\",\n \"Probability\": \"1.22723E-05\",\n \"SemanticContext\": \"13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility The carcinogenic potential of nitisinone was assessed in a 26-week oral gavage carcinogenicity study in Tg.rasH2 mice.\"\n }\n ]\n },\n {\n \"Term\": \"Eye pain\",\n \"MEDDRACode\": \"10015958\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"eye pain\",\n \"Probability\": \"0.9916943312\",\n \"SemanticContext\": \"ADVERSE REACTIONS Most common adverse reactions >1% are elevated tyrosine levels, thrombocytopenia, leukopenia, conjunctivitis, corneal opacity, keratitis, photophobia, eye pain, blepharitis, cataracts, granulocytopenia, epistaxis, pruritus, exfoliative dermatitis, dry skin, maculopapular rash and alopecia.\"\n },\n {\n \"VerbatimTerm\": \"eye pain\",\n \"Probability\": \"0.2802772522\",\n \"SemanticContext\": \"Maintain plasma tyrosine levels below 500 micromol/L. Inadequate restriction of tyrosine and phenylalanine intake can lead to elevations in plasma tyrosine levels and levels greater than 500 micromol/L may lead to the following: Ocular signs and symptoms including corneal ulcers, corneal opacities, keratitis, conjunctivitis, eye pain, and photophobia have been reported in patients treated with nitisinone [see Adverse Reactions 6.1 ] .\"\n },\n {\n \"VerbatimTerm\": \"eye pain\",\n \"Probability\": \"0.001738131\",\n \"SemanticContext\": \"Patients who develop photophobia, eye pain, or signs of inflammation such as redness, swelling, or burning of the eyes or tyrosine levels are > 500 micromol/L during treatment with NITYR should undergo slit-lamp reexamination and immediate measurement of the plasma tyrosine concentration.\"\n },\n {\n \"VerbatimTerm\": \"Eye Pain\",\n \"Probability\": \"0.9862341881\",\n \"SemanticContext\": \"*reported in at least 1% of patients; ** another oral formulation of nitisinone TABLE 1 Most Common Adverse Reactions * in Patients with HT-1 Treated with Nitisinone ** Elevated tyrosine levels >10% Leukopenia 3% Thrombocytopenia 3% Conjunctivitis 2% Corneal Opacity 2% Keratitis 2% Photophobia 2% Eye Pain 1% Blepharitis 1% Cataracts 1% Granulocytopenia 1% Epistaxis 1% Pruritus 1% Exfoliative Dermatitis 1% Dry Skin 1% Maculopapular Rash 1% Alopecia 1% .\"\n }\n ]\n },\n {\n \"Term\": \"Keratitis\",\n \"MEDDRACode\": \"10023332\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"keratitis\",\n \"Probability\": \"0.9960250854\",\n \"SemanticContext\": \"ADVERSE REACTIONS Most common adverse reactions >1% are elevated tyrosine levels, thrombocytopenia, leukopenia, conjunctivitis, corneal opacity, keratitis, photophobia, eye pain, blepharitis, cataracts, granulocytopenia, epistaxis, pruritus, exfoliative dermatitis, dry skin, maculopapular rash and alopecia.\"\n },\n {\n \"VerbatimTerm\": \"keratitis\",\n \"Probability\": \"0.3959064186\",\n \"SemanticContext\": \"Maintain plasma tyrosine levels below 500 micromol/L. Inadequate restriction of tyrosine and phenylalanine intake can lead to elevations in plasma tyrosine levels and levels greater than 500 micromol/L may lead to the following: Ocular signs and symptoms including corneal ulcers, corneal opacities, keratitis, conjunctivitis, eye pain, and photophobia have been reported in patients treated with nitisinone [see Adverse Reactions 6.1 ] .\"\n },\n {\n \"VerbatimTerm\": \"Keratitis\",\n \"Probability\": \"0.9920753241\",\n \"SemanticContext\": \"*reported in at least 1% of patients; ** another oral formulation of nitisinone TABLE 1 Most Common Adverse Reactions * in Patients with HT-1 Treated with Nitisinone ** Elevated tyrosine levels >10% Leukopenia 3% Thrombocytopenia 3% Conjunctivitis 2% Corneal Opacity 2% Keratitis 2% Photophobia 2% Eye Pain 1% Blepharitis 1% Cataracts 1% Granulocytopenia 1% Epistaxis 1% Pruritus 1% Exfoliative Dermatitis 1% Dry Skin 1% Maculopapular Rash 1% Alopecia 1% .\"\n }\n ]\n },\n {\n \"Term\": \"Drug level\",\n \"MEDDRACode\": \"10061823\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": true\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"pharmacokinetic studies\",\n \"Probability\": \"0.0004348457\",\n \"SemanticContext\": \"No pharmacokinetic studies of nitisinone have been performed in geriatric patients.\"\n }\n ]\n },\n {\n \"Term\": \"Breast feeding\",\n \"MEDDRACode\": \"10006247\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": true,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"breastfed\",\n \"Probability\": \"0.0002129078\",\n \"SemanticContext\": \"8.2 Lactation Risk Summary There are no data on the presence of nitisinone in human milk, the effects on the breastfed infant, or the effects on milk production.\"\n },\n {\n \"VerbatimTerm\": \"breastfed\",\n \"Probability\": \"6.20559E-05\",\n \"SemanticContext\": \"The development and health benefits of breastfeeding should be considered along with the mother’s clinical need for NITYR and any potential adverse effects on the breastfed infant from NITYR or from the underlying maternal condition.\"\n },\n {\n \"VerbatimTerm\": \"breastfeeding\",\n \"Probability\": \"4.87741E-05\",\n \"SemanticContext\": \"The development and health benefits of breastfeeding should be considered along with the mother’s clinical need for NITYR and any potential adverse effects on the breastfed infant from NITYR or from the underlying maternal condition.\"\n }\n ]\n },\n {\n \"Term\": \"Congenital anomaly\",\n \"MEDDRACode\": \"10010356\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"birth defects\",\n \"Probability\": \"0.114944756\",\n \"SemanticContext\": \"The background risk of major birth defects and miscarriage for the indicated population are unknown.\"\n },\n {\n \"VerbatimTerm\": \"birth defects\",\n \"Probability\": \"0.0714996159\",\n \"SemanticContext\": \"In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.\"\n }\n ]\n },\n {\n \"Term\": \"Caregiver\",\n \"MEDDRACode\": \"10007664\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"caregivers\",\n \"Probability\": \"6.1072E-06\",\n \"SemanticContext\": \"Advise patients and caregivers of the need to maintain dietary restriction of tyrosine and phenylalanine and to report any unexplained ocular, neurologic, or other symptoms promptly to their healthcare provider [see Warnings and Precautions 5.1 ] .\"\n }\n ]\n },\n {\n \"Term\": \"Slit-lamp examination\",\n \"MEDDRACode\": \"10041031\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"slit-lamp examination\",\n \"Probability\": \"0.0001762211\",\n \"SemanticContext\": \"Obtain slit-lamp examination prior to treatment, regularly during treatment; Reexamine patients if symptoms develop or tyrosine levels are > 500 micromol/L. Assess plasma tyrosine levels in patients with an abrupt change in neurologic status.\"\n },\n {\n \"VerbatimTerm\": \"slit-lamp examination\",\n \"Probability\": \"1.3375E-05\",\n \"SemanticContext\": \"Therefore, perform a baseline ophthalmologic examination including slit-lamp examination prior to initiating NITYR treatment and regularly thereafter.\"\n }\n ]\n },\n {\n \"Term\": \"Keratopathy\",\n \"MEDDRACode\": \"10023365\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"keratopathies\",\n \"Probability\": \"0.0316928327\",\n \"SemanticContext\": \"In a clinical study in a non HT-1 population without dietary restriction and reported tyrosine levels > 500 micromol/L both symptomatic and asymptomatic keratopathies have been observed.\"\n }\n ]\n },\n {\n \"Term\": \"Abortion spontaneous\",\n \"MEDDRACode\": \"10000234\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"miscarriage\",\n \"Probability\": \"0.3019028306\",\n \"SemanticContext\": \"The background risk of major birth defects and miscarriage for the indicated population are unknown.\"\n },\n {\n \"VerbatimTerm\": \"miscarriage\",\n \"Probability\": \"0.7700802088\",\n \"SemanticContext\": \"In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.\"\n }\n ]\n },\n {\n \"Term\": \"Ulcerative keratitis\",\n \"MEDDRACode\": \"10064996\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"corneal ulcers\",\n \"Probability\": \"0.8493527174\",\n \"SemanticContext\": \"Maintain plasma tyrosine levels below 500 micromol/L. Inadequate restriction of tyrosine and phenylalanine intake can lead to elevations in plasma tyrosine levels and levels greater than 500 micromol/L may lead to the following: Ocular signs and symptoms including corneal ulcers, corneal opacities, keratitis, conjunctivitis, eye pain, and photophobia have been reported in patients treated with nitisinone [see Adverse Reactions 6.1 ] .\"\n }\n ]\n },\n {\n \"Term\": \"Platelet count\",\n \"MEDDRACode\": \"10035525\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"platelet counts\",\n \"Probability\": \"0.0200046599\",\n \"SemanticContext\": \"Six patients had thrombocytopenia, three of which had platelet counts 30,000/microL or lower.\"\n },\n {\n \"VerbatimTerm\": \"platelet counts\",\n \"Probability\": \"0.0016482174\",\n \"SemanticContext\": \"In 4 patients with thrombocytopenia, platelet counts gradually returned to normal duration up to 47 days without change in the nitisinone dose.\"\n },\n {\n \"VerbatimTerm\": \"platelet count\",\n \"Probability\": \"6.14E-05\",\n \"SemanticContext\": \"All patients were treated with nitisinone at a starting dose of 0.3 to 0.5 mg/kg twice daily, and the dose was increased in some patients to 1 mg/kg twice daily based on weight, liver and kidney function tests, platelet count, serum amino acids, urinary phenolic acid, plasma and urine succinylacetone, erythrocyte PBG- synthase, and urine 5-ALA..\"\n }\n ]\n },\n {\n \"Term\": \"Gait disturbance\",\n \"MEDDRACode\": \"10017577\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"steps\",\n \"Probability\": \"0.0004326999\",\n \"SemanticContext\": \"If patient’s dosage requires more than two tablets, follow the steps below using multiple oral syringes to achieve the required dose.\"\n },\n {\n \"VerbatimTerm\": \"steps\",\n \"Probability\": \"0.0104697645\",\n \"SemanticContext\": \"If particles are still present in the syringe, repeat steps 9-10.\"\n },\n {\n \"VerbatimTerm\": \"steps\",\n \"Probability\": \"0.0015802085\",\n \"SemanticContext\": \"If particles are still present in the syringe, repeat steps 9-10.\"\n },\n {\n \"VerbatimTerm\": \"Step\",\n \"Probability\": \"0.0007086098\",\n \"SemanticContext\": \"If more than one tablet is needed, repeat the procedure starting from Step 2 and collect all the resulting powder together in the applesauce container.\"\n }\n ]\n },\n {\n \"Term\": \"Intellectual disability\",\n \"MEDDRACode\": \"10067989\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"intellectual disability\",\n \"Probability\": \"0.0345519185\",\n \"SemanticContext\": \"WARNINGS AND PRECAUTIONS Elevated Plasma Tyrosine Levels, Ocular Symptoms, Developmental Delay and Hyperkeratotic Plaques : Inadequate restriction of tyrosine and phenylalanine intake can lead to elevations in plasma tyrosine, which at levels above 500 micromol/L can result in symptoms, intellectual disability and developmental delay or painful hyperkeratotic plaques on the soles and palms; do not adjust NITYR dosage in order to lower the plasma tyrosine concentration.\"\n },\n {\n \"VerbatimTerm\": \"intellectual disability\",\n \"Probability\": \"0.0740502179\",\n \"SemanticContext\": \"Elevated Plasma Tyrosine Levels, Ocular Symptoms, Developmental Delay and Hyperkeratotic Plaques Inform patients that inadequate dietary restriction may be associated with ocular signs and symptoms, intellectual disability and developmental delay, and painful hyperkeratotic plaques on the soles and palms.\"\n },\n {\n \"VerbatimTerm\": \"intellectual disability\",\n \"Probability\": \"0.0342915356\",\n \"SemanticContext\": \"Variable degrees of intellectual disability and developmental delay.\"\n }\n ]\n },\n {\n \"Term\": \"Erythema\",\n \"MEDDRACode\": \"10015150\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"redness\",\n \"Probability\": \"0.0009130239\",\n \"SemanticContext\": \"Patients who develop photophobia, eye pain, or signs of inflammation such as redness, swelling, or burning of the eyes or tyrosine levels are > 500 micromol/L during treatment with NITYR should undergo slit-lamp reexamination and immediate measurement of the plasma tyrosine concentration.\"\n }\n ]\n }\n ],\n \"IndicationTerms\": []\n }\n ]\n },\n {\n \"GenericName\": \"clopidogrel bisulfate\",\n \"MeddraVersion\": \"24.0\",\n \"Labels\": [\n {\n \"Id\": \"USfdbc18a6-b364-4f85-9fd1-71d04b3a7ab1\",\n \"NDCCode\": \"63653-1171\",\n \"UpdatedDate\": \"Mar 11, 2021\",\n \"LabelSource\": {\n \"Country\": \"us\",\n \"ProductId\": \"01b14603-8f29-4fa3-8d7e-9d523f802e0b\",\n \"FileId\": \"fdbc18a6-b364-4f85-9fd1-71d04b3a7ab1\",\n \"Version\": \"34\"\n },\n \"AdverseEventTerms\": [\n {\n \"Term\": \"Acute generalised exanthematous pustulosis\",\n \"MEDDRACode\": \"10048799\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"acute generalized exanthematous pustulosis\",\n \"Probability\": \"0.65901649\",\n \"SemanticContext\": \"Blood and lymphatic system disorders: Agranulocytosis, aplastic anemia/pancytopenia, thrombotic thrombocytopenic purpura TTP , acquired hemophilia A Gastrointestinal disorders: Colitis including ulcerative or lymphocytic colitis , pancreatitis, stomatitis, gastric/duodenal ulcer, diarrhea General disorders and administration site condition: Fever Hepatobiliary disorders: Acute liver failure, hepatitis noninfectious , abnormal liver function test Immune system disorders: Hypersensitivity reactions, anaphylactoid reactions, serum sickness, insulin autoimmune syndrome, which can lead to severe hypoglycemia Musculoskeletal, connective tissue and bone disorders: Myalgia, arthralgia, arthritis Nervous system disorders: Taste disorders, headache, ageusia Psychiatric disorders: Confusion, hallucinations Respiratory, thoracic and mediastinal disorders: Bronchospasm, interstitial pneumonitis, eosinophilic pneumonia Renal and urinary disorders: Increased creatinine levels Skin and subcutaneous tissue disorders: Maculopapular, erythematous or exfoliative rash, urticaria, bullous dermatitis, eczema, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis AGEP , angioedema, drug-induced hypersensitivity syndrome, drug rash with eosinophilia and systemic symptoms DRESS , erythema multiforme, lichen planus, generalized pruritus Vascular disorders: Vasculitis, hypotension\"\n },\n {\n \"VerbatimTerm\": \"AGEP\",\n \"Probability\": \"0.3240773678\",\n \"SemanticContext\": \"Blood and lymphatic system disorders: Agranulocytosis, aplastic anemia/pancytopenia, thrombotic thrombocytopenic purpura TTP , acquired hemophilia A Gastrointestinal disorders: Colitis including ulcerative or lymphocytic colitis , pancreatitis, stomatitis, gastric/duodenal ulcer, diarrhea General disorders and administration site condition: Fever Hepatobiliary disorders: Acute liver failure, hepatitis noninfectious , abnormal liver function test Immune system disorders: Hypersensitivity reactions, anaphylactoid reactions, serum sickness, insulin autoimmune syndrome, which can lead to severe hypoglycemia Musculoskeletal, connective tissue and bone disorders: Myalgia, arthralgia, arthritis Nervous system disorders: Taste disorders, headache, ageusia Psychiatric disorders: Confusion, hallucinations Respiratory, thoracic and mediastinal disorders: Bronchospasm, interstitial pneumonitis, eosinophilic pneumonia Renal and urinary disorders: Increased creatinine levels Skin and subcutaneous tissue disorders: Maculopapular, erythematous or exfoliative rash, urticaria, bullous dermatitis, eczema, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis AGEP , angioedema, drug-induced hypersensitivity syndrome, drug rash with eosinophilia and systemic symptoms DRESS , erythema multiforme, lichen planus, generalized pruritus Vascular disorders: Vasculitis, hypotension\"\n }\n ]\n },\n {\n \"Term\": \"Aplastic anaemia\",\n \"MEDDRACode\": \"10002967\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"aplastic anemia\",\n \"Probability\": \"0.9988659024\",\n \"SemanticContext\": \"Blood and lymphatic system disorders: Agranulocytosis, aplastic anemia/pancytopenia, thrombotic thrombocytopenic purpura TTP , acquired hemophilia A Gastrointestinal disorders: Colitis including ulcerative or lymphocytic colitis , pancreatitis, stomatitis, gastric/duodenal ulcer, diarrhea General disorders and administration site condition: Fever Hepatobiliary disorders: Acute liver failure, hepatitis noninfectious , abnormal liver function test Immune system disorders: Hypersensitivity reactions, anaphylactoid reactions, serum sickness, insulin autoimmune syndrome, which can lead to severe hypoglycemia Musculoskeletal, connective tissue and bone disorders: Myalgia, arthralgia, arthritis Nervous system disorders: Taste disorders, headache, ageusia Psychiatric disorders: Confusion, hallucinations Respiratory, thoracic and mediastinal disorders: Bronchospasm, interstitial pneumonitis, eosinophilic pneumonia Renal and urinary disorders: Increased creatinine levels Skin and subcutaneous tissue disorders: Maculopapular, erythematous or exfoliative rash, urticaria, bullous dermatitis, eczema, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis AGEP , angioedema, drug-induced hypersensitivity syndrome, drug rash with eosinophilia and systemic symptoms DRESS , erythema multiforme, lichen planus, generalized pruritus Vascular disorders: Vasculitis, hypotension\"\n }\n ]\n },\n {\n \"Term\": \"Angiopathy\",\n \"MEDDRACode\": \"10059245\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Vascular disorders\",\n \"Probability\": \"0.2893764675\",\n \"SemanticContext\": \"Blood and lymphatic system disorders: Agranulocytosis, aplastic anemia/pancytopenia, thrombotic thrombocytopenic purpura TTP , acquired hemophilia A Gastrointestinal disorders: Colitis including ulcerative or lymphocytic colitis , pancreatitis, stomatitis, gastric/duodenal ulcer, diarrhea General disorders and administration site condition: Fever Hepatobiliary disorders: Acute liver failure, hepatitis noninfectious , abnormal liver function test Immune system disorders: Hypersensitivity reactions, anaphylactoid reactions, serum sickness, insulin autoimmune syndrome, which can lead to severe hypoglycemia Musculoskeletal, connective tissue and bone disorders: Myalgia, arthralgia, arthritis Nervous system disorders: Taste disorders, headache, ageusia Psychiatric disorders: Confusion, hallucinations Respiratory, thoracic and mediastinal disorders: Bronchospasm, interstitial pneumonitis, eosinophilic pneumonia Renal and urinary disorders: Increased creatinine levels Skin and subcutaneous tissue disorders: Maculopapular, erythematous or exfoliative rash, urticaria, bullous dermatitis, eczema, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis AGEP , angioedema, drug-induced hypersensitivity syndrome, drug rash with eosinophilia and systemic symptoms DRESS , erythema multiforme, lichen planus, generalized pruritus Vascular disorders: Vasculitis, hypotension\"\n }\n ]\n },\n {\n \"Term\": \"Arthralgia\",\n \"MEDDRACode\": \"10003239\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"arthralgia\",\n \"Probability\": \"0.9972888827\",\n \"SemanticContext\": \"Blood and lymphatic system disorders: Agranulocytosis, aplastic anemia/pancytopenia, thrombotic thrombocytopenic purpura TTP , acquired hemophilia A Gastrointestinal disorders: Colitis including ulcerative or lymphocytic colitis , pancreatitis, stomatitis, gastric/duodenal ulcer, diarrhea General disorders and administration site condition: Fever Hepatobiliary disorders: Acute liver failure, hepatitis noninfectious , abnormal liver function test Immune system disorders: Hypersensitivity reactions, anaphylactoid reactions, serum sickness, insulin autoimmune syndrome, which can lead to severe hypoglycemia Musculoskeletal, connective tissue and bone disorders: Myalgia, arthralgia, arthritis Nervous system disorders: Taste disorders, headache, ageusia Psychiatric disorders: Confusion, hallucinations Respiratory, thoracic and mediastinal disorders: Bronchospasm, interstitial pneumonitis, eosinophilic pneumonia Renal and urinary disorders: Increased creatinine levels Skin and subcutaneous tissue disorders: Maculopapular, erythematous or exfoliative rash, urticaria, bullous dermatitis, eczema, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis AGEP , angioedema, drug-induced hypersensitivity syndrome, drug rash with eosinophilia and systemic symptoms DRESS , erythema multiforme, lichen planus, generalized pruritus Vascular disorders: Vasculitis, hypotension\"\n }\n ]\n },\n {\n \"Term\": \"Blood creatinine increased\",\n \"MEDDRACode\": \"10005483\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Increased creatinine\",\n \"Probability\": \"0.9930081367\",\n \"SemanticContext\": \"Blood and lymphatic system disorders: Agranulocytosis, aplastic anemia/pancytopenia, thrombotic thrombocytopenic purpura TTP , acquired hemophilia A Gastrointestinal disorders: Colitis including ulcerative or lymphocytic colitis , pancreatitis, stomatitis, gastric/duodenal ulcer, diarrhea General disorders and administration site condition: Fever Hepatobiliary disorders: Acute liver failure, hepatitis noninfectious , abnormal liver function test Immune system disorders: Hypersensitivity reactions, anaphylactoid reactions, serum sickness, insulin autoimmune syndrome, which can lead to severe hypoglycemia Musculoskeletal, connective tissue and bone disorders: Myalgia, arthralgia, arthritis Nervous system disorders: Taste disorders, headache, ageusia Psychiatric disorders: Confusion, hallucinations Respiratory, thoracic and mediastinal disorders: Bronchospasm, interstitial pneumonitis, eosinophilic pneumonia Renal and urinary disorders: Increased creatinine levels Skin and subcutaneous tissue disorders: Maculopapular, erythematous or exfoliative rash, urticaria, bullous dermatitis, eczema, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis AGEP , angioedema, drug-induced hypersensitivity syndrome, drug rash with eosinophilia and systemic symptoms DRESS , erythema multiforme, lichen planus, generalized pruritus Vascular disorders: Vasculitis, hypotension\"\n }\n ]\n },\n {\n \"Term\": \"Acquired haemophilia\",\n \"MEDDRACode\": \"10053745\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"acquired hemophilia\",\n \"Probability\": \"0.9934672117\",\n \"SemanticContext\": \"Blood and lymphatic system disorders: Agranulocytosis, aplastic anemia/pancytopenia, thrombotic thrombocytopenic purpura TTP , acquired hemophilia A Gastrointestinal disorders: Colitis including ulcerative or lymphocytic colitis , pancreatitis, stomatitis, gastric/duodenal ulcer, diarrhea General disorders and administration site condition: Fever Hepatobiliary disorders: Acute liver failure, hepatitis noninfectious , abnormal liver function test Immune system disorders: Hypersensitivity reactions, anaphylactoid reactions, serum sickness, insulin autoimmune syndrome, which can lead to severe hypoglycemia Musculoskeletal, connective tissue and bone disorders: Myalgia, arthralgia, arthritis Nervous system disorders: Taste disorders, headache, ageusia Psychiatric disorders: Confusion, hallucinations Respiratory, thoracic and mediastinal disorders: Bronchospasm, interstitial pneumonitis, eosinophilic pneumonia Renal and urinary disorders: Increased creatinine levels Skin and subcutaneous tissue disorders: Maculopapular, erythematous or exfoliative rash, urticaria, bullous dermatitis, eczema, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis AGEP , angioedema, drug-induced hypersensitivity syndrome, drug rash with eosinophilia and systemic symptoms DRESS , erythema multiforme, lichen planus, generalized pruritus Vascular disorders: Vasculitis, hypotension\"\n }\n ]\n },\n {\n \"Term\": \"Colitis\",\n \"MEDDRACode\": \"10009887\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Colitis\",\n \"Probability\": \"0.9989324212\",\n \"SemanticContext\": \"Blood and lymphatic system disorders: Agranulocytosis, aplastic anemia/pancytopenia, thrombotic thrombocytopenic purpura TTP , acquired hemophilia A Gastrointestinal disorders: Colitis including ulcerative or lymphocytic colitis , pancreatitis, stomatitis, gastric/duodenal ulcer, diarrhea General disorders and administration site condition: Fever Hepatobiliary disorders: Acute liver failure, hepatitis noninfectious , abnormal liver function test Immune system disorders: Hypersensitivity reactions, anaphylactoid reactions, serum sickness, insulin autoimmune syndrome, which can lead to severe hypoglycemia Musculoskeletal, connective tissue and bone disorders: Myalgia, arthralgia, arthritis Nervous system disorders: Taste disorders, headache, ageusia Psychiatric disorders: Confusion, hallucinations Respiratory, thoracic and mediastinal disorders: Bronchospasm, interstitial pneumonitis, eosinophilic pneumonia Renal and urinary disorders: Increased creatinine levels Skin and subcutaneous tissue disorders: Maculopapular, erythematous or exfoliative rash, urticaria, bullous dermatitis, eczema, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis AGEP , angioedema, drug-induced hypersensitivity syndrome, drug rash with eosinophilia and systemic symptoms DRESS , erythema multiforme, lichen planus, generalized pruritus Vascular disorders: Vasculitis, hypotension\"\n }\n ]\n },\n {\n \"Term\": \"Colitis microscopic\",\n \"MEDDRACode\": \"10056979\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"lymphocytic colitis\",\n \"Probability\": \"0.9496940374\",\n \"SemanticContext\": \"Blood and lymphatic system disorders: Agranulocytosis, aplastic anemia/pancytopenia, thrombotic thrombocytopenic purpura TTP , acquired hemophilia A Gastrointestinal disorders: Colitis including ulcerative or lymphocytic colitis , pancreatitis, stomatitis, gastric/duodenal ulcer, diarrhea General disorders and administration site condition: Fever Hepatobiliary disorders: Acute liver failure, hepatitis noninfectious , abnormal liver function test Immune system disorders: Hypersensitivity reactions, anaphylactoid reactions, serum sickness, insulin autoimmune syndrome, which can lead to severe hypoglycemia Musculoskeletal, connective tissue and bone disorders: Myalgia, arthralgia, arthritis Nervous system disorders: Taste disorders, headache, ageusia Psychiatric disorders: Confusion, hallucinations Respiratory, thoracic and mediastinal disorders: Bronchospasm, interstitial pneumonitis, eosinophilic pneumonia Renal and urinary disorders: Increased creatinine levels Skin and subcutaneous tissue disorders: Maculopapular, erythematous or exfoliative rash, urticaria, bullous dermatitis, eczema, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis AGEP , angioedema, drug-induced hypersensitivity syndrome, drug rash with eosinophilia and systemic symptoms DRESS , erythema multiforme, lichen planus, generalized pruritus Vascular disorders: Vasculitis, hypotension\"\n }\n ]\n },\n {\n \"Term\": \"Dermatitis bullous\",\n \"MEDDRACode\": \"10012441\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"bullous dermatitis\",\n \"Probability\": \"0.9696852565\",\n \"SemanticContext\": \"Blood and lymphatic system disorders: Agranulocytosis, aplastic anemia/pancytopenia, thrombotic thrombocytopenic purpura TTP , acquired hemophilia A Gastrointestinal disorders: Colitis including ulcerative or lymphocytic colitis , pancreatitis, stomatitis, gastric/duodenal ulcer, diarrhea General disorders and administration site condition: Fever Hepatobiliary disorders: Acute liver failure, hepatitis noninfectious , abnormal liver function test Immune system disorders: Hypersensitivity reactions, anaphylactoid reactions, serum sickness, insulin autoimmune syndrome, which can lead to severe hypoglycemia Musculoskeletal, connective tissue and bone disorders: Myalgia, arthralgia, arthritis Nervous system disorders: Taste disorders, headache, ageusia Psychiatric disorders: Confusion, hallucinations Respiratory, thoracic and mediastinal disorders: Bronchospasm, interstitial pneumonitis, eosinophilic pneumonia Renal and urinary disorders: Increased creatinine levels Skin and subcutaneous tissue disorders: Maculopapular, erythematous or exfoliative rash, urticaria, bullous dermatitis, eczema, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis AGEP , angioedema, drug-induced hypersensitivity syndrome, drug rash with eosinophilia and systemic symptoms DRESS , erythema multiforme, lichen planus, generalized pruritus Vascular disorders: Vasculitis, hypotension\"\n }\n ]\n },\n {\n \"Term\": \"Eczema\",\n \"MEDDRACode\": \"10014184\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"eczema\",\n \"Probability\": \"0.9892866611\",\n \"SemanticContext\": \"Blood and lymphatic system disorders: Agranulocytosis, aplastic anemia/pancytopenia, thrombotic thrombocytopenic purpura TTP , acquired hemophilia A Gastrointestinal disorders: Colitis including ulcerative or lymphocytic colitis , pancreatitis, stomatitis, gastric/duodenal ulcer, diarrhea General disorders and administration site condition: Fever Hepatobiliary disorders: Acute liver failure, hepatitis noninfectious , abnormal liver function test Immune system disorders: Hypersensitivity reactions, anaphylactoid reactions, serum sickness, insulin autoimmune syndrome, which can lead to severe hypoglycemia Musculoskeletal, connective tissue and bone disorders: Myalgia, arthralgia, arthritis Nervous system disorders: Taste disorders, headache, ageusia Psychiatric disorders: Confusion, hallucinations Respiratory, thoracic and mediastinal disorders: Bronchospasm, interstitial pneumonitis, eosinophilic pneumonia Renal and urinary disorders: Increased creatinine levels Skin and subcutaneous tissue disorders: Maculopapular, erythematous or exfoliative rash, urticaria, bullous dermatitis, eczema, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis AGEP , angioedema, drug-induced hypersensitivity syndrome, drug rash with eosinophilia and systemic symptoms DRESS , erythema multiforme, lichen planus, generalized pruritus Vascular disorders: Vasculitis, hypotension\"\n }\n ]\n },\n {\n \"Term\": \"Factor VIII deficiency\",\n \"MEDDRACode\": \"10016080\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hemophilia A\",\n \"Probability\": \"0.9512542486\",\n \"SemanticContext\": \"Blood and lymphatic system disorders: Agranulocytosis, aplastic anemia/pancytopenia, thrombotic thrombocytopenic purpura TTP , acquired hemophilia A Gastrointestinal disorders: Colitis including ulcerative or lymphocytic colitis , pancreatitis, stomatitis, gastric/duodenal ulcer, diarrhea General disorders and administration site condition: Fever Hepatobiliary disorders: Acute liver failure, hepatitis noninfectious , abnormal liver function test Immune system disorders: Hypersensitivity reactions, anaphylactoid reactions, serum sickness, insulin autoimmune syndrome, which can lead to severe hypoglycemia Musculoskeletal, connective tissue and bone disorders: Myalgia, arthralgia, arthritis Nervous system disorders: Taste disorders, headache, ageusia Psychiatric disorders: Confusion, hallucinations Respiratory, thoracic and mediastinal disorders: Bronchospasm, interstitial pneumonitis, eosinophilic pneumonia Renal and urinary disorders: Increased creatinine levels Skin and subcutaneous tissue disorders: Maculopapular, erythematous or exfoliative rash, urticaria, bullous dermatitis, eczema, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis AGEP , angioedema, drug-induced hypersensitivity syndrome, drug rash with eosinophilia and systemic symptoms DRESS , erythema multiforme, lichen planus, generalized pruritus Vascular disorders: Vasculitis, hypotension\"\n }\n ]\n },\n {\n \"Term\": \"Acute hepatic failure\",\n \"MEDDRACode\": \"10000804\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Acute liver failure\",\n \"Probability\": \"0.9355264306\",\n \"SemanticContext\": \"Blood and lymphatic system disorders: Agranulocytosis, aplastic anemia/pancytopenia, thrombotic thrombocytopenic purpura TTP , acquired hemophilia A Gastrointestinal disorders: Colitis including ulcerative or lymphocytic colitis , pancreatitis, stomatitis, gastric/duodenal ulcer, diarrhea General disorders and administration site condition: Fever Hepatobiliary disorders: Acute liver failure, hepatitis noninfectious , abnormal liver function test Immune system disorders: Hypersensitivity reactions, anaphylactoid reactions, serum sickness, insulin autoimmune syndrome, which can lead to severe hypoglycemia Musculoskeletal, connective tissue and bone disorders: Myalgia, arthralgia, arthritis Nervous system disorders: Taste disorders, headache, ageusia Psychiatric disorders: Confusion, hallucinations Respiratory, thoracic and mediastinal disorders: Bronchospasm, interstitial pneumonitis, eosinophilic pneumonia Renal and urinary disorders: Increased creatinine levels Skin and subcutaneous tissue disorders: Maculopapular, erythematous or exfoliative rash, urticaria, bullous dermatitis, eczema, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis AGEP , angioedema, drug-induced hypersensitivity syndrome, drug rash with eosinophilia and systemic symptoms DRESS , erythema multiforme, lichen planus, generalized pruritus Vascular disorders: Vasculitis, hypotension\"\n }\n ]\n },\n {\n \"Term\": \"Bone disorder\",\n \"MEDDRACode\": \"10005956\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"bone disorders\",\n \"Probability\": \"0.0118712783\",\n \"SemanticContext\": \"Blood and lymphatic system disorders: Agranulocytosis, aplastic anemia/pancytopenia, thrombotic thrombocytopenic purpura TTP , acquired hemophilia A Gastrointestinal disorders: Colitis including ulcerative or lymphocytic colitis , pancreatitis, stomatitis, gastric/duodenal ulcer, diarrhea General disorders and administration site condition: Fever Hepatobiliary disorders: Acute liver failure, hepatitis noninfectious , abnormal liver function test Immune system disorders: Hypersensitivity reactions, anaphylactoid reactions, serum sickness, insulin autoimmune syndrome, which can lead to severe hypoglycemia Musculoskeletal, connective tissue and bone disorders: Myalgia, arthralgia, arthritis Nervous system disorders: Taste disorders, headache, ageusia Psychiatric disorders: Confusion, hallucinations Respiratory, thoracic and mediastinal disorders: Bronchospasm, interstitial pneumonitis, eosinophilic pneumonia Renal and urinary disorders: Increased creatinine levels Skin and subcutaneous tissue disorders: Maculopapular, erythematous or exfoliative rash, urticaria, bullous dermatitis, eczema, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis AGEP , angioedema, drug-induced hypersensitivity syndrome, drug rash with eosinophilia and systemic symptoms DRESS , erythema multiforme, lichen planus, generalized pruritus Vascular disorders: Vasculitis, hypotension\"\n }\n ]\n },\n {\n \"Term\": \"Bronchospasm\",\n \"MEDDRACode\": \"10006482\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Bronchospasm\",\n \"Probability\": \"0.9987204671\",\n \"SemanticContext\": \"Blood and lymphatic system disorders: Agranulocytosis, aplastic anemia/pancytopenia, thrombotic thrombocytopenic purpura TTP , acquired hemophilia A Gastrointestinal disorders: Colitis including ulcerative or lymphocytic colitis , pancreatitis, stomatitis, gastric/duodenal ulcer, diarrhea General disorders and administration site condition: Fever Hepatobiliary disorders: Acute liver failure, hepatitis noninfectious , abnormal liver function test Immune system disorders: Hypersensitivity reactions, anaphylactoid reactions, serum sickness, insulin autoimmune syndrome, which can lead to severe hypoglycemia Musculoskeletal, connective tissue and bone disorders: Myalgia, arthralgia, arthritis Nervous system disorders: Taste disorders, headache, ageusia Psychiatric disorders: Confusion, hallucinations Respiratory, thoracic and mediastinal disorders: Bronchospasm, interstitial pneumonitis, eosinophilic pneumonia Renal and urinary disorders: Increased creatinine levels Skin and subcutaneous tissue disorders: Maculopapular, erythematous or exfoliative rash, urticaria, bullous dermatitis, eczema, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis AGEP , angioedema, drug-induced hypersensitivity syndrome, drug rash with eosinophilia and systemic symptoms DRESS , erythema multiforme, lichen planus, generalized pruritus Vascular disorders: Vasculitis, hypotension\"\n }\n ]\n },\n {\n \"Term\": \"Haemoglobin S\",\n \"MEDDRACode\": \"10051600\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hemoglobin\",\n \"Probability\": \"0.0317761302\",\n \"SemanticContext\": \"3.7 2.7 Life-threatening bleeding 2.2 1.8 Fatal 0.2 0.2 5 g/dL hemoglobin drop 0.9 0.9 Requiring surgical intervention 0.7 0.7 Hemorrhagic strokes 0.1 0.1 Requiring inotropes 0.5 0.5 Requiring transfusion =4 units 1.2 1.0 Other major bleeding 1.6 1.0 Significantly disabling 0.4 0.3 Intraocular bleeding with significant loss of vision 0.05 0.03 Requiring 2--3 units of blood 1.3 0.9 Minor bleeding Led to interruption of study medication.\"\n }\n ]\n },\n {\n \"Term\": \"Hepatitis\",\n \"MEDDRACode\": \"10019717\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hepatitis\",\n \"Probability\": \"0.7173345685\",\n \"SemanticContext\": \"Blood and lymphatic system disorders: Agranulocytosis, aplastic anemia/pancytopenia, thrombotic thrombocytopenic purpura TTP , acquired hemophilia A Gastrointestinal disorders: Colitis including ulcerative or lymphocytic colitis , pancreatitis, stomatitis, gastric/duodenal ulcer, diarrhea General disorders and administration site condition: Fever Hepatobiliary disorders: Acute liver failure, hepatitis noninfectious , abnormal liver function test Immune system disorders: Hypersensitivity reactions, anaphylactoid reactions, serum sickness, insulin autoimmune syndrome, which can lead to severe hypoglycemia Musculoskeletal, connective tissue and bone disorders: Myalgia, arthralgia, arthritis Nervous system disorders: Taste disorders, headache, ageusia Psychiatric disorders: Confusion, hallucinations Respiratory, thoracic and mediastinal disorders: Bronchospasm, interstitial pneumonitis, eosinophilic pneumonia Renal and urinary disorders: Increased creatinine levels Skin and subcutaneous tissue disorders: Maculopapular, erythematous or exfoliative rash, urticaria, bullous dermatitis, eczema, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis AGEP , angioedema, drug-induced hypersensitivity syndrome, drug rash with eosinophilia and systemic symptoms DRESS , erythema multiforme, lichen planus, generalized pruritus Vascular disorders: Vasculitis, hypotension\"\n }\n ]\n },\n {\n \"Term\": \"Drug reaction with eosinophilia and systemic symptoms\",\n \"MEDDRACode\": \"10073508\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"drug rash with eosinophilia and systemic symptoms\",\n \"Probability\": \"0.5977883935\",\n \"SemanticContext\": \"Blood and lymphatic system disorders: Agranulocytosis, aplastic anemia/pancytopenia, thrombotic thrombocytopenic purpura TTP , acquired hemophilia A Gastrointestinal disorders: Colitis including ulcerative or lymphocytic colitis , pancreatitis, stomatitis, gastric/duodenal ulcer, diarrhea General disorders and administration site condition: Fever Hepatobiliary disorders: Acute liver failure, hepatitis noninfectious , abnormal liver function test Immune system disorders: Hypersensitivity reactions, anaphylactoid reactions, serum sickness, insulin autoimmune syndrome, which can lead to severe hypoglycemia Musculoskeletal, connective tissue and bone disorders: Myalgia, arthralgia, arthritis Nervous system disorders: Taste disorders, headache, ageusia Psychiatric disorders: Confusion, hallucinations Respiratory, thoracic and mediastinal disorders: Bronchospasm, interstitial pneumonitis, eosinophilic pneumonia Renal and urinary disorders: Increased creatinine levels Skin and subcutaneous tissue disorders: Maculopapular, erythematous or exfoliative rash, urticaria, bullous dermatitis, eczema, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis AGEP , angioedema, drug-induced hypersensitivity syndrome, drug rash with eosinophilia and systemic symptoms DRESS , erythema multiforme, lichen planus, generalized pruritus Vascular disorders: Vasculitis, hypotension\"\n }\n ]\n },\n {\n \"Term\": \"Haemoglobin\",\n \"MEDDRACode\": \"10018876\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hemoglobin\",\n \"Probability\": \"0.0317761302\",\n \"SemanticContext\": \"3.7 2.7 Life-threatening bleeding 2.2 1.8 Fatal 0.2 0.2 5 g/dL hemoglobin drop 0.9 0.9 Requiring surgical intervention 0.7 0.7 Hemorrhagic strokes 0.1 0.1 Requiring inotropes 0.5 0.5 Requiring transfusion =4 units 1.2 1.0 Other major bleeding 1.6 1.0 Significantly disabling 0.4 0.3 Intraocular bleeding with significant loss of vision 0.05 0.03 Requiring 2--3 units of blood 1.3 0.9 Minor bleeding Led to interruption of study medication.\"\n }\n ]\n },\n {\n \"Term\": \"Hallucination\",\n \"MEDDRACode\": \"10019063\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hallucinations\",\n \"Probability\": \"0.9558229446\",\n \"SemanticContext\": \"Blood and lymphatic system disorders: Agranulocytosis, aplastic anemia/pancytopenia, thrombotic thrombocytopenic purpura TTP , acquired hemophilia A Gastrointestinal disorders: Colitis including ulcerative or lymphocytic colitis , pancreatitis, stomatitis, gastric/duodenal ulcer, diarrhea General disorders and administration site condition: Fever Hepatobiliary disorders: Acute liver failure, hepatitis noninfectious , abnormal liver function test Immune system disorders: Hypersensitivity reactions, anaphylactoid reactions, serum sickness, insulin autoimmune syndrome, which can lead to severe hypoglycemia Musculoskeletal, connective tissue and bone disorders: Myalgia, arthralgia, arthritis Nervous system disorders: Taste disorders, headache, ageusia Psychiatric disorders: Confusion, hallucinations Respiratory, thoracic and mediastinal disorders: Bronchospasm, interstitial pneumonitis, eosinophilic pneumonia Renal and urinary disorders: Increased creatinine levels Skin and subcutaneous tissue disorders: Maculopapular, erythematous or exfoliative rash, urticaria, bullous dermatitis, eczema, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis AGEP , angioedema, drug-induced hypersensitivity syndrome, drug rash with eosinophilia and systemic symptoms DRESS , erythema multiforme, lichen planus, generalized pruritus Vascular disorders: Vasculitis, hypotension\"\n }\n ]\n },\n {\n \"Term\": \"Agranulocytosis\",\n \"MEDDRACode\": \"10001507\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Agranulocytosis\",\n \"Probability\": \"0.9991698265\",\n \"SemanticContext\": \"Blood and lymphatic system disorders: Agranulocytosis, aplastic anemia/pancytopenia, thrombotic thrombocytopenic purpura TTP , acquired hemophilia A Gastrointestinal disorders: Colitis including ulcerative or lymphocytic colitis , pancreatitis, stomatitis, gastric/duodenal ulcer, diarrhea General disorders and administration site condition: Fever Hepatobiliary disorders: Acute liver failure, hepatitis noninfectious , abnormal liver function test Immune system disorders: Hypersensitivity reactions, anaphylactoid reactions, serum sickness, insulin autoimmune syndrome, which can lead to severe hypoglycemia Musculoskeletal, connective tissue and bone disorders: Myalgia, arthralgia, arthritis Nervous system disorders: Taste disorders, headache, ageusia Psychiatric disorders: Confusion, hallucinations Respiratory, thoracic and mediastinal disorders: Bronchospasm, interstitial pneumonitis, eosinophilic pneumonia Renal and urinary disorders: Increased creatinine levels Skin and subcutaneous tissue disorders: Maculopapular, erythematous or exfoliative rash, urticaria, bullous dermatitis, eczema, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis AGEP , angioedema, drug-induced hypersensitivity syndrome, drug rash with eosinophilia and systemic symptoms DRESS , erythema multiforme, lichen planus, generalized pruritus Vascular disorders: Vasculitis, hypotension\"\n }\n ]\n },\n {\n \"Term\": \"Anaphylactoid reaction\",\n \"MEDDRACode\": \"10002216\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"anaphylactoid reactions\",\n \"Probability\": \"0.9983623028\",\n \"SemanticContext\": \"Blood and lymphatic system disorders: Agranulocytosis, aplastic anemia/pancytopenia, thrombotic thrombocytopenic purpura TTP , acquired hemophilia A Gastrointestinal disorders: Colitis including ulcerative or lymphocytic colitis , pancreatitis, stomatitis, gastric/duodenal ulcer, diarrhea General disorders and administration site condition: Fever Hepatobiliary disorders: Acute liver failure, hepatitis noninfectious , abnormal liver function test Immune system disorders: Hypersensitivity reactions, anaphylactoid reactions, serum sickness, insulin autoimmune syndrome, which can lead to severe hypoglycemia Musculoskeletal, connective tissue and bone disorders: Myalgia, arthralgia, arthritis Nervous system disorders: Taste disorders, headache, ageusia Psychiatric disorders: Confusion, hallucinations Respiratory, thoracic and mediastinal disorders: Bronchospasm, interstitial pneumonitis, eosinophilic pneumonia Renal and urinary disorders: Increased creatinine levels Skin and subcutaneous tissue disorders: Maculopapular, erythematous or exfoliative rash, urticaria, bullous dermatitis, eczema, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis AGEP , angioedema, drug-induced hypersensitivity syndrome, drug rash with eosinophilia and systemic symptoms DRESS , erythema multiforme, lichen planus, generalized pruritus Vascular disorders: Vasculitis, hypotension\"\n }\n ]\n },\n {\n \"Term\": \"Blindness\",\n \"MEDDRACode\": \"10005169\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"blind\",\n \"Probability\": \"0.0260895789\",\n \"SemanticContext\": \"COMMIT In patients with STEMI, the safety and efficacy of Plavix were evaluated in the randomized, placebo-controlled, double-blind study, COMMIT.\"\n },\n {\n \"VerbatimTerm\": \"blind\",\n \"Probability\": \"0.0044461191\",\n \"SemanticContext\": \"Figure Figure Figure Figure Figure 14.2 Recent Myocardial Infarction, Recent Stroke, or Established Peripheral Arterial Disease CAPRIE The CAPRIE trial was a 19,185-patient, 304-center, international, randomized, double-blind, parallel-group study comparing Plavix 75 mg daily to aspirin 325 mg daily .\"\n },\n {\n \"VerbatimTerm\": \"blind\",\n \"Probability\": \"0.0019577742\",\n \"SemanticContext\": \"Figure 8: Hazard Ratio and 95% CI by Baseline Subgroups in the CAPRIE Study Figure Figure 14.3 No Demonstrated Benefit of Plavix plus Aspirin in Patients with Multiple Risk Factors or Established Vascular Disease CHARISMA The CHARISMA trial was a 15,603 subject, randomized, double-blind, parallel group study comparing Plavix 75 mg daily to placebo for prevention of ischemic events in patients with vascular disease or multiple risk factors for atherosclerosis.\"\n }\n ]\n },\n {\n \"Term\": \"Haemorrhagic stroke\",\n \"MEDDRACode\": \"10019016\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Hemorrhagic strokes\",\n \"Probability\": \"0.8803622127\",\n \"SemanticContext\": \"3.7 2.7 Life-threatening bleeding 2.2 1.8 Fatal 0.2 0.2 5 g/dL hemoglobin drop 0.9 0.9 Requiring surgical intervention 0.7 0.7 Hemorrhagic strokes 0.1 0.1 Requiring inotropes 0.5 0.5 Requiring transfusion =4 units 1.2 1.0 Other major bleeding 1.6 1.0 Significantly disabling 0.4 0.3 Intraocular bleeding with significant loss of vision 0.05 0.03 Requiring 2--3 units of blood 1.3 0.9 Minor bleeding Led to interruption of study medication.\"\n },\n {\n \"VerbatimTerm\": \"Hemorrhagic stroke\",\n \"Probability\": \"0.9908500314\",\n \"SemanticContext\": \"noncerebral or cerebral bleeding 0.6 0.5 0.59 Major noncerebral 0.4 0.3 0.48 Fatal 0.2 0.2 0.90 Hemorrhagic stroke 0.2 0.2 0.91 Fatal 0.2 0.2 0.81 Other noncerebral bleeding nonmajor 3.6 3.1 0.005 Any noncerebral bleeding 3.9 3.4 0.004 .\"\n }\n ]\n },\n {\n \"Term\": \"Eosinophilic pneumonia\",\n \"MEDDRACode\": \"10014962\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"eosinophilic pneumonia\",\n \"Probability\": \"0.9987718463\",\n \"SemanticContext\": \"Blood and lymphatic system disorders: Agranulocytosis, aplastic anemia/pancytopenia, thrombotic thrombocytopenic purpura TTP , acquired hemophilia A Gastrointestinal disorders: Colitis including ulcerative or lymphocytic colitis , pancreatitis, stomatitis, gastric/duodenal ulcer, diarrhea General disorders and administration site condition: Fever Hepatobiliary disorders: Acute liver failure, hepatitis noninfectious , abnormal liver function test Immune system disorders: Hypersensitivity reactions, anaphylactoid reactions, serum sickness, insulin autoimmune syndrome, which can lead to severe hypoglycemia Musculoskeletal, connective tissue and bone disorders: Myalgia, arthralgia, arthritis Nervous system disorders: Taste disorders, headache, ageusia Psychiatric disorders: Confusion, hallucinations Respiratory, thoracic and mediastinal disorders: Bronchospasm, interstitial pneumonitis, eosinophilic pneumonia Renal and urinary disorders: Increased creatinine levels Skin and subcutaneous tissue disorders: Maculopapular, erythematous or exfoliative rash, urticaria, bullous dermatitis, eczema, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis AGEP , angioedema, drug-induced hypersensitivity syndrome, drug rash with eosinophilia and systemic symptoms DRESS , erythema multiforme, lichen planus, generalized pruritus Vascular disorders: Vasculitis, hypotension\"\n }\n ]\n },\n {\n \"Term\": \"Exfoliative rash\",\n \"MEDDRACode\": \"10064579\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"exfoliative rash\",\n \"Probability\": \"0.9864863753\",\n \"SemanticContext\": \"Blood and lymphatic system disorders: Agranulocytosis, aplastic anemia/pancytopenia, thrombotic thrombocytopenic purpura TTP , acquired hemophilia A Gastrointestinal disorders: Colitis including ulcerative or lymphocytic colitis , pancreatitis, stomatitis, gastric/duodenal ulcer, diarrhea General disorders and administration site condition: Fever Hepatobiliary disorders: Acute liver failure, hepatitis noninfectious , abnormal liver function test Immune system disorders: Hypersensitivity reactions, anaphylactoid reactions, serum sickness, insulin autoimmune syndrome, which can lead to severe hypoglycemia Musculoskeletal, connective tissue and bone disorders: Myalgia, arthralgia, arthritis Nervous system disorders: Taste disorders, headache, ageusia Psychiatric disorders: Confusion, hallucinations Respiratory, thoracic and mediastinal disorders: Bronchospasm, interstitial pneumonitis, eosinophilic pneumonia Renal and urinary disorders: Increased creatinine levels Skin and subcutaneous tissue disorders: Maculopapular, erythematous or exfoliative rash, urticaria, bullous dermatitis, eczema, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis AGEP , angioedema, drug-induced hypersensitivity syndrome, drug rash with eosinophilia and systemic symptoms DRESS , erythema multiforme, lichen planus, generalized pruritus Vascular disorders: Vasculitis, hypotension\"\n }\n ]\n },\n {\n \"Term\": \"Arthritis\",\n \"MEDDRACode\": \"10003246\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"arthritis\",\n \"Probability\": \"0.7320711613\",\n \"SemanticContext\": \"Blood and lymphatic system disorders: Agranulocytosis, aplastic anemia/pancytopenia, thrombotic thrombocytopenic purpura TTP , acquired hemophilia A Gastrointestinal disorders: Colitis including ulcerative or lymphocytic colitis , pancreatitis, stomatitis, gastric/duodenal ulcer, diarrhea General disorders and administration site condition: Fever Hepatobiliary disorders: Acute liver failure, hepatitis noninfectious , abnormal liver function test Immune system disorders: Hypersensitivity reactions, anaphylactoid reactions, serum sickness, insulin autoimmune syndrome, which can lead to severe hypoglycemia Musculoskeletal, connective tissue and bone disorders: Myalgia, arthralgia, arthritis Nervous system disorders: Taste disorders, headache, ageusia Psychiatric disorders: Confusion, hallucinations Respiratory, thoracic and mediastinal disorders: Bronchospasm, interstitial pneumonitis, eosinophilic pneumonia Renal and urinary disorders: Increased creatinine levels Skin and subcutaneous tissue disorders: Maculopapular, erythematous or exfoliative rash, urticaria, bullous dermatitis, eczema, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis AGEP , angioedema, drug-induced hypersensitivity syndrome, drug rash with eosinophilia and systemic symptoms DRESS , erythema multiforme, lichen planus, generalized pruritus Vascular disorders: Vasculitis, hypotension\"\n }\n ]\n },\n {\n \"Term\": \"Ageusia\",\n \"MEDDRACode\": \"10001480\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"ageusia\",\n \"Probability\": \"0.982395649\",\n \"SemanticContext\": \"Blood and lymphatic system disorders: Agranulocytosis, aplastic anemia/pancytopenia, thrombotic thrombocytopenic purpura TTP , acquired hemophilia A Gastrointestinal disorders: Colitis including ulcerative or lymphocytic colitis , pancreatitis, stomatitis, gastric/duodenal ulcer, diarrhea General disorders and administration site condition: Fever Hepatobiliary disorders: Acute liver failure, hepatitis noninfectious , abnormal liver function test Immune system disorders: Hypersensitivity reactions, anaphylactoid reactions, serum sickness, insulin autoimmune syndrome, which can lead to severe hypoglycemia Musculoskeletal, connective tissue and bone disorders: Myalgia, arthralgia, arthritis Nervous system disorders: Taste disorders, headache, ageusia Psychiatric disorders: Confusion, hallucinations Respiratory, thoracic and mediastinal disorders: Bronchospasm, interstitial pneumonitis, eosinophilic pneumonia Renal and urinary disorders: Increased creatinine levels Skin and subcutaneous tissue disorders: Maculopapular, erythematous or exfoliative rash, urticaria, bullous dermatitis, eczema, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis AGEP , angioedema, drug-induced hypersensitivity syndrome, drug rash with eosinophilia and systemic symptoms DRESS , erythema multiforme, lichen planus, generalized pruritus Vascular disorders: Vasculitis, hypotension\"\n }\n ]\n },\n {\n \"Term\": \"Duodenal ulcer\",\n \"MEDDRACode\": \"10013836\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"duodenal ulcer\",\n \"Probability\": \"0.9888503551\",\n \"SemanticContext\": \"Blood and lymphatic system disorders: Agranulocytosis, aplastic anemia/pancytopenia, thrombotic thrombocytopenic purpura TTP , acquired hemophilia A Gastrointestinal disorders: Colitis including ulcerative or lymphocytic colitis , pancreatitis, stomatitis, gastric/duodenal ulcer, diarrhea General disorders and administration site condition: Fever Hepatobiliary disorders: Acute liver failure, hepatitis noninfectious , abnormal liver function test Immune system disorders: Hypersensitivity reactions, anaphylactoid reactions, serum sickness, insulin autoimmune syndrome, which can lead to severe hypoglycemia Musculoskeletal, connective tissue and bone disorders: Myalgia, arthralgia, arthritis Nervous system disorders: Taste disorders, headache, ageusia Psychiatric disorders: Confusion, hallucinations Respiratory, thoracic and mediastinal disorders: Bronchospasm, interstitial pneumonitis, eosinophilic pneumonia Renal and urinary disorders: Increased creatinine levels Skin and subcutaneous tissue disorders: Maculopapular, erythematous or exfoliative rash, urticaria, bullous dermatitis, eczema, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis AGEP , angioedema, drug-induced hypersensitivity syndrome, drug rash with eosinophilia and systemic symptoms DRESS , erythema multiforme, lichen planus, generalized pruritus Vascular disorders: Vasculitis, hypotension\"\n }\n ]\n },\n {\n \"Term\": \"Gastrointestinal disorder\",\n \"MEDDRACode\": \"10017944\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Gastrointestinal disorders\",\n \"Probability\": \"0.2295943201\",\n \"SemanticContext\": \"Blood and lymphatic system disorders: Agranulocytosis, aplastic anemia/pancytopenia, thrombotic thrombocytopenic purpura TTP , acquired hemophilia A Gastrointestinal disorders: Colitis including ulcerative or lymphocytic colitis , pancreatitis, stomatitis, gastric/duodenal ulcer, diarrhea General disorders and administration site condition: Fever Hepatobiliary disorders: Acute liver failure, hepatitis noninfectious , abnormal liver function test Immune system disorders: Hypersensitivity reactions, anaphylactoid reactions, serum sickness, insulin autoimmune syndrome, which can lead to severe hypoglycemia Musculoskeletal, connective tissue and bone disorders: Myalgia, arthralgia, arthritis Nervous system disorders: Taste disorders, headache, ageusia Psychiatric disorders: Confusion, hallucinations Respiratory, thoracic and mediastinal disorders: Bronchospasm, interstitial pneumonitis, eosinophilic pneumonia Renal and urinary disorders: Increased creatinine levels Skin and subcutaneous tissue disorders: Maculopapular, erythematous or exfoliative rash, urticaria, bullous dermatitis, eczema, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis AGEP , angioedema, drug-induced hypersensitivity syndrome, drug rash with eosinophilia and systemic symptoms DRESS , erythema multiforme, lichen planus, generalized pruritus Vascular disorders: Vasculitis, hypotension\"\n }\n ]\n },\n {\n \"Term\": \"Immune system disorder\",\n \"MEDDRACode\": \"10021425\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Immune system disorders\",\n \"Probability\": \"0.1309396625\",\n \"SemanticContext\": \"Blood and lymphatic system disorders: Agranulocytosis, aplastic anemia/pancytopenia, thrombotic thrombocytopenic purpura TTP , acquired hemophilia A Gastrointestinal disorders: Colitis including ulcerative or lymphocytic colitis , pancreatitis, stomatitis, gastric/duodenal ulcer, diarrhea General disorders and administration site condition: Fever Hepatobiliary disorders: Acute liver failure, hepatitis noninfectious , abnormal liver function test Immune system disorders: Hypersensitivity reactions, anaphylactoid reactions, serum sickness, insulin autoimmune syndrome, which can lead to severe hypoglycemia Musculoskeletal, connective tissue and bone disorders: Myalgia, arthralgia, arthritis Nervous system disorders: Taste disorders, headache, ageusia Psychiatric disorders: Confusion, hallucinations Respiratory, thoracic and mediastinal disorders: Bronchospasm, interstitial pneumonitis, eosinophilic pneumonia Renal and urinary disorders: Increased creatinine levels Skin and subcutaneous tissue disorders: Maculopapular, erythematous or exfoliative rash, urticaria, bullous dermatitis, eczema, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis AGEP , angioedema, drug-induced hypersensitivity syndrome, drug rash with eosinophilia and systemic symptoms DRESS , erythema multiforme, lichen planus, generalized pruritus Vascular disorders: Vasculitis, hypotension\"\n }\n ]\n },\n {\n \"Term\": \"Myalgia\",\n \"MEDDRACode\": \"10028411\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Myalgia\",\n \"Probability\": \"0.9991652966\",\n \"SemanticContext\": \"Blood and lymphatic system disorders: Agranulocytosis, aplastic anemia/pancytopenia, thrombotic thrombocytopenic purpura TTP , acquired hemophilia A Gastrointestinal disorders: Colitis including ulcerative or lymphocytic colitis , pancreatitis, stomatitis, gastric/duodenal ulcer, diarrhea General disorders and administration site condition: Fever Hepatobiliary disorders: Acute liver failure, hepatitis noninfectious , abnormal liver function test Immune system disorders: Hypersensitivity reactions, anaphylactoid reactions, serum sickness, insulin autoimmune syndrome, which can lead to severe hypoglycemia Musculoskeletal, connective tissue and bone disorders: Myalgia, arthralgia, arthritis Nervous system disorders: Taste disorders, headache, ageusia Psychiatric disorders: Confusion, hallucinations Respiratory, thoracic and mediastinal disorders: Bronchospasm, interstitial pneumonitis, eosinophilic pneumonia Renal and urinary disorders: Increased creatinine levels Skin and subcutaneous tissue disorders: Maculopapular, erythematous or exfoliative rash, urticaria, bullous dermatitis, eczema, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis AGEP , angioedema, drug-induced hypersensitivity syndrome, drug rash with eosinophilia and systemic symptoms DRESS , erythema multiforme, lichen planus, generalized pruritus Vascular disorders: Vasculitis, hypotension\"\n }\n ]\n },\n {\n \"Term\": \"Nervous system disorder\",\n \"MEDDRACode\": \"10029202\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Nervous system disorders\",\n \"Probability\": \"0.0404457748\",\n \"SemanticContext\": \"Blood and lymphatic system disorders: Agranulocytosis, aplastic anemia/pancytopenia, thrombotic thrombocytopenic purpura TTP , acquired hemophilia A Gastrointestinal disorders: Colitis including ulcerative or lymphocytic colitis , pancreatitis, stomatitis, gastric/duodenal ulcer, diarrhea General disorders and administration site condition: Fever Hepatobiliary disorders: Acute liver failure, hepatitis noninfectious , abnormal liver function test Immune system disorders: Hypersensitivity reactions, anaphylactoid reactions, serum sickness, insulin autoimmune syndrome, which can lead to severe hypoglycemia Musculoskeletal, connective tissue and bone disorders: Myalgia, arthralgia, arthritis Nervous system disorders: Taste disorders, headache, ageusia Psychiatric disorders: Confusion, hallucinations Respiratory, thoracic and mediastinal disorders: Bronchospasm, interstitial pneumonitis, eosinophilic pneumonia Renal and urinary disorders: Increased creatinine levels Skin and subcutaneous tissue disorders: Maculopapular, erythematous or exfoliative rash, urticaria, bullous dermatitis, eczema, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis AGEP , angioedema, drug-induced hypersensitivity syndrome, drug rash with eosinophilia and systemic symptoms DRESS , erythema multiforme, lichen planus, generalized pruritus Vascular disorders: Vasculitis, hypotension\"\n }\n ]\n },\n {\n \"Term\": \"Liver function test abnormal\",\n \"MEDDRACode\": \"10024690\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"abnormal liver function test\",\n \"Probability\": \"0.8228216767\",\n \"SemanticContext\": \"Blood and lymphatic system disorders: Agranulocytosis, aplastic anemia/pancytopenia, thrombotic thrombocytopenic purpura TTP , acquired hemophilia A Gastrointestinal disorders: Colitis including ulcerative or lymphocytic colitis , pancreatitis, stomatitis, gastric/duodenal ulcer, diarrhea General disorders and administration site condition: Fever Hepatobiliary disorders: Acute liver failure, hepatitis noninfectious , abnormal liver function test Immune system disorders: Hypersensitivity reactions, anaphylactoid reactions, serum sickness, insulin autoimmune syndrome, which can lead to severe hypoglycemia Musculoskeletal, connective tissue and bone disorders: Myalgia, arthralgia, arthritis Nervous system disorders: Taste disorders, headache, ageusia Psychiatric disorders: Confusion, hallucinations Respiratory, thoracic and mediastinal disorders: Bronchospasm, interstitial pneumonitis, eosinophilic pneumonia Renal and urinary disorders: Increased creatinine levels Skin and subcutaneous tissue disorders: Maculopapular, erythematous or exfoliative rash, urticaria, bullous dermatitis, eczema, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis AGEP , angioedema, drug-induced hypersensitivity syndrome, drug rash with eosinophilia and systemic symptoms DRESS , erythema multiforme, lichen planus, generalized pruritus Vascular disorders: Vasculitis, hypotension\"\n }\n ]\n },\n {\n \"Term\": \"Haemorrhage\",\n \"MEDDRACode\": \"10055798\",\n \"Overdose\": true,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": true,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"major bleeding\",\n \"Probability\": \"0.661477387\",\n \"SemanticContext\": \"Bleeding CURE In CURE, Plavix use with aspirin was associated with an increase in major bleeding primarily gastrointestinal and at puncture sites compared to placebo with aspirin see Table 1 .\"\n },\n {\n \"VerbatimTerm\": \"major bleeding\",\n \"Probability\": \"0.8981873989\",\n \"SemanticContext\": \"Table 1: CURE Incidence of Bleeding Complications % patients Event Plavix + aspirin n=6259 Placebo + aspirin n=6303 Major bleeding Life-threatening and other major bleeding.\"\n },\n {\n \"VerbatimTerm\": \"major bleeding\",\n \"Probability\": \"0.994266808\",\n \"SemanticContext\": \"3.7 2.7 Life-threatening bleeding 2.2 1.8 Fatal 0.2 0.2 5 g/dL hemoglobin drop 0.9 0.9 Requiring surgical intervention 0.7 0.7 Hemorrhagic strokes 0.1 0.1 Requiring inotropes 0.5 0.5 Requiring transfusion =4 units 1.2 1.0 Other major bleeding 1.6 1.0 Significantly disabling 0.4 0.3 Intraocular bleeding with significant loss of vision 0.05 0.03 Requiring 2--3 units of blood 1.3 0.9 Minor bleeding Led to interruption of study medication.\"\n },\n {\n \"VerbatimTerm\": \"major bleeding\",\n \"Probability\": \"0.9767110944\",\n \"SemanticContext\": \"COMMIT In COMMIT, similar rates of major bleeding were observed in the Plavix and placebo groups, both of which also received aspirin see Table 2 .\"\n },\n {\n \"VerbatimTerm\": \"Major bleeding\",\n \"Probability\": \"0.8269562721\",\n \"SemanticContext\": \"Table 1: CURE Incidence of Bleeding Complications % patients Event Plavix + aspirin n=6259 Placebo + aspirin n=6303 Major bleeding Life-threatening and other major bleeding.\"\n },\n {\n \"VerbatimTerm\": \"Major bleeds\",\n \"Probability\": \"0.4434545934\",\n \"SemanticContext\": \"Table 2: Incidence of Bleeding Events in COMMIT % patients Type of Bleeding Plavix + aspirin n=22961 Placebo + aspirin n=22891 p-value Major Major bleeds were cerebral bleeds or noncerebral bleeds thought to have caused death or that required transfusion.\"\n }\n ]\n },\n {\n \"Term\": \"Pancytopenia\",\n \"MEDDRACode\": \"10033661\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"pancytopenia\",\n \"Probability\": \"0.9973233938\",\n \"SemanticContext\": \"Blood and lymphatic system disorders: Agranulocytosis, aplastic anemia/pancytopenia, thrombotic thrombocytopenic purpura TTP , acquired hemophilia A Gastrointestinal disorders: Colitis including ulcerative or lymphocytic colitis , pancreatitis, stomatitis, gastric/duodenal ulcer, diarrhea General disorders and administration site condition: Fever Hepatobiliary disorders: Acute liver failure, hepatitis noninfectious , abnormal liver function test Immune system disorders: Hypersensitivity reactions, anaphylactoid reactions, serum sickness, insulin autoimmune syndrome, which can lead to severe hypoglycemia Musculoskeletal, connective tissue and bone disorders: Myalgia, arthralgia, arthritis Nervous system disorders: Taste disorders, headache, ageusia Psychiatric disorders: Confusion, hallucinations Respiratory, thoracic and mediastinal disorders: Bronchospasm, interstitial pneumonitis, eosinophilic pneumonia Renal and urinary disorders: Increased creatinine levels Skin and subcutaneous tissue disorders: Maculopapular, erythematous or exfoliative rash, urticaria, bullous dermatitis, eczema, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis AGEP , angioedema, drug-induced hypersensitivity syndrome, drug rash with eosinophilia and systemic symptoms DRESS , erythema multiforme, lichen planus, generalized pruritus Vascular disorders: Vasculitis, hypotension\"\n }\n ]\n },\n {\n \"Term\": \"Hypoglycaemia\",\n \"MEDDRACode\": \"10020993\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"severe hypoglycemia\",\n \"Probability\": \"0.9964797497\",\n \"SemanticContext\": \"Blood and lymphatic system disorders: Agranulocytosis, aplastic anemia/pancytopenia, thrombotic thrombocytopenic purpura TTP , acquired hemophilia A Gastrointestinal disorders: Colitis including ulcerative or lymphocytic colitis , pancreatitis, stomatitis, gastric/duodenal ulcer, diarrhea General disorders and administration site condition: Fever Hepatobiliary disorders: Acute liver failure, hepatitis noninfectious , abnormal liver function test Immune system disorders: Hypersensitivity reactions, anaphylactoid reactions, serum sickness, insulin autoimmune syndrome, which can lead to severe hypoglycemia Musculoskeletal, connective tissue and bone disorders: Myalgia, arthralgia, arthritis Nervous system disorders: Taste disorders, headache, ageusia Psychiatric disorders: Confusion, hallucinations Respiratory, thoracic and mediastinal disorders: Bronchospasm, interstitial pneumonitis, eosinophilic pneumonia Renal and urinary disorders: Increased creatinine levels Skin and subcutaneous tissue disorders: Maculopapular, erythematous or exfoliative rash, urticaria, bullous dermatitis, eczema, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis AGEP , angioedema, drug-induced hypersensitivity syndrome, drug rash with eosinophilia and systemic symptoms DRESS , erythema multiforme, lichen planus, generalized pruritus Vascular disorders: Vasculitis, hypotension\"\n }\n ]\n },\n {\n \"Term\": \"Interstitial lung disease\",\n \"MEDDRACode\": \"10022611\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"interstitial pneumonitis\",\n \"Probability\": \"0.9914429188\",\n \"SemanticContext\": \"Blood and lymphatic system disorders: Agranulocytosis, aplastic anemia/pancytopenia, thrombotic thrombocytopenic purpura TTP , acquired hemophilia A Gastrointestinal disorders: Colitis including ulcerative or lymphocytic colitis , pancreatitis, stomatitis, gastric/duodenal ulcer, diarrhea General disorders and administration site condition: Fever Hepatobiliary disorders: Acute liver failure, hepatitis noninfectious , abnormal liver function test Immune system disorders: Hypersensitivity reactions, anaphylactoid reactions, serum sickness, insulin autoimmune syndrome, which can lead to severe hypoglycemia Musculoskeletal, connective tissue and bone disorders: Myalgia, arthralgia, arthritis Nervous system disorders: Taste disorders, headache, ageusia Psychiatric disorders: Confusion, hallucinations Respiratory, thoracic and mediastinal disorders: Bronchospasm, interstitial pneumonitis, eosinophilic pneumonia Renal and urinary disorders: Increased creatinine levels Skin and subcutaneous tissue disorders: Maculopapular, erythematous or exfoliative rash, urticaria, bullous dermatitis, eczema, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis AGEP , angioedema, drug-induced hypersensitivity syndrome, drug rash with eosinophilia and systemic symptoms DRESS , erythema multiforme, lichen planus, generalized pruritus Vascular disorders: Vasculitis, hypotension\"\n }\n ]\n },\n {\n \"Term\": \"Surgery\",\n \"MEDDRACode\": \"10042609\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"surgery\",\n \"Probability\": \"2.8289E-06\",\n \"SemanticContext\": \"Invasive Procedures Advise patients to inform physicians and dentists that they are taking Plavix before any surgery or dental procedure [see Warnings and Precautions 5.2 , 5.3 ] .\"\n },\n {\n \"VerbatimTerm\": \"surgery\",\n \"Probability\": \"1.59E-06\",\n \"SemanticContext\": \"If Plavix must be temporarily discontinued e.g., to treat bleeding or for surgery with a major risk of bleeding , restart it as soon as possible.\"\n },\n {\n \"VerbatimTerm\": \"surgery\",\n \"Probability\": \"4.03412E-05\",\n \"SemanticContext\": \"When possible, interrupt therapy with Plavix for five days prior to such surgery.\"\n },\n {\n \"VerbatimTerm\": \"surgery\",\n \"Probability\": \"6.4568E-06\",\n \"SemanticContext\": \"plan to have surgery or a dental procedure.\"\n },\n {\n \"VerbatimTerm\": \"surgery\",\n \"Probability\": \"6.327E-07\",\n \"SemanticContext\": \"They should talk to the doctor who prescribed Plavix for you before you have any surgery or invasive procedure.\"\n },\n {\n \"VerbatimTerm\": \"surgery\",\n \"Probability\": \"4.746E-07\",\n \"SemanticContext\": \"Talk with your doctor about stopping your Plavix before you have surgery.\"\n },\n {\n \"VerbatimTerm\": \"surgery\",\n \"Probability\": \"2.1578E-06\",\n \"SemanticContext\": \"Your doctor may tell you to stop taking Plavix at least 5 days before you have surgery to avoid excessive bleeding during surgery.\"\n },\n {\n \"VerbatimTerm\": \"surgery\",\n \"Probability\": \"5.039E-06\",\n \"SemanticContext\": \"Your doctor may tell you to stop taking Plavix at least 5 days before you have surgery to avoid excessive bleeding during surgery.\"\n }\n ]\n },\n {\n \"Term\": \"Headache\",\n \"MEDDRACode\": \"10019211\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"headache\",\n \"Probability\": \"0.9995513558\",\n \"SemanticContext\": \"Blood and lymphatic system disorders: Agranulocytosis, aplastic anemia/pancytopenia, thrombotic thrombocytopenic purpura TTP , acquired hemophilia A Gastrointestinal disorders: Colitis including ulcerative or lymphocytic colitis , pancreatitis, stomatitis, gastric/duodenal ulcer, diarrhea General disorders and administration site condition: Fever Hepatobiliary disorders: Acute liver failure, hepatitis noninfectious , abnormal liver function test Immune system disorders: Hypersensitivity reactions, anaphylactoid reactions, serum sickness, insulin autoimmune syndrome, which can lead to severe hypoglycemia Musculoskeletal, connective tissue and bone disorders: Myalgia, arthralgia, arthritis Nervous system disorders: Taste disorders, headache, ageusia Psychiatric disorders: Confusion, hallucinations Respiratory, thoracic and mediastinal disorders: Bronchospasm, interstitial pneumonitis, eosinophilic pneumonia Renal and urinary disorders: Increased creatinine levels Skin and subcutaneous tissue disorders: Maculopapular, erythematous or exfoliative rash, urticaria, bullous dermatitis, eczema, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis AGEP , angioedema, drug-induced hypersensitivity syndrome, drug rash with eosinophilia and systemic symptoms DRESS , erythema multiforme, lichen planus, generalized pruritus Vascular disorders: Vasculitis, hypotension\"\n },\n {\n \"VerbatimTerm\": \"headache\",\n \"Probability\": \"0.0070271194\",\n \"SemanticContext\": \"Get medical help right away if you have any of these symptoms and they cannot be explained by another medical condition: purplish spots called purpura on the skin or in the mouth mucous membranes due to bleeding under the skin your skin or the whites of your eyes are yellow jaundice you feel tired or weak your skin looks very pale fever fast heart rate or feeling short of breath headache speech changes confusion coma stroke seizure low amount of urine, or urine that is pink or has blood in it stomach area abdominal pain nausea, vomiting, or diarrhea vision changes persistent low blood sugar symptoms Tell your doctor if you have any side effect that bothers you or that does not go away.\"\n }\n ]\n },\n {\n \"Term\": \"Lichen planus\",\n \"MEDDRACode\": \"10024429\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"lichen planus\",\n \"Probability\": \"0.5090872645\",\n \"SemanticContext\": \"Blood and lymphatic system disorders: Agranulocytosis, aplastic anemia/pancytopenia, thrombotic thrombocytopenic purpura TTP , acquired hemophilia A Gastrointestinal disorders: Colitis including ulcerative or lymphocytic colitis , pancreatitis, stomatitis, gastric/duodenal ulcer, diarrhea General disorders and administration site condition: Fever Hepatobiliary disorders: Acute liver failure, hepatitis noninfectious , abnormal liver function test Immune system disorders: Hypersensitivity reactions, anaphylactoid reactions, serum sickness, insulin autoimmune syndrome, which can lead to severe hypoglycemia Musculoskeletal, connective tissue and bone disorders: Myalgia, arthralgia, arthritis Nervous system disorders: Taste disorders, headache, ageusia Psychiatric disorders: Confusion, hallucinations Respiratory, thoracic and mediastinal disorders: Bronchospasm, interstitial pneumonitis, eosinophilic pneumonia Renal and urinary disorders: Increased creatinine levels Skin and subcutaneous tissue disorders: Maculopapular, erythematous or exfoliative rash, urticaria, bullous dermatitis, eczema, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis AGEP , angioedema, drug-induced hypersensitivity syndrome, drug rash with eosinophilia and systemic symptoms DRESS , erythema multiforme, lichen planus, generalized pruritus Vascular disorders: Vasculitis, hypotension\"\n }\n ]\n },\n {\n \"Term\": \"Mediastinal disorder\",\n \"MEDDRACode\": \"10061280\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"mediastinal disorders\",\n \"Probability\": \"0.0267597139\",\n \"SemanticContext\": \"Blood and lymphatic system disorders: Agranulocytosis, aplastic anemia/pancytopenia, thrombotic thrombocytopenic purpura TTP , acquired hemophilia A Gastrointestinal disorders: Colitis including ulcerative or lymphocytic colitis , pancreatitis, stomatitis, gastric/duodenal ulcer, diarrhea General disorders and administration site condition: Fever Hepatobiliary disorders: Acute liver failure, hepatitis noninfectious , abnormal liver function test Immune system disorders: Hypersensitivity reactions, anaphylactoid reactions, serum sickness, insulin autoimmune syndrome, which can lead to severe hypoglycemia Musculoskeletal, connective tissue and bone disorders: Myalgia, arthralgia, arthritis Nervous system disorders: Taste disorders, headache, ageusia Psychiatric disorders: Confusion, hallucinations Respiratory, thoracic and mediastinal disorders: Bronchospasm, interstitial pneumonitis, eosinophilic pneumonia Renal and urinary disorders: Increased creatinine levels Skin and subcutaneous tissue disorders: Maculopapular, erythematous or exfoliative rash, urticaria, bullous dermatitis, eczema, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis AGEP , angioedema, drug-induced hypersensitivity syndrome, drug rash with eosinophilia and systemic symptoms DRESS , erythema multiforme, lichen planus, generalized pruritus Vascular disorders: Vasculitis, hypotension\"\n }\n ]\n },\n {\n \"Term\": \"Peritoneal cancer index\",\n \"MEDDRACode\": \"10080244\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"PCI\",\n \"Probability\": \"0.000862062\",\n \"SemanticContext\": \"The use of Plavix in CURE did not affect the number of patients treated with CABG or PCI with or without stenting 2253 patients [36.0%] in the Plavix group, 2324 patients [36.9%] in the placebo group; relative risk reduction of 4.0% .\"\n },\n {\n \"VerbatimTerm\": \"PCI\",\n \"Probability\": \"0.1451050341\",\n \"SemanticContext\": \"Fifty-five percent 55% of patients received thrombolytics and only 3% underwent PCI.\"\n }\n ]\n },\n {\n \"Term\": \"Stomatitis\",\n \"MEDDRACode\": \"10042128\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"stomatitis\",\n \"Probability\": \"0.9998669624\",\n \"SemanticContext\": \"Blood and lymphatic system disorders: Agranulocytosis, aplastic anemia/pancytopenia, thrombotic thrombocytopenic purpura TTP , acquired hemophilia A Gastrointestinal disorders: Colitis including ulcerative or lymphocytic colitis , pancreatitis, stomatitis, gastric/duodenal ulcer, diarrhea General disorders and administration site condition: Fever Hepatobiliary disorders: Acute liver failure, hepatitis noninfectious , abnormal liver function test Immune system disorders: Hypersensitivity reactions, anaphylactoid reactions, serum sickness, insulin autoimmune syndrome, which can lead to severe hypoglycemia Musculoskeletal, connective tissue and bone disorders: Myalgia, arthralgia, arthritis Nervous system disorders: Taste disorders, headache, ageusia Psychiatric disorders: Confusion, hallucinations Respiratory, thoracic and mediastinal disorders: Bronchospasm, interstitial pneumonitis, eosinophilic pneumonia Renal and urinary disorders: Increased creatinine levels Skin and subcutaneous tissue disorders: Maculopapular, erythematous or exfoliative rash, urticaria, bullous dermatitis, eczema, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis AGEP , angioedema, drug-induced hypersensitivity syndrome, drug rash with eosinophilia and systemic symptoms DRESS , erythema multiforme, lichen planus, generalized pruritus Vascular disorders: Vasculitis, hypotension\"\n }\n ]\n },\n {\n \"Term\": \"Epistaxis\",\n \"MEDDRACode\": \"10015090\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"nose bleeds\",\n \"Probability\": \"8.52982E-05\",\n \"SemanticContext\": \"While you take Plavix: you may bruise and bleed more easily you are more likely to have nose bleeds it will take longer for any bleeding to stop Call your doctor right away if you have any of these signs or symptoms of bleeding: unexpected bleeding or bleeding that lasts a long time blood in your urine pink, red or brown urine red or black stools looks like tar bruises that happen without a known cause or get larger cough up blood or blood clots vomit blood or your vomit looks like coffee grounds Do not stop taking Plavix without talking to the doctor who prescribes it for you.\"\n }\n ]\n },\n {\n \"Term\": \"Urticaria\",\n \"MEDDRACode\": \"10046735\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"urticaria\",\n \"Probability\": \"0.9932750463\",\n \"SemanticContext\": \"Blood and lymphatic system disorders: Agranulocytosis, aplastic anemia/pancytopenia, thrombotic thrombocytopenic purpura TTP , acquired hemophilia A Gastrointestinal disorders: Colitis including ulcerative or lymphocytic colitis , pancreatitis, stomatitis, gastric/duodenal ulcer, diarrhea General disorders and administration site condition: Fever Hepatobiliary disorders: Acute liver failure, hepatitis noninfectious , abnormal liver function test Immune system disorders: Hypersensitivity reactions, anaphylactoid reactions, serum sickness, insulin autoimmune syndrome, which can lead to severe hypoglycemia Musculoskeletal, connective tissue and bone disorders: Myalgia, arthralgia, arthritis Nervous system disorders: Taste disorders, headache, ageusia Psychiatric disorders: Confusion, hallucinations Respiratory, thoracic and mediastinal disorders: Bronchospasm, interstitial pneumonitis, eosinophilic pneumonia Renal and urinary disorders: Increased creatinine levels Skin and subcutaneous tissue disorders: Maculopapular, erythematous or exfoliative rash, urticaria, bullous dermatitis, eczema, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis AGEP , angioedema, drug-induced hypersensitivity syndrome, drug rash with eosinophilia and systemic symptoms DRESS , erythema multiforme, lichen planus, generalized pruritus Vascular disorders: Vasculitis, hypotension\"\n }\n ]\n },\n {\n \"Term\": \"Pruritus\",\n \"MEDDRACode\": \"10037087\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"generalized pruritus\",\n \"Probability\": \"0.9879045486\",\n \"SemanticContext\": \"Blood and lymphatic system disorders: Agranulocytosis, aplastic anemia/pancytopenia, thrombotic thrombocytopenic purpura TTP , acquired hemophilia A Gastrointestinal disorders: Colitis including ulcerative or lymphocytic colitis , pancreatitis, stomatitis, gastric/duodenal ulcer, diarrhea General disorders and administration site condition: Fever Hepatobiliary disorders: Acute liver failure, hepatitis noninfectious , abnormal liver function test Immune system disorders: Hypersensitivity reactions, anaphylactoid reactions, serum sickness, insulin autoimmune syndrome, which can lead to severe hypoglycemia Musculoskeletal, connective tissue and bone disorders: Myalgia, arthralgia, arthritis Nervous system disorders: Taste disorders, headache, ageusia Psychiatric disorders: Confusion, hallucinations Respiratory, thoracic and mediastinal disorders: Bronchospasm, interstitial pneumonitis, eosinophilic pneumonia Renal and urinary disorders: Increased creatinine levels Skin and subcutaneous tissue disorders: Maculopapular, erythematous or exfoliative rash, urticaria, bullous dermatitis, eczema, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis AGEP , angioedema, drug-induced hypersensitivity syndrome, drug rash with eosinophilia and systemic symptoms DRESS , erythema multiforme, lichen planus, generalized pruritus Vascular disorders: Vasculitis, hypotension\"\n }\n ]\n },\n {\n \"Term\": \"Hospitalisation\",\n \"MEDDRACode\": \"10054112\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hospitalization\",\n \"Probability\": \"0.4747996032\",\n \"SemanticContext\": \"CAPRIE Plavix vs Aspirin In CAPRIE, gastrointestinal hemorrhage occurred at a rate of 2.0% in those taking Plavix versus 2.7% in those taking aspirin; bleeding requiring hospitalization occurred in 0.7% and 1.1%, respectively.\"\n },\n {\n \"VerbatimTerm\": \"hospitalization\",\n \"Probability\": \"0.016715318\",\n \"SemanticContext\": \"Only about 20% of patients underwent revascularization during the initial hospitalization and few underwent emergent or urgent revascularization.\"\n }\n ]\n },\n {\n \"Term\": \"Gastrointestinal haemorrhage\",\n \"MEDDRACode\": \"10017955\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"gastrointestinal bleeding\",\n \"Probability\": \"0.3500906229\",\n \"SemanticContext\": \"7.4 Nonsteroidal Anti-inflammatory Drugs NSAIDs Coadministration of Plavix and NSAIDs increases the risk of gastrointestinal bleeding.\"\n }\n ]\n },\n {\n \"Term\": \"Bleeding time\",\n \"MEDDRACode\": \"10005136\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"bleeding time\",\n \"Probability\": \"0.026728332\",\n \"SemanticContext\": \"Platelet aggregation and bleeding time gradually return to baseline values after treatment is discontinued, generally in about 5 days.\"\n }\n ]\n },\n {\n \"Term\": \"Vasculitis\",\n \"MEDDRACode\": \"10047115\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Vasculitis\",\n \"Probability\": \"0.9816318154\",\n \"SemanticContext\": \"Blood and lymphatic system disorders: Agranulocytosis, aplastic anemia/pancytopenia, thrombotic thrombocytopenic purpura TTP , acquired hemophilia A Gastrointestinal disorders: Colitis including ulcerative or lymphocytic colitis , pancreatitis, stomatitis, gastric/duodenal ulcer, diarrhea General disorders and administration site condition: Fever Hepatobiliary disorders: Acute liver failure, hepatitis noninfectious , abnormal liver function test Immune system disorders: Hypersensitivity reactions, anaphylactoid reactions, serum sickness, insulin autoimmune syndrome, which can lead to severe hypoglycemia Musculoskeletal, connective tissue and bone disorders: Myalgia, arthralgia, arthritis Nervous system disorders: Taste disorders, headache, ageusia Psychiatric disorders: Confusion, hallucinations Respiratory, thoracic and mediastinal disorders: Bronchospasm, interstitial pneumonitis, eosinophilic pneumonia Renal and urinary disorders: Increased creatinine levels Skin and subcutaneous tissue disorders: Maculopapular, erythematous or exfoliative rash, urticaria, bullous dermatitis, eczema, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis AGEP , angioedema, drug-induced hypersensitivity syndrome, drug rash with eosinophilia and systemic symptoms DRESS , erythema multiforme, lichen planus, generalized pruritus Vascular disorders: Vasculitis, hypotension\"\n }\n ]\n },\n {\n \"Term\": \"Diarrhoea\",\n \"MEDDRACode\": \"10012735\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"diarrhea\",\n \"Probability\": \"0.9926951528\",\n \"SemanticContext\": \"Blood and lymphatic system disorders: Agranulocytosis, aplastic anemia/pancytopenia, thrombotic thrombocytopenic purpura TTP , acquired hemophilia A Gastrointestinal disorders: Colitis including ulcerative or lymphocytic colitis , pancreatitis, stomatitis, gastric/duodenal ulcer, diarrhea General disorders and administration site condition: Fever Hepatobiliary disorders: Acute liver failure, hepatitis noninfectious , abnormal liver function test Immune system disorders: Hypersensitivity reactions, anaphylactoid reactions, serum sickness, insulin autoimmune syndrome, which can lead to severe hypoglycemia Musculoskeletal, connective tissue and bone disorders: Myalgia, arthralgia, arthritis Nervous system disorders: Taste disorders, headache, ageusia Psychiatric disorders: Confusion, hallucinations Respiratory, thoracic and mediastinal disorders: Bronchospasm, interstitial pneumonitis, eosinophilic pneumonia Renal and urinary disorders: Increased creatinine levels Skin and subcutaneous tissue disorders: Maculopapular, erythematous or exfoliative rash, urticaria, bullous dermatitis, eczema, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis AGEP , angioedema, drug-induced hypersensitivity syndrome, drug rash with eosinophilia and systemic symptoms DRESS , erythema multiforme, lichen planus, generalized pruritus Vascular disorders: Vasculitis, hypotension\"\n },\n {\n \"VerbatimTerm\": \"diarrhea\",\n \"Probability\": \"0.0001854599\",\n \"SemanticContext\": \"Get medical help right away if you have any of these symptoms and they cannot be explained by another medical condition: purplish spots called purpura on the skin or in the mouth mucous membranes due to bleeding under the skin your skin or the whites of your eyes are yellow jaundice you feel tired or weak your skin looks very pale fever fast heart rate or feeling short of breath headache speech changes confusion coma stroke seizure low amount of urine, or urine that is pink or has blood in it stomach area abdominal pain nausea, vomiting, or diarrhea vision changes persistent low blood sugar symptoms Tell your doctor if you have any side effect that bothers you or that does not go away.\"\n }\n ]\n },\n {\n \"Term\": \"Haematoma\",\n \"MEDDRACode\": \"10018852\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hematoma\",\n \"Probability\": \"0.9947469831\",\n \"SemanticContext\": \"Other bleeding events that were reported more frequently in the Plavix group were epistaxis and hematoma.\"\n }\n ]\n },\n {\n \"Term\": \"Discharge\",\n \"MEDDRACode\": \"10080907\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"discharge\",\n \"Probability\": \"0.0005537271\",\n \"SemanticContext\": \"Patients were randomized to receive Plavix 75 mg once daily or placebo, in combination with aspirin 162 mg per day , for 28 days or until hospital discharge, whichever came first.\"\n }\n ]\n },\n {\n \"Term\": \"Ischaemia\",\n \"MEDDRACode\": \"10061255\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"ischemia\",\n \"Probability\": \"0.0040175915\",\n \"SemanticContext\": \"14 CLINICAL STUDIES 14.1 Acute Coronary Syndrome CURE The CURE study included 12,562 patients with ACS without ST-elevation UA or NSTEMI and presenting within 24 hours of onset of the most recent episode of chest pain or symptoms consistent with ischemia.\"\n },\n {\n \"VerbatimTerm\": \"ischemia\",\n \"Probability\": \"0.0027301311\",\n \"SemanticContext\": \"Patients were required to have either ECG changes compatible with new ischemia without ST-elevation or elevated cardiac enzymes or troponin I or T to at least twice the upper limit of normal.\"\n }\n ]\n },\n {\n \"Term\": \"Bundle branch block left\",\n \"MEDDRACode\": \"10006580\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"left bundle-branch block\",\n \"Probability\": \"0.0796395242\",\n \"SemanticContext\": \", ST-elevation, ST-depression or left bundle-branch block .\"\n }\n ]\n },\n {\n \"Term\": \"Rash\",\n \"MEDDRACode\": \"10037844\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"rash\",\n \"Probability\": \"0.9857642651\",\n \"SemanticContext\": \"5.5 Cross-Reactivity among Thienopyridines Hypersensitivity including rash, angioedema or hematologic reaction has been reported in patients receiving Plavix, including patients with a history of hypersensitivity or hematologic reaction to other thienopyridines [see Contraindications 4.2 and Adverse Reactions 6.2 ] .\"\n }\n ]\n },\n {\n \"Term\": \"Transfusion\",\n \"MEDDRACode\": \"10066152\",\n \"Overdose\": true,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"transfusion\",\n \"Probability\": \"0.1556912959\",\n \"SemanticContext\": \"3.7 2.7 Life-threatening bleeding 2.2 1.8 Fatal 0.2 0.2 5 g/dL hemoglobin drop 0.9 0.9 Requiring surgical intervention 0.7 0.7 Hemorrhagic strokes 0.1 0.1 Requiring inotropes 0.5 0.5 Requiring transfusion =4 units 1.2 1.0 Other major bleeding 1.6 1.0 Significantly disabling 0.4 0.3 Intraocular bleeding with significant loss of vision 0.05 0.03 Requiring 2--3 units of blood 1.3 0.9 Minor bleeding Led to interruption of study medication.\"\n },\n {\n \"VerbatimTerm\": \"transfusion\",\n \"Probability\": \"0.0891409516\",\n \"SemanticContext\": \"Table 2: Incidence of Bleeding Events in COMMIT % patients Type of Bleeding Plavix + aspirin n=22961 Placebo + aspirin n=22891 p-value Major Major bleeds were cerebral bleeds or noncerebral bleeds thought to have caused death or that required transfusion.\"\n }\n ]\n },\n {\n \"Term\": \"Haematuria\",\n \"MEDDRACode\": \"10018867\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hematuria\",\n \"Probability\": \"0.9954959154\",\n \"SemanticContext\": \"Other bleeding events that were reported more frequently in the clopidogrel group were epistaxis, hematuria, and bruise.\"\n }\n ]\n },\n {\n \"Term\": \"Renal impairment\",\n \"MEDDRACode\": \"10062237\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"renal impairment\",\n \"Probability\": \"0.0024128258\",\n \"SemanticContext\": \"Renally Impaired Patients After repeated doses of 75 mg Plavix per day, patients with severe renal impairment creatinine clearance from 5 to 15 mL/min and moderate renal impairment creatinine clearance from 30 to 60 mL/min showed low 25% inhibition of ADP-induced platelet aggregation.\"\n },\n {\n \"VerbatimTerm\": \"renal impairment\",\n \"Probability\": \"0.0031259358\",\n \"SemanticContext\": \"Renally Impaired Patients After repeated doses of 75 mg Plavix per day, patients with severe renal impairment creatinine clearance from 5 to 15 mL/min and moderate renal impairment creatinine clearance from 30 to 60 mL/min showed low 25% inhibition of ADP-induced platelet aggregation.\"\n }\n ]\n },\n {\n \"Term\": \"Chest pain\",\n \"MEDDRACode\": \"10008479\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"chest pain\",\n \"Probability\": \"0.2454411685\",\n \"SemanticContext\": \"14 CLINICAL STUDIES 14.1 Acute Coronary Syndrome CURE The CURE study included 12,562 patients with ACS without ST-elevation UA or NSTEMI and presenting within 24 hours of onset of the most recent episode of chest pain or symptoms consistent with ischemia.\"\n },\n {\n \"VerbatimTerm\": \"chest pain\",\n \"Probability\": \"0.0005758703\",\n \"SemanticContext\": \"Plavix is a prescription medicine used to treat people who have any of the following: chest pain due to heart problems poor circulation in their legs peripheral arterial disease a heart attack a stroke Plavix is used alone or with aspirin to lower your chance of having another serious problem with your heart or blood vessels such as heart attack, stroke, or blood clot that can lead to death.\"\n }\n ]\n },\n {\n \"Term\": \"Pyrexia\",\n \"MEDDRACode\": \"10037660\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Fever\",\n \"Probability\": \"0.9985638857\",\n \"SemanticContext\": \"Blood and lymphatic system disorders: Agranulocytosis, aplastic anemia/pancytopenia, thrombotic thrombocytopenic purpura TTP , acquired hemophilia A Gastrointestinal disorders: Colitis including ulcerative or lymphocytic colitis , pancreatitis, stomatitis, gastric/duodenal ulcer, diarrhea General disorders and administration site condition: Fever Hepatobiliary disorders: Acute liver failure, hepatitis noninfectious , abnormal liver function test Immune system disorders: Hypersensitivity reactions, anaphylactoid reactions, serum sickness, insulin autoimmune syndrome, which can lead to severe hypoglycemia Musculoskeletal, connective tissue and bone disorders: Myalgia, arthralgia, arthritis Nervous system disorders: Taste disorders, headache, ageusia Psychiatric disorders: Confusion, hallucinations Respiratory, thoracic and mediastinal disorders: Bronchospasm, interstitial pneumonitis, eosinophilic pneumonia Renal and urinary disorders: Increased creatinine levels Skin and subcutaneous tissue disorders: Maculopapular, erythematous or exfoliative rash, urticaria, bullous dermatitis, eczema, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis AGEP , angioedema, drug-induced hypersensitivity syndrome, drug rash with eosinophilia and systemic symptoms DRESS , erythema multiforme, lichen planus, generalized pruritus Vascular disorders: Vasculitis, hypotension\"\n },\n {\n \"VerbatimTerm\": \"fever\",\n \"Probability\": \"0.9941837788\",\n \"SemanticContext\": \"It is characterized by thrombocytopenia, microangiopathic hemolytic anemia schistocytes [fragmented RBCs] seen on peripheral smear , neurological findings, renal dysfunction, and fever [see Adverse Reactions 6.2 ].\"\n },\n {\n \"VerbatimTerm\": \"fever\",\n \"Probability\": \"0.0026381314\",\n \"SemanticContext\": \"Get medical help right away if you have any of these symptoms and they cannot be explained by another medical condition: purplish spots called purpura on the skin or in the mouth mucous membranes due to bleeding under the skin your skin or the whites of your eyes are yellow jaundice you feel tired or weak your skin looks very pale fever fast heart rate or feeling short of breath headache speech changes confusion coma stroke seizure low amount of urine, or urine that is pink or has blood in it stomach area abdominal pain nausea, vomiting, or diarrhea vision changes persistent low blood sugar symptoms Tell your doctor if you have any side effect that bothers you or that does not go away.\"\n }\n ]\n },\n {\n \"Term\": \"Percutaneous coronary intervention\",\n \"MEDDRACode\": \"10065608\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"PCI\",\n \"Probability\": \"0.000862062\",\n \"SemanticContext\": \"The use of Plavix in CURE did not affect the number of patients treated with CABG or PCI with or without stenting 2253 patients [36.0%] in the Plavix group, 2324 patients [36.9%] in the placebo group; relative risk reduction of 4.0% .\"\n },\n {\n \"VerbatimTerm\": \"PCI\",\n \"Probability\": \"0.1451050341\",\n \"SemanticContext\": \"Fifty-five percent 55% of patients received thrombolytics and only 3% underwent PCI.\"\n }\n ]\n },\n {\n \"Term\": \"Weight\",\n \"MEDDRACode\": \"10047890\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"weight\",\n \"Probability\": \"0.0065235794\",\n \"SemanticContext\": \"The empirical formula of clopidogrel bisulfate is C 16 H 16 ClNO 2 S•H 2 SO 4 and its molecular weight is 419.9.\"\n }\n ]\n },\n {\n \"Term\": \"Taste disorder\",\n \"MEDDRACode\": \"10082490\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Taste disorders\",\n \"Probability\": \"0.7464742661\",\n \"SemanticContext\": \"Blood and lymphatic system disorders: Agranulocytosis, aplastic anemia/pancytopenia, thrombotic thrombocytopenic purpura TTP , acquired hemophilia A Gastrointestinal disorders: Colitis including ulcerative or lymphocytic colitis , pancreatitis, stomatitis, gastric/duodenal ulcer, diarrhea General disorders and administration site condition: Fever Hepatobiliary disorders: Acute liver failure, hepatitis noninfectious , abnormal liver function test Immune system disorders: Hypersensitivity reactions, anaphylactoid reactions, serum sickness, insulin autoimmune syndrome, which can lead to severe hypoglycemia Musculoskeletal, connective tissue and bone disorders: Myalgia, arthralgia, arthritis Nervous system disorders: Taste disorders, headache, ageusia Psychiatric disorders: Confusion, hallucinations Respiratory, thoracic and mediastinal disorders: Bronchospasm, interstitial pneumonitis, eosinophilic pneumonia Renal and urinary disorders: Increased creatinine levels Skin and subcutaneous tissue disorders: Maculopapular, erythematous or exfoliative rash, urticaria, bullous dermatitis, eczema, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis AGEP , angioedema, drug-induced hypersensitivity syndrome, drug rash with eosinophilia and systemic symptoms DRESS , erythema multiforme, lichen planus, generalized pruritus Vascular disorders: Vasculitis, hypotension\"\n }\n ]\n },\n {\n \"Term\": \"Haemostasis\",\n \"MEDDRACode\": \"10067439\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hemostasis\",\n \"Probability\": \"0.0019720793\",\n \"SemanticContext\": \"7.5 Warfarin CYP2C9 Substrates Although the administration of clopidogrel 75 mg per day did not modify the pharmacokinetics of S-warfarin a CYP2C9 substrate or INR in patients receiving long-term warfarin therapy, coadministration of Plavix with warfarin increases the risk of bleeding because of independent effects on hemostasis.\"\n },\n {\n \"VerbatimTerm\": \"hemostasis\",\n \"Probability\": \"0.0002421737\",\n \"SemanticContext\": \"Because the half-life of clopidogrel's active metabolite is short, it may be possible to restore hemostasis by administering exogenous platelets; however, platelet transfusions within 4 hours of the loading dose or 2 hours of the maintenance dose may be less effective.\"\n },\n {\n \"VerbatimTerm\": \"hemostasis\",\n \"Probability\": \"0.0003882051\",\n \"SemanticContext\": \"Resume Plavix as soon as hemostasis is achieved.\"\n }\n ]\n },\n {\n \"Term\": \"Stevens-Johnson syndrome\",\n \"MEDDRACode\": \"10042033\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Stevens-Johnson syndrome\",\n \"Probability\": \"0.8978074193\",\n \"SemanticContext\": \"Blood and lymphatic system disorders: Agranulocytosis, aplastic anemia/pancytopenia, thrombotic thrombocytopenic purpura TTP , acquired hemophilia A Gastrointestinal disorders: Colitis including ulcerative or lymphocytic colitis , pancreatitis, stomatitis, gastric/duodenal ulcer, diarrhea General disorders and administration site condition: Fever Hepatobiliary disorders: Acute liver failure, hepatitis noninfectious , abnormal liver function test Immune system disorders: Hypersensitivity reactions, anaphylactoid reactions, serum sickness, insulin autoimmune syndrome, which can lead to severe hypoglycemia Musculoskeletal, connective tissue and bone disorders: Myalgia, arthralgia, arthritis Nervous system disorders: Taste disorders, headache, ageusia Psychiatric disorders: Confusion, hallucinations Respiratory, thoracic and mediastinal disorders: Bronchospasm, interstitial pneumonitis, eosinophilic pneumonia Renal and urinary disorders: Increased creatinine levels Skin and subcutaneous tissue disorders: Maculopapular, erythematous or exfoliative rash, urticaria, bullous dermatitis, eczema, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis AGEP , angioedema, drug-induced hypersensitivity syndrome, drug rash with eosinophilia and systemic symptoms DRESS , erythema multiforme, lichen planus, generalized pruritus Vascular disorders: Vasculitis, hypotension\"\n }\n ]\n },\n {\n \"Term\": \"Cough\",\n \"MEDDRACode\": \"10011224\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"cough\",\n \"Probability\": \"6.92949E-05\",\n \"SemanticContext\": \"While you take Plavix: you may bruise and bleed more easily you are more likely to have nose bleeds it will take longer for any bleeding to stop Call your doctor right away if you have any of these signs or symptoms of bleeding: unexpected bleeding or bleeding that lasts a long time blood in your urine pink, red or brown urine red or black stools looks like tar bruises that happen without a known cause or get larger cough up blood or blood clots vomit blood or your vomit looks like coffee grounds Do not stop taking Plavix without talking to the doctor who prescribes it for you.\"\n }\n ]\n },\n {\n \"Term\": \"Gastric ulcer\",\n \"MEDDRACode\": \"10017822\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"stomach ulcer\",\n \"Probability\": \"0.0055663586\",\n \"SemanticContext\": \"Do not take Plavix if you: currently have a condition that causes bleeding, such as a stomach ulcer are allergic to clopidogrel or other ingredients in Plavix.\"\n },\n {\n \"VerbatimTerm\": \"stomach ulcers\",\n \"Probability\": \"0.0006944239\",\n \"SemanticContext\": \"Before you take Plavix, tell your doctor if you: have a history of bowel gastrointestinal or stomach ulcers.\"\n }\n ]\n },\n {\n \"Term\": \"International normalised ratio\",\n \"MEDDRACode\": \"10022591\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"INR\",\n \"Probability\": \"7.776E-06\",\n \"SemanticContext\": \"7.5 Warfarin CYP2C9 Substrates Although the administration of clopidogrel 75 mg per day did not modify the pharmacokinetics of S-warfarin a CYP2C9 substrate or INR in patients receiving long-term warfarin therapy, coadministration of Plavix with warfarin increases the risk of bleeding because of independent effects on hemostasis.\"\n }\n ]\n },\n {\n \"Term\": \"Platelet count increased\",\n \"MEDDRACode\": \"10051608\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"increases platelet\",\n \"Probability\": \"0.1292964518\",\n \"SemanticContext\": \"DRUG INTERACTIONS CYP2C19 inducers: Increases levels of clopidogrel active metabolite and increases platelet inhibition.\"\n }\n ]\n },\n {\n \"Term\": \"Abdominal pain\",\n \"MEDDRACode\": \"10000081\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"abdominal pain\",\n \"Probability\": \"0.0057486594\",\n \"SemanticContext\": \"Get medical help right away if you have any of these symptoms and they cannot be explained by another medical condition: purplish spots called purpura on the skin or in the mouth mucous membranes due to bleeding under the skin your skin or the whites of your eyes are yellow jaundice you feel tired or weak your skin looks very pale fever fast heart rate or feeling short of breath headache speech changes confusion coma stroke seizure low amount of urine, or urine that is pink or has blood in it stomach area abdominal pain nausea, vomiting, or diarrhea vision changes persistent low blood sugar symptoms Tell your doctor if you have any side effect that bothers you or that does not go away.\"\n }\n ]\n },\n {\n \"Term\": \"Seizure\",\n \"MEDDRACode\": \"10039906\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"seizure\",\n \"Probability\": \"0.0067810714\",\n \"SemanticContext\": \"Get medical help right away if you have any of these symptoms and they cannot be explained by another medical condition: purplish spots called purpura on the skin or in the mouth mucous membranes due to bleeding under the skin your skin or the whites of your eyes are yellow jaundice you feel tired or weak your skin looks very pale fever fast heart rate or feeling short of breath headache speech changes confusion coma stroke seizure low amount of urine, or urine that is pink or has blood in it stomach area abdominal pain nausea, vomiting, or diarrhea vision changes persistent low blood sugar symptoms Tell your doctor if you have any side effect that bothers you or that does not go away.\"\n }\n ]\n },\n {\n \"Term\": \"Vitamin E\",\n \"MEDDRACode\": \"10058765\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"vitamins\",\n \"Probability\": \"4.294E-07\",\n \"SemanticContext\": \"Tell your doctor about all the medicines you take , including prescription, non-prescription medicines, vitamins and herbal supplements.\"\n }\n ]\n },\n {\n \"Term\": \"Purpura\",\n \"MEDDRACode\": \"10037549\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"purpura\",\n \"Probability\": \"0.0021750331\",\n \"SemanticContext\": \"Get medical help right away if you have any of these symptoms and they cannot be explained by another medical condition: purplish spots called purpura on the skin or in the mouth mucous membranes due to bleeding under the skin your skin or the whites of your eyes are yellow jaundice you feel tired or weak your skin looks very pale fever fast heart rate or feeling short of breath headache speech changes confusion coma stroke seizure low amount of urine, or urine that is pink or has blood in it stomach area abdominal pain nausea, vomiting, or diarrhea vision changes persistent low blood sugar symptoms Tell your doctor if you have any side effect that bothers you or that does not go away.\"\n }\n ]\n },\n {\n \"Term\": \"Acute coronary syndrome\",\n \"MEDDRACode\": \"10051592\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Acute coronary syndrome\",\n \"Probability\": \"0.2918512821\",\n \"SemanticContext\": \"Acute coronary syndrome -- For patients with non--ST-segment elevation ACS unstable angina [UA]/non--ST-elevation myocardial infarction [NSTEMI] , Plavix has been shown to reduce the rate of myocardial infarction MI and stroke.\"\n },\n {\n \"VerbatimTerm\": \"Acute coronary syndrome\",\n \"Probability\": \"0.7433675528\",\n \"SemanticContext\": \"DOSAGE AND ADMINISTRATION Acute coronary syndrome 2.1 -- Initiate Plavix with a single 300 mg oral loading dose and then continue at 75 mg once daily.\"\n },\n {\n \"VerbatimTerm\": \"Acute Coronary Syndrome\",\n \"Probability\": \"0.8770447969\",\n \"SemanticContext\": \"14 CLINICAL STUDIES 14.1 Acute Coronary Syndrome CURE The CURE study included 12,562 patients with ACS without ST-elevation UA or NSTEMI and presenting within 24 hours of onset of the most recent episode of chest pain or symptoms consistent with ischemia.\"\n },\n {\n \"VerbatimTerm\": \"Acute Coronary Syndrome\",\n \"Probability\": \"0.8104711175\",\n \"SemanticContext\": \"2 DOSAGE AND ADMINISTRATION 2.1 Acute Coronary Syndrome In patients who need an antiplatelet effect within hours, initiate Plavix with a single 300 mg oral loading dose and then continue at 75 mg once daily.\"\n },\n {\n \"VerbatimTerm\": \"Acute Coronary Syndrome\",\n \"Probability\": \"0.4651403427\",\n \"SemanticContext\": \"1 INDICATIONS AND USAGE 1.1 Acute Coronary Syndrome ACS Plavix is indicated to reduce the rate of myocardial infarction MI and stroke in patients with non--ST-segment elevation ACS unstable angina [UA]/non--ST-elevation myocardial infarction [NSTEMI] , including patients who are to be managed medically and those who are to be managed with coronary revascularization.\"\n },\n {\n \"VerbatimTerm\": \"acute coronary syndrome\",\n \"Probability\": \"0.0002053678\",\n \"SemanticContext\": \"Consider the use of a parenteral antiplatelet agent in acute coronary syndrome patients requiring coadministration of morphine or other opioid agonists.\"\n }\n ]\n },\n {\n \"Term\": \"Myocardial infarction\",\n \"MEDDRACode\": \"10028596\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"heart attack\",\n \"Probability\": \"0.0434338748\",\n \"SemanticContext\": \"People who stop taking Plavix too soon have a higher risk of having a heart attack or dying.\"\n },\n {\n \"VerbatimTerm\": \"heart attack\",\n \"Probability\": \"0.0054703057\",\n \"SemanticContext\": \"If you must stop Plavix because of bleeding, your risk of a heart attack may be higher.\"\n },\n {\n \"VerbatimTerm\": \"heart attack\",\n \"Probability\": \"0.0008300245\",\n \"SemanticContext\": \"Plavix is a prescription medicine used to treat people who have any of the following: chest pain due to heart problems poor circulation in their legs peripheral arterial disease a heart attack a stroke Plavix is used alone or with aspirin to lower your chance of having another serious problem with your heart or blood vessels such as heart attack, stroke, or blood clot that can lead to death.\"\n },\n {\n \"VerbatimTerm\": \"heart attack\",\n \"Probability\": \"0.0029726923\",\n \"SemanticContext\": \"Plavix is a prescription medicine used to treat people who have any of the following: chest pain due to heart problems poor circulation in their legs peripheral arterial disease a heart attack a stroke Plavix is used alone or with aspirin to lower your chance of having another serious problem with your heart or blood vessels such as heart attack, stroke, or blood clot that can lead to death.\"\n },\n {\n \"VerbatimTerm\": \"heart attack\",\n \"Probability\": \"0.008074522\",\n \"SemanticContext\": \"Stopping Plavix may increase your risk of heart attack or stroke.\"\n }\n ]\n },\n {\n \"Term\": \"Coronary artery bypass\",\n \"MEDDRACode\": \"10011077\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"CABG\",\n \"Probability\": \"0.000472039\",\n \"SemanticContext\": \"The use of Plavix in CURE did not affect the number of patients treated with CABG or PCI with or without stenting 2253 patients [36.0%] in the Plavix group, 2324 patients [36.9%] in the placebo group; relative risk reduction of 4.0% .\"\n }\n ]\n },\n {\n \"Term\": \"Cerebrovascular accident\",\n \"MEDDRACode\": \"10008190\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"stroke\",\n \"Probability\": \"0.2934138179\",\n \"SemanticContext\": \"Acute coronary syndrome -- For patients with non--ST-segment elevation ACS unstable angina [UA]/non--ST-elevation myocardial infarction [NSTEMI] , Plavix has been shown to reduce the rate of myocardial infarction MI and stroke.\"\n },\n {\n \"VerbatimTerm\": \"stroke\",\n \"Probability\": \"0.4315468073\",\n \"SemanticContext\": \"1.1 -- For patients with ST-elevation myocardial infarction STEMI , Plavix has been shown to reduce the rate of MI and stroke.\"\n },\n {\n \"VerbatimTerm\": \"stroke\",\n \"Probability\": \"0.2110714316\",\n \"SemanticContext\": \"Recent MI, recent stroke, or established peripheral arterial disease.\"\n },\n {\n \"VerbatimTerm\": \"stroke\",\n \"Probability\": \"0.6497662067\",\n \"SemanticContext\": \"Plavix has been shown to reduce the rate of MI and stroke.\"\n },\n {\n \"VerbatimTerm\": \"stroke\",\n \"Probability\": \"0.0997470319\",\n \"SemanticContext\": \"Recent MI, recent stroke, or established peripheral arterial disease: 75 mg once daily orally without a loading dose.\"\n },\n {\n \"VerbatimTerm\": \"stroke\",\n \"Probability\": \"0.8684433103\",\n \"SemanticContext\": \"The number of patients experiencing the primary outcome CV death, MI, or stroke was 582 9.3% in the Plavix-treated group and 719 11.4% in the placebo-treated group, a 20% relative risk reduction 95% CI of 10%--28%; p\\n<0.001 for the Plavix-treated group see Table 4 .\"\n },\n {\n \"VerbatimTerm\": \"stroke\",\n \"Probability\": \"0.9267276525\",\n \"SemanticContext\": \"Placebo + aspirin Relative Risk Reduction % 95% CI n=6259 n=6303 Primary outcome Cardiovascular death, MI, stroke 582 9.3% 719 11.4% 20% 10.3, 27.9 p \\n <0.001 All Individual Outcome Events: The individual components do not represent a breakdown of the primary and coprimary outcomes, but rather the total number of subjects experiencing an event during the course of the study.\"\n },\n {\n \"VerbatimTerm\": \"stroke\",\n \"Probability\": \"0.4832961261\",\n \"SemanticContext\": \"The primary endpoints were death from any cause and the first occurrence of re-infarction, stroke or death.\"\n },\n {\n \"VerbatimTerm\": \"stroke\",\n \"Probability\": \"0.3363900781\",\n \"SemanticContext\": \"As shown in Table 5 and Figure 4 and Figure 5 below, Plavix significantly reduced the relative risk of death from any cause by 7% p=0.029 , and the relative risk of the combination of re-infarction, stroke or death by 9% p=0.002 .\"\n },\n {\n \"VerbatimTerm\": \"stroke\",\n \"Probability\": \"0.7666653395\",\n \"SemanticContext\": \"Table 5: Outcome Events in COMMIT Event Plavix + aspirin N=22961 Placebo + aspirin N=22891 Odds ratio 95% CI p-value Composite endpoint: Death, MI, or Stroke 9 patients 2 clopidogrel and 7 placebo suffered both a nonfatal stroke and a nonfatal MI.\"\n },\n {\n \"VerbatimTerm\": \"stroke\",\n \"Probability\": \"0.2565222383\",\n \"SemanticContext\": \"2121 9.2% 2310 10.1% 0.91 0.86, 0.97 0.002 Death 1726 7.5% 1845 8.1% 0.93 0.87, 0.99 0.029 Nonfatal MI Nonfatal MI and nonfatal stroke exclude patients who died of any cause .\"\n },\n {\n \"VerbatimTerm\": \"stroke\",\n \"Probability\": \"0.4596955776\",\n \"SemanticContext\": \"In patients who survived an on-study stroke or myocardial infarction, the incidence of subsequent events was lower in the Plavix group.\"\n },\n {\n \"VerbatimTerm\": \"stroke\",\n \"Probability\": \"0.0007536113\",\n \"SemanticContext\": \"However, because aspirin is itself effective in reducing cardiovascular events in patients with recent myocardial infarction or stroke, the effect of Plavix is substantial.\"\n },\n {\n \"VerbatimTerm\": \"stroke\",\n \"Probability\": \"0.1782756448\",\n \"SemanticContext\": \"The CAPRIE trial enrolled a population that had recent MI, recent stroke, or PAD.\"\n },\n {\n \"VerbatimTerm\": \"stroke\",\n \"Probability\": \"0.0606042445\",\n \"SemanticContext\": \"The benefit was most apparent in patients who were enrolled because of peripheral arterial disease and less apparent in stroke patients.\"\n },\n {\n \"VerbatimTerm\": \"stroke\",\n \"Probability\": \"0.4629052281\",\n \"SemanticContext\": \"The study failed to demonstrate a reduction in the occurrence of the primary endpoint, a composite of CV death, MI, or stroke.\"\n },\n {\n \"VerbatimTerm\": \"stroke\",\n \"Probability\": \"0.1571142375\",\n \"SemanticContext\": \"1 INDICATIONS AND USAGE 1.1 Acute Coronary Syndrome ACS Plavix is indicated to reduce the rate of myocardial infarction MI and stroke in patients with non--ST-segment elevation ACS unstable angina [UA]/non--ST-elevation myocardial infarction [NSTEMI] , including patients who are to be managed medically and those who are to be managed with coronary revascularization.\"\n },\n {\n \"VerbatimTerm\": \"stroke\",\n \"Probability\": \"0.0102309883\",\n \"SemanticContext\": \"Plavix is indicated to reduce the rate of myocardial infarction and stroke in patients with acute ST-elevation myocardial infarction STEMI who are to be managed medically.\"\n },\n {\n \"VerbatimTerm\": \"stroke\",\n \"Probability\": \"0.0201994777\",\n \"SemanticContext\": \"1.2 Recent MI, Recent Stroke, or Established Peripheral Arterial Disease In patients with established peripheral arterial disease or with a history of recent myocardial infarction MI or recent stroke Plavix is indicated to reduce the rate of MI and stroke.\"\n },\n {\n \"VerbatimTerm\": \"stroke\",\n \"Probability\": \"0.1644727886\",\n \"SemanticContext\": \"1.2 Recent MI, Recent Stroke, or Established Peripheral Arterial Disease In patients with established peripheral arterial disease or with a history of recent myocardial infarction MI or recent stroke Plavix is indicated to reduce the rate of MI and stroke.\"\n },\n {\n \"VerbatimTerm\": \"stroke\",\n \"Probability\": \"0.0104034543\",\n \"SemanticContext\": \"There are risks to the pregnant woman and fetus associated with myocardial infarction and stroke [see Clinical Considerations ] .\"\n },\n {\n \"VerbatimTerm\": \"stroke\",\n \"Probability\": \"0.0465453565\",\n \"SemanticContext\": \"Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Myocardial infarction and stroke are medical emergencies.\"\n },\n {\n \"VerbatimTerm\": \"stroke\",\n \"Probability\": \"6.59022E-05\",\n \"SemanticContext\": \"Plavix is a prescription medicine used to treat people who have any of the following: chest pain due to heart problems poor circulation in their legs peripheral arterial disease a heart attack a stroke Plavix is used alone or with aspirin to lower your chance of having another serious problem with your heart or blood vessels such as heart attack, stroke, or blood clot that can lead to death.\"\n },\n {\n \"VerbatimTerm\": \"stroke\",\n \"Probability\": \"0.0018317699\",\n \"SemanticContext\": \"Plavix is a prescription medicine used to treat people who have any of the following: chest pain due to heart problems poor circulation in their legs peripheral arterial disease a heart attack a stroke Plavix is used alone or with aspirin to lower your chance of having another serious problem with your heart or blood vessels such as heart attack, stroke, or blood clot that can lead to death.\"\n },\n {\n \"VerbatimTerm\": \"stroke\",\n \"Probability\": \"4.60237E-05\",\n \"SemanticContext\": \"Especially tell your doctor if you take: aspirin, especially if you have had a stroke.\"\n },\n {\n \"VerbatimTerm\": \"stroke\",\n \"Probability\": \"0.0008145571\",\n \"SemanticContext\": \"Stopping Plavix may increase your risk of heart attack or stroke.\"\n },\n {\n \"VerbatimTerm\": \"stroke\",\n \"Probability\": \"0.0027376115\",\n \"SemanticContext\": \"Get medical help right away if you have any of these symptoms and they cannot be explained by another medical condition: purplish spots called purpura on the skin or in the mouth mucous membranes due to bleeding under the skin your skin or the whites of your eyes are yellow jaundice you feel tired or weak your skin looks very pale fever fast heart rate or feeling short of breath headache speech changes confusion coma stroke seizure low amount of urine, or urine that is pink or has blood in it stomach area abdominal pain nausea, vomiting, or diarrhea vision changes persistent low blood sugar symptoms Tell your doctor if you have any side effect that bothers you or that does not go away.\"\n },\n {\n \"VerbatimTerm\": \"strokes\",\n \"Probability\": \"0.6213240027\",\n \"SemanticContext\": \"Similar results were obtained when all-cause mortality and all-cause strokes were counted instead of vascular mortality and ischemic strokes risk reduction 6.9% .\"\n },\n {\n \"VerbatimTerm\": \"Stroke\",\n \"Probability\": \"0.9467107058\",\n \"SemanticContext\": \"CV death 318 5.1% 345 5.5% 7% -7.7, 20.6 MI 324 5.2% 419 6.6% 23% 11.0, 33.4 Stroke 75 1.2% 87 1.4% 14% -17.7, 36.6 .\"\n },\n {\n \"VerbatimTerm\": \"Stroke\",\n \"Probability\": \"0.8310248852\",\n \"SemanticContext\": \"Figure 2: Cardiovascular Death, Myocardial Infarction, and Stroke in the CURE Study The effect of Plavix did not differ significantly in various subgroups, as shown in Figure 3.\"\n },\n {\n \"VerbatimTerm\": \"Stroke\",\n \"Probability\": \"0.6182374954\",\n \"SemanticContext\": \"Table 5: Outcome Events in COMMIT Event Plavix + aspirin N=22961 Placebo + aspirin N=22891 Odds ratio 95% CI p-value Composite endpoint: Death, MI, or Stroke 9 patients 2 clopidogrel and 7 placebo suffered both a nonfatal stroke and a nonfatal MI.\"\n },\n {\n \"VerbatimTerm\": \"Stroke\",\n \"Probability\": \"0.878095746\",\n \"SemanticContext\": \"270 1.2% 330 1.4% 0.81 0.69, 0.95 0.011 Nonfatal Stroke 127 0.6% 142 0.6% 0.89 0.70, 1.13 0.33 .\"\n },\n {\n \"VerbatimTerm\": \"Stroke\",\n \"Probability\": \"0.3591675758\",\n \"SemanticContext\": \"Figure 5: Cumulative Event Rates for the Combined Endpoint Re-Infarction, Stroke or Death in the COMMIT Study All treated patients received aspirin.\"\n },\n {\n \"VerbatimTerm\": \"Stroke\",\n \"Probability\": \"0.2392391562\",\n \"SemanticContext\": \"Figure Figure Figure Figure Figure 14.2 Recent Myocardial Infarction, Recent Stroke, or Established Peripheral Arterial Disease CAPRIE The CAPRIE trial was a 19,185-patient, 304-center, international, randomized, double-blind, parallel-group study comparing Plavix 75 mg daily to aspirin 325 mg daily .\"\n },\n {\n \"VerbatimTerm\": \"Stroke\",\n \"Probability\": \"0.0352210104\",\n \"SemanticContext\": \"2.2 Recent MI, Recent Stroke, or Established Peripheral Arterial Disease 75 mg once daily orally without a loading dose [see Clinical Pharmacology 12.3 and Clinical Studies 14.2 ] .\"\n },\n {\n \"VerbatimTerm\": \"Stroke\",\n \"Probability\": \"0.0364888906\",\n \"SemanticContext\": \"1.2 Recent MI, Recent Stroke, or Established Peripheral Arterial Disease In patients with established peripheral arterial disease or with a history of recent myocardial infarction MI or recent stroke Plavix is indicated to reduce the rate of MI and stroke.\"\n }\n ]\n },\n {\n \"Term\": \"Peptic ulcer\",\n \"MEDDRACode\": \"10034341\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": true,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"peptic ulcer\",\n \"Probability\": \"0.9590862989\",\n \"SemanticContext\": \"CONTRAINDICATIONS Active pathological bleeding, such as peptic ulcer or intracranial hemorrhage 4.1 .\"\n },\n {\n \"VerbatimTerm\": \"peptic ulcer\",\n \"Probability\": \"0.9871211648\",\n \"SemanticContext\": \"4 CONTRAINDICATIONS 4.1 Active Bleeding Plavix is contraindicated in patients with active pathological bleeding such as peptic ulcer or intracranial hemorrhage.\"\n }\n ]\n },\n {\n \"Term\": \"Peripheral arterial occlusive disease\",\n \"MEDDRACode\": \"10062585\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"peripheral arterial disease\",\n \"Probability\": \"0.3853040338\",\n \"SemanticContext\": \"Recent MI, recent stroke, or established peripheral arterial disease.\"\n },\n {\n \"VerbatimTerm\": \"peripheral arterial disease\",\n \"Probability\": \"0.0085107982\",\n \"SemanticContext\": \"Recent MI, recent stroke, or established peripheral arterial disease: 75 mg once daily orally without a loading dose.\"\n },\n {\n \"VerbatimTerm\": \"peripheral arterial disease\",\n \"Probability\": \"0.2571347356\",\n \"SemanticContext\": \"To be eligible to enroll, patients had to have: 1 recent history of myocardial infarction within 35 days ; 2 recent histories of ischemic stroke within 6 months with at least a week of residual neurological signs; and/or 3 established peripheral arterial disease PAD .\"\n },\n {\n \"VerbatimTerm\": \"peripheral arterial disease\",\n \"Probability\": \"0.3086733222\",\n \"SemanticContext\": \"The benefit was most apparent in patients who were enrolled because of peripheral arterial disease and less apparent in stroke patients.\"\n },\n {\n \"VerbatimTerm\": \"peripheral arterial disease\",\n \"Probability\": \"0.0030032098\",\n \"SemanticContext\": \"1.2 Recent MI, Recent Stroke, or Established Peripheral Arterial Disease In patients with established peripheral arterial disease or with a history of recent myocardial infarction MI or recent stroke Plavix is indicated to reduce the rate of MI and stroke.\"\n },\n {\n \"VerbatimTerm\": \"peripheral arterial disease\",\n \"Probability\": \"0.0001408756\",\n \"SemanticContext\": \"Plavix is a prescription medicine used to treat people who have any of the following: chest pain due to heart problems poor circulation in their legs peripheral arterial disease a heart attack a stroke Plavix is used alone or with aspirin to lower your chance of having another serious problem with your heart or blood vessels such as heart attack, stroke, or blood clot that can lead to death.\"\n },\n {\n \"VerbatimTerm\": \"Peripheral Arterial Disease\",\n \"Probability\": \"0.0312390029\",\n \"SemanticContext\": \"Figure Figure Figure Figure Figure 14.2 Recent Myocardial Infarction, Recent Stroke, or Established Peripheral Arterial Disease CAPRIE The CAPRIE trial was a 19,185-patient, 304-center, international, randomized, double-blind, parallel-group study comparing Plavix 75 mg daily to aspirin 325 mg daily .\"\n },\n {\n \"VerbatimTerm\": \"Peripheral Arterial Disease\",\n \"Probability\": \"0.0006923378\",\n \"SemanticContext\": \"2.2 Recent MI, Recent Stroke, or Established Peripheral Arterial Disease 75 mg once daily orally without a loading dose [see Clinical Pharmacology 12.3 and Clinical Studies 14.2 ] .\"\n },\n {\n \"VerbatimTerm\": \"Peripheral Arterial Disease\",\n \"Probability\": \"0.0086576641\",\n \"SemanticContext\": \"1.2 Recent MI, Recent Stroke, or Established Peripheral Arterial Disease In patients with established peripheral arterial disease or with a history of recent myocardial infarction MI or recent stroke Plavix is indicated to reduce the rate of MI and stroke.\"\n }\n ]\n },\n {\n \"Term\": \"Troponin I\",\n \"MEDDRACode\": \"10050397\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"troponin I\",\n \"Probability\": \"1.87402E-05\",\n \"SemanticContext\": \"Patients were required to have either ECG changes compatible with new ischemia without ST-elevation or elevated cardiac enzymes or troponin I or T to at least twice the upper limit of normal.\"\n }\n ]\n },\n {\n \"Term\": \"Cyanosis\",\n \"MEDDRACode\": \"10011703\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"cyanotic\",\n \"Probability\": \"0.0795844495\",\n \"SemanticContext\": \"A randomized, placebo-controlled trial CLARINET did not demonstrate a clinical benefit of clopidogrel in neonates and infants with cyanotic congenital heart disease palliated with a systemic-to-pulmonary arterial shunt.\"\n }\n ]\n },\n {\n \"Term\": \"Carcinogenicity\",\n \"MEDDRACode\": \"10007269\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"tumorigenicity\",\n \"Probability\": \"0.0004028082\",\n \"SemanticContext\": \"13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility There was no evidence of tumorigenicity when clopidogrel was administered for 78 weeks to mice and 104 weeks to rats at dosages up to 77 mg/kg per day, which afforded plasma exposures >25 times that in humans at the recommended daily dose of 75 mg.\"\n }\n ]\n },\n {\n \"Term\": \"Drug interaction\",\n \"MEDDRACode\": \"10013710\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"DRUG INTERACTIONS\",\n \"Probability\": \"0.0001176214\",\n \"SemanticContext\": \"DRUG INTERACTIONS CYP2C19 inducers: Increases levels of clopidogrel active metabolite and increases platelet inhibition.\"\n },\n {\n \"VerbatimTerm\": \"DRUG INTERACTIONS\",\n \"Probability\": \"0.0007375777\",\n \"SemanticContext\": \"7 DRUG INTERACTIONS 7.1 CYP2C19 Inducers Since clopidogrel is metabolized to its active metabolite partly by CYP2C19, use of drugs that induce the activity of this enzyme would be expected to result in increased drug levels of the active metabolite of clopidogrel.\"\n },\n {\n \"VerbatimTerm\": \"Drug Interactions\",\n \"Probability\": \"0.0004745722\",\n \"SemanticContext\": \"Drug Interactions Effect of other drugs on Plavix Clopidogrel is metabolized to its active metabolite in part by CYP2C19.\"\n },\n {\n \"VerbatimTerm\": \"Drug Interactions\",\n \"Probability\": \"0.0036081076\",\n \"SemanticContext\": \"Concomitant administration of repaglinide with Plavix increased the systemic exposure to repaglinide AUC 0--8 by 5.1-fold following the loading dose 300 mg and by 3.9-fold on day 3 of the maintenance dose 75 mg of Plavix [see Drug Interactions 7.6 ] .\"\n },\n {\n \"VerbatimTerm\": \"Drug Interactions\",\n \"Probability\": \"0.001637876\",\n \"SemanticContext\": \"Dexlansoprazole, lansoprazole, and pantoprazole had less pronounced effects on the antiplatelet activity of Plavix than did omeprazole or esomeprazole [see Drug Interactions 7.1 ] .\"\n },\n {\n \"VerbatimTerm\": \"Drug Interactions\",\n \"Probability\": \"0.0007338226\",\n \"SemanticContext\": \"Avoid concomitant use of Plavix with omeprazole or esomeprazole because both significantly reduce the antiplatelet activity of Plavix [see Drug Interactions 7.1 ] .\"\n },\n {\n \"VerbatimTerm\": \"Drug Interactions\",\n \"Probability\": \"0.0001235902\",\n \"SemanticContext\": \"As a precaution, avoid concomitant use of strong CYP2C19 inducers [see Drug Interactions 7.1 and Clinical Pharmacology 12.3 ] .\"\n },\n {\n \"VerbatimTerm\": \"drug interaction\",\n \"Probability\": \"0.0003899038\",\n \"SemanticContext\": \"Proton pump inhibitors PPI The effect of proton pump inhibitors PPI on the systemic exposure to the clopidogrel active metabolite following multiple doses of Plavix 75 mg evaluated in dedicated drug interaction studies is presented in Figure 1.\"\n }\n ]\n },\n {\n \"Term\": \"Haemorrhage intracranial\",\n \"MEDDRACode\": \"10018985\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": true,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"intracranial hemorrhage\",\n \"Probability\": \"0.840202868\",\n \"SemanticContext\": \"CONTRAINDICATIONS Active pathological bleeding, such as peptic ulcer or intracranial hemorrhage 4.1 .\"\n },\n {\n \"VerbatimTerm\": \"intracranial hemorrhage\",\n \"Probability\": \"0.9968702793\",\n \"SemanticContext\": \"The incidence of intracranial hemorrhage 0.1% and fatal bleeding 0.2% were the same in both groups.\"\n },\n {\n \"VerbatimTerm\": \"intracranial hemorrhage\",\n \"Probability\": \"0.9947397113\",\n \"SemanticContext\": \"The incidence of intracranial hemorrhage was 0.4% for Plavix compared to 0.5% for aspirin.\"\n },\n {\n \"VerbatimTerm\": \"intracranial hemorrhage\",\n \"Probability\": \"0.9559108019\",\n \"SemanticContext\": \"4 CONTRAINDICATIONS 4.1 Active Bleeding Plavix is contraindicated in patients with active pathological bleeding such as peptic ulcer or intracranial hemorrhage.\"\n }\n ]\n },\n {\n \"Term\": \"Blood chloride\",\n \"MEDDRACode\": \"10005416\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"chloride\",\n \"Probability\": \"0.0004883111\",\n \"SemanticContext\": \"It also dissolves freely in methanol, dissolves sparingly in methylene chloride, and is practically insoluble in ethyl ether.\"\n }\n ]\n },\n {\n \"Term\": \"Prophylaxis\",\n \"MEDDRACode\": \"10036898\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"prevention\",\n \"Probability\": \"0.0002138913\",\n \"SemanticContext\": \"Figure 8: Hazard Ratio and 95% CI by Baseline Subgroups in the CAPRIE Study Figure Figure 14.3 No Demonstrated Benefit of Plavix plus Aspirin in Patients with Multiple Risk Factors or Established Vascular Disease CHARISMA The CHARISMA trial was a 15,603 subject, randomized, double-blind, parallel group study comparing Plavix 75 mg daily to placebo for prevention of ischemic events in patients with vascular disease or multiple risk factors for atherosclerosis.\"\n }\n ]\n },\n {\n \"Term\": \"Smear test\",\n \"MEDDRACode\": \"10041210\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"smear\",\n \"Probability\": \"0.0075626075\",\n \"SemanticContext\": \"It is characterized by thrombocytopenia, microangiopathic hemolytic anemia schistocytes [fragmented RBCs] seen on peripheral smear , neurological findings, renal dysfunction, and fever [see Adverse Reactions 6.2 ].\"\n }\n ]\n },\n {\n \"Term\": \"Thrombocytopenia\",\n \"MEDDRACode\": \"10043554\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"thrombocytopenia\",\n \"Probability\": \"0.9932730198\",\n \"SemanticContext\": \"It is characterized by thrombocytopenia, microangiopathic hemolytic anemia schistocytes [fragmented RBCs] seen on peripheral smear , neurological findings, renal dysfunction, and fever [see Adverse Reactions 6.2 ].\"\n }\n ]\n },\n {\n \"Term\": \"Electrocardiogram\",\n \"MEDDRACode\": \"10014362\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"ECG\",\n \"Probability\": \"7.96036E-05\",\n \"SemanticContext\": \"Patients were required to have either ECG changes compatible with new ischemia without ST-elevation or elevated cardiac enzymes or troponin I or T to at least twice the upper limit of normal.\"\n },\n {\n \"VerbatimTerm\": \"ECG\",\n \"Probability\": \"0.0033876598\",\n \"SemanticContext\": \"COMMIT included 45,852 patients presenting within 24 hours of the onset of the symptoms of myocardial infarction with supporting ECG abnormalities i.e .\"\n }\n ]\n },\n {\n \"Term\": \"Infarction\",\n \"MEDDRACode\": \"10061216\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"infarction\",\n \"Probability\": \"0.7809032202\",\n \"SemanticContext\": \"The primary endpoints were death from any cause and the first occurrence of re-infarction, stroke or death.\"\n },\n {\n \"VerbatimTerm\": \"infarction\",\n \"Probability\": \"0.6816880703\",\n \"SemanticContext\": \"As shown in Table 5 and Figure 4 and Figure 5 below, Plavix significantly reduced the relative risk of death from any cause by 7% p=0.029 , and the relative risk of the combination of re-infarction, stroke or death by 9% p=0.002 .\"\n },\n {\n \"VerbatimTerm\": \"Infarction\",\n \"Probability\": \"0.2946359217\",\n \"SemanticContext\": \"Figure 5: Cumulative Event Rates for the Combined Endpoint Re-Infarction, Stroke or Death in the COMMIT Study All treated patients received aspirin.\"\n }\n ]\n },\n {\n \"Term\": \"Elderly\",\n \"MEDDRACode\": \"10014348\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": true\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Elderly\",\n \"Probability\": \"0.0008027852\",\n \"SemanticContext\": \"Geriatric Patients Elderly =75 years and young healthy subjects had similar effects on platelet aggregation.\"\n },\n {\n \"VerbatimTerm\": \"elderly\",\n \"Probability\": \"2.60235E-05\",\n \"SemanticContext\": \"No dosage adjustment is necessary in elderly patients.\"\n }\n ]\n },\n {\n \"Term\": \"Thrombotic thrombocytopenic purpura\",\n \"MEDDRACode\": \"10043648\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Thrombotic thrombocytopenic purpura\",\n \"Probability\": \"0.5409739614\",\n \"SemanticContext\": \"Thrombotic thrombocytopenic purpura TTP has been reported.\"\n },\n {\n \"VerbatimTerm\": \"Thrombotic thrombocytopenic purpura\",\n \"Probability\": \"0.9180904627\",\n \"SemanticContext\": \"6 ADVERSE REACTIONS The following serious adverse reactions are discussed below and elsewhere in the labeling: Bleeding [see Warnings and Precautions 5.2 ] Thrombotic thrombocytopenic purpura [see Warnings and Precautions 5.4 ] 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions and durations of follow-up, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.\"\n },\n {\n \"VerbatimTerm\": \", thrombotic thrombocytopenic purpura\",\n \"Probability\": \"0.9606611729\",\n \"SemanticContext\": \"Blood and lymphatic system disorders: Agranulocytosis, aplastic anemia/pancytopenia, thrombotic thrombocytopenic purpura TTP , acquired hemophilia A Gastrointestinal disorders: Colitis including ulcerative or lymphocytic colitis , pancreatitis, stomatitis, gastric/duodenal ulcer, diarrhea General disorders and administration site condition: Fever Hepatobiliary disorders: Acute liver failure, hepatitis noninfectious , abnormal liver function test Immune system disorders: Hypersensitivity reactions, anaphylactoid reactions, serum sickness, insulin autoimmune syndrome, which can lead to severe hypoglycemia Musculoskeletal, connective tissue and bone disorders: Myalgia, arthralgia, arthritis Nervous system disorders: Taste disorders, headache, ageusia Psychiatric disorders: Confusion, hallucinations Respiratory, thoracic and mediastinal disorders: Bronchospasm, interstitial pneumonitis, eosinophilic pneumonia Renal and urinary disorders: Increased creatinine levels Skin and subcutaneous tissue disorders: Maculopapular, erythematous or exfoliative rash, urticaria, bullous dermatitis, eczema, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis AGEP , angioedema, drug-induced hypersensitivity syndrome, drug rash with eosinophilia and systemic symptoms DRESS , erythema multiforme, lichen planus, generalized pruritus Vascular disorders: Vasculitis, hypotension\"\n },\n {\n \"VerbatimTerm\": \"Thrombotic Thrombocytopenic Purpura\",\n \"Probability\": \"0.3308336139\",\n \"SemanticContext\": \"Bleeding Advise patients that they: will bruise and bleed more easily will take longer than usual to stop bleeding must report any unanticipated, prolonged, or excessive bleeding, or blood in their stool or urine [see Warnings and Precautions 5.2 ] Thrombotic Thrombocytopenic Purpura Instruct patients to get prompt medical attention if they experience symptoms of TTP that cannot otherwise be explained [see Warnings and Precautions 5.4 ] .\"\n },\n {\n \"VerbatimTerm\": \"Thrombotic Thrombocytopenic Purpura\",\n \"Probability\": \"0.9250958562\",\n \"SemanticContext\": \"5.4 Thrombotic Thrombocytopenic Purpura TTP TTP, sometimes fatal, has been reported following use of Plavix, sometimes after a short exposure \\n <2 weeks .\"\n },\n {\n \"VerbatimTerm\": \"Thrombotic Thrombocytopenic Purpura\",\n \"Probability\": \"0.0071125031\",\n \"SemanticContext\": \"A blood clotting problem called Thrombotic Thrombocytopenic Purpura TTP .\"\n }\n ]\n },\n {\n \"Term\": \"Arteriosclerosis\",\n \"MEDDRACode\": \"10003210\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"atherosclerosis\",\n \"Probability\": \"0.1044772267\",\n \"SemanticContext\": \"Figure 8: Hazard Ratio and 95% CI by Baseline Subgroups in the CAPRIE Study Figure Figure 14.3 No Demonstrated Benefit of Plavix plus Aspirin in Patients with Multiple Risk Factors or Established Vascular Disease CHARISMA The CHARISMA trial was a 15,603 subject, randomized, double-blind, parallel group study comparing Plavix 75 mg daily to placebo for prevention of ischemic events in patients with vascular disease or multiple risk factors for atherosclerosis.\"\n }\n ]\n },\n {\n \"Term\": \"Depression\",\n \"MEDDRACode\": \"10012378\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"depression\",\n \"Probability\": \"0.1601261795\",\n \"SemanticContext\": \", ST-elevation, ST-depression or left bundle-branch block .\"\n }\n ]\n },\n {\n \"Term\": \"Coronary revascularisation\",\n \"MEDDRACode\": \"10049887\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"coronary revascularization\",\n \"Probability\": \"0.0133781135\",\n \"SemanticContext\": \"1 INDICATIONS AND USAGE 1.1 Acute Coronary Syndrome ACS Plavix is indicated to reduce the rate of myocardial infarction MI and stroke in patients with non--ST-segment elevation ACS unstable angina [UA]/non--ST-elevation myocardial infarction [NSTEMI] , including patients who are to be managed medically and those who are to be managed with coronary revascularization.\"\n }\n ]\n },\n {\n \"Term\": \"Hypersensitivity\",\n \"MEDDRACode\": \"10020751\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": true,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"allergy\",\n \"Probability\": \"0.0002423525\",\n \"SemanticContext\": \"have had an allergy or reaction to any medicine used to treat your disease.\"\n }\n ]\n },\n {\n \"Term\": \"Angina unstable\",\n \"MEDDRACode\": \"10002388\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"unstable angina\",\n \"Probability\": \"0.000279814\",\n \"SemanticContext\": \"Acute coronary syndrome -- For patients with non--ST-segment elevation ACS unstable angina [UA]/non--ST-elevation myocardial infarction [NSTEMI] , Plavix has been shown to reduce the rate of myocardial infarction MI and stroke.\"\n },\n {\n \"VerbatimTerm\": \"unstable angina\",\n \"Probability\": \"0.0007454753\",\n \"SemanticContext\": \"1 INDICATIONS AND USAGE 1.1 Acute Coronary Syndrome ACS Plavix is indicated to reduce the rate of myocardial infarction MI and stroke in patients with non--ST-segment elevation ACS unstable angina [UA]/non--ST-elevation myocardial infarction [NSTEMI] , including patients who are to be managed medically and those who are to be managed with coronary revascularization.\"\n }\n ]\n },\n {\n \"Term\": \"Drug level increased\",\n \"MEDDRACode\": \"10013722\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"increased drug levels\",\n \"Probability\": \"0.0032616854\",\n \"SemanticContext\": \"7 DRUG INTERACTIONS 7.1 CYP2C19 Inducers Since clopidogrel is metabolized to its active metabolite partly by CYP2C19, use of drugs that induce the activity of this enzyme would be expected to result in increased drug levels of the active metabolite of clopidogrel.\"\n },\n {\n \"VerbatimTerm\": \"increased drug levels\",\n \"Probability\": \"0.0019706488\",\n \"SemanticContext\": \"Use of drugs that induce the activity of CYP2C19 would be expected to result in increased drug levels of the active metabolite of clopidogrel and might potentiate the bleeding risk.\"\n }\n ]\n },\n {\n \"Term\": \"Skin reaction\",\n \"MEDDRACode\": \"10040914\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"skin reactions\",\n \"Probability\": \"4.3622E-06\",\n \"SemanticContext\": \"Tell your doctor if you develop an allergic reaction including skin reactions while taking Plavix.\"\n }\n ]\n },\n {\n \"Term\": \"Thrombosis\",\n \"MEDDRACode\": \"10043607\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"blood clots\",\n \"Probability\": \"0.0001426339\",\n \"SemanticContext\": \"Plavix is a blood thinner medicine that lowers the chance of blood clots forming in your body.\"\n },\n {\n \"VerbatimTerm\": \"blood clots\",\n \"Probability\": \"2.7746E-06\",\n \"SemanticContext\": \"While you take Plavix: you may bruise and bleed more easily you are more likely to have nose bleeds it will take longer for any bleeding to stop Call your doctor right away if you have any of these signs or symptoms of bleeding: unexpected bleeding or bleeding that lasts a long time blood in your urine pink, red or brown urine red or black stools looks like tar bruises that happen without a known cause or get larger cough up blood or blood clots vomit blood or your vomit looks like coffee grounds Do not stop taking Plavix without talking to the doctor who prescribes it for you.\"\n },\n {\n \"VerbatimTerm\": \"blood clots\",\n \"Probability\": \"0.0136010051\",\n \"SemanticContext\": \"TTP is a blood clotting problem where blood clots form in blood vessels; and can happen anywhere in the body.\"\n },\n {\n \"VerbatimTerm\": \"blood clot\",\n \"Probability\": \"0.0012077987\",\n \"SemanticContext\": \"Plavix is a prescription medicine used to treat people who have any of the following: chest pain due to heart problems poor circulation in their legs peripheral arterial disease a heart attack a stroke Plavix is used alone or with aspirin to lower your chance of having another serious problem with your heart or blood vessels such as heart attack, stroke, or blood clot that can lead to death.\"\n },\n {\n \"VerbatimTerm\": \"blood clot\",\n \"Probability\": \"0.0005021691\",\n \"SemanticContext\": \"Platelets are blood cells that help your blood clot normally.\"\n },\n {\n \"VerbatimTerm\": \"blood clotting\",\n \"Probability\": \"0.0022746325\",\n \"SemanticContext\": \"A blood clotting problem called Thrombotic Thrombocytopenic Purpura TTP .\"\n },\n {\n \"VerbatimTerm\": \"blood clotting\",\n \"Probability\": \"0.180965662\",\n \"SemanticContext\": \"TTP is a blood clotting problem where blood clots form in blood vessels; and can happen anywhere in the body.\"\n }\n ]\n },\n {\n \"Term\": \"Spinal cord haematoma\",\n \"MEDDRACode\": \"10076051\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"spinal hematoma\",\n \"Probability\": \"0.0176209211\",\n \"SemanticContext\": \"Avoid neuraxial blockade during clopidogrel use because of the risk of spinal hematoma.\"\n }\n ]\n },\n {\n \"Term\": \"Planning to become pregnant\",\n \"MEDDRACode\": \"10076056\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"plan to become pregnant\",\n \"Probability\": \"6.4822E-06\",\n \"SemanticContext\": \"are pregnant or plan to become pregnant.\"\n }\n ]\n },\n {\n \"Term\": \"Fatigue\",\n \"MEDDRACode\": \"10016256\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"prostration\",\n \"Probability\": \"0.8510430455\",\n \"SemanticContext\": \"Symptoms of acute toxicity were vomiting, prostration, difficult breathing, and gastrointestinal hemorrhage in animals.\"\n }\n ]\n },\n {\n \"Term\": \"Infection\",\n \"MEDDRACode\": \"10021789\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"infections\",\n \"Probability\": \"5.26849E-05\",\n \"SemanticContext\": \"rifampin used to treat severe infections Know the medicines you take.\"\n }\n ]\n },\n {\n \"Term\": \"Jaundice\",\n \"MEDDRACode\": \"10023126\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"jaundice\",\n \"Probability\": \"3.9676E-05\",\n \"SemanticContext\": \"Get medical help right away if you have any of these symptoms and they cannot be explained by another medical condition: purplish spots called purpura on the skin or in the mouth mucous membranes due to bleeding under the skin your skin or the whites of your eyes are yellow jaundice you feel tired or weak your skin looks very pale fever fast heart rate or feeling short of breath headache speech changes confusion coma stroke seizure low amount of urine, or urine that is pink or has blood in it stomach area abdominal pain nausea, vomiting, or diarrhea vision changes persistent low blood sugar symptoms Tell your doctor if you have any side effect that bothers you or that does not go away.\"\n }\n ]\n },\n {\n \"Term\": \"Vomiting\",\n \"MEDDRACode\": \"10047700\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"vomiting\",\n \"Probability\": \"0.7022784948\",\n \"SemanticContext\": \"Symptoms of acute toxicity were vomiting, prostration, difficult breathing, and gastrointestinal hemorrhage in animals.\"\n },\n {\n \"VerbatimTerm\": \"vomiting\",\n \"Probability\": \"0.0014929175\",\n \"SemanticContext\": \"Get medical help right away if you have any of these symptoms and they cannot be explained by another medical condition: purplish spots called purpura on the skin or in the mouth mucous membranes due to bleeding under the skin your skin or the whites of your eyes are yellow jaundice you feel tired or weak your skin looks very pale fever fast heart rate or feeling short of breath headache speech changes confusion coma stroke seizure low amount of urine, or urine that is pink or has blood in it stomach area abdominal pain nausea, vomiting, or diarrhea vision changes persistent low blood sugar symptoms Tell your doctor if you have any side effect that bothers you or that does not go away.\"\n }\n ]\n },\n {\n \"Term\": \"Acute myocardial infarction\",\n \"MEDDRACode\": \"10000891\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"STEMI\",\n \"Probability\": \"0.030470401\",\n \"SemanticContext\": \"1.1 -- For patients with ST-elevation myocardial infarction STEMI , Plavix has been shown to reduce the rate of MI and stroke.\"\n },\n {\n \"VerbatimTerm\": \"STEMI\",\n \"Probability\": \"0.0671869814\",\n \"SemanticContext\": \"COMMIT In patients with STEMI, the safety and efficacy of Plavix were evaluated in the randomized, placebo-controlled, double-blind study, COMMIT.\"\n },\n {\n \"VerbatimTerm\": \"STEMI\",\n \"Probability\": \"0.0021434128\",\n \"SemanticContext\": \"Plavix is indicated to reduce the rate of myocardial infarction and stroke in patients with acute ST-elevation myocardial infarction STEMI who are to be managed medically.\"\n }\n ]\n },\n {\n \"Term\": \"Infant\",\n \"MEDDRACode\": \"10021731\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": true,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"neonates\",\n \"Probability\": \"0.0006655753\",\n \"SemanticContext\": \"A randomized, placebo-controlled trial CLARINET did not demonstrate a clinical benefit of clopidogrel in neonates and infants with cyanotic congenital heart disease palliated with a systemic-to-pulmonary arterial shunt.\"\n }\n ]\n },\n {\n \"Term\": \"Microangiopathic haemolytic anaemia\",\n \"MEDDRACode\": \"10027527\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"microangiopathic hemolytic anemia\",\n \"Probability\": \"0.9793682694\",\n \"SemanticContext\": \"It is characterized by thrombocytopenia, microangiopathic hemolytic anemia schistocytes [fragmented RBCs] seen on peripheral smear , neurological findings, renal dysfunction, and fever [see Adverse Reactions 6.2 ].\"\n }\n ]\n },\n {\n \"Term\": \"Plasmapheresis\",\n \"MEDDRACode\": \"10035486\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"plasmapheresis\",\n \"Probability\": \"0.005526185\",\n \"SemanticContext\": \"TTP is a serious condition that requires urgent treatment including plasmapheresis plasma exchange .\"\n }\n ]\n },\n {\n \"Term\": \"Electrocardiogram ST segment elevation\",\n \"MEDDRACode\": \"10014392\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"ST-segment elevation\",\n \"Probability\": \"0.00048244\",\n \"SemanticContext\": \"Acute coronary syndrome -- For patients with non--ST-segment elevation ACS unstable angina [UA]/non--ST-elevation myocardial infarction [NSTEMI] , Plavix has been shown to reduce the rate of myocardial infarction MI and stroke.\"\n },\n {\n \"VerbatimTerm\": \"ST-segment elevation\",\n \"Probability\": \"0.0060447454\",\n \"SemanticContext\": \"1 INDICATIONS AND USAGE 1.1 Acute Coronary Syndrome ACS Plavix is indicated to reduce the rate of myocardial infarction MI and stroke in patients with non--ST-segment elevation ACS unstable angina [UA]/non--ST-elevation myocardial infarction [NSTEMI] , including patients who are to be managed medically and those who are to be managed with coronary revascularization.\"\n }\n ]\n },\n {\n \"Term\": \"Fasting\",\n \"MEDDRACode\": \"10068315\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"fast\",\n \"Probability\": \"6.4462E-06\",\n \"SemanticContext\": \"Get medical help right away if you have any of these symptoms and they cannot be explained by another medical condition: purplish spots called purpura on the skin or in the mouth mucous membranes due to bleeding under the skin your skin or the whites of your eyes are yellow jaundice you feel tired or weak your skin looks very pale fever fast heart rate or feeling short of breath headache speech changes confusion coma stroke seizure low amount of urine, or urine that is pink or has blood in it stomach area abdominal pain nausea, vomiting, or diarrhea vision changes persistent low blood sugar symptoms Tell your doctor if you have any side effect that bothers you or that does not go away.\"\n }\n ]\n },\n {\n \"Term\": \"Pallor\",\n \"MEDDRACode\": \"10033546\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"pale\",\n \"Probability\": \"0.0001827478\",\n \"SemanticContext\": \"Get medical help right away if you have any of these symptoms and they cannot be explained by another medical condition: purplish spots called purpura on the skin or in the mouth mucous membranes due to bleeding under the skin your skin or the whites of your eyes are yellow jaundice you feel tired or weak your skin looks very pale fever fast heart rate or feeling short of breath headache speech changes confusion coma stroke seizure low amount of urine, or urine that is pink or has blood in it stomach area abdominal pain nausea, vomiting, or diarrhea vision changes persistent low blood sugar symptoms Tell your doctor if you have any side effect that bothers you or that does not go away.\"\n }\n ]\n },\n {\n \"Term\": \"Confusional state\",\n \"MEDDRACode\": \"10010305\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Confusion\",\n \"Probability\": \"0.8576098084\",\n \"SemanticContext\": \"Blood and lymphatic system disorders: Agranulocytosis, aplastic anemia/pancytopenia, thrombotic thrombocytopenic purpura TTP , acquired hemophilia A Gastrointestinal disorders: Colitis including ulcerative or lymphocytic colitis , pancreatitis, stomatitis, gastric/duodenal ulcer, diarrhea General disorders and administration site condition: Fever Hepatobiliary disorders: Acute liver failure, hepatitis noninfectious , abnormal liver function test Immune system disorders: Hypersensitivity reactions, anaphylactoid reactions, serum sickness, insulin autoimmune syndrome, which can lead to severe hypoglycemia Musculoskeletal, connective tissue and bone disorders: Myalgia, arthralgia, arthritis Nervous system disorders: Taste disorders, headache, ageusia Psychiatric disorders: Confusion, hallucinations Respiratory, thoracic and mediastinal disorders: Bronchospasm, interstitial pneumonitis, eosinophilic pneumonia Renal and urinary disorders: Increased creatinine levels Skin and subcutaneous tissue disorders: Maculopapular, erythematous or exfoliative rash, urticaria, bullous dermatitis, eczema, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis AGEP , angioedema, drug-induced hypersensitivity syndrome, drug rash with eosinophilia and systemic symptoms DRESS , erythema multiforme, lichen planus, generalized pruritus Vascular disorders: Vasculitis, hypotension\"\n },\n {\n \"VerbatimTerm\": \"confusion\",\n \"Probability\": \"0.0008726418\",\n \"SemanticContext\": \"Get medical help right away if you have any of these symptoms and they cannot be explained by another medical condition: purplish spots called purpura on the skin or in the mouth mucous membranes due to bleeding under the skin your skin or the whites of your eyes are yellow jaundice you feel tired or weak your skin looks very pale fever fast heart rate or feeling short of breath headache speech changes confusion coma stroke seizure low amount of urine, or urine that is pink or has blood in it stomach area abdominal pain nausea, vomiting, or diarrhea vision changes persistent low blood sugar symptoms Tell your doctor if you have any side effect that bothers you or that does not go away.\"\n }\n ]\n },\n {\n \"Term\": \"Toxic epidermal necrolysis\",\n \"MEDDRACode\": \"10044223\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"toxic epidermal necrolysis\",\n \"Probability\": \"0.9892287254\",\n \"SemanticContext\": \"Blood and lymphatic system disorders: Agranulocytosis, aplastic anemia/pancytopenia, thrombotic thrombocytopenic purpura TTP , acquired hemophilia A Gastrointestinal disorders: Colitis including ulcerative or lymphocytic colitis , pancreatitis, stomatitis, gastric/duodenal ulcer, diarrhea General disorders and administration site condition: Fever Hepatobiliary disorders: Acute liver failure, hepatitis noninfectious , abnormal liver function test Immune system disorders: Hypersensitivity reactions, anaphylactoid reactions, serum sickness, insulin autoimmune syndrome, which can lead to severe hypoglycemia Musculoskeletal, connective tissue and bone disorders: Myalgia, arthralgia, arthritis Nervous system disorders: Taste disorders, headache, ageusia Psychiatric disorders: Confusion, hallucinations Respiratory, thoracic and mediastinal disorders: Bronchospasm, interstitial pneumonitis, eosinophilic pneumonia Renal and urinary disorders: Increased creatinine levels Skin and subcutaneous tissue disorders: Maculopapular, erythematous or exfoliative rash, urticaria, bullous dermatitis, eczema, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis AGEP , angioedema, drug-induced hypersensitivity syndrome, drug rash with eosinophilia and systemic symptoms DRESS , erythema multiforme, lichen planus, generalized pruritus Vascular disorders: Vasculitis, hypotension\"\n }\n ]\n },\n {\n \"Term\": \"Abortion spontaneous\",\n \"MEDDRACode\": \"10000234\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"miscarriage\",\n \"Probability\": \"0.2019704878\",\n \"SemanticContext\": \"8.1 Pregnancy Risk Summary Available data from cases reported in published literature and postmarketing surveillance with clopidogrel use in pregnant women have not identified any drug-associated risks for major birth defects or miscarriage [see Data ] .\"\n },\n {\n \"VerbatimTerm\": \"miscarriage\",\n \"Probability\": \"0.3077663183\",\n \"SemanticContext\": \"The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown.\"\n },\n {\n \"VerbatimTerm\": \"miscarriage\",\n \"Probability\": \"0.808809638\",\n \"SemanticContext\": \"In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.\"\n },\n {\n \"VerbatimTerm\": \"miscarriage\",\n \"Probability\": \"0.643130064\",\n \"SemanticContext\": \"Data Human data The available data from published case reports over two decades of postmarketing use have not identified an association with clopidogrel use in pregnancy and major birth defects, miscarriage, or adverse fetal outcomes.\"\n }\n ]\n },\n {\n \"Term\": \"Blood methanol\",\n \"MEDDRACode\": \"10005663\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"methanol\",\n \"Probability\": \"0.0001006261\",\n \"SemanticContext\": \"It also dissolves freely in methanol, dissolves sparingly in methylene chloride, and is practically insoluble in ethyl ether.\"\n }\n ]\n },\n {\n \"Term\": \"Creatinine renal clearance\",\n \"MEDDRACode\": \"10011371\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"creatinine clearance\",\n \"Probability\": \"0.0040466487\",\n \"SemanticContext\": \"Renally Impaired Patients After repeated doses of 75 mg Plavix per day, patients with severe renal impairment creatinine clearance from 5 to 15 mL/min and moderate renal impairment creatinine clearance from 30 to 60 mL/min showed low 25% inhibition of ADP-induced platelet aggregation.\"\n },\n {\n \"VerbatimTerm\": \"creatinine clearance\",\n \"Probability\": \"0.0070218444\",\n \"SemanticContext\": \"Renally Impaired Patients After repeated doses of 75 mg Plavix per day, patients with severe renal impairment creatinine clearance from 5 to 15 mL/min and moderate renal impairment creatinine clearance from 30 to 60 mL/min showed low 25% inhibition of ADP-induced platelet aggregation.\"\n }\n ]\n },\n {\n \"Term\": \"Erythema multiforme\",\n \"MEDDRACode\": \"10015218\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"erythema multiforme\",\n \"Probability\": \"0.9763616323\",\n \"SemanticContext\": \"Blood and lymphatic system disorders: Agranulocytosis, aplastic anemia/pancytopenia, thrombotic thrombocytopenic purpura TTP , acquired hemophilia A Gastrointestinal disorders: Colitis including ulcerative or lymphocytic colitis , pancreatitis, stomatitis, gastric/duodenal ulcer, diarrhea General disorders and administration site condition: Fever Hepatobiliary disorders: Acute liver failure, hepatitis noninfectious , abnormal liver function test Immune system disorders: Hypersensitivity reactions, anaphylactoid reactions, serum sickness, insulin autoimmune syndrome, which can lead to severe hypoglycemia Musculoskeletal, connective tissue and bone disorders: Myalgia, arthralgia, arthritis Nervous system disorders: Taste disorders, headache, ageusia Psychiatric disorders: Confusion, hallucinations Respiratory, thoracic and mediastinal disorders: Bronchospasm, interstitial pneumonitis, eosinophilic pneumonia Renal and urinary disorders: Increased creatinine levels Skin and subcutaneous tissue disorders: Maculopapular, erythematous or exfoliative rash, urticaria, bullous dermatitis, eczema, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis AGEP , angioedema, drug-induced hypersensitivity syndrome, drug rash with eosinophilia and systemic symptoms DRESS , erythema multiforme, lichen planus, generalized pruritus Vascular disorders: Vasculitis, hypotension\"\n }\n ]\n },\n {\n \"Term\": \"Cerebral haemorrhage\",\n \"MEDDRACode\": \"10008111\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"cerebral bleeds\",\n \"Probability\": \"0.9155522585\",\n \"SemanticContext\": \"Table 2: Incidence of Bleeding Events in COMMIT % patients Type of Bleeding Plavix + aspirin n=22961 Placebo + aspirin n=22891 p-value Major Major bleeds were cerebral bleeds or noncerebral bleeds thought to have caused death or that required transfusion.\"\n },\n {\n \"VerbatimTerm\": \"cerebral bleeding\",\n \"Probability\": \"0.9282174706\",\n \"SemanticContext\": \"noncerebral or cerebral bleeding 0.6 0.5 0.59 Major noncerebral 0.4 0.3 0.48 Fatal 0.2 0.2 0.90 Hemorrhagic stroke 0.2 0.2 0.91 Fatal 0.2 0.2 0.81 Other noncerebral bleeding nonmajor 3.6 3.1 0.005 Any noncerebral bleeding 3.9 3.4 0.004 .\"\n }\n ]\n },\n {\n \"Term\": \"Hypotension\",\n \"MEDDRACode\": \"10021097\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hypotension\",\n \"Probability\": \"0.9901586771\",\n \"SemanticContext\": \"Blood and lymphatic system disorders: Agranulocytosis, aplastic anemia/pancytopenia, thrombotic thrombocytopenic purpura TTP , acquired hemophilia A Gastrointestinal disorders: Colitis including ulcerative or lymphocytic colitis , pancreatitis, stomatitis, gastric/duodenal ulcer, diarrhea General disorders and administration site condition: Fever Hepatobiliary disorders: Acute liver failure, hepatitis noninfectious , abnormal liver function test Immune system disorders: Hypersensitivity reactions, anaphylactoid reactions, serum sickness, insulin autoimmune syndrome, which can lead to severe hypoglycemia Musculoskeletal, connective tissue and bone disorders: Myalgia, arthralgia, arthritis Nervous system disorders: Taste disorders, headache, ageusia Psychiatric disorders: Confusion, hallucinations Respiratory, thoracic and mediastinal disorders: Bronchospasm, interstitial pneumonitis, eosinophilic pneumonia Renal and urinary disorders: Increased creatinine levels Skin and subcutaneous tissue disorders: Maculopapular, erythematous or exfoliative rash, urticaria, bullous dermatitis, eczema, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis AGEP , angioedema, drug-induced hypersensitivity syndrome, drug rash with eosinophilia and systemic symptoms DRESS , erythema multiforme, lichen planus, generalized pruritus Vascular disorders: Vasculitis, hypotension\"\n }\n ]\n },\n {\n \"Term\": \"Chromaturia\",\n \"MEDDRACode\": \"10008796\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"urine red\",\n \"Probability\": \"0.0008813441\",\n \"SemanticContext\": \"While you take Plavix: you may bruise and bleed more easily you are more likely to have nose bleeds it will take longer for any bleeding to stop Call your doctor right away if you have any of these signs or symptoms of bleeding: unexpected bleeding or bleeding that lasts a long time blood in your urine pink, red or brown urine red or black stools looks like tar bruises that happen without a known cause or get larger cough up blood or blood clots vomit blood or your vomit looks like coffee grounds Do not stop taking Plavix without talking to the doctor who prescribes it for you.\"\n }\n ]\n },\n {\n \"Term\": \"Faeces discoloured\",\n \"MEDDRACode\": \"10016100\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"black stools\",\n \"Probability\": \"0.0002076924\",\n \"SemanticContext\": \"While you take Plavix: you may bruise and bleed more easily you are more likely to have nose bleeds it will take longer for any bleeding to stop Call your doctor right away if you have any of these signs or symptoms of bleeding: unexpected bleeding or bleeding that lasts a long time blood in your urine pink, red or brown urine red or black stools looks like tar bruises that happen without a known cause or get larger cough up blood or blood clots vomit blood or your vomit looks like coffee grounds Do not stop taking Plavix without talking to the doctor who prescribes it for you.\"\n }\n ]\n },\n {\n \"Term\": \"Phytotherapy\",\n \"MEDDRACode\": \"10063339\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"herbal supplements\",\n \"Probability\": \"4.7968E-06\",\n \"SemanticContext\": \"Tell your doctor about all the medicines you take , including prescription, non-prescription medicines, vitamins and herbal supplements.\"\n }\n ]\n },\n {\n \"Term\": \"Platelet transfusion\",\n \"MEDDRACode\": \"10035543\",\n \"Overdose\": true,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"platelet transfusion\",\n \"Probability\": \"0.0086185634\",\n \"SemanticContext\": \"Based on biological plausibility, platelet transfusion may restore clotting ability.\"\n },\n {\n \"VerbatimTerm\": \"platelet transfusions\",\n \"Probability\": \"0.0020447671\",\n \"SemanticContext\": \"Because the half-life of clopidogrel's active metabolite is short, it may be possible to restore hemostasis by administering exogenous platelets; however, platelet transfusions within 4 hours of the loading dose or 2 hours of the maintenance dose may be less effective.\"\n }\n ]\n },\n {\n \"Term\": \"Congenital anomaly\",\n \"MEDDRACode\": \"10010356\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"birth defects\",\n \"Probability\": \"0.0303801298\",\n \"SemanticContext\": \"8.1 Pregnancy Risk Summary Available data from cases reported in published literature and postmarketing surveillance with clopidogrel use in pregnant women have not identified any drug-associated risks for major birth defects or miscarriage [see Data ] .\"\n },\n {\n \"VerbatimTerm\": \"birth defects\",\n \"Probability\": \"0.1230043173\",\n \"SemanticContext\": \"The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown.\"\n },\n {\n \"VerbatimTerm\": \"birth defects\",\n \"Probability\": \"0.0922400653\",\n \"SemanticContext\": \"All pregnancies have a background risk of birth defects, loss, or other adverse outcomes.\"\n },\n {\n \"VerbatimTerm\": \"birth defects\",\n \"Probability\": \"0.0811973214\",\n \"SemanticContext\": \"In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.\"\n },\n {\n \"VerbatimTerm\": \"birth defects\",\n \"Probability\": \"0.0529331565\",\n \"SemanticContext\": \"Data Human data The available data from published case reports over two decades of postmarketing use have not identified an association with clopidogrel use in pregnancy and major birth defects, miscarriage, or adverse fetal outcomes.\"\n }\n ]\n },\n {\n \"Term\": \"Lymphadenopathy\",\n \"MEDDRACode\": \"10025197\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"ADP\",\n \"Probability\": \"0.0439839959\",\n \"SemanticContext\": \"11 DESCRIPTION Plavix clopidogrel tablets is a thienopyridine class inhibitor of P2Y 12 ADP platelet receptors.\"\n },\n {\n \"VerbatimTerm\": \"ADP\",\n \"Probability\": \"0.3808053136\",\n \"SemanticContext\": \"Chemical Structure 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Clopidogrel is an inhibitor of platelet activation and aggregation through the irreversible binding of its active metabolite to the P2Y 12 class of ADP receptors on platelets.\"\n },\n {\n \"VerbatimTerm\": \"ADP\",\n \"Probability\": \"0.3208052516\",\n \"SemanticContext\": \"The active metabolite of clopidogrel selectively inhibits the binding of adenosine diphosphate ADP to its platelet P2Y 12 receptor and the subsequent ADP-mediated activation of the glycoprotein GPIIb/IIIa complex, thereby inhibiting platelet aggregation.\"\n },\n {\n \"VerbatimTerm\": \"ADP\",\n \"Probability\": \"0.307879746\",\n \"SemanticContext\": \"The active metabolite of clopidogrel selectively inhibits the binding of adenosine diphosphate ADP to its platelet P2Y 12 receptor and the subsequent ADP-mediated activation of the glycoprotein GPIIb/IIIa complex, thereby inhibiting platelet aggregation.\"\n },\n {\n \"VerbatimTerm\": \"ADP\",\n \"Probability\": \"0.2603496909\",\n \"SemanticContext\": \"Platelet aggregation induced by agonists other than ADP is also inhibited by blocking the amplification of platelet activation by released ADP.\"\n },\n {\n \"VerbatimTerm\": \"ADP\",\n \"Probability\": \"0.1173674464\",\n \"SemanticContext\": \"Platelet aggregation induced by agonists other than ADP is also inhibited by blocking the amplification of platelet activation by released ADP.\"\n },\n {\n \"VerbatimTerm\": \"ADP\",\n \"Probability\": \"0.3428119421\",\n \"SemanticContext\": \"Repeated doses of 75 mg Plavix per day inhibit ADP-induced platelet aggregation on the first day, and inhibition reaches steady state between Day 3 and Day 7.\"\n },\n {\n \"VerbatimTerm\": \"ADP\",\n \"Probability\": \"0.8103458285\",\n \"SemanticContext\": \"Renally Impaired Patients After repeated doses of 75 mg Plavix per day, patients with severe renal impairment creatinine clearance from 5 to 15 mL/min and moderate renal impairment creatinine clearance from 30 to 60 mL/min showed low 25% inhibition of ADP-induced platelet aggregation.\"\n },\n {\n \"VerbatimTerm\": \"ADP\",\n \"Probability\": \"0.8541935682\",\n \"SemanticContext\": \"Hepatically Impaired Patients After repeated doses of 75 mg Plavix per day for 10 days in patients with severe hepatic impairment, inhibition of ADP-induced platelet aggregation was similar to that observed in healthy subjects.\"\n },\n {\n \"VerbatimTerm\": \"ADP\",\n \"Probability\": \"0.9154211283\",\n \"SemanticContext\": \"Gender In a small study comparing men and women, less inhibition of ADP-induced platelet aggregation was observed in women.\"\n },\n {\n \"VerbatimTerm\": \"ADP\",\n \"Probability\": \"0.5316134095\",\n \"SemanticContext\": \"In a study in healthy male subjects when Plavix 75 mg per day was given with a standard breakfast, mean inhibition of ADP-induced platelet aggregation was reduced by less than 9%.\"\n },\n {\n \"VerbatimTerm\": \"ADP\",\n \"Probability\": \"0.7804009914\",\n \"SemanticContext\": \"C max ng/mL 300 mg 24 h 11 4 23 11 32 21 24 10 600 mg 24 h 17 6 39 23 44 27 36 13 75 mg Day 5 4 1 12 5 13 7 12 6 150 mg Day 5 7 2 18 7 19 5 16 9 IPA % Inhibition of platelet aggregation with 5 mcM ADP; larger value indicates greater platelet inhibition.\"\n }\n ]\n },\n {\n \"Term\": \"Myocardial necrosis marker\",\n \"MEDDRACode\": \"10075210\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"cardiac enzymes\",\n \"Probability\": \"0.0003234744\",\n \"SemanticContext\": \"Patients were required to have either ECG changes compatible with new ischemia without ST-elevation or elevated cardiac enzymes or troponin I or T to at least twice the upper limit of normal.\"\n }\n ]\n },\n {\n \"Term\": \"Hepatic function abnormal\",\n \"MEDDRACode\": \"10019670\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hepatic impairment\",\n \"Probability\": \"0.1543940306\",\n \"SemanticContext\": \"Hepatically Impaired Patients After repeated doses of 75 mg Plavix per day for 10 days in patients with severe hepatic impairment, inhibition of ADP-induced platelet aggregation was similar to that observed in healthy subjects.\"\n }\n ]\n },\n {\n \"Term\": \"Ischaemic stroke\",\n \"MEDDRACode\": \"10061256\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"ischemic stroke\",\n \"Probability\": \"0.0373215973\",\n \"SemanticContext\": \"To be eligible to enroll, patients had to have: 1 recent history of myocardial infarction within 35 days ; 2 recent histories of ischemic stroke within 6 months with at least a week of residual neurological signs; and/or 3 established peripheral arterial disease PAD .\"\n },\n {\n \"VerbatimTerm\": \"ischemic stroke\",\n \"Probability\": \"0.2445976138\",\n \"SemanticContext\": \"The trial's primary outcome was the time to first occurrence of new ischemic stroke fatal or not , new myocardial infarction fatal or not , or other vascular death.\"\n },\n {\n \"VerbatimTerm\": \"Ischemic stroke\",\n \"Probability\": \"0.4673937857\",\n \"SemanticContext\": \"Table 6: Outcome Events in the CAPRIE Primary Analysis Patients Plavix n=9599 Aspirin n=9586 Ischemic stroke fatal or not 438 4.6% 461 4.8% MI fatal or not 275 2.9% 333 3.5% Other vascular death 226 2.4% 226 2.4% Total 939 9.8% 1020 10.6% .\"\n },\n {\n \"VerbatimTerm\": \"ischemic strokes\",\n \"Probability\": \"0.3667013049\",\n \"SemanticContext\": \"Similar results were obtained when all-cause mortality and all-cause strokes were counted instead of vascular mortality and ischemic strokes risk reduction 6.9% .\"\n }\n ]\n },\n {\n \"Term\": \"Contusion\",\n \"MEDDRACode\": \"10050584\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"bruise\",\n \"Probability\": \"0.9962245226\",\n \"SemanticContext\": \"Other bleeding events that were reported more frequently in the clopidogrel group were epistaxis, hematuria, and bruise.\"\n },\n {\n \"VerbatimTerm\": \"bruise\",\n \"Probability\": \"0.0042572021\",\n \"SemanticContext\": \"Bleeding Advise patients that they: will bruise and bleed more easily will take longer than usual to stop bleeding must report any unanticipated, prolonged, or excessive bleeding, or blood in their stool or urine [see Warnings and Precautions 5.2 ] Thrombotic Thrombocytopenic Purpura Instruct patients to get prompt medical attention if they experience symptoms of TTP that cannot otherwise be explained [see Warnings and Precautions 5.4 ] .\"\n },\n {\n \"VerbatimTerm\": \"bruise\",\n \"Probability\": \"6.11758E-05\",\n \"SemanticContext\": \"While you take Plavix: you may bruise and bleed more easily you are more likely to have nose bleeds it will take longer for any bleeding to stop Call your doctor right away if you have any of these signs or symptoms of bleeding: unexpected bleeding or bleeding that lasts a long time blood in your urine pink, red or brown urine red or black stools looks like tar bruises that happen without a known cause or get larger cough up blood or blood clots vomit blood or your vomit looks like coffee grounds Do not stop taking Plavix without talking to the doctor who prescribes it for you.\"\n },\n {\n \"VerbatimTerm\": \"bruises\",\n \"Probability\": \"0.0046747923\",\n \"SemanticContext\": \"While you take Plavix: you may bruise and bleed more easily you are more likely to have nose bleeds it will take longer for any bleeding to stop Call your doctor right away if you have any of these signs or symptoms of bleeding: unexpected bleeding or bleeding that lasts a long time blood in your urine pink, red or brown urine red or black stools looks like tar bruises that happen without a known cause or get larger cough up blood or blood clots vomit blood or your vomit looks like coffee grounds Do not stop taking Plavix without talking to the doctor who prescribes it for you.\"\n }\n ]\n },\n {\n \"Term\": \"Angioedema\",\n \"MEDDRACode\": \"10002424\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"angioedema\",\n \"Probability\": \"0.890619278\",\n \"SemanticContext\": \"Blood and lymphatic system disorders: Agranulocytosis, aplastic anemia/pancytopenia, thrombotic thrombocytopenic purpura TTP , acquired hemophilia A Gastrointestinal disorders: Colitis including ulcerative or lymphocytic colitis , pancreatitis, stomatitis, gastric/duodenal ulcer, diarrhea General disorders and administration site condition: Fever Hepatobiliary disorders: Acute liver failure, hepatitis noninfectious , abnormal liver function test Immune system disorders: Hypersensitivity reactions, anaphylactoid reactions, serum sickness, insulin autoimmune syndrome, which can lead to severe hypoglycemia Musculoskeletal, connective tissue and bone disorders: Myalgia, arthralgia, arthritis Nervous system disorders: Taste disorders, headache, ageusia Psychiatric disorders: Confusion, hallucinations Respiratory, thoracic and mediastinal disorders: Bronchospasm, interstitial pneumonitis, eosinophilic pneumonia Renal and urinary disorders: Increased creatinine levels Skin and subcutaneous tissue disorders: Maculopapular, erythematous or exfoliative rash, urticaria, bullous dermatitis, eczema, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis AGEP , angioedema, drug-induced hypersensitivity syndrome, drug rash with eosinophilia and systemic symptoms DRESS , erythema multiforme, lichen planus, generalized pruritus Vascular disorders: Vasculitis, hypotension\"\n },\n {\n \"VerbatimTerm\": \"angioedema\",\n \"Probability\": \"0.9783755541\",\n \"SemanticContext\": \"5.5 Cross-Reactivity among Thienopyridines Hypersensitivity including rash, angioedema or hematologic reaction has been reported in patients receiving Plavix, including patients with a history of hypersensitivity or hematologic reaction to other thienopyridines [see Contraindications 4.2 and Adverse Reactions 6.2 ] .\"\n }\n ]\n },\n {\n \"Term\": \"Insulin autoimmune syndrome\",\n \"MEDDRACode\": \"10022472\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"insulin autoimmune syndrome\",\n \"Probability\": \"0.9842771292\",\n \"SemanticContext\": \"Blood and lymphatic system disorders: Agranulocytosis, aplastic anemia/pancytopenia, thrombotic thrombocytopenic purpura TTP , acquired hemophilia A Gastrointestinal disorders: Colitis including ulcerative or lymphocytic colitis , pancreatitis, stomatitis, gastric/duodenal ulcer, diarrhea General disorders and administration site condition: Fever Hepatobiliary disorders: Acute liver failure, hepatitis noninfectious , abnormal liver function test Immune system disorders: Hypersensitivity reactions, anaphylactoid reactions, serum sickness, insulin autoimmune syndrome, which can lead to severe hypoglycemia Musculoskeletal, connective tissue and bone disorders: Myalgia, arthralgia, arthritis Nervous system disorders: Taste disorders, headache, ageusia Psychiatric disorders: Confusion, hallucinations Respiratory, thoracic and mediastinal disorders: Bronchospasm, interstitial pneumonitis, eosinophilic pneumonia Renal and urinary disorders: Increased creatinine levels Skin and subcutaneous tissue disorders: Maculopapular, erythematous or exfoliative rash, urticaria, bullous dermatitis, eczema, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis AGEP , angioedema, drug-induced hypersensitivity syndrome, drug rash with eosinophilia and systemic symptoms DRESS , erythema multiforme, lichen planus, generalized pruritus Vascular disorders: Vasculitis, hypotension\"\n }\n ]\n },\n {\n \"Term\": \"Norepinephrine\",\n \"MEDDRACode\": \"10050925\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"norepinephrine\",\n \"Probability\": \"0.0483627319\",\n \"SemanticContext\": \"Nonsteroidal anti-inflammatory drugs NSAIDs , warfarin, selective serotonin and serotonin norepinephrine reuptake inhibitors SSRIs, SNRIs : Increases risk of bleeding.\"\n },\n {\n \"VerbatimTerm\": \"norepinephrine\",\n \"Probability\": \"0.0157415569\",\n \"SemanticContext\": \"7.6 SSRIs and SNRIs Since selective serotonin reuptake inhibitors SSRIs and serotonin norepinephrine reuptake inhibitors SNRIs affect platelet activation, the concomitant administration of SSRIs and SNRIs with clopidogrel may increase the risk of bleeding.\"\n },\n {\n \"VerbatimTerm\": \"norepinephrine\",\n \"Probability\": \"0.0232703388\",\n \"SemanticContext\": \"selective serotonin reuptake inhibitors SSRIs and serotonin norepinephrine reuptake inhibitors SNRIs .\"\n }\n ]\n },\n {\n \"Term\": \"Heart rate\",\n \"MEDDRACode\": \"10019299\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"heart rate\",\n \"Probability\": \"0.000333041\",\n \"SemanticContext\": \"Get medical help right away if you have any of these symptoms and they cannot be explained by another medical condition: purplish spots called purpura on the skin or in the mouth mucous membranes due to bleeding under the skin your skin or the whites of your eyes are yellow jaundice you feel tired or weak your skin looks very pale fever fast heart rate or feeling short of breath headache speech changes confusion coma stroke seizure low amount of urine, or urine that is pink or has blood in it stomach area abdominal pain nausea, vomiting, or diarrhea vision changes persistent low blood sugar symptoms Tell your doctor if you have any side effect that bothers you or that does not go away.\"\n }\n ]\n },\n {\n \"Term\": \"Pregnancy\",\n \"MEDDRACode\": \"10036556\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"pregnant\",\n \"Probability\": \"0.0103626549\",\n \"SemanticContext\": \"8.1 Pregnancy Risk Summary Available data from cases reported in published literature and postmarketing surveillance with clopidogrel use in pregnant women have not identified any drug-associated risks for major birth defects or miscarriage [see Data ] .\"\n },\n {\n \"VerbatimTerm\": \"pregnant\",\n \"Probability\": \"0.0067235231\",\n \"SemanticContext\": \"There are risks to the pregnant woman and fetus associated with myocardial infarction and stroke [see Clinical Considerations ] .\"\n },\n {\n \"VerbatimTerm\": \"pregnant\",\n \"Probability\": \"0.0002432466\",\n \"SemanticContext\": \"No evidence of fetotoxicity was observed when clopidogrel was administered to pregnant rats and rabbits during organogenesis at doses corresponding to 65 and 78 times the recommended daily human dose [see Data ] .\"\n },\n {\n \"VerbatimTerm\": \"pregnant\",\n \"Probability\": \"0.0002259016\",\n \"SemanticContext\": \"Therapy for the pregnant woman should not be withheld because of potential concerns regarding the effects of clopidogrel on the fetus.\"\n },\n {\n \"VerbatimTerm\": \"pregnant\",\n \"Probability\": \"0.0009138882\",\n \"SemanticContext\": \"Animal data Embryo-fetal developmental toxicology studies were performed in pregnant rats and rabbits with doses up to 500 and 300 mg/kg/day, respectively, administered during organogenesis.\"\n },\n {\n \"VerbatimTerm\": \"pregnant\",\n \"Probability\": \"0.0007160008\",\n \"SemanticContext\": \"are pregnant or plan to become pregnant.\"\n }\n ]\n },\n {\n \"Term\": \"Euphoric mood\",\n \"MEDDRACode\": \"10015535\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"high\",\n \"Probability\": \"0.0010814667\",\n \"SemanticContext\": \"Similar results were observed when a Plavix 300 mg loading dose was administered with a high-fat breakfast.\"\n },\n {\n \"VerbatimTerm\": \"high\",\n \"Probability\": \"0.0020379722\",\n \"SemanticContext\": \"The C max of the active metabolite is twice as high following a single 300 mg clopidogrel loading dose as it is after four days of 75 mg maintenance dose.\"\n },\n {\n \"VerbatimTerm\": \"high\",\n \"Probability\": \"0.0001058775\",\n \"SemanticContext\": \"However, at high concentrations in vitro , clopidogrel inhibits CYP2C9.\"\n },\n {\n \"VerbatimTerm\": \"higher\",\n \"Probability\": \"0.0005195141\",\n \"SemanticContext\": \"Mean inhibition of platelet aggregation at 4 hours post dose was 34% higher in the presence of rifampin compared to clopidogrel administered alone.\"\n },\n {\n \"VerbatimTerm\": \"higher\",\n \"Probability\": \"0.0010894537\",\n \"SemanticContext\": \"Mean platelet aggregation was higher up to 2 to 4 hours with morphine coadministration.\"\n },\n {\n \"VerbatimTerm\": \"higher\",\n \"Probability\": \"0.001920253\",\n \"SemanticContext\": \"Approximately 2% of White and 4% of Black patients are poor metabolizers; the prevalence of poor metabolism is higher in Asian patients e.g., 14% of Chinese .\"\n },\n {\n \"VerbatimTerm\": \"higher\",\n \"Probability\": \"3.3232E-06\",\n \"SemanticContext\": \"People who stop taking Plavix too soon have a higher risk of having a heart attack or dying.\"\n },\n {\n \"VerbatimTerm\": \"higher\",\n \"Probability\": \"9.05969E-05\",\n \"SemanticContext\": \"If you must stop Plavix because of bleeding, your risk of a heart attack may be higher.\"\n },\n {\n \"VerbatimTerm\": \"highest\",\n \"Probability\": \"0.0052726567\",\n \"SemanticContext\": \"Figure 1: Exposure to Clopidogrel Active Metabolite Following Multiple Doses of Plavix 75 mg Alone or with Proton Pump Inhibitors PPIs Pharmacodynamic and pharmacokinetic parameters measured in these studies showed that the interaction was highest with omeprazole and least with dexlansoprazole.\"\n }\n ]\n },\n {\n \"Term\": \"Platelet aggregation test\",\n \"MEDDRACode\": \"10084286\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"platelet aggregation\",\n \"Probability\": \"0.0045799315\",\n \"SemanticContext\": \"12.2 Pharmacodynamics Clopidogrel must be metabolized by CYP450 enzymes to produce the active metabolite that inhibits platelet aggregation.\"\n },\n {\n \"VerbatimTerm\": \"platelet aggregation\",\n \"Probability\": \"0.0044421554\",\n \"SemanticContext\": \"The active metabolite of clopidogrel selectively inhibits the binding of adenosine diphosphate ADP to its platelet P2Y 12 receptor and the subsequent ADP-mediated activation of the glycoprotein GPIIb/IIIa complex, thereby inhibiting platelet aggregation.\"\n },\n {\n \"VerbatimTerm\": \"platelet aggregation\",\n \"Probability\": \"0.0021621585\",\n \"SemanticContext\": \"Dose-dependent inhibition of platelet aggregation can be seen 2 hours after single oral doses of Plavix.\"\n },\n {\n \"VerbatimTerm\": \"platelet aggregation\",\n \"Probability\": \"0.000834316\",\n \"SemanticContext\": \"Repeated doses of 75 mg Plavix per day inhibit ADP-induced platelet aggregation on the first day, and inhibition reaches steady state between Day 3 and Day 7.\"\n },\n {\n \"VerbatimTerm\": \"platelet aggregation\",\n \"Probability\": \"0.0118410587\",\n \"SemanticContext\": \"Geriatric Patients Elderly =75 years and young healthy subjects had similar effects on platelet aggregation.\"\n },\n {\n \"VerbatimTerm\": \"platelet aggregation\",\n \"Probability\": \"0.0125222802\",\n \"SemanticContext\": \"Renally Impaired Patients After repeated doses of 75 mg Plavix per day, patients with severe renal impairment creatinine clearance from 5 to 15 mL/min and moderate renal impairment creatinine clearance from 30 to 60 mL/min showed low 25% inhibition of ADP-induced platelet aggregation.\"\n },\n {\n \"VerbatimTerm\": \"platelet aggregation\",\n \"Probability\": \"0.1247216761\",\n \"SemanticContext\": \"Hepatically Impaired Patients After repeated doses of 75 mg Plavix per day for 10 days in patients with severe hepatic impairment, inhibition of ADP-induced platelet aggregation was similar to that observed in healthy subjects.\"\n },\n {\n \"VerbatimTerm\": \"platelet aggregation\",\n \"Probability\": \"0.0641160607\",\n \"SemanticContext\": \"Gender In a small study comparing men and women, less inhibition of ADP-induced platelet aggregation was observed in women.\"\n },\n {\n \"VerbatimTerm\": \"platelet aggregation\",\n \"Probability\": \"0.0081897378\",\n \"SemanticContext\": \"In a study in healthy male subjects when Plavix 75 mg per day was given with a standard breakfast, mean inhibition of ADP-induced platelet aggregation was reduced by less than 9%.\"\n },\n {\n \"VerbatimTerm\": \"platelet aggregation\",\n \"Probability\": \"0.0007877052\",\n \"SemanticContext\": \"The active thiol metabolite binds rapidly and irreversibly to platelet receptors, thus inhibiting platelet aggregation for the lifespan of the platelet.\"\n },\n {\n \"VerbatimTerm\": \"platelet aggregation\",\n \"Probability\": \"0.0029977858\",\n \"SemanticContext\": \"Mean inhibition of platelet aggregation at 4 hours post dose was 34% higher in the presence of rifampin compared to clopidogrel administered alone.\"\n },\n {\n \"VerbatimTerm\": \"platelet aggregation\",\n \"Probability\": \"0.0001793504\",\n \"SemanticContext\": \"Mean platelet aggregation was higher up to 2 to 4 hours with morphine coadministration.\"\n },\n {\n \"VerbatimTerm\": \"platelet aggregation\",\n \"Probability\": \"3.99012E-05\",\n \"SemanticContext\": \"Clopidogrel active metabolite pharmacokinetics and antiplatelet effects, as measured by ex vivo platelet aggregation assays, differ according to CYP2C19 genotype.\"\n },\n {\n \"VerbatimTerm\": \"platelet aggregation\",\n \"Probability\": \"0.1179459393\",\n \"SemanticContext\": \"Decreased active metabolite exposure and diminished inhibition of platelet aggregation were observed in the poor metabolizers as compared to the other groups.\"\n },\n {\n \"VerbatimTerm\": \"platelet aggregation\",\n \"Probability\": \"0.0042560399\",\n \"SemanticContext\": \"C max ng/mL 300 mg 24 h 11 4 23 11 32 21 24 10 600 mg 24 h 17 6 39 23 44 27 36 13 75 mg Day 5 4 1 12 5 13 7 12 6 150 mg Day 5 7 2 18 7 19 5 16 9 IPA % Inhibition of platelet aggregation with 5 mcM ADP; larger value indicates greater platelet inhibition.\"\n },\n {\n \"VerbatimTerm\": \"platelet aggregation\",\n \"Probability\": \"0.0008664429\",\n \"SemanticContext\": \"Inhibition of platelet aggregation by clopidogrel is achieved through an active metabolite.\"\n },\n {\n \"VerbatimTerm\": \"platelet aggregation\",\n \"Probability\": \"0.0042732656\",\n \"SemanticContext\": \"P2Y12 inhibitors thienopyridines , inhibit platelet aggregation for the lifetime of the platelet 7--10 days .\"\n },\n {\n \"VerbatimTerm\": \"Platelet aggregation\",\n \"Probability\": \"0.0055781007\",\n \"SemanticContext\": \"Platelet aggregation induced by agonists other than ADP is also inhibited by blocking the amplification of platelet activation by released ADP.\"\n },\n {\n \"VerbatimTerm\": \"Platelet aggregation\",\n \"Probability\": \"0.0143364668\",\n \"SemanticContext\": \"Platelet aggregation and bleeding time gradually return to baseline values after treatment is discontinued, generally in about 5 days.\"\n }\n ]\n },\n {\n \"Term\": \"Blood glucose\",\n \"MEDDRACode\": \"10005553\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"glucose\",\n \"Probability\": \"2.93459E-05\",\n \"SemanticContext\": \"Increased frequency of glucose monitoring may be required during concomitant use.\"\n }\n ]\n },\n {\n \"Term\": \"Emotional distress\",\n \"MEDDRACode\": \"10049119\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"suffered\",\n \"Probability\": \"0.8524371982\",\n \"SemanticContext\": \"Table 5: Outcome Events in COMMIT Event Plavix + aspirin N=22961 Placebo + aspirin N=22891 Odds ratio 95% CI p-value Composite endpoint: Death, MI, or Stroke 9 patients 2 clopidogrel and 7 placebo suffered both a nonfatal stroke and a nonfatal MI.\"\n }\n ]\n },\n {\n \"Term\": \"Anaphylactic reaction\",\n \"MEDDRACode\": \"10002198\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": true,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"anaphylaxis\",\n \"Probability\": \"0.7738231421\",\n \"SemanticContext\": \"4.2 Hypersensitivity Plavix is contraindicated in patients with hypersensitivity e.g., anaphylaxis to clopidogrel or any component of the product [see Adverse Reactions 6.2 ] .\"\n }\n ]\n },\n {\n \"Term\": \"No adverse event\",\n \"MEDDRACode\": \"10067482\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": true,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"No adverse effects\",\n \"Probability\": \"0.0009956658\",\n \"SemanticContext\": \"No adverse effects on breastfed infants have been observed with maternal clopidogrel use during lactation in a small number of postmarketing cases.\"\n }\n ]\n },\n {\n \"Term\": \"Nausea\",\n \"MEDDRACode\": \"10028813\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"nausea\",\n \"Probability\": \"0.0016857982\",\n \"SemanticContext\": \"Get medical help right away if you have any of these symptoms and they cannot be explained by another medical condition: purplish spots called purpura on the skin or in the mouth mucous membranes due to bleeding under the skin your skin or the whites of your eyes are yellow jaundice you feel tired or weak your skin looks very pale fever fast heart rate or feeling short of breath headache speech changes confusion coma stroke seizure low amount of urine, or urine that is pink or has blood in it stomach area abdominal pain nausea, vomiting, or diarrhea vision changes persistent low blood sugar symptoms Tell your doctor if you have any side effect that bothers you or that does not go away.\"\n }\n ]\n },\n {\n \"Term\": \"Dyspnoea\",\n \"MEDDRACode\": \"10013968\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"short of breath\",\n \"Probability\": \"0.0061486363\",\n \"SemanticContext\": \"Get medical help right away if you have any of these symptoms and they cannot be explained by another medical condition: purplish spots called purpura on the skin or in the mouth mucous membranes due to bleeding under the skin your skin or the whites of your eyes are yellow jaundice you feel tired or weak your skin looks very pale fever fast heart rate or feeling short of breath headache speech changes confusion coma stroke seizure low amount of urine, or urine that is pink or has blood in it stomach area abdominal pain nausea, vomiting, or diarrhea vision changes persistent low blood sugar symptoms Tell your doctor if you have any side effect that bothers you or that does not go away.\"\n }\n ]\n },\n {\n \"Term\": \"Ultrasound scan\",\n \"MEDDRACode\": \"10045434\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"U.S.\",\n \"Probability\": \"3.79572E-05\",\n \"SemanticContext\": \"PLAVIX ® clopidogrel tablets for oral use Initial U.S. Approval: 1997 WARNING: DIMINISHED ANTIPLATELET EFFECT IN PATIENTS WITH TWO LOSS-OF-FUNCTION ALLELES OF THE CYP2C19 GENE See full prescribing information for complete boxed warning.\"\n },\n {\n \"VerbatimTerm\": \"U.S.\",\n \"Probability\": \"0.0001907051\",\n \"SemanticContext\": \"In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.\"\n },\n {\n \"VerbatimTerm\": \"U.S.\",\n \"Probability\": \"0.0001446605\",\n \"SemanticContext\": \"Active ingredient: clopidogrel bisulfate Inactive ingredients: Tablet: hydrogenated castor oil, hydroxypropyl cellulose, mannitol, microcrystalline cellulose, polyethylene glycol 6000 Film coating: ferric oxide, hypromellose 2910, lactose monohydrate, titanium dioxide, triacetin, Carnauba wax This Medication Guide has been approved by the U.S. Food and Drug Administration.\"\n }\n ]\n },\n {\n \"Term\": \"Haematemesis\",\n \"MEDDRACode\": \"10018830\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"vomit blood\",\n \"Probability\": \"3.3167E-06\",\n \"SemanticContext\": \"While you take Plavix: you may bruise and bleed more easily you are more likely to have nose bleeds it will take longer for any bleeding to stop Call your doctor right away if you have any of these signs or symptoms of bleeding: unexpected bleeding or bleeding that lasts a long time blood in your urine pink, red or brown urine red or black stools looks like tar bruises that happen without a known cause or get larger cough up blood or blood clots vomit blood or your vomit looks like coffee grounds Do not stop taking Plavix without talking to the doctor who prescribes it for you.\"\n }\n ]\n },\n {\n \"Term\": \"Breast feeding\",\n \"MEDDRACode\": \"10006247\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": true,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"breastfeeding\",\n \"Probability\": \"5.73666E-05\",\n \"SemanticContext\": \"are breastfeeding or plan to breastfeed.\"\n },\n {\n \"VerbatimTerm\": \"breastfeeding\",\n \"Probability\": \"1.4482E-06\",\n \"SemanticContext\": \"A decision should be made with your healthcare provider to avoid or discontinue breastfeeding when continuing Plavix is needed.\"\n },\n {\n \"VerbatimTerm\": \"breastfeeding\",\n \"Probability\": \"8.32321E-05\",\n \"SemanticContext\": \"The developmental and health benefits of breastfeeding should be considered along with mother's clinical need for Plavix and any potential adverse effects on the breastfed infant from Plavix or from underlying maternal condition.\"\n },\n {\n \"VerbatimTerm\": \"breastfed\",\n \"Probability\": \"0.0009042025\",\n \"SemanticContext\": \"No adverse effects on breastfed infants have been observed with maternal clopidogrel use during lactation in a small number of postmarketing cases.\"\n },\n {\n \"VerbatimTerm\": \"breastfed\",\n \"Probability\": \"3.99092E-05\",\n \"SemanticContext\": \"The developmental and health benefits of breastfeeding should be considered along with mother's clinical need for Plavix and any potential adverse effects on the breastfed infant from Plavix or from underlying maternal condition.\"\n }\n ]\n },\n {\n \"Term\": \"Gene mutation\",\n \"MEDDRACode\": \"10064571\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"gene mutation\",\n \"Probability\": \"0.0001237094\",\n \"SemanticContext\": \"Clopidogrel was not genotoxic in four in vitro tests Ames test, DNA-repair test in rat hepatocytes, gene mutation assay in Chinese hamster fibroblasts, and metaphase chromosome analysis of human lymphocytes and in one in vivo test micronucleus test by oral route in mice .\"\n }\n ]\n },\n {\n \"Term\": \"Overdose\",\n \"MEDDRACode\": \"10033295\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Overdose\",\n \"Probability\": \"0.222651124\",\n \"SemanticContext\": \"Overdose following clopidogrel administration may result in bleeding complications.\"\n }\n ]\n },\n {\n \"Term\": \"Therapeutic procedure\",\n \"MEDDRACode\": \"10053757\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Invasive Procedures\",\n \"Probability\": \"0.0005051494\",\n \"SemanticContext\": \"Invasive Procedures Advise patients to inform physicians and dentists that they are taking Plavix before any surgery or dental procedure [see Warnings and Precautions 5.2 , 5.3 ] .\"\n },\n {\n \"VerbatimTerm\": \"invasive procedure\",\n \"Probability\": \"8.002E-07\",\n \"SemanticContext\": \"They should talk to the doctor who prescribed Plavix for you before you have any surgery or invasive procedure.\"\n }\n ]\n },\n {\n \"Term\": \"Heart disease congenital\",\n \"MEDDRACode\": \"10019273\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"congenital heart disease\",\n \"Probability\": \"0.0018433928\",\n \"SemanticContext\": \"A randomized, placebo-controlled trial CLARINET did not demonstrate a clinical benefit of clopidogrel in neonates and infants with cyanotic congenital heart disease palliated with a systemic-to-pulmonary arterial shunt.\"\n }\n ]\n },\n {\n \"Term\": \"Coagulopathy\",\n \"MEDDRACode\": \"10009802\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"clotting\",\n \"Probability\": \"0.0142088234\",\n \"SemanticContext\": \"Based on biological plausibility, platelet transfusion may restore clotting ability.\"\n },\n {\n \"VerbatimTerm\": \"clot\",\n \"Probability\": \"0.0037913322\",\n \"SemanticContext\": \"Plavix helps to prevent platelets from sticking together and forming a clot that can block an artery.\"\n }\n ]\n },\n {\n \"Term\": \"Lymphocyte count\",\n \"MEDDRACode\": \"10025251\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"lymphocytes\",\n \"Probability\": \"0.0001171546\",\n \"SemanticContext\": \"Clopidogrel was not genotoxic in four in vitro tests Ames test, DNA-repair test in rat hepatocytes, gene mutation assay in Chinese hamster fibroblasts, and metaphase chromosome analysis of human lymphocytes and in one in vivo test micronucleus test by oral route in mice .\"\n }\n ]\n },\n {\n \"Term\": \"Therapy interrupted\",\n \"MEDDRACode\": \"10066377\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"interrupt therapy\",\n \"Probability\": \"0.0014758706\",\n \"SemanticContext\": \"When possible, interrupt therapy with Plavix for five days prior to such surgery.\"\n }\n ]\n },\n {\n \"Term\": \"Pancreatitis\",\n \"MEDDRACode\": \"10033645\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"pancreatitis\",\n \"Probability\": \"0.9947627783\",\n \"SemanticContext\": \"Blood and lymphatic system disorders: Agranulocytosis, aplastic anemia/pancytopenia, thrombotic thrombocytopenic purpura TTP , acquired hemophilia A Gastrointestinal disorders: Colitis including ulcerative or lymphocytic colitis , pancreatitis, stomatitis, gastric/duodenal ulcer, diarrhea General disorders and administration site condition: Fever Hepatobiliary disorders: Acute liver failure, hepatitis noninfectious , abnormal liver function test Immune system disorders: Hypersensitivity reactions, anaphylactoid reactions, serum sickness, insulin autoimmune syndrome, which can lead to severe hypoglycemia Musculoskeletal, connective tissue and bone disorders: Myalgia, arthralgia, arthritis Nervous system disorders: Taste disorders, headache, ageusia Psychiatric disorders: Confusion, hallucinations Respiratory, thoracic and mediastinal disorders: Bronchospasm, interstitial pneumonitis, eosinophilic pneumonia Renal and urinary disorders: Increased creatinine levels Skin and subcutaneous tissue disorders: Maculopapular, erythematous or exfoliative rash, urticaria, bullous dermatitis, eczema, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis AGEP , angioedema, drug-induced hypersensitivity syndrome, drug rash with eosinophilia and systemic symptoms DRESS , erythema multiforme, lichen planus, generalized pruritus Vascular disorders: Vasculitis, hypotension\"\n }\n ]\n },\n {\n \"Term\": \"Serum sickness\",\n \"MEDDRACode\": \"10040400\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"serum sickness\",\n \"Probability\": \"0.9931681156\",\n \"SemanticContext\": \"Blood and lymphatic system disorders: Agranulocytosis, aplastic anemia/pancytopenia, thrombotic thrombocytopenic purpura TTP , acquired hemophilia A Gastrointestinal disorders: Colitis including ulcerative or lymphocytic colitis , pancreatitis, stomatitis, gastric/duodenal ulcer, diarrhea General disorders and administration site condition: Fever Hepatobiliary disorders: Acute liver failure, hepatitis noninfectious , abnormal liver function test Immune system disorders: Hypersensitivity reactions, anaphylactoid reactions, serum sickness, insulin autoimmune syndrome, which can lead to severe hypoglycemia Musculoskeletal, connective tissue and bone disorders: Myalgia, arthralgia, arthritis Nervous system disorders: Taste disorders, headache, ageusia Psychiatric disorders: Confusion, hallucinations Respiratory, thoracic and mediastinal disorders: Bronchospasm, interstitial pneumonitis, eosinophilic pneumonia Renal and urinary disorders: Increased creatinine levels Skin and subcutaneous tissue disorders: Maculopapular, erythematous or exfoliative rash, urticaria, bullous dermatitis, eczema, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis AGEP , angioedema, drug-induced hypersensitivity syndrome, drug rash with eosinophilia and systemic symptoms DRESS , erythema multiforme, lichen planus, generalized pruritus Vascular disorders: Vasculitis, hypotension\"\n }\n ]\n },\n {\n \"Term\": \"Lipids\",\n \"MEDDRACode\": \"10024587\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"lipid\",\n \"Probability\": \"0.0001764894\",\n \"SemanticContext\": \"The benefits associated with Plavix were independent of the use of other acute and long-term cardiovascular therapies, including heparin/LMWH, intravenous glycoprotein IIb/IIIa GPIIb/IIIa inhibitors, lipid-lowering drugs, beta-blockers, and ACE inhibitors.\"\n }\n ]\n },\n {\n \"Term\": \"Coma\",\n \"MEDDRACode\": \"10010071\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"coma\",\n \"Probability\": \"0.0023098588\",\n \"SemanticContext\": \"Get medical help right away if you have any of these symptoms and they cannot be explained by another medical condition: purplish spots called purpura on the skin or in the mouth mucous membranes due to bleeding under the skin your skin or the whites of your eyes are yellow jaundice you feel tired or weak your skin looks very pale fever fast heart rate or feeling short of breath headache speech changes confusion coma stroke seizure low amount of urine, or urine that is pink or has blood in it stomach area abdominal pain nausea, vomiting, or diarrhea vision changes persistent low blood sugar symptoms Tell your doctor if you have any side effect that bothers you or that does not go away.\"\n }\n ]\n }\n ],\n \"IndicationTerms\": []\n }\n ]\n },\n {\n \"GenericName\": \"baclofen injection\",\n \"MeddraVersion\": \"24.0\",\n \"Labels\": [\n {\n \"Id\": \"USc0efff86-c45a-e816-e053-2a95a90a442c\",\n \"NDCCode\": \"66794-151\",\n \"UpdatedDate\": \"Apr 30, 2021\",\n \"LabelSource\": {\n \"Country\": \"us\",\n \"ProductId\": \"00d3e846-dd92-448d-9ab8-6a07be823cc1\",\n \"FileId\": \"c0efff86-c45a-e816-e053-2a95a90a442c\",\n \"Version\": \"33\"\n },\n \"AdverseEventTerms\": [\n {\n \"Term\": \"Alopecia\",\n \"MEDDRACode\": \"10001760\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Alopecia\",\n \"Probability\": \"0.9979755282\",\n \"SemanticContext\": \"Skin and Appendages: Alopecia and sweating.\"\n },\n {\n \"VerbatimTerm\": \"alopecia\",\n \"Probability\": \"0.9990440607\",\n \"SemanticContext\": \"Skin and Appendages: Rash, sweating, alopecia, contact dermatitis and skin ulcer.\"\n }\n ]\n },\n {\n \"Term\": \"Anal incontinence\",\n \"MEDDRACode\": \"10077605\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"fecal incontinence\",\n \"Probability\": \"0.9952065945\",\n \"SemanticContext\": \"Digestive System: Dysphagia, fecal incontinence, gastrointestinal hemorrhage and tongue disorder.\"\n }\n ]\n },\n {\n \"Term\": \"Asthenia\",\n \"MEDDRACode\": \"10003549\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Asthenia\",\n \"Probability\": \"0.9991170168\",\n \"SemanticContext\": \"Table 1: Most Common =1% Adverse Reactions in Patients with Spasticity of Spinal Origin in Prospectively Monitored Clinical Trials Adverse Reactions Percent N=576 Screening Percent N=474 Titration† Percent N=430 Maintenance ‡ Hypotonia 5.4 13.5 25.3 Somnolence 5.7 5.9 20.9 Dizziness 1.7 1.9 7.9 Paresthesia 2.4 2.1 6.7 Nausea and Vomiting 1.6 2.3 5.6 Headache 1.6 2.5 5.1 Constipation 0.2 1.5 5.1 Convulsion 0.5 1.3 4.7 Urinary Retention 0.7 1.7 1.9 Dry Mouth 0.2 0.4 3.3 Accidental Injury 0.0 0.2 3.5 Asthenia 0.7 1.3 1.4 Confusion 0.5 0.6 2.3 Death 0.2 0.4 3.0 Pain 0.0 0.6 3.0 Speech Disorder 0.0 0.2 3.5 Hypotension 1.0 0.2 1.9 Ambylopia 0.5 0.2 2.3 Diarrhea 0.0 0.8 2.3 Hypoventilation 0.2 0.8 2.1 Coma 0.0 1.5 0.9 Impotence 0.2 0.4 1.6 Peripheral Edema 0.0 0.0 2.3 Urinary Incontinence 0.0 0.8 1.4 Insomnia 0.0 0.4 1.6 Anxiety 0.2 0.4 0.9 Depression 0.0 0.0 1.6 Dypsnea 0.3 0.0 1.2 Fever 0.5 0.2 0.7 Pneumonia 0.2 0.2 1.2 Urinary Frequency 0.0 0.6 0.9 Urticaria 0.2 0.2 1.2 Anorexia 0.0 0.4 0.9 Diplopia 0.0 0.4 0.9 Dysautonomia 0.2 0.2 0.9 Hallucinations 0.3 0.4 0.5 Hypertension 0.2 0.6 0.5 .\"\n },\n {\n \"VerbatimTerm\": \"Asthenia\",\n \"Probability\": \"0.999278903\",\n \"SemanticContext\": \"Table 2: Most Common =1% Adverse Reactions in Patients with Spasticity of Cerebral Origin Adverse Reactions Percent N=211 Screening* Percent N=153 Titration† Percent N=150 Maintenance ‡ Hypotonia 2.4 14.4 34.7 Somnolence 7.6 10.5 18.7 Headache 6.6 7.8 10.7 Nausea and Vomiting 6.6 10.5 4.0 Vomiting 6.2 8.5 4.0 Urinary Retention 0.9 6.5 8.0 Convulsion 0.9 3.3 10.0 Dizziness 2.4 2.6 8.0 Nausea 1.4 3.3 7.3 Hypoventilation 1.4 1.3 4.0 Hypertonia 0.0 0.7 6.0 Paresthesia 1.9 0.7 3.3 Hypotension 1.9 0.7 2.0 Increased Salivation 0.0 2.6 2.7 Back Pain 0.9 0.7 2.0 Constipation 0.5 1.3 2.0 Pain 0.0 0.0 4.0 Pruritus 0.0 0.0 4.0 Diarrhea 0.5 0.7 2.0 Peripheral Edema 0.0 0.0 3.3 Thinking Abnormal 0.5 1.3 0.7 Agitation 0.5 0.0 1.3 Asthenia 0.0 0.0 2.0 Chills 0.5 0.0 1.3 Coma 0.5 0.0 1.3 Dry Mouth 0.5 0.0 1.3 Pneumonia 0.0 0.0 2.0 Speech Disorder 0.5 0.7 0.7 Tremor 0.5 0.0 1.3 Urinary Incontinence 0.0 0.0 2.0 Urination Impaired 0.0 0.0 2.0 .\"\n }\n ]\n },\n {\n \"Term\": \"Abdominal pain\",\n \"MEDDRACode\": \"10000081\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"abdominal pain\",\n \"Probability\": \"0.9680619836\",\n \"SemanticContext\": \"Body as a Whole: Suicide, lack of drug effect, abdominal pain, hypothermia, neck rigidity, chest pain, chills, face edema, flu syndrome and overdose.\"\n },\n {\n \"VerbatimTerm\": \"abdominal pain\",\n \"Probability\": \"0.9967279434\",\n \"SemanticContext\": \"Body as a Whole: Death, fever, abdominal pain, carcinoma, malaise and hypothermia.\"\n }\n ]\n },\n {\n \"Term\": \"Ageusia\",\n \"MEDDRACode\": \"10001480\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"taste loss\",\n \"Probability\": \"0.9511079192\",\n \"SemanticContext\": \"Special Senses: Abnormal vision, abnormality of accommodation, photophobia, taste loss and tinnitus.\"\n }\n ]\n },\n {\n \"Term\": \"Amnesia\",\n \"MEDDRACode\": \"10001949\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"amnesia\",\n \"Probability\": \"0.9816149473\",\n \"SemanticContext\": \"The following adverse reactions, not described in the table, and arranged in decreasing order of frequency, and classified by body system, were reported: Nervous System: Abnormal gait, thinking abnormal, tremor, amnesia, twitching, vasodilatation, cerebrovascular accident, nystagmus, personality disorder, psychotic depression, cerebral ischemia, emotional lability, euphoria, hypertonia, ileus, drug dependence, incoordination, paranoid reaction and ptosis.\"\n },\n {\n \"VerbatimTerm\": \"amnesia\",\n \"Probability\": \"0.9975839257\",\n \"SemanticContext\": \"In the total cohort, the following adverse reactions, not described in Table 2, and arranged in decreasing order of frequency, and classified by body system, were reported: Nervous System: Akathisia, ataxia, confusion, depression, opisthotonos, amnesia, anxiety, hallucinations, hysteria, insomnia, nystagmus, personality disorder, reflexes decreased, and vasodilitation.\"\n }\n ]\n },\n {\n \"Term\": \"Anaemia\",\n \"MEDDRACode\": \"10002034\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Anemia\",\n \"Probability\": \"0.992176652\",\n \"SemanticContext\": \"Hemic and Lymphatic System: Anemia.\"\n }\n ]\n },\n {\n \"Term\": \"Cerebrovascular accident\",\n \"MEDDRACode\": \"10008190\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"cerebrovascular accident\",\n \"Probability\": \"0.99525249\",\n \"SemanticContext\": \"The following adverse reactions, not described in the table, and arranged in decreasing order of frequency, and classified by body system, were reported: Nervous System: Abnormal gait, thinking abnormal, tremor, amnesia, twitching, vasodilatation, cerebrovascular accident, nystagmus, personality disorder, psychotic depression, cerebral ischemia, emotional lability, euphoria, hypertonia, ileus, drug dependence, incoordination, paranoid reaction and ptosis.\"\n }\n ]\n },\n {\n \"Term\": \"Autonomic nervous system imbalance\",\n \"MEDDRACode\": \"10003840\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Dysautonomia\",\n \"Probability\": \"0.7351658344\",\n \"SemanticContext\": \"Table 1: Most Common =1% Adverse Reactions in Patients with Spasticity of Spinal Origin in Prospectively Monitored Clinical Trials Adverse Reactions Percent N=576 Screening Percent N=474 Titration† Percent N=430 Maintenance ‡ Hypotonia 5.4 13.5 25.3 Somnolence 5.7 5.9 20.9 Dizziness 1.7 1.9 7.9 Paresthesia 2.4 2.1 6.7 Nausea and Vomiting 1.6 2.3 5.6 Headache 1.6 2.5 5.1 Constipation 0.2 1.5 5.1 Convulsion 0.5 1.3 4.7 Urinary Retention 0.7 1.7 1.9 Dry Mouth 0.2 0.4 3.3 Accidental Injury 0.0 0.2 3.5 Asthenia 0.7 1.3 1.4 Confusion 0.5 0.6 2.3 Death 0.2 0.4 3.0 Pain 0.0 0.6 3.0 Speech Disorder 0.0 0.2 3.5 Hypotension 1.0 0.2 1.9 Ambylopia 0.5 0.2 2.3 Diarrhea 0.0 0.8 2.3 Hypoventilation 0.2 0.8 2.1 Coma 0.0 1.5 0.9 Impotence 0.2 0.4 1.6 Peripheral Edema 0.0 0.0 2.3 Urinary Incontinence 0.0 0.8 1.4 Insomnia 0.0 0.4 1.6 Anxiety 0.2 0.4 0.9 Depression 0.0 0.0 1.6 Dypsnea 0.3 0.0 1.2 Fever 0.5 0.2 0.7 Pneumonia 0.2 0.2 1.2 Urinary Frequency 0.0 0.6 0.9 Urticaria 0.2 0.2 1.2 Anorexia 0.0 0.4 0.9 Diplopia 0.0 0.4 0.9 Dysautonomia 0.2 0.2 0.9 Hallucinations 0.3 0.4 0.5 Hypertension 0.2 0.6 0.5 .\"\n }\n ]\n },\n {\n \"Term\": \"Back pain\",\n \"MEDDRACode\": \"10003988\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Back Pain\",\n \"Probability\": \"0.9963549972\",\n \"SemanticContext\": \"Table 2: Most Common =1% Adverse Reactions in Patients with Spasticity of Cerebral Origin Adverse Reactions Percent N=211 Screening* Percent N=153 Titration† Percent N=150 Maintenance ‡ Hypotonia 2.4 14.4 34.7 Somnolence 7.6 10.5 18.7 Headache 6.6 7.8 10.7 Nausea and Vomiting 6.6 10.5 4.0 Vomiting 6.2 8.5 4.0 Urinary Retention 0.9 6.5 8.0 Convulsion 0.9 3.3 10.0 Dizziness 2.4 2.6 8.0 Nausea 1.4 3.3 7.3 Hypoventilation 1.4 1.3 4.0 Hypertonia 0.0 0.7 6.0 Paresthesia 1.9 0.7 3.3 Hypotension 1.9 0.7 2.0 Increased Salivation 0.0 2.6 2.7 Back Pain 0.9 0.7 2.0 Constipation 0.5 1.3 2.0 Pain 0.0 0.0 4.0 Pruritus 0.0 0.0 4.0 Diarrhea 0.5 0.7 2.0 Peripheral Edema 0.0 0.0 3.3 Thinking Abnormal 0.5 1.3 0.7 Agitation 0.5 0.0 1.3 Asthenia 0.0 0.0 2.0 Chills 0.5 0.0 1.3 Coma 0.5 0.0 1.3 Dry Mouth 0.5 0.0 1.3 Pneumonia 0.0 0.0 2.0 Speech Disorder 0.5 0.7 0.7 Tremor 0.5 0.0 1.3 Urinary Incontinence 0.0 0.0 2.0 Urination Impaired 0.0 0.0 2.0 .\"\n }\n ]\n },\n {\n \"Term\": \"Chest pain\",\n \"MEDDRACode\": \"10008479\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"chest pain\",\n \"Probability\": \"0.756934166\",\n \"SemanticContext\": \"Body as a Whole: Suicide, lack of drug effect, abdominal pain, hypothermia, neck rigidity, chest pain, chills, face edema, flu syndrome and overdose.\"\n }\n ]\n },\n {\n \"Term\": \"Drug dependence\",\n \"MEDDRACode\": \"10013663\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"drug dependence\",\n \"Probability\": \"0.9726734161\",\n \"SemanticContext\": \"The following adverse reactions, not described in the table, and arranged in decreasing order of frequency, and classified by body system, were reported: Nervous System: Abnormal gait, thinking abnormal, tremor, amnesia, twitching, vasodilatation, cerebrovascular accident, nystagmus, personality disorder, psychotic depression, cerebral ischemia, emotional lability, euphoria, hypertonia, ileus, drug dependence, incoordination, paranoid reaction and ptosis.\"\n }\n ]\n },\n {\n \"Term\": \"Dry mouth\",\n \"MEDDRACode\": \"10013781\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Dry Mouth\",\n \"Probability\": \"0.9993752241\",\n \"SemanticContext\": \"Table 1: Most Common =1% Adverse Reactions in Patients with Spasticity of Spinal Origin in Prospectively Monitored Clinical Trials Adverse Reactions Percent N=576 Screening Percent N=474 Titration† Percent N=430 Maintenance ‡ Hypotonia 5.4 13.5 25.3 Somnolence 5.7 5.9 20.9 Dizziness 1.7 1.9 7.9 Paresthesia 2.4 2.1 6.7 Nausea and Vomiting 1.6 2.3 5.6 Headache 1.6 2.5 5.1 Constipation 0.2 1.5 5.1 Convulsion 0.5 1.3 4.7 Urinary Retention 0.7 1.7 1.9 Dry Mouth 0.2 0.4 3.3 Accidental Injury 0.0 0.2 3.5 Asthenia 0.7 1.3 1.4 Confusion 0.5 0.6 2.3 Death 0.2 0.4 3.0 Pain 0.0 0.6 3.0 Speech Disorder 0.0 0.2 3.5 Hypotension 1.0 0.2 1.9 Ambylopia 0.5 0.2 2.3 Diarrhea 0.0 0.8 2.3 Hypoventilation 0.2 0.8 2.1 Coma 0.0 1.5 0.9 Impotence 0.2 0.4 1.6 Peripheral Edema 0.0 0.0 2.3 Urinary Incontinence 0.0 0.8 1.4 Insomnia 0.0 0.4 1.6 Anxiety 0.2 0.4 0.9 Depression 0.0 0.0 1.6 Dypsnea 0.3 0.0 1.2 Fever 0.5 0.2 0.7 Pneumonia 0.2 0.2 1.2 Urinary Frequency 0.0 0.6 0.9 Urticaria 0.2 0.2 1.2 Anorexia 0.0 0.4 0.9 Diplopia 0.0 0.4 0.9 Dysautonomia 0.2 0.2 0.9 Hallucinations 0.3 0.4 0.5 Hypertension 0.2 0.6 0.5 .\"\n },\n {\n \"VerbatimTerm\": \"Dry Mouth\",\n \"Probability\": \"0.9996701479\",\n \"SemanticContext\": \"Table 2: Most Common =1% Adverse Reactions in Patients with Spasticity of Cerebral Origin Adverse Reactions Percent N=211 Screening* Percent N=153 Titration† Percent N=150 Maintenance ‡ Hypotonia 2.4 14.4 34.7 Somnolence 7.6 10.5 18.7 Headache 6.6 7.8 10.7 Nausea and Vomiting 6.6 10.5 4.0 Vomiting 6.2 8.5 4.0 Urinary Retention 0.9 6.5 8.0 Convulsion 0.9 3.3 10.0 Dizziness 2.4 2.6 8.0 Nausea 1.4 3.3 7.3 Hypoventilation 1.4 1.3 4.0 Hypertonia 0.0 0.7 6.0 Paresthesia 1.9 0.7 3.3 Hypotension 1.9 0.7 2.0 Increased Salivation 0.0 2.6 2.7 Back Pain 0.9 0.7 2.0 Constipation 0.5 1.3 2.0 Pain 0.0 0.0 4.0 Pruritus 0.0 0.0 4.0 Diarrhea 0.5 0.7 2.0 Peripheral Edema 0.0 0.0 3.3 Thinking Abnormal 0.5 1.3 0.7 Agitation 0.5 0.0 1.3 Asthenia 0.0 0.0 2.0 Chills 0.5 0.0 1.3 Coma 0.5 0.0 1.3 Dry Mouth 0.5 0.0 1.3 Pneumonia 0.0 0.0 2.0 Speech Disorder 0.5 0.7 0.7 Tremor 0.5 0.0 1.3 Urinary Incontinence 0.0 0.0 2.0 Urination Impaired 0.0 0.0 2.0 .\"\n }\n ]\n },\n {\n \"Term\": \"Cerebral ischaemia\",\n \"MEDDRACode\": \"10008120\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"cerebral ischemia\",\n \"Probability\": \"0.9983564019\",\n \"SemanticContext\": \"The following adverse reactions, not described in the table, and arranged in decreasing order of frequency, and classified by body system, were reported: Nervous System: Abnormal gait, thinking abnormal, tremor, amnesia, twitching, vasodilatation, cerebrovascular accident, nystagmus, personality disorder, psychotic depression, cerebral ischemia, emotional lability, euphoria, hypertonia, ileus, drug dependence, incoordination, paranoid reaction and ptosis.\"\n }\n ]\n },\n {\n \"Term\": \"Drug ineffective\",\n \"MEDDRACode\": \"10013709\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"lack of drug effect\",\n \"Probability\": \"0.6642891765\",\n \"SemanticContext\": \"Body as a Whole: Suicide, lack of drug effect, abdominal pain, hypothermia, neck rigidity, chest pain, chills, face edema, flu syndrome and overdose.\"\n }\n ]\n },\n {\n \"Term\": \"Anxiety\",\n \"MEDDRACode\": \"10002855\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Anxiety\",\n \"Probability\": \"0.9010040164\",\n \"SemanticContext\": \"Table 1: Most Common =1% Adverse Reactions in Patients with Spasticity of Spinal Origin in Prospectively Monitored Clinical Trials Adverse Reactions Percent N=576 Screening Percent N=474 Titration† Percent N=430 Maintenance ‡ Hypotonia 5.4 13.5 25.3 Somnolence 5.7 5.9 20.9 Dizziness 1.7 1.9 7.9 Paresthesia 2.4 2.1 6.7 Nausea and Vomiting 1.6 2.3 5.6 Headache 1.6 2.5 5.1 Constipation 0.2 1.5 5.1 Convulsion 0.5 1.3 4.7 Urinary Retention 0.7 1.7 1.9 Dry Mouth 0.2 0.4 3.3 Accidental Injury 0.0 0.2 3.5 Asthenia 0.7 1.3 1.4 Confusion 0.5 0.6 2.3 Death 0.2 0.4 3.0 Pain 0.0 0.6 3.0 Speech Disorder 0.0 0.2 3.5 Hypotension 1.0 0.2 1.9 Ambylopia 0.5 0.2 2.3 Diarrhea 0.0 0.8 2.3 Hypoventilation 0.2 0.8 2.1 Coma 0.0 1.5 0.9 Impotence 0.2 0.4 1.6 Peripheral Edema 0.0 0.0 2.3 Urinary Incontinence 0.0 0.8 1.4 Insomnia 0.0 0.4 1.6 Anxiety 0.2 0.4 0.9 Depression 0.0 0.0 1.6 Dypsnea 0.3 0.0 1.2 Fever 0.5 0.2 0.7 Pneumonia 0.2 0.2 1.2 Urinary Frequency 0.0 0.6 0.9 Urticaria 0.2 0.2 1.2 Anorexia 0.0 0.4 0.9 Diplopia 0.0 0.4 0.9 Dysautonomia 0.2 0.2 0.9 Hallucinations 0.3 0.4 0.5 Hypertension 0.2 0.6 0.5 .\"\n },\n {\n \"VerbatimTerm\": \"anxiety\",\n \"Probability\": \"0.9969456196\",\n \"SemanticContext\": \"In the total cohort, the following adverse reactions, not described in Table 2, and arranged in decreasing order of frequency, and classified by body system, were reported: Nervous System: Akathisia, ataxia, confusion, depression, opisthotonos, amnesia, anxiety, hallucinations, hysteria, insomnia, nystagmus, personality disorder, reflexes decreased, and vasodilitation.\"\n }\n ]\n },\n {\n \"Term\": \"Eyelid ptosis\",\n \"MEDDRACode\": \"10015995\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"ptosis\",\n \"Probability\": \"0.984482944\",\n \"SemanticContext\": \"The following adverse reactions, not described in the table, and arranged in decreasing order of frequency, and classified by body system, were reported: Nervous System: Abnormal gait, thinking abnormal, tremor, amnesia, twitching, vasodilatation, cerebrovascular accident, nystagmus, personality disorder, psychotic depression, cerebral ischemia, emotional lability, euphoria, hypertonia, ileus, drug dependence, incoordination, paranoid reaction and ptosis.\"\n }\n ]\n },\n {\n \"Term\": \"Gastroenteritis\",\n \"MEDDRACode\": \"10017888\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"gastroenteritis\",\n \"Probability\": \"0.9985368848\",\n \"SemanticContext\": \"Digestive System: Flatulence, dysphagia, dyspepsia and gastroenteritis.\"\n }\n ]\n },\n {\n \"Term\": \"Gastrointestinal haemorrhage\",\n \"MEDDRACode\": \"10017955\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"gastrointestinal hemorrhage\",\n \"Probability\": \"0.9834729433\",\n \"SemanticContext\": \"Digestive System: Dysphagia, fecal incontinence, gastrointestinal hemorrhage and tongue disorder.\"\n }\n ]\n },\n {\n \"Term\": \"Dyspepsia\",\n \"MEDDRACode\": \"10013946\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"dyspepsia\",\n \"Probability\": \"0.9988103509\",\n \"SemanticContext\": \"Digestive System: Flatulence, dysphagia, dyspepsia and gastroenteritis.\"\n }\n ]\n },\n {\n \"Term\": \"Deep vein thrombosis\",\n \"MEDDRACode\": \"10051055\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"deep vein thrombosis\",\n \"Probability\": \"0.0196383297\",\n \"SemanticContext\": \"It may be important to titrate the dose to maintain some degree of muscle tone and allow occasional spasms to: 1 help support circulatory function, 2 possibly prevent the formation of deep vein thrombosis, 3 optimize activities of daily living and ease of care.\"\n }\n ]\n },\n {\n \"Term\": \"Face oedema\",\n \"MEDDRACode\": \"10016029\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"face edema\",\n \"Probability\": \"0.6533192396\",\n \"SemanticContext\": \"Body as a Whole: Suicide, lack of drug effect, abdominal pain, hypothermia, neck rigidity, chest pain, chills, face edema, flu syndrome and overdose.\"\n }\n ]\n },\n {\n \"Term\": \"Haematuria\",\n \"MEDDRACode\": \"10018867\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Hematuria\",\n \"Probability\": \"0.9981999993\",\n \"SemanticContext\": \"Urogenital: Hematuria and kidney failure.\"\n }\n ]\n },\n {\n \"Term\": \"Ejaculation disorder\",\n \"MEDDRACode\": \"10014326\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Abnormal ejaculation\",\n \"Probability\": \"0.9715366364\",\n \"SemanticContext\": \"Urogenital: Abnormal ejaculation, kidney calculus, oliguria and vaginitis.\"\n }\n ]\n },\n {\n \"Term\": \"Euphoric mood\",\n \"MEDDRACode\": \"10015535\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"high\",\n \"Probability\": \"0.1701633036\",\n \"SemanticContext\": \"GABLOFEN baclofen injection , for intrathecal use Initial U.S. Approval: 1992 WARNING: DO NOT DISCONTINUE ABRUPTLY See full prescribing information for complete boxed warning Abrupt discontinuation of intrathecal baclofen, regardless of the cause, has resulted in sequelae that include high fever, altered mental status, exaggerated rebound spasticity, and muscle rigidity, that in rare cases has advanced to rhabdomyolysis, multiple organ-system failure and death.\"\n },\n {\n \"VerbatimTerm\": \"high\",\n \"Probability\": \"0.0072815716\",\n \"SemanticContext\": \"17 PATIENT COUNSELING INFORMATION Risks Related to Sudden Withdrawal of GABLOFEN Advise patients and caregivers that sudden withdrawal of GABLOFEN, regardless of the cause, can result in serious complications that include high fever, confusion, muscle stiffness, multiple organ-system failure, and death.\"\n },\n {\n \"VerbatimTerm\": \"high\",\n \"Probability\": \"0.1077453494\",\n \"SemanticContext\": \"5.5 Withdrawal Abrupt withdrawal of intrathecal baclofen, regardless of the cause, has resulted in sequelae that included high fever, altered mental status, exaggerated rebound spasticity and muscle rigidity that in rare cases progressed to rhabdomyolysis, multiple organ-system failure, and death.\"\n }\n ]\n },\n {\n \"Term\": \"Gait disturbance\",\n \"MEDDRACode\": \"10017577\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"steps\",\n \"Probability\": \"0.0006917119\",\n \"SemanticContext\": \"Treatment Suggestions for Overdose There is no specific antidote for treating overdoses of GABLOFEN; however, the following steps should ordinarily be undertaken: 1 Residual intrathecal baclofen solution should be removed from the pump as soon as possible.\"\n }\n ]\n },\n {\n \"Term\": \"Injury\",\n \"MEDDRACode\": \"10022116\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"injury\",\n \"Probability\": \"0.1978013217\",\n \"SemanticContext\": \"· Spasticity due to traumatic brain injury: wait at least one year after injury before considering GABLOFEN therapy.\"\n },\n {\n \"VerbatimTerm\": \"injury\",\n \"Probability\": \"0.0009743869\",\n \"SemanticContext\": \"Patients with spasticity due to traumatic brain injury should wait at least one year after the injury before consideration of long term intrathecal baclofen therapy.\"\n }\n ]\n },\n {\n \"Term\": \"Drainage\",\n \"MEDDRACode\": \"10084562\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"drainage\",\n \"Probability\": \"0.9766523838\",\n \"SemanticContext\": \"The nine adverse reactions leading to discontinuation were: infection 3 , CSF leaks 2 , meningitis 2 , drainage 1 , and unmanageable trunk control 1 .\"\n }\n ]\n },\n {\n \"Term\": \"Coordination abnormal\",\n \"MEDDRACode\": \"10010947\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"incoordination\",\n \"Probability\": \"0.9936362505\",\n \"SemanticContext\": \"The following adverse reactions, not described in the table, and arranged in decreasing order of frequency, and classified by body system, were reported: Nervous System: Abnormal gait, thinking abnormal, tremor, amnesia, twitching, vasodilatation, cerebrovascular accident, nystagmus, personality disorder, psychotic depression, cerebral ischemia, emotional lability, euphoria, hypertonia, ileus, drug dependence, incoordination, paranoid reaction and ptosis.\"\n }\n ]\n },\n {\n \"Term\": \"Completed suicide\",\n \"MEDDRACode\": \"10010144\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Suicide\",\n \"Probability\": \"0.8719303608\",\n \"SemanticContext\": \"Body as a Whole: Suicide, lack of drug effect, abdominal pain, hypothermia, neck rigidity, chest pain, chills, face edema, flu syndrome and overdose.\"\n }\n ]\n },\n {\n \"Term\": \"Diarrhoea\",\n \"MEDDRACode\": \"10012735\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Diarrhea\",\n \"Probability\": \"0.9995839\",\n \"SemanticContext\": \"Table 1: Most Common =1% Adverse Reactions in Patients with Spasticity of Spinal Origin in Prospectively Monitored Clinical Trials Adverse Reactions Percent N=576 Screening Percent N=474 Titration† Percent N=430 Maintenance ‡ Hypotonia 5.4 13.5 25.3 Somnolence 5.7 5.9 20.9 Dizziness 1.7 1.9 7.9 Paresthesia 2.4 2.1 6.7 Nausea and Vomiting 1.6 2.3 5.6 Headache 1.6 2.5 5.1 Constipation 0.2 1.5 5.1 Convulsion 0.5 1.3 4.7 Urinary Retention 0.7 1.7 1.9 Dry Mouth 0.2 0.4 3.3 Accidental Injury 0.0 0.2 3.5 Asthenia 0.7 1.3 1.4 Confusion 0.5 0.6 2.3 Death 0.2 0.4 3.0 Pain 0.0 0.6 3.0 Speech Disorder 0.0 0.2 3.5 Hypotension 1.0 0.2 1.9 Ambylopia 0.5 0.2 2.3 Diarrhea 0.0 0.8 2.3 Hypoventilation 0.2 0.8 2.1 Coma 0.0 1.5 0.9 Impotence 0.2 0.4 1.6 Peripheral Edema 0.0 0.0 2.3 Urinary Incontinence 0.0 0.8 1.4 Insomnia 0.0 0.4 1.6 Anxiety 0.2 0.4 0.9 Depression 0.0 0.0 1.6 Dypsnea 0.3 0.0 1.2 Fever 0.5 0.2 0.7 Pneumonia 0.2 0.2 1.2 Urinary Frequency 0.0 0.6 0.9 Urticaria 0.2 0.2 1.2 Anorexia 0.0 0.4 0.9 Diplopia 0.0 0.4 0.9 Dysautonomia 0.2 0.2 0.9 Hallucinations 0.3 0.4 0.5 Hypertension 0.2 0.6 0.5 .\"\n },\n {\n \"VerbatimTerm\": \"Diarrhea\",\n \"Probability\": \"0.9996671677\",\n \"SemanticContext\": \"Table 2: Most Common =1% Adverse Reactions in Patients with Spasticity of Cerebral Origin Adverse Reactions Percent N=211 Screening* Percent N=153 Titration† Percent N=150 Maintenance ‡ Hypotonia 2.4 14.4 34.7 Somnolence 7.6 10.5 18.7 Headache 6.6 7.8 10.7 Nausea and Vomiting 6.6 10.5 4.0 Vomiting 6.2 8.5 4.0 Urinary Retention 0.9 6.5 8.0 Convulsion 0.9 3.3 10.0 Dizziness 2.4 2.6 8.0 Nausea 1.4 3.3 7.3 Hypoventilation 1.4 1.3 4.0 Hypertonia 0.0 0.7 6.0 Paresthesia 1.9 0.7 3.3 Hypotension 1.9 0.7 2.0 Increased Salivation 0.0 2.6 2.7 Back Pain 0.9 0.7 2.0 Constipation 0.5 1.3 2.0 Pain 0.0 0.0 4.0 Pruritus 0.0 0.0 4.0 Diarrhea 0.5 0.7 2.0 Peripheral Edema 0.0 0.0 3.3 Thinking Abnormal 0.5 1.3 0.7 Agitation 0.5 0.0 1.3 Asthenia 0.0 0.0 2.0 Chills 0.5 0.0 1.3 Coma 0.5 0.0 1.3 Dry Mouth 0.5 0.0 1.3 Pneumonia 0.0 0.0 2.0 Speech Disorder 0.5 0.7 0.7 Tremor 0.5 0.0 1.3 Urinary Incontinence 0.0 0.0 2.0 Urination Impaired 0.0 0.0 2.0 .\"\n }\n ]\n },\n {\n \"Term\": \"Erectile dysfunction\",\n \"MEDDRACode\": \"10061461\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Impotence\",\n \"Probability\": \"0.983607769\",\n \"SemanticContext\": \"Table 1: Most Common =1% Adverse Reactions in Patients with Spasticity of Spinal Origin in Prospectively Monitored Clinical Trials Adverse Reactions Percent N=576 Screening Percent N=474 Titration† Percent N=430 Maintenance ‡ Hypotonia 5.4 13.5 25.3 Somnolence 5.7 5.9 20.9 Dizziness 1.7 1.9 7.9 Paresthesia 2.4 2.1 6.7 Nausea and Vomiting 1.6 2.3 5.6 Headache 1.6 2.5 5.1 Constipation 0.2 1.5 5.1 Convulsion 0.5 1.3 4.7 Urinary Retention 0.7 1.7 1.9 Dry Mouth 0.2 0.4 3.3 Accidental Injury 0.0 0.2 3.5 Asthenia 0.7 1.3 1.4 Confusion 0.5 0.6 2.3 Death 0.2 0.4 3.0 Pain 0.0 0.6 3.0 Speech Disorder 0.0 0.2 3.5 Hypotension 1.0 0.2 1.9 Ambylopia 0.5 0.2 2.3 Diarrhea 0.0 0.8 2.3 Hypoventilation 0.2 0.8 2.1 Coma 0.0 1.5 0.9 Impotence 0.2 0.4 1.6 Peripheral Edema 0.0 0.0 2.3 Urinary Incontinence 0.0 0.8 1.4 Insomnia 0.0 0.4 1.6 Anxiety 0.2 0.4 0.9 Depression 0.0 0.0 1.6 Dypsnea 0.3 0.0 1.2 Fever 0.5 0.2 0.7 Pneumonia 0.2 0.2 1.2 Urinary Frequency 0.0 0.6 0.9 Urticaria 0.2 0.2 1.2 Anorexia 0.0 0.4 0.9 Diplopia 0.0 0.4 0.9 Dysautonomia 0.2 0.2 0.9 Hallucinations 0.3 0.4 0.5 Hypertension 0.2 0.6 0.5 .\"\n }\n ]\n },\n {\n \"Term\": \"Head injury\",\n \"MEDDRACode\": \"10019196\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"head injury\",\n \"Probability\": \"0.5522610545\",\n \"SemanticContext\": \"The following adverse reactions occurred among the 62 patients receiving intrathecal baclofen in two randomized, placebo-controlled trials involving cerebral palsy and head injury patients, respectively: agitation, constipation, somnolence, leukocytosis, nausea, vomiting, nystagmus, chills, urinary retention, and hypotonia.\"\n }\n ]\n },\n {\n \"Term\": \"Dysphagia\",\n \"MEDDRACode\": \"10013950\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"dysphagia\",\n \"Probability\": \"0.9991990328\",\n \"SemanticContext\": \"Digestive System: Flatulence, dysphagia, dyspepsia and gastroenteritis.\"\n },\n {\n \"VerbatimTerm\": \"Dysphagia\",\n \"Probability\": \"0.9989900589\",\n \"SemanticContext\": \"Digestive System: Dysphagia, fecal incontinence, gastrointestinal hemorrhage and tongue disorder.\"\n }\n ]\n },\n {\n \"Term\": \"Affect lability\",\n \"MEDDRACode\": \"10054196\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"emotional lability\",\n \"Probability\": \"0.9884824753\",\n \"SemanticContext\": \"The following adverse reactions, not described in the table, and arranged in decreasing order of frequency, and classified by body system, were reported: Nervous System: Abnormal gait, thinking abnormal, tremor, amnesia, twitching, vasodilatation, cerebrovascular accident, nystagmus, personality disorder, psychotic depression, cerebral ischemia, emotional lability, euphoria, hypertonia, ileus, drug dependence, incoordination, paranoid reaction and ptosis.\"\n }\n ]\n },\n {\n \"Term\": \"Akathisia\",\n \"MEDDRACode\": \"10001540\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Akathisia\",\n \"Probability\": \"0.9963890314\",\n \"SemanticContext\": \"In the total cohort, the following adverse reactions, not described in Table 2, and arranged in decreasing order of frequency, and classified by body system, were reported: Nervous System: Akathisia, ataxia, confusion, depression, opisthotonos, amnesia, anxiety, hallucinations, hysteria, insomnia, nystagmus, personality disorder, reflexes decreased, and vasodilitation.\"\n }\n ]\n },\n {\n \"Term\": \"Accommodation disorder\",\n \"MEDDRACode\": \"10000389\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"abnormality of accommodation\",\n \"Probability\": \"0.7534254193\",\n \"SemanticContext\": \"Special Senses: Abnormal vision, abnormality of accommodation, photophobia, taste loss and tinnitus.\"\n },\n {\n \"VerbatimTerm\": \"Abnormality of accommodation\",\n \"Probability\": \"0.3076655269\",\n \"SemanticContext\": \"Special Senses: Abnormality of accommodation.\"\n }\n ]\n },\n {\n \"Term\": \"Albuminuria\",\n \"MEDDRACode\": \"10001580\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"albuminuria\",\n \"Probability\": \"0.9981855154\",\n \"SemanticContext\": \"Metabolic and Nutritional Disorders: Weight loss, albuminuria, dehydration and hyperglycemia.\"\n }\n ]\n },\n {\n \"Term\": \"Dehydration\",\n \"MEDDRACode\": \"10012174\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"dehydration\",\n \"Probability\": \"0.999414742\",\n \"SemanticContext\": \"Metabolic and Nutritional Disorders: Weight loss, albuminuria, dehydration and hyperglycemia.\"\n }\n ]\n },\n {\n \"Term\": \"Hyperglycaemia\",\n \"MEDDRACode\": \"10020635\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hyperglycemia\",\n \"Probability\": \"0.9962112308\",\n \"SemanticContext\": \"Metabolic and Nutritional Disorders: Weight loss, albuminuria, dehydration and hyperglycemia.\"\n }\n ]\n },\n {\n \"Term\": \"Influenza\",\n \"MEDDRACode\": \"10022000\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"flu syndrome\",\n \"Probability\": \"0.6350937486\",\n \"SemanticContext\": \"Body as a Whole: Suicide, lack of drug effect, abdominal pain, hypothermia, neck rigidity, chest pain, chills, face edema, flu syndrome and overdose.\"\n }\n ]\n },\n {\n \"Term\": \"Muscle twitching\",\n \"MEDDRACode\": \"10028347\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"twitching\",\n \"Probability\": \"0.9949461222\",\n \"SemanticContext\": \"The following adverse reactions, not described in the table, and arranged in decreasing order of frequency, and classified by body system, were reported: Nervous System: Abnormal gait, thinking abnormal, tremor, amnesia, twitching, vasodilatation, cerebrovascular accident, nystagmus, personality disorder, psychotic depression, cerebral ischemia, emotional lability, euphoria, hypertonia, ileus, drug dependence, incoordination, paranoid reaction and ptosis.\"\n }\n ]\n },\n {\n \"Term\": \"Malaise\",\n \"MEDDRACode\": \"10025482\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"malaise\",\n \"Probability\": \"0.9887955189\",\n \"SemanticContext\": \"Body as a Whole: Death, fever, abdominal pain, carcinoma, malaise and hypothermia.\"\n }\n ]\n },\n {\n \"Term\": \"Hallucination\",\n \"MEDDRACode\": \"10019063\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Hallucinations\",\n \"Probability\": \"0.8851475716\",\n \"SemanticContext\": \"Table 1: Most Common =1% Adverse Reactions in Patients with Spasticity of Spinal Origin in Prospectively Monitored Clinical Trials Adverse Reactions Percent N=576 Screening Percent N=474 Titration† Percent N=430 Maintenance ‡ Hypotonia 5.4 13.5 25.3 Somnolence 5.7 5.9 20.9 Dizziness 1.7 1.9 7.9 Paresthesia 2.4 2.1 6.7 Nausea and Vomiting 1.6 2.3 5.6 Headache 1.6 2.5 5.1 Constipation 0.2 1.5 5.1 Convulsion 0.5 1.3 4.7 Urinary Retention 0.7 1.7 1.9 Dry Mouth 0.2 0.4 3.3 Accidental Injury 0.0 0.2 3.5 Asthenia 0.7 1.3 1.4 Confusion 0.5 0.6 2.3 Death 0.2 0.4 3.0 Pain 0.0 0.6 3.0 Speech Disorder 0.0 0.2 3.5 Hypotension 1.0 0.2 1.9 Ambylopia 0.5 0.2 2.3 Diarrhea 0.0 0.8 2.3 Hypoventilation 0.2 0.8 2.1 Coma 0.0 1.5 0.9 Impotence 0.2 0.4 1.6 Peripheral Edema 0.0 0.0 2.3 Urinary Incontinence 0.0 0.8 1.4 Insomnia 0.0 0.4 1.6 Anxiety 0.2 0.4 0.9 Depression 0.0 0.0 1.6 Dypsnea 0.3 0.0 1.2 Fever 0.5 0.2 0.7 Pneumonia 0.2 0.2 1.2 Urinary Frequency 0.0 0.6 0.9 Urticaria 0.2 0.2 1.2 Anorexia 0.0 0.4 0.9 Diplopia 0.0 0.4 0.9 Dysautonomia 0.2 0.2 0.9 Hallucinations 0.3 0.4 0.5 Hypertension 0.2 0.6 0.5 .\"\n },\n {\n \"VerbatimTerm\": \"hallucinations\",\n \"Probability\": \"0.9976140261\",\n \"SemanticContext\": \"In the total cohort, the following adverse reactions, not described in Table 2, and arranged in decreasing order of frequency, and classified by body system, were reported: Nervous System: Akathisia, ataxia, confusion, depression, opisthotonos, amnesia, anxiety, hallucinations, hysteria, insomnia, nystagmus, personality disorder, reflexes decreased, and vasodilitation.\"\n }\n ]\n },\n {\n \"Term\": \"Hypertension\",\n \"MEDDRACode\": \"10020772\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Hypertension\",\n \"Probability\": \"0.9539878368\",\n \"SemanticContext\": \"Table 1: Most Common =1% Adverse Reactions in Patients with Spasticity of Spinal Origin in Prospectively Monitored Clinical Trials Adverse Reactions Percent N=576 Screening Percent N=474 Titration† Percent N=430 Maintenance ‡ Hypotonia 5.4 13.5 25.3 Somnolence 5.7 5.9 20.9 Dizziness 1.7 1.9 7.9 Paresthesia 2.4 2.1 6.7 Nausea and Vomiting 1.6 2.3 5.6 Headache 1.6 2.5 5.1 Constipation 0.2 1.5 5.1 Convulsion 0.5 1.3 4.7 Urinary Retention 0.7 1.7 1.9 Dry Mouth 0.2 0.4 3.3 Accidental Injury 0.0 0.2 3.5 Asthenia 0.7 1.3 1.4 Confusion 0.5 0.6 2.3 Death 0.2 0.4 3.0 Pain 0.0 0.6 3.0 Speech Disorder 0.0 0.2 3.5 Hypotension 1.0 0.2 1.9 Ambylopia 0.5 0.2 2.3 Diarrhea 0.0 0.8 2.3 Hypoventilation 0.2 0.8 2.1 Coma 0.0 1.5 0.9 Impotence 0.2 0.4 1.6 Peripheral Edema 0.0 0.0 2.3 Urinary Incontinence 0.0 0.8 1.4 Insomnia 0.0 0.4 1.6 Anxiety 0.2 0.4 0.9 Depression 0.0 0.0 1.6 Dypsnea 0.3 0.0 1.2 Fever 0.5 0.2 0.7 Pneumonia 0.2 0.2 1.2 Urinary Frequency 0.0 0.6 0.9 Urticaria 0.2 0.2 1.2 Anorexia 0.0 0.4 0.9 Diplopia 0.0 0.4 0.9 Dysautonomia 0.2 0.2 0.9 Hallucinations 0.3 0.4 0.5 Hypertension 0.2 0.6 0.5 .\"\n }\n ]\n },\n {\n \"Term\": \"Palpitations\",\n \"MEDDRACode\": \"10033557\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"palpitations\",\n \"Probability\": \"0.998611629\",\n \"SemanticContext\": \"Cardiovascular: Postural hypotension, bradycardia, palpitations, syncope, arrhythmia ventricular, deep thrombophlebitis, pallor and tachycardia.\"\n }\n ]\n },\n {\n \"Term\": \"Oedema peripheral\",\n \"MEDDRACode\": \"10030124\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Peripheral Edema\",\n \"Probability\": \"0.9980062246\",\n \"SemanticContext\": \"Table 1: Most Common =1% Adverse Reactions in Patients with Spasticity of Spinal Origin in Prospectively Monitored Clinical Trials Adverse Reactions Percent N=576 Screening Percent N=474 Titration† Percent N=430 Maintenance ‡ Hypotonia 5.4 13.5 25.3 Somnolence 5.7 5.9 20.9 Dizziness 1.7 1.9 7.9 Paresthesia 2.4 2.1 6.7 Nausea and Vomiting 1.6 2.3 5.6 Headache 1.6 2.5 5.1 Constipation 0.2 1.5 5.1 Convulsion 0.5 1.3 4.7 Urinary Retention 0.7 1.7 1.9 Dry Mouth 0.2 0.4 3.3 Accidental Injury 0.0 0.2 3.5 Asthenia 0.7 1.3 1.4 Confusion 0.5 0.6 2.3 Death 0.2 0.4 3.0 Pain 0.0 0.6 3.0 Speech Disorder 0.0 0.2 3.5 Hypotension 1.0 0.2 1.9 Ambylopia 0.5 0.2 2.3 Diarrhea 0.0 0.8 2.3 Hypoventilation 0.2 0.8 2.1 Coma 0.0 1.5 0.9 Impotence 0.2 0.4 1.6 Peripheral Edema 0.0 0.0 2.3 Urinary Incontinence 0.0 0.8 1.4 Insomnia 0.0 0.4 1.6 Anxiety 0.2 0.4 0.9 Depression 0.0 0.0 1.6 Dypsnea 0.3 0.0 1.2 Fever 0.5 0.2 0.7 Pneumonia 0.2 0.2 1.2 Urinary Frequency 0.0 0.6 0.9 Urticaria 0.2 0.2 1.2 Anorexia 0.0 0.4 0.9 Diplopia 0.0 0.4 0.9 Dysautonomia 0.2 0.2 0.9 Hallucinations 0.3 0.4 0.5 Hypertension 0.2 0.6 0.5 .\"\n },\n {\n \"VerbatimTerm\": \"Peripheral Edema\",\n \"Probability\": \"0.9980433583\",\n \"SemanticContext\": \"Table 2: Most Common =1% Adverse Reactions in Patients with Spasticity of Cerebral Origin Adverse Reactions Percent N=211 Screening* Percent N=153 Titration† Percent N=150 Maintenance ‡ Hypotonia 2.4 14.4 34.7 Somnolence 7.6 10.5 18.7 Headache 6.6 7.8 10.7 Nausea and Vomiting 6.6 10.5 4.0 Vomiting 6.2 8.5 4.0 Urinary Retention 0.9 6.5 8.0 Convulsion 0.9 3.3 10.0 Dizziness 2.4 2.6 8.0 Nausea 1.4 3.3 7.3 Hypoventilation 1.4 1.3 4.0 Hypertonia 0.0 0.7 6.0 Paresthesia 1.9 0.7 3.3 Hypotension 1.9 0.7 2.0 Increased Salivation 0.0 2.6 2.7 Back Pain 0.9 0.7 2.0 Constipation 0.5 1.3 2.0 Pain 0.0 0.0 4.0 Pruritus 0.0 0.0 4.0 Diarrhea 0.5 0.7 2.0 Peripheral Edema 0.0 0.0 3.3 Thinking Abnormal 0.5 1.3 0.7 Agitation 0.5 0.0 1.3 Asthenia 0.0 0.0 2.0 Chills 0.5 0.0 1.3 Coma 0.5 0.0 1.3 Dry Mouth 0.5 0.0 1.3 Pneumonia 0.0 0.0 2.0 Speech Disorder 0.5 0.7 0.7 Tremor 0.5 0.0 1.3 Urinary Incontinence 0.0 0.0 2.0 Urination Impaired 0.0 0.0 2.0 .\"\n }\n ]\n },\n {\n \"Term\": \"Hypertonia\",\n \"MEDDRACode\": \"10020852\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hypertonia\",\n \"Probability\": \"0.9960574508\",\n \"SemanticContext\": \"The following adverse reactions, not described in the table, and arranged in decreasing order of frequency, and classified by body system, were reported: Nervous System: Abnormal gait, thinking abnormal, tremor, amnesia, twitching, vasodilatation, cerebrovascular accident, nystagmus, personality disorder, psychotic depression, cerebral ischemia, emotional lability, euphoria, hypertonia, ileus, drug dependence, incoordination, paranoid reaction and ptosis.\"\n },\n {\n \"VerbatimTerm\": \"Hypertonia\",\n \"Probability\": \"0.9870418906\",\n \"SemanticContext\": \"Table 2: Most Common =1% Adverse Reactions in Patients with Spasticity of Cerebral Origin Adverse Reactions Percent N=211 Screening* Percent N=153 Titration† Percent N=150 Maintenance ‡ Hypotonia 2.4 14.4 34.7 Somnolence 7.6 10.5 18.7 Headache 6.6 7.8 10.7 Nausea and Vomiting 6.6 10.5 4.0 Vomiting 6.2 8.5 4.0 Urinary Retention 0.9 6.5 8.0 Convulsion 0.9 3.3 10.0 Dizziness 2.4 2.6 8.0 Nausea 1.4 3.3 7.3 Hypoventilation 1.4 1.3 4.0 Hypertonia 0.0 0.7 6.0 Paresthesia 1.9 0.7 3.3 Hypotension 1.9 0.7 2.0 Increased Salivation 0.0 2.6 2.7 Back Pain 0.9 0.7 2.0 Constipation 0.5 1.3 2.0 Pain 0.0 0.0 4.0 Pruritus 0.0 0.0 4.0 Diarrhea 0.5 0.7 2.0 Peripheral Edema 0.0 0.0 3.3 Thinking Abnormal 0.5 1.3 0.7 Agitation 0.5 0.0 1.3 Asthenia 0.0 0.0 2.0 Chills 0.5 0.0 1.3 Coma 0.5 0.0 1.3 Dry Mouth 0.5 0.0 1.3 Pneumonia 0.0 0.0 2.0 Speech Disorder 0.5 0.7 0.7 Tremor 0.5 0.0 1.3 Urinary Incontinence 0.0 0.0 2.0 Urination Impaired 0.0 0.0 2.0 .\"\n }\n ]\n },\n {\n \"Term\": \"Skin ulcer\",\n \"MEDDRACode\": \"10040943\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"skin ulcer\",\n \"Probability\": \"0.9077714682\",\n \"SemanticContext\": \"Skin and Appendages: Rash, sweating, alopecia, contact dermatitis and skin ulcer.\"\n }\n ]\n },\n {\n \"Term\": \"Orthostatic hypotension\",\n \"MEDDRACode\": \"10031127\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Postural hypotension\",\n \"Probability\": \"0.9980005622\",\n \"SemanticContext\": \"Cardiovascular: Postural hypotension, bradycardia, palpitations, syncope, arrhythmia ventricular, deep thrombophlebitis, pallor and tachycardia.\"\n }\n ]\n },\n {\n \"Term\": \"Rhinitis\",\n \"MEDDRACode\": \"10039083\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"rhinitis\",\n \"Probability\": \"0.9957359433\",\n \"SemanticContext\": \"Respiratory: Respiratory disorder, aspiration pneumonia, hyperventilation, pulmonary embolus and rhinitis.\"\n }\n ]\n },\n {\n \"Term\": \"Photophobia\",\n \"MEDDRACode\": \"10034960\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"photophobia\",\n \"Probability\": \"0.9980505705\",\n \"SemanticContext\": \"Special Senses: Abnormal vision, abnormality of accommodation, photophobia, taste loss and tinnitus.\"\n }\n ]\n },\n {\n \"Term\": \"Pollakiuria\",\n \"MEDDRACode\": \"10036018\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Urinary Frequency\",\n \"Probability\": \"0.9976239204\",\n \"SemanticContext\": \"Table 1: Most Common =1% Adverse Reactions in Patients with Spasticity of Spinal Origin in Prospectively Monitored Clinical Trials Adverse Reactions Percent N=576 Screening Percent N=474 Titration† Percent N=430 Maintenance ‡ Hypotonia 5.4 13.5 25.3 Somnolence 5.7 5.9 20.9 Dizziness 1.7 1.9 7.9 Paresthesia 2.4 2.1 6.7 Nausea and Vomiting 1.6 2.3 5.6 Headache 1.6 2.5 5.1 Constipation 0.2 1.5 5.1 Convulsion 0.5 1.3 4.7 Urinary Retention 0.7 1.7 1.9 Dry Mouth 0.2 0.4 3.3 Accidental Injury 0.0 0.2 3.5 Asthenia 0.7 1.3 1.4 Confusion 0.5 0.6 2.3 Death 0.2 0.4 3.0 Pain 0.0 0.6 3.0 Speech Disorder 0.0 0.2 3.5 Hypotension 1.0 0.2 1.9 Ambylopia 0.5 0.2 2.3 Diarrhea 0.0 0.8 2.3 Hypoventilation 0.2 0.8 2.1 Coma 0.0 1.5 0.9 Impotence 0.2 0.4 1.6 Peripheral Edema 0.0 0.0 2.3 Urinary Incontinence 0.0 0.8 1.4 Insomnia 0.0 0.4 1.6 Anxiety 0.2 0.4 0.9 Depression 0.0 0.0 1.6 Dypsnea 0.3 0.0 1.2 Fever 0.5 0.2 0.7 Pneumonia 0.2 0.2 1.2 Urinary Frequency 0.0 0.6 0.9 Urticaria 0.2 0.2 1.2 Anorexia 0.0 0.4 0.9 Diplopia 0.0 0.4 0.9 Dysautonomia 0.2 0.2 0.9 Hallucinations 0.3 0.4 0.5 Hypertension 0.2 0.6 0.5 .\"\n }\n ]\n },\n {\n \"Term\": \"Renal failure\",\n \"MEDDRACode\": \"10038435\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"kidney failure\",\n \"Probability\": \"0.9985957146\",\n \"SemanticContext\": \"Urogenital: Hematuria and kidney failure.\"\n }\n ]\n },\n {\n \"Term\": \"Major depression\",\n \"MEDDRACode\": \"10057840\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"psychotic depression\",\n \"Probability\": \"0.9838540554\",\n \"SemanticContext\": \"The following adverse reactions, not described in the table, and arranged in decreasing order of frequency, and classified by body system, were reported: Nervous System: Abnormal gait, thinking abnormal, tremor, amnesia, twitching, vasodilatation, cerebrovascular accident, nystagmus, personality disorder, psychotic depression, cerebral ischemia, emotional lability, euphoria, hypertonia, ileus, drug dependence, incoordination, paranoid reaction and ptosis.\"\n }\n ]\n },\n {\n \"Term\": \"Nephrolithiasis\",\n \"MEDDRACode\": \"10029148\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"kidney calculus\",\n \"Probability\": \"0.997923553\",\n \"SemanticContext\": \"Urogenital: Abnormal ejaculation, kidney calculus, oliguria and vaginitis.\"\n }\n ]\n },\n {\n \"Term\": \"Syncope\",\n \"MEDDRACode\": \"10042772\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"syncope\",\n \"Probability\": \"0.9985320568\",\n \"SemanticContext\": \"Cardiovascular: Postural hypotension, bradycardia, palpitations, syncope, arrhythmia ventricular, deep thrombophlebitis, pallor and tachycardia.\"\n }\n ]\n },\n {\n \"Term\": \"Tachycardia\",\n \"MEDDRACode\": \"10043071\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"tachycardia\",\n \"Probability\": \"0.9957214594\",\n \"SemanticContext\": \"Cardiovascular: Postural hypotension, bradycardia, palpitations, syncope, arrhythmia ventricular, deep thrombophlebitis, pallor and tachycardia.\"\n }\n ]\n },\n {\n \"Term\": \"Visual impairment\",\n \"MEDDRACode\": \"10047571\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Abnormal vision\",\n \"Probability\": \"0.9873462319\",\n \"SemanticContext\": \"Special Senses: Abnormal vision, abnormality of accommodation, photophobia, taste loss and tinnitus.\"\n }\n ]\n },\n {\n \"Term\": \"Vomiting\",\n \"MEDDRACode\": \"10047700\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"vomiting\",\n \"Probability\": \"0.9593838453\",\n \"SemanticContext\": \"Nonetheless, many of the more commonly reported reactions -- hypotonia, somnolence, dizziness, paresthesia, nausea/vomiting and headache -- appear clearly drug-related.\"\n },\n {\n \"VerbatimTerm\": \"vomiting\",\n \"Probability\": \"0.9990454912\",\n \"SemanticContext\": \"The following adverse reactions occurred among the 62 patients receiving intrathecal baclofen in two randomized, placebo-controlled trials involving cerebral palsy and head injury patients, respectively: agitation, constipation, somnolence, leukocytosis, nausea, vomiting, nystagmus, chills, urinary retention, and hypotonia.\"\n },\n {\n \"VerbatimTerm\": \"Vomiting\",\n \"Probability\": \"0.9996808767\",\n \"SemanticContext\": \"Table 2: Most Common =1% Adverse Reactions in Patients with Spasticity of Cerebral Origin Adverse Reactions Percent N=211 Screening* Percent N=153 Titration† Percent N=150 Maintenance ‡ Hypotonia 2.4 14.4 34.7 Somnolence 7.6 10.5 18.7 Headache 6.6 7.8 10.7 Nausea and Vomiting 6.6 10.5 4.0 Vomiting 6.2 8.5 4.0 Urinary Retention 0.9 6.5 8.0 Convulsion 0.9 3.3 10.0 Dizziness 2.4 2.6 8.0 Nausea 1.4 3.3 7.3 Hypoventilation 1.4 1.3 4.0 Hypertonia 0.0 0.7 6.0 Paresthesia 1.9 0.7 3.3 Hypotension 1.9 0.7 2.0 Increased Salivation 0.0 2.6 2.7 Back Pain 0.9 0.7 2.0 Constipation 0.5 1.3 2.0 Pain 0.0 0.0 4.0 Pruritus 0.0 0.0 4.0 Diarrhea 0.5 0.7 2.0 Peripheral Edema 0.0 0.0 3.3 Thinking Abnormal 0.5 1.3 0.7 Agitation 0.5 0.0 1.3 Asthenia 0.0 0.0 2.0 Chills 0.5 0.0 1.3 Coma 0.5 0.0 1.3 Dry Mouth 0.5 0.0 1.3 Pneumonia 0.0 0.0 2.0 Speech Disorder 0.5 0.7 0.7 Tremor 0.5 0.0 1.3 Urinary Incontinence 0.0 0.0 2.0 Urination Impaired 0.0 0.0 2.0 .\"\n }\n ]\n },\n {\n \"Term\": \"Arrhythmia\",\n \"MEDDRACode\": \"10003119\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"arrhythmia\",\n \"Probability\": \"0.5291064978\",\n \"SemanticContext\": \"Dosage may be repeated if life-threatening signs, such as arrhythmia, convulsions or coma occur.\"\n }\n ]\n },\n {\n \"Term\": \"Thinking abnormal\",\n \"MEDDRACode\": \"10043431\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"thinking abnormal\",\n \"Probability\": \"0.9881713986\",\n \"SemanticContext\": \"The following adverse reactions, not described in the table, and arranged in decreasing order of frequency, and classified by body system, were reported: Nervous System: Abnormal gait, thinking abnormal, tremor, amnesia, twitching, vasodilatation, cerebrovascular accident, nystagmus, personality disorder, psychotic depression, cerebral ischemia, emotional lability, euphoria, hypertonia, ileus, drug dependence, incoordination, paranoid reaction and ptosis.\"\n },\n {\n \"VerbatimTerm\": \"Thinking Abnormal\",\n \"Probability\": \"0.9880751967\",\n \"SemanticContext\": \"Table 2: Most Common =1% Adverse Reactions in Patients with Spasticity of Cerebral Origin Adverse Reactions Percent N=211 Screening* Percent N=153 Titration† Percent N=150 Maintenance ‡ Hypotonia 2.4 14.4 34.7 Somnolence 7.6 10.5 18.7 Headache 6.6 7.8 10.7 Nausea and Vomiting 6.6 10.5 4.0 Vomiting 6.2 8.5 4.0 Urinary Retention 0.9 6.5 8.0 Convulsion 0.9 3.3 10.0 Dizziness 2.4 2.6 8.0 Nausea 1.4 3.3 7.3 Hypoventilation 1.4 1.3 4.0 Hypertonia 0.0 0.7 6.0 Paresthesia 1.9 0.7 3.3 Hypotension 1.9 0.7 2.0 Increased Salivation 0.0 2.6 2.7 Back Pain 0.9 0.7 2.0 Constipation 0.5 1.3 2.0 Pain 0.0 0.0 4.0 Pruritus 0.0 0.0 4.0 Diarrhea 0.5 0.7 2.0 Peripheral Edema 0.0 0.0 3.3 Thinking Abnormal 0.5 1.3 0.7 Agitation 0.5 0.0 1.3 Asthenia 0.0 0.0 2.0 Chills 0.5 0.0 1.3 Coma 0.5 0.0 1.3 Dry Mouth 0.5 0.0 1.3 Pneumonia 0.0 0.0 2.0 Speech Disorder 0.5 0.7 0.7 Tremor 0.5 0.0 1.3 Urinary Incontinence 0.0 0.0 2.0 Urination Impaired 0.0 0.0 2.0 .\"\n }\n ]\n },\n {\n \"Term\": \"Vasodilatation\",\n \"MEDDRACode\": \"10047141\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"vasodilatation\",\n \"Probability\": \"0.9927242398\",\n \"SemanticContext\": \"The following adverse reactions, not described in the table, and arranged in decreasing order of frequency, and classified by body system, were reported: Nervous System: Abnormal gait, thinking abnormal, tremor, amnesia, twitching, vasodilatation, cerebrovascular accident, nystagmus, personality disorder, psychotic depression, cerebral ischemia, emotional lability, euphoria, hypertonia, ileus, drug dependence, incoordination, paranoid reaction and ptosis.\"\n }\n ]\n },\n {\n \"Term\": \"Ventricular arrhythmia\",\n \"MEDDRACode\": \"10047281\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"arrhythmia ventricular\",\n \"Probability\": \"0.9980646372\",\n \"SemanticContext\": \"Cardiovascular: Postural hypotension, bradycardia, palpitations, syncope, arrhythmia ventricular, deep thrombophlebitis, pallor and tachycardia.\"\n }\n ]\n },\n {\n \"Term\": \"Paranoia\",\n \"MEDDRACode\": \"10033864\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"paranoid reaction\",\n \"Probability\": \"0.974424541\",\n \"SemanticContext\": \"The following adverse reactions, not described in the table, and arranged in decreasing order of frequency, and classified by body system, were reported: Nervous System: Abnormal gait, thinking abnormal, tremor, amnesia, twitching, vasodilatation, cerebrovascular accident, nystagmus, personality disorder, psychotic depression, cerebral ischemia, emotional lability, euphoria, hypertonia, ileus, drug dependence, incoordination, paranoid reaction and ptosis.\"\n }\n ]\n },\n {\n \"Term\": \"Hyperventilation\",\n \"MEDDRACode\": \"10020910\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hyperventilation\",\n \"Probability\": \"0.9996393919\",\n \"SemanticContext\": \"Respiratory: Respiratory disorder, aspiration pneumonia, hyperventilation, pulmonary embolus and rhinitis.\"\n },\n {\n \"VerbatimTerm\": \"hyperventilation\",\n \"Probability\": \"0.9973031282\",\n \"SemanticContext\": \"Respiratory: Apnea, dyspnea and hyperventilation.\"\n }\n ]\n },\n {\n \"Term\": \"No adverse event\",\n \"MEDDRACode\": \"10067482\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"No adverse reactions\",\n \"Probability\": \"0.0930879712\",\n \"SemanticContext\": \"No adverse reactions were reported among the 32 patients receiving placebo in these studies.\"\n }\n ]\n },\n {\n \"Term\": \"Nuchal rigidity\",\n \"MEDDRACode\": \"10058483\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"neck rigidity\",\n \"Probability\": \"0.8167695999\",\n \"SemanticContext\": \"Body as a Whole: Suicide, lack of drug effect, abdominal pain, hypothermia, neck rigidity, chest pain, chills, face edema, flu syndrome and overdose.\"\n }\n ]\n },\n {\n \"Term\": \"Nystagmus\",\n \"MEDDRACode\": \"10029864\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"nystagmus\",\n \"Probability\": \"0.9980610609\",\n \"SemanticContext\": \"The following adverse reactions, not described in the table, and arranged in decreasing order of frequency, and classified by body system, were reported: Nervous System: Abnormal gait, thinking abnormal, tremor, amnesia, twitching, vasodilatation, cerebrovascular accident, nystagmus, personality disorder, psychotic depression, cerebral ischemia, emotional lability, euphoria, hypertonia, ileus, drug dependence, incoordination, paranoid reaction and ptosis.\"\n },\n {\n \"VerbatimTerm\": \"nystagmus\",\n \"Probability\": \"0.997975111\",\n \"SemanticContext\": \"The following adverse reactions occurred among the 62 patients receiving intrathecal baclofen in two randomized, placebo-controlled trials involving cerebral palsy and head injury patients, respectively: agitation, constipation, somnolence, leukocytosis, nausea, vomiting, nystagmus, chills, urinary retention, and hypotonia.\"\n },\n {\n \"VerbatimTerm\": \"nystagmus\",\n \"Probability\": \"0.998472333\",\n \"SemanticContext\": \"In the total cohort, the following adverse reactions, not described in Table 2, and arranged in decreasing order of frequency, and classified by body system, were reported: Nervous System: Akathisia, ataxia, confusion, depression, opisthotonos, amnesia, anxiety, hallucinations, hysteria, insomnia, nystagmus, personality disorder, reflexes decreased, and vasodilitation.\"\n }\n ]\n },\n {\n \"Term\": \"Pulmonary embolism\",\n \"MEDDRACode\": \"10037377\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"pulmonary embolus\",\n \"Probability\": \"0.9858500957\",\n \"SemanticContext\": \"Respiratory: Respiratory disorder, aspiration pneumonia, hyperventilation, pulmonary embolus and rhinitis.\"\n }\n ]\n },\n {\n \"Term\": \"Muscle relaxant therapy\",\n \"MEDDRACode\": \"10058909\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"muscle relaxant\",\n \"Probability\": \"0.0010532737\",\n \"SemanticContext\": \"11 DESCRIPTION GABLOFEN baclofen injection is a muscle relaxant and antispastic.\"\n },\n {\n \"VerbatimTerm\": \"muscle relaxant\",\n \"Probability\": \"0.0001557767\",\n \"SemanticContext\": \"structure 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action The precise mechanism of action of baclofen as a muscle relaxant and antispasticity agent is not fully understood.\"\n }\n ]\n },\n {\n \"Term\": \"Blood sodium\",\n \"MEDDRACode\": \"10005799\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"3.0899E-05\",\n \"SemanticContext\": \"It is slightly soluble in water, very slightly soluble in methanol and ethanol, practically insoluble in acetone and ether, soluble in 0.1N hydrochloric acid, 0.1N sodium hydroxide, and insoluble in chloroform.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0001223818\",\n \"SemanticContext\": \"Each mL of GABLOFEN contains baclofen USP 50 mcg, 500 mcg, 1,000 mcg or 2,000 mcg and sodium chloride 9 mg in Water for Injection; pH range is 5.5 to 7.5.\"\n },\n {\n \"VerbatimTerm\": \"Sodium\",\n \"Probability\": \"0.0002911091\",\n \"SemanticContext\": \"For patients who require concentrations other than 500 mcg/mL, 1,000 mcg/mL, or 2,000 mcg/mL, GABLOFEN must be diluted with sterile preservative free Sodium Chloride for Injection, USP.\"\n }\n ]\n },\n {\n \"Term\": \"Neoplasm malignant\",\n \"MEDDRACode\": \"10028997\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"carcinoma\",\n \"Probability\": \"0.4777509272\",\n \"SemanticContext\": \"Body as a Whole: Death, fever, abdominal pain, carcinoma, malaise and hypothermia.\"\n }\n ]\n },\n {\n \"Term\": \"Personality disorder\",\n \"MEDDRACode\": \"10034721\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"personality disorder\",\n \"Probability\": \"0.9731386304\",\n \"SemanticContext\": \"The following adverse reactions, not described in the table, and arranged in decreasing order of frequency, and classified by body system, were reported: Nervous System: Abnormal gait, thinking abnormal, tremor, amnesia, twitching, vasodilatation, cerebrovascular accident, nystagmus, personality disorder, psychotic depression, cerebral ischemia, emotional lability, euphoria, hypertonia, ileus, drug dependence, incoordination, paranoid reaction and ptosis.\"\n },\n {\n \"VerbatimTerm\": \"personality disorder\",\n \"Probability\": \"0.9236085415\",\n \"SemanticContext\": \"In the total cohort, the following adverse reactions, not described in Table 2, and arranged in decreasing order of frequency, and classified by body system, were reported: Nervous System: Akathisia, ataxia, confusion, depression, opisthotonos, amnesia, anxiety, hallucinations, hysteria, insomnia, nystagmus, personality disorder, reflexes decreased, and vasodilitation.\"\n }\n ]\n },\n {\n \"Term\": \"Respiratory disorder\",\n \"MEDDRACode\": \"10038683\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Respiratory disorder\",\n \"Probability\": \"0.9768698812\",\n \"SemanticContext\": \"Respiratory: Respiratory disorder, aspiration pneumonia, hyperventilation, pulmonary embolus and rhinitis.\"\n }\n ]\n },\n {\n \"Term\": \"Petechiae\",\n \"MEDDRACode\": \"10034754\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"petechial rash\",\n \"Probability\": \"0.9832130671\",\n \"SemanticContext\": \"Hemic and Lymphatic System: Leukocytosis and petechial rash.\"\n }\n ]\n },\n {\n \"Term\": \"Weight decreased\",\n \"MEDDRACode\": \"10047895\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Weight loss\",\n \"Probability\": \"0.9993594289\",\n \"SemanticContext\": \"Metabolic and Nutritional Disorders: Weight loss, albuminuria, dehydration and hyperglycemia.\"\n }\n ]\n },\n {\n \"Term\": \"Urticaria\",\n \"MEDDRACode\": \"10046735\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Urticaria\",\n \"Probability\": \"0.9987746477\",\n \"SemanticContext\": \"Table 1: Most Common =1% Adverse Reactions in Patients with Spasticity of Spinal Origin in Prospectively Monitored Clinical Trials Adverse Reactions Percent N=576 Screening Percent N=474 Titration† Percent N=430 Maintenance ‡ Hypotonia 5.4 13.5 25.3 Somnolence 5.7 5.9 20.9 Dizziness 1.7 1.9 7.9 Paresthesia 2.4 2.1 6.7 Nausea and Vomiting 1.6 2.3 5.6 Headache 1.6 2.5 5.1 Constipation 0.2 1.5 5.1 Convulsion 0.5 1.3 4.7 Urinary Retention 0.7 1.7 1.9 Dry Mouth 0.2 0.4 3.3 Accidental Injury 0.0 0.2 3.5 Asthenia 0.7 1.3 1.4 Confusion 0.5 0.6 2.3 Death 0.2 0.4 3.0 Pain 0.0 0.6 3.0 Speech Disorder 0.0 0.2 3.5 Hypotension 1.0 0.2 1.9 Ambylopia 0.5 0.2 2.3 Diarrhea 0.0 0.8 2.3 Hypoventilation 0.2 0.8 2.1 Coma 0.0 1.5 0.9 Impotence 0.2 0.4 1.6 Peripheral Edema 0.0 0.0 2.3 Urinary Incontinence 0.0 0.8 1.4 Insomnia 0.0 0.4 1.6 Anxiety 0.2 0.4 0.9 Depression 0.0 0.0 1.6 Dypsnea 0.3 0.0 1.2 Fever 0.5 0.2 0.7 Pneumonia 0.2 0.2 1.2 Urinary Frequency 0.0 0.6 0.9 Urticaria 0.2 0.2 1.2 Anorexia 0.0 0.4 0.9 Diplopia 0.0 0.4 0.9 Dysautonomia 0.2 0.2 0.9 Hallucinations 0.3 0.4 0.5 Hypertension 0.2 0.6 0.5 .\"\n }\n ]\n },\n {\n \"Term\": \"Speech disorder\",\n \"MEDDRACode\": \"10041466\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Speech Disorder\",\n \"Probability\": \"0.5655671358\",\n \"SemanticContext\": \"Table 1: Most Common =1% Adverse Reactions in Patients with Spasticity of Spinal Origin in Prospectively Monitored Clinical Trials Adverse Reactions Percent N=576 Screening Percent N=474 Titration† Percent N=430 Maintenance ‡ Hypotonia 5.4 13.5 25.3 Somnolence 5.7 5.9 20.9 Dizziness 1.7 1.9 7.9 Paresthesia 2.4 2.1 6.7 Nausea and Vomiting 1.6 2.3 5.6 Headache 1.6 2.5 5.1 Constipation 0.2 1.5 5.1 Convulsion 0.5 1.3 4.7 Urinary Retention 0.7 1.7 1.9 Dry Mouth 0.2 0.4 3.3 Accidental Injury 0.0 0.2 3.5 Asthenia 0.7 1.3 1.4 Confusion 0.5 0.6 2.3 Death 0.2 0.4 3.0 Pain 0.0 0.6 3.0 Speech Disorder 0.0 0.2 3.5 Hypotension 1.0 0.2 1.9 Ambylopia 0.5 0.2 2.3 Diarrhea 0.0 0.8 2.3 Hypoventilation 0.2 0.8 2.1 Coma 0.0 1.5 0.9 Impotence 0.2 0.4 1.6 Peripheral Edema 0.0 0.0 2.3 Urinary Incontinence 0.0 0.8 1.4 Insomnia 0.0 0.4 1.6 Anxiety 0.2 0.4 0.9 Depression 0.0 0.0 1.6 Dypsnea 0.3 0.0 1.2 Fever 0.5 0.2 0.7 Pneumonia 0.2 0.2 1.2 Urinary Frequency 0.0 0.6 0.9 Urticaria 0.2 0.2 1.2 Anorexia 0.0 0.4 0.9 Diplopia 0.0 0.4 0.9 Dysautonomia 0.2 0.2 0.9 Hallucinations 0.3 0.4 0.5 Hypertension 0.2 0.6 0.5 .\"\n },\n {\n \"VerbatimTerm\": \"Speech Disorder\",\n \"Probability\": \"0.6060043573\",\n \"SemanticContext\": \"Table 2: Most Common =1% Adverse Reactions in Patients with Spasticity of Cerebral Origin Adverse Reactions Percent N=211 Screening* Percent N=153 Titration† Percent N=150 Maintenance ‡ Hypotonia 2.4 14.4 34.7 Somnolence 7.6 10.5 18.7 Headache 6.6 7.8 10.7 Nausea and Vomiting 6.6 10.5 4.0 Vomiting 6.2 8.5 4.0 Urinary Retention 0.9 6.5 8.0 Convulsion 0.9 3.3 10.0 Dizziness 2.4 2.6 8.0 Nausea 1.4 3.3 7.3 Hypoventilation 1.4 1.3 4.0 Hypertonia 0.0 0.7 6.0 Paresthesia 1.9 0.7 3.3 Hypotension 1.9 0.7 2.0 Increased Salivation 0.0 2.6 2.7 Back Pain 0.9 0.7 2.0 Constipation 0.5 1.3 2.0 Pain 0.0 0.0 4.0 Pruritus 0.0 0.0 4.0 Diarrhea 0.5 0.7 2.0 Peripheral Edema 0.0 0.0 3.3 Thinking Abnormal 0.5 1.3 0.7 Agitation 0.5 0.0 1.3 Asthenia 0.0 0.0 2.0 Chills 0.5 0.0 1.3 Coma 0.5 0.0 1.3 Dry Mouth 0.5 0.0 1.3 Pneumonia 0.0 0.0 2.0 Speech Disorder 0.5 0.7 0.7 Tremor 0.5 0.0 1.3 Urinary Incontinence 0.0 0.0 2.0 Urination Impaired 0.0 0.0 2.0 .\"\n }\n ]\n },\n {\n \"Term\": \"Tinnitus\",\n \"MEDDRACode\": \"10043882\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"tinnitus\",\n \"Probability\": \"0.9919463992\",\n \"SemanticContext\": \"Special Senses: Abnormal vision, abnormality of accommodation, photophobia, taste loss and tinnitus.\"\n }\n ]\n },\n {\n \"Term\": \"Wound dehiscence\",\n \"MEDDRACode\": \"10048031\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"wound dehiscence\",\n \"Probability\": \"0.9352967143\",\n \"SemanticContext\": \"These include: pump pocket infections 3 , meningitis 2 , wound dehiscence 1 , gynecological fibroids 1 and pump overpressurization 1 with unknown, if any, sequela.\"\n }\n ]\n },\n {\n \"Term\": \"Cerebral palsy\",\n \"MEDDRACode\": \"10008129\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"cerebral palsy\",\n \"Probability\": \"0.9632945061\",\n \"SemanticContext\": \"The following adverse reactions occurred among the 62 patients receiving intrathecal baclofen in two randomized, placebo-controlled trials involving cerebral palsy and head injury patients, respectively: agitation, constipation, somnolence, leukocytosis, nausea, vomiting, nystagmus, chills, urinary retention, and hypotonia.\"\n },\n {\n \"VerbatimTerm\": \"cerebral palsy\",\n \"Probability\": \"0.15394333\",\n \"SemanticContext\": \"Spasticity of Cerebral Origin The efficacy of intrathecal baclofen was investigated in three controlled clinical trials; two enrolled patients with cerebral palsy and one enrolled patients with spasticity due to previous brain injury.\"\n },\n {\n \"VerbatimTerm\": \"cerebral palsy\",\n \"Probability\": \"0.1569348276\",\n \"SemanticContext\": \"The first study, a randomized controlled cross-over trial of 51 patients with cerebral palsy, provided strong, statistically significant results; intrathecal baclofen was superior to placebo in reducing spasticity as measured by the Ashworth Scale.\"\n }\n ]\n },\n {\n \"Term\": \"Hypotension\",\n \"MEDDRACode\": \"10021097\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hypotension\",\n \"Probability\": \"0.9992895126\",\n \"SemanticContext\": \"ADVERSE REACTIONS · The most common adverse reactions in patients with spasticity of spinal origin were somnolence, dizziness, nausea, hypotension, headache, convulsions and hypotonia.\"\n },\n {\n \"VerbatimTerm\": \"hypotension\",\n \"Probability\": \"0.9930868149\",\n \"SemanticContext\": \"DRUG INTERACTIONS Combined use with morphine: hypotension and dyspnea 7 . . . .\"\n },\n {\n \"VerbatimTerm\": \"hypotension\",\n \"Probability\": \"0.9997345209\",\n \"SemanticContext\": \"6 ADVERSE REACTIONS 6.1 Spasticity of Spinal Cord Origin Most Common Adverse Reactions in Patients with Spasticity of Spinal Origin In pre- and post-marketing clinical trials, the most common adverse reactions associated with use of intrathecal baclofen which were not seen at an equivalent incidence among placebo-treated patients were: somnolence, dizziness, nausea, hypotension, headache, convulsions and hypotonia.\"\n },\n {\n \"VerbatimTerm\": \"hypotension\",\n \"Probability\": \"0.9997725487\",\n \"SemanticContext\": \"The following events occurred among the 31 patients receiving intrathecal baclofen in two randomized, placebo-controlled trials: hypotension 2 , dizziness 2 , headache 2 , dyspnea 1 .\"\n },\n {\n \"VerbatimTerm\": \"hypotension\",\n \"Probability\": \"0.9969867468\",\n \"SemanticContext\": \"Nonetheless, many of the more commonly reported reactions -- somnolence, dizziness, headache, nausea, hypotension, hypotonia and coma -- appear clearly drug-related.\"\n },\n {\n \"VerbatimTerm\": \"hypotension\",\n \"Probability\": \"0.3497559428\",\n \"SemanticContext\": \"Interactions attributed to the combined use of GABLOFEN and epidural morphine include hypotension and dyspnea.\"\n },\n {\n \"VerbatimTerm\": \"hypotension\",\n \"Probability\": \"0.0758281946\",\n \"SemanticContext\": \"Early symptoms of baclofen withdrawal may include return of baseline spasticity, pruritus, hypotension, and paresthesias.\"\n },\n {\n \"VerbatimTerm\": \"Hypotension\",\n \"Probability\": \"0.9993590117\",\n \"SemanticContext\": \"Table 1: Most Common =1% Adverse Reactions in Patients with Spasticity of Spinal Origin in Prospectively Monitored Clinical Trials Adverse Reactions Percent N=576 Screening Percent N=474 Titration† Percent N=430 Maintenance ‡ Hypotonia 5.4 13.5 25.3 Somnolence 5.7 5.9 20.9 Dizziness 1.7 1.9 7.9 Paresthesia 2.4 2.1 6.7 Nausea and Vomiting 1.6 2.3 5.6 Headache 1.6 2.5 5.1 Constipation 0.2 1.5 5.1 Convulsion 0.5 1.3 4.7 Urinary Retention 0.7 1.7 1.9 Dry Mouth 0.2 0.4 3.3 Accidental Injury 0.0 0.2 3.5 Asthenia 0.7 1.3 1.4 Confusion 0.5 0.6 2.3 Death 0.2 0.4 3.0 Pain 0.0 0.6 3.0 Speech Disorder 0.0 0.2 3.5 Hypotension 1.0 0.2 1.9 Ambylopia 0.5 0.2 2.3 Diarrhea 0.0 0.8 2.3 Hypoventilation 0.2 0.8 2.1 Coma 0.0 1.5 0.9 Impotence 0.2 0.4 1.6 Peripheral Edema 0.0 0.0 2.3 Urinary Incontinence 0.0 0.8 1.4 Insomnia 0.0 0.4 1.6 Anxiety 0.2 0.4 0.9 Depression 0.0 0.0 1.6 Dypsnea 0.3 0.0 1.2 Fever 0.5 0.2 0.7 Pneumonia 0.2 0.2 1.2 Urinary Frequency 0.0 0.6 0.9 Urticaria 0.2 0.2 1.2 Anorexia 0.0 0.4 0.9 Diplopia 0.0 0.4 0.9 Dysautonomia 0.2 0.2 0.9 Hallucinations 0.3 0.4 0.5 Hypertension 0.2 0.6 0.5 .\"\n },\n {\n \"VerbatimTerm\": \"Hypotension\",\n \"Probability\": \"0.9997509122\",\n \"SemanticContext\": \"Table 2: Most Common =1% Adverse Reactions in Patients with Spasticity of Cerebral Origin Adverse Reactions Percent N=211 Screening* Percent N=153 Titration† Percent N=150 Maintenance ‡ Hypotonia 2.4 14.4 34.7 Somnolence 7.6 10.5 18.7 Headache 6.6 7.8 10.7 Nausea and Vomiting 6.6 10.5 4.0 Vomiting 6.2 8.5 4.0 Urinary Retention 0.9 6.5 8.0 Convulsion 0.9 3.3 10.0 Dizziness 2.4 2.6 8.0 Nausea 1.4 3.3 7.3 Hypoventilation 1.4 1.3 4.0 Hypertonia 0.0 0.7 6.0 Paresthesia 1.9 0.7 3.3 Hypotension 1.9 0.7 2.0 Increased Salivation 0.0 2.6 2.7 Back Pain 0.9 0.7 2.0 Constipation 0.5 1.3 2.0 Pain 0.0 0.0 4.0 Pruritus 0.0 0.0 4.0 Diarrhea 0.5 0.7 2.0 Peripheral Edema 0.0 0.0 3.3 Thinking Abnormal 0.5 1.3 0.7 Agitation 0.5 0.0 1.3 Asthenia 0.0 0.0 2.0 Chills 0.5 0.0 1.3 Coma 0.5 0.0 1.3 Dry Mouth 0.5 0.0 1.3 Pneumonia 0.0 0.0 2.0 Speech Disorder 0.5 0.7 0.7 Tremor 0.5 0.0 1.3 Urinary Incontinence 0.0 0.0 2.0 Urination Impaired 0.0 0.0 2.0 .\"\n }\n ]\n },\n {\n \"Term\": \"Infection\",\n \"MEDDRACode\": \"10021789\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"infections\",\n \"Probability\": \"0.8396464586\",\n \"SemanticContext\": \"These include: pump pocket infections 3 , meningitis 2 , wound dehiscence 1 , gynecological fibroids 1 and pump overpressurization 1 with unknown, if any, sequela.\"\n },\n {\n \"VerbatimTerm\": \"infection\",\n \"Probability\": \"0.9976136684\",\n \"SemanticContext\": \"The nine adverse reactions leading to discontinuation were: infection 3 , CSF leaks 2 , meningitis 2 , drainage 1 , and unmanageable trunk control 1 .\"\n },\n {\n \"VerbatimTerm\": \"infection\",\n \"Probability\": \"0.0456000566\",\n \"SemanticContext\": \"Strict aseptic technique in filling is required to avoid bacterial contamination and serious infection.\"\n },\n {\n \"VerbatimTerm\": \"infection\",\n \"Probability\": \"0.061140269\",\n \"SemanticContext\": \"Some clinical characteristics of the advanced intrathecal baclofen withdrawal syndrome may resemble autonomic dysreflexia, infection sepsis , malignant hyperthermia, neuroleptic-malignant syndrome, or other conditions associated with a hypermetabolic state or widespread rhabdomyolysis.\"\n },\n {\n \"VerbatimTerm\": \"infection\",\n \"Probability\": \"0.0074903071\",\n \"SemanticContext\": \"5.9 Infections Patients should be infection-free prior to the screening trial with GABLOFEN because the presence of a systemic infection may interfere with an assessment of the patient's response to bolus GABLOFEN.\"\n },\n {\n \"VerbatimTerm\": \"infection\",\n \"Probability\": \"0.0025528073\",\n \"SemanticContext\": \"Patients should be infection-free prior to implantation of the pump because the presence of infection may increase the risk of surgical complications.\"\n },\n {\n \"VerbatimTerm\": \"infection\",\n \"Probability\": \"0.0991984606\",\n \"SemanticContext\": \"Patients should be infection-free prior to implantation of the pump because the presence of infection may increase the risk of surgical complications.\"\n },\n {\n \"VerbatimTerm\": \"Infections\",\n \"Probability\": \"0.1125017405\",\n \"SemanticContext\": \"5.9 Infections Patients should be infection-free prior to the screening trial with GABLOFEN because the presence of a systemic infection may interfere with an assessment of the patient's response to bolus GABLOFEN.\"\n }\n ]\n },\n {\n \"Term\": \"Pallor\",\n \"MEDDRACode\": \"10033546\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"pallor\",\n \"Probability\": \"0.9980996847\",\n \"SemanticContext\": \"Cardiovascular: Postural hypotension, bradycardia, palpitations, syncope, arrhythmia ventricular, deep thrombophlebitis, pallor and tachycardia.\"\n }\n ]\n },\n {\n \"Term\": \"Apnoea\",\n \"MEDDRACode\": \"10002974\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Apnea\",\n \"Probability\": \"0.9991253614\",\n \"SemanticContext\": \"Respiratory: Apnea, dyspnea and hyperventilation.\"\n }\n ]\n },\n {\n \"Term\": \"Decreased appetite\",\n \"MEDDRACode\": \"10061428\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Anorexia\",\n \"Probability\": \"0.9981281161\",\n \"SemanticContext\": \"Table 1: Most Common =1% Adverse Reactions in Patients with Spasticity of Spinal Origin in Prospectively Monitored Clinical Trials Adverse Reactions Percent N=576 Screening Percent N=474 Titration† Percent N=430 Maintenance ‡ Hypotonia 5.4 13.5 25.3 Somnolence 5.7 5.9 20.9 Dizziness 1.7 1.9 7.9 Paresthesia 2.4 2.1 6.7 Nausea and Vomiting 1.6 2.3 5.6 Headache 1.6 2.5 5.1 Constipation 0.2 1.5 5.1 Convulsion 0.5 1.3 4.7 Urinary Retention 0.7 1.7 1.9 Dry Mouth 0.2 0.4 3.3 Accidental Injury 0.0 0.2 3.5 Asthenia 0.7 1.3 1.4 Confusion 0.5 0.6 2.3 Death 0.2 0.4 3.0 Pain 0.0 0.6 3.0 Speech Disorder 0.0 0.2 3.5 Hypotension 1.0 0.2 1.9 Ambylopia 0.5 0.2 2.3 Diarrhea 0.0 0.8 2.3 Hypoventilation 0.2 0.8 2.1 Coma 0.0 1.5 0.9 Impotence 0.2 0.4 1.6 Peripheral Edema 0.0 0.0 2.3 Urinary Incontinence 0.0 0.8 1.4 Insomnia 0.0 0.4 1.6 Anxiety 0.2 0.4 0.9 Depression 0.0 0.0 1.6 Dypsnea 0.3 0.0 1.2 Fever 0.5 0.2 0.7 Pneumonia 0.2 0.2 1.2 Urinary Frequency 0.0 0.6 0.9 Urticaria 0.2 0.2 1.2 Anorexia 0.0 0.4 0.9 Diplopia 0.0 0.4 0.9 Dysautonomia 0.2 0.2 0.9 Hallucinations 0.3 0.4 0.5 Hypertension 0.2 0.6 0.5 .\"\n }\n ]\n },\n {\n \"Term\": \"Blood methanol\",\n \"MEDDRACode\": \"10005663\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"methanol\",\n \"Probability\": \"0.0001469553\",\n \"SemanticContext\": \"It is slightly soluble in water, very slightly soluble in methanol and ethanol, practically insoluble in acetone and ether, soluble in 0.1N hydrochloric acid, 0.1N sodium hydroxide, and insoluble in chloroform.\"\n }\n ]\n },\n {\n \"Term\": \"Sedation\",\n \"MEDDRACode\": \"10039897\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"sedation\",\n \"Probability\": \"0.3460124135\",\n \"SemanticContext\": \"In people, as well as in animals, baclofen has been shown to have general CNS depressant properties as indicated by the production of sedation with tolerance, somnolence, ataxia, and respiratory and cardiovascular depression.\"\n }\n ]\n },\n {\n \"Term\": \"Skin exfoliation\",\n \"MEDDRACode\": \"10040844\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Scale\",\n \"Probability\": \"0.3205697536\",\n \"SemanticContext\": \"The first study, a randomized controlled cross-over trial of 51 patients with cerebral palsy, provided strong, statistically significant results; intrathecal baclofen was superior to placebo in reducing spasticity as measured by the Ashworth Scale.\"\n }\n ]\n },\n {\n \"Term\": \"Paraesthesia\",\n \"MEDDRACode\": \"10033775\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"paresthesia\",\n \"Probability\": \"0.9966076612\",\n \"SemanticContext\": \"Nonetheless, many of the more commonly reported reactions -- hypotonia, somnolence, dizziness, paresthesia, nausea/vomiting and headache -- appear clearly drug-related.\"\n },\n {\n \"VerbatimTerm\": \"Paresthesia\",\n \"Probability\": \"0.9986326098\",\n \"SemanticContext\": \"Table 1: Most Common =1% Adverse Reactions in Patients with Spasticity of Spinal Origin in Prospectively Monitored Clinical Trials Adverse Reactions Percent N=576 Screening Percent N=474 Titration† Percent N=430 Maintenance ‡ Hypotonia 5.4 13.5 25.3 Somnolence 5.7 5.9 20.9 Dizziness 1.7 1.9 7.9 Paresthesia 2.4 2.1 6.7 Nausea and Vomiting 1.6 2.3 5.6 Headache 1.6 2.5 5.1 Constipation 0.2 1.5 5.1 Convulsion 0.5 1.3 4.7 Urinary Retention 0.7 1.7 1.9 Dry Mouth 0.2 0.4 3.3 Accidental Injury 0.0 0.2 3.5 Asthenia 0.7 1.3 1.4 Confusion 0.5 0.6 2.3 Death 0.2 0.4 3.0 Pain 0.0 0.6 3.0 Speech Disorder 0.0 0.2 3.5 Hypotension 1.0 0.2 1.9 Ambylopia 0.5 0.2 2.3 Diarrhea 0.0 0.8 2.3 Hypoventilation 0.2 0.8 2.1 Coma 0.0 1.5 0.9 Impotence 0.2 0.4 1.6 Peripheral Edema 0.0 0.0 2.3 Urinary Incontinence 0.0 0.8 1.4 Insomnia 0.0 0.4 1.6 Anxiety 0.2 0.4 0.9 Depression 0.0 0.0 1.6 Dypsnea 0.3 0.0 1.2 Fever 0.5 0.2 0.7 Pneumonia 0.2 0.2 1.2 Urinary Frequency 0.0 0.6 0.9 Urticaria 0.2 0.2 1.2 Anorexia 0.0 0.4 0.9 Diplopia 0.0 0.4 0.9 Dysautonomia 0.2 0.2 0.9 Hallucinations 0.3 0.4 0.5 Hypertension 0.2 0.6 0.5 .\"\n },\n {\n \"VerbatimTerm\": \"Paresthesia\",\n \"Probability\": \"0.9975414276\",\n \"SemanticContext\": \"Table 2: Most Common =1% Adverse Reactions in Patients with Spasticity of Cerebral Origin Adverse Reactions Percent N=211 Screening* Percent N=153 Titration† Percent N=150 Maintenance ‡ Hypotonia 2.4 14.4 34.7 Somnolence 7.6 10.5 18.7 Headache 6.6 7.8 10.7 Nausea and Vomiting 6.6 10.5 4.0 Vomiting 6.2 8.5 4.0 Urinary Retention 0.9 6.5 8.0 Convulsion 0.9 3.3 10.0 Dizziness 2.4 2.6 8.0 Nausea 1.4 3.3 7.3 Hypoventilation 1.4 1.3 4.0 Hypertonia 0.0 0.7 6.0 Paresthesia 1.9 0.7 3.3 Hypotension 1.9 0.7 2.0 Increased Salivation 0.0 2.6 2.7 Back Pain 0.9 0.7 2.0 Constipation 0.5 1.3 2.0 Pain 0.0 0.0 4.0 Pruritus 0.0 0.0 4.0 Diarrhea 0.5 0.7 2.0 Peripheral Edema 0.0 0.0 3.3 Thinking Abnormal 0.5 1.3 0.7 Agitation 0.5 0.0 1.3 Asthenia 0.0 0.0 2.0 Chills 0.5 0.0 1.3 Coma 0.5 0.0 1.3 Dry Mouth 0.5 0.0 1.3 Pneumonia 0.0 0.0 2.0 Speech Disorder 0.5 0.7 0.7 Tremor 0.5 0.0 1.3 Urinary Incontinence 0.0 0.0 2.0 Urination Impaired 0.0 0.0 2.0 .\"\n },\n {\n \"VerbatimTerm\": \"paresthesias\",\n \"Probability\": \"0.018655479\",\n \"SemanticContext\": \"Early symptoms of baclofen withdrawal may include return of baseline spasticity, pruritus, hypotension, and paresthesias.\"\n }\n ]\n },\n {\n \"Term\": \"Blood ketone body\",\n \"MEDDRACode\": \"10057593\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"acetone\",\n \"Probability\": \"0.0001202064\",\n \"SemanticContext\": \"It is slightly soluble in water, very slightly soluble in methanol and ethanol, practically insoluble in acetone and ether, soluble in 0.1N hydrochloric acid, 0.1N sodium hydroxide, and insoluble in chloroform.\"\n }\n ]\n },\n {\n \"Term\": \"Hyporeflexia\",\n \"MEDDRACode\": \"10021089\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"reflexes decreased\",\n \"Probability\": \"0.996547997\",\n \"SemanticContext\": \"In the total cohort, the following adverse reactions, not described in Table 2, and arranged in decreasing order of frequency, and classified by body system, were reported: Nervous System: Akathisia, ataxia, confusion, depression, opisthotonos, amnesia, anxiety, hallucinations, hysteria, insomnia, nystagmus, personality disorder, reflexes decreased, and vasodilitation.\"\n }\n ]\n },\n {\n \"Term\": \"Caregiver\",\n \"MEDDRACode\": \"10007664\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"caregivers\",\n \"Probability\": \"0.0002361834\",\n \"SemanticContext\": \"Patients and caregivers should be advised of the importance of keeping scheduled refill visits and should be educated on the early symptoms of baclofen withdrawal.\"\n },\n {\n \"VerbatimTerm\": \"caregivers\",\n \"Probability\": \"0.0004797876\",\n \"SemanticContext\": \"17 PATIENT COUNSELING INFORMATION Risks Related to Sudden Withdrawal of GABLOFEN Advise patients and caregivers that sudden withdrawal of GABLOFEN, regardless of the cause, can result in serious complications that include high fever, confusion, muscle stiffness, multiple organ-system failure, and death.\"\n },\n {\n \"VerbatimTerm\": \"caregivers\",\n \"Probability\": \"0.0002099574\",\n \"SemanticContext\": \"Inform patients and caregivers that sudden withdrawal occurs most frequently due to a delivery problem with the catheter or the pump, or failure to refill the pump on schedule.\"\n },\n {\n \"VerbatimTerm\": \"caregivers\",\n \"Probability\": \"1.45131E-05\",\n \"SemanticContext\": \"Advise patients and their caregivers to pay careful attention to infusion system alarms.\"\n },\n {\n \"VerbatimTerm\": \"caregivers\",\n \"Probability\": \"2.59093E-05\",\n \"SemanticContext\": \"Instruct patients and caregivers that if they miss their scheduled pump refill, they should immediately contact their physician to reschedule the refill before the pump runs out of drug.\"\n },\n {\n \"VerbatimTerm\": \"caregivers\",\n \"Probability\": \"5.89484E-05\",\n \"SemanticContext\": \"GABLOFEN Overdose Inform patients and their caregivers that GABLOFEN overdose may occur suddenly or insidiously, and that symptoms may include confusion, drowsiness, lightheadedness, dizziness, slow or shallow breathing, seizures, loss of muscle tone, loss of consciousness, and coma.\"\n },\n {\n \"VerbatimTerm\": \"caregivers\",\n \"Probability\": \"0.000493139\",\n \"SemanticContext\": \"Increased Risk of Drowsiness with Alcohol and Other CNS Depressants Inform patients and their caregivers that the drowsiness associated with GABLOFEN use can be worsened by alcohol and other CNS depressants.\"\n },\n {\n \"VerbatimTerm\": \"caregivers\",\n \"Probability\": \"0.0016280711\",\n \"SemanticContext\": \"It is mandatory that the patient, all patient caregivers, and the physicians responsible for the patient receive adequate information regarding the risks of this mode of treatment.\"\n },\n {\n \"VerbatimTerm\": \"caregivers\",\n \"Probability\": \"0.0001619458\",\n \"SemanticContext\": \"All medical personnel and caregivers should be instructed in 1 the signs and symptoms of overdose, 2 procedures to be followed in the event of overdose and 3 proper home care of the pump and insertion site.\"\n },\n {\n \"VerbatimTerm\": \"caregivers\",\n \"Probability\": \"0.0002361834\",\n \"SemanticContext\": \"Patients and caregivers should be advised of the importance of keeping scheduled refill visits and should be educated on the early symptoms of baclofen withdrawal.\"\n },\n {\n \"VerbatimTerm\": \"Caregiver\",\n \"Probability\": \"0.0178115368\",\n \"SemanticContext\": \"5.3 Prescriber, Caregiver and Patient Training and Screening Procedure/Post-Implantation Environment GABLOFEN is for use in single bolus intrathecal injections via a catheter placed in the lumbar intrathecal space or injection by lumbar puncture and in the implantable Medtronic SynchroMed® II Programmable Pump or other pumps labeled for intrathecal administration of GABLOFEN.\"\n }\n ]\n },\n {\n \"Term\": \"Pregnancy\",\n \"MEDDRACode\": \"10036556\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"pregnant\",\n \"Probability\": \"0.0016259849\",\n \"SemanticContext\": \"\\n 8.1 Pregnancy Risk Summary There are no adequate data on the developmental risk associated with the use of GABLOFEN in pregnant women.\"\n },\n {\n \"VerbatimTerm\": \"pregnant\",\n \"Probability\": \"0.0003729761\",\n \"SemanticContext\": \"In animal studies, oral administration of baclofen to pregnant rats produced an increase in fetal malformations see Data .\"\n },\n {\n \"VerbatimTerm\": \"pregnant\",\n \"Probability\": \"0.0035159588\",\n \"SemanticContext\": \"Data Animal Data Baclofen given orally to pregnant rats has been shown to increase the incidence of omphaloceles ventral hernias in fetuses at a dose associated with maternal toxicity.\"\n }\n ]\n },\n {\n \"Term\": \"Pneumonia aspiration\",\n \"MEDDRACode\": \"10035669\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"aspiration pneumonia\",\n \"Probability\": \"0.9969450235\",\n \"SemanticContext\": \"Respiratory: Respiratory disorder, aspiration pneumonia, hyperventilation, pulmonary embolus and rhinitis.\"\n },\n {\n \"VerbatimTerm\": \"aspiration pneumonia\",\n \"Probability\": \"0.6953552961\",\n \"SemanticContext\": \"His medical history included spinal cord injury, aspiration pneumonia, septic shock, disseminated intravascular coagulopathy, severe metabolic acidosis, hepatic toxicity, and status epilepticus.\"\n }\n ]\n },\n {\n \"Term\": \"Device kink\",\n \"MEDDRACode\": \"10070305\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"catheter kink\",\n \"Probability\": \"0.0010780096\",\n \"SemanticContext\": \"In most patients, it will be necessary to increase the dose gradually over time to maintain effectiveness; a sudden requirement for substantial dose escalation typically indicates a catheter complication i.e., catheter kink or dislodgement .\"\n },\n {\n \"VerbatimTerm\": \"catheter kink\",\n \"Probability\": \"0.0012643337\",\n \"SemanticContext\": \"A sudden large requirement for dose escalation suggests a catheter complication i.e., catheter kink or dislodgement .\"\n },\n {\n \"VerbatimTerm\": \"catheter kink\",\n \"Probability\": \"0.0012749135\",\n \"SemanticContext\": \"A sudden large requirement for dose escalation suggests a catheter complication i.e., catheter kink or dislodgement .\"\n }\n ]\n },\n {\n \"Term\": \"Spinal cord injury\",\n \"MEDDRACode\": \"10041552\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"spinal cord injuries\",\n \"Probability\": \"0.0001116576\",\n \"SemanticContext\": \"Special attention should be given to patients at apparent risk e.g., spinal cord injuries at T-6 or above, communication difficulties, history of withdrawal symptoms from oral or intrathecal baclofen .\"\n },\n {\n \"VerbatimTerm\": \"spinal cord injury\",\n \"Probability\": \"0.2055060863\",\n \"SemanticContext\": \"His medical history included spinal cord injury, aspiration pneumonia, septic shock, disseminated intravascular coagulopathy, severe metabolic acidosis, hepatic toxicity, and status epilepticus.\"\n }\n ]\n },\n {\n \"Term\": \"Syringomyelia\",\n \"MEDDRACode\": \"10042928\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0134341121\",\n \"SemanticContext\": \"· Potential for contamination due to non-sterile external surface of prefilled syringe.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0045556426\",\n \"SemanticContext\": \"A 1 mL syringe 50 mcg/mL is available for use in the screening trial.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0012491345\",\n \"SemanticContext\": \"2.3 Preparation Information Screening Use the 1 mL screening syringe only 50 mcg/mL for bolus injection into the subarachnoid space.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0003699958\",\n \"SemanticContext\": \"For a 50 mcg bolus dose, use 1 mL of the screening syringe.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0102623105\",\n \"SemanticContext\": \"The use of GABLOFEN prefilled syringe in an aseptic setting i.e., operating room to fill sterile intrathecal pumps prior to implantation in patients is not recommended.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0004423261\",\n \"SemanticContext\": \"For outpatient use, modify aseptic procedures to avoid contamination of sterile surfaces through contact with the non-sterile exterior of the GABLOFEN prefilled syringe when filling the pump reservoir [see Warnings and Precautions 5.2 ].\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0028333366\",\n \"SemanticContext\": \"3 DOSAGE FORMS AND STRENGTHS GABLOFEN baclofen injection is available, for intrathecal use only, in: Single-dose syringe of 1 mL containing 50 mcg 50 mcg/mL Single-dose syringes and vials of 10,000 mcg per 20 mL 500 mcg/mL Single-dose syringes and vials of 20,000 mcg per 20 mL 1,000 mcg/mL Single-dose syringes and vials of 40,000 mcg per 20 mL 2,000 mcg/mL\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0101132393\",\n \"SemanticContext\": \"The use of GABLOFEN prefilled syringe in an aseptic setting e.g., operating room to fill sterile intrathecal pumps prior to implantation in patients is not recommended, unless the external surface of the prefilled syringe is treated to ensure sterility.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0003117323\",\n \"SemanticContext\": \"The use of GABLOFEN prefilled syringe in an aseptic setting e.g., operating room to fill sterile intrathecal pumps prior to implantation in patients is not recommended, unless the external surface of the prefilled syringe is treated to ensure sterility.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0038326383\",\n \"SemanticContext\": \"Procedures should also be put in place while refilling implantable intrathecal pumps in an outpatient setting to avoid contamination of sterile surfaces through contact with the non-sterile exterior of the GABLOFEN prefilled syringe.\"\n },\n {\n \"VerbatimTerm\": \"syringes\",\n \"Probability\": \"0.0134442449\",\n \"SemanticContext\": \"For the maximum screening dose of 100 mcg, use 2 mL of 50 mcg/mL baclofen injection 2 screening syringes .\"\n },\n {\n \"VerbatimTerm\": \"syringes\",\n \"Probability\": \"0.0029373169\",\n \"SemanticContext\": \"The external surface of GABLOFEN prefilled syringes all strengths, including the 50 mcg/mL strength are non-sterile.\"\n },\n {\n \"VerbatimTerm\": \"syringes\",\n \"Probability\": \"0.0017159283\",\n \"SemanticContext\": \"3 DOSAGE FORMS AND STRENGTHS GABLOFEN baclofen injection is available, for intrathecal use only, in: Single-dose syringe of 1 mL containing 50 mcg 50 mcg/mL Single-dose syringes and vials of 10,000 mcg per 20 mL 500 mcg/mL Single-dose syringes and vials of 20,000 mcg per 20 mL 1,000 mcg/mL Single-dose syringes and vials of 40,000 mcg per 20 mL 2,000 mcg/mL\"\n },\n {\n \"VerbatimTerm\": \"syringes\",\n \"Probability\": \"0.0012876689\",\n \"SemanticContext\": \"3 DOSAGE FORMS AND STRENGTHS GABLOFEN baclofen injection is available, for intrathecal use only, in: Single-dose syringe of 1 mL containing 50 mcg 50 mcg/mL Single-dose syringes and vials of 10,000 mcg per 20 mL 500 mcg/mL Single-dose syringes and vials of 20,000 mcg per 20 mL 1,000 mcg/mL Single-dose syringes and vials of 40,000 mcg per 20 mL 2,000 mcg/mL\"\n },\n {\n \"VerbatimTerm\": \"syringes\",\n \"Probability\": \"0.0003946126\",\n \"SemanticContext\": \"3 DOSAGE FORMS AND STRENGTHS GABLOFEN baclofen injection is available, for intrathecal use only, in: Single-dose syringe of 1 mL containing 50 mcg 50 mcg/mL Single-dose syringes and vials of 10,000 mcg per 20 mL 500 mcg/mL Single-dose syringes and vials of 20,000 mcg per 20 mL 1,000 mcg/mL Single-dose syringes and vials of 40,000 mcg per 20 mL 2,000 mcg/mL\"\n },\n {\n \"VerbatimTerm\": \"syringes\",\n \"Probability\": \"0.0039747059\",\n \"SemanticContext\": \"5.2 Potential for Contamination due to Non-sterile External Surface of Prefilled Syringe Although the drug solution and pathway in the GABLOFEN prefilled syringes are sterile, the external surface of the prefilled syringes all strengths, including the 50 mcg/mL strength are non-sterile.\"\n },\n {\n \"VerbatimTerm\": \"syringes\",\n \"Probability\": \"0.0004801154\",\n \"SemanticContext\": \"5.2 Potential for Contamination due to Non-sterile External Surface of Prefilled Syringe Although the drug solution and pathway in the GABLOFEN prefilled syringes are sterile, the external surface of the prefilled syringes all strengths, including the 50 mcg/mL strength are non-sterile.\"\n },\n {\n \"VerbatimTerm\": \"Syringe\",\n \"Probability\": \"0.0033780038\",\n \"SemanticContext\": \"5.2 Potential for Contamination due to Non-sterile External Surface of Prefilled Syringe Although the drug solution and pathway in the GABLOFEN prefilled syringes are sterile, the external surface of the prefilled syringes all strengths, including the 50 mcg/mL strength are non-sterile.\"\n }\n ]\n },\n {\n \"Term\": \"Oliguria\",\n \"MEDDRACode\": \"10030302\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"oliguria\",\n \"Probability\": \"0.998606205\",\n \"SemanticContext\": \"Urogenital: Abnormal ejaculation, kidney calculus, oliguria and vaginitis.\"\n }\n ]\n },\n {\n \"Term\": \"Urinary incontinence\",\n \"MEDDRACode\": \"10046543\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Urinary Incontinence\",\n \"Probability\": \"0.9969267845\",\n \"SemanticContext\": \"Table 1: Most Common =1% Adverse Reactions in Patients with Spasticity of Spinal Origin in Prospectively Monitored Clinical Trials Adverse Reactions Percent N=576 Screening Percent N=474 Titration† Percent N=430 Maintenance ‡ Hypotonia 5.4 13.5 25.3 Somnolence 5.7 5.9 20.9 Dizziness 1.7 1.9 7.9 Paresthesia 2.4 2.1 6.7 Nausea and Vomiting 1.6 2.3 5.6 Headache 1.6 2.5 5.1 Constipation 0.2 1.5 5.1 Convulsion 0.5 1.3 4.7 Urinary Retention 0.7 1.7 1.9 Dry Mouth 0.2 0.4 3.3 Accidental Injury 0.0 0.2 3.5 Asthenia 0.7 1.3 1.4 Confusion 0.5 0.6 2.3 Death 0.2 0.4 3.0 Pain 0.0 0.6 3.0 Speech Disorder 0.0 0.2 3.5 Hypotension 1.0 0.2 1.9 Ambylopia 0.5 0.2 2.3 Diarrhea 0.0 0.8 2.3 Hypoventilation 0.2 0.8 2.1 Coma 0.0 1.5 0.9 Impotence 0.2 0.4 1.6 Peripheral Edema 0.0 0.0 2.3 Urinary Incontinence 0.0 0.8 1.4 Insomnia 0.0 0.4 1.6 Anxiety 0.2 0.4 0.9 Depression 0.0 0.0 1.6 Dypsnea 0.3 0.0 1.2 Fever 0.5 0.2 0.7 Pneumonia 0.2 0.2 1.2 Urinary Frequency 0.0 0.6 0.9 Urticaria 0.2 0.2 1.2 Anorexia 0.0 0.4 0.9 Diplopia 0.0 0.4 0.9 Dysautonomia 0.2 0.2 0.9 Hallucinations 0.3 0.4 0.5 Hypertension 0.2 0.6 0.5 .\"\n },\n {\n \"VerbatimTerm\": \"Urinary Incontinence\",\n \"Probability\": \"0.9957441092\",\n \"SemanticContext\": \"Table 2: Most Common =1% Adverse Reactions in Patients with Spasticity of Cerebral Origin Adverse Reactions Percent N=211 Screening* Percent N=153 Titration† Percent N=150 Maintenance ‡ Hypotonia 2.4 14.4 34.7 Somnolence 7.6 10.5 18.7 Headache 6.6 7.8 10.7 Nausea and Vomiting 6.6 10.5 4.0 Vomiting 6.2 8.5 4.0 Urinary Retention 0.9 6.5 8.0 Convulsion 0.9 3.3 10.0 Dizziness 2.4 2.6 8.0 Nausea 1.4 3.3 7.3 Hypoventilation 1.4 1.3 4.0 Hypertonia 0.0 0.7 6.0 Paresthesia 1.9 0.7 3.3 Hypotension 1.9 0.7 2.0 Increased Salivation 0.0 2.6 2.7 Back Pain 0.9 0.7 2.0 Constipation 0.5 1.3 2.0 Pain 0.0 0.0 4.0 Pruritus 0.0 0.0 4.0 Diarrhea 0.5 0.7 2.0 Peripheral Edema 0.0 0.0 3.3 Thinking Abnormal 0.5 1.3 0.7 Agitation 0.5 0.0 1.3 Asthenia 0.0 0.0 2.0 Chills 0.5 0.0 1.3 Coma 0.5 0.0 1.3 Dry Mouth 0.5 0.0 1.3 Pneumonia 0.0 0.0 2.0 Speech Disorder 0.5 0.7 0.7 Tremor 0.5 0.0 1.3 Urinary Incontinence 0.0 0.0 2.0 Urination Impaired 0.0 0.0 2.0 .\"\n }\n ]\n },\n {\n \"Term\": \"Somnolence\",\n \"MEDDRACode\": \"10041349\",\n \"Overdose\": true,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"somnolence\",\n \"Probability\": \"0.9351402521\",\n \"SemanticContext\": \"· Overdose may cause drowsiness, lightheadedness, dizziness, somnolence, respiratory depression, seizures, rostral progression of hypotonia and loss of consciousness progressing to coma.\"\n },\n {\n \"VerbatimTerm\": \"somnolence\",\n \"Probability\": \"0.9988358617\",\n \"SemanticContext\": \"ADVERSE REACTIONS · The most common adverse reactions in patients with spasticity of spinal origin were somnolence, dizziness, nausea, hypotension, headache, convulsions and hypotonia.\"\n },\n {\n \"VerbatimTerm\": \"somnolence\",\n \"Probability\": \"0.9981004596\",\n \"SemanticContext\": \"· The most common adverse reactions in patients with spasticity of cerebral origin were agitation, constipation, somnolence, leukocytosis, chills, urinary retention and hypotonia.\"\n },\n {\n \"VerbatimTerm\": \"somnolence\",\n \"Probability\": \"0.9997218847\",\n \"SemanticContext\": \"6 ADVERSE REACTIONS 6.1 Spasticity of Spinal Cord Origin Most Common Adverse Reactions in Patients with Spasticity of Spinal Origin In pre- and post-marketing clinical trials, the most common adverse reactions associated with use of intrathecal baclofen which were not seen at an equivalent incidence among placebo-treated patients were: somnolence, dizziness, nausea, hypotension, headache, convulsions and hypotonia.\"\n },\n {\n \"VerbatimTerm\": \"somnolence\",\n \"Probability\": \"0.991448164\",\n \"SemanticContext\": \"Nonetheless, many of the more commonly reported reactions -- hypotonia, somnolence, dizziness, paresthesia, nausea/vomiting and headache -- appear clearly drug-related.\"\n },\n {\n \"VerbatimTerm\": \"somnolence\",\n \"Probability\": \"0.9996033907\",\n \"SemanticContext\": \"6.2 Spasticity of Cerebral Origin Most Common Adverse Reactions In pre-marketing clinical trials, the most common adverse reactions associated with use of intrathecal baclofen which were not seen at an equivalent incidence among placebo-treated patients included: agitation, constipation, somnolence, leukocytosis, chills, urinary retention and hypotonia.\"\n },\n {\n \"VerbatimTerm\": \"somnolence\",\n \"Probability\": \"0.9990677238\",\n \"SemanticContext\": \"The following adverse reactions occurred among the 62 patients receiving intrathecal baclofen in two randomized, placebo-controlled trials involving cerebral palsy and head injury patients, respectively: agitation, constipation, somnolence, leukocytosis, nausea, vomiting, nystagmus, chills, urinary retention, and hypotonia.\"\n },\n {\n \"VerbatimTerm\": \"somnolence\",\n \"Probability\": \"0.9930300713\",\n \"SemanticContext\": \"Nonetheless, many of the more commonly reported reactions -- somnolence, dizziness, headache, nausea, hypotension, hypotonia and coma -- appear clearly drug-related.\"\n },\n {\n \"VerbatimTerm\": \"somnolence\",\n \"Probability\": \"0.2412379384\",\n \"SemanticContext\": \"In people, as well as in animals, baclofen has been shown to have general CNS depressant properties as indicated by the production of sedation with tolerance, somnolence, ataxia, and respiratory and cardiovascular depression.\"\n },\n {\n \"VerbatimTerm\": \"somnolence\",\n \"Probability\": \"0.9335188866\",\n \"SemanticContext\": \"Symptoms of Intrathecal Baclofen Overdose Drowsiness, lightheadedness, dizziness, somnolence, respiratory depression, seizures, rostral progression of hypotonia and loss of consciousness progressing to coma of up to 72 hours duration.\"\n },\n {\n \"VerbatimTerm\": \"somnolence\",\n \"Probability\": \"0.6911922693\",\n \"SemanticContext\": \"Less sudden and/or less severe forms of overdose may present with signs of drowsiness, lightheadedness, dizziness, somnolence, respiratory depression, seizures, rostral progression of hypotonia and loss of consciousness progressing to coma.\"\n },\n {\n \"VerbatimTerm\": \"Somnolence\",\n \"Probability\": \"0.9983104467\",\n \"SemanticContext\": \"Table 1: Most Common =1% Adverse Reactions in Patients with Spasticity of Spinal Origin in Prospectively Monitored Clinical Trials Adverse Reactions Percent N=576 Screening Percent N=474 Titration† Percent N=430 Maintenance ‡ Hypotonia 5.4 13.5 25.3 Somnolence 5.7 5.9 20.9 Dizziness 1.7 1.9 7.9 Paresthesia 2.4 2.1 6.7 Nausea and Vomiting 1.6 2.3 5.6 Headache 1.6 2.5 5.1 Constipation 0.2 1.5 5.1 Convulsion 0.5 1.3 4.7 Urinary Retention 0.7 1.7 1.9 Dry Mouth 0.2 0.4 3.3 Accidental Injury 0.0 0.2 3.5 Asthenia 0.7 1.3 1.4 Confusion 0.5 0.6 2.3 Death 0.2 0.4 3.0 Pain 0.0 0.6 3.0 Speech Disorder 0.0 0.2 3.5 Hypotension 1.0 0.2 1.9 Ambylopia 0.5 0.2 2.3 Diarrhea 0.0 0.8 2.3 Hypoventilation 0.2 0.8 2.1 Coma 0.0 1.5 0.9 Impotence 0.2 0.4 1.6 Peripheral Edema 0.0 0.0 2.3 Urinary Incontinence 0.0 0.8 1.4 Insomnia 0.0 0.4 1.6 Anxiety 0.2 0.4 0.9 Depression 0.0 0.0 1.6 Dypsnea 0.3 0.0 1.2 Fever 0.5 0.2 0.7 Pneumonia 0.2 0.2 1.2 Urinary Frequency 0.0 0.6 0.9 Urticaria 0.2 0.2 1.2 Anorexia 0.0 0.4 0.9 Diplopia 0.0 0.4 0.9 Dysautonomia 0.2 0.2 0.9 Hallucinations 0.3 0.4 0.5 Hypertension 0.2 0.6 0.5 .\"\n },\n {\n \"VerbatimTerm\": \"Somnolence\",\n \"Probability\": \"0.9985097051\",\n \"SemanticContext\": \"Table 2: Most Common =1% Adverse Reactions in Patients with Spasticity of Cerebral Origin Adverse Reactions Percent N=211 Screening* Percent N=153 Titration† Percent N=150 Maintenance ‡ Hypotonia 2.4 14.4 34.7 Somnolence 7.6 10.5 18.7 Headache 6.6 7.8 10.7 Nausea and Vomiting 6.6 10.5 4.0 Vomiting 6.2 8.5 4.0 Urinary Retention 0.9 6.5 8.0 Convulsion 0.9 3.3 10.0 Dizziness 2.4 2.6 8.0 Nausea 1.4 3.3 7.3 Hypoventilation 1.4 1.3 4.0 Hypertonia 0.0 0.7 6.0 Paresthesia 1.9 0.7 3.3 Hypotension 1.9 0.7 2.0 Increased Salivation 0.0 2.6 2.7 Back Pain 0.9 0.7 2.0 Constipation 0.5 1.3 2.0 Pain 0.0 0.0 4.0 Pruritus 0.0 0.0 4.0 Diarrhea 0.5 0.7 2.0 Peripheral Edema 0.0 0.0 3.3 Thinking Abnormal 0.5 1.3 0.7 Agitation 0.5 0.0 1.3 Asthenia 0.0 0.0 2.0 Chills 0.5 0.0 1.3 Coma 0.5 0.0 1.3 Dry Mouth 0.5 0.0 1.3 Pneumonia 0.0 0.0 2.0 Speech Disorder 0.5 0.7 0.7 Tremor 0.5 0.0 1.3 Urinary Incontinence 0.0 0.0 2.0 Urination Impaired 0.0 0.0 2.0 .\"\n }\n ]\n },\n {\n \"Term\": \"Seizure\",\n \"MEDDRACode\": \"10039906\",\n \"Overdose\": true,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"seizures\",\n \"Probability\": \"0.9645382166\",\n \"SemanticContext\": \"· Overdose may cause drowsiness, lightheadedness, dizziness, somnolence, respiratory depression, seizures, rostral progression of hypotonia and loss of consciousness progressing to coma.\"\n },\n {\n \"VerbatimTerm\": \"seizures\",\n \"Probability\": \"0.1155394316\",\n \"SemanticContext\": \"GABLOFEN Overdose Inform patients and their caregivers that GABLOFEN overdose may occur suddenly or insidiously, and that symptoms may include confusion, drowsiness, lightheadedness, dizziness, slow or shallow breathing, seizures, loss of muscle tone, loss of consciousness, and coma.\"\n },\n {\n \"VerbatimTerm\": \"seizures\",\n \"Probability\": \"0.9759637117\",\n \"SemanticContext\": \"Symptoms of Intrathecal Baclofen Overdose Drowsiness, lightheadedness, dizziness, somnolence, respiratory depression, seizures, rostral progression of hypotonia and loss of consciousness progressing to coma of up to 72 hours duration.\"\n },\n {\n \"VerbatimTerm\": \"seizures\",\n \"Probability\": \"0.0655250549\",\n \"SemanticContext\": \"Caution in administering physostigmine is advised, however, because its use has been associated with the induction of seizures and bradycardia.\"\n },\n {\n \"VerbatimTerm\": \"seizures\",\n \"Probability\": \"0.8549741507\",\n \"SemanticContext\": \"Less sudden and/or less severe forms of overdose may present with signs of drowsiness, lightheadedness, dizziness, somnolence, respiratory depression, seizures, rostral progression of hypotonia and loss of consciousness progressing to coma.\"\n },\n {\n \"VerbatimTerm\": \"Seizures\",\n \"Probability\": \"0.5528285503\",\n \"SemanticContext\": \"Seizures have been reported during overdose and with withdrawal from intrathecal baclofen as well as in patients maintained on therapeutic doses of intrathecal baclofen.\"\n }\n ]\n },\n {\n \"Term\": \"Muscle spasms\",\n \"MEDDRACode\": \"10028334\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"spasms\",\n \"Probability\": \"0.0461740196\",\n \"SemanticContext\": \"· Maintenance Therapy : Titrate patients individually; Lowest dose with an optimal response should be used, generally 300 mcg/day to 800 mcg/day for spasticity of spinal cord origin and 90 mcg/day to 700 mcg/day for spasticity of cerebral origin; Titrate GABLOFEN to maintain some degree of muscle tone and allow occasional spasms.\"\n },\n {\n \"VerbatimTerm\": \"spasms\",\n \"Probability\": \"0.0094051957\",\n \"SemanticContext\": \"14 CLINICAL STUDIES Spasticity of Spinal Cord Origin Evidence supporting the efficacy of intrathecal baclofen was obtained in randomized, controlled investigations that compared the effects of either a single intrathecal dose or a three day intrathecal infusion of intrathecal baclofen to placebo in patients with severe spasticity and spasms due to either spinal cord trauma or multiple sclerosis.\"\n },\n {\n \"VerbatimTerm\": \"spasms\",\n \"Probability\": \"0.3594961464\",\n \"SemanticContext\": \"Intrathecal baclofen was superior to placebo on both principal outcome measures employed: change from baseline in the Ashworth rating of spasticity and the frequency of spasms.\"\n },\n {\n \"VerbatimTerm\": \"spasms\",\n \"Probability\": \"0.32223472\",\n \"SemanticContext\": \"A positive response consists of a significant decrease in muscle tone and/or frequency and/or severity of spasms.\"\n },\n {\n \"VerbatimTerm\": \"spasms\",\n \"Probability\": \"0.2051461935\",\n \"SemanticContext\": \"For example, patients who have increased spasms at night may require a 20% increase in their hourly infusion rate.\"\n },\n {\n \"VerbatimTerm\": \"spasms\",\n \"Probability\": \"0.0133960843\",\n \"SemanticContext\": \"It may be important to titrate the dose to maintain some degree of muscle tone and allow occasional spasms to: 1 help support circulatory function, 2 possibly prevent the formation of deep vein thrombosis, 3 optimize activities of daily living and ease of care.\"\n },\n {\n \"VerbatimTerm\": \"spasms\",\n \"Probability\": \"0.0183911324\",\n \"SemanticContext\": \"2.6 Maintenance Therapy Spasticity of Spinal Cord Origin Patients The clinical goal is to maintain muscle tone as close to normal as possible, and to minimize the frequency and severity of spasms to the extent possible, without inducing intolerable side effects.\"\n },\n {\n \"VerbatimTerm\": \"spasms\",\n \"Probability\": \"0.0076252818\",\n \"SemanticContext\": \"Spasticity of Cerebral Origin Patients The clinical goal is to maintain muscle tone as close to normal as possible and to minimize the frequency and severity of spasms to the extent possible, without inducing intolerable side effects, or to titrate the dose to the desired degree of muscle tone for optimal functions.\"\n }\n ]\n },\n {\n \"Term\": \"Lumbar puncture\",\n \"MEDDRACode\": \"10024999\",\n \"Overdose\": true,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"lumbar puncture\",\n \"Probability\": \"0.0010195673\",\n \"SemanticContext\": \"DOSAGE AND ADMINISTRATION · GABLOFEN is intended for use by the intrathecal route in single bolus test doses via spinal catheter or lumbar puncture and, for chronic use in the Medtronic SynchroMed ® II Programmable Pump or other pumps labeled for intrathecal administration of GABLOFEN; Refer to the pump manufacturer's manual and follow the specific instructions and precautions for programming the pump and/or refilling the reservoir.\"\n },\n {\n \"VerbatimTerm\": \"lumbar puncture\",\n \"Probability\": \"0.0006832778\",\n \"SemanticContext\": \"GABLOFEN is intended for use by the intrathecal route in single bolus test doses via spinal catheter or lumbar puncture and, for chronic use, only with the Medtronic SynchroMed ® II Programmable Pump or other pumps labeled for intrathecal administration of GABLOFEN [see Clinical Studies 14 ] .\"\n },\n {\n \"VerbatimTerm\": \"lumbar puncture\",\n \"Probability\": \"0.0001104945\",\n \"SemanticContext\": \"If lumbar puncture is not contraindicated, consideration should be given to withdrawing 30 to 40 mL of CSF to reduce CSF baclofen concentration.\"\n },\n {\n \"VerbatimTerm\": \"lumbar puncture\",\n \"Probability\": \"0.3018576205\",\n \"SemanticContext\": \"5.3 Prescriber, Caregiver and Patient Training and Screening Procedure/Post-Implantation Environment GABLOFEN is for use in single bolus intrathecal injections via a catheter placed in the lumbar intrathecal space or injection by lumbar puncture and in the implantable Medtronic SynchroMed® II Programmable Pump or other pumps labeled for intrathecal administration of GABLOFEN.\"\n },\n {\n \"VerbatimTerm\": \"lumbar puncture\",\n \"Probability\": \"0.00040254\",\n \"SemanticContext\": \"Evaluation consisting of a screening procedure requires that GABLOFEN be administered into the intrathecal space via a catheter or lumbar puncture [see Dosage and Administration 2.2 ] .\"\n }\n ]\n },\n {\n \"Term\": \"Circulatory collapse\",\n \"MEDDRACode\": \"10009192\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"cardiovascular collapse\",\n \"Probability\": \"0.2660150528\",\n \"SemanticContext\": \"· Potentially life-threatening CNS depression, cardiovascular collapse, and/or respiratory failure; Resuscitative equipment and trained staff must be available during screening, dose titration, and refills 5.3 5 .\"\n },\n {\n \"VerbatimTerm\": \"cardiovascular collapse\",\n \"Probability\": \"0.3269443512\",\n \"SemanticContext\": \"Because of the possibility of potentially life-threatening CNS depression, cardiovascular collapse, and/or respiratory failure, physicians must be adequately trained and educated in chronic intrathecal infusion therapy.\"\n }\n ]\n },\n {\n \"Term\": \"Weight\",\n \"MEDDRACode\": \"10047890\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"weight\",\n \"Probability\": \"0.008479327\",\n \"SemanticContext\": \"Baclofen's chemical name is 4-amino-3- 4-chlorophenyl butanoic acid, and its structural formula is: Baclofen C 10 H 12 ClNO 2 Baclofen is a white to off-white powder, with a molecular weight of 213.66.\"\n }\n ]\n },\n {\n \"Term\": \"Tremor\",\n \"MEDDRACode\": \"10044565\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"tremor\",\n \"Probability\": \"0.992992878\",\n \"SemanticContext\": \"The following adverse reactions, not described in the table, and arranged in decreasing order of frequency, and classified by body system, were reported: Nervous System: Abnormal gait, thinking abnormal, tremor, amnesia, twitching, vasodilatation, cerebrovascular accident, nystagmus, personality disorder, psychotic depression, cerebral ischemia, emotional lability, euphoria, hypertonia, ileus, drug dependence, incoordination, paranoid reaction and ptosis.\"\n },\n {\n \"VerbatimTerm\": \"Tremor\",\n \"Probability\": \"0.9972729683\",\n \"SemanticContext\": \"Table 2: Most Common =1% Adverse Reactions in Patients with Spasticity of Cerebral Origin Adverse Reactions Percent N=211 Screening* Percent N=153 Titration† Percent N=150 Maintenance ‡ Hypotonia 2.4 14.4 34.7 Somnolence 7.6 10.5 18.7 Headache 6.6 7.8 10.7 Nausea and Vomiting 6.6 10.5 4.0 Vomiting 6.2 8.5 4.0 Urinary Retention 0.9 6.5 8.0 Convulsion 0.9 3.3 10.0 Dizziness 2.4 2.6 8.0 Nausea 1.4 3.3 7.3 Hypoventilation 1.4 1.3 4.0 Hypertonia 0.0 0.7 6.0 Paresthesia 1.9 0.7 3.3 Hypotension 1.9 0.7 2.0 Increased Salivation 0.0 2.6 2.7 Back Pain 0.9 0.7 2.0 Constipation 0.5 1.3 2.0 Pain 0.0 0.0 4.0 Pruritus 0.0 0.0 4.0 Diarrhea 0.5 0.7 2.0 Peripheral Edema 0.0 0.0 3.3 Thinking Abnormal 0.5 1.3 0.7 Agitation 0.5 0.0 1.3 Asthenia 0.0 0.0 2.0 Chills 0.5 0.0 1.3 Coma 0.5 0.0 1.3 Dry Mouth 0.5 0.0 1.3 Pneumonia 0.0 0.0 2.0 Speech Disorder 0.5 0.7 0.7 Tremor 0.5 0.0 1.3 Urinary Incontinence 0.0 0.0 2.0 Urination Impaired 0.0 0.0 2.0 .\"\n }\n ]\n },\n {\n \"Term\": \"Muscle rigidity\",\n \"MEDDRACode\": \"10028330\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"muscle rigidity\",\n \"Probability\": \"0.5930575728\",\n \"SemanticContext\": \"GABLOFEN baclofen injection , for intrathecal use Initial U.S. Approval: 1992 WARNING: DO NOT DISCONTINUE ABRUPTLY See full prescribing information for complete boxed warning Abrupt discontinuation of intrathecal baclofen, regardless of the cause, has resulted in sequelae that include high fever, altered mental status, exaggerated rebound spasticity, and muscle rigidity, that in rare cases has advanced to rhabdomyolysis, multiple organ-system failure and death.\"\n },\n {\n \"VerbatimTerm\": \"muscle rigidity\",\n \"Probability\": \"0.546335578\",\n \"SemanticContext\": \"5.5 Withdrawal Abrupt withdrawal of intrathecal baclofen, regardless of the cause, has resulted in sequelae that included high fever, altered mental status, exaggerated rebound spasticity and muscle rigidity that in rare cases progressed to rhabdomyolysis, multiple organ-system failure, and death.\"\n }\n ]\n },\n {\n \"Term\": \"Congenital anomaly\",\n \"MEDDRACode\": \"10010356\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"birth defects\",\n \"Probability\": \"0.0803901851\",\n \"SemanticContext\": \"The background risk of major birth defects and miscarriage for the indicated population is unknown.\"\n },\n {\n \"VerbatimTerm\": \"birth defects\",\n \"Probability\": \"0.0714996159\",\n \"SemanticContext\": \"In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.\"\n }\n ]\n },\n {\n \"Term\": \"Infertility\",\n \"MEDDRACode\": \"10021926\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"sterility\",\n \"Probability\": \"0.0038420856\",\n \"SemanticContext\": \"The use of GABLOFEN prefilled syringe in an aseptic setting e.g., operating room to fill sterile intrathecal pumps prior to implantation in patients is not recommended, unless the external surface of the prefilled syringe is treated to ensure sterility.\"\n }\n ]\n },\n {\n \"Term\": \"Withdrawal syndrome\",\n \"MEDDRACode\": \"10048010\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"withdrawal syndrome\",\n \"Probability\": \"0.5473827124\",\n \"SemanticContext\": \"Some clinical characteristics of the advanced intrathecal baclofen withdrawal syndrome may resemble autonomic dysreflexia, infection sepsis , malignant hyperthermia, neuroleptic-malignant syndrome, or other conditions associated with a hypermetabolic state or widespread rhabdomyolysis.\"\n }\n ]\n },\n {\n \"Term\": \"Pruritus\",\n \"MEDDRACode\": \"10037087\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"itching\",\n \"Probability\": \"0.0776232481\",\n \"SemanticContext\": \"Inform patients that early symptoms of GABLOFEN withdrawal may include increased spasticity, itching, and tingling of extremities.\"\n }\n ]\n },\n {\n \"Term\": \"Mass\",\n \"MEDDRACode\": \"10026865\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"mass\",\n \"Probability\": \"0.0008717179\",\n \"SemanticContext\": \"Cases of intrathecal mass at the tip of the implanted catheter leading to withdrawal symptoms have also been reported, most of them involving pharmacy compounded analgesic admixtures [see Warnings and Precautions 5.10 ] .\"\n },\n {\n \"VerbatimTerm\": \"mass\",\n \"Probability\": \"0.0003239214\",\n \"SemanticContext\": \"5.11 Intrathecal Mass Formation Cases of intrathecal mass at the tip of the implanted catheter have been reported, most of them involving pharmacy compounded analgesic admixtures.\"\n },\n {\n \"VerbatimTerm\": \"mass\",\n \"Probability\": \"0.0154822767\",\n \"SemanticContext\": \"The most frequent symptoms associated with intrathecal mass are: 1 decreased therapeutic response worsening spasticity, return of spasticity when previously well controlled, withdrawal symptoms, poor response to escalating doses, or frequent or large dosage increases , 2 pain, 3 neurological deficit/dysfunction.\"\n },\n {\n \"VerbatimTerm\": \"mass\",\n \"Probability\": \"0.0008114278\",\n \"SemanticContext\": \"In patients with new neurological signs or symptoms suggestive of an intrathecal mass, consider a neurosurgical consultation, since many of the symptoms of inflammatory mass are not unlike the symptoms experienced by patients with severe spasticity from their disease.\"\n },\n {\n \"VerbatimTerm\": \"mass\",\n \"Probability\": \"0.0008889735\",\n \"SemanticContext\": \"In patients with new neurological signs or symptoms suggestive of an intrathecal mass, consider a neurosurgical consultation, since many of the symptoms of inflammatory mass are not unlike the symptoms experienced by patients with severe spasticity from their disease.\"\n },\n {\n \"VerbatimTerm\": \"mass\",\n \"Probability\": \"0.0006215572\",\n \"SemanticContext\": \"In some cases, performance of an imaging procedure may be appropriate to confirm or rule-out the diagnosis of an intrathecal mass.\"\n },\n {\n \"VerbatimTerm\": \"mass\",\n \"Probability\": \"0.0002408922\",\n \"SemanticContext\": \"\\n 8.4 Pediatric Use Children should be of sufficient body mass to accommodate the implantable pump for chronic infusion.\"\n },\n {\n \"VerbatimTerm\": \"Mass\",\n \"Probability\": \"0.0020875931\",\n \"SemanticContext\": \"5.11 Intrathecal Mass Formation Cases of intrathecal mass at the tip of the implanted catheter have been reported, most of them involving pharmacy compounded analgesic admixtures.\"\n }\n ]\n },\n {\n \"Term\": \"Hypersensitivity\",\n \"MEDDRACode\": \"10020751\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": true,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Hypersensitivity\",\n \"Probability\": \"0.268520385\",\n \"SemanticContext\": \"CONTRAINDICATIONS · Hypersensitivity to baclofen 4 4 .\"\n },\n {\n \"VerbatimTerm\": \"hypersensitivity\",\n \"Probability\": \"0.0056526959\",\n \"SemanticContext\": \"4 CONTRAINDICATIONS GABLOFEN is contraindicated in patients with a hypersensitivity to baclofen.\"\n }\n ]\n },\n {\n \"Term\": \"Posturing\",\n \"MEDDRACode\": \"10036437\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"posture\",\n \"Probability\": \"0.0018803477\",\n \"SemanticContext\": \"· Dose Titration : Spasticity may be necessary to sustain upright posture and balance in locomotion or may be useful to obtain optimal function and care.\"\n },\n {\n \"VerbatimTerm\": \"posture\",\n \"Probability\": \"4.16697E-05\",\n \"SemanticContext\": \"Additional Considerations Pertaining to Dosage Adjustment Careful dose titration of GABLOFEN is needed when spasticity is necessary to sustain upright posture and balance in locomotion or whenever spasticity is used to obtain optimal function and care.\"\n }\n ]\n },\n {\n \"Term\": \"Muscle spasticity\",\n \"MEDDRACode\": \"10028335\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"spasticity\",\n \"Probability\": \"0.736415267\",\n \"SemanticContext\": \"GABLOFEN baclofen injection , for intrathecal use Initial U.S. Approval: 1992 WARNING: DO NOT DISCONTINUE ABRUPTLY See full prescribing information for complete boxed warning Abrupt discontinuation of intrathecal baclofen, regardless of the cause, has resulted in sequelae that include high fever, altered mental status, exaggerated rebound spasticity, and muscle rigidity, that in rare cases has advanced to rhabdomyolysis, multiple organ-system failure and death.\"\n },\n {\n \"VerbatimTerm\": \"spasticity\",\n \"Probability\": \"0.0119492412\",\n \"SemanticContext\": \"5.4 INDICATIONS AND USAGE · GABLOFEN is a gamma-aminobutyric acid GABA ergic agonist indicated for use in the management of severe spasticity of cerebral or spinal origin in adult and pediatric patients age 4 years and above.\"\n },\n {\n \"VerbatimTerm\": \"spasticity\",\n \"Probability\": \"0.0001377463\",\n \"SemanticContext\": \"· Maintenance Therapy : Titrate patients individually; Lowest dose with an optimal response should be used, generally 300 mcg/day to 800 mcg/day for spasticity of spinal cord origin and 90 mcg/day to 700 mcg/day for spasticity of cerebral origin; Titrate GABLOFEN to maintain some degree of muscle tone and allow occasional spasms.\"\n },\n {\n \"VerbatimTerm\": \"spasticity\",\n \"Probability\": \"0.0014446378\",\n \"SemanticContext\": \"· Maintenance Therapy : Titrate patients individually; Lowest dose with an optimal response should be used, generally 300 mcg/day to 800 mcg/day for spasticity of spinal cord origin and 90 mcg/day to 700 mcg/day for spasticity of cerebral origin; Titrate GABLOFEN to maintain some degree of muscle tone and allow occasional spasms.\"\n },\n {\n \"VerbatimTerm\": \"spasticity\",\n \"Probability\": \"0.5288552046\",\n \"SemanticContext\": \"ADVERSE REACTIONS · The most common adverse reactions in patients with spasticity of spinal origin were somnolence, dizziness, nausea, hypotension, headache, convulsions and hypotonia.\"\n },\n {\n \"VerbatimTerm\": \"spasticity\",\n \"Probability\": \"0.6854017973\",\n \"SemanticContext\": \"· The most common adverse reactions in patients with spasticity of cerebral origin were agitation, constipation, somnolence, leukocytosis, chills, urinary retention and hypotonia.\"\n },\n {\n \"VerbatimTerm\": \"spasticity\",\n \"Probability\": \"0.0043002665\",\n \"SemanticContext\": \"Adverse Reactions Associated with Discontinuation of Treatment 8/474 patients with spasticity of spinal cord origin receiving long term infusion of intrathecal baclofen in pre- and post-marketing clinical studies in the U.S. discontinued treatment due to adverse reactions.\"\n },\n {\n \"VerbatimTerm\": \"spasticity\",\n \"Probability\": \"0.086001873\",\n \"SemanticContext\": \"Fatalities Three deaths, none of which were attributed to intrathecal baclofen, were reported in patients in clinical trials involving patients with spasticity of cerebral origin.\"\n },\n {\n \"VerbatimTerm\": \"spasticity\",\n \"Probability\": \"0.1032344699\",\n \"SemanticContext\": \"See Warnings on other deaths reported in spinal spasticity patients.\"\n },\n {\n \"VerbatimTerm\": \"spasticity\",\n \"Probability\": \"0.0180122852\",\n \"SemanticContext\": \"Events Observed during the Pre-marketing Evaluation of Intrathecal Baclofen Adverse events associated with the use of intrathecal baclofen reflect experience gained with a total of 211 U.S. patients with spasticity of cerebral origin, of whom 112 were pediatric patients under age 16 at enrollment .\"\n },\n {\n \"VerbatimTerm\": \"spasticity\",\n \"Probability\": \"0.0016769469\",\n \"SemanticContext\": \"Doses used in this patient population for long-term infusion are generally lower than those required for patients with spasticity of spinal cord origin.\"\n },\n {\n \"VerbatimTerm\": \"spasticity\",\n \"Probability\": \"0.0139607787\",\n \"SemanticContext\": \"14 CLINICAL STUDIES Spasticity of Spinal Cord Origin Evidence supporting the efficacy of intrathecal baclofen was obtained in randomized, controlled investigations that compared the effects of either a single intrathecal dose or a three day intrathecal infusion of intrathecal baclofen to placebo in patients with severe spasticity and spasms due to either spinal cord trauma or multiple sclerosis.\"\n },\n {\n \"VerbatimTerm\": \"spasticity\",\n \"Probability\": \"0.021853745\",\n \"SemanticContext\": \"Intrathecal baclofen was superior to placebo on both principal outcome measures employed: change from baseline in the Ashworth rating of spasticity and the frequency of spasms.\"\n },\n {\n \"VerbatimTerm\": \"spasticity\",\n \"Probability\": \"0.3034094572\",\n \"SemanticContext\": \"Spasticity of Cerebral Origin The efficacy of intrathecal baclofen was investigated in three controlled clinical trials; two enrolled patients with cerebral palsy and one enrolled patients with spasticity due to previous brain injury.\"\n },\n {\n \"VerbatimTerm\": \"spasticity\",\n \"Probability\": \"0.3540015817\",\n \"SemanticContext\": \"The first study, a randomized controlled cross-over trial of 51 patients with cerebral palsy, provided strong, statistically significant results; intrathecal baclofen was superior to placebo in reducing spasticity as measured by the Ashworth Scale.\"\n },\n {\n \"VerbatimTerm\": \"spasticity\",\n \"Probability\": \"0.0067651272\",\n \"SemanticContext\": \"A second cross-over study was conducted in 11 patients with spasticity arising from brain injury.\"\n },\n {\n \"VerbatimTerm\": \"spasticity\",\n \"Probability\": \"8.7503E-06\",\n \"SemanticContext\": \"Additional Considerations Pertaining to Dosage Adjustment Careful dose titration of GABLOFEN is needed when spasticity is necessary to sustain upright posture and balance in locomotion or whenever spasticity is used to obtain optimal function and care.\"\n },\n {\n \"VerbatimTerm\": \"spasticity\",\n \"Probability\": \"0.0003083646\",\n \"SemanticContext\": \"Additional Considerations Pertaining to Dosage Adjustment Careful dose titration of GABLOFEN is needed when spasticity is necessary to sustain upright posture and balance in locomotion or whenever spasticity is used to obtain optimal function and care.\"\n },\n {\n \"VerbatimTerm\": \"spasticity\",\n \"Probability\": \"0.0983365476\",\n \"SemanticContext\": \"Very often, the maintenance dose needs to be adjusted during the first few months of therapy while patients adjust to changes in lifestyle due to the alleviation of spasticity.\"\n },\n {\n \"VerbatimTerm\": \"spasticity\",\n \"Probability\": \"0.0973350108\",\n \"SemanticContext\": \"Very often the maintenance dose needs to be adjusted during the first few months of therapy while patients adjust to changes in lifestyle due to the alleviation of spasticity.\"\n },\n {\n \"VerbatimTerm\": \"spasticity\",\n \"Probability\": \"0.0006586611\",\n \"SemanticContext\": \"Pediatric Patients Use same dosing recommendations for patients with spasticity of cerebral origin.\"\n },\n {\n \"VerbatimTerm\": \"spasticity\",\n \"Probability\": \"0.0193453729\",\n \"SemanticContext\": \"There is not sufficient experience to make firm recommendations for tolerance treatment; however, this “tolerance” has been treated on occasion, in hospital, by a “drug holiday” consisting of the gradual reduction of intrathecal baclofen over a 2 to 4 week period and switching to alternative methods of spasticity management.\"\n },\n {\n \"VerbatimTerm\": \"spasticity\",\n \"Probability\": \"0.0025318563\",\n \"SemanticContext\": \"1 INDICATIONS AND USAGE GABLOFEN is indicated for use in the management of severe spasticity in adult and pediatric patients age 4 years and above.\"\n },\n {\n \"VerbatimTerm\": \"spasticity\",\n \"Probability\": \"0.011868149\",\n \"SemanticContext\": \"For spasticity of spinal cord origin, chronic infusion of GABLOFEN via an implantable pump should be reserved for patients unresponsive to oral baclofen therapy, or those who experience intolerable CNS side effects at effective doses.\"\n },\n {\n \"VerbatimTerm\": \"spasticity\",\n \"Probability\": \"0.0004979968\",\n \"SemanticContext\": \"Patients with spasticity due to traumatic brain injury should wait at least one year after the injury before consideration of long term intrathecal baclofen therapy.\"\n },\n {\n \"VerbatimTerm\": \"spasticity\",\n \"Probability\": \"0.0134831667\",\n \"SemanticContext\": \"Inform patients that early symptoms of GABLOFEN withdrawal may include increased spasticity, itching, and tingling of extremities.\"\n },\n {\n \"VerbatimTerm\": \"spasticity\",\n \"Probability\": \"0.0280512571\",\n \"SemanticContext\": \"Carefully calculate refill intervals to prevent depletion of the reservoir, as this would result in the return of severe spasticity and possibly symptoms of withdrawal.\"\n },\n {\n \"VerbatimTerm\": \"spasticity\",\n \"Probability\": \"0.9424708486\",\n \"SemanticContext\": \"5.5 Withdrawal Abrupt withdrawal of intrathecal baclofen, regardless of the cause, has resulted in sequelae that included high fever, altered mental status, exaggerated rebound spasticity and muscle rigidity that in rare cases progressed to rhabdomyolysis, multiple organ-system failure, and death.\"\n },\n {\n \"VerbatimTerm\": \"spasticity\",\n \"Probability\": \"0.0096406639\",\n \"SemanticContext\": \"Early symptoms of baclofen withdrawal may include return of baseline spasticity, pruritus, hypotension, and paresthesias.\"\n },\n {\n \"VerbatimTerm\": \"spasticity\",\n \"Probability\": \"0.8951638937\",\n \"SemanticContext\": \"As a group, the patients who died were relatively young mean age was 47 with a range from 25 to 63 , but the majority suffered from severe spasticity of many years duration, were nonambulatory, had various medical complications such as pneumonia, urinary tract infections, and decubiti, and/or had received multiple concomitant medications.\"\n },\n {\n \"VerbatimTerm\": \"spasticity\",\n \"Probability\": \"0.0083747506\",\n \"SemanticContext\": \"The most frequent symptoms associated with intrathecal mass are: 1 decreased therapeutic response worsening spasticity, return of spasticity when previously well controlled, withdrawal symptoms, poor response to escalating doses, or frequent or large dosage increases , 2 pain, 3 neurological deficit/dysfunction.\"\n },\n {\n \"VerbatimTerm\": \"spasticity\",\n \"Probability\": \"0.0117048919\",\n \"SemanticContext\": \"The most frequent symptoms associated with intrathecal mass are: 1 decreased therapeutic response worsening spasticity, return of spasticity when previously well controlled, withdrawal symptoms, poor response to escalating doses, or frequent or large dosage increases , 2 pain, 3 neurological deficit/dysfunction.\"\n },\n {\n \"VerbatimTerm\": \"spasticity\",\n \"Probability\": \"0.0028291941\",\n \"SemanticContext\": \"In patients with new neurological signs or symptoms suggestive of an intrathecal mass, consider a neurosurgical consultation, since many of the symptoms of inflammatory mass are not unlike the symptoms experienced by patients with severe spasticity from their disease.\"\n },\n {\n \"VerbatimTerm\": \"Spasticity\",\n \"Probability\": \"0.192415148\",\n \"SemanticContext\": \"· Spasticity due to traumatic brain injury: wait at least one year after injury before considering GABLOFEN therapy.\"\n },\n {\n \"VerbatimTerm\": \"Spasticity\",\n \"Probability\": \"0.0083869994\",\n \"SemanticContext\": \"· Dose Titration : Spasticity may be necessary to sustain upright posture and balance in locomotion or may be useful to obtain optimal function and care.\"\n },\n {\n \"VerbatimTerm\": \"Spasticity\",\n \"Probability\": \"0.5340502858\",\n \"SemanticContext\": \"6 ADVERSE REACTIONS 6.1 Spasticity of Spinal Cord Origin Most Common Adverse Reactions in Patients with Spasticity of Spinal Origin In pre- and post-marketing clinical trials, the most common adverse reactions associated with use of intrathecal baclofen which were not seen at an equivalent incidence among placebo-treated patients were: somnolence, dizziness, nausea, hypotension, headache, convulsions and hypotonia.\"\n },\n {\n \"VerbatimTerm\": \"Spasticity\",\n \"Probability\": \"0.0030314922\",\n \"SemanticContext\": \"6 ADVERSE REACTIONS 6.1 Spasticity of Spinal Cord Origin Most Common Adverse Reactions in Patients with Spasticity of Spinal Origin In pre- and post-marketing clinical trials, the most common adverse reactions associated with use of intrathecal baclofen which were not seen at an equivalent incidence among placebo-treated patients were: somnolence, dizziness, nausea, hypotension, headache, convulsions and hypotonia.\"\n },\n {\n \"VerbatimTerm\": \"Spasticity\",\n \"Probability\": \"0.0071312189\",\n \"SemanticContext\": \"Table 1: Most Common =1% Adverse Reactions in Patients with Spasticity of Spinal Origin in Prospectively Monitored Clinical Trials Adverse Reactions Percent N=576 Screening Percent N=474 Titration† Percent N=430 Maintenance ‡ Hypotonia 5.4 13.5 25.3 Somnolence 5.7 5.9 20.9 Dizziness 1.7 1.9 7.9 Paresthesia 2.4 2.1 6.7 Nausea and Vomiting 1.6 2.3 5.6 Headache 1.6 2.5 5.1 Constipation 0.2 1.5 5.1 Convulsion 0.5 1.3 4.7 Urinary Retention 0.7 1.7 1.9 Dry Mouth 0.2 0.4 3.3 Accidental Injury 0.0 0.2 3.5 Asthenia 0.7 1.3 1.4 Confusion 0.5 0.6 2.3 Death 0.2 0.4 3.0 Pain 0.0 0.6 3.0 Speech Disorder 0.0 0.2 3.5 Hypotension 1.0 0.2 1.9 Ambylopia 0.5 0.2 2.3 Diarrhea 0.0 0.8 2.3 Hypoventilation 0.2 0.8 2.1 Coma 0.0 1.5 0.9 Impotence 0.2 0.4 1.6 Peripheral Edema 0.0 0.0 2.3 Urinary Incontinence 0.0 0.8 1.4 Insomnia 0.0 0.4 1.6 Anxiety 0.2 0.4 0.9 Depression 0.0 0.0 1.6 Dypsnea 0.3 0.0 1.2 Fever 0.5 0.2 0.7 Pneumonia 0.2 0.2 1.2 Urinary Frequency 0.0 0.6 0.9 Urticaria 0.2 0.2 1.2 Anorexia 0.0 0.4 0.9 Diplopia 0.0 0.4 0.9 Dysautonomia 0.2 0.2 0.9 Hallucinations 0.3 0.4 0.5 Hypertension 0.2 0.6 0.5 .\"\n },\n {\n \"VerbatimTerm\": \"Spasticity\",\n \"Probability\": \"0.2582484484\",\n \"SemanticContext\": \"6.2 Spasticity of Cerebral Origin Most Common Adverse Reactions In pre-marketing clinical trials, the most common adverse reactions associated with use of intrathecal baclofen which were not seen at an equivalent incidence among placebo-treated patients included: agitation, constipation, somnolence, leukocytosis, chills, urinary retention and hypotonia.\"\n },\n {\n \"VerbatimTerm\": \"Spasticity\",\n \"Probability\": \"0.0154060721\",\n \"SemanticContext\": \"Table 2: Most Common =1% Adverse Reactions in Patients with Spasticity of Cerebral Origin Adverse Reactions Percent N=211 Screening* Percent N=153 Titration† Percent N=150 Maintenance ‡ Hypotonia 2.4 14.4 34.7 Somnolence 7.6 10.5 18.7 Headache 6.6 7.8 10.7 Nausea and Vomiting 6.6 10.5 4.0 Vomiting 6.2 8.5 4.0 Urinary Retention 0.9 6.5 8.0 Convulsion 0.9 3.3 10.0 Dizziness 2.4 2.6 8.0 Nausea 1.4 3.3 7.3 Hypoventilation 1.4 1.3 4.0 Hypertonia 0.0 0.7 6.0 Paresthesia 1.9 0.7 3.3 Hypotension 1.9 0.7 2.0 Increased Salivation 0.0 2.6 2.7 Back Pain 0.9 0.7 2.0 Constipation 0.5 1.3 2.0 Pain 0.0 0.0 4.0 Pruritus 0.0 0.0 4.0 Diarrhea 0.5 0.7 2.0 Peripheral Edema 0.0 0.0 3.3 Thinking Abnormal 0.5 1.3 0.7 Agitation 0.5 0.0 1.3 Asthenia 0.0 0.0 2.0 Chills 0.5 0.0 1.3 Coma 0.5 0.0 1.3 Dry Mouth 0.5 0.0 1.3 Pneumonia 0.0 0.0 2.0 Speech Disorder 0.5 0.7 0.7 Tremor 0.5 0.0 1.3 Urinary Incontinence 0.0 0.0 2.0 Urination Impaired 0.0 0.0 2.0 .\"\n },\n {\n \"VerbatimTerm\": \"Spasticity\",\n \"Probability\": \"0.3436486125\",\n \"SemanticContext\": \"14 CLINICAL STUDIES Spasticity of Spinal Cord Origin Evidence supporting the efficacy of intrathecal baclofen was obtained in randomized, controlled investigations that compared the effects of either a single intrathecal dose or a three day intrathecal infusion of intrathecal baclofen to placebo in patients with severe spasticity and spasms due to either spinal cord trauma or multiple sclerosis.\"\n },\n {\n \"VerbatimTerm\": \"Spasticity\",\n \"Probability\": \"0.062143892\",\n \"SemanticContext\": \"Spasticity of Cerebral Origin The efficacy of intrathecal baclofen was investigated in three controlled clinical trials; two enrolled patients with cerebral palsy and one enrolled patients with spasticity due to previous brain injury.\"\n },\n {\n \"VerbatimTerm\": \"Spasticity\",\n \"Probability\": \"0.0002013147\",\n \"SemanticContext\": \"Adult Patients with Spasticity of Spinal Cord Origin After the first 24 hours, for adult patients, the daily dosage should be increased slowly by 10% to 30% increments and only once every 24 hours, until the desired clinical effect is achieved.\"\n },\n {\n \"VerbatimTerm\": \"Spasticity\",\n \"Probability\": \"0.0007250309\",\n \"SemanticContext\": \"Adult Patients with Spasticity of Cerebral Origin After the first 24 hours, the daily dose should be increased slowly by 5% to 15% only once every 24 hours, until the desired clinical effect is achieved.\"\n },\n {\n \"VerbatimTerm\": \"Spasticity\",\n \"Probability\": \"0.0016829669\",\n \"SemanticContext\": \"2.6 Maintenance Therapy Spasticity of Spinal Cord Origin Patients The clinical goal is to maintain muscle tone as close to normal as possible, and to minimize the frequency and severity of spasms to the extent possible, without inducing intolerable side effects.\"\n },\n {\n \"VerbatimTerm\": \"Spasticity\",\n \"Probability\": \"0.0531773865\",\n \"SemanticContext\": \"Spasticity of Cerebral Origin Patients The clinical goal is to maintain muscle tone as close to normal as possible and to minimize the frequency and severity of spasms to the extent possible, without inducing intolerable side effects, or to titrate the dose to the desired degree of muscle tone for optimal functions.\"\n },\n {\n \"VerbatimTerm\": \"Spasticity\",\n \"Probability\": \"0.4099370241\",\n \"SemanticContext\": \"5.7 Fatalities Spasticity of Spinal Cord Origin There were 16 deaths reported among the 576 U.S. patients treated with intrathecal baclofen in pre- and post-marketing studies evaluated as of December 1992.\"\n },\n {\n \"VerbatimTerm\": \"Spasticity\",\n \"Probability\": \"0.3854193091\",\n \"SemanticContext\": \"Spasticity of Cerebral Origin There were three deaths occurring among the 211 patients treated with intrathecal baclofen in pre-marketing studies as of March 1996.\"\n }\n ]\n },\n {\n \"Term\": \"Coagulopathy\",\n \"MEDDRACode\": \"10009802\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"coagulopathy\",\n \"Probability\": \"0.7077948451\",\n \"SemanticContext\": \"His medical history included spinal cord injury, aspiration pneumonia, septic shock, disseminated intravascular coagulopathy, severe metabolic acidosis, hepatic toxicity, and status epilepticus.\"\n }\n ]\n },\n {\n \"Term\": \"Emotional distress\",\n \"MEDDRACode\": \"10049119\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"suffering\",\n \"Probability\": \"0.2932106853\",\n \"SemanticContext\": \"5.6 Possible Exacerbation of Psychotic Disorders, Schizophrenia, or Confusional States Patients suffering from psychotic disorders, schizophrenia, or confusional states should be treated cautiously with GABLOFEN and kept under careful surveillance, because exacerbations of these conditions have been observed with oral administration.\"\n },\n {\n \"VerbatimTerm\": \"suffered\",\n \"Probability\": \"0.3947143555\",\n \"SemanticContext\": \"As a group, the patients who died were relatively young mean age was 47 with a range from 25 to 63 , but the majority suffered from severe spasticity of many years duration, were nonambulatory, had various medical complications such as pneumonia, urinary tract infections, and decubiti, and/or had received multiple concomitant medications.\"\n }\n ]\n },\n {\n \"Term\": \"Investigation\",\n \"MEDDRACode\": \"10062026\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"investigations\",\n \"Probability\": \"0.0006371737\",\n \"SemanticContext\": \"14 CLINICAL STUDIES Spasticity of Spinal Cord Origin Evidence supporting the efficacy of intrathecal baclofen was obtained in randomized, controlled investigations that compared the effects of either a single intrathecal dose or a three day intrathecal infusion of intrathecal baclofen to placebo in patients with severe spasticity and spasms due to either spinal cord trauma or multiple sclerosis.\"\n }\n ]\n },\n {\n \"Term\": \"Dizziness\",\n \"MEDDRACode\": \"10013573\",\n \"Overdose\": true,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"dizziness\",\n \"Probability\": \"0.9735876322\",\n \"SemanticContext\": \"· Overdose may cause drowsiness, lightheadedness, dizziness, somnolence, respiratory depression, seizures, rostral progression of hypotonia and loss of consciousness progressing to coma.\"\n },\n {\n \"VerbatimTerm\": \"dizziness\",\n \"Probability\": \"0.99961555\",\n \"SemanticContext\": \"ADVERSE REACTIONS · The most common adverse reactions in patients with spasticity of spinal origin were somnolence, dizziness, nausea, hypotension, headache, convulsions and hypotonia.\"\n },\n {\n \"VerbatimTerm\": \"dizziness\",\n \"Probability\": \"0.9999194741\",\n \"SemanticContext\": \"6 ADVERSE REACTIONS 6.1 Spasticity of Spinal Cord Origin Most Common Adverse Reactions in Patients with Spasticity of Spinal Origin In pre- and post-marketing clinical trials, the most common adverse reactions associated with use of intrathecal baclofen which were not seen at an equivalent incidence among placebo-treated patients were: somnolence, dizziness, nausea, hypotension, headache, convulsions and hypotonia.\"\n },\n {\n \"VerbatimTerm\": \"dizziness\",\n \"Probability\": \"0.9997142553\",\n \"SemanticContext\": \"The following events occurred among the 31 patients receiving intrathecal baclofen in two randomized, placebo-controlled trials: hypotension 2 , dizziness 2 , headache 2 , dyspnea 1 .\"\n },\n {\n \"VerbatimTerm\": \"dizziness\",\n \"Probability\": \"0.9977505803\",\n \"SemanticContext\": \"Nonetheless, many of the more commonly reported reactions -- hypotonia, somnolence, dizziness, paresthesia, nausea/vomiting and headache -- appear clearly drug-related.\"\n },\n {\n \"VerbatimTerm\": \"dizziness\",\n \"Probability\": \"0.9986176491\",\n \"SemanticContext\": \"Nonetheless, many of the more commonly reported reactions -- somnolence, dizziness, headache, nausea, hypotension, hypotonia and coma -- appear clearly drug-related.\"\n },\n {\n \"VerbatimTerm\": \"dizziness\",\n \"Probability\": \"0.0390752256\",\n \"SemanticContext\": \"GABLOFEN Overdose Inform patients and their caregivers that GABLOFEN overdose may occur suddenly or insidiously, and that symptoms may include confusion, drowsiness, lightheadedness, dizziness, slow or shallow breathing, seizures, loss of muscle tone, loss of consciousness, and coma.\"\n },\n {\n \"VerbatimTerm\": \"dizziness\",\n \"Probability\": \"0.9674178958\",\n \"SemanticContext\": \"Symptoms of Intrathecal Baclofen Overdose Drowsiness, lightheadedness, dizziness, somnolence, respiratory depression, seizures, rostral progression of hypotonia and loss of consciousness progressing to coma of up to 72 hours duration.\"\n },\n {\n \"VerbatimTerm\": \"dizziness\",\n \"Probability\": \"0.7855550051\",\n \"SemanticContext\": \"Less sudden and/or less severe forms of overdose may present with signs of drowsiness, lightheadedness, dizziness, somnolence, respiratory depression, seizures, rostral progression of hypotonia and loss of consciousness progressing to coma.\"\n },\n {\n \"VerbatimTerm\": \"Dizziness\",\n \"Probability\": \"0.9997502565\",\n \"SemanticContext\": \"Table 1: Most Common =1% Adverse Reactions in Patients with Spasticity of Spinal Origin in Prospectively Monitored Clinical Trials Adverse Reactions Percent N=576 Screening Percent N=474 Titration† Percent N=430 Maintenance ‡ Hypotonia 5.4 13.5 25.3 Somnolence 5.7 5.9 20.9 Dizziness 1.7 1.9 7.9 Paresthesia 2.4 2.1 6.7 Nausea and Vomiting 1.6 2.3 5.6 Headache 1.6 2.5 5.1 Constipation 0.2 1.5 5.1 Convulsion 0.5 1.3 4.7 Urinary Retention 0.7 1.7 1.9 Dry Mouth 0.2 0.4 3.3 Accidental Injury 0.0 0.2 3.5 Asthenia 0.7 1.3 1.4 Confusion 0.5 0.6 2.3 Death 0.2 0.4 3.0 Pain 0.0 0.6 3.0 Speech Disorder 0.0 0.2 3.5 Hypotension 1.0 0.2 1.9 Ambylopia 0.5 0.2 2.3 Diarrhea 0.0 0.8 2.3 Hypoventilation 0.2 0.8 2.1 Coma 0.0 1.5 0.9 Impotence 0.2 0.4 1.6 Peripheral Edema 0.0 0.0 2.3 Urinary Incontinence 0.0 0.8 1.4 Insomnia 0.0 0.4 1.6 Anxiety 0.2 0.4 0.9 Depression 0.0 0.0 1.6 Dypsnea 0.3 0.0 1.2 Fever 0.5 0.2 0.7 Pneumonia 0.2 0.2 1.2 Urinary Frequency 0.0 0.6 0.9 Urticaria 0.2 0.2 1.2 Anorexia 0.0 0.4 0.9 Diplopia 0.0 0.4 0.9 Dysautonomia 0.2 0.2 0.9 Hallucinations 0.3 0.4 0.5 Hypertension 0.2 0.6 0.5 .\"\n },\n {\n \"VerbatimTerm\": \"Dizziness\",\n \"Probability\": \"0.9996339083\",\n \"SemanticContext\": \"Table 2: Most Common =1% Adverse Reactions in Patients with Spasticity of Cerebral Origin Adverse Reactions Percent N=211 Screening* Percent N=153 Titration† Percent N=150 Maintenance ‡ Hypotonia 2.4 14.4 34.7 Somnolence 7.6 10.5 18.7 Headache 6.6 7.8 10.7 Nausea and Vomiting 6.6 10.5 4.0 Vomiting 6.2 8.5 4.0 Urinary Retention 0.9 6.5 8.0 Convulsion 0.9 3.3 10.0 Dizziness 2.4 2.6 8.0 Nausea 1.4 3.3 7.3 Hypoventilation 1.4 1.3 4.0 Hypertonia 0.0 0.7 6.0 Paresthesia 1.9 0.7 3.3 Hypotension 1.9 0.7 2.0 Increased Salivation 0.0 2.6 2.7 Back Pain 0.9 0.7 2.0 Constipation 0.5 1.3 2.0 Pain 0.0 0.0 4.0 Pruritus 0.0 0.0 4.0 Diarrhea 0.5 0.7 2.0 Peripheral Edema 0.0 0.0 3.3 Thinking Abnormal 0.5 1.3 0.7 Agitation 0.5 0.0 1.3 Asthenia 0.0 0.0 2.0 Chills 0.5 0.0 1.3 Coma 0.5 0.0 1.3 Dry Mouth 0.5 0.0 1.3 Pneumonia 0.0 0.0 2.0 Speech Disorder 0.5 0.7 0.7 Tremor 0.5 0.0 1.3 Urinary Incontinence 0.0 0.0 2.0 Urination Impaired 0.0 0.0 2.0 .\"\n }\n ]\n },\n {\n \"Term\": \"Respiratory depression\",\n \"MEDDRACode\": \"10038678\",\n \"Overdose\": true,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"respiratory depression\",\n \"Probability\": \"0.9667945504\",\n \"SemanticContext\": \"· Overdose may cause drowsiness, lightheadedness, dizziness, somnolence, respiratory depression, seizures, rostral progression of hypotonia and loss of consciousness progressing to coma.\"\n },\n {\n \"VerbatimTerm\": \"respiratory depression\",\n \"Probability\": \"0.9617540836\",\n \"SemanticContext\": \"Symptoms of Intrathecal Baclofen Overdose Drowsiness, lightheadedness, dizziness, somnolence, respiratory depression, seizures, rostral progression of hypotonia and loss of consciousness progressing to coma of up to 72 hours duration.\"\n },\n {\n \"VerbatimTerm\": \"respiratory depression\",\n \"Probability\": \"0.001342237\",\n \"SemanticContext\": \"2 Patients with respiratory depression should be intubated if necessary, until the drug is eliminated.\"\n },\n {\n \"VerbatimTerm\": \"respiratory depression\",\n \"Probability\": \"0.0877860785\",\n \"SemanticContext\": \"Anecdotal reports suggest that intravenous physostigmine may reverse central side effects, notably drowsiness and respiratory depression.\"\n },\n {\n \"VerbatimTerm\": \"respiratory depression\",\n \"Probability\": \"0.8668707609\",\n \"SemanticContext\": \"Less sudden and/or less severe forms of overdose may present with signs of drowsiness, lightheadedness, dizziness, somnolence, respiratory depression, seizures, rostral progression of hypotonia and loss of consciousness progressing to coma.\"\n }\n ]\n },\n {\n \"Term\": \"Craniocerebral injury\",\n \"MEDDRACode\": \"10070976\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"traumatic brain injury\",\n \"Probability\": \"0.5377733707\",\n \"SemanticContext\": \"· Spasticity due to traumatic brain injury: wait at least one year after injury before considering GABLOFEN therapy.\"\n },\n {\n \"VerbatimTerm\": \"traumatic brain injury\",\n \"Probability\": \"0.0066966414\",\n \"SemanticContext\": \"Patients with spasticity due to traumatic brain injury should wait at least one year after the injury before consideration of long term intrathecal baclofen therapy.\"\n }\n ]\n },\n {\n \"Term\": \"Brain injury\",\n \"MEDDRACode\": \"10067967\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"brain injury\",\n \"Probability\": \"0.1828480959\",\n \"SemanticContext\": \"Spasticity of Cerebral Origin The efficacy of intrathecal baclofen was investigated in three controlled clinical trials; two enrolled patients with cerebral palsy and one enrolled patients with spasticity due to previous brain injury.\"\n },\n {\n \"VerbatimTerm\": \"brain injury\",\n \"Probability\": \"0.0087846816\",\n \"SemanticContext\": \"A second cross-over study was conducted in 11 patients with spasticity arising from brain injury.\"\n }\n ]\n },\n {\n \"Term\": \"Nervousness\",\n \"MEDDRACode\": \"10029216\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"nervous\",\n \"Probability\": \"1.89346E-05\",\n \"SemanticContext\": \"· GABLOFEN should be reserved for patients unresponsive to oral baclofen therapy, or those who experience intolerable central nervous system side effects at effective doses.\"\n },\n {\n \"VerbatimTerm\": \"nervous\",\n \"Probability\": \"0.0100182593\",\n \"SemanticContext\": \"Rapid, accurate diagnosis and treatment in an emergency-room or intensive-care setting are important in order to prevent the potentially life-threatening central nervous system and systemic effects of intrathecal baclofen withdrawal.\"\n },\n {\n \"VerbatimTerm\": \"nervous\",\n \"Probability\": \"0.0002083778\",\n \"SemanticContext\": \"Patients should also be cautioned that the central nervous system depressant effects of intrathecal baclofen may be additive to those of alcohol and other CNS depressants.\"\n },\n {\n \"VerbatimTerm\": \"Nervous\",\n \"Probability\": \"0.9267116189\",\n \"SemanticContext\": \"The following adverse reactions, not described in the table, and arranged in decreasing order of frequency, and classified by body system, were reported: Nervous System: Abnormal gait, thinking abnormal, tremor, amnesia, twitching, vasodilatation, cerebrovascular accident, nystagmus, personality disorder, psychotic depression, cerebral ischemia, emotional lability, euphoria, hypertonia, ileus, drug dependence, incoordination, paranoid reaction and ptosis.\"\n },\n {\n \"VerbatimTerm\": \"Nervous\",\n \"Probability\": \"0.9461452365\",\n \"SemanticContext\": \"In the total cohort, the following adverse reactions, not described in Table 2, and arranged in decreasing order of frequency, and classified by body system, were reported: Nervous System: Akathisia, ataxia, confusion, depression, opisthotonos, amnesia, anxiety, hallucinations, hysteria, insomnia, nystagmus, personality disorder, reflexes decreased, and vasodilitation.\"\n }\n ]\n },\n {\n \"Term\": \"Headache\",\n \"MEDDRACode\": \"10019211\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"headache\",\n \"Probability\": \"0.9995565414\",\n \"SemanticContext\": \"ADVERSE REACTIONS · The most common adverse reactions in patients with spasticity of spinal origin were somnolence, dizziness, nausea, hypotension, headache, convulsions and hypotonia.\"\n },\n {\n \"VerbatimTerm\": \"headache\",\n \"Probability\": \"0.9996130466\",\n \"SemanticContext\": \"6 ADVERSE REACTIONS 6.1 Spasticity of Spinal Cord Origin Most Common Adverse Reactions in Patients with Spasticity of Spinal Origin In pre- and post-marketing clinical trials, the most common adverse reactions associated with use of intrathecal baclofen which were not seen at an equivalent incidence among placebo-treated patients were: somnolence, dizziness, nausea, hypotension, headache, convulsions and hypotonia.\"\n },\n {\n \"VerbatimTerm\": \"headache\",\n \"Probability\": \"0.9996160269\",\n \"SemanticContext\": \"The following events occurred among the 31 patients receiving intrathecal baclofen in two randomized, placebo-controlled trials: hypotension 2 , dizziness 2 , headache 2 , dyspnea 1 .\"\n },\n {\n \"VerbatimTerm\": \"headache\",\n \"Probability\": \"0.9522145987\",\n \"SemanticContext\": \"Nonetheless, many of the more commonly reported reactions -- hypotonia, somnolence, dizziness, paresthesia, nausea/vomiting and headache -- appear clearly drug-related.\"\n },\n {\n \"VerbatimTerm\": \"headache\",\n \"Probability\": \"0.9992134571\",\n \"SemanticContext\": \"Nonetheless, many of the more commonly reported reactions -- somnolence, dizziness, headache, nausea, hypotension, hypotonia and coma -- appear clearly drug-related.\"\n },\n {\n \"VerbatimTerm\": \"Headache\",\n \"Probability\": \"0.9996703863\",\n \"SemanticContext\": \"Table 1: Most Common =1% Adverse Reactions in Patients with Spasticity of Spinal Origin in Prospectively Monitored Clinical Trials Adverse Reactions Percent N=576 Screening Percent N=474 Titration† Percent N=430 Maintenance ‡ Hypotonia 5.4 13.5 25.3 Somnolence 5.7 5.9 20.9 Dizziness 1.7 1.9 7.9 Paresthesia 2.4 2.1 6.7 Nausea and Vomiting 1.6 2.3 5.6 Headache 1.6 2.5 5.1 Constipation 0.2 1.5 5.1 Convulsion 0.5 1.3 4.7 Urinary Retention 0.7 1.7 1.9 Dry Mouth 0.2 0.4 3.3 Accidental Injury 0.0 0.2 3.5 Asthenia 0.7 1.3 1.4 Confusion 0.5 0.6 2.3 Death 0.2 0.4 3.0 Pain 0.0 0.6 3.0 Speech Disorder 0.0 0.2 3.5 Hypotension 1.0 0.2 1.9 Ambylopia 0.5 0.2 2.3 Diarrhea 0.0 0.8 2.3 Hypoventilation 0.2 0.8 2.1 Coma 0.0 1.5 0.9 Impotence 0.2 0.4 1.6 Peripheral Edema 0.0 0.0 2.3 Urinary Incontinence 0.0 0.8 1.4 Insomnia 0.0 0.4 1.6 Anxiety 0.2 0.4 0.9 Depression 0.0 0.0 1.6 Dypsnea 0.3 0.0 1.2 Fever 0.5 0.2 0.7 Pneumonia 0.2 0.2 1.2 Urinary Frequency 0.0 0.6 0.9 Urticaria 0.2 0.2 1.2 Anorexia 0.0 0.4 0.9 Diplopia 0.0 0.4 0.9 Dysautonomia 0.2 0.2 0.9 Hallucinations 0.3 0.4 0.5 Hypertension 0.2 0.6 0.5 .\"\n },\n {\n \"VerbatimTerm\": \"Headache\",\n \"Probability\": \"0.9997912645\",\n \"SemanticContext\": \"Table 2: Most Common =1% Adverse Reactions in Patients with Spasticity of Cerebral Origin Adverse Reactions Percent N=211 Screening* Percent N=153 Titration† Percent N=150 Maintenance ‡ Hypotonia 2.4 14.4 34.7 Somnolence 7.6 10.5 18.7 Headache 6.6 7.8 10.7 Nausea and Vomiting 6.6 10.5 4.0 Vomiting 6.2 8.5 4.0 Urinary Retention 0.9 6.5 8.0 Convulsion 0.9 3.3 10.0 Dizziness 2.4 2.6 8.0 Nausea 1.4 3.3 7.3 Hypoventilation 1.4 1.3 4.0 Hypertonia 0.0 0.7 6.0 Paresthesia 1.9 0.7 3.3 Hypotension 1.9 0.7 2.0 Increased Salivation 0.0 2.6 2.7 Back Pain 0.9 0.7 2.0 Constipation 0.5 1.3 2.0 Pain 0.0 0.0 4.0 Pruritus 0.0 0.0 4.0 Diarrhea 0.5 0.7 2.0 Peripheral Edema 0.0 0.0 3.3 Thinking Abnormal 0.5 1.3 0.7 Agitation 0.5 0.0 1.3 Asthenia 0.0 0.0 2.0 Chills 0.5 0.0 1.3 Coma 0.5 0.0 1.3 Dry Mouth 0.5 0.0 1.3 Pneumonia 0.0 0.0 2.0 Speech Disorder 0.5 0.7 0.7 Tremor 0.5 0.0 1.3 Urinary Incontinence 0.0 0.0 2.0 Urination Impaired 0.0 0.0 2.0 .\"\n }\n ]\n },\n {\n \"Term\": \"Pyrexia\",\n \"MEDDRACode\": \"10037660\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"fever\",\n \"Probability\": \"0.9985747337\",\n \"SemanticContext\": \"GABLOFEN baclofen injection , for intrathecal use Initial U.S. Approval: 1992 WARNING: DO NOT DISCONTINUE ABRUPTLY See full prescribing information for complete boxed warning Abrupt discontinuation of intrathecal baclofen, regardless of the cause, has resulted in sequelae that include high fever, altered mental status, exaggerated rebound spasticity, and muscle rigidity, that in rare cases has advanced to rhabdomyolysis, multiple organ-system failure and death.\"\n },\n {\n \"VerbatimTerm\": \"fever\",\n \"Probability\": \"0.9998000264\",\n \"SemanticContext\": \"Body as a Whole: Death, fever, abdominal pain, carcinoma, malaise and hypothermia.\"\n },\n {\n \"VerbatimTerm\": \"fever\",\n \"Probability\": \"0.8317830563\",\n \"SemanticContext\": \"17 PATIENT COUNSELING INFORMATION Risks Related to Sudden Withdrawal of GABLOFEN Advise patients and caregivers that sudden withdrawal of GABLOFEN, regardless of the cause, can result in serious complications that include high fever, confusion, muscle stiffness, multiple organ-system failure, and death.\"\n },\n {\n \"VerbatimTerm\": \"fever\",\n \"Probability\": \"0.9981570244\",\n \"SemanticContext\": \"5.5 Withdrawal Abrupt withdrawal of intrathecal baclofen, regardless of the cause, has resulted in sequelae that included high fever, altered mental status, exaggerated rebound spasticity and muscle rigidity that in rare cases progressed to rhabdomyolysis, multiple organ-system failure, and death.\"\n },\n {\n \"VerbatimTerm\": \"Fever\",\n \"Probability\": \"0.9995969534\",\n \"SemanticContext\": \"Table 1: Most Common =1% Adverse Reactions in Patients with Spasticity of Spinal Origin in Prospectively Monitored Clinical Trials Adverse Reactions Percent N=576 Screening Percent N=474 Titration† Percent N=430 Maintenance ‡ Hypotonia 5.4 13.5 25.3 Somnolence 5.7 5.9 20.9 Dizziness 1.7 1.9 7.9 Paresthesia 2.4 2.1 6.7 Nausea and Vomiting 1.6 2.3 5.6 Headache 1.6 2.5 5.1 Constipation 0.2 1.5 5.1 Convulsion 0.5 1.3 4.7 Urinary Retention 0.7 1.7 1.9 Dry Mouth 0.2 0.4 3.3 Accidental Injury 0.0 0.2 3.5 Asthenia 0.7 1.3 1.4 Confusion 0.5 0.6 2.3 Death 0.2 0.4 3.0 Pain 0.0 0.6 3.0 Speech Disorder 0.0 0.2 3.5 Hypotension 1.0 0.2 1.9 Ambylopia 0.5 0.2 2.3 Diarrhea 0.0 0.8 2.3 Hypoventilation 0.2 0.8 2.1 Coma 0.0 1.5 0.9 Impotence 0.2 0.4 1.6 Peripheral Edema 0.0 0.0 2.3 Urinary Incontinence 0.0 0.8 1.4 Insomnia 0.0 0.4 1.6 Anxiety 0.2 0.4 0.9 Depression 0.0 0.0 1.6 Dypsnea 0.3 0.0 1.2 Fever 0.5 0.2 0.7 Pneumonia 0.2 0.2 1.2 Urinary Frequency 0.0 0.6 0.9 Urticaria 0.2 0.2 1.2 Anorexia 0.0 0.4 0.9 Diplopia 0.0 0.4 0.9 Dysautonomia 0.2 0.2 0.9 Hallucinations 0.3 0.4 0.5 Hypertension 0.2 0.6 0.5 .\"\n }\n ]\n },\n {\n \"Term\": \"Rhabdomyolysis\",\n \"MEDDRACode\": \"10039020\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"rhabdomyolysis\",\n \"Probability\": \"0.6672228575\",\n \"SemanticContext\": \"GABLOFEN baclofen injection , for intrathecal use Initial U.S. Approval: 1992 WARNING: DO NOT DISCONTINUE ABRUPTLY See full prescribing information for complete boxed warning Abrupt discontinuation of intrathecal baclofen, regardless of the cause, has resulted in sequelae that include high fever, altered mental status, exaggerated rebound spasticity, and muscle rigidity, that in rare cases has advanced to rhabdomyolysis, multiple organ-system failure and death.\"\n },\n {\n \"VerbatimTerm\": \"rhabdomyolysis\",\n \"Probability\": \"0.7417690158\",\n \"SemanticContext\": \"5.5 Withdrawal Abrupt withdrawal of intrathecal baclofen, regardless of the cause, has resulted in sequelae that included high fever, altered mental status, exaggerated rebound spasticity and muscle rigidity that in rare cases progressed to rhabdomyolysis, multiple organ-system failure, and death.\"\n },\n {\n \"VerbatimTerm\": \"rhabdomyolysis\",\n \"Probability\": \"0.3697875142\",\n \"SemanticContext\": \"Some clinical characteristics of the advanced intrathecal baclofen withdrawal syndrome may resemble autonomic dysreflexia, infection sepsis , malignant hyperthermia, neuroleptic-malignant syndrome, or other conditions associated with a hypermetabolic state or widespread rhabdomyolysis.\"\n }\n ]\n },\n {\n \"Term\": \"Urinary retention\",\n \"MEDDRACode\": \"10046555\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"urinary retention\",\n \"Probability\": \"0.9900952578\",\n \"SemanticContext\": \"· The most common adverse reactions in patients with spasticity of cerebral origin were agitation, constipation, somnolence, leukocytosis, chills, urinary retention and hypotonia.\"\n },\n {\n \"VerbatimTerm\": \"urinary retention\",\n \"Probability\": \"0.9894291162\",\n \"SemanticContext\": \"6.2 Spasticity of Cerebral Origin Most Common Adverse Reactions In pre-marketing clinical trials, the most common adverse reactions associated with use of intrathecal baclofen which were not seen at an equivalent incidence among placebo-treated patients included: agitation, constipation, somnolence, leukocytosis, chills, urinary retention and hypotonia.\"\n },\n {\n \"VerbatimTerm\": \"urinary retention\",\n \"Probability\": \"0.9887657166\",\n \"SemanticContext\": \"The following adverse reactions occurred among the 62 patients receiving intrathecal baclofen in two randomized, placebo-controlled trials involving cerebral palsy and head injury patients, respectively: agitation, constipation, somnolence, leukocytosis, nausea, vomiting, nystagmus, chills, urinary retention, and hypotonia.\"\n },\n {\n \"VerbatimTerm\": \"Urinary Retention\",\n \"Probability\": \"0.998337388\",\n \"SemanticContext\": \"Table 1: Most Common =1% Adverse Reactions in Patients with Spasticity of Spinal Origin in Prospectively Monitored Clinical Trials Adverse Reactions Percent N=576 Screening Percent N=474 Titration† Percent N=430 Maintenance ‡ Hypotonia 5.4 13.5 25.3 Somnolence 5.7 5.9 20.9 Dizziness 1.7 1.9 7.9 Paresthesia 2.4 2.1 6.7 Nausea and Vomiting 1.6 2.3 5.6 Headache 1.6 2.5 5.1 Constipation 0.2 1.5 5.1 Convulsion 0.5 1.3 4.7 Urinary Retention 0.7 1.7 1.9 Dry Mouth 0.2 0.4 3.3 Accidental Injury 0.0 0.2 3.5 Asthenia 0.7 1.3 1.4 Confusion 0.5 0.6 2.3 Death 0.2 0.4 3.0 Pain 0.0 0.6 3.0 Speech Disorder 0.0 0.2 3.5 Hypotension 1.0 0.2 1.9 Ambylopia 0.5 0.2 2.3 Diarrhea 0.0 0.8 2.3 Hypoventilation 0.2 0.8 2.1 Coma 0.0 1.5 0.9 Impotence 0.2 0.4 1.6 Peripheral Edema 0.0 0.0 2.3 Urinary Incontinence 0.0 0.8 1.4 Insomnia 0.0 0.4 1.6 Anxiety 0.2 0.4 0.9 Depression 0.0 0.0 1.6 Dypsnea 0.3 0.0 1.2 Fever 0.5 0.2 0.7 Pneumonia 0.2 0.2 1.2 Urinary Frequency 0.0 0.6 0.9 Urticaria 0.2 0.2 1.2 Anorexia 0.0 0.4 0.9 Diplopia 0.0 0.4 0.9 Dysautonomia 0.2 0.2 0.9 Hallucinations 0.3 0.4 0.5 Hypertension 0.2 0.6 0.5 .\"\n },\n {\n \"VerbatimTerm\": \"Urinary Retention\",\n \"Probability\": \"0.9985831976\",\n \"SemanticContext\": \"Table 2: Most Common =1% Adverse Reactions in Patients with Spasticity of Cerebral Origin Adverse Reactions Percent N=211 Screening* Percent N=153 Titration† Percent N=150 Maintenance ‡ Hypotonia 2.4 14.4 34.7 Somnolence 7.6 10.5 18.7 Headache 6.6 7.8 10.7 Nausea and Vomiting 6.6 10.5 4.0 Vomiting 6.2 8.5 4.0 Urinary Retention 0.9 6.5 8.0 Convulsion 0.9 3.3 10.0 Dizziness 2.4 2.6 8.0 Nausea 1.4 3.3 7.3 Hypoventilation 1.4 1.3 4.0 Hypertonia 0.0 0.7 6.0 Paresthesia 1.9 0.7 3.3 Hypotension 1.9 0.7 2.0 Increased Salivation 0.0 2.6 2.7 Back Pain 0.9 0.7 2.0 Constipation 0.5 1.3 2.0 Pain 0.0 0.0 4.0 Pruritus 0.0 0.0 4.0 Diarrhea 0.5 0.7 2.0 Peripheral Edema 0.0 0.0 3.3 Thinking Abnormal 0.5 1.3 0.7 Agitation 0.5 0.0 1.3 Asthenia 0.0 0.0 2.0 Chills 0.5 0.0 1.3 Coma 0.5 0.0 1.3 Dry Mouth 0.5 0.0 1.3 Pneumonia 0.0 0.0 2.0 Speech Disorder 0.5 0.7 0.7 Tremor 0.5 0.0 1.3 Urinary Incontinence 0.0 0.0 2.0 Urination Impaired 0.0 0.0 2.0 .\"\n }\n ]\n },\n {\n \"Term\": \"Musculoskeletal stiffness\",\n \"MEDDRACode\": \"10052904\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"muscle stiffness\",\n \"Probability\": \"0.0659223199\",\n \"SemanticContext\": \"17 PATIENT COUNSELING INFORMATION Risks Related to Sudden Withdrawal of GABLOFEN Advise patients and caregivers that sudden withdrawal of GABLOFEN, regardless of the cause, can result in serious complications that include high fever, confusion, muscle stiffness, multiple organ-system failure, and death.\"\n }\n ]\n },\n {\n \"Term\": \"Hypotonia\",\n \"MEDDRACode\": \"10021118\",\n \"Overdose\": true,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hypotonia\",\n \"Probability\": \"0.9682492018\",\n \"SemanticContext\": \"· Overdose may cause drowsiness, lightheadedness, dizziness, somnolence, respiratory depression, seizures, rostral progression of hypotonia and loss of consciousness progressing to coma.\"\n },\n {\n \"VerbatimTerm\": \"hypotonia\",\n \"Probability\": \"0.9959019423\",\n \"SemanticContext\": \"ADVERSE REACTIONS · The most common adverse reactions in patients with spasticity of spinal origin were somnolence, dizziness, nausea, hypotension, headache, convulsions and hypotonia.\"\n },\n {\n \"VerbatimTerm\": \"hypotonia\",\n \"Probability\": \"0.9907783866\",\n \"SemanticContext\": \"· The most common adverse reactions in patients with spasticity of cerebral origin were agitation, constipation, somnolence, leukocytosis, chills, urinary retention and hypotonia.\"\n },\n {\n \"VerbatimTerm\": \"hypotonia\",\n \"Probability\": \"0.9955381155\",\n \"SemanticContext\": \"6 ADVERSE REACTIONS 6.1 Spasticity of Spinal Cord Origin Most Common Adverse Reactions in Patients with Spasticity of Spinal Origin In pre- and post-marketing clinical trials, the most common adverse reactions associated with use of intrathecal baclofen which were not seen at an equivalent incidence among placebo-treated patients were: somnolence, dizziness, nausea, hypotension, headache, convulsions and hypotonia.\"\n },\n {\n \"VerbatimTerm\": \"hypotonia\",\n \"Probability\": \"0.9959027767\",\n \"SemanticContext\": \"Nonetheless, many of the more commonly reported reactions -- hypotonia, somnolence, dizziness, paresthesia, nausea/vomiting and headache -- appear clearly drug-related.\"\n },\n {\n \"VerbatimTerm\": \"hypotonia\",\n \"Probability\": \"0.9907491803\",\n \"SemanticContext\": \"6.2 Spasticity of Cerebral Origin Most Common Adverse Reactions In pre-marketing clinical trials, the most common adverse reactions associated with use of intrathecal baclofen which were not seen at an equivalent incidence among placebo-treated patients included: agitation, constipation, somnolence, leukocytosis, chills, urinary retention and hypotonia.\"\n },\n {\n \"VerbatimTerm\": \"hypotonia\",\n \"Probability\": \"0.9933166504\",\n \"SemanticContext\": \"The following adverse reactions occurred among the 62 patients receiving intrathecal baclofen in two randomized, placebo-controlled trials involving cerebral palsy and head injury patients, respectively: agitation, constipation, somnolence, leukocytosis, nausea, vomiting, nystagmus, chills, urinary retention, and hypotonia.\"\n },\n {\n \"VerbatimTerm\": \"hypotonia\",\n \"Probability\": \"0.9778500795\",\n \"SemanticContext\": \"Nonetheless, many of the more commonly reported reactions -- somnolence, dizziness, headache, nausea, hypotension, hypotonia and coma -- appear clearly drug-related.\"\n },\n {\n \"VerbatimTerm\": \"hypotonia\",\n \"Probability\": \"0.9749862552\",\n \"SemanticContext\": \"Symptoms of Intrathecal Baclofen Overdose Drowsiness, lightheadedness, dizziness, somnolence, respiratory depression, seizures, rostral progression of hypotonia and loss of consciousness progressing to coma of up to 72 hours duration.\"\n },\n {\n \"VerbatimTerm\": \"hypotonia\",\n \"Probability\": \"0.8478288054\",\n \"SemanticContext\": \"Less sudden and/or less severe forms of overdose may present with signs of drowsiness, lightheadedness, dizziness, somnolence, respiratory depression, seizures, rostral progression of hypotonia and loss of consciousness progressing to coma.\"\n },\n {\n \"VerbatimTerm\": \"Hypotonia\",\n \"Probability\": \"0.9820445776\",\n \"SemanticContext\": \"Table 1: Most Common =1% Adverse Reactions in Patients with Spasticity of Spinal Origin in Prospectively Monitored Clinical Trials Adverse Reactions Percent N=576 Screening Percent N=474 Titration† Percent N=430 Maintenance ‡ Hypotonia 5.4 13.5 25.3 Somnolence 5.7 5.9 20.9 Dizziness 1.7 1.9 7.9 Paresthesia 2.4 2.1 6.7 Nausea and Vomiting 1.6 2.3 5.6 Headache 1.6 2.5 5.1 Constipation 0.2 1.5 5.1 Convulsion 0.5 1.3 4.7 Urinary Retention 0.7 1.7 1.9 Dry Mouth 0.2 0.4 3.3 Accidental Injury 0.0 0.2 3.5 Asthenia 0.7 1.3 1.4 Confusion 0.5 0.6 2.3 Death 0.2 0.4 3.0 Pain 0.0 0.6 3.0 Speech Disorder 0.0 0.2 3.5 Hypotension 1.0 0.2 1.9 Ambylopia 0.5 0.2 2.3 Diarrhea 0.0 0.8 2.3 Hypoventilation 0.2 0.8 2.1 Coma 0.0 1.5 0.9 Impotence 0.2 0.4 1.6 Peripheral Edema 0.0 0.0 2.3 Urinary Incontinence 0.0 0.8 1.4 Insomnia 0.0 0.4 1.6 Anxiety 0.2 0.4 0.9 Depression 0.0 0.0 1.6 Dypsnea 0.3 0.0 1.2 Fever 0.5 0.2 0.7 Pneumonia 0.2 0.2 1.2 Urinary Frequency 0.0 0.6 0.9 Urticaria 0.2 0.2 1.2 Anorexia 0.0 0.4 0.9 Diplopia 0.0 0.4 0.9 Dysautonomia 0.2 0.2 0.9 Hallucinations 0.3 0.4 0.5 Hypertension 0.2 0.6 0.5 .\"\n },\n {\n \"VerbatimTerm\": \"Hypotonia\",\n \"Probability\": \"0.9830172062\",\n \"SemanticContext\": \"Table 2: Most Common =1% Adverse Reactions in Patients with Spasticity of Cerebral Origin Adverse Reactions Percent N=211 Screening* Percent N=153 Titration† Percent N=150 Maintenance ‡ Hypotonia 2.4 14.4 34.7 Somnolence 7.6 10.5 18.7 Headache 6.6 7.8 10.7 Nausea and Vomiting 6.6 10.5 4.0 Vomiting 6.2 8.5 4.0 Urinary Retention 0.9 6.5 8.0 Convulsion 0.9 3.3 10.0 Dizziness 2.4 2.6 8.0 Nausea 1.4 3.3 7.3 Hypoventilation 1.4 1.3 4.0 Hypertonia 0.0 0.7 6.0 Paresthesia 1.9 0.7 3.3 Hypotension 1.9 0.7 2.0 Increased Salivation 0.0 2.6 2.7 Back Pain 0.9 0.7 2.0 Constipation 0.5 1.3 2.0 Pain 0.0 0.0 4.0 Pruritus 0.0 0.0 4.0 Diarrhea 0.5 0.7 2.0 Peripheral Edema 0.0 0.0 3.3 Thinking Abnormal 0.5 1.3 0.7 Agitation 0.5 0.0 1.3 Asthenia 0.0 0.0 2.0 Chills 0.5 0.0 1.3 Coma 0.5 0.0 1.3 Dry Mouth 0.5 0.0 1.3 Pneumonia 0.0 0.0 2.0 Speech Disorder 0.5 0.7 0.7 Tremor 0.5 0.0 1.3 Urinary Incontinence 0.0 0.0 2.0 Urination Impaired 0.0 0.0 2.0 .\"\n }\n ]\n },\n {\n \"Term\": \"Hyperthermia malignant\",\n \"MEDDRACode\": \"10020844\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"malignant hyperthermia\",\n \"Probability\": \"0.1240656972\",\n \"SemanticContext\": \"Some clinical characteristics of the advanced intrathecal baclofen withdrawal syndrome may resemble autonomic dysreflexia, infection sepsis , malignant hyperthermia, neuroleptic-malignant syndrome, or other conditions associated with a hypermetabolic state or widespread rhabdomyolysis.\"\n }\n ]\n },\n {\n \"Term\": \"Depressed level of consciousness\",\n \"MEDDRACode\": \"10012373\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"decreased alertness\",\n \"Probability\": \"0.00418818\",\n \"SemanticContext\": \"Operation of Automobiles and Other Dangerous Machinery Advise patients that GABLOFEN may cause drowsiness, and that they should exercise caution regarding the operation of automobiles or other dangerous machinery, or activities made hazardous by decreased alertness.\"\n },\n {\n \"VerbatimTerm\": \"decreased alertness\",\n \"Probability\": \"0.0028517544\",\n \"SemanticContext\": \"Patients should be cautioned regarding the operation of automobiles or other dangerous machinery, and activities made hazardous by decreased alertness.\"\n }\n ]\n },\n {\n \"Term\": \"Prophylaxis\",\n \"MEDDRACode\": \"10036898\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Prevention\",\n \"Probability\": \"0.0082624555\",\n \"SemanticContext\": \"Prevention of abrupt discontinuation of intrathecal baclofen requires careful attention to programming and monitoring of the infusion system, refill scheduling and procedures, and pump alarms.\"\n },\n {\n \"VerbatimTerm\": \"Prevention\",\n \"Probability\": \"0.0082624555\",\n \"SemanticContext\": \"Prevention of abrupt discontinuation of intrathecal baclofen requires careful attention to programming and monitoring of the infusion system, refill scheduling and procedures, and pump alarms.\"\n }\n ]\n },\n {\n \"Term\": \"Respiratory failure\",\n \"MEDDRACode\": \"10038695\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"respiratory failure\",\n \"Probability\": \"0.2072489858\",\n \"SemanticContext\": \"· Potentially life-threatening CNS depression, cardiovascular collapse, and/or respiratory failure; Resuscitative equipment and trained staff must be available during screening, dose titration, and refills 5.3 5 .\"\n },\n {\n \"VerbatimTerm\": \"respiratory failure\",\n \"Probability\": \"0.2296115458\",\n \"SemanticContext\": \"Because of the possibility of potentially life-threatening CNS depression, cardiovascular collapse, and/or respiratory failure, physicians must be adequately trained and educated in chronic intrathecal infusion therapy.\"\n }\n ]\n },\n {\n \"Term\": \"Meningitis\",\n \"MEDDRACode\": \"10027199\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"meningitis\",\n \"Probability\": \"0.9841993451\",\n \"SemanticContext\": \"These include: pump pocket infections 3 , meningitis 2 , wound dehiscence 1 , gynecological fibroids 1 and pump overpressurization 1 with unknown, if any, sequela.\"\n },\n {\n \"VerbatimTerm\": \"meningitis\",\n \"Probability\": \"0.9973291755\",\n \"SemanticContext\": \"The nine adverse reactions leading to discontinuation were: infection 3 , CSF leaks 2 , meningitis 2 , drainage 1 , and unmanageable trunk control 1 .\"\n }\n ]\n },\n {\n \"Term\": \"Opisthotonus\",\n \"MEDDRACode\": \"10030899\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"opisthotonos\",\n \"Probability\": \"0.9993817806\",\n \"SemanticContext\": \"In the total cohort, the following adverse reactions, not described in Table 2, and arranged in decreasing order of frequency, and classified by body system, were reported: Nervous System: Akathisia, ataxia, confusion, depression, opisthotonos, amnesia, anxiety, hallucinations, hysteria, insomnia, nystagmus, personality disorder, reflexes decreased, and vasodilitation.\"\n }\n ]\n },\n {\n \"Term\": \"Dyspnoea\",\n \"MEDDRACode\": \"10013968\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"dyspnea\",\n \"Probability\": \"0.9910209179\",\n \"SemanticContext\": \"DRUG INTERACTIONS Combined use with morphine: hypotension and dyspnea 7 . . . .\"\n },\n {\n \"VerbatimTerm\": \"dyspnea\",\n \"Probability\": \"0.9983164072\",\n \"SemanticContext\": \"The following events occurred among the 31 patients receiving intrathecal baclofen in two randomized, placebo-controlled trials: hypotension 2 , dizziness 2 , headache 2 , dyspnea 1 .\"\n },\n {\n \"VerbatimTerm\": \"dyspnea\",\n \"Probability\": \"0.9983782768\",\n \"SemanticContext\": \"Respiratory: Apnea, dyspnea and hyperventilation.\"\n },\n {\n \"VerbatimTerm\": \"dyspnea\",\n \"Probability\": \"0.1106330454\",\n \"SemanticContext\": \"Interactions attributed to the combined use of GABLOFEN and epidural morphine include hypotension and dyspnea.\"\n }\n ]\n },\n {\n \"Term\": \"Induction and maintenance of anaesthesia\",\n \"MEDDRACode\": \"10021723\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"induction\",\n \"Probability\": \"0.0011250079\",\n \"SemanticContext\": \"Caution in administering physostigmine is advised, however, because its use has been associated with the induction of seizures and bradycardia.\"\n }\n ]\n },\n {\n \"Term\": \"Neoplasm\",\n \"MEDDRACode\": \"10028980\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"tumors\",\n \"Probability\": \"0.0182145238\",\n \"SemanticContext\": \"13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis No increase in tumors was seen in rats receiving baclofen orally for two years.\"\n }\n ]\n },\n {\n \"Term\": \"Exomphalos\",\n \"MEDDRACode\": \"10015677\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"omphaloceles\",\n \"Probability\": \"0.0393585265\",\n \"SemanticContext\": \"Data Animal Data Baclofen given orally to pregnant rats has been shown to increase the incidence of omphaloceles ventral hernias in fetuses at a dose associated with maternal toxicity.\"\n }\n ]\n },\n {\n \"Term\": \"Foetal malformation\",\n \"MEDDRACode\": \"10060919\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"fetal malformations\",\n \"Probability\": \"0.0048833489\",\n \"SemanticContext\": \"In animal studies, oral administration of baclofen to pregnant rats produced an increase in fetal malformations see Data .\"\n }\n ]\n },\n {\n \"Term\": \"Pulmonary congestion\",\n \"MEDDRACode\": \"10037368\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"pulmonary congestion\",\n \"Probability\": \"0.0665026009\",\n \"SemanticContext\": \"An autopsy revealed pulmonary congestion and bilateral pleural effusions.\"\n }\n ]\n },\n {\n \"Term\": \"Tongue disorder\",\n \"MEDDRACode\": \"10043951\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"tongue disorder\",\n \"Probability\": \"0.8214718103\",\n \"SemanticContext\": \"Digestive System: Dysphagia, fecal incontinence, gastrointestinal hemorrhage and tongue disorder.\"\n }\n ]\n },\n {\n \"Term\": \"Drug interaction\",\n \"MEDDRACode\": \"10013710\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Interactions\",\n \"Probability\": \"0.0025314093\",\n \"SemanticContext\": \"Interactions attributed to the combined use of GABLOFEN and epidural morphine include hypotension and dyspnea.\"\n }\n ]\n },\n {\n \"Term\": \"Congenital nephrotic syndrome\",\n \"MEDDRACode\": \"10060737\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"CNS\",\n \"Probability\": \"0.0133179128\",\n \"SemanticContext\": \"In people, as well as in animals, baclofen has been shown to have general CNS depressant properties as indicated by the production of sedation with tolerance, somnolence, ataxia, and respiratory and cardiovascular depression.\"\n },\n {\n \"VerbatimTerm\": \"CNS\",\n \"Probability\": \"8.0969E-06\",\n \"SemanticContext\": \"For spasticity of spinal cord origin, chronic infusion of GABLOFEN via an implantable pump should be reserved for patients unresponsive to oral baclofen therapy, or those who experience intolerable CNS side effects at effective doses.\"\n },\n {\n \"VerbatimTerm\": \"CNS\",\n \"Probability\": \"0.0114183128\",\n \"SemanticContext\": \"Increased Risk of Drowsiness with Alcohol and Other CNS Depressants Inform patients and their caregivers that the drowsiness associated with GABLOFEN use can be worsened by alcohol and other CNS depressants.\"\n },\n {\n \"VerbatimTerm\": \"CNS\",\n \"Probability\": \"0.0120953321\",\n \"SemanticContext\": \"Increased Risk of Drowsiness with Alcohol and Other CNS Depressants Inform patients and their caregivers that the drowsiness associated with GABLOFEN use can be worsened by alcohol and other CNS depressants.\"\n },\n {\n \"VerbatimTerm\": \"CNS\",\n \"Probability\": \"0.001039207\",\n \"SemanticContext\": \"Patients should also be cautioned that the central nervous system depressant effects of intrathecal baclofen may be additive to those of alcohol and other CNS depressants.\"\n }\n ]\n },\n {\n \"Term\": \"Pleural effusion\",\n \"MEDDRACode\": \"10035598\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"bilateral pleural effusions\",\n \"Probability\": \"0.3306728601\",\n \"SemanticContext\": \"An autopsy revealed pulmonary congestion and bilateral pleural effusions.\"\n }\n ]\n },\n {\n \"Term\": \"Vaginal infection\",\n \"MEDDRACode\": \"10046914\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"vaginitis\",\n \"Probability\": \"0.9910646081\",\n \"SemanticContext\": \"Urogenital: Abnormal ejaculation, kidney calculus, oliguria and vaginitis.\"\n }\n ]\n },\n {\n \"Term\": \"Ataxia\",\n \"MEDDRACode\": \"10003591\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"ataxia\",\n \"Probability\": \"0.997877121\",\n \"SemanticContext\": \"In the total cohort, the following adverse reactions, not described in Table 2, and arranged in decreasing order of frequency, and classified by body system, were reported: Nervous System: Akathisia, ataxia, confusion, depression, opisthotonos, amnesia, anxiety, hallucinations, hysteria, insomnia, nystagmus, personality disorder, reflexes decreased, and vasodilitation.\"\n },\n {\n \"VerbatimTerm\": \"ataxia\",\n \"Probability\": \"0.214039892\",\n \"SemanticContext\": \"In people, as well as in animals, baclofen has been shown to have general CNS depressant properties as indicated by the production of sedation with tolerance, somnolence, ataxia, and respiratory and cardiovascular depression.\"\n }\n ]\n },\n {\n \"Term\": \"Hypopnoea\",\n \"MEDDRACode\": \"10021079\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"shallow breathing\",\n \"Probability\": \"0.1193873584\",\n \"SemanticContext\": \"GABLOFEN Overdose Inform patients and their caregivers that GABLOFEN overdose may occur suddenly or insidiously, and that symptoms may include confusion, drowsiness, lightheadedness, dizziness, slow or shallow breathing, seizures, loss of muscle tone, loss of consciousness, and coma.\"\n }\n ]\n },\n {\n \"Term\": \"Ileus\",\n \"MEDDRACode\": \"10021328\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"ileus\",\n \"Probability\": \"0.9949247837\",\n \"SemanticContext\": \"The following adverse reactions, not described in the table, and arranged in decreasing order of frequency, and classified by body system, were reported: Nervous System: Abnormal gait, thinking abnormal, tremor, amnesia, twitching, vasodilatation, cerebrovascular accident, nystagmus, personality disorder, psychotic depression, cerebral ischemia, emotional lability, euphoria, hypertonia, ileus, drug dependence, incoordination, paranoid reaction and ptosis.\"\n }\n ]\n },\n {\n \"Term\": \"Insomnia\",\n \"MEDDRACode\": \"10022437\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Insomnia\",\n \"Probability\": \"0.9127836823\",\n \"SemanticContext\": \"Table 1: Most Common =1% Adverse Reactions in Patients with Spasticity of Spinal Origin in Prospectively Monitored Clinical Trials Adverse Reactions Percent N=576 Screening Percent N=474 Titration† Percent N=430 Maintenance ‡ Hypotonia 5.4 13.5 25.3 Somnolence 5.7 5.9 20.9 Dizziness 1.7 1.9 7.9 Paresthesia 2.4 2.1 6.7 Nausea and Vomiting 1.6 2.3 5.6 Headache 1.6 2.5 5.1 Constipation 0.2 1.5 5.1 Convulsion 0.5 1.3 4.7 Urinary Retention 0.7 1.7 1.9 Dry Mouth 0.2 0.4 3.3 Accidental Injury 0.0 0.2 3.5 Asthenia 0.7 1.3 1.4 Confusion 0.5 0.6 2.3 Death 0.2 0.4 3.0 Pain 0.0 0.6 3.0 Speech Disorder 0.0 0.2 3.5 Hypotension 1.0 0.2 1.9 Ambylopia 0.5 0.2 2.3 Diarrhea 0.0 0.8 2.3 Hypoventilation 0.2 0.8 2.1 Coma 0.0 1.5 0.9 Impotence 0.2 0.4 1.6 Peripheral Edema 0.0 0.0 2.3 Urinary Incontinence 0.0 0.8 1.4 Insomnia 0.0 0.4 1.6 Anxiety 0.2 0.4 0.9 Depression 0.0 0.0 1.6 Dypsnea 0.3 0.0 1.2 Fever 0.5 0.2 0.7 Pneumonia 0.2 0.2 1.2 Urinary Frequency 0.0 0.6 0.9 Urticaria 0.2 0.2 1.2 Anorexia 0.0 0.4 0.9 Diplopia 0.0 0.4 0.9 Dysautonomia 0.2 0.2 0.9 Hallucinations 0.3 0.4 0.5 Hypertension 0.2 0.6 0.5 .\"\n },\n {\n \"VerbatimTerm\": \"insomnia\",\n \"Probability\": \"0.9972063303\",\n \"SemanticContext\": \"In the total cohort, the following adverse reactions, not described in Table 2, and arranged in decreasing order of frequency, and classified by body system, were reported: Nervous System: Akathisia, ataxia, confusion, depression, opisthotonos, amnesia, anxiety, hallucinations, hysteria, insomnia, nystagmus, personality disorder, reflexes decreased, and vasodilitation.\"\n }\n ]\n },\n {\n \"Term\": \"Conversion disorder\",\n \"MEDDRACode\": \"10010893\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hysteria\",\n \"Probability\": \"0.9796718359\",\n \"SemanticContext\": \"In the total cohort, the following adverse reactions, not described in Table 2, and arranged in decreasing order of frequency, and classified by body system, were reported: Nervous System: Akathisia, ataxia, confusion, depression, opisthotonos, amnesia, anxiety, hallucinations, hysteria, insomnia, nystagmus, personality disorder, reflexes decreased, and vasodilitation.\"\n }\n ]\n },\n {\n \"Term\": \"Dermatitis contact\",\n \"MEDDRACode\": \"10012442\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"contact dermatitis\",\n \"Probability\": \"0.9815013409\",\n \"SemanticContext\": \"Skin and Appendages: Rash, sweating, alopecia, contact dermatitis and skin ulcer.\"\n }\n ]\n },\n {\n \"Term\": \"Autonomic dysreflexia\",\n \"MEDDRACode\": \"10068196\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"autonomic dysreflexia\",\n \"Probability\": \"0.2456524968\",\n \"SemanticContext\": \"Some clinical characteristics of the advanced intrathecal baclofen withdrawal syndrome may resemble autonomic dysreflexia, infection sepsis , malignant hyperthermia, neuroleptic-malignant syndrome, or other conditions associated with a hypermetabolic state or widespread rhabdomyolysis.\"\n },\n {\n \"VerbatimTerm\": \"autonomic dysreflexia\",\n \"Probability\": \"0.001624465\",\n \"SemanticContext\": \"5.8 Use with Caution in Patients with a History of Autonomic Dysreflexia GABLOFEN should be used with caution in patients with a history of autonomic dysreflexia.\"\n },\n {\n \"VerbatimTerm\": \"Autonomic Dysreflexia\",\n \"Probability\": \"4.50642E-05\",\n \"SemanticContext\": \"5.8 Use with Caution in Patients with a History of Autonomic Dysreflexia GABLOFEN should be used with caution in patients with a history of autonomic dysreflexia.\"\n }\n ]\n },\n {\n \"Term\": \"Diplopia\",\n \"MEDDRACode\": \"10013036\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Diplopia\",\n \"Probability\": \"0.9966768026\",\n \"SemanticContext\": \"Table 1: Most Common =1% Adverse Reactions in Patients with Spasticity of Spinal Origin in Prospectively Monitored Clinical Trials Adverse Reactions Percent N=576 Screening Percent N=474 Titration† Percent N=430 Maintenance ‡ Hypotonia 5.4 13.5 25.3 Somnolence 5.7 5.9 20.9 Dizziness 1.7 1.9 7.9 Paresthesia 2.4 2.1 6.7 Nausea and Vomiting 1.6 2.3 5.6 Headache 1.6 2.5 5.1 Constipation 0.2 1.5 5.1 Convulsion 0.5 1.3 4.7 Urinary Retention 0.7 1.7 1.9 Dry Mouth 0.2 0.4 3.3 Accidental Injury 0.0 0.2 3.5 Asthenia 0.7 1.3 1.4 Confusion 0.5 0.6 2.3 Death 0.2 0.4 3.0 Pain 0.0 0.6 3.0 Speech Disorder 0.0 0.2 3.5 Hypotension 1.0 0.2 1.9 Ambylopia 0.5 0.2 2.3 Diarrhea 0.0 0.8 2.3 Hypoventilation 0.2 0.8 2.1 Coma 0.0 1.5 0.9 Impotence 0.2 0.4 1.6 Peripheral Edema 0.0 0.0 2.3 Urinary Incontinence 0.0 0.8 1.4 Insomnia 0.0 0.4 1.6 Anxiety 0.2 0.4 0.9 Depression 0.0 0.0 1.6 Dypsnea 0.3 0.0 1.2 Fever 0.5 0.2 0.7 Pneumonia 0.2 0.2 1.2 Urinary Frequency 0.0 0.6 0.9 Urticaria 0.2 0.2 1.2 Anorexia 0.0 0.4 0.9 Diplopia 0.0 0.4 0.9 Dysautonomia 0.2 0.2 0.9 Hallucinations 0.3 0.4 0.5 Hypertension 0.2 0.6 0.5 .\"\n }\n ]\n },\n {\n \"Term\": \"Intensive care\",\n \"MEDDRACode\": \"10022519\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"intensive-care\",\n \"Probability\": \"7.8607E-06\",\n \"SemanticContext\": \"Rapid, accurate diagnosis and treatment in an emergency-room or intensive-care setting are important in order to prevent the potentially life-threatening central nervous system and systemic effects of intrathecal baclofen withdrawal.\"\n }\n ]\n },\n {\n \"Term\": \"Manipulation\",\n \"MEDDRACode\": \"10062053\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"manipulation\",\n \"Probability\": \"3.63792E-05\",\n \"SemanticContext\": \"A period of observation appropriate to the clinical situation should follow each refill or manipulation of the drug reservoir.\"\n }\n ]\n },\n {\n \"Term\": \"Sepsis\",\n \"MEDDRACode\": \"10040047\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"sepsis\",\n \"Probability\": \"0.2910525203\",\n \"SemanticContext\": \"Some clinical characteristics of the advanced intrathecal baclofen withdrawal syndrome may resemble autonomic dysreflexia, infection sepsis , malignant hyperthermia, neuroleptic-malignant syndrome, or other conditions associated with a hypermetabolic state or widespread rhabdomyolysis.\"\n }\n ]\n },\n {\n \"Term\": \"Hyperhidrosis\",\n \"MEDDRACode\": \"10020642\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"sweating\",\n \"Probability\": \"0.9933481216\",\n \"SemanticContext\": \"Skin and Appendages: Alopecia and sweating.\"\n },\n {\n \"VerbatimTerm\": \"sweating\",\n \"Probability\": \"0.9992053509\",\n \"SemanticContext\": \"Skin and Appendages: Rash, sweating, alopecia, contact dermatitis and skin ulcer.\"\n }\n ]\n },\n {\n \"Term\": \"Hypothermia\",\n \"MEDDRACode\": \"10021113\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hypothermia\",\n \"Probability\": \"0.8961439133\",\n \"SemanticContext\": \"Body as a Whole: Suicide, lack of drug effect, abdominal pain, hypothermia, neck rigidity, chest pain, chills, face edema, flu syndrome and overdose.\"\n },\n {\n \"VerbatimTerm\": \"hypothermia\",\n \"Probability\": \"0.9858011603\",\n \"SemanticContext\": \"Body as a Whole: Death, fever, abdominal pain, carcinoma, malaise and hypothermia.\"\n }\n ]\n },\n {\n \"Term\": \"Hypoventilation\",\n \"MEDDRACode\": \"10021133\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Hypoventilation\",\n \"Probability\": \"0.9993246794\",\n \"SemanticContext\": \"Table 1: Most Common =1% Adverse Reactions in Patients with Spasticity of Spinal Origin in Prospectively Monitored Clinical Trials Adverse Reactions Percent N=576 Screening Percent N=474 Titration† Percent N=430 Maintenance ‡ Hypotonia 5.4 13.5 25.3 Somnolence 5.7 5.9 20.9 Dizziness 1.7 1.9 7.9 Paresthesia 2.4 2.1 6.7 Nausea and Vomiting 1.6 2.3 5.6 Headache 1.6 2.5 5.1 Constipation 0.2 1.5 5.1 Convulsion 0.5 1.3 4.7 Urinary Retention 0.7 1.7 1.9 Dry Mouth 0.2 0.4 3.3 Accidental Injury 0.0 0.2 3.5 Asthenia 0.7 1.3 1.4 Confusion 0.5 0.6 2.3 Death 0.2 0.4 3.0 Pain 0.0 0.6 3.0 Speech Disorder 0.0 0.2 3.5 Hypotension 1.0 0.2 1.9 Ambylopia 0.5 0.2 2.3 Diarrhea 0.0 0.8 2.3 Hypoventilation 0.2 0.8 2.1 Coma 0.0 1.5 0.9 Impotence 0.2 0.4 1.6 Peripheral Edema 0.0 0.0 2.3 Urinary Incontinence 0.0 0.8 1.4 Insomnia 0.0 0.4 1.6 Anxiety 0.2 0.4 0.9 Depression 0.0 0.0 1.6 Dypsnea 0.3 0.0 1.2 Fever 0.5 0.2 0.7 Pneumonia 0.2 0.2 1.2 Urinary Frequency 0.0 0.6 0.9 Urticaria 0.2 0.2 1.2 Anorexia 0.0 0.4 0.9 Diplopia 0.0 0.4 0.9 Dysautonomia 0.2 0.2 0.9 Hallucinations 0.3 0.4 0.5 Hypertension 0.2 0.6 0.5 .\"\n },\n {\n \"VerbatimTerm\": \"Hypoventilation\",\n \"Probability\": \"0.9987796545\",\n \"SemanticContext\": \"Table 2: Most Common =1% Adverse Reactions in Patients with Spasticity of Cerebral Origin Adverse Reactions Percent N=211 Screening* Percent N=153 Titration† Percent N=150 Maintenance ‡ Hypotonia 2.4 14.4 34.7 Somnolence 7.6 10.5 18.7 Headache 6.6 7.8 10.7 Nausea and Vomiting 6.6 10.5 4.0 Vomiting 6.2 8.5 4.0 Urinary Retention 0.9 6.5 8.0 Convulsion 0.9 3.3 10.0 Dizziness 2.4 2.6 8.0 Nausea 1.4 3.3 7.3 Hypoventilation 1.4 1.3 4.0 Hypertonia 0.0 0.7 6.0 Paresthesia 1.9 0.7 3.3 Hypotension 1.9 0.7 2.0 Increased Salivation 0.0 2.6 2.7 Back Pain 0.9 0.7 2.0 Constipation 0.5 1.3 2.0 Pain 0.0 0.0 4.0 Pruritus 0.0 0.0 4.0 Diarrhea 0.5 0.7 2.0 Peripheral Edema 0.0 0.0 3.3 Thinking Abnormal 0.5 1.3 0.7 Agitation 0.5 0.0 1.3 Asthenia 0.0 0.0 2.0 Chills 0.5 0.0 1.3 Coma 0.5 0.0 1.3 Dry Mouth 0.5 0.0 1.3 Pneumonia 0.0 0.0 2.0 Speech Disorder 0.5 0.7 0.7 Tremor 0.5 0.0 1.3 Urinary Incontinence 0.0 0.0 2.0 Urination Impaired 0.0 0.0 2.0 .\"\n }\n ]\n },\n {\n \"Term\": \"Metabolic acidosis\",\n \"MEDDRACode\": \"10027417\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"metabolic acidosis\",\n \"Probability\": \"0.9423723817\",\n \"SemanticContext\": \"His medical history included spinal cord injury, aspiration pneumonia, septic shock, disseminated intravascular coagulopathy, severe metabolic acidosis, hepatic toxicity, and status epilepticus.\"\n }\n ]\n },\n {\n \"Term\": \"Physical assault\",\n \"MEDDRACode\": \"10034983\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"battery\",\n \"Probability\": \"0.0002189279\",\n \"SemanticContext\": \"Common reasons for abrupt interruption of intrathecal baclofen therapy included malfunction of the catheter especially disconnection , low volume in the pump reservoir, and end of pump battery life; human error may have played a causal or contributing role in some cases.\"\n }\n ]\n },\n {\n \"Term\": \"Septic shock\",\n \"MEDDRACode\": \"10040070\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"septic shock\",\n \"Probability\": \"0.9200776815\",\n \"SemanticContext\": \"His medical history included spinal cord injury, aspiration pneumonia, septic shock, disseminated intravascular coagulopathy, severe metabolic acidosis, hepatic toxicity, and status epilepticus.\"\n }\n ]\n },\n {\n \"Term\": \"Therapeutic response decreased\",\n \"MEDDRACode\": \"10043414\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"decreased therapeutic response\",\n \"Probability\": \"0.0165718496\",\n \"SemanticContext\": \"The most frequent symptoms associated with intrathecal mass are: 1 decreased therapeutic response worsening spasticity, return of spasticity when previously well controlled, withdrawal symptoms, poor response to escalating doses, or frequent or large dosage increases , 2 pain, 3 neurological deficit/dysfunction.\"\n }\n ]\n },\n {\n \"Term\": \"Imaging procedure\",\n \"MEDDRACode\": \"10068979\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"imaging procedure\",\n \"Probability\": \"0.0002557635\",\n \"SemanticContext\": \"In some cases, performance of an imaging procedure may be appropriate to confirm or rule-out the diagnosis of an intrathecal mass.\"\n }\n ]\n },\n {\n \"Term\": \"Intrathecal injection\",\n \"MEDDRACode\": \"10082593\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"intrathecal injections\",\n \"Probability\": \"0.0016980767\",\n \"SemanticContext\": \"5.3 Prescriber, Caregiver and Patient Training and Screening Procedure/Post-Implantation Environment GABLOFEN is for use in single bolus intrathecal injections via a catheter placed in the lumbar intrathecal space or injection by lumbar puncture and in the implantable Medtronic SynchroMed® II Programmable Pump or other pumps labeled for intrathecal administration of GABLOFEN.\"\n }\n ]\n },\n {\n \"Term\": \"Constipation\",\n \"MEDDRACode\": \"10010774\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"constipation\",\n \"Probability\": \"0.998745203\",\n \"SemanticContext\": \"· The most common adverse reactions in patients with spasticity of cerebral origin were agitation, constipation, somnolence, leukocytosis, chills, urinary retention and hypotonia.\"\n },\n {\n \"VerbatimTerm\": \"constipation\",\n \"Probability\": \"0.9998098016\",\n \"SemanticContext\": \"6.2 Spasticity of Cerebral Origin Most Common Adverse Reactions In pre-marketing clinical trials, the most common adverse reactions associated with use of intrathecal baclofen which were not seen at an equivalent incidence among placebo-treated patients included: agitation, constipation, somnolence, leukocytosis, chills, urinary retention and hypotonia.\"\n },\n {\n \"VerbatimTerm\": \"constipation\",\n \"Probability\": \"0.9992953539\",\n \"SemanticContext\": \"The following adverse reactions occurred among the 62 patients receiving intrathecal baclofen in two randomized, placebo-controlled trials involving cerebral palsy and head injury patients, respectively: agitation, constipation, somnolence, leukocytosis, nausea, vomiting, nystagmus, chills, urinary retention, and hypotonia.\"\n },\n {\n \"VerbatimTerm\": \"Constipation\",\n \"Probability\": \"0.9996561408\",\n \"SemanticContext\": \"Table 1: Most Common =1% Adverse Reactions in Patients with Spasticity of Spinal Origin in Prospectively Monitored Clinical Trials Adverse Reactions Percent N=576 Screening Percent N=474 Titration† Percent N=430 Maintenance ‡ Hypotonia 5.4 13.5 25.3 Somnolence 5.7 5.9 20.9 Dizziness 1.7 1.9 7.9 Paresthesia 2.4 2.1 6.7 Nausea and Vomiting 1.6 2.3 5.6 Headache 1.6 2.5 5.1 Constipation 0.2 1.5 5.1 Convulsion 0.5 1.3 4.7 Urinary Retention 0.7 1.7 1.9 Dry Mouth 0.2 0.4 3.3 Accidental Injury 0.0 0.2 3.5 Asthenia 0.7 1.3 1.4 Confusion 0.5 0.6 2.3 Death 0.2 0.4 3.0 Pain 0.0 0.6 3.0 Speech Disorder 0.0 0.2 3.5 Hypotension 1.0 0.2 1.9 Ambylopia 0.5 0.2 2.3 Diarrhea 0.0 0.8 2.3 Hypoventilation 0.2 0.8 2.1 Coma 0.0 1.5 0.9 Impotence 0.2 0.4 1.6 Peripheral Edema 0.0 0.0 2.3 Urinary Incontinence 0.0 0.8 1.4 Insomnia 0.0 0.4 1.6 Anxiety 0.2 0.4 0.9 Depression 0.0 0.0 1.6 Dypsnea 0.3 0.0 1.2 Fever 0.5 0.2 0.7 Pneumonia 0.2 0.2 1.2 Urinary Frequency 0.0 0.6 0.9 Urticaria 0.2 0.2 1.2 Anorexia 0.0 0.4 0.9 Diplopia 0.0 0.4 0.9 Dysautonomia 0.2 0.2 0.9 Hallucinations 0.3 0.4 0.5 Hypertension 0.2 0.6 0.5 .\"\n },\n {\n \"VerbatimTerm\": \"Constipation\",\n \"Probability\": \"0.9997199774\",\n \"SemanticContext\": \"Table 2: Most Common =1% Adverse Reactions in Patients with Spasticity of Cerebral Origin Adverse Reactions Percent N=211 Screening* Percent N=153 Titration† Percent N=150 Maintenance ‡ Hypotonia 2.4 14.4 34.7 Somnolence 7.6 10.5 18.7 Headache 6.6 7.8 10.7 Nausea and Vomiting 6.6 10.5 4.0 Vomiting 6.2 8.5 4.0 Urinary Retention 0.9 6.5 8.0 Convulsion 0.9 3.3 10.0 Dizziness 2.4 2.6 8.0 Nausea 1.4 3.3 7.3 Hypoventilation 1.4 1.3 4.0 Hypertonia 0.0 0.7 6.0 Paresthesia 1.9 0.7 3.3 Hypotension 1.9 0.7 2.0 Increased Salivation 0.0 2.6 2.7 Back Pain 0.9 0.7 2.0 Constipation 0.5 1.3 2.0 Pain 0.0 0.0 4.0 Pruritus 0.0 0.0 4.0 Diarrhea 0.5 0.7 2.0 Peripheral Edema 0.0 0.0 3.3 Thinking Abnormal 0.5 1.3 0.7 Agitation 0.5 0.0 1.3 Asthenia 0.0 0.0 2.0 Chills 0.5 0.0 1.3 Coma 0.5 0.0 1.3 Dry Mouth 0.5 0.0 1.3 Pneumonia 0.0 0.0 2.0 Speech Disorder 0.5 0.7 0.7 Tremor 0.5 0.0 1.3 Urinary Incontinence 0.0 0.0 2.0 Urination Impaired 0.0 0.0 2.0 .\"\n }\n ]\n },\n {\n \"Term\": \"Urinary tract infection\",\n \"MEDDRACode\": \"10046571\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"urinary tract infections\",\n \"Probability\": \"0.9633568525\",\n \"SemanticContext\": \"As a group, the patients who died were relatively young mean age was 47 with a range from 25 to 63 , but the majority suffered from severe spasticity of many years duration, were nonambulatory, had various medical complications such as pneumonia, urinary tract infections, and decubiti, and/or had received multiple concomitant medications.\"\n }\n ]\n },\n {\n \"Term\": \"Autopsy\",\n \"MEDDRACode\": \"10050117\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"autopsy\",\n \"Probability\": \"0.1035970151\",\n \"SemanticContext\": \"An autopsy demonstrated severe fibrosis of the coronary conduction system.\"\n },\n {\n \"VerbatimTerm\": \"autopsy\",\n \"Probability\": \"0.0022295415\",\n \"SemanticContext\": \"An autopsy revealed pulmonary congestion and bilateral pleural effusions.\"\n }\n ]\n },\n {\n \"Term\": \"Pain\",\n \"MEDDRACode\": \"10033371\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Pain\",\n \"Probability\": \"0.9804580212\",\n \"SemanticContext\": \"Table 1: Most Common =1% Adverse Reactions in Patients with Spasticity of Spinal Origin in Prospectively Monitored Clinical Trials Adverse Reactions Percent N=576 Screening Percent N=474 Titration† Percent N=430 Maintenance ‡ Hypotonia 5.4 13.5 25.3 Somnolence 5.7 5.9 20.9 Dizziness 1.7 1.9 7.9 Paresthesia 2.4 2.1 6.7 Nausea and Vomiting 1.6 2.3 5.6 Headache 1.6 2.5 5.1 Constipation 0.2 1.5 5.1 Convulsion 0.5 1.3 4.7 Urinary Retention 0.7 1.7 1.9 Dry Mouth 0.2 0.4 3.3 Accidental Injury 0.0 0.2 3.5 Asthenia 0.7 1.3 1.4 Confusion 0.5 0.6 2.3 Death 0.2 0.4 3.0 Pain 0.0 0.6 3.0 Speech Disorder 0.0 0.2 3.5 Hypotension 1.0 0.2 1.9 Ambylopia 0.5 0.2 2.3 Diarrhea 0.0 0.8 2.3 Hypoventilation 0.2 0.8 2.1 Coma 0.0 1.5 0.9 Impotence 0.2 0.4 1.6 Peripheral Edema 0.0 0.0 2.3 Urinary Incontinence 0.0 0.8 1.4 Insomnia 0.0 0.4 1.6 Anxiety 0.2 0.4 0.9 Depression 0.0 0.0 1.6 Dypsnea 0.3 0.0 1.2 Fever 0.5 0.2 0.7 Pneumonia 0.2 0.2 1.2 Urinary Frequency 0.0 0.6 0.9 Urticaria 0.2 0.2 1.2 Anorexia 0.0 0.4 0.9 Diplopia 0.0 0.4 0.9 Dysautonomia 0.2 0.2 0.9 Hallucinations 0.3 0.4 0.5 Hypertension 0.2 0.6 0.5 .\"\n },\n {\n \"VerbatimTerm\": \"Pain\",\n \"Probability\": \"0.9969793558\",\n \"SemanticContext\": \"Table 2: Most Common =1% Adverse Reactions in Patients with Spasticity of Cerebral Origin Adverse Reactions Percent N=211 Screening* Percent N=153 Titration† Percent N=150 Maintenance ‡ Hypotonia 2.4 14.4 34.7 Somnolence 7.6 10.5 18.7 Headache 6.6 7.8 10.7 Nausea and Vomiting 6.6 10.5 4.0 Vomiting 6.2 8.5 4.0 Urinary Retention 0.9 6.5 8.0 Convulsion 0.9 3.3 10.0 Dizziness 2.4 2.6 8.0 Nausea 1.4 3.3 7.3 Hypoventilation 1.4 1.3 4.0 Hypertonia 0.0 0.7 6.0 Paresthesia 1.9 0.7 3.3 Hypotension 1.9 0.7 2.0 Increased Salivation 0.0 2.6 2.7 Back Pain 0.9 0.7 2.0 Constipation 0.5 1.3 2.0 Pain 0.0 0.0 4.0 Pruritus 0.0 0.0 4.0 Diarrhea 0.5 0.7 2.0 Peripheral Edema 0.0 0.0 3.3 Thinking Abnormal 0.5 1.3 0.7 Agitation 0.5 0.0 1.3 Asthenia 0.0 0.0 2.0 Chills 0.5 0.0 1.3 Coma 0.5 0.0 1.3 Dry Mouth 0.5 0.0 1.3 Pneumonia 0.0 0.0 2.0 Speech Disorder 0.5 0.7 0.7 Tremor 0.5 0.0 1.3 Urinary Incontinence 0.0 0.0 2.0 Urination Impaired 0.0 0.0 2.0 .\"\n },\n {\n \"VerbatimTerm\": \"pain\",\n \"Probability\": \"0.1681650579\",\n \"SemanticContext\": \"The most frequent symptoms associated with intrathecal mass are: 1 decreased therapeutic response worsening spasticity, return of spasticity when previously well controlled, withdrawal symptoms, poor response to escalating doses, or frequent or large dosage increases , 2 pain, 3 neurological deficit/dysfunction.\"\n }\n ]\n },\n {\n \"Term\": \"Dysuria\",\n \"MEDDRACode\": \"10013990\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Urination Impaired\",\n \"Probability\": \"0.9940157533\",\n \"SemanticContext\": \"Table 2: Most Common =1% Adverse Reactions in Patients with Spasticity of Cerebral Origin Adverse Reactions Percent N=211 Screening* Percent N=153 Titration† Percent N=150 Maintenance ‡ Hypotonia 2.4 14.4 34.7 Somnolence 7.6 10.5 18.7 Headache 6.6 7.8 10.7 Nausea and Vomiting 6.6 10.5 4.0 Vomiting 6.2 8.5 4.0 Urinary Retention 0.9 6.5 8.0 Convulsion 0.9 3.3 10.0 Dizziness 2.4 2.6 8.0 Nausea 1.4 3.3 7.3 Hypoventilation 1.4 1.3 4.0 Hypertonia 0.0 0.7 6.0 Paresthesia 1.9 0.7 3.3 Hypotension 1.9 0.7 2.0 Increased Salivation 0.0 2.6 2.7 Back Pain 0.9 0.7 2.0 Constipation 0.5 1.3 2.0 Pain 0.0 0.0 4.0 Pruritus 0.0 0.0 4.0 Diarrhea 0.5 0.7 2.0 Peripheral Edema 0.0 0.0 3.3 Thinking Abnormal 0.5 1.3 0.7 Agitation 0.5 0.0 1.3 Asthenia 0.0 0.0 2.0 Chills 0.5 0.0 1.3 Coma 0.5 0.0 1.3 Dry Mouth 0.5 0.0 1.3 Pneumonia 0.0 0.0 2.0 Speech Disorder 0.5 0.7 0.7 Tremor 0.5 0.0 1.3 Urinary Incontinence 0.0 0.0 2.0 Urination Impaired 0.0 0.0 2.0 .\"\n }\n ]\n },\n {\n \"Term\": \"Salivary hypersecretion\",\n \"MEDDRACode\": \"10039424\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Increased Salivation\",\n \"Probability\": \"0.9991211891\",\n \"SemanticContext\": \"Table 2: Most Common =1% Adverse Reactions in Patients with Spasticity of Cerebral Origin Adverse Reactions Percent N=211 Screening* Percent N=153 Titration† Percent N=150 Maintenance ‡ Hypotonia 2.4 14.4 34.7 Somnolence 7.6 10.5 18.7 Headache 6.6 7.8 10.7 Nausea and Vomiting 6.6 10.5 4.0 Vomiting 6.2 8.5 4.0 Urinary Retention 0.9 6.5 8.0 Convulsion 0.9 3.3 10.0 Dizziness 2.4 2.6 8.0 Nausea 1.4 3.3 7.3 Hypoventilation 1.4 1.3 4.0 Hypertonia 0.0 0.7 6.0 Paresthesia 1.9 0.7 3.3 Hypotension 1.9 0.7 2.0 Increased Salivation 0.0 2.6 2.7 Back Pain 0.9 0.7 2.0 Constipation 0.5 1.3 2.0 Pain 0.0 0.0 4.0 Pruritus 0.0 0.0 4.0 Diarrhea 0.5 0.7 2.0 Peripheral Edema 0.0 0.0 3.3 Thinking Abnormal 0.5 1.3 0.7 Agitation 0.5 0.0 1.3 Asthenia 0.0 0.0 2.0 Chills 0.5 0.0 1.3 Coma 0.5 0.0 1.3 Dry Mouth 0.5 0.0 1.3 Pneumonia 0.0 0.0 2.0 Speech Disorder 0.5 0.7 0.7 Tremor 0.5 0.0 1.3 Urinary Incontinence 0.0 0.0 2.0 Urination Impaired 0.0 0.0 2.0 .\"\n }\n ]\n },\n {\n \"Term\": \"Rash\",\n \"MEDDRACode\": \"10037844\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Rash\",\n \"Probability\": \"0.9991710186\",\n \"SemanticContext\": \"Skin and Appendages: Rash, sweating, alopecia, contact dermatitis and skin ulcer.\"\n }\n ]\n },\n {\n \"Term\": \"Injection\",\n \"MEDDRACode\": \"10052995\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": true,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": true,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"injection\",\n \"Probability\": \"0.0039976835\",\n \"SemanticContext\": \"GABLOFEN baclofen injection , for intrathecal use Initial U.S. Approval: 1992 WARNING: DO NOT DISCONTINUE ABRUPTLY See full prescribing information for complete boxed warning Abrupt discontinuation of intrathecal baclofen, regardless of the cause, has resulted in sequelae that include high fever, altered mental status, exaggerated rebound spasticity, and muscle rigidity, that in rare cases has advanced to rhabdomyolysis, multiple organ-system failure and death.\"\n },\n {\n \"VerbatimTerm\": \"injection\",\n \"Probability\": \"0.0005984604\",\n \"SemanticContext\": \"11 DESCRIPTION GABLOFEN baclofen injection is a muscle relaxant and antispastic.\"\n },\n {\n \"VerbatimTerm\": \"injection\",\n \"Probability\": \"5.84886E-05\",\n \"SemanticContext\": \"Intrathecal Bolus After a bolus lumbar injection of 50 mcg or 100 mcg intrathecal baclofen in seven patients, the average CSF elimination half-life was 1.51 hours over the first four hours and the average CSF clearance was approximately 30 mL/hour.\"\n },\n {\n \"VerbatimTerm\": \"injection\",\n \"Probability\": \"0.0002361536\",\n \"SemanticContext\": \"If the initial response is less than desired, a second bolus injection may be administered 24 hours after the first.\"\n },\n {\n \"VerbatimTerm\": \"injection\",\n \"Probability\": \"0.0004245043\",\n \"SemanticContext\": \"2.3 Preparation Information Screening Use the 1 mL screening syringe only 50 mcg/mL for bolus injection into the subarachnoid space.\"\n },\n {\n \"VerbatimTerm\": \"injection\",\n \"Probability\": \"6.96332E-05\",\n \"SemanticContext\": \"Use 1.5 mL of 50 mcg/mL baclofen injection for a 75 mcg bolus dose.\"\n },\n {\n \"VerbatimTerm\": \"injection\",\n \"Probability\": \"0.0004880726\",\n \"SemanticContext\": \"For the maximum screening dose of 100 mcg, use 2 mL of 50 mcg/mL baclofen injection 2 screening syringes .\"\n },\n {\n \"VerbatimTerm\": \"injection\",\n \"Probability\": \"0.0373207629\",\n \"SemanticContext\": \"3 DOSAGE FORMS AND STRENGTHS GABLOFEN baclofen injection is available, for intrathecal use only, in: Single-dose syringe of 1 mL containing 50 mcg 50 mcg/mL Single-dose syringes and vials of 10,000 mcg per 20 mL 500 mcg/mL Single-dose syringes and vials of 20,000 mcg per 20 mL 1,000 mcg/mL Single-dose syringes and vials of 40,000 mcg per 20 mL 2,000 mcg/mL\"\n },\n {\n \"VerbatimTerm\": \"injection\",\n \"Probability\": \"0.0017490387\",\n \"SemanticContext\": \"5 WARNINGS AND PRECAUTIONS 5.1 Risk of Life-Threatening Overdose During Pump Refills Use extreme caution when filling the Medtronic SynchroMed ® II Programmable Pump which is equipped with an injection port that allows direct access to the intrathecal catheter.\"\n },\n {\n \"VerbatimTerm\": \"injection\",\n \"Probability\": \"0.0003950894\",\n \"SemanticContext\": \"Direct injection into the catheter through the catheter access port may cause a life-threatening overdose.\"\n },\n {\n \"VerbatimTerm\": \"injection\",\n \"Probability\": \"0.0397621095\",\n \"SemanticContext\": \"5.3 Prescriber, Caregiver and Patient Training and Screening Procedure/Post-Implantation Environment GABLOFEN is for use in single bolus intrathecal injections via a catheter placed in the lumbar intrathecal space or injection by lumbar puncture and in the implantable Medtronic SynchroMed® II Programmable Pump or other pumps labeled for intrathecal administration of GABLOFEN.\"\n },\n {\n \"VerbatimTerm\": \"injection\",\n \"Probability\": \"3.06724E-05\",\n \"SemanticContext\": \"The pump system should not be implanted until the patient's response to bolus GABLOFEN injection is adequately evaluated.\"\n },\n {\n \"VerbatimTerm\": \"injection\",\n \"Probability\": \"0.0001665056\",\n \"SemanticContext\": \"Direct injection into this catheter access port may cause a life-threatening overdose.\"\n },\n {\n \"VerbatimTerm\": \"Injection\",\n \"Probability\": \"0.0031565428\",\n \"SemanticContext\": \"DOSAGE FORMS AND STRENGTHS Injection: 50 mcg/mL, 500 mcg/mL, 1,000 mcg/mL, 2,000 mcg/mL 3 .\"\n },\n {\n \"VerbatimTerm\": \"Injection\",\n \"Probability\": \"0.0008297563\",\n \"SemanticContext\": \"Each mL of GABLOFEN contains baclofen USP 50 mcg, 500 mcg, 1,000 mcg or 2,000 mcg and sodium chloride 9 mg in Water for Injection; pH range is 5.5 to 7.5.\"\n },\n {\n \"VerbatimTerm\": \"Injection\",\n \"Probability\": \"0.0043913424\",\n \"SemanticContext\": \"For patients who require concentrations other than 500 mcg/mL, 1,000 mcg/mL, or 2,000 mcg/mL, GABLOFEN must be diluted with sterile preservative free Sodium Chloride for Injection, USP.\"\n }\n ]\n },\n {\n \"Term\": \"Loss of consciousness\",\n \"MEDDRACode\": \"10024855\",\n \"Overdose\": true,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"loss of consciousness\",\n \"Probability\": \"0.8553227186\",\n \"SemanticContext\": \"· Overdose may cause drowsiness, lightheadedness, dizziness, somnolence, respiratory depression, seizures, rostral progression of hypotonia and loss of consciousness progressing to coma.\"\n },\n {\n \"VerbatimTerm\": \"loss of consciousness\",\n \"Probability\": \"0.6352372766\",\n \"SemanticContext\": \"GABLOFEN Overdose Inform patients and their caregivers that GABLOFEN overdose may occur suddenly or insidiously, and that symptoms may include confusion, drowsiness, lightheadedness, dizziness, slow or shallow breathing, seizures, loss of muscle tone, loss of consciousness, and coma.\"\n },\n {\n \"VerbatimTerm\": \"loss of consciousness\",\n \"Probability\": \"0.403190732\",\n \"SemanticContext\": \"Symptoms of Intrathecal Baclofen Overdose Drowsiness, lightheadedness, dizziness, somnolence, respiratory depression, seizures, rostral progression of hypotonia and loss of consciousness progressing to coma of up to 72 hours duration.\"\n },\n {\n \"VerbatimTerm\": \"loss of consciousness\",\n \"Probability\": \"0.0593946576\",\n \"SemanticContext\": \"Less sudden and/or less severe forms of overdose may present with signs of drowsiness, lightheadedness, dizziness, somnolence, respiratory depression, seizures, rostral progression of hypotonia and loss of consciousness progressing to coma.\"\n }\n ]\n },\n {\n \"Term\": \"Depression\",\n \"MEDDRACode\": \"10012378\",\n \"Overdose\": true,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"depression\",\n \"Probability\": \"0.9982158542\",\n \"SemanticContext\": \"In the total cohort, the following adverse reactions, not described in Table 2, and arranged in decreasing order of frequency, and classified by body system, were reported: Nervous System: Akathisia, ataxia, confusion, depression, opisthotonos, amnesia, anxiety, hallucinations, hysteria, insomnia, nystagmus, personality disorder, reflexes decreased, and vasodilitation.\"\n },\n {\n \"VerbatimTerm\": \"depression\",\n \"Probability\": \"0.149951607\",\n \"SemanticContext\": \"In people, as well as in animals, baclofen has been shown to have general CNS depressant properties as indicated by the production of sedation with tolerance, somnolence, ataxia, and respiratory and cardiovascular depression.\"\n },\n {\n \"VerbatimTerm\": \"Depression\",\n \"Probability\": \"0.9758380651\",\n \"SemanticContext\": \"Table 1: Most Common =1% Adverse Reactions in Patients with Spasticity of Spinal Origin in Prospectively Monitored Clinical Trials Adverse Reactions Percent N=576 Screening Percent N=474 Titration† Percent N=430 Maintenance ‡ Hypotonia 5.4 13.5 25.3 Somnolence 5.7 5.9 20.9 Dizziness 1.7 1.9 7.9 Paresthesia 2.4 2.1 6.7 Nausea and Vomiting 1.6 2.3 5.6 Headache 1.6 2.5 5.1 Constipation 0.2 1.5 5.1 Convulsion 0.5 1.3 4.7 Urinary Retention 0.7 1.7 1.9 Dry Mouth 0.2 0.4 3.3 Accidental Injury 0.0 0.2 3.5 Asthenia 0.7 1.3 1.4 Confusion 0.5 0.6 2.3 Death 0.2 0.4 3.0 Pain 0.0 0.6 3.0 Speech Disorder 0.0 0.2 3.5 Hypotension 1.0 0.2 1.9 Ambylopia 0.5 0.2 2.3 Diarrhea 0.0 0.8 2.3 Hypoventilation 0.2 0.8 2.1 Coma 0.0 1.5 0.9 Impotence 0.2 0.4 1.6 Peripheral Edema 0.0 0.0 2.3 Urinary Incontinence 0.0 0.8 1.4 Insomnia 0.0 0.4 1.6 Anxiety 0.2 0.4 0.9 Depression 0.0 0.0 1.6 Dypsnea 0.3 0.0 1.2 Fever 0.5 0.2 0.7 Pneumonia 0.2 0.2 1.2 Urinary Frequency 0.0 0.6 0.9 Urticaria 0.2 0.2 1.2 Anorexia 0.0 0.4 0.9 Diplopia 0.0 0.4 0.9 Dysautonomia 0.2 0.2 0.9 Hallucinations 0.3 0.4 0.5 Hypertension 0.2 0.6 0.5 .\"\n }\n ]\n },\n {\n \"Term\": \"Cyst\",\n \"MEDDRACode\": \"10011732\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"cysts\",\n \"Probability\": \"0.7583121061\",\n \"SemanticContext\": \"In most cases these cysts disappeared spontaneously while patients continued to receive the drug.\"\n }\n ]\n },\n {\n \"Term\": \"Systemic infection\",\n \"MEDDRACode\": \"10077116\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"systemic infection\",\n \"Probability\": \"0.010140121\",\n \"SemanticContext\": \"5.9 Infections Patients should be infection-free prior to the screening trial with GABLOFEN because the presence of a systemic infection may interfere with an assessment of the patient's response to bolus GABLOFEN.\"\n },\n {\n \"VerbatimTerm\": \"systemic infection\",\n \"Probability\": \"0.1145266593\",\n \"SemanticContext\": \"Moreover, a systemic infection may complicate dosing.\"\n }\n ]\n },\n {\n \"Term\": \"Multiple sclerosis\",\n \"MEDDRACode\": \"10028245\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"multiple sclerosis\",\n \"Probability\": \"0.0316520631\",\n \"SemanticContext\": \"14 CLINICAL STUDIES Spasticity of Spinal Cord Origin Evidence supporting the efficacy of intrathecal baclofen was obtained in randomized, controlled investigations that compared the effects of either a single intrathecal dose or a three day intrathecal infusion of intrathecal baclofen to placebo in patients with severe spasticity and spasms due to either spinal cord trauma or multiple sclerosis.\"\n },\n {\n \"VerbatimTerm\": \"multiple sclerosis\",\n \"Probability\": \"0.012237072\",\n \"SemanticContext\": \"Ovarian cysts have been found by palpation in about 4% of the multiple sclerosis patients who were treated with oral baclofen for up to one year.\"\n },\n {\n \"VerbatimTerm\": \"Multiple Sclerosis\",\n \"Probability\": \"0.0399596691\",\n \"SemanticContext\": \"One patient, a 44 year-old male with Multiple Sclerosis, died in hospital on the second day following pump implantation.\"\n }\n ]\n },\n {\n \"Term\": \"Blood ethanol\",\n \"MEDDRACode\": \"10005513\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"ethanol\",\n \"Probability\": \"0.0002537966\",\n \"SemanticContext\": \"It is slightly soluble in water, very slightly soluble in methanol and ethanol, practically insoluble in acetone and ether, soluble in 0.1N hydrochloric acid, 0.1N sodium hydroxide, and insoluble in chloroform.\"\n }\n ]\n },\n {\n \"Term\": \"Blood chloride\",\n \"MEDDRACode\": \"10005416\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"chloride\",\n \"Probability\": \"0.0002138913\",\n \"SemanticContext\": \"Each mL of GABLOFEN contains baclofen USP 50 mcg, 500 mcg, 1,000 mcg or 2,000 mcg and sodium chloride 9 mg in Water for Injection; pH range is 5.5 to 7.5.\"\n },\n {\n \"VerbatimTerm\": \"Chloride\",\n \"Probability\": \"0.0002998114\",\n \"SemanticContext\": \"For patients who require concentrations other than 500 mcg/mL, 1,000 mcg/mL, or 2,000 mcg/mL, GABLOFEN must be diluted with sterile preservative free Sodium Chloride for Injection, USP.\"\n }\n ]\n },\n {\n \"Term\": \"Bradycardia\",\n \"MEDDRACode\": \"10006093\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"bradycardia\",\n \"Probability\": \"0.9989314079\",\n \"SemanticContext\": \"Cardiovascular: Postural hypotension, bradycardia, palpitations, syncope, arrhythmia ventricular, deep thrombophlebitis, pallor and tachycardia.\"\n },\n {\n \"VerbatimTerm\": \"bradycardia\",\n \"Probability\": \"0.0658302307\",\n \"SemanticContext\": \"Caution in administering physostigmine is advised, however, because its use has been associated with the induction of seizures and bradycardia.\"\n },\n {\n \"VerbatimTerm\": \"Bradycardia\",\n \"Probability\": \"0.9835832715\",\n \"SemanticContext\": \"Cardiovascular: Bradycardia.\"\n }\n ]\n },\n {\n \"Term\": \"Pneumonia\",\n \"MEDDRACode\": \"10035664\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Pneumonia\",\n \"Probability\": \"0.998339653\",\n \"SemanticContext\": \"Table 1: Most Common =1% Adverse Reactions in Patients with Spasticity of Spinal Origin in Prospectively Monitored Clinical Trials Adverse Reactions Percent N=576 Screening Percent N=474 Titration† Percent N=430 Maintenance ‡ Hypotonia 5.4 13.5 25.3 Somnolence 5.7 5.9 20.9 Dizziness 1.7 1.9 7.9 Paresthesia 2.4 2.1 6.7 Nausea and Vomiting 1.6 2.3 5.6 Headache 1.6 2.5 5.1 Constipation 0.2 1.5 5.1 Convulsion 0.5 1.3 4.7 Urinary Retention 0.7 1.7 1.9 Dry Mouth 0.2 0.4 3.3 Accidental Injury 0.0 0.2 3.5 Asthenia 0.7 1.3 1.4 Confusion 0.5 0.6 2.3 Death 0.2 0.4 3.0 Pain 0.0 0.6 3.0 Speech Disorder 0.0 0.2 3.5 Hypotension 1.0 0.2 1.9 Ambylopia 0.5 0.2 2.3 Diarrhea 0.0 0.8 2.3 Hypoventilation 0.2 0.8 2.1 Coma 0.0 1.5 0.9 Impotence 0.2 0.4 1.6 Peripheral Edema 0.0 0.0 2.3 Urinary Incontinence 0.0 0.8 1.4 Insomnia 0.0 0.4 1.6 Anxiety 0.2 0.4 0.9 Depression 0.0 0.0 1.6 Dypsnea 0.3 0.0 1.2 Fever 0.5 0.2 0.7 Pneumonia 0.2 0.2 1.2 Urinary Frequency 0.0 0.6 0.9 Urticaria 0.2 0.2 1.2 Anorexia 0.0 0.4 0.9 Diplopia 0.0 0.4 0.9 Dysautonomia 0.2 0.2 0.9 Hallucinations 0.3 0.4 0.5 Hypertension 0.2 0.6 0.5 .\"\n },\n {\n \"VerbatimTerm\": \"Pneumonia\",\n \"Probability\": \"0.9969011545\",\n \"SemanticContext\": \"Table 2: Most Common =1% Adverse Reactions in Patients with Spasticity of Cerebral Origin Adverse Reactions Percent N=211 Screening* Percent N=153 Titration† Percent N=150 Maintenance ‡ Hypotonia 2.4 14.4 34.7 Somnolence 7.6 10.5 18.7 Headache 6.6 7.8 10.7 Nausea and Vomiting 6.6 10.5 4.0 Vomiting 6.2 8.5 4.0 Urinary Retention 0.9 6.5 8.0 Convulsion 0.9 3.3 10.0 Dizziness 2.4 2.6 8.0 Nausea 1.4 3.3 7.3 Hypoventilation 1.4 1.3 4.0 Hypertonia 0.0 0.7 6.0 Paresthesia 1.9 0.7 3.3 Hypotension 1.9 0.7 2.0 Increased Salivation 0.0 2.6 2.7 Back Pain 0.9 0.7 2.0 Constipation 0.5 1.3 2.0 Pain 0.0 0.0 4.0 Pruritus 0.0 0.0 4.0 Diarrhea 0.5 0.7 2.0 Peripheral Edema 0.0 0.0 3.3 Thinking Abnormal 0.5 1.3 0.7 Agitation 0.5 0.0 1.3 Asthenia 0.0 0.0 2.0 Chills 0.5 0.0 1.3 Coma 0.5 0.0 1.3 Dry Mouth 0.5 0.0 1.3 Pneumonia 0.0 0.0 2.0 Speech Disorder 0.5 0.7 0.7 Tremor 0.5 0.0 1.3 Urinary Incontinence 0.0 0.0 2.0 Urination Impaired 0.0 0.0 2.0 .\"\n },\n {\n \"VerbatimTerm\": \"pneumonia\",\n \"Probability\": \"0.991406858\",\n \"SemanticContext\": \"As a group, the patients who died were relatively young mean age was 47 with a range from 25 to 63 , but the majority suffered from severe spasticity of many years duration, were nonambulatory, had various medical complications such as pneumonia, urinary tract infections, and decubiti, and/or had received multiple concomitant medications.\"\n }\n ]\n },\n {\n \"Term\": \"Axillary web syndrome\",\n \"MEDDRACode\": \"10074387\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"cord\",\n \"Probability\": \"4.76591E-05\",\n \"SemanticContext\": \"· Maintenance Therapy : Titrate patients individually; Lowest dose with an optimal response should be used, generally 300 mcg/day to 800 mcg/day for spasticity of spinal cord origin and 90 mcg/day to 700 mcg/day for spasticity of cerebral origin; Titrate GABLOFEN to maintain some degree of muscle tone and allow occasional spasms.\"\n },\n {\n \"VerbatimTerm\": \"cord\",\n \"Probability\": \"0.064329952\",\n \"SemanticContext\": \"Adverse Reactions Associated with Discontinuation of Treatment 8/474 patients with spasticity of spinal cord origin receiving long term infusion of intrathecal baclofen in pre- and post-marketing clinical studies in the U.S. discontinued treatment due to adverse reactions.\"\n },\n {\n \"VerbatimTerm\": \"cord\",\n \"Probability\": \"0.0019065738\",\n \"SemanticContext\": \"Doses used in this patient population for long-term infusion are generally lower than those required for patients with spasticity of spinal cord origin.\"\n },\n {\n \"VerbatimTerm\": \"cord\",\n \"Probability\": \"0.0176375508\",\n \"SemanticContext\": \"14 CLINICAL STUDIES Spasticity of Spinal Cord Origin Evidence supporting the efficacy of intrathecal baclofen was obtained in randomized, controlled investigations that compared the effects of either a single intrathecal dose or a three day intrathecal infusion of intrathecal baclofen to placebo in patients with severe spasticity and spasms due to either spinal cord trauma or multiple sclerosis.\"\n },\n {\n \"VerbatimTerm\": \"cord\",\n \"Probability\": \"0.0045163631\",\n \"SemanticContext\": \"For spasticity of spinal cord origin, chronic infusion of GABLOFEN via an implantable pump should be reserved for patients unresponsive to oral baclofen therapy, or those who experience intolerable CNS side effects at effective doses.\"\n },\n {\n \"VerbatimTerm\": \"Cord\",\n \"Probability\": \"0.1157414615\",\n \"SemanticContext\": \"6 ADVERSE REACTIONS 6.1 Spasticity of Spinal Cord Origin Most Common Adverse Reactions in Patients with Spasticity of Spinal Origin In pre- and post-marketing clinical trials, the most common adverse reactions associated with use of intrathecal baclofen which were not seen at an equivalent incidence among placebo-treated patients were: somnolence, dizziness, nausea, hypotension, headache, convulsions and hypotonia.\"\n },\n {\n \"VerbatimTerm\": \"Cord\",\n \"Probability\": \"0.1879442632\",\n \"SemanticContext\": \"14 CLINICAL STUDIES Spasticity of Spinal Cord Origin Evidence supporting the efficacy of intrathecal baclofen was obtained in randomized, controlled investigations that compared the effects of either a single intrathecal dose or a three day intrathecal infusion of intrathecal baclofen to placebo in patients with severe spasticity and spasms due to either spinal cord trauma or multiple sclerosis.\"\n },\n {\n \"VerbatimTerm\": \"Cord\",\n \"Probability\": \"0.0007899404\",\n \"SemanticContext\": \"Adult Patients with Spasticity of Spinal Cord Origin After the first 24 hours, for adult patients, the daily dosage should be increased slowly by 10% to 30% increments and only once every 24 hours, until the desired clinical effect is achieved.\"\n },\n {\n \"VerbatimTerm\": \"Cord\",\n \"Probability\": \"0.0036619008\",\n \"SemanticContext\": \"2.6 Maintenance Therapy Spasticity of Spinal Cord Origin Patients The clinical goal is to maintain muscle tone as close to normal as possible, and to minimize the frequency and severity of spasms to the extent possible, without inducing intolerable side effects.\"\n },\n {\n \"VerbatimTerm\": \"Cord\",\n \"Probability\": \"0.1800244153\",\n \"SemanticContext\": \"5.7 Fatalities Spasticity of Spinal Cord Origin There were 16 deaths reported among the 576 U.S. patients treated with intrathecal baclofen in pre- and post-marketing studies evaluated as of December 1992.\"\n }\n ]\n },\n {\n \"Term\": \"Nausea\",\n \"MEDDRACode\": \"10028813\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"nausea\",\n \"Probability\": \"0.9994642735\",\n \"SemanticContext\": \"ADVERSE REACTIONS · The most common adverse reactions in patients with spasticity of spinal origin were somnolence, dizziness, nausea, hypotension, headache, convulsions and hypotonia.\"\n },\n {\n \"VerbatimTerm\": \"nausea\",\n \"Probability\": \"0.9998832941\",\n \"SemanticContext\": \"6 ADVERSE REACTIONS 6.1 Spasticity of Spinal Cord Origin Most Common Adverse Reactions in Patients with Spasticity of Spinal Origin In pre- and post-marketing clinical trials, the most common adverse reactions associated with use of intrathecal baclofen which were not seen at an equivalent incidence among placebo-treated patients were: somnolence, dizziness, nausea, hypotension, headache, convulsions and hypotonia.\"\n },\n {\n \"VerbatimTerm\": \"nausea\",\n \"Probability\": \"0.9886760712\",\n \"SemanticContext\": \"Nonetheless, many of the more commonly reported reactions -- hypotonia, somnolence, dizziness, paresthesia, nausea/vomiting and headache -- appear clearly drug-related.\"\n },\n {\n \"VerbatimTerm\": \"nausea\",\n \"Probability\": \"0.9991154671\",\n \"SemanticContext\": \"The following adverse reactions occurred among the 62 patients receiving intrathecal baclofen in two randomized, placebo-controlled trials involving cerebral palsy and head injury patients, respectively: agitation, constipation, somnolence, leukocytosis, nausea, vomiting, nystagmus, chills, urinary retention, and hypotonia.\"\n },\n {\n \"VerbatimTerm\": \"nausea\",\n \"Probability\": \"0.9980700016\",\n \"SemanticContext\": \"Nonetheless, many of the more commonly reported reactions -- somnolence, dizziness, headache, nausea, hypotension, hypotonia and coma -- appear clearly drug-related.\"\n },\n {\n \"VerbatimTerm\": \"Nausea\",\n \"Probability\": \"0.9993743896\",\n \"SemanticContext\": \"Table 2: Most Common =1% Adverse Reactions in Patients with Spasticity of Cerebral Origin Adverse Reactions Percent N=211 Screening* Percent N=153 Titration† Percent N=150 Maintenance ‡ Hypotonia 2.4 14.4 34.7 Somnolence 7.6 10.5 18.7 Headache 6.6 7.8 10.7 Nausea and Vomiting 6.6 10.5 4.0 Vomiting 6.2 8.5 4.0 Urinary Retention 0.9 6.5 8.0 Convulsion 0.9 3.3 10.0 Dizziness 2.4 2.6 8.0 Nausea 1.4 3.3 7.3 Hypoventilation 1.4 1.3 4.0 Hypertonia 0.0 0.7 6.0 Paresthesia 1.9 0.7 3.3 Hypotension 1.9 0.7 2.0 Increased Salivation 0.0 2.6 2.7 Back Pain 0.9 0.7 2.0 Constipation 0.5 1.3 2.0 Pain 0.0 0.0 4.0 Pruritus 0.0 0.0 4.0 Diarrhea 0.5 0.7 2.0 Peripheral Edema 0.0 0.0 3.3 Thinking Abnormal 0.5 1.3 0.7 Agitation 0.5 0.0 1.3 Asthenia 0.0 0.0 2.0 Chills 0.5 0.0 1.3 Coma 0.5 0.0 1.3 Dry Mouth 0.5 0.0 1.3 Pneumonia 0.0 0.0 2.0 Speech Disorder 0.5 0.7 0.7 Tremor 0.5 0.0 1.3 Urinary Incontinence 0.0 0.0 2.0 Urination Impaired 0.0 0.0 2.0 .\"\n }\n ]\n },\n {\n \"Term\": \"Confusional state\",\n \"MEDDRACode\": \"10010305\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"confusional states\",\n \"Probability\": \"0.4881514609\",\n \"SemanticContext\": \"· Possible exacerbation of psychotic disorders, schizophrenia or confusional states 5.6 5 .\"\n },\n {\n \"VerbatimTerm\": \"confusional states\",\n \"Probability\": \"0.0104629099\",\n \"SemanticContext\": \"5.6 Possible Exacerbation of Psychotic Disorders, Schizophrenia, or Confusional States Patients suffering from psychotic disorders, schizophrenia, or confusional states should be treated cautiously with GABLOFEN and kept under careful surveillance, because exacerbations of these conditions have been observed with oral administration.\"\n },\n {\n \"VerbatimTerm\": \"Confusional States\",\n \"Probability\": \"0.0058569014\",\n \"SemanticContext\": \"5.6 Possible Exacerbation of Psychotic Disorders, Schizophrenia, or Confusional States Patients suffering from psychotic disorders, schizophrenia, or confusional states should be treated cautiously with GABLOFEN and kept under careful surveillance, because exacerbations of these conditions have been observed with oral administration.\"\n }\n ]\n },\n {\n \"Term\": \"Psychotic disorder\",\n \"MEDDRACode\": \"10061920\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"psychotic disorders\",\n \"Probability\": \"0.8532530069\",\n \"SemanticContext\": \"· Possible exacerbation of psychotic disorders, schizophrenia or confusional states 5.6 5 .\"\n },\n {\n \"VerbatimTerm\": \"psychotic disorders\",\n \"Probability\": \"0.027210921\",\n \"SemanticContext\": \"5.6 Possible Exacerbation of Psychotic Disorders, Schizophrenia, or Confusional States Patients suffering from psychotic disorders, schizophrenia, or confusional states should be treated cautiously with GABLOFEN and kept under careful surveillance, because exacerbations of these conditions have been observed with oral administration.\"\n },\n {\n \"VerbatimTerm\": \"Psychotic Disorders\",\n \"Probability\": \"0.058254838\",\n \"SemanticContext\": \"5.6 Possible Exacerbation of Psychotic Disorders, Schizophrenia, or Confusional States Patients suffering from psychotic disorders, schizophrenia, or confusional states should be treated cautiously with GABLOFEN and kept under careful surveillance, because exacerbations of these conditions have been observed with oral administration.\"\n }\n ]\n },\n {\n \"Term\": \"Blood lead\",\n \"MEDDRACode\": \"10005639\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"led\",\n \"Probability\": \"0.0023545325\",\n \"SemanticContext\": \"Eight of 474 patients who received chronic infusion via implanted pumps had adverse experiences which led to a discontinuation of long term treatment in the pre- and post-marketing studies.\"\n },\n {\n \"VerbatimTerm\": \"leading\",\n \"Probability\": \"0.03559044\",\n \"SemanticContext\": \"The nine adverse reactions leading to discontinuation were: infection 3 , CSF leaks 2 , meningitis 2 , drainage 1 , and unmanageable trunk control 1 .\"\n },\n {\n \"VerbatimTerm\": \"leading\",\n \"Probability\": \"0.0007857084\",\n \"SemanticContext\": \"Cases of intrathecal mass at the tip of the implanted catheter leading to withdrawal symptoms have also been reported, most of them involving pharmacy compounded analgesic admixtures [see Warnings and Precautions 5.10 ] .\"\n }\n ]\n },\n {\n \"Term\": \"Drug tolerance\",\n \"MEDDRACode\": \"10052804\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"tolerance\",\n \"Probability\": \"0.012594074\",\n \"SemanticContext\": \"In people, as well as in animals, baclofen has been shown to have general CNS depressant properties as indicated by the production of sedation with tolerance, somnolence, ataxia, and respiratory and cardiovascular depression.\"\n },\n {\n \"VerbatimTerm\": \"tolerance\",\n \"Probability\": \"5.03105E-05\",\n \"SemanticContext\": \"There is not sufficient experience to make firm recommendations for tolerance treatment; however, this “tolerance” has been treated on occasion, in hospital, by a “drug holiday” consisting of the gradual reduction of intrathecal baclofen over a 2 to 4 week period and switching to alternative methods of spasticity management.\"\n },\n {\n \"VerbatimTerm\": \"tolerance\",\n \"Probability\": \"4.62718E-05\",\n \"SemanticContext\": \"There is not sufficient experience to make firm recommendations for tolerance treatment; however, this “tolerance” has been treated on occasion, in hospital, by a “drug holiday” consisting of the gradual reduction of intrathecal baclofen over a 2 to 4 week period and switching to alternative methods of spasticity management.\"\n }\n ]\n },\n {\n \"Term\": \"Schizophrenia\",\n \"MEDDRACode\": \"10039626\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"schizophrenia\",\n \"Probability\": \"0.9735611677\",\n \"SemanticContext\": \"· Possible exacerbation of psychotic disorders, schizophrenia or confusional states 5.6 5 .\"\n },\n {\n \"VerbatimTerm\": \"schizophrenia\",\n \"Probability\": \"0.0376684666\",\n \"SemanticContext\": \"5.6 Possible Exacerbation of Psychotic Disorders, Schizophrenia, or Confusional States Patients suffering from psychotic disorders, schizophrenia, or confusional states should be treated cautiously with GABLOFEN and kept under careful surveillance, because exacerbations of these conditions have been observed with oral administration.\"\n },\n {\n \"VerbatimTerm\": \"Schizophrenia\",\n \"Probability\": \"0.1763511598\",\n \"SemanticContext\": \"5.6 Possible Exacerbation of Psychotic Disorders, Schizophrenia, or Confusional States Patients suffering from psychotic disorders, schizophrenia, or confusional states should be treated cautiously with GABLOFEN and kept under careful surveillance, because exacerbations of these conditions have been observed with oral administration.\"\n }\n ]\n },\n {\n \"Term\": \"Crigler-Najjar syndrome\",\n \"MEDDRACode\": \"10011386\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"CNS\",\n \"Probability\": \"0.0133179128\",\n \"SemanticContext\": \"In people, as well as in animals, baclofen has been shown to have general CNS depressant properties as indicated by the production of sedation with tolerance, somnolence, ataxia, and respiratory and cardiovascular depression.\"\n },\n {\n \"VerbatimTerm\": \"CNS\",\n \"Probability\": \"8.0969E-06\",\n \"SemanticContext\": \"For spasticity of spinal cord origin, chronic infusion of GABLOFEN via an implantable pump should be reserved for patients unresponsive to oral baclofen therapy, or those who experience intolerable CNS side effects at effective doses.\"\n },\n {\n \"VerbatimTerm\": \"CNS\",\n \"Probability\": \"0.0114183128\",\n \"SemanticContext\": \"Increased Risk of Drowsiness with Alcohol and Other CNS Depressants Inform patients and their caregivers that the drowsiness associated with GABLOFEN use can be worsened by alcohol and other CNS depressants.\"\n },\n {\n \"VerbatimTerm\": \"CNS\",\n \"Probability\": \"0.0120953321\",\n \"SemanticContext\": \"Increased Risk of Drowsiness with Alcohol and Other CNS Depressants Inform patients and their caregivers that the drowsiness associated with GABLOFEN use can be worsened by alcohol and other CNS depressants.\"\n },\n {\n \"VerbatimTerm\": \"CNS\",\n \"Probability\": \"0.001039207\",\n \"SemanticContext\": \"Patients should also be cautioned that the central nervous system depressant effects of intrathecal baclofen may be additive to those of alcohol and other CNS depressants.\"\n }\n ]\n },\n {\n \"Term\": \"Agitation\",\n \"MEDDRACode\": \"10001497\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"agitation\",\n \"Probability\": \"0.9895687699\",\n \"SemanticContext\": \"· The most common adverse reactions in patients with spasticity of cerebral origin were agitation, constipation, somnolence, leukocytosis, chills, urinary retention and hypotonia.\"\n },\n {\n \"VerbatimTerm\": \"agitation\",\n \"Probability\": \"0.9984906912\",\n \"SemanticContext\": \"6.2 Spasticity of Cerebral Origin Most Common Adverse Reactions In pre-marketing clinical trials, the most common adverse reactions associated with use of intrathecal baclofen which were not seen at an equivalent incidence among placebo-treated patients included: agitation, constipation, somnolence, leukocytosis, chills, urinary retention and hypotonia.\"\n },\n {\n \"VerbatimTerm\": \"agitation\",\n \"Probability\": \"0.9945995808\",\n \"SemanticContext\": \"The following adverse reactions occurred among the 62 patients receiving intrathecal baclofen in two randomized, placebo-controlled trials involving cerebral palsy and head injury patients, respectively: agitation, constipation, somnolence, leukocytosis, nausea, vomiting, nystagmus, chills, urinary retention, and hypotonia.\"\n },\n {\n \"VerbatimTerm\": \"Agitation\",\n \"Probability\": \"0.9920496941\",\n \"SemanticContext\": \"Table 2: Most Common =1% Adverse Reactions in Patients with Spasticity of Cerebral Origin Adverse Reactions Percent N=211 Screening* Percent N=153 Titration† Percent N=150 Maintenance ‡ Hypotonia 2.4 14.4 34.7 Somnolence 7.6 10.5 18.7 Headache 6.6 7.8 10.7 Nausea and Vomiting 6.6 10.5 4.0 Vomiting 6.2 8.5 4.0 Urinary Retention 0.9 6.5 8.0 Convulsion 0.9 3.3 10.0 Dizziness 2.4 2.6 8.0 Nausea 1.4 3.3 7.3 Hypoventilation 1.4 1.3 4.0 Hypertonia 0.0 0.7 6.0 Paresthesia 1.9 0.7 3.3 Hypotension 1.9 0.7 2.0 Increased Salivation 0.0 2.6 2.7 Back Pain 0.9 0.7 2.0 Constipation 0.5 1.3 2.0 Pain 0.0 0.0 4.0 Pruritus 0.0 0.0 4.0 Diarrhea 0.5 0.7 2.0 Peripheral Edema 0.0 0.0 3.3 Thinking Abnormal 0.5 1.3 0.7 Agitation 0.5 0.0 1.3 Asthenia 0.0 0.0 2.0 Chills 0.5 0.0 1.3 Coma 0.5 0.0 1.3 Dry Mouth 0.5 0.0 1.3 Pneumonia 0.0 0.0 2.0 Speech Disorder 0.5 0.7 0.7 Tremor 0.5 0.0 1.3 Urinary Incontinence 0.0 0.0 2.0 Urination Impaired 0.0 0.0 2.0 .\"\n }\n ]\n },\n {\n \"Term\": \"Ultrasound scan\",\n \"MEDDRACode\": \"10045434\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"U.S.\",\n \"Probability\": \"0.0004858971\",\n \"SemanticContext\": \"GABLOFEN baclofen injection , for intrathecal use Initial U.S. Approval: 1992 WARNING: DO NOT DISCONTINUE ABRUPTLY See full prescribing information for complete boxed warning Abrupt discontinuation of intrathecal baclofen, regardless of the cause, has resulted in sequelae that include high fever, altered mental status, exaggerated rebound spasticity, and muscle rigidity, that in rare cases has advanced to rhabdomyolysis, multiple organ-system failure and death.\"\n },\n {\n \"VerbatimTerm\": \"U.S.\",\n \"Probability\": \"0.0004358888\",\n \"SemanticContext\": \"Adverse Reactions Associated with Discontinuation of Treatment 8/474 patients with spasticity of spinal cord origin receiving long term infusion of intrathecal baclofen in pre- and post-marketing clinical studies in the U.S. discontinued treatment due to adverse reactions.\"\n },\n {\n \"VerbatimTerm\": \"U.S.\",\n \"Probability\": \"0.0010111332\",\n \"SemanticContext\": \"Adverse experiences reported during all U.S. studies both controlled and uncontrolled are shown in Table 1.\"\n },\n {\n \"VerbatimTerm\": \"U.S.\",\n \"Probability\": \"0.002556175\",\n \"SemanticContext\": \"Adverse Reactions Associated with Discontinuation of Treatment Nine of 211 patients receiving intrathecal baclofen in pre-marketing clinical studies in the U.S. discontinued long-term infusion due to adverse reactions associated with intrathecal therapy.\"\n },\n {\n \"VerbatimTerm\": \"U.S.\",\n \"Probability\": \"0.0001235008\",\n \"SemanticContext\": \"Events Observed during the Pre-marketing Evaluation of Intrathecal Baclofen Adverse events associated with the use of intrathecal baclofen reflect experience gained with a total of 211 U.S. patients with spasticity of cerebral origin, of whom 112 were pediatric patients under age 16 at enrollment .\"\n },\n {\n \"VerbatimTerm\": \"U.S.\",\n \"Probability\": \"0.0001934171\",\n \"SemanticContext\": \"In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.\"\n },\n {\n \"VerbatimTerm\": \"U.S.\",\n \"Probability\": \"0.0007827878\",\n \"SemanticContext\": \"5.7 Fatalities Spasticity of Spinal Cord Origin There were 16 deaths reported among the 576 U.S. patients treated with intrathecal baclofen in pre- and post-marketing studies evaluated as of December 1992.\"\n }\n ]\n },\n {\n \"Term\": \"Infusion\",\n \"MEDDRACode\": \"10060345\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"infusion\",\n \"Probability\": \"4.76252E-05\",\n \"SemanticContext\": \"Prevention of abrupt discontinuation of intrathecal baclofen requires careful attention to programming and monitoring of the infusion system, refill scheduling and procedures, and pump alarms.\"\n },\n {\n \"VerbatimTerm\": \"infusion\",\n \"Probability\": \"2.82165E-05\",\n \"SemanticContext\": \"Consult the technical manual of the implantable infusion system for additional post-implant clinician and patient information.\"\n },\n {\n \"VerbatimTerm\": \"infusion\",\n \"Probability\": \"3.97942E-05\",\n \"SemanticContext\": \"· Patients should first respond to a screening dose of intrathecal baclofen prior to consideration for long term infusion via an implantable pump.\"\n },\n {\n \"VerbatimTerm\": \"infusion\",\n \"Probability\": \"1.46138E-05\",\n \"SemanticContext\": \"· Screening : Patients who do not respond to a 100 mcg intrathecal bolus should not be considered for an implanted pump for chronic infusion.\"\n },\n {\n \"VerbatimTerm\": \"infusion\",\n \"Probability\": \"0.0008802116\",\n \"SemanticContext\": \"Adverse Reactions Associated with Discontinuation of Treatment 8/474 patients with spasticity of spinal cord origin receiving long term infusion of intrathecal baclofen in pre- and post-marketing clinical studies in the U.S. discontinued treatment due to adverse reactions.\"\n },\n {\n \"VerbatimTerm\": \"infusion\",\n \"Probability\": \"0.0052650273\",\n \"SemanticContext\": \"Incidence in Controlled Trials Experience with intrathecal baclofen obtained in parallel, placebo-controlled, randomized studies provides only a limited basis for estimating the incidence of adverse reactions because the studies were of very brief duration up to three days of infusion and involved only a total of 63 patients.\"\n },\n {\n \"VerbatimTerm\": \"infusion\",\n \"Probability\": \"0.0026308894\",\n \"SemanticContext\": \"Eight of 474 patients who received chronic infusion via implanted pumps had adverse experiences which led to a discontinuation of long term treatment in the pre- and post-marketing studies.\"\n },\n {\n \"VerbatimTerm\": \"infusion\",\n \"Probability\": \"0.0080777407\",\n \"SemanticContext\": \"Adverse Reactions Associated with Discontinuation of Treatment Nine of 211 patients receiving intrathecal baclofen in pre-marketing clinical studies in the U.S. discontinued long-term infusion due to adverse reactions associated with intrathecal therapy.\"\n },\n {\n \"VerbatimTerm\": \"infusion\",\n \"Probability\": \"0.000359416\",\n \"SemanticContext\": \"Doses used in this patient population for long-term infusion are generally lower than those required for patients with spasticity of spinal cord origin.\"\n },\n {\n \"VerbatimTerm\": \"infusion\",\n \"Probability\": \"0.0001267791\",\n \"SemanticContext\": \"Continuous Infusion Adult Patients Intrathecal baclofen's antispastic action is first seen at 6 to 8 hours after initiation of continuous infusion.\"\n },\n {\n \"VerbatimTerm\": \"infusion\",\n \"Probability\": \"0.0008139908\",\n \"SemanticContext\": \"12.3 Pharmacokinetics The pharmacokinetics of cerebrospinal fluid CSF clearance of intrathecal baclofen calculated from intrathecal bolus or continuous infusion studies approximates CSF turnover, suggesting elimination is by bulk-flow removal of CSF.\"\n },\n {\n \"VerbatimTerm\": \"infusion\",\n \"Probability\": \"0.0009703934\",\n \"SemanticContext\": \"Continuous Infusion The mean CSF clearance for intrathecal baclofen was approximately 30 mL/hour in a study involving ten patients on continuous intrathecal infusion.\"\n },\n {\n \"VerbatimTerm\": \"infusion\",\n \"Probability\": \"0.0016956925\",\n \"SemanticContext\": \"Limited pharmacokinetic data suggest that a lumbar-cisternal concentration gradient of about 4:1 is established along the neuroaxis during baclofen infusion.\"\n },\n {\n \"VerbatimTerm\": \"infusion\",\n \"Probability\": \"2.14944E-05\",\n \"SemanticContext\": \"This is based upon simultaneous CSF sampling via cisternal and lumbar tap in 5 patients receiving continuous baclofen infusion at the lumbar level at doses associated with therapeutic efficacy; the interpatient variability was great.\"\n },\n {\n \"VerbatimTerm\": \"infusion\",\n \"Probability\": \"4.78624E-05\",\n \"SemanticContext\": \"Six pediatric patients age 8 to 18 years receiving continuous intrathecal baclofen infusion at doses of 77 to 400 mcg/day had plasma baclofen levels near or below 10 ng/mL.\"\n },\n {\n \"VerbatimTerm\": \"infusion\",\n \"Probability\": \"0.0002554953\",\n \"SemanticContext\": \"14 CLINICAL STUDIES Spasticity of Spinal Cord Origin Evidence supporting the efficacy of intrathecal baclofen was obtained in randomized, controlled investigations that compared the effects of either a single intrathecal dose or a three day intrathecal infusion of intrathecal baclofen to placebo in patients with severe spasticity and spasms due to either spinal cord trauma or multiple sclerosis.\"\n },\n {\n \"VerbatimTerm\": \"infusion\",\n \"Probability\": \"2.10029E-05\",\n \"SemanticContext\": \"2.2 Screening Phase Prior to pump implantation and initiation of chronic infusion of GABLOFEN, patients must demonstrate a positive clinical response to a GABLOFEN bolus dose administered intrathecally in a screening trial.\"\n },\n {\n \"VerbatimTerm\": \"infusion\",\n \"Probability\": \"1.56468E-05\",\n \"SemanticContext\": \"Patients who do not respond to a 100 mcg intrathecal bolus should not be considered candidates for an implanted pump for chronic infusion.\"\n },\n {\n \"VerbatimTerm\": \"infusion\",\n \"Probability\": \"4.04157E-05\",\n \"SemanticContext\": \"Delivery Regimen GABLOFEN is most often administered in a continuous infusion mode immediately following implant.\"\n },\n {\n \"VerbatimTerm\": \"infusion\",\n \"Probability\": \"6.2156E-06\",\n \"SemanticContext\": \"For those patients implanted with programmable pumps who have achieved relatively satisfactory control on continuous infusion, further benefit may be attained using more complex schedules of GABLOFEN delivery.\"\n },\n {\n \"VerbatimTerm\": \"infusion\",\n \"Probability\": \"4.99894E-05\",\n \"SemanticContext\": \"For example, patients who have increased spasms at night may require a 20% increase in their hourly infusion rate.\"\n },\n {\n \"VerbatimTerm\": \"infusion\",\n \"Probability\": \"4.24574E-05\",\n \"SemanticContext\": \"An attempt should be made to discontinue concomitant oral antispasticity medication to avoid possible overdose or adverse drug interactions, either prior to screening or following implant and initiation of chronic GABLOFEN infusion.\"\n },\n {\n \"VerbatimTerm\": \"infusion\",\n \"Probability\": \"7.475E-06\",\n \"SemanticContext\": \"Maintenance dosage for long term continuous infusion of intrathecal baclofen has ranged from 12 mcg/day to 2,003 mcg/day, with most patients adequately maintained on 300 micrograms to 800 micrograms per day.\"\n },\n {\n \"VerbatimTerm\": \"infusion\",\n \"Probability\": \"7.475E-06\",\n \"SemanticContext\": \"Maintenance dosage for long term continuous infusion of intrathecal baclofen has ranged from 22 mcg/day to 1,400 mcg/day, with most patients adequately maintained on 90 micrograms to 703 micrograms per day.\"\n },\n {\n \"VerbatimTerm\": \"infusion\",\n \"Probability\": \"9.9953E-06\",\n \"SemanticContext\": \"After the “drug holiday,” intrathecal baclofen may be restarted at the initial continuous infusion dose.\"\n },\n {\n \"VerbatimTerm\": \"infusion\",\n \"Probability\": \"3.55825E-05\",\n \"SemanticContext\": \"Patients should first respond to a screening dose of intrathecal baclofen prior to consideration for long term infusion via an implantable pump.\"\n },\n {\n \"VerbatimTerm\": \"infusion\",\n \"Probability\": \"4.01434E-05\",\n \"SemanticContext\": \"For spasticity of spinal cord origin, chronic infusion of GABLOFEN via an implantable pump should be reserved for patients unresponsive to oral baclofen therapy, or those who experience intolerable CNS side effects at effective doses.\"\n },\n {\n \"VerbatimTerm\": \"infusion\",\n \"Probability\": \"4.292E-05\",\n \"SemanticContext\": \"Prior to implantation of a device for chronic intrathecal infusion of GABLOFEN, patients must show a response to GABLOFEN in a screening trial [see Dosage and Administration 2.2 ] .\"\n },\n {\n \"VerbatimTerm\": \"infusion\",\n \"Probability\": \"5.2624E-06\",\n \"SemanticContext\": \"Advise patients and their caregivers to pay careful attention to infusion system alarms.\"\n },\n {\n \"VerbatimTerm\": \"infusion\",\n \"Probability\": \"1.7563E-05\",\n \"SemanticContext\": \"There are no animal data on developmental risk associated with baclofen administered via continuous intrathecal infusion.\"\n },\n {\n \"VerbatimTerm\": \"infusion\",\n \"Probability\": \"8.7083E-06\",\n \"SemanticContext\": \"Because of the possibility of potentially life-threatening CNS depression, cardiovascular collapse, and/or respiratory failure, physicians must be adequately trained and educated in chronic intrathecal infusion therapy.\"\n },\n {\n \"VerbatimTerm\": \"infusion\",\n \"Probability\": \"0.0030330718\",\n \"SemanticContext\": \"Following surgical implantation of the pump, particularly during the initial phases of pump use, the patient should be monitored closely until it is certain that the patient's response to the infusion is acceptable and reasonably stable.\"\n },\n {\n \"VerbatimTerm\": \"infusion\",\n \"Probability\": \"0.0034304559\",\n \"SemanticContext\": \"On each occasion that the dosing rate of the pump and/or the concentration of GABLOFEN in the reservoir is adjusted, close medical monitoring is required until it is certain that the patient's response to the infusion is acceptable and reasonably stable.\"\n },\n {\n \"VerbatimTerm\": \"infusion\",\n \"Probability\": \"4.76252E-05\",\n \"SemanticContext\": \"Prevention of abrupt discontinuation of intrathecal baclofen requires careful attention to programming and monitoring of the infusion system, refill scheduling and procedures, and pump alarms.\"\n },\n {\n \"VerbatimTerm\": \"infusion\",\n \"Probability\": \"3.57734E-05\",\n \"SemanticContext\": \"\\n 8.4 Pediatric Use Children should be of sufficient body mass to accommodate the implantable pump for chronic infusion.\"\n },\n {\n \"VerbatimTerm\": \"Infusion\",\n \"Probability\": \"0.0003346503\",\n \"SemanticContext\": \"Continuous Infusion Adult Patients Intrathecal baclofen's antispastic action is first seen at 6 to 8 hours after initiation of continuous infusion.\"\n },\n {\n \"VerbatimTerm\": \"Infusion\",\n \"Probability\": \"0.0003491044\",\n \"SemanticContext\": \"Continuous Infusion The mean CSF clearance for intrathecal baclofen was approximately 30 mL/hour in a study involving ten patients on continuous intrathecal infusion.\"\n },\n {\n \"VerbatimTerm\": \"infusions\",\n \"Probability\": \"0.0001682937\",\n \"SemanticContext\": \"Pediatric Patients No additional information on continuous infusions is available for pediatric patients.\"\n }\n ]\n },\n {\n \"Term\": \"Social avoidant behaviour\",\n \"MEDDRACode\": \"10041243\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"withdrawing\",\n \"Probability\": \"1.41152E-05\",\n \"SemanticContext\": \"If lumbar puncture is not contraindicated, consideration should be given to withdrawing 30 to 40 mL of CSF to reduce CSF baclofen concentration.\"\n }\n ]\n },\n {\n \"Term\": \"Abdominal hernia\",\n \"MEDDRACode\": \"10060954\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"ventral hernias\",\n \"Probability\": \"0.0460315049\",\n \"SemanticContext\": \"Data Animal Data Baclofen given orally to pregnant rats has been shown to increase the incidence of omphaloceles ventral hernias in fetuses at a dose associated with maternal toxicity.\"\n }\n ]\n },\n {\n \"Term\": \"Panic reaction\",\n \"MEDDRACode\": \"10033670\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"alarms\",\n \"Probability\": \"0.0047378242\",\n \"SemanticContext\": \"Prevention of abrupt discontinuation of intrathecal baclofen requires careful attention to programming and monitoring of the infusion system, refill scheduling and procedures, and pump alarms.\"\n },\n {\n \"VerbatimTerm\": \"alarms\",\n \"Probability\": \"0.0004826486\",\n \"SemanticContext\": \"Advise patients and their caregivers to pay careful attention to infusion system alarms.\"\n },\n {\n \"VerbatimTerm\": \"alarms\",\n \"Probability\": \"0.0047378242\",\n \"SemanticContext\": \"Prevention of abrupt discontinuation of intrathecal baclofen requires careful attention to programming and monitoring of the infusion system, refill scheduling and procedures, and pump alarms.\"\n }\n ]\n },\n {\n \"Term\": \"Coma\",\n \"MEDDRACode\": \"10010071\",\n \"Overdose\": true,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"coma\",\n \"Probability\": \"0.8786374331\",\n \"SemanticContext\": \"· Overdose may cause drowsiness, lightheadedness, dizziness, somnolence, respiratory depression, seizures, rostral progression of hypotonia and loss of consciousness progressing to coma.\"\n },\n {\n \"VerbatimTerm\": \"coma\",\n \"Probability\": \"0.0681142807\",\n \"SemanticContext\": \"Eleven patients who developed coma secondary to overdose had their treatment temporarily suspended, but all were subsequently re-started and were not, therefore, considered to be true discontinuations.\"\n },\n {\n \"VerbatimTerm\": \"coma\",\n \"Probability\": \"0.9745111465\",\n \"SemanticContext\": \"Nonetheless, many of the more commonly reported reactions -- somnolence, dizziness, headache, nausea, hypotension, hypotonia and coma -- appear clearly drug-related.\"\n },\n {\n \"VerbatimTerm\": \"coma\",\n \"Probability\": \"0.6545295715\",\n \"SemanticContext\": \"GABLOFEN Overdose Inform patients and their caregivers that GABLOFEN overdose may occur suddenly or insidiously, and that symptoms may include confusion, drowsiness, lightheadedness, dizziness, slow or shallow breathing, seizures, loss of muscle tone, loss of consciousness, and coma.\"\n },\n {\n \"VerbatimTerm\": \"coma\",\n \"Probability\": \"0.5310364366\",\n \"SemanticContext\": \"Symptoms of Intrathecal Baclofen Overdose Drowsiness, lightheadedness, dizziness, somnolence, respiratory depression, seizures, rostral progression of hypotonia and loss of consciousness progressing to coma of up to 72 hours duration.\"\n },\n {\n \"VerbatimTerm\": \"coma\",\n \"Probability\": \"0.990534246\",\n \"SemanticContext\": \"In most cases reported, coma was reversible without sequelae after drug was discontinued.\"\n },\n {\n \"VerbatimTerm\": \"coma\",\n \"Probability\": \"0.4025771022\",\n \"SemanticContext\": \"Dosage may be repeated if life-threatening signs, such as arrhythmia, convulsions or coma occur.\"\n },\n {\n \"VerbatimTerm\": \"coma\",\n \"Probability\": \"0.0032506585\",\n \"SemanticContext\": \"Acute massive overdose may present as coma.\"\n },\n {\n \"VerbatimTerm\": \"coma\",\n \"Probability\": \"0.210876286\",\n \"SemanticContext\": \"Less sudden and/or less severe forms of overdose may present with signs of drowsiness, lightheadedness, dizziness, somnolence, respiratory depression, seizures, rostral progression of hypotonia and loss of consciousness progressing to coma.\"\n },\n {\n \"VerbatimTerm\": \"Coma\",\n \"Probability\": \"0.9956092834\",\n \"SemanticContext\": \"Table 1: Most Common =1% Adverse Reactions in Patients with Spasticity of Spinal Origin in Prospectively Monitored Clinical Trials Adverse Reactions Percent N=576 Screening Percent N=474 Titration† Percent N=430 Maintenance ‡ Hypotonia 5.4 13.5 25.3 Somnolence 5.7 5.9 20.9 Dizziness 1.7 1.9 7.9 Paresthesia 2.4 2.1 6.7 Nausea and Vomiting 1.6 2.3 5.6 Headache 1.6 2.5 5.1 Constipation 0.2 1.5 5.1 Convulsion 0.5 1.3 4.7 Urinary Retention 0.7 1.7 1.9 Dry Mouth 0.2 0.4 3.3 Accidental Injury 0.0 0.2 3.5 Asthenia 0.7 1.3 1.4 Confusion 0.5 0.6 2.3 Death 0.2 0.4 3.0 Pain 0.0 0.6 3.0 Speech Disorder 0.0 0.2 3.5 Hypotension 1.0 0.2 1.9 Ambylopia 0.5 0.2 2.3 Diarrhea 0.0 0.8 2.3 Hypoventilation 0.2 0.8 2.1 Coma 0.0 1.5 0.9 Impotence 0.2 0.4 1.6 Peripheral Edema 0.0 0.0 2.3 Urinary Incontinence 0.0 0.8 1.4 Insomnia 0.0 0.4 1.6 Anxiety 0.2 0.4 0.9 Depression 0.0 0.0 1.6 Dypsnea 0.3 0.0 1.2 Fever 0.5 0.2 0.7 Pneumonia 0.2 0.2 1.2 Urinary Frequency 0.0 0.6 0.9 Urticaria 0.2 0.2 1.2 Anorexia 0.0 0.4 0.9 Diplopia 0.0 0.4 0.9 Dysautonomia 0.2 0.2 0.9 Hallucinations 0.3 0.4 0.5 Hypertension 0.2 0.6 0.5 .\"\n },\n {\n \"VerbatimTerm\": \"Coma\",\n \"Probability\": \"0.9962704182\",\n \"SemanticContext\": \"Table 2: Most Common =1% Adverse Reactions in Patients with Spasticity of Cerebral Origin Adverse Reactions Percent N=211 Screening* Percent N=153 Titration† Percent N=150 Maintenance ‡ Hypotonia 2.4 14.4 34.7 Somnolence 7.6 10.5 18.7 Headache 6.6 7.8 10.7 Nausea and Vomiting 6.6 10.5 4.0 Vomiting 6.2 8.5 4.0 Urinary Retention 0.9 6.5 8.0 Convulsion 0.9 3.3 10.0 Dizziness 2.4 2.6 8.0 Nausea 1.4 3.3 7.3 Hypoventilation 1.4 1.3 4.0 Hypertonia 0.0 0.7 6.0 Paresthesia 1.9 0.7 3.3 Hypotension 1.9 0.7 2.0 Increased Salivation 0.0 2.6 2.7 Back Pain 0.9 0.7 2.0 Constipation 0.5 1.3 2.0 Pain 0.0 0.0 4.0 Pruritus 0.0 0.0 4.0 Diarrhea 0.5 0.7 2.0 Peripheral Edema 0.0 0.0 3.3 Thinking Abnormal 0.5 1.3 0.7 Agitation 0.5 0.0 1.3 Asthenia 0.0 0.0 2.0 Chills 0.5 0.0 1.3 Coma 0.5 0.0 1.3 Dry Mouth 0.5 0.0 1.3 Pneumonia 0.0 0.0 2.0 Speech Disorder 0.5 0.7 0.7 Tremor 0.5 0.0 1.3 Urinary Incontinence 0.0 0.0 2.0 Urination Impaired 0.0 0.0 2.0 .\"\n }\n ]\n },\n {\n \"Term\": \"Decubitus ulcer\",\n \"MEDDRACode\": \"10011985\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"decubiti\",\n \"Probability\": \"0.5475075841\",\n \"SemanticContext\": \"As a group, the patients who died were relatively young mean age was 47 with a range from 25 to 63 , but the majority suffered from severe spasticity of many years duration, were nonambulatory, had various medical complications such as pneumonia, urinary tract infections, and decubiti, and/or had received multiple concomitant medications.\"\n }\n ]\n },\n {\n \"Term\": \"Myocardial infarction\",\n \"MEDDRACode\": \"10028596\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"myocardial infarction\",\n \"Probability\": \"0.3156104684\",\n \"SemanticContext\": \"A second patient, a 52 year-old woman with MS and a history of an inferior wall myocardial infarction, was found dead in bed 12 days after pump implantation, 2 hours after having had documented normal vital signs.\"\n }\n ]\n },\n {\n \"Term\": \"Status epilepticus\",\n \"MEDDRACode\": \"10041962\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"status epilepticus\",\n \"Probability\": \"0.9267529249\",\n \"SemanticContext\": \"His medical history included spinal cord injury, aspiration pneumonia, septic shock, disseminated intravascular coagulopathy, severe metabolic acidosis, hepatic toxicity, and status epilepticus.\"\n },\n {\n \"VerbatimTerm\": \"status epilepticus\",\n \"Probability\": \"0.0829408467\",\n \"SemanticContext\": \"Twelve days after screening he was not implanted , he again experienced status epilepticus with subsequent significant neurological deterioration.\"\n }\n ]\n },\n {\n \"Term\": \"Infant\",\n \"MEDDRACode\": \"10021731\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": true,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"infant\",\n \"Probability\": \"1.58928E-05\",\n \"SemanticContext\": \"There are no adequate data on the effects of GABLOFEN on the breastfed infant or on milk production.\"\n },\n {\n \"VerbatimTerm\": \"infant\",\n \"Probability\": \"8.89501E-05\",\n \"SemanticContext\": \"The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for GABLOFEN and any potential adverse effects on the breastfed infant from GABLOFEN or from the underlying maternal condition.\"\n },\n {\n \"VerbatimTerm\": \"infants\",\n \"Probability\": \"1.05041E-05\",\n \"SemanticContext\": \"At recommended oral doses, baclofen is present in human milk and withdrawal symptoms can occur in breastfed infants when maternal administration of baclofen is stopped or when breastfeeding is stopped.\"\n }\n ]\n },\n {\n \"Term\": \"Abortion spontaneous\",\n \"MEDDRACode\": \"10000234\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"miscarriage\",\n \"Probability\": \"0.3075837493\",\n \"SemanticContext\": \"The background risk of major birth defects and miscarriage for the indicated population is unknown.\"\n },\n {\n \"VerbatimTerm\": \"miscarriage\",\n \"Probability\": \"0.7700802088\",\n \"SemanticContext\": \"In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.\"\n }\n ]\n },\n {\n \"Term\": \"Neuroleptic malignant syndrome\",\n \"MEDDRACode\": \"10029282\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"neuroleptic-malignant syndrome\",\n \"Probability\": \"0.0621715784\",\n \"SemanticContext\": \"Some clinical characteristics of the advanced intrathecal baclofen withdrawal syndrome may resemble autonomic dysreflexia, infection sepsis , malignant hyperthermia, neuroleptic-malignant syndrome, or other conditions associated with a hypermetabolic state or widespread rhabdomyolysis.\"\n }\n ]\n },\n {\n \"Term\": \"Overdose\",\n \"MEDDRACode\": \"10033295\",\n \"Overdose\": true,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"overdose\",\n \"Probability\": \"0.0757880807\",\n \"SemanticContext\": \"WARNINGS AND PRECAUTIONS · Do not directly inject GABLOFEN into the pump catheter access port, as this may cause a life-threatening overdose.\"\n },\n {\n \"VerbatimTerm\": \"overdose\",\n \"Probability\": \"0.6130270958\",\n \"SemanticContext\": \"Eleven patients who developed coma secondary to overdose had their treatment temporarily suspended, but all were subsequently re-started and were not, therefore, considered to be true discontinuations.\"\n },\n {\n \"VerbatimTerm\": \"overdose\",\n \"Probability\": \"0.5379621983\",\n \"SemanticContext\": \"Body as a Whole: Suicide, lack of drug effect, abdominal pain, hypothermia, neck rigidity, chest pain, chills, face edema, flu syndrome and overdose.\"\n },\n {\n \"VerbatimTerm\": \"overdose\",\n \"Probability\": \"0.0110329092\",\n \"SemanticContext\": \"Except in overdose related emergencies, the dose of GABLOFEN should ordinarily be reduced slowly if the drug is discontinued for any reason.\"\n },\n {\n \"VerbatimTerm\": \"overdose\",\n \"Probability\": \"0.0001164744\",\n \"SemanticContext\": \"An attempt should be made to discontinue concomitant oral antispasticity medication to avoid possible overdose or adverse drug interactions, either prior to screening or following implant and initiation of chronic GABLOFEN infusion.\"\n },\n {\n \"VerbatimTerm\": \"overdose\",\n \"Probability\": \"0.0006417036\",\n \"SemanticContext\": \"GABLOFEN Overdose Inform patients and their caregivers that GABLOFEN overdose may occur suddenly or insidiously, and that symptoms may include confusion, drowsiness, lightheadedness, dizziness, slow or shallow breathing, seizures, loss of muscle tone, loss of consciousness, and coma.\"\n },\n {\n \"VerbatimTerm\": \"overdose\",\n \"Probability\": \"0.0057242513\",\n \"SemanticContext\": \"If an overdose appears likely, patients should be brought immediately to a hospital for assessment and possible emptying of the pump.\"\n },\n {\n \"VerbatimTerm\": \"overdose\",\n \"Probability\": \"0.422857821\",\n \"SemanticContext\": \"Symptoms of intrathecal baclofen overdose were reported in a sensitive adult patient after receiving a 25 mcg intrathecal bolus.\"\n },\n {\n \"VerbatimTerm\": \"overdose\",\n \"Probability\": \"0.2887293994\",\n \"SemanticContext\": \"Direct injection into the catheter through the catheter access port may cause a life-threatening overdose.\"\n },\n {\n \"VerbatimTerm\": \"overdose\",\n \"Probability\": \"0.0027316511\",\n \"SemanticContext\": \"All medical personnel and caregivers should be instructed in 1 the signs and symptoms of overdose, 2 procedures to be followed in the event of overdose and 3 proper home care of the pump and insertion site.\"\n },\n {\n \"VerbatimTerm\": \"overdose\",\n \"Probability\": \"0.0774755478\",\n \"SemanticContext\": \"All medical personnel and caregivers should be instructed in 1 the signs and symptoms of overdose, 2 procedures to be followed in the event of overdose and 3 proper home care of the pump and insertion site.\"\n },\n {\n \"VerbatimTerm\": \"overdose\",\n \"Probability\": \"0.0175239146\",\n \"SemanticContext\": \"5.4 Overdose Signs of overdose may appear suddenly or insidiously.\"\n },\n {\n \"VerbatimTerm\": \"overdose\",\n \"Probability\": \"0.0521504879\",\n \"SemanticContext\": \"Acute massive overdose may present as coma.\"\n },\n {\n \"VerbatimTerm\": \"overdose\",\n \"Probability\": \"0.4386432171\",\n \"SemanticContext\": \"Less sudden and/or less severe forms of overdose may present with signs of drowsiness, lightheadedness, dizziness, somnolence, respiratory depression, seizures, rostral progression of hypotonia and loss of consciousness progressing to coma.\"\n },\n {\n \"VerbatimTerm\": \"overdose\",\n \"Probability\": \"0.0075124204\",\n \"SemanticContext\": \"Should overdose appear likely, the patient should be taken immediately to a hospital for assessment and emptying of the pump reservoir.\"\n },\n {\n \"VerbatimTerm\": \"overdose\",\n \"Probability\": \"0.630145669\",\n \"SemanticContext\": \"In cases reported to date, overdose has generally been related to pump malfunction or dosing error [see Overdosage 10 ] Extreme caution must be used when filling the implantable pump.\"\n },\n {\n \"VerbatimTerm\": \"overdose\",\n \"Probability\": \"0.1062407494\",\n \"SemanticContext\": \"Direct injection into this catheter access port may cause a life-threatening overdose.\"\n },\n {\n \"VerbatimTerm\": \"overdose\",\n \"Probability\": \"0.6297286749\",\n \"SemanticContext\": \"Seizures have been reported during overdose and with withdrawal from intrathecal baclofen as well as in patients maintained on therapeutic doses of intrathecal baclofen.\"\n },\n {\n \"VerbatimTerm\": \"Overdose\",\n \"Probability\": \"0.7096788287\",\n \"SemanticContext\": \"· Overdose may cause drowsiness, lightheadedness, dizziness, somnolence, respiratory depression, seizures, rostral progression of hypotonia and loss of consciousness progressing to coma.\"\n },\n {\n \"VerbatimTerm\": \"Overdose\",\n \"Probability\": \"0.0350585282\",\n \"SemanticContext\": \"GABLOFEN Overdose Inform patients and their caregivers that GABLOFEN overdose may occur suddenly or insidiously, and that symptoms may include confusion, drowsiness, lightheadedness, dizziness, slow or shallow breathing, seizures, loss of muscle tone, loss of consciousness, and coma.\"\n },\n {\n \"VerbatimTerm\": \"Overdose\",\n \"Probability\": \"0.1170141399\",\n \"SemanticContext\": \"Symptoms of Intrathecal Baclofen Overdose Drowsiness, lightheadedness, dizziness, somnolence, respiratory depression, seizures, rostral progression of hypotonia and loss of consciousness progressing to coma of up to 72 hours duration.\"\n },\n {\n \"VerbatimTerm\": \"Overdose\",\n \"Probability\": \"0.0015536845\",\n \"SemanticContext\": \"Treatment Suggestions for Overdose There is no specific antidote for treating overdoses of GABLOFEN; however, the following steps should ordinarily be undertaken: 1 Residual intrathecal baclofen solution should be removed from the pump as soon as possible.\"\n },\n {\n \"VerbatimTerm\": \"Overdose\",\n \"Probability\": \"0.8644657135\",\n \"SemanticContext\": \"5 WARNINGS AND PRECAUTIONS 5.1 Risk of Life-Threatening Overdose During Pump Refills Use extreme caution when filling the Medtronic SynchroMed ® II Programmable Pump which is equipped with an injection port that allows direct access to the intrathecal catheter.\"\n },\n {\n \"VerbatimTerm\": \"Overdose\",\n \"Probability\": \"0.0140767097\",\n \"SemanticContext\": \"5.4 Overdose Signs of overdose may appear suddenly or insidiously.\"\n },\n {\n \"VerbatimTerm\": \"dose over\",\n \"Probability\": \"0.0851144791\",\n \"SemanticContext\": \"Most patients require gradual increases in dose over time to maintain optimal response during chronic therapy.\"\n },\n {\n \"VerbatimTerm\": \"dose over\",\n \"Probability\": \"0.0168969631\",\n \"SemanticContext\": \"Many patients require gradual increases in dose over time to maintain optimal response during chronic therapy.\"\n },\n {\n \"VerbatimTerm\": \"overdoses\",\n \"Probability\": \"0.0008115172\",\n \"SemanticContext\": \"Treatment Suggestions for Overdose There is no specific antidote for treating overdoses of GABLOFEN; however, the following steps should ordinarily be undertaken: 1 Residual intrathecal baclofen solution should be removed from the pump as soon as possible.\"\n },\n {\n \"VerbatimTerm\": \"overdoses\",\n \"Probability\": \"0.0069004595\",\n \"SemanticContext\": \"Physostigmine may not be effective in reversing large overdoses and patients may need to be maintained with respiratory support.\"\n }\n ]\n },\n {\n \"Term\": \"Breast feeding\",\n \"MEDDRACode\": \"10006247\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": true,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"breastfed\",\n \"Probability\": \"6.7561E-06\",\n \"SemanticContext\": \"There are no adequate data on the effects of GABLOFEN on the breastfed infant or on milk production.\"\n },\n {\n \"VerbatimTerm\": \"breastfed\",\n \"Probability\": \"5.0455E-06\",\n \"SemanticContext\": \"At recommended oral doses, baclofen is present in human milk and withdrawal symptoms can occur in breastfed infants when maternal administration of baclofen is stopped or when breastfeeding is stopped.\"\n },\n {\n \"VerbatimTerm\": \"breastfed\",\n \"Probability\": \"6.17666E-05\",\n \"SemanticContext\": \"The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for GABLOFEN and any potential adverse effects on the breastfed infant from GABLOFEN or from the underlying maternal condition.\"\n },\n {\n \"VerbatimTerm\": \"breastfeeding\",\n \"Probability\": \"1.40714E-05\",\n \"SemanticContext\": \"At recommended oral doses, baclofen is present in human milk and withdrawal symptoms can occur in breastfed infants when maternal administration of baclofen is stopped or when breastfeeding is stopped.\"\n },\n {\n \"VerbatimTerm\": \"breastfeeding\",\n \"Probability\": \"0.0001483262\",\n \"SemanticContext\": \"The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for GABLOFEN and any potential adverse effects on the breastfed infant from GABLOFEN or from the underlying maternal condition.\"\n }\n ]\n },\n {\n \"Term\": \"Fibrosis\",\n \"MEDDRACode\": \"10016642\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"fibrosis\",\n \"Probability\": \"0.1719830632\",\n \"SemanticContext\": \"An autopsy demonstrated severe fibrosis of the coronary conduction system.\"\n }\n ]\n },\n {\n \"Term\": \"Home care\",\n \"MEDDRACode\": \"10076301\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"home care\",\n \"Probability\": \"0.0001014219\",\n \"SemanticContext\": \"All medical personnel and caregivers should be instructed in 1 the signs and symptoms of overdose, 2 procedures to be followed in the event of overdose and 3 proper home care of the pump and insertion site.\"\n }\n ]\n },\n {\n \"Term\": \"Flatulence\",\n \"MEDDRACode\": \"10016766\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Flatulence\",\n \"Probability\": \"0.997241497\",\n \"SemanticContext\": \"Digestive System: Flatulence, dysphagia, dyspepsia and gastroenteritis.\"\n }\n ]\n },\n {\n \"Term\": \"Uterine leiomyoma\",\n \"MEDDRACode\": \"10046798\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"fibroids\",\n \"Probability\": \"0.8621364832\",\n \"SemanticContext\": \"These include: pump pocket infections 3 , meningitis 2 , wound dehiscence 1 , gynecological fibroids 1 and pump overpressurization 1 with unknown, if any, sequela.\"\n }\n ]\n },\n {\n \"Term\": \"Chills\",\n \"MEDDRACode\": \"10008531\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"chills\",\n \"Probability\": \"0.999424696\",\n \"SemanticContext\": \"· The most common adverse reactions in patients with spasticity of cerebral origin were agitation, constipation, somnolence, leukocytosis, chills, urinary retention and hypotonia.\"\n },\n {\n \"VerbatimTerm\": \"chills\",\n \"Probability\": \"0.8902263045\",\n \"SemanticContext\": \"Body as a Whole: Suicide, lack of drug effect, abdominal pain, hypothermia, neck rigidity, chest pain, chills, face edema, flu syndrome and overdose.\"\n },\n {\n \"VerbatimTerm\": \"chills\",\n \"Probability\": \"0.9993845224\",\n \"SemanticContext\": \"6.2 Spasticity of Cerebral Origin Most Common Adverse Reactions In pre-marketing clinical trials, the most common adverse reactions associated with use of intrathecal baclofen which were not seen at an equivalent incidence among placebo-treated patients included: agitation, constipation, somnolence, leukocytosis, chills, urinary retention and hypotonia.\"\n },\n {\n \"VerbatimTerm\": \"chills\",\n \"Probability\": \"0.9991985559\",\n \"SemanticContext\": \"The following adverse reactions occurred among the 62 patients receiving intrathecal baclofen in two randomized, placebo-controlled trials involving cerebral palsy and head injury patients, respectively: agitation, constipation, somnolence, leukocytosis, nausea, vomiting, nystagmus, chills, urinary retention, and hypotonia.\"\n },\n {\n \"VerbatimTerm\": \"Chills\",\n \"Probability\": \"0.999233067\",\n \"SemanticContext\": \"Table 2: Most Common =1% Adverse Reactions in Patients with Spasticity of Cerebral Origin Adverse Reactions Percent N=211 Screening* Percent N=153 Titration† Percent N=150 Maintenance ‡ Hypotonia 2.4 14.4 34.7 Somnolence 7.6 10.5 18.7 Headache 6.6 7.8 10.7 Nausea and Vomiting 6.6 10.5 4.0 Vomiting 6.2 8.5 4.0 Urinary Retention 0.9 6.5 8.0 Convulsion 0.9 3.3 10.0 Dizziness 2.4 2.6 8.0 Nausea 1.4 3.3 7.3 Hypoventilation 1.4 1.3 4.0 Hypertonia 0.0 0.7 6.0 Paresthesia 1.9 0.7 3.3 Hypotension 1.9 0.7 2.0 Increased Salivation 0.0 2.6 2.7 Back Pain 0.9 0.7 2.0 Constipation 0.5 1.3 2.0 Pain 0.0 0.0 4.0 Pruritus 0.0 0.0 4.0 Diarrhea 0.5 0.7 2.0 Peripheral Edema 0.0 0.0 3.3 Thinking Abnormal 0.5 1.3 0.7 Agitation 0.5 0.0 1.3 Asthenia 0.0 0.0 2.0 Chills 0.5 0.0 1.3 Coma 0.5 0.0 1.3 Dry Mouth 0.5 0.0 1.3 Pneumonia 0.0 0.0 2.0 Speech Disorder 0.5 0.7 0.7 Tremor 0.5 0.0 1.3 Urinary Incontinence 0.0 0.0 2.0 Urination Impaired 0.0 0.0 2.0 .\"\n }\n ]\n },\n {\n \"Term\": \"Leukocytosis\",\n \"MEDDRACode\": \"10024378\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"leukocytosis\",\n \"Probability\": \"0.9972062111\",\n \"SemanticContext\": \"· The most common adverse reactions in patients with spasticity of cerebral origin were agitation, constipation, somnolence, leukocytosis, chills, urinary retention and hypotonia.\"\n },\n {\n \"VerbatimTerm\": \"leukocytosis\",\n \"Probability\": \"0.9987156987\",\n \"SemanticContext\": \"6.2 Spasticity of Cerebral Origin Most Common Adverse Reactions In pre-marketing clinical trials, the most common adverse reactions associated with use of intrathecal baclofen which were not seen at an equivalent incidence among placebo-treated patients included: agitation, constipation, somnolence, leukocytosis, chills, urinary retention and hypotonia.\"\n },\n {\n \"VerbatimTerm\": \"leukocytosis\",\n \"Probability\": \"0.998811245\",\n \"SemanticContext\": \"The following adverse reactions occurred among the 62 patients receiving intrathecal baclofen in two randomized, placebo-controlled trials involving cerebral palsy and head injury patients, respectively: agitation, constipation, somnolence, leukocytosis, nausea, vomiting, nystagmus, chills, urinary retention, and hypotonia.\"\n },\n {\n \"VerbatimTerm\": \"Leukocytosis\",\n \"Probability\": \"0.9954131842\",\n \"SemanticContext\": \"Hemic and Lymphatic System: Leukocytosis and petechial rash.\"\n }\n ]\n },\n {\n \"Term\": \"Ovarian cyst\",\n \"MEDDRACode\": \"10033132\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Ovarian Cysts\",\n \"Probability\": \"0.1108877361\",\n \"SemanticContext\": \"5.12 Ovarian Cysts A dose-related increase in incidence of ovarian cysts was observed in female rats treated chronically with oral baclofen.\"\n },\n {\n \"VerbatimTerm\": \"ovarian cysts\",\n \"Probability\": \"0.7005878687\",\n \"SemanticContext\": \"5.12 Ovarian Cysts A dose-related increase in incidence of ovarian cysts was observed in female rats treated chronically with oral baclofen.\"\n },\n {\n \"VerbatimTerm\": \"Ovarian cysts\",\n \"Probability\": \"0.4943831861\",\n \"SemanticContext\": \"Ovarian cysts have been found by palpation in about 4% of the multiple sclerosis patients who were treated with oral baclofen for up to one year.\"\n },\n {\n \"VerbatimTerm\": \"Ovarian cysts\",\n \"Probability\": \"0.7515124083\",\n \"SemanticContext\": \"Ovarian cysts are estimated to occur spontaneously in approximately 1% to 5% of the normal female population.\"\n }\n ]\n }\n ],\n \"IndicationTerms\": []\n }\n ]\n },\n {\n \"GenericName\": \"cyclobenzaprine hydrochloride\",\n \"MeddraVersion\": \"24.0\",\n \"Labels\": [\n {\n \"Id\": \"US0280b504-4a42-44f3-8a1a-34a20eac054a\",\n \"NDCCode\": \"16571-782\",\n \"UpdatedDate\": \"Jun 29, 2021\",\n \"LabelSource\": {\n \"Country\": \"us\",\n \"ProductId\": \"0280b504-4a42-44f3-8a1a-34a20eac054a\",\n \"FileId\": \"0280b504-4a42-44f3-8a1a-34a20eac054a\",\n \"Version\": \"1\"\n },\n \"AdverseEventTerms\": [\n {\n \"Term\": \"Alopecia\",\n \"MEDDRACode\": \"10001760\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"alopecia\",\n \"Probability\": \"0.9944093227\",\n \"SemanticContext\": \"Skin: Photosensitization; alopecia.\"\n }\n ]\n },\n {\n \"Term\": \"Withdrawal syndrome\",\n \"MEDDRACode\": \"10048010\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"withdrawal symptoms\",\n \"Probability\": \"0.0157597363\",\n \"SemanticContext\": \"DRUG ABUSE AND DEPENDENCE Pharmacologic similarities among the tricyclic drugs require that certain withdrawal symptoms be considered when cyclobenzaprine hydrochloride is administered, even though they have not been reported to occur with this drug.\"\n }\n ]\n },\n {\n \"Term\": \"Asthenia\",\n \"MEDDRACode\": \"10003549\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"weakness\",\n \"Probability\": \"0.9947344065\",\n \"SemanticContext\": \"Musculoskeletal: Local weakness.\"\n }\n ]\n },\n {\n \"Term\": \"Drug abuse\",\n \"MEDDRACode\": \"10013654\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"DRUG ABUSE\",\n \"Probability\": \"0.0001523197\",\n \"SemanticContext\": \"DRUG ABUSE AND DEPENDENCE Pharmacologic similarities among the tricyclic drugs require that certain withdrawal symptoms be considered when cyclobenzaprine hydrochloride is administered, even though they have not been reported to occur with this drug.\"\n }\n ]\n },\n {\n \"Term\": \"Headache\",\n \"MEDDRACode\": \"10019211\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"headache\",\n \"Probability\": \"0.0199416876\",\n \"SemanticContext\": \"Abrupt cessation of treatment after prolonged administration rarely may produce nausea, headache, and malaise.\"\n },\n {\n \"VerbatimTerm\": \"headache\",\n \"Probability\": \"0.9985259771\",\n \"SemanticContext\": \"Adverse reactions which were reported in 1% to 3% of the patients were: fatigue/tiredness, asthenia, nausea, constipation, dyspepsia, unpleasant taste, blurred vision, headache, nervousness, and confusion.\"\n },\n {\n \"VerbatimTerm\": \"Headache\",\n \"Probability\": \"0.9990298748\",\n \"SemanticContext\": \"ADVERSE REACTIONS Incidence of most common adverse reactions in the 2 double-blind 3 , placebo-controlled 5 mg studies incidence of > 3% on cyclobenzaprine hydrochloride 5 mg : Cyclobenzaprine Hydrochloride 5 mg Cyclobenzaprine Hydrochloride 10 mg Placebo N=464 N=249 N=469 Drowsiness 29% 38% 10% Dry Mouth 21% 32% 7% Fatigue 6% 6% 3% Headache 5% 5% 8% .\"\n }\n ]\n },\n {\n \"Term\": \"Aggression\",\n \"MEDDRACode\": \"10001488\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"aggressive behavior\",\n \"Probability\": \"0.972868681\",\n \"SemanticContext\": \"Nervous System and Psychiatric: Decreased or increased libido; abnormal gait; delusions; aggressive behavior; paranoia; peripheral neuropathy; Bell’s palsy; alteration in EEG patterns; extrapyramidal symptoms.\"\n }\n ]\n },\n {\n \"Term\": \"Breast enlargement\",\n \"MEDDRACode\": \"10006242\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"breast enlargement\",\n \"Probability\": \"0.9947039485\",\n \"SemanticContext\": \"Urogenital: Impaired urination; dilatation of urinary tract; impotence; testicular swelling; gynecomastia; breast enlargement; galactorrhea.\"\n }\n ]\n },\n {\n \"Term\": \"Constipation\",\n \"MEDDRACode\": \"10010774\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"constipation\",\n \"Probability\": \"0.9996082783\",\n \"SemanticContext\": \"Adverse reactions which were reported in 1% to 3% of the patients were: abdominal pain, acid regurgitation, constipation, diarrhea, dizziness, nausea, irritability, mental acuity decreased, nervousness, upper respiratory infection, and pharyngitis.\"\n },\n {\n \"VerbatimTerm\": \"constipation\",\n \"Probability\": \"0.9996546507\",\n \"SemanticContext\": \"Adverse reactions which were reported in 1% to 3% of the patients were: fatigue/tiredness, asthenia, nausea, constipation, dyspepsia, unpleasant taste, blurred vision, headache, nervousness, and confusion.\"\n }\n ]\n },\n {\n \"Term\": \"Decreased appetite\",\n \"MEDDRACode\": \"10061428\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"anorexia\",\n \"Probability\": \"0.9922780991\",\n \"SemanticContext\": \"Digestive: Vomiting; anorexia; diarrhea; gastrointestinal pain; gastritis; thirst; flatulence; edema of the tongue; abnormal liver function and rare reports of hepatitis, jaundice and cholestasis.\"\n }\n ]\n },\n {\n \"Term\": \"Agitation\",\n \"MEDDRACode\": \"10001497\",\n \"Overdose\": true,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"agitation\",\n \"Probability\": \"0.9988384247\",\n \"SemanticContext\": \"Nervous System and Psychiatric: Seizures, ataxia; vertigo; dysarthria; tremors; hypertonia; convulsions; muscle twitching; disorientation; insomnia; depressed mood; abnormal sensations; anxiety; agitation; psychosis, abnormal thinking and dreaming; hallucinations; excitement; paresthesia; diplopia, serotonin syndrome.\"\n },\n {\n \"VerbatimTerm\": \"agitation\",\n \"Probability\": \"0.9987588525\",\n \"SemanticContext\": \"Less frequent manifestations include tremor, agitation, coma, ataxia, hypertension, slurred speech, confusion, dizziness, nausea, vomiting, and hallucinations.\"\n },\n {\n \"VerbatimTerm\": \"agitation\",\n \"Probability\": \"0.9832594395\",\n \"SemanticContext\": \"Serotonin syndrome symptoms may include mental status changes e.g., confusion, agitation, hallucinations , autonomic instability e.g., diaphoresis, tachycardia, labile blood pressure, hyperthermia , neuromuscular abnormalities e.g., tremor, ataxia, hyperreflexia, clonus, muscle rigidity , and/or gastrointestinal symptoms e.g., nausea, vomiting, diarrhea .\"\n }\n ]\n },\n {\n \"Term\": \"Delusion\",\n \"MEDDRACode\": \"10012239\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"delusions\",\n \"Probability\": \"0.9897831678\",\n \"SemanticContext\": \"Nervous System and Psychiatric: Decreased or increased libido; abnormal gait; delusions; aggressive behavior; paranoia; peripheral neuropathy; Bell’s palsy; alteration in EEG patterns; extrapyramidal symptoms.\"\n }\n ]\n },\n {\n \"Term\": \"Dyspepsia\",\n \"MEDDRACode\": \"10013946\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"dyspepsia\",\n \"Probability\": \"0.9986094236\",\n \"SemanticContext\": \"Adverse reactions which were reported in 1% to 3% of the patients were: fatigue/tiredness, asthenia, nausea, constipation, dyspepsia, unpleasant taste, blurred vision, headache, nervousness, and confusion.\"\n }\n ]\n },\n {\n \"Term\": \"Dyspnoea\",\n \"MEDDRACode\": \"10013968\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Dyspnea\",\n \"Probability\": \"0.9980536699\",\n \"SemanticContext\": \"Respiratory: Dyspnea.\"\n }\n ]\n },\n {\n \"Term\": \"Depressed mood\",\n \"MEDDRACode\": \"10012374\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"depressed mood\",\n \"Probability\": \"0.9622634053\",\n \"SemanticContext\": \"Nervous System and Psychiatric: Seizures, ataxia; vertigo; dysarthria; tremors; hypertonia; convulsions; muscle twitching; disorientation; insomnia; depressed mood; abnormal sensations; anxiety; agitation; psychosis, abnormal thinking and dreaming; hallucinations; excitement; paresthesia; diplopia, serotonin syndrome.\"\n }\n ]\n },\n {\n \"Term\": \"Diplopia\",\n \"MEDDRACode\": \"10013036\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"diplopia\",\n \"Probability\": \"0.9867476225\",\n \"SemanticContext\": \"Nervous System and Psychiatric: Seizures, ataxia; vertigo; dysarthria; tremors; hypertonia; convulsions; muscle twitching; disorientation; insomnia; depressed mood; abnormal sensations; anxiety; agitation; psychosis, abnormal thinking and dreaming; hallucinations; excitement; paresthesia; diplopia, serotonin syndrome.\"\n }\n ]\n },\n {\n \"Term\": \"Facial paralysis\",\n \"MEDDRACode\": \"10016062\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Bell’s palsy\",\n \"Probability\": \"0.5127782226\",\n \"SemanticContext\": \"Nervous System and Psychiatric: Decreased or increased libido; abnormal gait; delusions; aggressive behavior; paranoia; peripheral neuropathy; Bell’s palsy; alteration in EEG patterns; extrapyramidal symptoms.\"\n }\n ]\n },\n {\n \"Term\": \"Gynaecomastia\",\n \"MEDDRACode\": \"10018800\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"gynecomastia\",\n \"Probability\": \"0.9929379821\",\n \"SemanticContext\": \"Urogenital: Impaired urination; dilatation of urinary tract; impotence; testicular swelling; gynecomastia; breast enlargement; galactorrhea.\"\n }\n ]\n },\n {\n \"Term\": \"Extrapyramidal disorder\",\n \"MEDDRACode\": \"10015832\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"extrapyramidal symptoms\",\n \"Probability\": \"0.6731302738\",\n \"SemanticContext\": \"Nervous System and Psychiatric: Decreased or increased libido; abnormal gait; delusions; aggressive behavior; paranoia; peripheral neuropathy; Bell’s palsy; alteration in EEG patterns; extrapyramidal symptoms.\"\n }\n ]\n },\n {\n \"Term\": \"Gastrointestinal pain\",\n \"MEDDRACode\": \"10017999\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"gastrointestinal pain\",\n \"Probability\": \"0.8828792572\",\n \"SemanticContext\": \"Digestive: Vomiting; anorexia; diarrhea; gastrointestinal pain; gastritis; thirst; flatulence; edema of the tongue; abnormal liver function and rare reports of hepatitis, jaundice and cholestasis.\"\n }\n ]\n },\n {\n \"Term\": \"Fatigue\",\n \"MEDDRACode\": \"10016256\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Fatigue\",\n \"Probability\": \"0.9989652634\",\n \"SemanticContext\": \"ADVERSE REACTIONS Incidence of most common adverse reactions in the 2 double-blind 3 , placebo-controlled 5 mg studies incidence of > 3% on cyclobenzaprine hydrochloride 5 mg : Cyclobenzaprine Hydrochloride 5 mg Cyclobenzaprine Hydrochloride 10 mg Placebo N=464 N=249 N=469 Drowsiness 29% 38% 10% Dry Mouth 21% 32% 7% Fatigue 6% 6% 3% Headache 5% 5% 8% .\"\n },\n {\n \"VerbatimTerm\": \"fatigue\",\n \"Probability\": \"0.9977622032\",\n \"SemanticContext\": \"Adverse reactions which were reported in 1% to 3% of the patients were: fatigue/tiredness, asthenia, nausea, constipation, dyspepsia, unpleasant taste, blurred vision, headache, nervousness, and confusion.\"\n }\n ]\n },\n {\n \"Term\": \"Gait disturbance\",\n \"MEDDRACode\": \"10017577\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"abnormal gait\",\n \"Probability\": \"0.9971269369\",\n \"SemanticContext\": \"Nervous System and Psychiatric: Decreased or increased libido; abnormal gait; delusions; aggressive behavior; paranoia; peripheral neuropathy; Bell’s palsy; alteration in EEG patterns; extrapyramidal symptoms.\"\n }\n ]\n },\n {\n \"Term\": \"Hypertonia\",\n \"MEDDRACode\": \"10020852\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hypertonia\",\n \"Probability\": \"0.9944103956\",\n \"SemanticContext\": \"Nervous System and Psychiatric: Seizures, ataxia; vertigo; dysarthria; tremors; hypertonia; convulsions; muscle twitching; disorientation; insomnia; depressed mood; abnormal sensations; anxiety; agitation; psychosis, abnormal thinking and dreaming; hallucinations; excitement; paresthesia; diplopia, serotonin syndrome.\"\n }\n ]\n },\n {\n \"Term\": \"Eosinophilia\",\n \"MEDDRACode\": \"10014950\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"eosinophilia\",\n \"Probability\": \"0.9950367212\",\n \"SemanticContext\": \"Hematic and Lymphatic: Purpura; bone marrow depression; leukopenia; eosinophilia; thrombocytopenia.\"\n }\n ]\n },\n {\n \"Term\": \"Gastritis\",\n \"MEDDRACode\": \"10017853\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"gastritis\",\n \"Probability\": \"0.3934694827\",\n \"SemanticContext\": \"Digestive: Vomiting; anorexia; diarrhea; gastrointestinal pain; gastritis; thirst; flatulence; edema of the tongue; abnormal liver function and rare reports of hepatitis, jaundice and cholestasis.\"\n }\n ]\n },\n {\n \"Term\": \"Cholestasis\",\n \"MEDDRACode\": \"10008635\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"cholestasis\",\n \"Probability\": \"0.9677400589\",\n \"SemanticContext\": \"Digestive: Vomiting; anorexia; diarrhea; gastrointestinal pain; gastritis; thirst; flatulence; edema of the tongue; abnormal liver function and rare reports of hepatitis, jaundice and cholestasis.\"\n }\n ]\n },\n {\n \"Term\": \"Electroencephalogram\",\n \"MEDDRACode\": \"10014407\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"EEG\",\n \"Probability\": \"0.2909118533\",\n \"SemanticContext\": \"Nervous System and Psychiatric: Decreased or increased libido; abnormal gait; delusions; aggressive behavior; paranoia; peripheral neuropathy; Bell’s palsy; alteration in EEG patterns; extrapyramidal symptoms.\"\n }\n ]\n },\n {\n \"Term\": \"Galactorrhoea\",\n \"MEDDRACode\": \"10017600\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"galactorrhea\",\n \"Probability\": \"0.9740775824\",\n \"SemanticContext\": \"Urogenital: Impaired urination; dilatation of urinary tract; impotence; testicular swelling; gynecomastia; breast enlargement; galactorrhea.\"\n }\n ]\n },\n {\n \"Term\": \"Dependence\",\n \"MEDDRACode\": \"10012335\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"DEPENDENCE\",\n \"Probability\": \"0.0021167099\",\n \"SemanticContext\": \"DRUG ABUSE AND DEPENDENCE Pharmacologic similarities among the tricyclic drugs require that certain withdrawal symptoms be considered when cyclobenzaprine hydrochloride is administered, even though they have not been reported to occur with this drug.\"\n }\n ]\n },\n {\n \"Term\": \"Ageusia\",\n \"MEDDRACode\": \"10001480\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Ageusia\",\n \"Probability\": \"0.7228981256\",\n \"SemanticContext\": \"Special Senses: Ageusia; tinnitus.\"\n }\n ]\n },\n {\n \"Term\": \"Erectile dysfunction\",\n \"MEDDRACode\": \"10061461\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"impotence\",\n \"Probability\": \"0.9883630276\",\n \"SemanticContext\": \"Urogenital: Impaired urination; dilatation of urinary tract; impotence; testicular swelling; gynecomastia; breast enlargement; galactorrhea.\"\n }\n ]\n },\n {\n \"Term\": \"Abdominal pain\",\n \"MEDDRACode\": \"10000081\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"abdominal pain\",\n \"Probability\": \"0.9987299442\",\n \"SemanticContext\": \"Adverse reactions which were reported in 1% to 3% of the patients were: abdominal pain, acid regurgitation, constipation, diarrhea, dizziness, nausea, irritability, mental acuity decreased, nervousness, upper respiratory infection, and pharyngitis.\"\n }\n ]\n },\n {\n \"Term\": \"Angioedema\",\n \"MEDDRACode\": \"10002424\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"angioedema\",\n \"Probability\": \"0.9992837906\",\n \"SemanticContext\": \"Hypersensitivity: Anaphylaxis; angioedema; pruritus; facial edema; urticaria; rash.\"\n }\n ]\n },\n {\n \"Term\": \"Anxiety\",\n \"MEDDRACode\": \"10002855\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"anxiety\",\n \"Probability\": \"0.9906642437\",\n \"SemanticContext\": \"Nervous System and Psychiatric: Seizures, ataxia; vertigo; dysarthria; tremors; hypertonia; convulsions; muscle twitching; disorientation; insomnia; depressed mood; abnormal sensations; anxiety; agitation; psychosis, abnormal thinking and dreaming; hallucinations; excitement; paresthesia; diplopia, serotonin syndrome.\"\n }\n ]\n },\n {\n \"Term\": \"Anaphylactic reaction\",\n \"MEDDRACode\": \"10002198\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Anaphylaxis\",\n \"Probability\": \"0.9964577556\",\n \"SemanticContext\": \"Hypersensitivity: Anaphylaxis; angioedema; pruritus; facial edema; urticaria; rash.\"\n }\n ]\n },\n {\n \"Term\": \"Malaise\",\n \"MEDDRACode\": \"10025482\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"malaise\",\n \"Probability\": \"0.0055109262\",\n \"SemanticContext\": \"Abrupt cessation of treatment after prolonged administration rarely may produce nausea, headache, and malaise.\"\n },\n {\n \"VerbatimTerm\": \"malaise\",\n \"Probability\": \"0.9675858021\",\n \"SemanticContext\": \"The following adverse reactions have been reported in post-marketing experience or with an incidence of less than 1% of patients in clinical trials with the 10 mg tablet: Body as a Whole: Syncope; malaise.\"\n }\n ]\n },\n {\n \"Term\": \"Ileus paralytic\",\n \"MEDDRACode\": \"10021333\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Paralytic ileus\",\n \"Probability\": \"0.9990592599\",\n \"SemanticContext\": \"Digestive: Paralytic ileus, tongue discoloration; stomatitis; parotid swelling.\"\n }\n ]\n },\n {\n \"Term\": \"Inappropriate antidiuretic hormone secretion\",\n \"MEDDRACode\": \"10053198\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Inappropriate ADH\",\n \"Probability\": \"0.9545845985\",\n \"SemanticContext\": \"Endocrine: Inappropriate ADH syndrome.\"\n }\n ]\n },\n {\n \"Term\": \"Leukopenia\",\n \"MEDDRACode\": \"10024384\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"leukopenia\",\n \"Probability\": \"0.9880138636\",\n \"SemanticContext\": \"Hematic and Lymphatic: Purpura; bone marrow depression; leukopenia; eosinophilia; thrombocytopenia.\"\n }\n ]\n },\n {\n \"Term\": \"Hepatic function abnormal\",\n \"MEDDRACode\": \"10019670\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hepatic impairment\",\n \"Probability\": \"0.0654761791\",\n \"SemanticContext\": \"The plasma concentration of cyclobenzaprine is generally higher in the elderly and in patients with hepatic impairment.\"\n },\n {\n \"VerbatimTerm\": \"hepatic impairment\",\n \"Probability\": \"0.1949709058\",\n \"SemanticContext\": \"\\n \\n Hepatic Impairment\\n In a pharmacokinetic study of sixteen subjects with hepatic impairment 15 mild, 1 moderate per Child-Pugh score , both AUC and C max were approximately double the values seen in the healthy control group.\"\n },\n {\n \"VerbatimTerm\": \"hepatic impairment\",\n \"Probability\": \"3.3496E-06\",\n \"SemanticContext\": \"Based on the findings, cyclobenzaprine hydrochloride should be used with caution in subjects with mild hepatic impairment starting with the 5 mg dose and titrating slowly upward.\"\n },\n {\n \"VerbatimTerm\": \"hepatic impairment\",\n \"Probability\": \"0.0018433332\",\n \"SemanticContext\": \"\\n \\n Impaired Hepatic Function\\n The plasma concentration of cyclobenzaprine is increased in patients with hepatic impairment see CLINICAL PHARMACOLOGY, Pharmacokinetics, Hepatic Impairment .\"\n },\n {\n \"VerbatimTerm\": \"hepatic impairment\",\n \"Probability\": \"3.8089E-06\",\n \"SemanticContext\": \"Cyclobenzaprine hydrochloride should be used with caution in subjects with mild hepatic impairment starting with a 5 mg dose and titrating slowly upward.\"\n },\n {\n \"VerbatimTerm\": \"Hepatic Impairment\",\n \"Probability\": \"0.0393208265\",\n \"SemanticContext\": \"\\n \\n Hepatic Impairment\\n In a pharmacokinetic study of sixteen subjects with hepatic impairment 15 mild, 1 moderate per Child-Pugh score , both AUC and C max were approximately double the values seen in the healthy control group.\"\n },\n {\n \"VerbatimTerm\": \"Hepatic Impairment\",\n \"Probability\": \"0.9190671444\",\n \"SemanticContext\": \"\\n \\n Impaired Hepatic Function\\n The plasma concentration of cyclobenzaprine is increased in patients with hepatic impairment see CLINICAL PHARMACOLOGY, Pharmacokinetics, Hepatic Impairment .\"\n }\n ]\n },\n {\n \"Term\": \"Jaundice\",\n \"MEDDRACode\": \"10023126\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"jaundice\",\n \"Probability\": \"0.9705443382\",\n \"SemanticContext\": \"Digestive: Vomiting; anorexia; diarrhea; gastrointestinal pain; gastritis; thirst; flatulence; edema of the tongue; abnormal liver function and rare reports of hepatitis, jaundice and cholestasis.\"\n }\n ]\n },\n {\n \"Term\": \"Insomnia\",\n \"MEDDRACode\": \"10022437\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"insomnia\",\n \"Probability\": \"0.9840753675\",\n \"SemanticContext\": \"Nervous System and Psychiatric: Seizures, ataxia; vertigo; dysarthria; tremors; hypertonia; convulsions; muscle twitching; disorientation; insomnia; depressed mood; abnormal sensations; anxiety; agitation; psychosis, abnormal thinking and dreaming; hallucinations; excitement; paresthesia; diplopia, serotonin syndrome.\"\n }\n ]\n },\n {\n \"Term\": \"Muscle twitching\",\n \"MEDDRACode\": \"10028347\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"muscle twitching\",\n \"Probability\": \"0.9990830421\",\n \"SemanticContext\": \"Nervous System and Psychiatric: Seizures, ataxia; vertigo; dysarthria; tremors; hypertonia; convulsions; muscle twitching; disorientation; insomnia; depressed mood; abnormal sensations; anxiety; agitation; psychosis, abnormal thinking and dreaming; hallucinations; excitement; paresthesia; diplopia, serotonin syndrome.\"\n }\n ]\n },\n {\n \"Term\": \"Oedema\",\n \"MEDDRACode\": \"10030095\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"edema\",\n \"Probability\": \"0.903968215\",\n \"SemanticContext\": \"Digestive: Vomiting; anorexia; diarrhea; gastrointestinal pain; gastritis; thirst; flatulence; edema of the tongue; abnormal liver function and rare reports of hepatitis, jaundice and cholestasis.\"\n },\n {\n \"VerbatimTerm\": \"edema\",\n \"Probability\": \"0.9824576378\",\n \"SemanticContext\": \"Hypersensitivity: Anaphylaxis; angioedema; pruritus; facial edema; urticaria; rash.\"\n },\n {\n \"VerbatimTerm\": \"edema\",\n \"Probability\": \"0.2544763684\",\n \"SemanticContext\": \"Causal Relationship Unknown Other reactions, reported rarely for cyclobenzaprine hydrochloride under circumstances where a causal relationship could not be established or reported for other tricyclic drugs, are listed to serve as alerting information to physicians: Body as a whole: Chest pain; edema.\"\n }\n ]\n },\n {\n \"Term\": \"Neuropathy peripheral\",\n \"MEDDRACode\": \"10029331\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"peripheral neuropathy\",\n \"Probability\": \"0.9744826555\",\n \"SemanticContext\": \"Nervous System and Psychiatric: Decreased or increased libido; abnormal gait; delusions; aggressive behavior; paranoia; peripheral neuropathy; Bell’s palsy; alteration in EEG patterns; extrapyramidal symptoms.\"\n }\n ]\n },\n {\n \"Term\": \"Palpitations\",\n \"MEDDRACode\": \"10033557\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"palpitation\",\n \"Probability\": \"0.9925374985\",\n \"SemanticContext\": \"Cardiovascular: Tachycardia; arrhythmia; vasodilatation; palpitation; hypotension.\"\n }\n ]\n },\n {\n \"Term\": \"Rash\",\n \"MEDDRACode\": \"10037844\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"rash\",\n \"Probability\": \"0.9983888268\",\n \"SemanticContext\": \"Hypersensitivity: Anaphylaxis; angioedema; pruritus; facial edema; urticaria; rash.\"\n }\n ]\n },\n {\n \"Term\": \"Pollakiuria\",\n \"MEDDRACode\": \"10036018\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Urinary frequency\",\n \"Probability\": \"0.9439188242\",\n \"SemanticContext\": \"Urogenital: Urinary frequency and/or retention.\"\n }\n ]\n },\n {\n \"Term\": \"Urticaria\",\n \"MEDDRACode\": \"10046735\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"urticaria\",\n \"Probability\": \"0.9954849482\",\n \"SemanticContext\": \"Hypersensitivity: Anaphylaxis; angioedema; pruritus; facial edema; urticaria; rash.\"\n }\n ]\n },\n {\n \"Term\": \"Tinnitus\",\n \"MEDDRACode\": \"10043882\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"tinnitus\",\n \"Probability\": \"0.9026172161\",\n \"SemanticContext\": \"Special Senses: Ageusia; tinnitus.\"\n }\n ]\n },\n {\n \"Term\": \"Tongue discolouration\",\n \"MEDDRACode\": \"10043949\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"tongue discoloration\",\n \"Probability\": \"0.9989788532\",\n \"SemanticContext\": \"Digestive: Paralytic ileus, tongue discoloration; stomatitis; parotid swelling.\"\n }\n ]\n },\n {\n \"Term\": \"Paraesthesia\",\n \"MEDDRACode\": \"10033775\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"paresthesia\",\n \"Probability\": \"0.9944508076\",\n \"SemanticContext\": \"Nervous System and Psychiatric: Seizures, ataxia; vertigo; dysarthria; tremors; hypertonia; convulsions; muscle twitching; disorientation; insomnia; depressed mood; abnormal sensations; anxiety; agitation; psychosis, abnormal thinking and dreaming; hallucinations; excitement; paresthesia; diplopia, serotonin syndrome.\"\n }\n ]\n },\n {\n \"Term\": \"Thinking abnormal\",\n \"MEDDRACode\": \"10043431\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"abnormal thinking\",\n \"Probability\": \"0.9978167415\",\n \"SemanticContext\": \"Nervous System and Psychiatric: Seizures, ataxia; vertigo; dysarthria; tremors; hypertonia; convulsions; muscle twitching; disorientation; insomnia; depressed mood; abnormal sensations; anxiety; agitation; psychosis, abnormal thinking and dreaming; hallucinations; excitement; paresthesia; diplopia, serotonin syndrome.\"\n }\n ]\n },\n {\n \"Term\": \"Thrombocytopenia\",\n \"MEDDRACode\": \"10043554\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"thrombocytopenia\",\n \"Probability\": \"0.9946605563\",\n \"SemanticContext\": \"Hematic and Lymphatic: Purpura; bone marrow depression; leukopenia; eosinophilia; thrombocytopenia.\"\n }\n ]\n },\n {\n \"Term\": \"Vision blurred\",\n \"MEDDRACode\": \"10047513\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"blurred vision\",\n \"Probability\": \"0.9984791279\",\n \"SemanticContext\": \"Adverse reactions which were reported in 1% to 3% of the patients were: fatigue/tiredness, asthenia, nausea, constipation, dyspepsia, unpleasant taste, blurred vision, headache, nervousness, and confusion.\"\n }\n ]\n },\n {\n \"Term\": \"Dry mouth\",\n \"MEDDRACode\": \"10013781\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Dry Mouth\",\n \"Probability\": \"0.9998781681\",\n \"SemanticContext\": \"ADVERSE REACTIONS Incidence of most common adverse reactions in the 2 double-blind 3 , placebo-controlled 5 mg studies incidence of > 3% on cyclobenzaprine hydrochloride 5 mg : Cyclobenzaprine Hydrochloride 5 mg Cyclobenzaprine Hydrochloride 10 mg Placebo N=464 N=249 N=469 Drowsiness 29% 38% 10% Dry Mouth 21% 32% 7% Fatigue 6% 6% 3% Headache 5% 5% 8% .\"\n },\n {\n \"VerbatimTerm\": \"Dry Mouth\",\n \"Probability\": \"0.9998683929\",\n \"SemanticContext\": \"Clinical Studies With Cyclobenzaprine Hydrochloride 10 mg Surveillance Program With Cyclobenzaprine Hydrochloride 10 mg Drowsiness 39% 16% Dry Mouth 27% 7% Dizziness 11% 3% .\"\n },\n {\n \"VerbatimTerm\": \"dry mouth\",\n \"Probability\": \"0.9996939898\",\n \"SemanticContext\": \"The adverse reactions reported most frequently with cyclobenzaprine hydrochloride were drowsiness, dry mouth and dizziness.\"\n },\n {\n \"VerbatimTerm\": \"dry mouth\",\n \"Probability\": \"0.9989061356\",\n \"SemanticContext\": \"Although the frequency and severity of adverse reactions observed in patients treated with cyclobenzaprine hydrochloride were comparable to those observed in patients treated with diazepam, dry mouth was observed more frequently in patients treated with cyclobenzaprine hydrochloride and dizziness more frequently in those treated with diazepam.\"\n },\n {\n \"VerbatimTerm\": \"dry mouth\",\n \"Probability\": \"0.9989061356\",\n \"SemanticContext\": \"Although the frequency and severity of adverse reactions observed in patients treated with cyclobenzaprine hydrochloride were comparable to those observed in patients treated with diazepam, dry mouth was observed more frequently in patients treated with cyclobenzaprine hydrochloride and dizziness more frequently in those treated with diazepam.\"\n }\n ]\n },\n {\n \"Term\": \"Blood aluminium\",\n \"MEDDRACode\": \"10005318\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"aluminum\",\n \"Probability\": \"0.0002532899\",\n \"SemanticContext\": \"In addition 5 mg also contains D&C yellow #10 aluminum lake and FD&C yellow #6 aluminum lake and 10 mg also contains yellow iron oxide.\"\n },\n {\n \"VerbatimTerm\": \"aluminum\",\n \"Probability\": \"8.01303E-05\",\n \"SemanticContext\": \"In addition 5 mg also contains D&C yellow #10 aluminum lake and FD&C yellow #6 aluminum lake and 10 mg also contains yellow iron oxide.\"\n }\n ]\n },\n {\n \"Term\": \"Libido increased\",\n \"MEDDRACode\": \"10024421\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"increased libido\",\n \"Probability\": \"0.9985076189\",\n \"SemanticContext\": \"Nervous System and Psychiatric: Decreased or increased libido; abnormal gait; delusions; aggressive behavior; paranoia; peripheral neuropathy; Bell’s palsy; alteration in EEG patterns; extrapyramidal symptoms.\"\n }\n ]\n },\n {\n \"Term\": \"Hepatic failure\",\n \"MEDDRACode\": \"10019663\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hepatic insufficiency\",\n \"Probability\": \"0.0066225529\",\n \"SemanticContext\": \"Due to the lack of data in subjects with more severe hepatic insufficiency, the use of cyclobenzaprine hydrochloride in subjects with moderate to severe impairment is not recommended.\"\n },\n {\n \"VerbatimTerm\": \"hepatic insufficiency\",\n \"Probability\": \"0.0066225529\",\n \"SemanticContext\": \"Due to the lack of data in subjects with more severe hepatic insufficiency, the use of cyclobenzaprine hydrochloride in subjects with moderate to severe impairment is not recommended.\"\n }\n ]\n },\n {\n \"Term\": \"Nervousness\",\n \"MEDDRACode\": \"10029216\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"nervousness\",\n \"Probability\": \"0.9840260744\",\n \"SemanticContext\": \"Adverse reactions which were reported in 1% to 3% of the patients were: abdominal pain, acid regurgitation, constipation, diarrhea, dizziness, nausea, irritability, mental acuity decreased, nervousness, upper respiratory infection, and pharyngitis.\"\n },\n {\n \"VerbatimTerm\": \"nervousness\",\n \"Probability\": \"0.982411325\",\n \"SemanticContext\": \"Adverse reactions which were reported in 1% to 3% of the patients were: fatigue/tiredness, asthenia, nausea, constipation, dyspepsia, unpleasant taste, blurred vision, headache, nervousness, and confusion.\"\n }\n ]\n },\n {\n \"Term\": \"Arrhythmia\",\n \"MEDDRACode\": \"10003119\",\n \"Overdose\": true,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": true,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"dysrhythmias\",\n \"Probability\": \"0.0067441761\",\n \"SemanticContext\": \"Serum alkalinization, to a pH of 7.45 to 7.55, using intravenous sodium bicarbonate and hyperventilation as needed , should be instituted for patients with dysrhythmias and/or QRS widening.\"\n },\n {\n \"VerbatimTerm\": \"Dysrhythmias\",\n \"Probability\": \"0.1067393124\",\n \"SemanticContext\": \"Dysrhythmias unresponsive to sodium bicarbonate therapy/hyperventilation may respond to lidocaine, bretylium or phenytoin.\"\n }\n ]\n },\n {\n \"Term\": \"Pain\",\n \"MEDDRACode\": \"10033371\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"pain\",\n \"Probability\": \"0.0503908694\",\n \"SemanticContext\": \"Muscle spasm, local pain and tenderness, limitation of motion, and restriction in activities of daily living were evaluated.\"\n },\n {\n \"VerbatimTerm\": \"pain\",\n \"Probability\": \"0.0503908694\",\n \"SemanticContext\": \"Muscle spasm, local pain and tenderness, limitation of motion, and restriction in activities of daily living were evaluated.\"\n },\n {\n \"VerbatimTerm\": \"pain\",\n \"Probability\": \"0.0081471503\",\n \"SemanticContext\": \"Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living.\"\n }\n ]\n },\n {\n \"Term\": \"Ataxia\",\n \"MEDDRACode\": \"10003591\",\n \"Overdose\": true,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"ataxia\",\n \"Probability\": \"0.9965388775\",\n \"SemanticContext\": \"Nervous System and Psychiatric: Seizures, ataxia; vertigo; dysarthria; tremors; hypertonia; convulsions; muscle twitching; disorientation; insomnia; depressed mood; abnormal sensations; anxiety; agitation; psychosis, abnormal thinking and dreaming; hallucinations; excitement; paresthesia; diplopia, serotonin syndrome.\"\n },\n {\n \"VerbatimTerm\": \"ataxia\",\n \"Probability\": \"0.9994520545\",\n \"SemanticContext\": \"Less frequent manifestations include tremor, agitation, coma, ataxia, hypertension, slurred speech, confusion, dizziness, nausea, vomiting, and hallucinations.\"\n },\n {\n \"VerbatimTerm\": \"ataxia\",\n \"Probability\": \"0.9868199825\",\n \"SemanticContext\": \"Serotonin syndrome symptoms may include mental status changes e.g., confusion, agitation, hallucinations , autonomic instability e.g., diaphoresis, tachycardia, labile blood pressure, hyperthermia , neuromuscular abnormalities e.g., tremor, ataxia, hyperreflexia, clonus, muscle rigidity , and/or gastrointestinal symptoms e.g., nausea, vomiting, diarrhea .\"\n }\n ]\n },\n {\n \"Term\": \"Cerebrovascular accident\",\n \"MEDDRACode\": \"10008190\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"stroke\",\n \"Probability\": \"0.9506457448\",\n \"SemanticContext\": \"Cardiovascular: Hypertension; myocardial infarction; heart block; stroke.\"\n },\n {\n \"VerbatimTerm\": \"stroke\",\n \"Probability\": \"0.8608566523\",\n \"SemanticContext\": \"Tricyclic antidepressants have been reported to produce arrhythmias, sinus tachycardia, prolongation of the conduction time leading to myocardial infarction and stroke.\"\n }\n ]\n },\n {\n \"Term\": \"Upper respiratory tract infection\",\n \"MEDDRACode\": \"10046306\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"upper respiratory infection\",\n \"Probability\": \"0.9956339598\",\n \"SemanticContext\": \"Adverse reactions which were reported in 1% to 3% of the patients were: abdominal pain, acid regurgitation, constipation, diarrhea, dizziness, nausea, irritability, mental acuity decreased, nervousness, upper respiratory infection, and pharyngitis.\"\n }\n ]\n },\n {\n \"Term\": \"Weight\",\n \"MEDDRACode\": \"10047890\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"weight\",\n \"Probability\": \"0.0016126335\",\n \"SemanticContext\": \"DESCRIPTION Cyclobenzaprine hydrochloride, USP is a white, crystalline tricyclic amine salt with the molecular formula C 20 H 21 N • HCl and a molecular weight of 311.9.\"\n }\n ]\n },\n {\n \"Term\": \"Somnolence\",\n \"MEDDRACode\": \"10041349\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Drowsiness\",\n \"Probability\": \"0.9935473204\",\n \"SemanticContext\": \"ADVERSE REACTIONS Incidence of most common adverse reactions in the 2 double-blind 3 , placebo-controlled 5 mg studies incidence of > 3% on cyclobenzaprine hydrochloride 5 mg : Cyclobenzaprine Hydrochloride 5 mg Cyclobenzaprine Hydrochloride 10 mg Placebo N=464 N=249 N=469 Drowsiness 29% 38% 10% Dry Mouth 21% 32% 7% Fatigue 6% 6% 3% Headache 5% 5% 8% .\"\n },\n {\n \"VerbatimTerm\": \"Drowsiness\",\n \"Probability\": \"0.9914924502\",\n \"SemanticContext\": \"Clinical Studies With Cyclobenzaprine Hydrochloride 10 mg Surveillance Program With Cyclobenzaprine Hydrochloride 10 mg Drowsiness 39% 16% Dry Mouth 27% 7% Dizziness 11% 3% .\"\n },\n {\n \"VerbatimTerm\": \"drowsiness\",\n \"Probability\": \"0.9994384646\",\n \"SemanticContext\": \"The adverse reactions reported most frequently with cyclobenzaprine hydrochloride were drowsiness, dry mouth and dizziness.\"\n },\n {\n \"VerbatimTerm\": \"drowsiness\",\n \"Probability\": \"0.1103040576\",\n \"SemanticContext\": \"However combination therapy of cyclobenzaprine hydrochloride with naproxen was associated with more side effects than therapy with naproxen alone, primarily in the form of drowsiness.\"\n },\n {\n \"VerbatimTerm\": \"drowsiness\",\n \"Probability\": \"0.8789641857\",\n \"SemanticContext\": \"The incidence of drowsiness, the most frequent adverse reaction, was similar with both drugs.\"\n },\n {\n \"VerbatimTerm\": \"drowsiness\",\n \"Probability\": \"0.8789641857\",\n \"SemanticContext\": \"The incidence of drowsiness, the most frequent adverse reaction, was similar with both drugs.\"\n },\n {\n \"VerbatimTerm\": \"drowsiness\",\n \"Probability\": \"0.9929476976\",\n \"SemanticContext\": \"Manifestations The most common effects associated with cyclobenzaprine overdose are drowsiness and tachycardia.\"\n }\n ]\n },\n {\n \"Term\": \"Seizure\",\n \"MEDDRACode\": \"10039906\",\n \"Overdose\": true,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": true,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Seizures\",\n \"Probability\": \"0.995521903\",\n \"SemanticContext\": \"Nervous System and Psychiatric: Seizures, ataxia; vertigo; dysarthria; tremors; hypertonia; convulsions; muscle twitching; disorientation; insomnia; depressed mood; abnormal sensations; anxiety; agitation; psychosis, abnormal thinking and dreaming; hallucinations; excitement; paresthesia; diplopia, serotonin syndrome.\"\n },\n {\n \"VerbatimTerm\": \"Seizures\",\n \"Probability\": \"0.1018606722\",\n \"SemanticContext\": \"Seizures should be controlled with benzodiazepines or, if these are ineffective, other anticonvulsants e.g., phenobarbital, phenytoin .\"\n },\n {\n \"VerbatimTerm\": \"seizures\",\n \"Probability\": \"0.6742423773\",\n \"SemanticContext\": \"Hyperpyretic crisis seizures, and deaths have occurred in patients receiving cyclobenzaprine or structurally similar tricyclic antidepressants concomitantly with MAO inhibitor drugs.\"\n },\n {\n \"VerbatimTerm\": \"seizures\",\n \"Probability\": \"0.9801057577\",\n \"SemanticContext\": \"Rare but potentially critical manifestations of overdose are cardiac arrest, chest pain, cardiac dysrhythmias, severe hypotension, seizures, and neuroleptic malignant syndrome.\"\n },\n {\n \"VerbatimTerm\": \"seizures\",\n \"Probability\": \"0.023593992\",\n \"SemanticContext\": \"Observation with cardiac monitoring and observation for signs of CNS or respiratory depression, hypotension, cardiac dysrhythmias and/or conduction blocks, and seizures is necessary.\"\n },\n {\n \"VerbatimTerm\": \"seizure\",\n \"Probability\": \"0.0188690722\",\n \"SemanticContext\": \"Tricyclic antidepressants may enhance the seizure risk in patients taking tramadol.\"\n },\n {\n \"VerbatimTerm\": \"seizure\",\n \"Probability\": \"0.0188690722\",\n \"SemanticContext\": \"Tricyclic antidepressants may enhance the seizure risk in patients taking tramadol.\"\n }\n ]\n },\n {\n \"Term\": \"Tremor\",\n \"MEDDRACode\": \"10044565\",\n \"Overdose\": true,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"tremors\",\n \"Probability\": \"0.9973595142\",\n \"SemanticContext\": \"Nervous System and Psychiatric: Seizures, ataxia; vertigo; dysarthria; tremors; hypertonia; convulsions; muscle twitching; disorientation; insomnia; depressed mood; abnormal sensations; anxiety; agitation; psychosis, abnormal thinking and dreaming; hallucinations; excitement; paresthesia; diplopia, serotonin syndrome.\"\n },\n {\n \"VerbatimTerm\": \"tremor\",\n \"Probability\": \"0.9978377819\",\n \"SemanticContext\": \"Less frequent manifestations include tremor, agitation, coma, ataxia, hypertension, slurred speech, confusion, dizziness, nausea, vomiting, and hallucinations.\"\n },\n {\n \"VerbatimTerm\": \"tremor\",\n \"Probability\": \"0.9873960614\",\n \"SemanticContext\": \"Serotonin syndrome symptoms may include mental status changes e.g., confusion, agitation, hallucinations , autonomic instability e.g., diaphoresis, tachycardia, labile blood pressure, hyperthermia , neuromuscular abnormalities e.g., tremor, ataxia, hyperreflexia, clonus, muscle rigidity , and/or gastrointestinal symptoms e.g., nausea, vomiting, diarrhea .\"\n }\n ]\n },\n {\n \"Term\": \"Barbiturates\",\n \"MEDDRACode\": \"10063229\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"barbiturates\",\n \"Probability\": \"0.0014317036\",\n \"SemanticContext\": \"Cyclobenzaprine hydrochloride may enhance the effects of alcohol, barbiturates, and other CNS depressants.\"\n },\n {\n \"VerbatimTerm\": \"barbiturates\",\n \"Probability\": \"0.0061124563\",\n \"SemanticContext\": \"Cyclobenzaprine hydrochloride may enhance the effects of alcohol, barbiturates, and other CNS depressants.\"\n },\n {\n \"VerbatimTerm\": \"barbiturates\",\n \"Probability\": \"0.0014317036\",\n \"SemanticContext\": \"Cyclobenzaprine hydrochloride may enhance the effects of alcohol, barbiturates, and other CNS depressants.\"\n }\n ]\n },\n {\n \"Term\": \"Hypersensitivity\",\n \"MEDDRACode\": \"10020751\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": true,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Hypersensitivity\",\n \"Probability\": \"0.9793182611\",\n \"SemanticContext\": \"Hypersensitivity: Anaphylaxis; angioedema; pruritus; facial edema; urticaria; rash.\"\n },\n {\n \"VerbatimTerm\": \"Hypersensitivity\",\n \"Probability\": \"0.0747979879\",\n \"SemanticContext\": \"CONTRAINDICATIONS Hypersensitivity to any component of this product.\"\n }\n ]\n },\n {\n \"Term\": \"Myalgia\",\n \"MEDDRACode\": \"10028411\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Myalgia\",\n \"Probability\": \"0.9929311275\",\n \"SemanticContext\": \"Musculoskeletal: Myalgia.\"\n }\n ]\n },\n {\n \"Term\": \"Euphoric mood\",\n \"MEDDRACode\": \"10015535\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"higher\",\n \"Probability\": \"0.0014476478\",\n \"SemanticContext\": \"Drug accumulates when dosed three times a day, reaching steady-state within 3 to 4 days at plasma concentrations about four-fold higher than after a single dose.\"\n },\n {\n \"VerbatimTerm\": \"higher\",\n \"Probability\": \"0.0322656035\",\n \"SemanticContext\": \"The plasma concentration of cyclobenzaprine is generally higher in the elderly and in patients with hepatic impairment.\"\n },\n {\n \"VerbatimTerm\": \"higher\",\n \"Probability\": \"0.0115801692\",\n \"SemanticContext\": \"\\n \\n Elderly\\n In a pharmacokinetic study in elderly individuals =65 yrs old , mean n=10 steady-state cyclobenzaprine AUC values were approximately 1.7 fold 171 ng.hr/mL, range 96.1 to 255.3 higher than those seen in a group of eighteen younger adults 101.4 ng.hr/mL, range 36.1 to 182.9 from another study.\"\n },\n {\n \"VerbatimTerm\": \"higher\",\n \"Probability\": \"0.0006974936\",\n \"SemanticContext\": \"In the higher dose groups this microscopic change was seen after 26 weeks and even earlier in rats which died prior to 26 weeks; at lower doses, the change was not seen until after 26 weeks.\"\n },\n {\n \"VerbatimTerm\": \"highest\",\n \"Probability\": \"0.00510028\",\n \"SemanticContext\": \"Elderly male subjects had the highest observed mean increase, approximately 2.4 fold 198.3 ng.hr/mL, range 155.6 to 255.3 versus 83.2 ng.hr/mL, range 41.1 to 142.5 for younger males while levels in elderly females were increased to a much lesser extent, approximately 1.2 fold 143.8 ng.hr/mL, range 96.1 to 196.3 versus 115.9 ng.hr/mL, range 36.1 to 182.9 for younger females .\"\n }\n ]\n },\n {\n \"Term\": \"Dysarthria\",\n \"MEDDRACode\": \"10013887\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"slurred speech\",\n \"Probability\": \"0.9990338683\",\n \"SemanticContext\": \"Less frequent manifestations include tremor, agitation, coma, ataxia, hypertension, slurred speech, confusion, dizziness, nausea, vomiting, and hallucinations.\"\n }\n ]\n },\n {\n \"Term\": \"Parotid gland enlargement\",\n \"MEDDRACode\": \"10034023\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"parotid swelling\",\n \"Probability\": \"0.9960734248\",\n \"SemanticContext\": \"Digestive: Paralytic ileus, tongue discoloration; stomatitis; parotid swelling.\"\n }\n ]\n },\n {\n \"Term\": \"Regurgitation\",\n \"MEDDRACode\": \"10067171\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"regurgitation\",\n \"Probability\": \"0.9929788113\",\n \"SemanticContext\": \"Adverse reactions which were reported in 1% to 3% of the patients were: abdominal pain, acid regurgitation, constipation, diarrhea, dizziness, nausea, irritability, mental acuity decreased, nervousness, upper respiratory infection, and pharyngitis.\"\n }\n ]\n },\n {\n \"Term\": \"Tenderness\",\n \"MEDDRACode\": \"10043224\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"tenderness\",\n \"Probability\": \"0.038433075\",\n \"SemanticContext\": \"Muscle spasm, local pain and tenderness, limitation of motion, and restriction in activities of daily living were evaluated.\"\n },\n {\n \"VerbatimTerm\": \"tenderness\",\n \"Probability\": \"0.038433075\",\n \"SemanticContext\": \"Muscle spasm, local pain and tenderness, limitation of motion, and restriction in activities of daily living were evaluated.\"\n },\n {\n \"VerbatimTerm\": \"tenderness\",\n \"Probability\": \"0.0030643344\",\n \"SemanticContext\": \"Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living.\"\n }\n ]\n },\n {\n \"Term\": \"Drug level\",\n \"MEDDRACode\": \"10061823\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"drug levels\",\n \"Probability\": \"0.0007793605\",\n \"SemanticContext\": \"Monitoring of plasma drug levels should not guide management of the patient.\"\n }\n ]\n },\n {\n \"Term\": \"Muscle spasms\",\n \"MEDDRACode\": \"10028334\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"muscle spasm\",\n \"Probability\": \"0.1837010086\",\n \"SemanticContext\": \"It is ineffective in muscle spasm due to central nervous system disease.\"\n },\n {\n \"VerbatimTerm\": \"muscle spasm\",\n \"Probability\": \"0.0587342978\",\n \"SemanticContext\": \"Secondary endpoints included a physician’s evaluation of the presence and extent of palpable muscle spasm.\"\n },\n {\n \"VerbatimTerm\": \"muscle spasm\",\n \"Probability\": \"0.0107852221\",\n \"SemanticContext\": \"Physician-assessed secondary endpoints also showed that cyclobenzaprine hydrochloride 5 mg was associated with a greater reduction in palpable muscle spasm than placebo.\"\n },\n {\n \"VerbatimTerm\": \"muscle spasm\",\n \"Probability\": \"0.0587342978\",\n \"SemanticContext\": \"Secondary endpoints included a physician’s evaluation of the presence and extent of palpable muscle spasm.\"\n },\n {\n \"VerbatimTerm\": \"muscle spasm\",\n \"Probability\": \"0.0107852221\",\n \"SemanticContext\": \"Physician-assessed secondary endpoints also showed that cyclobenzaprine hydrochloride 5 mg was associated with a greater reduction in palpable muscle spasm than placebo.\"\n },\n {\n \"VerbatimTerm\": \"muscle spasm\",\n \"Probability\": \"0.0024381578\",\n \"SemanticContext\": \"Cyclobenzaprine hydrochloride tablets, USP should be used only for short periods up to two or three weeks because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted.\"\n },\n {\n \"VerbatimTerm\": \"muscle spasm\",\n \"Probability\": \"0.2163402438\",\n \"SemanticContext\": \"In short term studies for indications other than muscle spasm associated with acute musculoskeletal conditions, and usually at doses somewhat greater than those recommended for skeletal muscle spasm, some of the more serious central nervous system reactions noted with the tricyclic antidepressants have occurred see WARNINGS , below, and ADVERSE REACTIONS .\"\n },\n {\n \"VerbatimTerm\": \"muscle spasm\",\n \"Probability\": \"0.2836820483\",\n \"SemanticContext\": \"In short term studies for indications other than muscle spasm associated with acute musculoskeletal conditions, and usually at doses somewhat greater than those recommended for skeletal muscle spasm, some of the more serious central nervous system reactions noted with the tricyclic antidepressants have occurred see WARNINGS , below, and ADVERSE REACTIONS .\"\n },\n {\n \"VerbatimTerm\": \"Muscle spasm\",\n \"Probability\": \"0.211199522\",\n \"SemanticContext\": \"Muscle spasm, local pain and tenderness, limitation of motion, and restriction in activities of daily living were evaluated.\"\n },\n {\n \"VerbatimTerm\": \"Muscle spasm\",\n \"Probability\": \"0.211199522\",\n \"SemanticContext\": \"Muscle spasm, local pain and tenderness, limitation of motion, and restriction in activities of daily living were evaluated.\"\n }\n ]\n },\n {\n \"Term\": \"Testicular swelling\",\n \"MEDDRACode\": \"10043354\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"testicular swelling\",\n \"Probability\": \"0.9982007146\",\n \"SemanticContext\": \"Urogenital: Impaired urination; dilatation of urinary tract; impotence; testicular swelling; gynecomastia; breast enlargement; galactorrhea.\"\n }\n ]\n },\n {\n \"Term\": \"Muscle relaxant therapy\",\n \"MEDDRACode\": \"10058909\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"muscle relaxant\",\n \"Probability\": \"0.0020706952\",\n \"SemanticContext\": \"Such studies show that cyclobenzaprine acts primarily within the central nervous system at brain stem as opposed to spinal cord levels, although its action on the latter may contribute to its overall skeletal muscle relaxant activity.\"\n }\n ]\n },\n {\n \"Term\": \"Dysuria\",\n \"MEDDRACode\": \"10013990\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Impaired urination\",\n \"Probability\": \"0.9986191988\",\n \"SemanticContext\": \"Urogenital: Impaired urination; dilatation of urinary tract; impotence; testicular swelling; gynecomastia; breast enlargement; galactorrhea.\"\n }\n ]\n },\n {\n \"Term\": \"Atrioventricular block\",\n \"MEDDRACode\": \"10003671\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": true,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"heart block\",\n \"Probability\": \"0.8909904957\",\n \"SemanticContext\": \"Cardiovascular: Hypertension; myocardial infarction; heart block; stroke.\"\n },\n {\n \"VerbatimTerm\": \"heart block\",\n \"Probability\": \"0.2521891892\",\n \"SemanticContext\": \"Acute recovery phase of myocardial infarction, and patients with arrhythmias, heart block or conduction disturbances, or congestive heart failure.\"\n }\n ]\n },\n {\n \"Term\": \"Axillary web syndrome\",\n \"MEDDRACode\": \"10074387\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"cord\",\n \"Probability\": \"0.0106969178\",\n \"SemanticContext\": \"Such studies show that cyclobenzaprine acts primarily within the central nervous system at brain stem as opposed to spinal cord levels, although its action on the latter may contribute to its overall skeletal muscle relaxant activity.\"\n },\n {\n \"VerbatimTerm\": \"cord\",\n \"Probability\": \"0.005125016\",\n \"SemanticContext\": \"Cyclobenzaprine hydrochloride tablets, USP have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.\"\n }\n ]\n },\n {\n \"Term\": \"Hyperhidrosis\",\n \"MEDDRACode\": \"10020642\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"diaphoresis\",\n \"Probability\": \"0.9847797155\",\n \"SemanticContext\": \"Serotonin syndrome symptoms may include mental status changes e.g., confusion, agitation, hallucinations , autonomic instability e.g., diaphoresis, tachycardia, labile blood pressure, hyperthermia , neuromuscular abnormalities e.g., tremor, ataxia, hyperreflexia, clonus, muscle rigidity , and/or gastrointestinal symptoms e.g., nausea, vomiting, diarrhea .\"\n }\n ]\n },\n {\n \"Term\": \"Drug interaction\",\n \"MEDDRACode\": \"10013710\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"interactions\",\n \"Probability\": \"0.0003964603\",\n \"SemanticContext\": \"Drug Interactions Cyclobenzaprine may have life-threatening interactions with MAO inhibitors see CONTRAINDICATIONS .\"\n },\n {\n \"VerbatimTerm\": \"interactions\",\n \"Probability\": \"0.000572741\",\n \"SemanticContext\": \"Drug Interactions Cyclobenzaprine may have life-threatening interactions with MAO inhibitors see CONTRAINDICATIONS .\"\n }\n ]\n },\n {\n \"Term\": \"Hyperthyroidism\",\n \"MEDDRACode\": \"10020850\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": true,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Hyperthyroidism\",\n \"Probability\": \"0.0074933469\",\n \"SemanticContext\": \"Hyperthyroidism.\"\n }\n ]\n },\n {\n \"Term\": \"Irritability\",\n \"MEDDRACode\": \"10022998\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"irritability\",\n \"Probability\": \"0.9989296198\",\n \"SemanticContext\": \"Adverse reactions which were reported in 1% to 3% of the patients were: abdominal pain, acid regurgitation, constipation, diarrhea, dizziness, nausea, irritability, mental acuity decreased, nervousness, upper respiratory infection, and pharyngitis.\"\n }\n ]\n },\n {\n \"Term\": \"Purpura\",\n \"MEDDRACode\": \"10037549\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Purpura\",\n \"Probability\": \"0.9952380657\",\n \"SemanticContext\": \"Hematic and Lymphatic: Purpura; bone marrow depression; leukopenia; eosinophilia; thrombocytopenia.\"\n }\n ]\n },\n {\n \"Term\": \"Chest pain\",\n \"MEDDRACode\": \"10008479\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Chest pain\",\n \"Probability\": \"0.645435214\",\n \"SemanticContext\": \"Causal Relationship Unknown Other reactions, reported rarely for cyclobenzaprine hydrochloride under circumstances where a causal relationship could not be established or reported for other tricyclic drugs, are listed to serve as alerting information to physicians: Body as a whole: Chest pain; edema.\"\n },\n {\n \"VerbatimTerm\": \"chest pain\",\n \"Probability\": \"0.9818091393\",\n \"SemanticContext\": \"Rare but potentially critical manifestations of overdose are cardiac arrest, chest pain, cardiac dysrhythmias, severe hypotension, seizures, and neuroleptic malignant syndrome.\"\n }\n ]\n },\n {\n \"Term\": \"Overdose\",\n \"MEDDRACode\": \"10033295\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"overdose\",\n \"Probability\": \"0.0485566258\",\n \"SemanticContext\": \"Multiple drug ingestion including alcohol is common in deliberate cyclobenzaprine overdose.\"\n },\n {\n \"VerbatimTerm\": \"overdose\",\n \"Probability\": \"0.0220955908\",\n \"SemanticContext\": \"As management of overdose is complex and changing, it is recommended that the physician contact a poison control center for current information on treatment.\"\n },\n {\n \"VerbatimTerm\": \"overdose\",\n \"Probability\": \"0.0174742043\",\n \"SemanticContext\": \"Signs and symptoms of toxicity may develop rapidly after cyclobenzaprine overdose; therefore, hospital monitoring is required as soon as possible.\"\n },\n {\n \"VerbatimTerm\": \"overdose\",\n \"Probability\": \"0.8489627838\",\n \"SemanticContext\": \"Manifestations The most common effects associated with cyclobenzaprine overdose are drowsiness and tachycardia.\"\n },\n {\n \"VerbatimTerm\": \"overdose\",\n \"Probability\": \"0.7878990769\",\n \"SemanticContext\": \"Rare but potentially critical manifestations of overdose are cardiac arrest, chest pain, cardiac dysrhythmias, severe hypotension, seizures, and neuroleptic malignant syndrome.\"\n },\n {\n \"VerbatimTerm\": \"overdose\",\n \"Probability\": \"0.0298533142\",\n \"SemanticContext\": \"Management\\n \\n General\\n As management of overdose is complex and changing, it is recommended that the physician contact a poison control center for current information on treatment.\"\n },\n {\n \"VerbatimTerm\": \"overdose\",\n \"Probability\": \"0.0338377655\",\n \"SemanticContext\": \"\\n \\n Gastrointestinal Decontamination\\n All patients suspected of an overdose with cyclobenzaprine hydrochloride should receive gastrointestinal decontamination.\"\n },\n {\n \"VerbatimTerm\": \"overdose\",\n \"Probability\": \"0.2725927234\",\n \"SemanticContext\": \"\\n \\n Cardiovascular\\n A maximal limb-lead QRS duration of =0.10 seconds may be the best indication of the severity of the overdose.\"\n }\n ]\n },\n {\n \"Term\": \"Cerebral palsy\",\n \"MEDDRACode\": \"10008129\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"cerebral palsy\",\n \"Probability\": \"0.0113793314\",\n \"SemanticContext\": \"Cyclobenzaprine hydrochloride tablets, USP have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.\"\n }\n ]\n },\n {\n \"Term\": \"Autonomic nervous system imbalance\",\n \"MEDDRACode\": \"10003840\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"autonomic instability\",\n \"Probability\": \"0.8542119265\",\n \"SemanticContext\": \"Serotonin syndrome symptoms may include mental status changes e.g., confusion, agitation, hallucinations , autonomic instability e.g., diaphoresis, tachycardia, labile blood pressure, hyperthermia , neuromuscular abnormalities e.g., tremor, ataxia, hyperreflexia, clonus, muscle rigidity , and/or gastrointestinal symptoms e.g., nausea, vomiting, diarrhea .\"\n }\n ]\n },\n {\n \"Term\": \"Intraocular pressure increased\",\n \"MEDDRACode\": \"10022806\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"increased intraocular pressure\",\n \"Probability\": \"0.0051212013\",\n \"SemanticContext\": \"PRECAUTIONS General Because of its atropine-like action, cyclobenzaprine hydrochloride should be used with caution in patients with a history of urinary retention, angle-closure glaucoma, increased intraocular pressure, and in patients taking anticholinergic medication.\"\n }\n ]\n },\n {\n \"Term\": \"Diarrhoea\",\n \"MEDDRACode\": \"10012735\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"diarrhea\",\n \"Probability\": \"0.9997353554\",\n \"SemanticContext\": \"Adverse reactions which were reported in 1% to 3% of the patients were: abdominal pain, acid regurgitation, constipation, diarrhea, dizziness, nausea, irritability, mental acuity decreased, nervousness, upper respiratory infection, and pharyngitis.\"\n },\n {\n \"VerbatimTerm\": \"diarrhea\",\n \"Probability\": \"0.9966337681\",\n \"SemanticContext\": \"Digestive: Vomiting; anorexia; diarrhea; gastrointestinal pain; gastritis; thirst; flatulence; edema of the tongue; abnormal liver function and rare reports of hepatitis, jaundice and cholestasis.\"\n },\n {\n \"VerbatimTerm\": \"diarrhea\",\n \"Probability\": \"0.9506492615\",\n \"SemanticContext\": \"Serotonin syndrome symptoms may include mental status changes e.g., confusion, agitation, hallucinations , autonomic instability e.g., diaphoresis, tachycardia, labile blood pressure, hyperthermia , neuromuscular abnormalities e.g., tremor, ataxia, hyperreflexia, clonus, muscle rigidity , and/or gastrointestinal symptoms e.g., nausea, vomiting, diarrhea .\"\n }\n ]\n },\n {\n \"Term\": \"Blood iron\",\n \"MEDDRACode\": \"10005616\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"iron\",\n \"Probability\": \"0.1097299159\",\n \"SemanticContext\": \"In addition 5 mg also contains D&C yellow #10 aluminum lake and FD&C yellow #6 aluminum lake and 10 mg also contains yellow iron oxide.\"\n }\n ]\n },\n {\n \"Term\": \"Urinary retention\",\n \"MEDDRACode\": \"10046555\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"urinary retention\",\n \"Probability\": \"0.0002070367\",\n \"SemanticContext\": \"PRECAUTIONS General Because of its atropine-like action, cyclobenzaprine hydrochloride should be used with caution in patients with a history of urinary retention, angle-closure glaucoma, increased intraocular pressure, and in patients taking anticholinergic medication.\"\n }\n ]\n },\n {\n \"Term\": \"Protein total\",\n \"MEDDRACode\": \"10050537\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"plasma proteins\",\n \"Probability\": \"0.0001254678\",\n \"SemanticContext\": \"It is highly bound to plasma proteins.\"\n }\n ]\n },\n {\n \"Term\": \"Elderly\",\n \"MEDDRACode\": \"10014348\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": true\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"elderly\",\n \"Probability\": \"0.0008436739\",\n \"SemanticContext\": \"The plasma concentration of cyclobenzaprine is generally higher in the elderly and in patients with hepatic impairment.\"\n },\n {\n \"VerbatimTerm\": \"elderly\",\n \"Probability\": \"0.0001390576\",\n \"SemanticContext\": \"\\n \\n Elderly\\n In a pharmacokinetic study in elderly individuals =65 yrs old , mean n=10 steady-state cyclobenzaprine AUC values were approximately 1.7 fold 171 ng.hr/mL, range 96.1 to 255.3 higher than those seen in a group of eighteen younger adults 101.4 ng.hr/mL, range 36.1 to 182.9 from another study.\"\n },\n {\n \"VerbatimTerm\": \"elderly\",\n \"Probability\": \"0.0008139014\",\n \"SemanticContext\": \"Elderly male subjects had the highest observed mean increase, approximately 2.4 fold 198.3 ng.hr/mL, range 155.6 to 255.3 versus 83.2 ng.hr/mL, range 41.1 to 142.5 for younger males while levels in elderly females were increased to a much lesser extent, approximately 1.2 fold 143.8 ng.hr/mL, range 96.1 to 196.3 versus 115.9 ng.hr/mL, range 36.1 to 182.9 for younger females .\"\n },\n {\n \"VerbatimTerm\": \"elderly\",\n \"Probability\": \"0.0003141165\",\n \"SemanticContext\": \"In light of these findings, therapy with cyclobenzaprine hydrochloride in the elderly should be initiated with a 5 mg dose and titrated slowly upward.\"\n },\n {\n \"VerbatimTerm\": \"elderly\",\n \"Probability\": \"4.15852E-05\",\n \"SemanticContext\": \"Less frequent dosing should be considered for hepatically impaired or elderly patients see PRECAUTIONS, Impaired Hepatic Function , and Use in the Elderly .\"\n },\n {\n \"VerbatimTerm\": \"elderly\",\n \"Probability\": \"0.0015259087\",\n \"SemanticContext\": \"In the elderly, the frequency and severity of adverse events associated with the use of cyclobenzaprine, with or without concomitant medications, is increased.\"\n },\n {\n \"VerbatimTerm\": \"elderly\",\n \"Probability\": \"4.78103E-05\",\n \"SemanticContext\": \"In elderly patients, cyclobenzaprine hydrochloride should be initiated with a 5 mg dose and titrated slowly upward.\"\n },\n {\n \"VerbatimTerm\": \"elderly\",\n \"Probability\": \"0.0015259087\",\n \"SemanticContext\": \"In the elderly, the frequency and severity of adverse events associated with the use of cyclobenzaprine, with or without concomitant medications, is increased.\"\n },\n {\n \"VerbatimTerm\": \"elderly\",\n \"Probability\": \"4.78103E-05\",\n \"SemanticContext\": \"In elderly patients, cyclobenzaprine hydrochloride should be initiated with a 5 mg dose and titrated slowly upward.\"\n },\n {\n \"VerbatimTerm\": \"elderly\",\n \"Probability\": \"4.52825E-05\",\n \"SemanticContext\": \"Use in the Elderly The plasma concentration of cyclobenzaprine is increased in the elderly see CLINICAL PHARMACOLOGY, Pharmacokinetics, Elderly .\"\n },\n {\n \"VerbatimTerm\": \"elderly\",\n \"Probability\": \"0.0021934211\",\n \"SemanticContext\": \"The elderly may also be more at risk for CNS adverse events such as hallucinations and confusion, cardiac events resulting in falls or other sequelae, drug-drug and drug-disease interactions.\"\n },\n {\n \"VerbatimTerm\": \"elderly\",\n \"Probability\": \"0.0003969669\",\n \"SemanticContext\": \"For these reasons, in the elderly, cyclobenzaprine should be used only if clearly needed.\"\n },\n {\n \"VerbatimTerm\": \"elderly\",\n \"Probability\": \"4.52825E-05\",\n \"SemanticContext\": \"Use in the Elderly The plasma concentration of cyclobenzaprine is increased in the elderly see CLINICAL PHARMACOLOGY, Pharmacokinetics, Elderly .\"\n },\n {\n \"VerbatimTerm\": \"elderly\",\n \"Probability\": \"0.0021934211\",\n \"SemanticContext\": \"The elderly may also be more at risk for CNS adverse events such as hallucinations and confusion, cardiac events resulting in falls or other sequelae, drug-drug and drug-disease interactions.\"\n },\n {\n \"VerbatimTerm\": \"elderly\",\n \"Probability\": \"0.0003969669\",\n \"SemanticContext\": \"For these reasons, in the elderly, cyclobenzaprine should be used only if clearly needed.\"\n },\n {\n \"VerbatimTerm\": \"Elderly\",\n \"Probability\": \"0.0027744174\",\n \"SemanticContext\": \"See PRECAUTIONS, Use in the Elderly and PRECAUTIONS, Impaired Hepatic Function .\"\n },\n {\n \"VerbatimTerm\": \"Elderly\",\n \"Probability\": \"0.0003803968\",\n \"SemanticContext\": \"\\n \\n Elderly\\n In a pharmacokinetic study in elderly individuals =65 yrs old , mean n=10 steady-state cyclobenzaprine AUC values were approximately 1.7 fold 171 ng.hr/mL, range 96.1 to 255.3 higher than those seen in a group of eighteen younger adults 101.4 ng.hr/mL, range 36.1 to 182.9 from another study.\"\n },\n {\n \"VerbatimTerm\": \"Elderly\",\n \"Probability\": \"0.0038112998\",\n \"SemanticContext\": \"Elderly male subjects had the highest observed mean increase, approximately 2.4 fold 198.3 ng.hr/mL, range 155.6 to 255.3 versus 83.2 ng.hr/mL, range 41.1 to 142.5 for younger males while levels in elderly females were increased to a much lesser extent, approximately 1.2 fold 143.8 ng.hr/mL, range 96.1 to 196.3 versus 115.9 ng.hr/mL, range 36.1 to 182.9 for younger females .\"\n },\n {\n \"VerbatimTerm\": \"Elderly\",\n \"Probability\": \"0.000916183\",\n \"SemanticContext\": \"Less frequent dosing should be considered for hepatically impaired or elderly patients see PRECAUTIONS, Impaired Hepatic Function , and Use in the Elderly .\"\n },\n {\n \"VerbatimTerm\": \"Elderly\",\n \"Probability\": \"2.77732E-05\",\n \"SemanticContext\": \"Use in the Elderly The plasma concentration of cyclobenzaprine is increased in the elderly see CLINICAL PHARMACOLOGY, Pharmacokinetics, Elderly .\"\n },\n {\n \"VerbatimTerm\": \"Elderly\",\n \"Probability\": \"0.005592972\",\n \"SemanticContext\": \"Use in the Elderly The plasma concentration of cyclobenzaprine is increased in the elderly see CLINICAL PHARMACOLOGY, Pharmacokinetics, Elderly .\"\n },\n {\n \"VerbatimTerm\": \"Elderly\",\n \"Probability\": \"2.77732E-05\",\n \"SemanticContext\": \"Use in the Elderly The plasma concentration of cyclobenzaprine is increased in the elderly see CLINICAL PHARMACOLOGY, Pharmacokinetics, Elderly .\"\n },\n {\n \"VerbatimTerm\": \"Elderly\",\n \"Probability\": \"0.005592972\",\n \"SemanticContext\": \"Use in the Elderly The plasma concentration of cyclobenzaprine is increased in the elderly see CLINICAL PHARMACOLOGY, Pharmacokinetics, Elderly .\"\n }\n ]\n },\n {\n \"Term\": \"Poisoning\",\n \"MEDDRACode\": \"10061355\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"poison\",\n \"Probability\": \"0.0003408492\",\n \"SemanticContext\": \"As management of overdose is complex and changing, it is recommended that the physician contact a poison control center for current information on treatment.\"\n },\n {\n \"VerbatimTerm\": \"poison\",\n \"Probability\": \"0.0028554499\",\n \"SemanticContext\": \"Management\\n \\n General\\n As management of overdose is complex and changing, it is recommended that the physician contact a poison control center for current information on treatment.\"\n },\n {\n \"VerbatimTerm\": \"poison\",\n \"Probability\": \"0.0004294515\",\n \"SemanticContext\": \"Physostigmine is not recommended except to treat life-threatening symptoms that have been unresponsive to other therapies, and then only in close consultation with a poison control center.\"\n },\n {\n \"VerbatimTerm\": \"poison\",\n \"Probability\": \"0.007055819\",\n \"SemanticContext\": \"It is strongly recommended that the physician contact the local poison control center for specific pediatric treatment.\"\n }\n ]\n },\n {\n \"Term\": \"Hallucination\",\n \"MEDDRACode\": \"10019063\",\n \"Overdose\": true,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": true\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hallucinations\",\n \"Probability\": \"0.9973604679\",\n \"SemanticContext\": \"Nervous System and Psychiatric: Seizures, ataxia; vertigo; dysarthria; tremors; hypertonia; convulsions; muscle twitching; disorientation; insomnia; depressed mood; abnormal sensations; anxiety; agitation; psychosis, abnormal thinking and dreaming; hallucinations; excitement; paresthesia; diplopia, serotonin syndrome.\"\n },\n {\n \"VerbatimTerm\": \"hallucinations\",\n \"Probability\": \"0.9892952442\",\n \"SemanticContext\": \"Less frequent manifestations include tremor, agitation, coma, ataxia, hypertension, slurred speech, confusion, dizziness, nausea, vomiting, and hallucinations.\"\n },\n {\n \"VerbatimTerm\": \"hallucinations\",\n \"Probability\": \"0.9789422154\",\n \"SemanticContext\": \"Serotonin syndrome symptoms may include mental status changes e.g., confusion, agitation, hallucinations , autonomic instability e.g., diaphoresis, tachycardia, labile blood pressure, hyperthermia , neuromuscular abnormalities e.g., tremor, ataxia, hyperreflexia, clonus, muscle rigidity , and/or gastrointestinal symptoms e.g., nausea, vomiting, diarrhea .\"\n },\n {\n \"VerbatimTerm\": \"hallucinations\",\n \"Probability\": \"0.4768155217\",\n \"SemanticContext\": \"The elderly may also be more at risk for CNS adverse events such as hallucinations and confusion, cardiac events resulting in falls or other sequelae, drug-drug and drug-disease interactions.\"\n },\n {\n \"VerbatimTerm\": \"hallucinations\",\n \"Probability\": \"0.4768155217\",\n \"SemanticContext\": \"The elderly may also be more at risk for CNS adverse events such as hallucinations and confusion, cardiac events resulting in falls or other sequelae, drug-drug and drug-disease interactions.\"\n }\n ]\n },\n {\n \"Term\": \"Skin exfoliation\",\n \"MEDDRACode\": \"10040844\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"scale\",\n \"Probability\": \"0.7927489281\",\n \"SemanticContext\": \"Each endpoint consisted of a score on a 5-point rating scale from 0 or worst outcome to 4 or best outcome .\"\n },\n {\n \"VerbatimTerm\": \"scale\",\n \"Probability\": \"0.7927489281\",\n \"SemanticContext\": \"Each endpoint consisted of a score on a 5-point rating scale from 0 or worst outcome to 4 or best outcome .\"\n }\n ]\n },\n {\n \"Term\": \"Labile blood pressure\",\n \"MEDDRACode\": \"10023533\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"labile blood pressure\",\n \"Probability\": \"0.815844357\",\n \"SemanticContext\": \"Serotonin syndrome symptoms may include mental status changes e.g., confusion, agitation, hallucinations , autonomic instability e.g., diaphoresis, tachycardia, labile blood pressure, hyperthermia , neuromuscular abnormalities e.g., tremor, ataxia, hyperreflexia, clonus, muscle rigidity , and/or gastrointestinal symptoms e.g., nausea, vomiting, diarrhea .\"\n }\n ]\n },\n {\n \"Term\": \"Sinus tachycardia\",\n \"MEDDRACode\": \"10040752\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"sinus tachycardia\",\n \"Probability\": \"0.9354588389\",\n \"SemanticContext\": \"Tricyclic antidepressants have been reported to produce arrhythmias, sinus tachycardia, prolongation of the conduction time leading to myocardial infarction and stroke.\"\n }\n ]\n },\n {\n \"Term\": \"Drug-disease interaction\",\n \"MEDDRACode\": \"10074868\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": true\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"drug-disease interactions\",\n \"Probability\": \"0.0033915937\",\n \"SemanticContext\": \"The elderly may also be more at risk for CNS adverse events such as hallucinations and confusion, cardiac events resulting in falls or other sequelae, drug-drug and drug-disease interactions.\"\n },\n {\n \"VerbatimTerm\": \"drug-disease interactions\",\n \"Probability\": \"0.0033915937\",\n \"SemanticContext\": \"The elderly may also be more at risk for CNS adverse events such as hallucinations and confusion, cardiac events resulting in falls or other sequelae, drug-drug and drug-disease interactions.\"\n }\n ]\n },\n {\n \"Term\": \"Crigler-Najjar syndrome\",\n \"MEDDRACode\": \"10011386\",\n \"Overdose\": true,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": true\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"CNS\",\n \"Probability\": \"0.0081802011\",\n \"SemanticContext\": \"Cyclobenzaprine hydrochloride may enhance the effects of alcohol, barbiturates, and other CNS depressants.\"\n },\n {\n \"VerbatimTerm\": \"CNS\",\n \"Probability\": \"0.0002165735\",\n \"SemanticContext\": \"Information for Patients Cyclobenzaprine hydrochloride, especially when used with alcohol or other CNS depressants, may impair mental and/or physical abilities required for performance of hazardous tasks, such as operating machinery or driving a motor vehicle.\"\n },\n {\n \"VerbatimTerm\": \"CNS\",\n \"Probability\": \"0.0160163641\",\n \"SemanticContext\": \"Observation with cardiac monitoring and observation for signs of CNS or respiratory depression, hypotension, cardiac dysrhythmias and/or conduction blocks, and seizures is necessary.\"\n },\n {\n \"VerbatimTerm\": \"CNS\",\n \"Probability\": \"0.0547144413\",\n \"SemanticContext\": \"\\n \\n CNS\\n In patients with CNS depression, early intubation is advised because of the potential for abrupt deterioration.\"\n },\n {\n \"VerbatimTerm\": \"CNS\",\n \"Probability\": \"0.0828211606\",\n \"SemanticContext\": \"Cyclobenzaprine hydrochloride may enhance the effects of alcohol, barbiturates, and other CNS depressants.\"\n },\n {\n \"VerbatimTerm\": \"CNS\",\n \"Probability\": \"0.0002165735\",\n \"SemanticContext\": \"Information for Patients Cyclobenzaprine hydrochloride, especially when used with alcohol or other CNS depressants, may impair mental and/or physical abilities required for performance of hazardous tasks, such as operating machinery or driving a motor vehicle.\"\n },\n {\n \"VerbatimTerm\": \"CNS\",\n \"Probability\": \"0.0081802011\",\n \"SemanticContext\": \"Cyclobenzaprine hydrochloride may enhance the effects of alcohol, barbiturates, and other CNS depressants.\"\n },\n {\n \"VerbatimTerm\": \"CNS\",\n \"Probability\": \"0.0128895938\",\n \"SemanticContext\": \"The elderly may also be more at risk for CNS adverse events such as hallucinations and confusion, cardiac events resulting in falls or other sequelae, drug-drug and drug-disease interactions.\"\n },\n {\n \"VerbatimTerm\": \"CNS\",\n \"Probability\": \"0.0128895938\",\n \"SemanticContext\": \"The elderly may also be more at risk for CNS adverse events such as hallucinations and confusion, cardiac events resulting in falls or other sequelae, drug-drug and drug-disease interactions.\"\n }\n ]\n },\n {\n \"Term\": \"Disorientation\",\n \"MEDDRACode\": \"10013395\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": true\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"disorientation\",\n \"Probability\": \"0.9698177576\",\n \"SemanticContext\": \"Nervous System and Psychiatric: Seizures, ataxia; vertigo; dysarthria; tremors; hypertonia; convulsions; muscle twitching; disorientation; insomnia; depressed mood; abnormal sensations; anxiety; agitation; psychosis, abnormal thinking and dreaming; hallucinations; excitement; paresthesia; diplopia, serotonin syndrome.\"\n }\n ]\n },\n {\n \"Term\": \"Sedation\",\n \"MEDDRACode\": \"10039897\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"sedation\",\n \"Probability\": \"0.0301811993\",\n \"SemanticContext\": \"Pharmacological studies in animals showed a similarity between the effects of cyclobenzaprine and the structurally related tricyclic antidepressants, including reserpine antagonism, norepinephrine potentiation, potent peripheral and central anticholinergic effects, and sedation.\"\n },\n {\n \"VerbatimTerm\": \"sedation\",\n \"Probability\": \"0.1028018296\",\n \"SemanticContext\": \"Analysis of the data from controlled studies shows that cyclobenzaprine hydrochloride produces clinical improvement whether or not sedation occurs.\"\n },\n {\n \"VerbatimTerm\": \"sedation\",\n \"Probability\": \"0.1028018296\",\n \"SemanticContext\": \"Analysis of the data from controlled studies shows that cyclobenzaprine hydrochloride produces clinical improvement whether or not sedation occurs.\"\n }\n ]\n },\n {\n \"Term\": \"Respiratory depression\",\n \"MEDDRACode\": \"10038678\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"respiratory depression\",\n \"Probability\": \"0.0785554945\",\n \"SemanticContext\": \"Observation with cardiac monitoring and observation for signs of CNS or respiratory depression, hypotension, cardiac dysrhythmias and/or conduction blocks, and seizures is necessary.\"\n }\n ]\n },\n {\n \"Term\": \"Pharyngitis\",\n \"MEDDRACode\": \"10034835\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"pharyngitis\",\n \"Probability\": \"0.9988191128\",\n \"SemanticContext\": \"Adverse reactions which were reported in 1% to 3% of the patients were: abdominal pain, acid regurgitation, constipation, diarrhea, dizziness, nausea, irritability, mental acuity decreased, nervousness, upper respiratory infection, and pharyngitis.\"\n }\n ]\n },\n {\n \"Term\": \"Pruritus\",\n \"MEDDRACode\": \"10037087\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"pruritus\",\n \"Probability\": \"0.9990310669\",\n \"SemanticContext\": \"Hypersensitivity: Anaphylaxis; angioedema; pruritus; facial edema; urticaria; rash.\"\n }\n ]\n },\n {\n \"Term\": \"Blood bicarbonate\",\n \"MEDDRACode\": \"10005357\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"bicarbonate\",\n \"Probability\": \"4.25833E-05\",\n \"SemanticContext\": \"Serum alkalinization, to a pH of 7.45 to 7.55, using intravenous sodium bicarbonate and hyperventilation as needed , should be instituted for patients with dysrhythmias and/or QRS widening.\"\n },\n {\n \"VerbatimTerm\": \"bicarbonate\",\n \"Probability\": \"1.99749E-05\",\n \"SemanticContext\": \"Dysrhythmias unresponsive to sodium bicarbonate therapy/hyperventilation may respond to lidocaine, bretylium or phenytoin.\"\n }\n ]\n },\n {\n \"Term\": \"Coma\",\n \"MEDDRACode\": \"10010071\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"coma\",\n \"Probability\": \"0.999450922\",\n \"SemanticContext\": \"Less frequent manifestations include tremor, agitation, coma, ataxia, hypertension, slurred speech, confusion, dizziness, nausea, vomiting, and hallucinations.\"\n }\n ]\n },\n {\n \"Term\": \"Clonus\",\n \"MEDDRACode\": \"10009346\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"clonus\",\n \"Probability\": \"0.9912756681\",\n \"SemanticContext\": \"Serotonin syndrome symptoms may include mental status changes e.g., confusion, agitation, hallucinations , autonomic instability e.g., diaphoresis, tachycardia, labile blood pressure, hyperthermia , neuromuscular abnormalities e.g., tremor, ataxia, hyperreflexia, clonus, muscle rigidity , and/or gastrointestinal symptoms e.g., nausea, vomiting, diarrhea .\"\n }\n ]\n },\n {\n \"Term\": \"Muscle rigidity\",\n \"MEDDRACode\": \"10028330\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"muscle rigidity\",\n \"Probability\": \"0.9705276489\",\n \"SemanticContext\": \"Serotonin syndrome symptoms may include mental status changes e.g., confusion, agitation, hallucinations , autonomic instability e.g., diaphoresis, tachycardia, labile blood pressure, hyperthermia , neuromuscular abnormalities e.g., tremor, ataxia, hyperreflexia, clonus, muscle rigidity , and/or gastrointestinal symptoms e.g., nausea, vomiting, diarrhea .\"\n }\n ]\n },\n {\n \"Term\": \"Symptomatic treatment\",\n \"MEDDRACode\": \"10083815\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"symptomatic treatment\",\n \"Probability\": \"7.5827E-06\",\n \"SemanticContext\": \"Treatment with cyclobenzaprine hydrochloride and any concomitant serotonergic agents should be discontinued immediately if the above reactions occur and supportive symptomatic treatment should be initiated.\"\n }\n ]\n },\n {\n \"Term\": \"Blood lead\",\n \"MEDDRACode\": \"10005639\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"lead\",\n \"Probability\": \"2.20805E-05\",\n \"SemanticContext\": \"\\n \\n Cardiovascular\\n A maximal limb-lead QRS duration of =0.10 seconds may be the best indication of the severity of the overdose.\"\n },\n {\n \"VerbatimTerm\": \"leading\",\n \"Probability\": \"0.1286013126\",\n \"SemanticContext\": \"Tricyclic antidepressants have been reported to produce arrhythmias, sinus tachycardia, prolongation of the conduction time leading to myocardial infarction and stroke.\"\n }\n ]\n },\n {\n \"Term\": \"Cardiac monitoring\",\n \"MEDDRACode\": \"10053438\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"cardiac monitoring\",\n \"Probability\": \"0.0001361072\",\n \"SemanticContext\": \"In order to protect against the rare but potentially critical manifestations described above, obtain an ECG and immediately initiate cardiac monitoring.\"\n },\n {\n \"VerbatimTerm\": \"cardiac monitoring\",\n \"Probability\": \"0.0001541674\",\n \"SemanticContext\": \"Observation with cardiac monitoring and observation for signs of CNS or respiratory depression, hypotension, cardiac dysrhythmias and/or conduction blocks, and seizures is necessary.\"\n }\n ]\n },\n {\n \"Term\": \"Dialysis\",\n \"MEDDRACode\": \"10061105\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Dialysis\",\n \"Probability\": \"0.0016621053\",\n \"SemanticContext\": \"Dialysis is probably of no value because of low plasma concentrations of the drug.\"\n }\n ]\n },\n {\n \"Term\": \"Electrocardiogram\",\n \"MEDDRACode\": \"10014362\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"electrocardiogram\",\n \"Probability\": \"0.0001300275\",\n \"SemanticContext\": \"Changes in the electrocardiogram, particularly in QRS axis or width, are clinically significant indicators of cyclobenzaprine toxicity.\"\n },\n {\n \"VerbatimTerm\": \"ECG\",\n \"Probability\": \"0.001970768\",\n \"SemanticContext\": \"In order to protect against the rare but potentially critical manifestations described above, obtain an ECG and immediately initiate cardiac monitoring.\"\n }\n ]\n },\n {\n \"Term\": \"Endotracheal intubation\",\n \"MEDDRACode\": \"10067450\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"intubation\",\n \"Probability\": \"0.0002887547\",\n \"SemanticContext\": \"\\n \\n CNS\\n In patients with CNS depression, early intubation is advised because of the potential for abrupt deterioration.\"\n }\n ]\n },\n {\n \"Term\": \"Suicide attempt\",\n \"MEDDRACode\": \"10042464\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"attempt suicide\",\n \"Probability\": \"0.2459854484\",\n \"SemanticContext\": \"\\n \\n Psychiatric Follow-Up\\n Since overdosage is often deliberate, patients may attempt suicide by other means during the recovery phase.\"\n }\n ]\n },\n {\n \"Term\": \"Psychotic disorder\",\n \"MEDDRACode\": \"10061920\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"psychosis\",\n \"Probability\": \"0.9932460785\",\n \"SemanticContext\": \"Nervous System and Psychiatric: Seizures, ataxia; vertigo; dysarthria; tremors; hypertonia; convulsions; muscle twitching; disorientation; insomnia; depressed mood; abnormal sensations; anxiety; agitation; psychosis, abnormal thinking and dreaming; hallucinations; excitement; paresthesia; diplopia, serotonin syndrome.\"\n }\n ]\n },\n {\n \"Term\": \"Stomatitis\",\n \"MEDDRACode\": \"10042128\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"stomatitis\",\n \"Probability\": \"0.9944093227\",\n \"SemanticContext\": \"Digestive: Paralytic ileus, tongue discoloration; stomatitis; parotid swelling.\"\n }\n ]\n },\n {\n \"Term\": \"Physiotherapy\",\n \"MEDDRACode\": \"10034998\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"physical therapy\",\n \"Probability\": \"0.000164479\",\n \"SemanticContext\": \"INDICATIONS AND USAGE Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions.\"\n }\n ]\n },\n {\n \"Term\": \"Pregnancy\",\n \"MEDDRACode\": \"10036556\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"pregnant\",\n \"Probability\": \"0.0003085732\",\n \"SemanticContext\": \"There are, however, no adequate and well-controlled studies in pregnant women.\"\n },\n {\n \"VerbatimTerm\": \"pregnant\",\n \"Probability\": \"0.0003175139\",\n \"SemanticContext\": \"There are, however, no adequate and well-controlled studies in pregnant women.\"\n }\n ]\n },\n {\n \"Term\": \"Flatulence\",\n \"MEDDRACode\": \"10016766\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"flatulence\",\n \"Probability\": \"0.7032960653\",\n \"SemanticContext\": \"Digestive: Vomiting; anorexia; diarrhea; gastrointestinal pain; gastritis; thirst; flatulence; edema of the tongue; abnormal liver function and rare reports of hepatitis, jaundice and cholestasis.\"\n }\n ]\n },\n {\n \"Term\": \"Weight increased\",\n \"MEDDRACode\": \"10047899\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"weight gain\",\n \"Probability\": \"0.9244043231\",\n \"SemanticContext\": \"Metabolic, Nutritional and Immune: Elevation and lowering of blood sugar levels; weight gain or loss.\"\n }\n ]\n },\n {\n \"Term\": \"Myelosuppression\",\n \"MEDDRACode\": \"10028584\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"bone marrow depression\",\n \"Probability\": \"0.9889153838\",\n \"SemanticContext\": \"Hematic and Lymphatic: Purpura; bone marrow depression; leukopenia; eosinophilia; thrombocytopenia.\"\n }\n ]\n },\n {\n \"Term\": \"Muscle spasticity\",\n \"MEDDRACode\": \"10028335\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"spasticity\",\n \"Probability\": \"0.0025488138\",\n \"SemanticContext\": \"Cyclobenzaprine hydrochloride tablets, USP have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.\"\n }\n ]\n },\n {\n \"Term\": \"Blindness\",\n \"MEDDRACode\": \"10005169\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"blind\",\n \"Probability\": \"0.0092766285\",\n \"SemanticContext\": \"ADVERSE REACTIONS Incidence of most common adverse reactions in the 2 double-blind 3 , placebo-controlled 5 mg studies incidence of > 3% on cyclobenzaprine hydrochloride 5 mg : Cyclobenzaprine Hydrochloride 5 mg Cyclobenzaprine Hydrochloride 10 mg Placebo N=464 N=249 N=469 Drowsiness 29% 38% 10% Dry Mouth 21% 32% 7% Fatigue 6% 6% 3% Headache 5% 5% 8% .\"\n },\n {\n \"VerbatimTerm\": \"blind\",\n \"Probability\": \"0.0011662543\",\n \"SemanticContext\": \"Clinical Studies Eight double-blind controlled clinical studies were performed in 642 patients comparing cyclobenzaprine hydrochloride 10 mg, diazepam 1 , and placebo.\"\n },\n {\n \"VerbatimTerm\": \"blind\",\n \"Probability\": \"0.006503433\",\n \"SemanticContext\": \"The efficacy of cyclobenzaprine hydrochloride 5 mg was demonstrated in two seven-day, double-blind, controlled clinical trials enrolling 1405 patients.\"\n },\n {\n \"VerbatimTerm\": \"blind\",\n \"Probability\": \"0.0233566463\",\n \"SemanticContext\": \"The overall effectiveness of cyclobenzaprine hydrochloride was similar to that observed in the double-blind controlled studies; the overall incidence of adverse effects was less see ADVERSE REACTIONS .\"\n },\n {\n \"VerbatimTerm\": \"blind\",\n \"Probability\": \"0.0011662543\",\n \"SemanticContext\": \"Clinical Studies Eight double-blind controlled clinical studies were performed in 642 patients comparing cyclobenzaprine hydrochloride 10 mg, diazepam 1 , and placebo.\"\n },\n {\n \"VerbatimTerm\": \"blind\",\n \"Probability\": \"0.006503433\",\n \"SemanticContext\": \"The efficacy of cyclobenzaprine hydrochloride 5 mg was demonstrated in two seven-day, double-blind, controlled clinical trials enrolling 1405 patients.\"\n },\n {\n \"VerbatimTerm\": \"blind\",\n \"Probability\": \"0.0233566463\",\n \"SemanticContext\": \"The overall effectiveness of cyclobenzaprine hydrochloride was similar to that observed in the double-blind controlled studies; the overall incidence of adverse effects was less see ADVERSE REACTIONS .\"\n }\n ]\n },\n {\n \"Term\": \"Nausea\",\n \"MEDDRACode\": \"10028813\",\n \"Overdose\": true,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"nausea\",\n \"Probability\": \"0.0367343426\",\n \"SemanticContext\": \"Abrupt cessation of treatment after prolonged administration rarely may produce nausea, headache, and malaise.\"\n },\n {\n \"VerbatimTerm\": \"nausea\",\n \"Probability\": \"0.9999088049\",\n \"SemanticContext\": \"Adverse reactions which were reported in 1% to 3% of the patients were: abdominal pain, acid regurgitation, constipation, diarrhea, dizziness, nausea, irritability, mental acuity decreased, nervousness, upper respiratory infection, and pharyngitis.\"\n },\n {\n \"VerbatimTerm\": \"nausea\",\n \"Probability\": \"0.9994387031\",\n \"SemanticContext\": \"Adverse reactions which were reported in 1% to 3% of the patients were: fatigue/tiredness, asthenia, nausea, constipation, dyspepsia, unpleasant taste, blurred vision, headache, nervousness, and confusion.\"\n },\n {\n \"VerbatimTerm\": \"nausea\",\n \"Probability\": \"0.998493135\",\n \"SemanticContext\": \"Less frequent manifestations include tremor, agitation, coma, ataxia, hypertension, slurred speech, confusion, dizziness, nausea, vomiting, and hallucinations.\"\n },\n {\n \"VerbatimTerm\": \"nausea\",\n \"Probability\": \"0.9775562286\",\n \"SemanticContext\": \"Serotonin syndrome symptoms may include mental status changes e.g., confusion, agitation, hallucinations , autonomic instability e.g., diaphoresis, tachycardia, labile blood pressure, hyperthermia , neuromuscular abnormalities e.g., tremor, ataxia, hyperreflexia, clonus, muscle rigidity , and/or gastrointestinal symptoms e.g., nausea, vomiting, diarrhea .\"\n }\n ]\n },\n {\n \"Term\": \"Dizziness\",\n \"MEDDRACode\": \"10013573\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"dizziness\",\n \"Probability\": \"0.9998468161\",\n \"SemanticContext\": \"Adverse reactions which were reported in 1% to 3% of the patients were: abdominal pain, acid regurgitation, constipation, diarrhea, dizziness, nausea, irritability, mental acuity decreased, nervousness, upper respiratory infection, and pharyngitis.\"\n },\n {\n \"VerbatimTerm\": \"dizziness\",\n \"Probability\": \"0.9939413071\",\n \"SemanticContext\": \"The adverse reactions reported most frequently with cyclobenzaprine hydrochloride were drowsiness, dry mouth and dizziness.\"\n },\n {\n \"VerbatimTerm\": \"dizziness\",\n \"Probability\": \"0.9265520573\",\n \"SemanticContext\": \"Although the frequency and severity of adverse reactions observed in patients treated with cyclobenzaprine hydrochloride were comparable to those observed in patients treated with diazepam, dry mouth was observed more frequently in patients treated with cyclobenzaprine hydrochloride and dizziness more frequently in those treated with diazepam.\"\n },\n {\n \"VerbatimTerm\": \"dizziness\",\n \"Probability\": \"0.9265520573\",\n \"SemanticContext\": \"Although the frequency and severity of adverse reactions observed in patients treated with cyclobenzaprine hydrochloride were comparable to those observed in patients treated with diazepam, dry mouth was observed more frequently in patients treated with cyclobenzaprine hydrochloride and dizziness more frequently in those treated with diazepam.\"\n },\n {\n \"VerbatimTerm\": \"dizziness\",\n \"Probability\": \"0.9992244244\",\n \"SemanticContext\": \"Less frequent manifestations include tremor, agitation, coma, ataxia, hypertension, slurred speech, confusion, dizziness, nausea, vomiting, and hallucinations.\"\n },\n {\n \"VerbatimTerm\": \"Dizziness\",\n \"Probability\": \"0.9983415008\",\n \"SemanticContext\": \"Clinical Studies With Cyclobenzaprine Hydrochloride 10 mg Surveillance Program With Cyclobenzaprine Hydrochloride 10 mg Drowsiness 39% 16% Dry Mouth 27% 7% Dizziness 11% 3% .\"\n }\n ]\n },\n {\n \"Term\": \"Confusional state\",\n \"MEDDRACode\": \"10010305\",\n \"Overdose\": true,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": true\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"confusion\",\n \"Probability\": \"0.8914651871\",\n \"SemanticContext\": \"Adverse reactions which were reported in 1% to 3% of the patients were: fatigue/tiredness, asthenia, nausea, constipation, dyspepsia, unpleasant taste, blurred vision, headache, nervousness, and confusion.\"\n },\n {\n \"VerbatimTerm\": \"confusion\",\n \"Probability\": \"0.9830533266\",\n \"SemanticContext\": \"Less frequent manifestations include tremor, agitation, coma, ataxia, hypertension, slurred speech, confusion, dizziness, nausea, vomiting, and hallucinations.\"\n },\n {\n \"VerbatimTerm\": \"confusion\",\n \"Probability\": \"0.7794851065\",\n \"SemanticContext\": \"Serotonin syndrome symptoms may include mental status changes e.g., confusion, agitation, hallucinations , autonomic instability e.g., diaphoresis, tachycardia, labile blood pressure, hyperthermia , neuromuscular abnormalities e.g., tremor, ataxia, hyperreflexia, clonus, muscle rigidity , and/or gastrointestinal symptoms e.g., nausea, vomiting, diarrhea .\"\n },\n {\n \"VerbatimTerm\": \"confusion\",\n \"Probability\": \"0.2658261657\",\n \"SemanticContext\": \"The elderly may also be more at risk for CNS adverse events such as hallucinations and confusion, cardiac events resulting in falls or other sequelae, drug-drug and drug-disease interactions.\"\n },\n {\n \"VerbatimTerm\": \"confusion\",\n \"Probability\": \"0.2658261657\",\n \"SemanticContext\": \"The elderly may also be more at risk for CNS adverse events such as hallucinations and confusion, cardiac events resulting in falls or other sequelae, drug-drug and drug-disease interactions.\"\n }\n ]\n },\n {\n \"Term\": \"QRS axis\",\n \"MEDDRACode\": \"10057622\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"QRS axis\",\n \"Probability\": \"0.0005396307\",\n \"SemanticContext\": \"Changes in the electrocardiogram, particularly in QRS axis or width, are clinically significant indicators of cyclobenzaprine toxicity.\"\n }\n ]\n },\n {\n \"Term\": \"Mental status changes\",\n \"MEDDRACode\": \"10048294\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"mental status changes\",\n \"Probability\": \"0.3546604812\",\n \"SemanticContext\": \"Serotonin syndrome symptoms may include mental status changes e.g., confusion, agitation, hallucinations , autonomic instability e.g., diaphoresis, tachycardia, labile blood pressure, hyperthermia , neuromuscular abnormalities e.g., tremor, ataxia, hyperreflexia, clonus, muscle rigidity , and/or gastrointestinal symptoms e.g., nausea, vomiting, diarrhea .\"\n }\n ]\n },\n {\n \"Term\": \"Hypotension\",\n \"MEDDRACode\": \"10021097\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hypotension\",\n \"Probability\": \"0.9968621731\",\n \"SemanticContext\": \"Cardiovascular: Tachycardia; arrhythmia; vasodilatation; palpitation; hypotension.\"\n },\n {\n \"VerbatimTerm\": \"hypotension\",\n \"Probability\": \"0.9647689462\",\n \"SemanticContext\": \"Rare but potentially critical manifestations of overdose are cardiac arrest, chest pain, cardiac dysrhythmias, severe hypotension, seizures, and neuroleptic malignant syndrome.\"\n },\n {\n \"VerbatimTerm\": \"hypotension\",\n \"Probability\": \"0.0784017444\",\n \"SemanticContext\": \"Observation with cardiac monitoring and observation for signs of CNS or respiratory depression, hypotension, cardiac dysrhythmias and/or conduction blocks, and seizures is necessary.\"\n }\n ]\n },\n {\n \"Term\": \"Tachycardia\",\n \"MEDDRACode\": \"10043071\",\n \"Overdose\": true,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Tachycardia\",\n \"Probability\": \"0.9995301962\",\n \"SemanticContext\": \"Cardiovascular: Tachycardia; arrhythmia; vasodilatation; palpitation; hypotension.\"\n },\n {\n \"VerbatimTerm\": \"tachycardia\",\n \"Probability\": \"0.9958404303\",\n \"SemanticContext\": \"Manifestations The most common effects associated with cyclobenzaprine overdose are drowsiness and tachycardia.\"\n },\n {\n \"VerbatimTerm\": \"tachycardia\",\n \"Probability\": \"0.9872706532\",\n \"SemanticContext\": \"Serotonin syndrome symptoms may include mental status changes e.g., confusion, agitation, hallucinations , autonomic instability e.g., diaphoresis, tachycardia, labile blood pressure, hyperthermia , neuromuscular abnormalities e.g., tremor, ataxia, hyperreflexia, clonus, muscle rigidity , and/or gastrointestinal symptoms e.g., nausea, vomiting, diarrhea .\"\n }\n ]\n },\n {\n \"Term\": \"Vomiting\",\n \"MEDDRACode\": \"10047700\",\n \"Overdose\": true,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Vomiting\",\n \"Probability\": \"0.9980262518\",\n \"SemanticContext\": \"Digestive: Vomiting; anorexia; diarrhea; gastrointestinal pain; gastritis; thirst; flatulence; edema of the tongue; abnormal liver function and rare reports of hepatitis, jaundice and cholestasis.\"\n },\n {\n \"VerbatimTerm\": \"vomiting\",\n \"Probability\": \"0.9983869195\",\n \"SemanticContext\": \"Less frequent manifestations include tremor, agitation, coma, ataxia, hypertension, slurred speech, confusion, dizziness, nausea, vomiting, and hallucinations.\"\n },\n {\n \"VerbatimTerm\": \"vomiting\",\n \"Probability\": \"0.9505976439\",\n \"SemanticContext\": \"Serotonin syndrome symptoms may include mental status changes e.g., confusion, agitation, hallucinations , autonomic instability e.g., diaphoresis, tachycardia, labile blood pressure, hyperthermia , neuromuscular abnormalities e.g., tremor, ataxia, hyperreflexia, clonus, muscle rigidity , and/or gastrointestinal symptoms e.g., nausea, vomiting, diarrhea .\"\n }\n ]\n },\n {\n \"Term\": \"Hepatitis\",\n \"MEDDRACode\": \"10019717\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hepatitis\",\n \"Probability\": \"0.9717646241\",\n \"SemanticContext\": \"Digestive: Vomiting; anorexia; diarrhea; gastrointestinal pain; gastritis; thirst; flatulence; edema of the tongue; abnormal liver function and rare reports of hepatitis, jaundice and cholestasis.\"\n }\n ]\n },\n {\n \"Term\": \"Gastric lavage\",\n \"MEDDRACode\": \"10017792\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"gastric lavage\",\n \"Probability\": \"6.9836E-06\",\n \"SemanticContext\": \"This should include large volume gastric lavage followed by activated charcoal.\"\n }\n ]\n },\n {\n \"Term\": \"Hyperreflexia\",\n \"MEDDRACode\": \"10020745\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hyperreflexia\",\n \"Probability\": \"0.987578392\",\n \"SemanticContext\": \"Serotonin syndrome symptoms may include mental status changes e.g., confusion, agitation, hallucinations , autonomic instability e.g., diaphoresis, tachycardia, labile blood pressure, hyperthermia , neuromuscular abnormalities e.g., tremor, ataxia, hyperreflexia, clonus, muscle rigidity , and/or gastrointestinal symptoms e.g., nausea, vomiting, diarrhea .\"\n }\n ]\n },\n {\n \"Term\": \"Analgesic drug level\",\n \"MEDDRACode\": \"10060090\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"acetaminophen\",\n \"Probability\": \"0.0030997992\",\n \"SemanticContext\": \"ULTRACET ® tramadol HCl and acetaminophen tablets, PriCara, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc..\"\n },\n {\n \"VerbatimTerm\": \"acetaminophen\",\n \"Probability\": \"0.0030997992\",\n \"SemanticContext\": \"ULTRACET ® tramadol HCl and acetaminophen tablets, PriCara, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc..\"\n }\n ]\n },\n {\n \"Term\": \"Hyperthermia\",\n \"MEDDRACode\": \"10020843\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hyperthermia\",\n \"Probability\": \"0.8502167463\",\n \"SemanticContext\": \"Serotonin syndrome symptoms may include mental status changes e.g., confusion, agitation, hallucinations , autonomic instability e.g., diaphoresis, tachycardia, labile blood pressure, hyperthermia , neuromuscular abnormalities e.g., tremor, ataxia, hyperreflexia, clonus, muscle rigidity , and/or gastrointestinal symptoms e.g., nausea, vomiting, diarrhea .\"\n }\n ]\n },\n {\n \"Term\": \"Serotonin syndrome\",\n \"MEDDRACode\": \"10040108\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"serotonin syndrome\",\n \"Probability\": \"0.9370566607\",\n \"SemanticContext\": \"Nervous System and Psychiatric: Seizures, ataxia; vertigo; dysarthria; tremors; hypertonia; convulsions; muscle twitching; disorientation; insomnia; depressed mood; abnormal sensations; anxiety; agitation; psychosis, abnormal thinking and dreaming; hallucinations; excitement; paresthesia; diplopia, serotonin syndrome.\"\n },\n {\n \"VerbatimTerm\": \"serotonin syndrome\",\n \"Probability\": \"0.6422703862\",\n \"SemanticContext\": \"Postmarketing cases of serotonin syndrome have been reported during combined use of cyclobenzaprine hydrochloride and other drugs, such as SSRIs, SNRIs, TCAs, tramadol, bupropion, meperidine, verapamil, or MAO inhibitors.\"\n },\n {\n \"VerbatimTerm\": \"serotonin syndrome\",\n \"Probability\": \"0.0003307164\",\n \"SemanticContext\": \"Patients should be cautioned about the risk of serotonin syndrome with the concomitant use of cyclobenzaprine hydrochloride and other drugs, such as SSRIs, SNRIs, TCAs, tramadol, bupropion, meperidine, verapamil, or MAO inhibitors.\"\n },\n {\n \"VerbatimTerm\": \"serotonin syndrome\",\n \"Probability\": \"0.0003775954\",\n \"SemanticContext\": \"Patients should be advised of the signs and symptoms of serotonin syndrome, and be instructed to seek medical care immediately if they experience these symptoms see WARNINGS , and see PRECAUTIONS , Drug Interactions .\"\n },\n {\n \"VerbatimTerm\": \"serotonin syndrome\",\n \"Probability\": \"0.4780703485\",\n \"SemanticContext\": \"WARNINGS Serotonin Syndrome The development of a potentially life-threatening serotonin syndrome has been reported with cyclobenzaprine hydrochloride when used in combination with other drugs, such as selective serotonin reuptake inhibitors SSRIs , serotonin norepinephrine reuptake inhibitors SNRIs , tricyclic antidepressants TCAs , tramadol, bupropion, meperidine, verapamil, or MAO inhibitors.\"\n },\n {\n \"VerbatimTerm\": \"serotonin syndrome\",\n \"Probability\": \"0.0003307164\",\n \"SemanticContext\": \"Patients should be cautioned about the risk of serotonin syndrome with the concomitant use of cyclobenzaprine hydrochloride and other drugs, such as SSRIs, SNRIs, TCAs, tramadol, bupropion, meperidine, verapamil, or MAO inhibitors.\"\n },\n {\n \"VerbatimTerm\": \"serotonin syndrome\",\n \"Probability\": \"0.0003775954\",\n \"SemanticContext\": \"Patients should be advised of the signs and symptoms of serotonin syndrome, and be instructed to seek medical care immediately if they experience these symptoms see WARNINGS , and see PRECAUTIONS , Drug Interactions .\"\n },\n {\n \"VerbatimTerm\": \"serotonin syndrome\",\n \"Probability\": \"0.6422703862\",\n \"SemanticContext\": \"Postmarketing cases of serotonin syndrome have been reported during combined use of cyclobenzaprine hydrochloride and other drugs, such as SSRIs, SNRIs, TCAs, tramadol, bupropion, meperidine, verapamil, or MAO inhibitors.\"\n },\n {\n \"VerbatimTerm\": \"Serotonin Syndrome\",\n \"Probability\": \"0.541564405\",\n \"SemanticContext\": \"WARNINGS Serotonin Syndrome The development of a potentially life-threatening serotonin syndrome has been reported with cyclobenzaprine hydrochloride when used in combination with other drugs, such as selective serotonin reuptake inhibitors SSRIs , serotonin norepinephrine reuptake inhibitors SNRIs , tricyclic antidepressants TCAs , tramadol, bupropion, meperidine, verapamil, or MAO inhibitors.\"\n },\n {\n \"VerbatimTerm\": \"Serotonin syndrome\",\n \"Probability\": \"0.9442594051\",\n \"SemanticContext\": \"Serotonin syndrome symptoms may include mental status changes e.g., confusion, agitation, hallucinations , autonomic instability e.g., diaphoresis, tachycardia, labile blood pressure, hyperthermia , neuromuscular abnormalities e.g., tremor, ataxia, hyperreflexia, clonus, muscle rigidity , and/or gastrointestinal symptoms e.g., nausea, vomiting, diarrhea .\"\n }\n ]\n },\n {\n \"Term\": \"Cardiac arrest\",\n \"MEDDRACode\": \"10007515\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"cardiac arrest\",\n \"Probability\": \"0.963525176\",\n \"SemanticContext\": \"Rare but potentially critical manifestations of overdose are cardiac arrest, chest pain, cardiac dysrhythmias, severe hypotension, seizures, and neuroleptic malignant syndrome.\"\n }\n ]\n },\n {\n \"Term\": \"Hyperventilation\",\n \"MEDDRACode\": \"10020910\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hyperventilation\",\n \"Probability\": \"0.1651994288\",\n \"SemanticContext\": \"Serum alkalinization, to a pH of 7.45 to 7.55, using intravenous sodium bicarbonate and hyperventilation as needed , should be instituted for patients with dysrhythmias and/or QRS widening.\"\n },\n {\n \"VerbatimTerm\": \"hyperventilation\",\n \"Probability\": \"0.0426529944\",\n \"SemanticContext\": \"Dysrhythmias unresponsive to sodium bicarbonate therapy/hyperventilation may respond to lidocaine, bretylium or phenytoin.\"\n }\n ]\n },\n {\n \"Term\": \"Paranoia\",\n \"MEDDRACode\": \"10033864\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"paranoia\",\n \"Probability\": \"0.9877178669\",\n \"SemanticContext\": \"Nervous System and Psychiatric: Decreased or increased libido; abnormal gait; delusions; aggressive behavior; paranoia; peripheral neuropathy; Bell’s palsy; alteration in EEG patterns; extrapyramidal symptoms.\"\n }\n ]\n },\n {\n \"Term\": \"Blood isopropanol\",\n \"MEDDRACode\": \"10005622\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"isopropanol\",\n \"Probability\": \"0.0004113019\",\n \"SemanticContext\": \"It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents.\"\n }\n ]\n },\n {\n \"Term\": \"Musculoskeletal disorder\",\n \"MEDDRACode\": \"10048592\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"musculoskeletal disorders\",\n \"Probability\": \"0.0149629116\",\n \"SemanticContext\": \"1 VALIUM ® diazepam, Roche\\n \\n Surveillance Program\\n A post-marketing surveillance program was carried out in 7607 patients with acute musculoskeletal disorders, and included 297 patients treated with cyclobenzaprine hydrochloride 10 mg for 30 days or longer.\"\n },\n {\n \"VerbatimTerm\": \"musculoskeletal disorders\",\n \"Probability\": \"0.0149629116\",\n \"SemanticContext\": \"1 VALIUM ® diazepam, Roche\\n \\n Surveillance Program\\n A post-marketing surveillance program was carried out in 7607 patients with acute musculoskeletal disorders, and included 297 patients treated with cyclobenzaprine hydrochloride 10 mg for 30 days or longer.\"\n }\n ]\n },\n {\n \"Term\": \"Vertigo\",\n \"MEDDRACode\": \"10047340\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"vertigo\",\n \"Probability\": \"0.9984399676\",\n \"SemanticContext\": \"Nervous System and Psychiatric: Seizures, ataxia; vertigo; dysarthria; tremors; hypertonia; convulsions; muscle twitching; disorientation; insomnia; depressed mood; abnormal sensations; anxiety; agitation; psychosis, abnormal thinking and dreaming; hallucinations; excitement; paresthesia; diplopia, serotonin syndrome.\"\n }\n ]\n },\n {\n \"Term\": \"Unresponsive to stimuli\",\n \"MEDDRACode\": \"10045555\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"unresponsive\",\n \"Probability\": \"0.0012461841\",\n \"SemanticContext\": \"Dysrhythmias unresponsive to sodium bicarbonate therapy/hyperventilation may respond to lidocaine, bretylium or phenytoin.\"\n },\n {\n \"VerbatimTerm\": \"unresponsive\",\n \"Probability\": \"0.000128895\",\n \"SemanticContext\": \"Physostigmine is not recommended except to treat life-threatening symptoms that have been unresponsive to other therapies, and then only in close consultation with a poison control center.\"\n }\n ]\n },\n {\n \"Term\": \"Syncope\",\n \"MEDDRACode\": \"10042772\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Syncope\",\n \"Probability\": \"0.9259492159\",\n \"SemanticContext\": \"The following adverse reactions have been reported in post-marketing experience or with an incidence of less than 1% of patients in clinical trials with the 10 mg tablet: Body as a Whole: Syncope; malaise.\"\n }\n ]\n },\n {\n \"Term\": \"Thirst\",\n \"MEDDRACode\": \"10043458\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"thirst\",\n \"Probability\": \"0.6004287004\",\n \"SemanticContext\": \"Digestive: Vomiting; anorexia; diarrhea; gastrointestinal pain; gastritis; thirst; flatulence; edema of the tongue; abnormal liver function and rare reports of hepatitis, jaundice and cholestasis.\"\n }\n ]\n },\n {\n \"Term\": \"Vasodilatation\",\n \"MEDDRACode\": \"10047141\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"vasodilatation\",\n \"Probability\": \"0.9974578619\",\n \"SemanticContext\": \"Cardiovascular: Tachycardia; arrhythmia; vasodilatation; palpitation; hypotension.\"\n }\n ]\n },\n {\n \"Term\": \"Myocardial infarction\",\n \"MEDDRACode\": \"10028596\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": true,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"myocardial infarction\",\n \"Probability\": \"0.7511422634\",\n \"SemanticContext\": \"Cardiovascular: Hypertension; myocardial infarction; heart block; stroke.\"\n },\n {\n \"VerbatimTerm\": \"myocardial infarction\",\n \"Probability\": \"0.2144370675\",\n \"SemanticContext\": \"Acute recovery phase of myocardial infarction, and patients with arrhythmias, heart block or conduction disturbances, or congestive heart failure.\"\n },\n {\n \"VerbatimTerm\": \"myocardial infarction\",\n \"Probability\": \"0.9102101326\",\n \"SemanticContext\": \"Tricyclic antidepressants have been reported to produce arrhythmias, sinus tachycardia, prolongation of the conduction time leading to myocardial infarction and stroke.\"\n }\n ]\n },\n {\n \"Term\": \"Fall\",\n \"MEDDRACode\": \"10016173\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": true\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"falls\",\n \"Probability\": \"0.0497906804\",\n \"SemanticContext\": \"The elderly may also be more at risk for CNS adverse events such as hallucinations and confusion, cardiac events resulting in falls or other sequelae, drug-drug and drug-disease interactions.\"\n },\n {\n \"VerbatimTerm\": \"falls\",\n \"Probability\": \"0.0497906804\",\n \"SemanticContext\": \"The elderly may also be more at risk for CNS adverse events such as hallucinations and confusion, cardiac events resulting in falls or other sequelae, drug-drug and drug-disease interactions.\"\n }\n ]\n },\n {\n \"Term\": \"Cardiac failure congestive\",\n \"MEDDRACode\": \"10007559\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": true,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"congestive heart failure\",\n \"Probability\": \"0.4727336466\",\n \"SemanticContext\": \"Acute recovery phase of myocardial infarction, and patients with arrhythmias, heart block or conduction disturbances, or congestive heart failure.\"\n }\n ]\n },\n {\n \"Term\": \"Psychomotor hyperactivity\",\n \"MEDDRACode\": \"10037211\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hyperactivity\",\n \"Probability\": \"0.0035328567\",\n \"SemanticContext\": \"Cyclobenzaprine reduced or abolished skeletal muscle hyperactivity in several animal models.\"\n }\n ]\n },\n {\n \"Term\": \"Norepinephrine\",\n \"MEDDRACode\": \"10050925\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"norepinephrine\",\n \"Probability\": \"0.0160111785\",\n \"SemanticContext\": \"Pharmacological studies in animals showed a similarity between the effects of cyclobenzaprine and the structurally related tricyclic antidepressants, including reserpine antagonism, norepinephrine potentiation, potent peripheral and central anticholinergic effects, and sedation.\"\n },\n {\n \"VerbatimTerm\": \"norepinephrine\",\n \"Probability\": \"0.0247528553\",\n \"SemanticContext\": \"WARNINGS Serotonin Syndrome The development of a potentially life-threatening serotonin syndrome has been reported with cyclobenzaprine hydrochloride when used in combination with other drugs, such as selective serotonin reuptake inhibitors SSRIs , serotonin norepinephrine reuptake inhibitors SNRIs , tricyclic antidepressants TCAs , tramadol, bupropion, meperidine, verapamil, or MAO inhibitors.\"\n }\n ]\n },\n {\n \"Term\": \"Hypertension\",\n \"MEDDRACode\": \"10020772\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Hypertension\",\n \"Probability\": \"0.7813887\",\n \"SemanticContext\": \"Cardiovascular: Hypertension; myocardial infarction; heart block; stroke.\"\n },\n {\n \"VerbatimTerm\": \"hypertension\",\n \"Probability\": \"0.9994199872\",\n \"SemanticContext\": \"Less frequent manifestations include tremor, agitation, coma, ataxia, hypertension, slurred speech, confusion, dizziness, nausea, vomiting, and hallucinations.\"\n }\n ]\n },\n {\n \"Term\": \"Congenital nephrotic syndrome\",\n \"MEDDRACode\": \"10060737\",\n \"Overdose\": true,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": true\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"CNS\",\n \"Probability\": \"0.0081802011\",\n \"SemanticContext\": \"Cyclobenzaprine hydrochloride may enhance the effects of alcohol, barbiturates, and other CNS depressants.\"\n },\n {\n \"VerbatimTerm\": \"CNS\",\n \"Probability\": \"0.0002165735\",\n \"SemanticContext\": \"Information for Patients Cyclobenzaprine hydrochloride, especially when used with alcohol or other CNS depressants, may impair mental and/or physical abilities required for performance of hazardous tasks, such as operating machinery or driving a motor vehicle.\"\n },\n {\n \"VerbatimTerm\": \"CNS\",\n \"Probability\": \"0.0160163641\",\n \"SemanticContext\": \"Observation with cardiac monitoring and observation for signs of CNS or respiratory depression, hypotension, cardiac dysrhythmias and/or conduction blocks, and seizures is necessary.\"\n },\n {\n \"VerbatimTerm\": \"CNS\",\n \"Probability\": \"0.0547144413\",\n \"SemanticContext\": \"\\n \\n CNS\\n In patients with CNS depression, early intubation is advised because of the potential for abrupt deterioration.\"\n },\n {\n \"VerbatimTerm\": \"CNS\",\n \"Probability\": \"0.0828211606\",\n \"SemanticContext\": \"Cyclobenzaprine hydrochloride may enhance the effects of alcohol, barbiturates, and other CNS depressants.\"\n },\n {\n \"VerbatimTerm\": \"CNS\",\n \"Probability\": \"0.0002165735\",\n \"SemanticContext\": \"Information for Patients Cyclobenzaprine hydrochloride, especially when used with alcohol or other CNS depressants, may impair mental and/or physical abilities required for performance of hazardous tasks, such as operating machinery or driving a motor vehicle.\"\n },\n {\n \"VerbatimTerm\": \"CNS\",\n \"Probability\": \"0.0081802011\",\n \"SemanticContext\": \"Cyclobenzaprine hydrochloride may enhance the effects of alcohol, barbiturates, and other CNS depressants.\"\n },\n {\n \"VerbatimTerm\": \"CNS\",\n \"Probability\": \"0.0128895938\",\n \"SemanticContext\": \"The elderly may also be more at risk for CNS adverse events such as hallucinations and confusion, cardiac events resulting in falls or other sequelae, drug-drug and drug-disease interactions.\"\n },\n {\n \"VerbatimTerm\": \"CNS\",\n \"Probability\": \"0.0128895938\",\n \"SemanticContext\": \"The elderly may also be more at risk for CNS adverse events such as hallucinations and confusion, cardiac events resulting in falls or other sequelae, drug-drug and drug-disease interactions.\"\n }\n ]\n },\n {\n \"Term\": \"Lipidosis\",\n \"MEDDRACode\": \"10024585\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"lipidosis\",\n \"Probability\": \"0.2815196514\",\n \"SemanticContext\": \"Carcinogenesis, Mutagenesis, Impairment of Fertility In rats treated with cyclobenzaprine hydrochloride for up to 67 weeks at doses of approximately 5 to 40 times the maximum recommended human dose, pale, sometimes enlarged, livers were noted and there was a dose-related hepatocyte vacuolation with lipidosis.\"\n }\n ]\n },\n {\n \"Term\": \"Blood sodium\",\n \"MEDDRACode\": \"10005799\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0012529492\",\n \"SemanticContext\": \"Each tablet contains the following inactive ingredients: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, pregelatinized starch maize and titanium dioxide.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0001194584\",\n \"SemanticContext\": \"Serum alkalinization, to a pH of 7.45 to 7.55, using intravenous sodium bicarbonate and hyperventilation as needed , should be instituted for patients with dysrhythmias and/or QRS widening.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"3.90253E-05\",\n \"SemanticContext\": \"Dysrhythmias unresponsive to sodium bicarbonate therapy/hyperventilation may respond to lidocaine, bretylium or phenytoin.\"\n }\n ]\n },\n {\n \"Term\": \"Depressed level of consciousness\",\n \"MEDDRACode\": \"10012373\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"CNS depression\",\n \"Probability\": \"0.0059461892\",\n \"SemanticContext\": \"\\n \\n CNS\\n In patients with CNS depression, early intubation is advised because of the potential for abrupt deterioration.\"\n }\n ]\n },\n {\n \"Term\": \"Neuroleptic malignant syndrome\",\n \"MEDDRACode\": \"10029282\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"neuroleptic malignant syndrome\",\n \"Probability\": \"0.8536249399\",\n \"SemanticContext\": \"Rare but potentially critical manifestations of overdose are cardiac arrest, chest pain, cardiac dysrhythmias, severe hypotension, seizures, and neuroleptic malignant syndrome.\"\n }\n ]\n },\n {\n \"Term\": \"Exercise adequate\",\n \"MEDDRACode\": \"10015636\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": true,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"exercised\",\n \"Probability\": \"4.361E-06\",\n \"SemanticContext\": \"Because cyclobenzaprine is closely related to the tricyclic antidepressants, some of which are known to be excreted in human milk, caution should be exercised when cyclobenzaprine hydrochloride is administered to a nursing woman.\"\n },\n {\n \"VerbatimTerm\": \"exercised\",\n \"Probability\": \"4.361E-06\",\n \"SemanticContext\": \"Because cyclobenzaprine is closely related to the tricyclic antidepressants, some of which are known to be excreted in human milk, caution should be exercised when cyclobenzaprine hydrochloride is administered to a nursing woman.\"\n }\n ]\n },\n {\n \"Term\": \"Angle closure glaucoma\",\n \"MEDDRACode\": \"10002500\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"angle-closure glaucoma\",\n \"Probability\": \"0.0009659231\",\n \"SemanticContext\": \"PRECAUTIONS General Because of its atropine-like action, cyclobenzaprine hydrochloride should be used with caution in patients with a history of urinary retention, angle-closure glaucoma, increased intraocular pressure, and in patients taking anticholinergic medication.\"\n }\n ]\n },\n {\n \"Term\": \"Back pain\",\n \"MEDDRACode\": \"10003988\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"backache\",\n \"Probability\": \"0.8700745106\",\n \"SemanticContext\": \"Primary endpoints for both trials were determined by patient-generated data and included global impression of change, medication helpfulness, and relief from starting backache.\"\n },\n {\n \"VerbatimTerm\": \"backache\",\n \"Probability\": \"0.8700745106\",\n \"SemanticContext\": \"Primary endpoints for both trials were determined by patient-generated data and included global impression of change, medication helpfulness, and relief from starting backache.\"\n }\n ]\n },\n {\n \"Term\": \"Blood magnesium\",\n \"MEDDRACode\": \"10005651\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"magnesium\",\n \"Probability\": \"0.0008861721\",\n \"SemanticContext\": \"Each tablet contains the following inactive ingredients: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, pregelatinized starch maize and titanium dioxide.\"\n }\n ]\n }\n ],\n \"IndicationTerms\": []\n }\n ]\n },\n {\n \"GenericName\": \"ge recombinant varicella zoster virus (vzv) glycoprotein e\",\n \"MeddraVersion\": \"24.0\",\n \"Labels\": [\n {\n \"Id\": \"US177f1d31-b9d7-4ac1-9e19-45b88bc6ac1e\",\n \"NDCCode\": \"58160-819\",\n \"UpdatedDate\": \"Mar 30, 2021\",\n \"LabelSource\": {\n \"Country\": \"us\",\n \"ProductId\": \"0280849d-5c78-4a9d-8941-4eab429f6bd8\",\n \"FileId\": \"177f1d31-b9d7-4ac1-9e19-45b88bc6ac1e\",\n \"Version\": \"11\"\n },\n \"AdverseEventTerms\": [\n {\n \"Term\": \"Abdominal pain\",\n \"MEDDRACode\": \"10000081\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"abdominal pain\",\n \"Probability\": \"0.9328160286\",\n \"SemanticContext\": \"g GI = Gastrointestinal symptoms including nausea, vomiting, diarrhea, and/or abdominal pain.\"\n }\n ]\n },\n {\n \"Term\": \"Angioedema\",\n \"MEDDRACode\": \"10002424\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"angioedema\",\n \"Probability\": \"0.9994184971\",\n \"SemanticContext\": \"Immune System Disorders Hypersensitivity reactions, including angioedema, rash, and urticaria.\"\n }\n ]\n },\n {\n \"Term\": \"Diarrhoea\",\n \"MEDDRACode\": \"10012735\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"diarrhea\",\n \"Probability\": \"0.998134017\",\n \"SemanticContext\": \"g GI = Gastrointestinal symptoms including nausea, vomiting, diarrhea, and/or abdominal pain.\"\n }\n ]\n },\n {\n \"Term\": \"Elderly\",\n \"MEDDRACode\": \"10014348\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"elderly\",\n \"Probability\": \"0.0008268058\",\n \"SemanticContext\": \"Causes of death among subjects were consistent with those generally reported in adult and elderly populations.\"\n }\n ]\n },\n {\n \"Term\": \"Gouty arthritis\",\n \"MEDDRACode\": \"10018634\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"gouty arthritis\",\n \"Probability\": \"0.7161930799\",\n \"SemanticContext\": \"Gout including gouty arthritis was reported by 0.18% n = 27 versus 0.05% n = 8 of subjects who received SHINGRIX and placebo, respectively, within 30 days of vaccination; available information is insufficient to determine a causal relationship with SHINGRIX.\"\n }\n ]\n },\n {\n \"Term\": \"Gout\",\n \"MEDDRACode\": \"10018627\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Gout\",\n \"Probability\": \"0.9423456788\",\n \"SemanticContext\": \"Gout including gouty arthritis was reported by 0.18% n = 27 versus 0.05% n = 8 of subjects who received SHINGRIX and placebo, respectively, within 30 days of vaccination; available information is insufficient to determine a causal relationship with SHINGRIX.\"\n }\n ]\n },\n {\n \"Term\": \"Hypersensitivity\",\n \"MEDDRACode\": \"10020751\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": true,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"allergic reaction\",\n \"Probability\": \"0.0493834317\",\n \"SemanticContext\": \"CONTRAINDICATIONS History of severe allergic reaction e.g., anaphylaxis to any component of the vaccine or after a previous dose of SHINGRIX.\"\n },\n {\n \"VerbatimTerm\": \"allergic reaction\",\n \"Probability\": \"0.0001494288\",\n \"SemanticContext\": \"4 CONTRAINDICATIONS Do not administer SHINGRIX to anyone with a history of a severe allergic reaction e.g., anaphylaxis to any component of the vaccine or after a previous dose of SHINGRIX [see Description 11 ] .\"\n }\n ]\n },\n {\n \"Term\": \"Optic ischaemic neuropathy\",\n \"MEDDRACode\": \"10030924\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Optic ischemic neuropathy\",\n \"Probability\": \"0.9622062445\",\n \"SemanticContext\": \"Optic ischemic neuropathy was reported in 3 subjects 0.02% who received SHINGRIX all within 50 days after vaccination and 0 subjects who received placebo; available information is insufficient to determine a causal relationship with SHINGRIX.\"\n }\n ]\n },\n {\n \"Term\": \"Nervous system disorder\",\n \"MEDDRACode\": \"10029202\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Nervous System Disorders\",\n \"Probability\": \"0.0197765529\",\n \"SemanticContext\": \"Nervous System Disorders Guillain-Barré syndrome.\"\n }\n ]\n },\n {\n \"Term\": \"Pain\",\n \"MEDDRACode\": \"10033371\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"pain\",\n \"Probability\": \"0.9773798585\",\n \"SemanticContext\": \"5.2, 6.2 ADVERSE REACTIONS • Solicited local adverse reactions in subjects aged 50 years and older were pain 78.0% , redness 38.1% , and swelling 25.9% .\"\n },\n {\n \"VerbatimTerm\": \"pain\",\n \"Probability\": \"0.9989548922\",\n \"SemanticContext\": \"Across both studies, the percentages of subjects aged 50 years and older reporting each solicited local adverse reaction and each solicited general adverse event following administration of SHINGRIX both doses combined were pain 78.0% , redness 38.1% , and swelling 25.9% ; and myalgia 44.7% , fatigue 44.5% , headache 37.7% , shivering 26.8% , fever 20.5% , and gastrointestinal symptoms 17.3% , respectively.\"\n },\n {\n \"VerbatimTerm\": \"pain\",\n \"Probability\": \"0.948466301\",\n \"SemanticContext\": \"d Grade 3 pain: Defined as significant pain at rest; prevents normal everyday activities.\"\n },\n {\n \"VerbatimTerm\": \"pain\",\n \"Probability\": \"0.6786940694\",\n \"SemanticContext\": \"Suspected HZ cases were followed prospectively for the development of PHN, an HZ-related complication defined as HZ-associated pain rated as 3 or greater on a 0- to 10-point scale by the study subject occurring or persisting at least 90 days following the onset of rash in confirmed cases of HZ.\"\n },\n {\n \"VerbatimTerm\": \"pain\",\n \"Probability\": \"0.074332267\",\n \"SemanticContext\": \"Reduction of Use of Pain Medication Among subjects with confirmed HZ, the use of HZ-associated pain medications was reported for 10 of 23 subjects 43.5% who received SHINGRIX and for 160 of 223 subjects 71.7% who received placebo.\"\n },\n {\n \"VerbatimTerm\": \"pain\",\n \"Probability\": \"0.5844970345\",\n \"SemanticContext\": \"c PHN = Postherpetic neuralgia defined as HZ-associated pain rated as 3 or greater on a 0- to 10 point scale occurring or persisting at least 90 days following the onset of rash using Zoster Brief Pain Inventory questionnaire.\"\n },\n {\n \"VerbatimTerm\": \"Pain\",\n \"Probability\": \"0.996376574\",\n \"SemanticContext\": \"Percentage of Subjects with Solicited Local Adverse Reactions and General Adverse Events within 7 Days a of Vaccination in Adults Aged 50 to 59 Years, 60 to 69 Years, and 70 Years and Older b Total Vaccinated Cohort with 7-Day Diary Card Aged 50 - 59 Years Aged 60 - 69 Years Aged =70 Years SHINGRIX % Placebo c % SHINGRIX % Placebo c % SHINGRIX % Placebo c % Local Adverse Reactions n = 1,315 n = 1,312 n = 1,311 n = 1,305 n = 2,258 n = 2,263 Pain 88.4 14.4 82.8 11.1 69.2 8.8 Pain, Grade 3 d 10.3 0.5 6.9 0.5 4.0 0.2 Redness 38.7 1.2 38.4 1.6 37.7 1.2 Redness, >100 mm 2.8 0.0 2.6 0.0 3.1 0.0 Swelling 30.5 0.8 26.5 1.0 23.0 1.1 Swelling, >100 mm 1.1 0.0 0.5 0.0 1.3 0.0 General Adverse Events n = 1,315 n = 1,312 n = 1,309 n = 1,305 n =2,252 n = 2,264 Myalgia 56.9 15.2 49.0 11.2 35.1 9.9 Myalgia, Grade 3 e 8.9 0.9 5.3 0.8 2.8 0.4 Fatigue 57.0 19.8 45.7 16.8 36.6 14.4 Fatigue, Grade 3 e 8.5 1.8 5.0 0.8 3.5 0.8 Headache 50.6 21.6 39.6 15.6 29.0 11.8 Headache, Grade 3 e 6.0 1.7 3.7 0.2 1.5 0.4 Shivering 35.8 7.4 30.3 5.7 19.5 4.9 Shivering, Grade 3 e 6.8 0.2 4.5 0.3 2.2 0.3 Fever 27.8 3.0 23.9 3.4 14.3 2.7 Fever, Grade 3 f 0.4 0.2 0.5 0.2 0.1 0.1 GI g 24.3 10.7 16.7 8.7 13.5 7.6 GI, Grade 3 e 2.1 0.7 0.9 0.6 1.2 0.4 .\"\n },\n {\n \"VerbatimTerm\": \"Pain\",\n \"Probability\": \"0.6169523001\",\n \"SemanticContext\": \"Percentage of Subjects with Solicited Local Adverse Reactions and General Adverse Events within 7 Days a of Vaccination in Adults Aged 50 to 59 Years, 60 to 69 Years, and 70 Years and Older b Total Vaccinated Cohort with 7-Day Diary Card Aged 50 - 59 Years Aged 60 - 69 Years Aged =70 Years SHINGRIX % Placebo c % SHINGRIX % Placebo c % SHINGRIX % Placebo c % Local Adverse Reactions n = 1,315 n = 1,312 n = 1,311 n = 1,305 n = 2,258 n = 2,263 Pain 88.4 14.4 82.8 11.1 69.2 8.8 Pain, Grade 3 d 10.3 0.5 6.9 0.5 4.0 0.2 Redness 38.7 1.2 38.4 1.6 37.7 1.2 Redness, >100 mm 2.8 0.0 2.6 0.0 3.1 0.0 Swelling 30.5 0.8 26.5 1.0 23.0 1.1 Swelling, >100 mm 1.1 0.0 0.5 0.0 1.3 0.0 General Adverse Events n = 1,315 n = 1,312 n = 1,309 n = 1,305 n =2,252 n = 2,264 Myalgia 56.9 15.2 49.0 11.2 35.1 9.9 Myalgia, Grade 3 e 8.9 0.9 5.3 0.8 2.8 0.4 Fatigue 57.0 19.8 45.7 16.8 36.6 14.4 Fatigue, Grade 3 e 8.5 1.8 5.0 0.8 3.5 0.8 Headache 50.6 21.6 39.6 15.6 29.0 11.8 Headache, Grade 3 e 6.0 1.7 3.7 0.2 1.5 0.4 Shivering 35.8 7.4 30.3 5.7 19.5 4.9 Shivering, Grade 3 e 6.8 0.2 4.5 0.3 2.2 0.3 Fever 27.8 3.0 23.9 3.4 14.3 2.7 Fever, Grade 3 f 0.4 0.2 0.5 0.2 0.1 0.1 GI g 24.3 10.7 16.7 8.7 13.5 7.6 GI, Grade 3 e 2.1 0.7 0.9 0.6 1.2 0.4 .\"\n },\n {\n \"VerbatimTerm\": \"Pain\",\n \"Probability\": \"0.0061126053\",\n \"SemanticContext\": \"Reduction of Use of Pain Medication Among subjects with confirmed HZ, the use of HZ-associated pain medications was reported for 10 of 23 subjects 43.5% who received SHINGRIX and for 160 of 223 subjects 71.7% who received placebo.\"\n },\n {\n \"VerbatimTerm\": \"Pain\",\n \"Probability\": \"0.1442117989\",\n \"SemanticContext\": \"c PHN = Postherpetic neuralgia defined as HZ-associated pain rated as 3 or greater on a 0- to 10 point scale occurring or persisting at least 90 days following the onset of rash using Zoster Brief Pain Inventory questionnaire.\"\n }\n ]\n },\n {\n \"Term\": \"Injection site pruritus\",\n \"MEDDRACode\": \"10022093\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"injection site pruritus\",\n \"Probability\": \"0.9997884035\",\n \"SemanticContext\": \"Unsolicited adverse events that occurred in =1% of recipients of SHINGRIX and at a rate at least 1.5-fold higher than placebo included chills 3.5% versus 0.2% , injection site pruritus 2.2% versus 0.2% , malaise 1.7% versus 0.3% , arthralgia 1.7% versus 1.2% , nausea 1.4% versus 0.5% , and dizziness 1.2% versus 0.8% .\"\n }\n ]\n },\n {\n \"Term\": \"Malaise\",\n \"MEDDRACode\": \"10025482\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"malaise\",\n \"Probability\": \"0.9992263317\",\n \"SemanticContext\": \"Unsolicited adverse events that occurred in =1% of recipients of SHINGRIX and at a rate at least 1.5-fold higher than placebo included chills 3.5% versus 0.2% , injection site pruritus 2.2% versus 0.2% , malaise 1.7% versus 0.3% , arthralgia 1.7% versus 1.2% , nausea 1.4% versus 0.5% , and dizziness 1.2% versus 0.8% .\"\n }\n ]\n },\n {\n \"Term\": \"Tremor\",\n \"MEDDRACode\": \"10044565\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"shake\",\n \"Probability\": \"0.0041259825\",\n \"SemanticContext\": \"Gently shake the vial to thoroughly mix contents until powder is completely dissolved.\"\n }\n ]\n },\n {\n \"Term\": \"Vomiting\",\n \"MEDDRACode\": \"10047700\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"vomiting\",\n \"Probability\": \"0.9987901449\",\n \"SemanticContext\": \"g GI = Gastrointestinal symptoms including nausea, vomiting, diarrhea, and/or abdominal pain.\"\n }\n ]\n },\n {\n \"Term\": \"Chills\",\n \"MEDDRACode\": \"10008531\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"chills\",\n \"Probability\": \"0.999861002\",\n \"SemanticContext\": \"Unsolicited adverse events that occurred in =1% of recipients of SHINGRIX and at a rate at least 1.5-fold higher than placebo included chills 3.5% versus 0.2% , injection site pruritus 2.2% versus 0.2% , malaise 1.7% versus 0.3% , arthralgia 1.7% versus 1.2% , nausea 1.4% versus 0.5% , and dizziness 1.2% versus 0.8% .\"\n }\n ]\n },\n {\n \"Term\": \"Nausea\",\n \"MEDDRACode\": \"10028813\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"nausea\",\n \"Probability\": \"0.9983665943\",\n \"SemanticContext\": \"g GI = Gastrointestinal symptoms including nausea, vomiting, diarrhea, and/or abdominal pain.\"\n },\n {\n \"VerbatimTerm\": \"nausea\",\n \"Probability\": \"0.9997874498\",\n \"SemanticContext\": \"Unsolicited adverse events that occurred in =1% of recipients of SHINGRIX and at a rate at least 1.5-fold higher than placebo included chills 3.5% versus 0.2% , injection site pruritus 2.2% versus 0.2% , malaise 1.7% versus 0.3% , arthralgia 1.7% versus 1.2% , nausea 1.4% versus 0.5% , and dizziness 1.2% versus 0.8% .\"\n }\n ]\n },\n {\n \"Term\": \"Injection\",\n \"MEDDRACode\": \"10052995\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"intramuscular injection\",\n \"Probability\": \"0.0016176105\",\n \"SemanticContext\": \"SHINGRIX Zoster Vaccine Recombinant, Adjuvanted , suspension for intramuscular injection Initial U.S. Approval: 2017 RECENT MAJOR CHANGES 1 .\"\n },\n {\n \"VerbatimTerm\": \"intramuscular injection\",\n \"Probability\": \"0.000204742\",\n \"SemanticContext\": \"11 DESCRIPTION SHINGRIX Zoster Vaccine Recombinant, Adjuvanted is a sterile suspension for intramuscular injection.\"\n },\n {\n \"VerbatimTerm\": \"intramuscular injection\",\n \"Probability\": \"0.0416247845\",\n \"SemanticContext\": \"2 DOSAGE AND ADMINISTRATION For intramuscular injection only.\"\n },\n {\n \"VerbatimTerm\": \"intramuscular injection\",\n \"Probability\": \"0.0017172098\",\n \"SemanticContext\": \"Figure 1 Figure 2b Figure 3 Figure 4 2.2 Administration Instructions For intramuscular injection only.\"\n },\n {\n \"VerbatimTerm\": \"intramuscular injection\",\n \"Probability\": \"0.0014910698\",\n \"SemanticContext\": \"The preferred site for intramuscular injection is the deltoid region of the upper arm.\"\n },\n {\n \"VerbatimTerm\": \"intramuscular injection\",\n \"Probability\": \"0.0029586852\",\n \"SemanticContext\": \"Data Animal Data: In a reproductive and developmental toxicity study, female rats were administered SHINGRIX or the AS01 B adjuvant alone by intramuscular injection 28 and 14 days prior to mating, on gestation Days 3, 8, 11, and 15, and on lactation Day 7.\"\n }\n ]\n },\n {\n \"Term\": \"Arthralgia\",\n \"MEDDRACode\": \"10003239\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"arthralgia\",\n \"Probability\": \"0.9993822575\",\n \"SemanticContext\": \"Unsolicited adverse events that occurred in =1% of recipients of SHINGRIX and at a rate at least 1.5-fold higher than placebo included chills 3.5% versus 0.2% , injection site pruritus 2.2% versus 0.2% , malaise 1.7% versus 0.3% , arthralgia 1.7% versus 1.2% , nausea 1.4% versus 0.5% , and dizziness 1.2% versus 0.8% .\"\n }\n ]\n },\n {\n \"Term\": \"Condom\",\n \"MEDDRACode\": \"10010274\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"rubber\",\n \"Probability\": \"0.0004217327\",\n \"SemanticContext\": \"The vial stoppers are not made with natural rubber latex.\"\n }\n ]\n },\n {\n \"Term\": \"Paroxysmal nocturnal haemoglobinuria\",\n \"MEDDRACode\": \"10034042\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"PHN\",\n \"Probability\": \"0.0028251112\",\n \"SemanticContext\": \"Subjects were followed for the development of HZ and postherpetic neuralgia PHN for a median of 3.1 years range: 0 to 3.7 years .\"\n },\n {\n \"VerbatimTerm\": \"PHN\",\n \"Probability\": \"0.2297208607\",\n \"SemanticContext\": \"Suspected HZ cases were followed prospectively for the development of PHN, an HZ-related complication defined as HZ-associated pain rated as 3 or greater on a 0- to 10-point scale by the study subject occurring or persisting at least 90 days following the onset of rash in confirmed cases of HZ.\"\n },\n {\n \"VerbatimTerm\": \"PHN\",\n \"Probability\": \"0.0682806373\",\n \"SemanticContext\": \"Occurrence of PHN Among all subjects aged 50 years or older in the mTVC, no cases of PHN were reported in the vaccine group compared with 18 cases reported in the placebo group.\"\n },\n {\n \"VerbatimTerm\": \"PHN\",\n \"Probability\": \"0.836982131\",\n \"SemanticContext\": \"Occurrence of PHN Among all subjects aged 50 years or older in the mTVC, no cases of PHN were reported in the vaccine group compared with 18 cases reported in the placebo group.\"\n },\n {\n \"VerbatimTerm\": \"PHN\",\n \"Probability\": \"0.0090480447\",\n \"SemanticContext\": \"Subjects were followed for the development of HZ and PHN for a median of 3.9 years range: 0 to 4.5 years .\"\n },\n {\n \"VerbatimTerm\": \"PHN\",\n \"Probability\": \"0.0928482413\",\n \"SemanticContext\": \"Suspected HZ cases were followed prospectively for the development of PHN as for Study 1.\"\n },\n {\n \"VerbatimTerm\": \"PHN\",\n \"Probability\": \"0.0164114535\",\n \"SemanticContext\": \"Efficacy against PHN Among all subjects aged 70 years or older in the mTVC, 4 cases of PHN were reported in the vaccine group, compared with 28 cases reported in the placebo group.\"\n },\n {\n \"VerbatimTerm\": \"PHN\",\n \"Probability\": \"0.8534038067\",\n \"SemanticContext\": \"Efficacy against PHN Among all subjects aged 70 years or older in the mTVC, 4 cases of PHN were reported in the vaccine group, compared with 28 cases reported in the placebo group.\"\n },\n {\n \"VerbatimTerm\": \"PHN\",\n \"Probability\": \"0.6436961889\",\n \"SemanticContext\": \"Vaccine efficacy against PHN was 85.5% 95% CI: [58.5; 96.3] .\"\n },\n {\n \"VerbatimTerm\": \"PHN\",\n \"Probability\": \"0.010217607\",\n \"SemanticContext\": \"The benefit of SHINGRIX in the prevention of PHN can be attributed to the effect of the vaccine on the prevention of HZ.\"\n },\n {\n \"VerbatimTerm\": \"PHN\",\n \"Probability\": \"0.0247023106\",\n \"SemanticContext\": \"14.3 Pooled Efficacy Analyses across Studies 1 and 2 The efficacy of SHINGRIX to prevent HZ and PHN in subjects 70 years and older was evaluated by combining the results from Studies 1 and 2 through a pre-specified pooled analysis in the mTVC.\"\n },\n {\n \"VerbatimTerm\": \"PHN\",\n \"Probability\": \"0.1972961724\",\n \"SemanticContext\": \"Efficacy against PHN Table 5 compares the overall rates of PHN in the vaccine and placebo groups across both studies.\"\n },\n {\n \"VerbatimTerm\": \"PHN\",\n \"Probability\": \"0.1603035033\",\n \"SemanticContext\": \"Efficacy against PHN Table 5 compares the overall rates of PHN in the vaccine and placebo groups across both studies.\"\n },\n {\n \"VerbatimTerm\": \"PHN\",\n \"Probability\": \"0.77010113\",\n \"SemanticContext\": \"Efficacy of SHINGRIX on Overall Incidence of Postherpetic Neuralgia Compared with Placebo in Studies 1 and 2 Pooled Data a mTVC b Age Group Years SHINGRIX Placebo % Efficacy 95% CI N n Incidence Rate of PHN c per 1,000 Person-Years N n Incidence Rate of PHN per 1,000 Person-Years Overall =70 8,250 4 0.1 8,346 36 1.2 88.8 68.7, 97.1 70 - 79 6,468 2 0.1 6,554 29 1.2 93.0 72.5, 99.2 =80 1,782 2 0.3 1,792 7 1.1 71.2 -51.5, 97.1 .\"\n },\n {\n \"VerbatimTerm\": \"PHN\",\n \"Probability\": \"0.5797979236\",\n \"SemanticContext\": \"Efficacy of SHINGRIX on Overall Incidence of Postherpetic Neuralgia Compared with Placebo in Studies 1 and 2 Pooled Data a mTVC b Age Group Years SHINGRIX Placebo % Efficacy 95% CI N n Incidence Rate of PHN c per 1,000 Person-Years N n Incidence Rate of PHN per 1,000 Person-Years Overall =70 8,250 4 0.1 8,346 36 1.2 88.8 68.7, 97.1 70 - 79 6,468 2 0.1 6,554 29 1.2 93.0 72.5, 99.2 =80 1,782 2 0.3 1,792 7 1.1 71.2 -51.5, 97.1 .\"\n },\n {\n \"VerbatimTerm\": \"PHN\",\n \"Probability\": \"0.6397769451\",\n \"SemanticContext\": \"N = Number of subjects included in each group; n = Number of subjects having at least 1 PHN; CI = Confidence Interval.\"\n },\n {\n \"VerbatimTerm\": \"PHN\",\n \"Probability\": \"0.4791490138\",\n \"SemanticContext\": \"c PHN = Postherpetic neuralgia defined as HZ-associated pain rated as 3 or greater on a 0- to 10 point scale occurring or persisting at least 90 days following the onset of rash using Zoster Brief Pain Inventory questionnaire.\"\n },\n {\n \"VerbatimTerm\": \"PHN\",\n \"Probability\": \"0.010217607\",\n \"SemanticContext\": \"The benefit of SHINGRIX in the prevention of PHN can be attributed to the effect of the vaccine on the prevention of HZ.\"\n },\n {\n \"VerbatimTerm\": \"PHN\",\n \"Probability\": \"0.0015787184\",\n \"SemanticContext\": \"The efficacy of SHINGRIX in the prevention of PHN in subjects with confirmed HZ could not be demonstrated.\"\n }\n ]\n },\n {\n \"Term\": \"Polymerase chain reaction\",\n \"MEDDRACode\": \"10050967\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Polymerase Chain Reaction\",\n \"Probability\": \"0.0015808344\",\n \"SemanticContext\": \"Confirmed HZ cases were determined by either Polymerase Chain Reaction PCR 89.4% or by a Clinical Evaluation Committee 10.6% .\"\n }\n ]\n },\n {\n \"Term\": \"General symptom\",\n \"MEDDRACode\": \"10060891\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"general symptoms\",\n \"Probability\": \"0.1097225845\",\n \"SemanticContext\": \"The incidence of solicited local and general symptoms was lower in subjects aged 70 years and older compared with those aged 50 to 69 years.\"\n }\n ]\n },\n {\n \"Term\": \"Blood albumin\",\n \"MEDDRACode\": \"10005285\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"albumin\",\n \"Probability\": \"5.58233E-05\",\n \"SemanticContext\": \"The gE antigen is obtained by culturing genetically engineered Chinese Hamster Ovary cells, which carry a truncated gE gene, in media containing amino acids, with no albumin, antibiotics, or animal-derived proteins.\"\n }\n ]\n },\n {\n \"Term\": \"Lymphadenitis\",\n \"MEDDRACode\": \"10025188\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"lymphadenitis\",\n \"Probability\": \"0.9882332087\",\n \"SemanticContext\": \"One subject\\n <0.01% reported lymphadenitis and 1 subject \\n <0.01% reported fever greater than 39°C; there was a basis for a causal relationship with SHINGRIX.\"\n }\n ]\n },\n {\n \"Term\": \"Salmonellosis\",\n \"MEDDRACode\": \"10039447\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Salmonella\",\n \"Probability\": \"0.0002899766\",\n \"SemanticContext\": \"The adjuvant suspension component is AS01 B which is composed of 3- O -desacyl-4’-monophosphoryl lipid A MPL from Salmonella minnesota and QS-21, a saponin purified from plant extract Quillaja saponaria Molina, combined in a liposomal formulation.\"\n }\n ]\n },\n {\n \"Term\": \"Pallor\",\n \"MEDDRACode\": \"10033546\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"pale\",\n \"Probability\": \"0.0064616203\",\n \"SemanticContext\": \"The AS01 B adjuvant suspension component is an opalescent, colorless to pale brownish liquid supplied in vials.\"\n },\n {\n \"VerbatimTerm\": \"pale\",\n \"Probability\": \"0.1633428633\",\n \"SemanticContext\": \"After reconstitution, SHINGRIX is a sterile, opalescent, colorless to pale brownish liquid.\"\n },\n {\n \"VerbatimTerm\": \"pale\",\n \"Probability\": \"0.0058875978\",\n \"SemanticContext\": \"The reconstituted vaccine should be an opalescent, colorless to pale brownish liquid.\"\n }\n ]\n },\n {\n \"Term\": \"Ultrasound scan\",\n \"MEDDRACode\": \"10045434\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"U.S.\",\n \"Probability\": \"0.0002158582\",\n \"SemanticContext\": \"SHINGRIX Zoster Vaccine Recombinant, Adjuvanted , suspension for intramuscular injection Initial U.S. Approval: 2017 RECENT MAJOR CHANGES 1 .\"\n },\n {\n \"VerbatimTerm\": \"U.S.\",\n \"Probability\": \"0.0001907051\",\n \"SemanticContext\": \"In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.\"\n }\n ]\n },\n {\n \"Term\": \"Blood phosphorus\",\n \"MEDDRACode\": \"10005717\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"phosphate\",\n \"Probability\": \"0.0001782179\",\n \"SemanticContext\": \"The liposomes are composed of dioleoyl phosphatidylcholine DOPC and cholesterol in phosphate-buffered saline solution containing disodium phosphate anhydrous, potassium dihydrogen phosphate, sodium chloride, and water for injection.\"\n },\n {\n \"VerbatimTerm\": \"phosphate\",\n \"Probability\": \"0.0005634725\",\n \"SemanticContext\": \"The liposomes are composed of dioleoyl phosphatidylcholine DOPC and cholesterol in phosphate-buffered saline solution containing disodium phosphate anhydrous, potassium dihydrogen phosphate, sodium chloride, and water for injection.\"\n },\n {\n \"VerbatimTerm\": \"phosphate\",\n \"Probability\": \"0.0041419268\",\n \"SemanticContext\": \"The liposomes are composed of dioleoyl phosphatidylcholine DOPC and cholesterol in phosphate-buffered saline solution containing disodium phosphate anhydrous, potassium dihydrogen phosphate, sodium chloride, and water for injection.\"\n },\n {\n \"VerbatimTerm\": \"phosphate\",\n \"Probability\": \"3.31788E-05\",\n \"SemanticContext\": \"Each dose also contains 20 mg of sucrose as stabilizer , 4.385 mg of sodium chloride, 1 mg of DOPC, 0.54 mg of potassium dihydrogen phosphate, 0.25 mg of cholesterol, 0.160 mg of sodium dihydrogen phosphate dihydrate, 0.15 mg of disodium phosphate anhydrous, 0.116 mg of dipotassium phosphate, and 0.08 mg of polysorbate 80.\"\n },\n {\n \"VerbatimTerm\": \"phosphate\",\n \"Probability\": \"3.13675E-05\",\n \"SemanticContext\": \"Each dose also contains 20 mg of sucrose as stabilizer , 4.385 mg of sodium chloride, 1 mg of DOPC, 0.54 mg of potassium dihydrogen phosphate, 0.25 mg of cholesterol, 0.160 mg of sodium dihydrogen phosphate dihydrate, 0.15 mg of disodium phosphate anhydrous, 0.116 mg of dipotassium phosphate, and 0.08 mg of polysorbate 80.\"\n },\n {\n \"VerbatimTerm\": \"phosphate\",\n \"Probability\": \"0.0002280772\",\n \"SemanticContext\": \"Each dose also contains 20 mg of sucrose as stabilizer , 4.385 mg of sodium chloride, 1 mg of DOPC, 0.54 mg of potassium dihydrogen phosphate, 0.25 mg of cholesterol, 0.160 mg of sodium dihydrogen phosphate dihydrate, 0.15 mg of disodium phosphate anhydrous, 0.116 mg of dipotassium phosphate, and 0.08 mg of polysorbate 80.\"\n },\n {\n \"VerbatimTerm\": \"phosphate\",\n \"Probability\": \"0.0001213767\",\n \"SemanticContext\": \"Each dose also contains 20 mg of sucrose as stabilizer , 4.385 mg of sodium chloride, 1 mg of DOPC, 0.54 mg of potassium dihydrogen phosphate, 0.25 mg of cholesterol, 0.160 mg of sodium dihydrogen phosphate dihydrate, 0.15 mg of disodium phosphate anhydrous, 0.116 mg of dipotassium phosphate, and 0.08 mg of polysorbate 80.\"\n }\n ]\n },\n {\n \"Term\": \"Post herpetic neuralgia\",\n \"MEDDRACode\": \"10036376\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"postherpetic neuralgia\",\n \"Probability\": \"0.0045317113\",\n \"SemanticContext\": \"Subjects were followed for the development of HZ and postherpetic neuralgia PHN for a median of 3.1 years range: 0 to 3.7 years .\"\n },\n {\n \"VerbatimTerm\": \"PHN\",\n \"Probability\": \"0.0028251112\",\n \"SemanticContext\": \"Subjects were followed for the development of HZ and postherpetic neuralgia PHN for a median of 3.1 years range: 0 to 3.7 years .\"\n },\n {\n \"VerbatimTerm\": \"PHN\",\n \"Probability\": \"0.2297208607\",\n \"SemanticContext\": \"Suspected HZ cases were followed prospectively for the development of PHN, an HZ-related complication defined as HZ-associated pain rated as 3 or greater on a 0- to 10-point scale by the study subject occurring or persisting at least 90 days following the onset of rash in confirmed cases of HZ.\"\n },\n {\n \"VerbatimTerm\": \"PHN\",\n \"Probability\": \"0.0682806373\",\n \"SemanticContext\": \"Occurrence of PHN Among all subjects aged 50 years or older in the mTVC, no cases of PHN were reported in the vaccine group compared with 18 cases reported in the placebo group.\"\n },\n {\n \"VerbatimTerm\": \"PHN\",\n \"Probability\": \"0.836982131\",\n \"SemanticContext\": \"Occurrence of PHN Among all subjects aged 50 years or older in the mTVC, no cases of PHN were reported in the vaccine group compared with 18 cases reported in the placebo group.\"\n },\n {\n \"VerbatimTerm\": \"PHN\",\n \"Probability\": \"0.0090480447\",\n \"SemanticContext\": \"Subjects were followed for the development of HZ and PHN for a median of 3.9 years range: 0 to 4.5 years .\"\n },\n {\n \"VerbatimTerm\": \"PHN\",\n \"Probability\": \"0.0928482413\",\n \"SemanticContext\": \"Suspected HZ cases were followed prospectively for the development of PHN as for Study 1.\"\n },\n {\n \"VerbatimTerm\": \"PHN\",\n \"Probability\": \"0.0164114535\",\n \"SemanticContext\": \"Efficacy against PHN Among all subjects aged 70 years or older in the mTVC, 4 cases of PHN were reported in the vaccine group, compared with 28 cases reported in the placebo group.\"\n },\n {\n \"VerbatimTerm\": \"PHN\",\n \"Probability\": \"0.8534038067\",\n \"SemanticContext\": \"Efficacy against PHN Among all subjects aged 70 years or older in the mTVC, 4 cases of PHN were reported in the vaccine group, compared with 28 cases reported in the placebo group.\"\n },\n {\n \"VerbatimTerm\": \"PHN\",\n \"Probability\": \"0.6436961889\",\n \"SemanticContext\": \"Vaccine efficacy against PHN was 85.5% 95% CI: [58.5; 96.3] .\"\n },\n {\n \"VerbatimTerm\": \"PHN\",\n \"Probability\": \"0.010217607\",\n \"SemanticContext\": \"The benefit of SHINGRIX in the prevention of PHN can be attributed to the effect of the vaccine on the prevention of HZ.\"\n },\n {\n \"VerbatimTerm\": \"PHN\",\n \"Probability\": \"0.0247023106\",\n \"SemanticContext\": \"14.3 Pooled Efficacy Analyses across Studies 1 and 2 The efficacy of SHINGRIX to prevent HZ and PHN in subjects 70 years and older was evaluated by combining the results from Studies 1 and 2 through a pre-specified pooled analysis in the mTVC.\"\n },\n {\n \"VerbatimTerm\": \"PHN\",\n \"Probability\": \"0.1972961724\",\n \"SemanticContext\": \"Efficacy against PHN Table 5 compares the overall rates of PHN in the vaccine and placebo groups across both studies.\"\n },\n {\n \"VerbatimTerm\": \"PHN\",\n \"Probability\": \"0.1603035033\",\n \"SemanticContext\": \"Efficacy against PHN Table 5 compares the overall rates of PHN in the vaccine and placebo groups across both studies.\"\n },\n {\n \"VerbatimTerm\": \"PHN\",\n \"Probability\": \"0.77010113\",\n \"SemanticContext\": \"Efficacy of SHINGRIX on Overall Incidence of Postherpetic Neuralgia Compared with Placebo in Studies 1 and 2 Pooled Data a mTVC b Age Group Years SHINGRIX Placebo % Efficacy 95% CI N n Incidence Rate of PHN c per 1,000 Person-Years N n Incidence Rate of PHN per 1,000 Person-Years Overall =70 8,250 4 0.1 8,346 36 1.2 88.8 68.7, 97.1 70 - 79 6,468 2 0.1 6,554 29 1.2 93.0 72.5, 99.2 =80 1,782 2 0.3 1,792 7 1.1 71.2 -51.5, 97.1 .\"\n },\n {\n \"VerbatimTerm\": \"PHN\",\n \"Probability\": \"0.5797979236\",\n \"SemanticContext\": \"Efficacy of SHINGRIX on Overall Incidence of Postherpetic Neuralgia Compared with Placebo in Studies 1 and 2 Pooled Data a mTVC b Age Group Years SHINGRIX Placebo % Efficacy 95% CI N n Incidence Rate of PHN c per 1,000 Person-Years N n Incidence Rate of PHN per 1,000 Person-Years Overall =70 8,250 4 0.1 8,346 36 1.2 88.8 68.7, 97.1 70 - 79 6,468 2 0.1 6,554 29 1.2 93.0 72.5, 99.2 =80 1,782 2 0.3 1,792 7 1.1 71.2 -51.5, 97.1 .\"\n },\n {\n \"VerbatimTerm\": \"PHN\",\n \"Probability\": \"0.6397769451\",\n \"SemanticContext\": \"N = Number of subjects included in each group; n = Number of subjects having at least 1 PHN; CI = Confidence Interval.\"\n },\n {\n \"VerbatimTerm\": \"PHN\",\n \"Probability\": \"0.4791490138\",\n \"SemanticContext\": \"c PHN = Postherpetic neuralgia defined as HZ-associated pain rated as 3 or greater on a 0- to 10 point scale occurring or persisting at least 90 days following the onset of rash using Zoster Brief Pain Inventory questionnaire.\"\n },\n {\n \"VerbatimTerm\": \"PHN\",\n \"Probability\": \"0.010217607\",\n \"SemanticContext\": \"The benefit of SHINGRIX in the prevention of PHN can be attributed to the effect of the vaccine on the prevention of HZ.\"\n },\n {\n \"VerbatimTerm\": \"PHN\",\n \"Probability\": \"0.0015787184\",\n \"SemanticContext\": \"The efficacy of SHINGRIX in the prevention of PHN in subjects with confirmed HZ could not be demonstrated.\"\n },\n {\n \"VerbatimTerm\": \"Postherpetic Neuralgia\",\n \"Probability\": \"0.5473903418\",\n \"SemanticContext\": \"Efficacy of SHINGRIX on Overall Incidence of Postherpetic Neuralgia Compared with Placebo in Studies 1 and 2 Pooled Data a mTVC b Age Group Years SHINGRIX Placebo % Efficacy 95% CI N n Incidence Rate of PHN c per 1,000 Person-Years N n Incidence Rate of PHN per 1,000 Person-Years Overall =70 8,250 4 0.1 8,346 36 1.2 88.8 68.7, 97.1 70 - 79 6,468 2 0.1 6,554 29 1.2 93.0 72.5, 99.2 =80 1,782 2 0.3 1,792 7 1.1 71.2 -51.5, 97.1 .\"\n },\n {\n \"VerbatimTerm\": \"Postherpetic neuralgia\",\n \"Probability\": \"0.3073654473\",\n \"SemanticContext\": \"c PHN = Postherpetic neuralgia defined as HZ-associated pain rated as 3 or greater on a 0- to 10 point scale occurring or persisting at least 90 days following the onset of rash using Zoster Brief Pain Inventory questionnaire.\"\n }\n ]\n },\n {\n \"Term\": \"Herpes zoster\",\n \"MEDDRACode\": \"10019974\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"herpes zoster\",\n \"Probability\": \"0.1634691656\",\n \"SemanticContext\": \"INDICATIONS AND USAGE SHINGRIX is a vaccine indicated for prevention of herpes zoster shingles in adults aged 50 years and older.\"\n },\n {\n \"VerbatimTerm\": \"herpes zoster\",\n \"Probability\": \"0.426025182\",\n \"SemanticContext\": \"12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action The risk of developing herpes zoster HZ increases with age and appears to be related to a decline in VZV-specific immunity.\"\n },\n {\n \"VerbatimTerm\": \"herpes zoster\",\n \"Probability\": \"0.3343528211\",\n \"SemanticContext\": \"1 INDICATIONS AND USAGE SHINGRIX is a vaccine indicated for prevention of herpes zoster shingles in adults aged 50 years and older.\"\n },\n {\n \"VerbatimTerm\": \"Herpes Zoster\",\n \"Probability\": \"0.2694777548\",\n \"SemanticContext\": \"Efficacy against Herpes Zoster Compared with placebo, SHINGRIX significantly reduced the risk of developing HZ by 97.2% 95% CI: 93.7, 99.0 in subjects 50 years and older Table 2 .\"\n },\n {\n \"VerbatimTerm\": \"Herpes Zoster\",\n \"Probability\": \"0.6287593842\",\n \"SemanticContext\": \"Efficacy of SHINGRIX on Incidence of Herpes Zoster Compared with Placebo in Study 1 a mTVC b Age Group Years SHINGRIX Placebo % Efficacy 95% CI N n Incidence Rate of HZ per 1,000 Person-Years N n Incidence Rate of HZ per 1,000 Person-Years Overall =50 c 7,344 6 0.3 7,415 210 9.1 97.2 93.7, 99.0 50 - 59 3,492 3 0.3 3,525 87 7.8 96.6 89.6, 99.3 60 - 69 2,141 2 0.3 2,166 75 10.8 97.4 90.1, 99.7 =70 1,711 1 0.2 1,724 48 9.4 97.9 87.9, 100.0 .\"\n },\n {\n \"VerbatimTerm\": \"Herpes Zoster\",\n \"Probability\": \"0.045391053\",\n \"SemanticContext\": \"Efficacy against Herpes Zoster Vaccine efficacy results against HZ in subjects 70 years and older are shown in Table 3.\"\n },\n {\n \"VerbatimTerm\": \"Herpes Zoster\",\n \"Probability\": \"0.6287593842\",\n \"SemanticContext\": \"Efficacy of SHINGRIX on Incidence of Herpes Zoster Compared with Placebo in Study 2 a mTVC b Age Group Years SHINGRIX Placebo % Efficacy 95% CI N n Incidence Rate of HZ per 1,000 Person-Years N n Incidence Rate of HZ per 1,000 Person-Years Overall =70 c 6,541 23 0.9 6,622 223 9.2 89.8 84.3, 93.7 70 - 79 5,114 17 0.9 5,189 169 8.8 90.0 83.5, 94.3 =80 1,427 6 1.2 1,433 54 11.0 89.1 74.7, 96.2 .\"\n },\n {\n \"VerbatimTerm\": \"Herpes Zoster\",\n \"Probability\": \"0.2694777548\",\n \"SemanticContext\": \"Efficacy against Herpes Zoster Compared with placebo, SHINGRIX significantly reduced the risk of developing HZ by 91.3% 95% CI: 86.9, 94.5 in subjects 70 years and older Table 4 .\"\n },\n {\n \"VerbatimTerm\": \"Herpes Zoster\",\n \"Probability\": \"0.5652958155\",\n \"SemanticContext\": \"Efficacy of SHINGRIX on Incidence of Herpes Zoster Compared with Placebo in Studies 1 and 2 Pooled Data a mTVC b Age Group Years SHINGRIX Placebo % Efficacy 95% CI N n Incidence Rate of HZ per 1,000 Person-Years N n Incidence Rate of HZ per 1,000 Person-Years Overall =70 c 8,250 25 0.8 8,346 284 9.3 91.3 86.9, 94.5 70 - 79 6,468 19 0.8 6,554 216 8.9 91.3 86.0, 94.9 =80 1,782 6 1.0 1,792 68 11.1 91.4 80.2, 96.9 .\"\n },\n {\n \"VerbatimTerm\": \"Herpes zoster\",\n \"Probability\": \"0.7843371034\",\n \"SemanticContext\": \"N = Number of subjects included in each group; n = Number of subjects having at least 1 confirmed HZ episode; HZ = Herpes zoster; CI = Confidence Interval.\"\n },\n {\n \"VerbatimTerm\": \"Herpes zoster\",\n \"Probability\": \"0.7843371034\",\n \"SemanticContext\": \"N = Number of subjects included in each group; n = Number of subjects having at least 1 confirmed HZ episode; HZ = Herpes zoster; CI = Confidence Interval.\"\n },\n {\n \"VerbatimTerm\": \"Herpes zoster\",\n \"Probability\": \"0.7843371034\",\n \"SemanticContext\": \"N = Number of subjects included in each group; n = Number of subjects having at least 1 confirmed HZ episode; HZ = Herpes zoster; CI = Confidence Interval.\"\n }\n ]\n },\n {\n \"Term\": \"Protein total\",\n \"MEDDRACode\": \"10050537\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"proteins\",\n \"Probability\": \"0.0005557835\",\n \"SemanticContext\": \"The gE antigen is obtained by culturing genetically engineered Chinese Hamster Ovary cells, which carry a truncated gE gene, in media containing amino acids, with no albumin, antibiotics, or animal-derived proteins.\"\n },\n {\n \"VerbatimTerm\": \"proteins\",\n \"Probability\": \"0.0002793074\",\n \"SemanticContext\": \"Each dose may also contain residual amounts of host cell proteins =3.0% and DNA =2.1 picograms from the manufacturing process.\"\n },\n {\n \"VerbatimTerm\": \"protein\",\n \"Probability\": \"9.03956E-05\",\n \"SemanticContext\": \"The gE protein is purified by several chromatographic steps, formulated with excipients, filled into vials, and lyophilized.\"\n }\n ]\n },\n {\n \"Term\": \"Abortion spontaneous\",\n \"MEDDRACode\": \"10000234\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"miscarriage\",\n \"Probability\": \"0.808809638\",\n \"SemanticContext\": \"In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.\"\n }\n ]\n },\n {\n \"Term\": \"Congenital anomaly\",\n \"MEDDRACode\": \"10010356\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"birth defect\",\n \"Probability\": \"0.1576089859\",\n \"SemanticContext\": \"8.1 Pregnancy Risk Summary All pregnancies have a risk of birth defect, loss, or other adverse outcomes.\"\n },\n {\n \"VerbatimTerm\": \"birth defects\",\n \"Probability\": \"0.0811973214\",\n \"SemanticContext\": \"In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.\"\n }\n ]\n },\n {\n \"Term\": \"Immunodeficiency\",\n \"MEDDRACode\": \"10061598\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"immunocompromised\",\n \"Probability\": \"0.0210090876\",\n \"SemanticContext\": \"The study excluded, among others, subjects who were immunocompromised, had a history of previous HZ, were vaccinated against varicella or HZ, and patients whose survival was not expected to be at least 4 years or with conditions that might interfere with study evaluations.\"\n }\n ]\n },\n {\n \"Term\": \"Drug interaction\",\n \"MEDDRACode\": \"10013710\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"DRUG INTERACTIONS\",\n \"Probability\": \"0.000523746\",\n \"SemanticContext\": \"7 DRUG INTERACTIONS 7.1 Concomitant Vaccine Administration For concomitant administration of SHINGRIX with inactivated influenza vaccine [see Clinical Studies 14.5 ].\"\n }\n ]\n },\n {\n \"Term\": \"Headache\",\n \"MEDDRACode\": \"10019211\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"headache\",\n \"Probability\": \"0.9998367429\",\n \"SemanticContext\": \"6.1 • Solicited general adverse reactions in subjects aged 50 years and older were myalgia 44.7% , fatigue 44.5% , headache 37.7% , shivering 26.8% , fever 20.5% , and gastrointestinal symptoms 17.3% .\"\n },\n {\n \"VerbatimTerm\": \"headache\",\n \"Probability\": \"0.9998163581\",\n \"SemanticContext\": \"Across both studies, the percentages of subjects aged 50 years and older reporting each solicited local adverse reaction and each solicited general adverse event following administration of SHINGRIX both doses combined were pain 78.0% , redness 38.1% , and swelling 25.9% ; and myalgia 44.7% , fatigue 44.5% , headache 37.7% , shivering 26.8% , fever 20.5% , and gastrointestinal symptoms 17.3% , respectively.\"\n },\n {\n \"VerbatimTerm\": \"headache\",\n \"Probability\": \"0.9968432784\",\n \"SemanticContext\": \"e Grade 3 myalgia, fatigue, headache, shivering, GI: Defined as preventing normal activity.\"\n },\n {\n \"VerbatimTerm\": \"headache\",\n \"Probability\": \"0.9993282557\",\n \"SemanticContext\": \"Grade 3 solicited general adverse events headache, shivering, myalgia, and fatigue were reported more frequently by subjects after Dose 2 2.3%, 3.1%, 3.6%, and 3.5%, respectively compared with Dose 1 1.4%, 1.4%, 2.3%, and 2.4%, respectively .\"\n },\n {\n \"VerbatimTerm\": \"Headache\",\n \"Probability\": \"0.9993380308\",\n \"SemanticContext\": \"Percentage of Subjects with Solicited Local Adverse Reactions and General Adverse Events within 7 Days a of Vaccination in Adults Aged 50 to 59 Years, 60 to 69 Years, and 70 Years and Older b Total Vaccinated Cohort with 7-Day Diary Card Aged 50 - 59 Years Aged 60 - 69 Years Aged =70 Years SHINGRIX % Placebo c % SHINGRIX % Placebo c % SHINGRIX % Placebo c % Local Adverse Reactions n = 1,315 n = 1,312 n = 1,311 n = 1,305 n = 2,258 n = 2,263 Pain 88.4 14.4 82.8 11.1 69.2 8.8 Pain, Grade 3 d 10.3 0.5 6.9 0.5 4.0 0.2 Redness 38.7 1.2 38.4 1.6 37.7 1.2 Redness, >100 mm 2.8 0.0 2.6 0.0 3.1 0.0 Swelling 30.5 0.8 26.5 1.0 23.0 1.1 Swelling, >100 mm 1.1 0.0 0.5 0.0 1.3 0.0 General Adverse Events n = 1,315 n = 1,312 n = 1,309 n = 1,305 n =2,252 n = 2,264 Myalgia 56.9 15.2 49.0 11.2 35.1 9.9 Myalgia, Grade 3 e 8.9 0.9 5.3 0.8 2.8 0.4 Fatigue 57.0 19.8 45.7 16.8 36.6 14.4 Fatigue, Grade 3 e 8.5 1.8 5.0 0.8 3.5 0.8 Headache 50.6 21.6 39.6 15.6 29.0 11.8 Headache, Grade 3 e 6.0 1.7 3.7 0.2 1.5 0.4 Shivering 35.8 7.4 30.3 5.7 19.5 4.9 Shivering, Grade 3 e 6.8 0.2 4.5 0.3 2.2 0.3 Fever 27.8 3.0 23.9 3.4 14.3 2.7 Fever, Grade 3 f 0.4 0.2 0.5 0.2 0.1 0.1 GI g 24.3 10.7 16.7 8.7 13.5 7.6 GI, Grade 3 e 2.1 0.7 0.9 0.6 1.2 0.4 .\"\n },\n {\n \"VerbatimTerm\": \"Headache\",\n \"Probability\": \"0.9711561799\",\n \"SemanticContext\": \"Percentage of Subjects with Solicited Local Adverse Reactions and General Adverse Events within 7 Days a of Vaccination in Adults Aged 50 to 59 Years, 60 to 69 Years, and 70 Years and Older b Total Vaccinated Cohort with 7-Day Diary Card Aged 50 - 59 Years Aged 60 - 69 Years Aged =70 Years SHINGRIX % Placebo c % SHINGRIX % Placebo c % SHINGRIX % Placebo c % Local Adverse Reactions n = 1,315 n = 1,312 n = 1,311 n = 1,305 n = 2,258 n = 2,263 Pain 88.4 14.4 82.8 11.1 69.2 8.8 Pain, Grade 3 d 10.3 0.5 6.9 0.5 4.0 0.2 Redness 38.7 1.2 38.4 1.6 37.7 1.2 Redness, >100 mm 2.8 0.0 2.6 0.0 3.1 0.0 Swelling 30.5 0.8 26.5 1.0 23.0 1.1 Swelling, >100 mm 1.1 0.0 0.5 0.0 1.3 0.0 General Adverse Events n = 1,315 n = 1,312 n = 1,309 n = 1,305 n =2,252 n = 2,264 Myalgia 56.9 15.2 49.0 11.2 35.1 9.9 Myalgia, Grade 3 e 8.9 0.9 5.3 0.8 2.8 0.4 Fatigue 57.0 19.8 45.7 16.8 36.6 14.4 Fatigue, Grade 3 e 8.5 1.8 5.0 0.8 3.5 0.8 Headache 50.6 21.6 39.6 15.6 29.0 11.8 Headache, Grade 3 e 6.0 1.7 3.7 0.2 1.5 0.4 Shivering 35.8 7.4 30.3 5.7 19.5 4.9 Shivering, Grade 3 e 6.8 0.2 4.5 0.3 2.2 0.3 Fever 27.8 3.0 23.9 3.4 14.3 2.7 Fever, Grade 3 f 0.4 0.2 0.5 0.2 0.1 0.1 GI g 24.3 10.7 16.7 8.7 13.5 7.6 GI, Grade 3 e 2.1 0.7 0.9 0.6 1.2 0.4 .\"\n },\n {\n \"VerbatimTerm\": \"Headache\",\n \"Probability\": \"0.993298471\",\n \"SemanticContext\": \"Headache and shivering were reported more frequently by subjects after Dose 2 28.2% and 21.4%, respectively compared with Dose 1 24.4% and 13.8%, respectively .\"\n }\n ]\n },\n {\n \"Term\": \"Influenza\",\n \"MEDDRACode\": \"10022000\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Influenza\",\n \"Probability\": \"0.000547111\",\n \"SemanticContext\": \"14.5 Concomitant Administration with Influenza Vaccine In an open-label clinical study, subjects 50 years and older received 1 dose each of SHINGRIX and FLUARIX QUADRIVALENT QIV at Month 0 and 1 dose of SHINGRIX at Month 2 n = 413 , or 1 dose of QIV at Month 0 and 1 dose of SHINGRIX at Months 2 and 4 n = 415 .\"\n },\n {\n \"VerbatimTerm\": \"influenza\",\n \"Probability\": \"3.03968E-05\",\n \"SemanticContext\": \"7 DRUG INTERACTIONS 7.1 Concomitant Vaccine Administration For concomitant administration of SHINGRIX with inactivated influenza vaccine [see Clinical Studies 14.5 ].\"\n }\n ]\n },\n {\n \"Term\": \"Blood potassium\",\n \"MEDDRACode\": \"10005721\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"potassium\",\n \"Probability\": \"0.0068637133\",\n \"SemanticContext\": \"The liposomes are composed of dioleoyl phosphatidylcholine DOPC and cholesterol in phosphate-buffered saline solution containing disodium phosphate anhydrous, potassium dihydrogen phosphate, sodium chloride, and water for injection.\"\n },\n {\n \"VerbatimTerm\": \"potassium\",\n \"Probability\": \"8.01005E-05\",\n \"SemanticContext\": \"Each dose also contains 20 mg of sucrose as stabilizer , 4.385 mg of sodium chloride, 1 mg of DOPC, 0.54 mg of potassium dihydrogen phosphate, 0.25 mg of cholesterol, 0.160 mg of sodium dihydrogen phosphate dihydrate, 0.15 mg of disodium phosphate anhydrous, 0.116 mg of dipotassium phosphate, and 0.08 mg of polysorbate 80.\"\n }\n ]\n },\n {\n \"Term\": \"Culture\",\n \"MEDDRACode\": \"10061447\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"culturing\",\n \"Probability\": \"0.0001767576\",\n \"SemanticContext\": \"The gE antigen is obtained by culturing genetically engineered Chinese Hamster Ovary cells, which carry a truncated gE gene, in media containing amino acids, with no albumin, antibiotics, or animal-derived proteins.\"\n }\n ]\n },\n {\n \"Term\": \"Skin exfoliation\",\n \"MEDDRACode\": \"10040844\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"scale\",\n \"Probability\": \"0.6455769539\",\n \"SemanticContext\": \"Suspected HZ cases were followed prospectively for the development of PHN, an HZ-related complication defined as HZ-associated pain rated as 3 or greater on a 0- to 10-point scale by the study subject occurring or persisting at least 90 days following the onset of rash in confirmed cases of HZ.\"\n },\n {\n \"VerbatimTerm\": \"scale\",\n \"Probability\": \"0.8735331297\",\n \"SemanticContext\": \"c PHN = Postherpetic neuralgia defined as HZ-associated pain rated as 3 or greater on a 0- to 10 point scale occurring or persisting at least 90 days following the onset of rash using Zoster Brief Pain Inventory questionnaire.\"\n }\n ]\n },\n {\n \"Term\": \"Guillain-Barre syndrome\",\n \"MEDDRACode\": \"10018767\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Guillain-Barré syndrome\",\n \"Probability\": \"0.9920892715\",\n \"SemanticContext\": \"Warnings and Precautions, Guillain-Barré syndrome 5.2 03/2021 .\"\n },\n {\n \"VerbatimTerm\": \"Guillain-Barré syndrome\",\n \"Probability\": \"0.9899915457\",\n \"SemanticContext\": \"WARNINGS AND PRECAUTIONS In a postmarketing observational study, an increased risk of Guillain-Barré syndrome was observed during the 42 days following vaccination with SHINGRIX.\"\n },\n {\n \"VerbatimTerm\": \"Guillain-Barré syndrome\",\n \"Probability\": \"0.96819067\",\n \"SemanticContext\": \"Nervous System Disorders Guillain-Barré syndrome.\"\n },\n {\n \"VerbatimTerm\": \"Guillain-Barré Syndrome\",\n \"Probability\": \"0.087919414\",\n \"SemanticContext\": \"Postmarketing Observational Study of the Risk of Guillain-Barré Syndrome following Vaccination with SHINGRIX The association between vaccination with SHINGRIX and GBS was evaluated among Medicare beneficiaries aged 65 years or older.\"\n },\n {\n \"VerbatimTerm\": \"Guillain- Barré Syndrome\",\n \"Probability\": \"0.8570751548\",\n \"SemanticContext\": \"\\n 5.2 Guillain- Barré Syndrome GBS In a postmarketing observational study, an increased risk of GBS was observed during the 42 days following vaccination with SHINGRIX [see Adverse Reactions 6.2 ].\"\n }\n ]\n },\n {\n \"Term\": \"Swelling\",\n \"MEDDRACode\": \"10042674\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"swelling\",\n \"Probability\": \"0.9890780449\",\n \"SemanticContext\": \"5.2, 6.2 ADVERSE REACTIONS • Solicited local adverse reactions in subjects aged 50 years and older were pain 78.0% , redness 38.1% , and swelling 25.9% .\"\n },\n {\n \"VerbatimTerm\": \"swelling\",\n \"Probability\": \"0.9979402423\",\n \"SemanticContext\": \"Across both studies, the percentages of subjects aged 50 years and older reporting each solicited local adverse reaction and each solicited general adverse event following administration of SHINGRIX both doses combined were pain 78.0% , redness 38.1% , and swelling 25.9% ; and myalgia 44.7% , fatigue 44.5% , headache 37.7% , shivering 26.8% , fever 20.5% , and gastrointestinal symptoms 17.3% , respectively.\"\n },\n {\n \"VerbatimTerm\": \"Swelling\",\n \"Probability\": \"0.9943072796\",\n \"SemanticContext\": \"Percentage of Subjects with Solicited Local Adverse Reactions and General Adverse Events within 7 Days a of Vaccination in Adults Aged 50 to 59 Years, 60 to 69 Years, and 70 Years and Older b Total Vaccinated Cohort with 7-Day Diary Card Aged 50 - 59 Years Aged 60 - 69 Years Aged =70 Years SHINGRIX % Placebo c % SHINGRIX % Placebo c % SHINGRIX % Placebo c % Local Adverse Reactions n = 1,315 n = 1,312 n = 1,311 n = 1,305 n = 2,258 n = 2,263 Pain 88.4 14.4 82.8 11.1 69.2 8.8 Pain, Grade 3 d 10.3 0.5 6.9 0.5 4.0 0.2 Redness 38.7 1.2 38.4 1.6 37.7 1.2 Redness, >100 mm 2.8 0.0 2.6 0.0 3.1 0.0 Swelling 30.5 0.8 26.5 1.0 23.0 1.1 Swelling, >100 mm 1.1 0.0 0.5 0.0 1.3 0.0 General Adverse Events n = 1,315 n = 1,312 n = 1,309 n = 1,305 n =2,252 n = 2,264 Myalgia 56.9 15.2 49.0 11.2 35.1 9.9 Myalgia, Grade 3 e 8.9 0.9 5.3 0.8 2.8 0.4 Fatigue 57.0 19.8 45.7 16.8 36.6 14.4 Fatigue, Grade 3 e 8.5 1.8 5.0 0.8 3.5 0.8 Headache 50.6 21.6 39.6 15.6 29.0 11.8 Headache, Grade 3 e 6.0 1.7 3.7 0.2 1.5 0.4 Shivering 35.8 7.4 30.3 5.7 19.5 4.9 Shivering, Grade 3 e 6.8 0.2 4.5 0.3 2.2 0.3 Fever 27.8 3.0 23.9 3.4 14.3 2.7 Fever, Grade 3 f 0.4 0.2 0.5 0.2 0.1 0.1 GI g 24.3 10.7 16.7 8.7 13.5 7.6 GI, Grade 3 e 2.1 0.7 0.9 0.6 1.2 0.4 .\"\n },\n {\n \"VerbatimTerm\": \"Swelling\",\n \"Probability\": \"0.9131188393\",\n \"SemanticContext\": \"Percentage of Subjects with Solicited Local Adverse Reactions and General Adverse Events within 7 Days a of Vaccination in Adults Aged 50 to 59 Years, 60 to 69 Years, and 70 Years and Older b Total Vaccinated Cohort with 7-Day Diary Card Aged 50 - 59 Years Aged 60 - 69 Years Aged =70 Years SHINGRIX % Placebo c % SHINGRIX % Placebo c % SHINGRIX % Placebo c % Local Adverse Reactions n = 1,315 n = 1,312 n = 1,311 n = 1,305 n = 2,258 n = 2,263 Pain 88.4 14.4 82.8 11.1 69.2 8.8 Pain, Grade 3 d 10.3 0.5 6.9 0.5 4.0 0.2 Redness 38.7 1.2 38.4 1.6 37.7 1.2 Redness, >100 mm 2.8 0.0 2.6 0.0 3.1 0.0 Swelling 30.5 0.8 26.5 1.0 23.0 1.1 Swelling, >100 mm 1.1 0.0 0.5 0.0 1.3 0.0 General Adverse Events n = 1,315 n = 1,312 n = 1,309 n = 1,305 n =2,252 n = 2,264 Myalgia 56.9 15.2 49.0 11.2 35.1 9.9 Myalgia, Grade 3 e 8.9 0.9 5.3 0.8 2.8 0.4 Fatigue 57.0 19.8 45.7 16.8 36.6 14.4 Fatigue, Grade 3 e 8.5 1.8 5.0 0.8 3.5 0.8 Headache 50.6 21.6 39.6 15.6 29.0 11.8 Headache, Grade 3 e 6.0 1.7 3.7 0.2 1.5 0.4 Shivering 35.8 7.4 30.3 5.7 19.5 4.9 Shivering, Grade 3 e 6.8 0.2 4.5 0.3 2.2 0.3 Fever 27.8 3.0 23.9 3.4 14.3 2.7 Fever, Grade 3 f 0.4 0.2 0.5 0.2 0.1 0.1 GI g 24.3 10.7 16.7 8.7 13.5 7.6 GI, Grade 3 e 2.1 0.7 0.9 0.6 1.2 0.4 .\"\n }\n ]\n },\n {\n \"Term\": \"Prophylaxis\",\n \"MEDDRACode\": \"10036898\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"prevention\",\n \"Probability\": \"0.0056435466\",\n \"SemanticContext\": \"INDICATIONS AND USAGE SHINGRIX is a vaccine indicated for prevention of herpes zoster shingles in adults aged 50 years and older.\"\n },\n {\n \"VerbatimTerm\": \"prevention\",\n \"Probability\": \"0.0005449951\",\n \"SemanticContext\": \"• SHINGRIX is not indicated for prevention of primary varicella infection chickenpox .\"\n },\n {\n \"VerbatimTerm\": \"prevention\",\n \"Probability\": \"0.0004516244\",\n \"SemanticContext\": \"The benefit of SHINGRIX in the prevention of PHN can be attributed to the effect of the vaccine on the prevention of HZ.\"\n },\n {\n \"VerbatimTerm\": \"prevention\",\n \"Probability\": \"0.0002255142\",\n \"SemanticContext\": \"The benefit of SHINGRIX in the prevention of PHN can be attributed to the effect of the vaccine on the prevention of HZ.\"\n },\n {\n \"VerbatimTerm\": \"prevention\",\n \"Probability\": \"0.0004516244\",\n \"SemanticContext\": \"The benefit of SHINGRIX in the prevention of PHN can be attributed to the effect of the vaccine on the prevention of HZ.\"\n },\n {\n \"VerbatimTerm\": \"prevention\",\n \"Probability\": \"0.0002255142\",\n \"SemanticContext\": \"The benefit of SHINGRIX in the prevention of PHN can be attributed to the effect of the vaccine on the prevention of HZ.\"\n },\n {\n \"VerbatimTerm\": \"prevention\",\n \"Probability\": \"5.53091E-05\",\n \"SemanticContext\": \"The efficacy of SHINGRIX in the prevention of PHN in subjects with confirmed HZ could not be demonstrated.\"\n },\n {\n \"VerbatimTerm\": \"prevention\",\n \"Probability\": \"0.0065340996\",\n \"SemanticContext\": \"1 INDICATIONS AND USAGE SHINGRIX is a vaccine indicated for prevention of herpes zoster shingles in adults aged 50 years and older.\"\n },\n {\n \"VerbatimTerm\": \"prevention\",\n \"Probability\": \"4.57623E-05\",\n \"SemanticContext\": \"Limitations of Use : • SHINGRIX is not indicated for prevention of primary varicella infection chickenpox .\"\n },\n {\n \"VerbatimTerm\": \"prevention\",\n \"Probability\": \"0.0003163517\",\n \"SemanticContext\": \"SHINGRIX is not indicated for prevention of primary varicella infection chickenpox .\"\n },\n {\n \"VerbatimTerm\": \"Prevention\",\n \"Probability\": \"3.05003E-05\",\n \"SemanticContext\": \"• Provide the Vaccine Information Statements, which are available free of charge at the Centers for Disease Control and Prevention CDC website www.cdc.gov/vaccines .\"\n }\n ]\n },\n {\n \"Term\": \"Foetal malformation\",\n \"MEDDRACode\": \"10060919\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"fetal malformations\",\n \"Probability\": \"0.1482973993\",\n \"SemanticContext\": \"There were no vaccine-related fetal malformations or variations.\"\n }\n ]\n },\n {\n \"Term\": \"Immunisation\",\n \"MEDDRACode\": \"10021430\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"vaccination\",\n \"Probability\": \"0.0023052692\",\n \"SemanticContext\": \"WARNINGS AND PRECAUTIONS In a postmarketing observational study, an increased risk of Guillain-Barré syndrome was observed during the 42 days following vaccination with SHINGRIX.\"\n },\n {\n \"VerbatimTerm\": \"vaccination\",\n \"Probability\": \"0.0003596842\",\n \"SemanticContext\": \"At the time of vaccination, the mean age of the population was 69 years; 7,286 24.9% subjects were aged 50 to 59 years, 4,488 15.3% subjects were aged 60 to 69 years, and 17,531 59.8% subjects were aged 70 years and older.\"\n },\n {\n \"VerbatimTerm\": \"vaccination\",\n \"Probability\": \"0.0052280128\",\n \"SemanticContext\": \"Solicited Adverse Events In Studies 1 and 2, data on solicited local and general adverse events were collected using standardized diary cards for 7 days following each vaccine dose or placebo i.e., day of vaccination and the next 6 days in a subset of subjects n = 4,886 receiving SHINGRIX, n = 4,881 receiving placebo with at least 1 documented dose .\"\n },\n {\n \"VerbatimTerm\": \"vaccination\",\n \"Probability\": \"0.0283835232\",\n \"SemanticContext\": \"a 7 days included day of vaccination and the subsequent 6 days.\"\n },\n {\n \"VerbatimTerm\": \"vaccination\",\n \"Probability\": \"0.0294647813\",\n \"SemanticContext\": \"Unsolicited Adverse Events Unsolicited adverse events that occurred within 30 days following each vaccination Day 0 to 29 were recorded on a diary card by all subjects.\"\n },\n {\n \"VerbatimTerm\": \"vaccination\",\n \"Probability\": \"0.3264240026\",\n \"SemanticContext\": \"In the 2 studies, unsolicited adverse events occurring within 30 days of vaccination were reported in 50.5% and 32.0% of subjects who received SHINGRIX n = 14,645 and placebo n = 14,660 , respectively Total Vaccinated Cohort .\"\n },\n {\n \"VerbatimTerm\": \"vaccination\",\n \"Probability\": \"0.0006101429\",\n \"SemanticContext\": \"Gout including gouty arthritis was reported by 0.18% n = 27 versus 0.05% n = 8 of subjects who received SHINGRIX and placebo, respectively, within 30 days of vaccination; available information is insufficient to determine a causal relationship with SHINGRIX.\"\n },\n {\n \"VerbatimTerm\": \"vaccination\",\n \"Probability\": \"0.0037626624\",\n \"SemanticContext\": \"Serious Adverse Events SAEs In the 2 studies, SAEs were reported at similar rates in subjects who received SHINGRIX 2.3% and placebo 2.2% from the first administered dose up to 30 days post last vaccination.\"\n },\n {\n \"VerbatimTerm\": \"vaccination\",\n \"Probability\": \"0.0040504336\",\n \"SemanticContext\": \"SAEs were reported for 10.1% of subjects who received SHINGRIX and for 10.4% of subjects who received placebo from the first administered dose up to 1 year post last vaccination.\"\n },\n {\n \"VerbatimTerm\": \"vaccination\",\n \"Probability\": \"0.0062631965\",\n \"SemanticContext\": \"Optic ischemic neuropathy was reported in 3 subjects 0.02% who received SHINGRIX all within 50 days after vaccination and 0 subjects who received placebo; available information is insufficient to determine a causal relationship with SHINGRIX.\"\n },\n {\n \"VerbatimTerm\": \"vaccination\",\n \"Probability\": \"0.0035693944\",\n \"SemanticContext\": \"Deaths From the first administered dose up to 30 days post last vaccination, deaths were reported for 0.04% of subjects who received SHINGRIX and 0.05% of subjects who received placebo in the 2 studies.\"\n },\n {\n \"VerbatimTerm\": \"vaccination\",\n \"Probability\": \"0.0017670393\",\n \"SemanticContext\": \"From the first administered dose up to 1 year post last vaccination, deaths were reported for 0.8% of subjects who received SHINGRIX and for 0.9% of subjects who received placebo.\"\n },\n {\n \"VerbatimTerm\": \"vaccination\",\n \"Probability\": \"0.0042244792\",\n \"SemanticContext\": \"Potential Immune-Mediated Diseases In the 2 studies, new onset potential immune-mediated diseases pIMDs or exacerbation of existing pIMDs were reported for 0.6% of subjects who received SHINGRIX and 0.7% of subjects who received placebo from the first administered dose up to 1 year post last vaccination.\"\n },\n {\n \"VerbatimTerm\": \"vaccination\",\n \"Probability\": \"0.0021881163\",\n \"SemanticContext\": \"Postmarketing Observational Study of the Risk of Guillain-Barré Syndrome following Vaccination with SHINGRIX The association between vaccination with SHINGRIX and GBS was evaluated among Medicare beneficiaries aged 65 years or older.\"\n },\n {\n \"VerbatimTerm\": \"vaccination\",\n \"Probability\": \"0.0044140816\",\n \"SemanticContext\": \"The risk of GBS following vaccination with SHINGRIX was assessed in self-controlled case series analyses using a risk window of 1 to 42 days post-vaccination and a control window of 43 to 183 days post-vaccination.\"\n },\n {\n \"VerbatimTerm\": \"vaccination\",\n \"Probability\": \"0.0010361671\",\n \"SemanticContext\": \"The risk of GBS following vaccination with SHINGRIX was assessed in self-controlled case series analyses using a risk window of 1 to 42 days post-vaccination and a control window of 43 to 183 days post-vaccination.\"\n },\n {\n \"VerbatimTerm\": \"vaccination\",\n \"Probability\": \"0.0029852092\",\n \"SemanticContext\": \"The risk of GBS following vaccination with SHINGRIX was assessed in self-controlled case series analyses using a risk window of 1 to 42 days post-vaccination and a control window of 43 to 183 days post-vaccination.\"\n },\n {\n \"VerbatimTerm\": \"vaccination\",\n \"Probability\": \"0.0026928782\",\n \"SemanticContext\": \"The primary analysis claims-based, all doses found an increased risk of GBS during the 42 days following vaccination with SHINGRIX, with an estimated 3 excess cases of GBS per million doses administered to adults aged 65 years or older.\"\n },\n {\n \"VerbatimTerm\": \"vaccination\",\n \"Probability\": \"0.0067073405\",\n \"SemanticContext\": \"In a descriptive analysis, vaccine efficacy against HZ in subjects aged 50 years and older was 93.1% 95% CI: 81.3, 98.2 in the fourth year post-vaccination.\"\n },\n {\n \"VerbatimTerm\": \"vaccination\",\n \"Probability\": \"0.0059975684\",\n \"SemanticContext\": \"In a descriptive analysis, vaccine efficacy against HZ in subjects 70 years and older was 85.1% 95% CI: 64.5, 94.8 in the fourth year after vaccination.\"\n },\n {\n \"VerbatimTerm\": \"vaccination\",\n \"Probability\": \"0.000156492\",\n \"SemanticContext\": \"5 WARNINGS AND PRECAUTIONS 5.1 Preventing and Managing Allergic Vaccine Reactions Prior to administration, the healthcare provider should review the immunization history for possible vaccine sensitivity and previous vaccination-related adverse reactions.\"\n },\n {\n \"VerbatimTerm\": \"vaccination\",\n \"Probability\": \"0.0022826195\",\n \"SemanticContext\": \"\\n 5.2 Guillain- Barré Syndrome GBS In a postmarketing observational study, an increased risk of GBS was observed during the 42 days following vaccination with SHINGRIX [see Adverse Reactions 6.2 ].\"\n },\n {\n \"VerbatimTerm\": \"Vaccination\",\n \"Probability\": \"0.0001363754\",\n \"SemanticContext\": \"Percentage of Subjects with Solicited Local Adverse Reactions and General Adverse Events within 7 Days a of Vaccination in Adults Aged 50 to 59 Years, 60 to 69 Years, and 70 Years and Older b Total Vaccinated Cohort with 7-Day Diary Card Aged 50 - 59 Years Aged 60 - 69 Years Aged =70 Years SHINGRIX % Placebo c % SHINGRIX % Placebo c % SHINGRIX % Placebo c % Local Adverse Reactions n = 1,315 n = 1,312 n = 1,311 n = 1,305 n = 2,258 n = 2,263 Pain 88.4 14.4 82.8 11.1 69.2 8.8 Pain, Grade 3 d 10.3 0.5 6.9 0.5 4.0 0.2 Redness 38.7 1.2 38.4 1.6 37.7 1.2 Redness, >100 mm 2.8 0.0 2.6 0.0 3.1 0.0 Swelling 30.5 0.8 26.5 1.0 23.0 1.1 Swelling, >100 mm 1.1 0.0 0.5 0.0 1.3 0.0 General Adverse Events n = 1,315 n = 1,312 n = 1,309 n = 1,305 n =2,252 n = 2,264 Myalgia 56.9 15.2 49.0 11.2 35.1 9.9 Myalgia, Grade 3 e 8.9 0.9 5.3 0.8 2.8 0.4 Fatigue 57.0 19.8 45.7 16.8 36.6 14.4 Fatigue, Grade 3 e 8.5 1.8 5.0 0.8 3.5 0.8 Headache 50.6 21.6 39.6 15.6 29.0 11.8 Headache, Grade 3 e 6.0 1.7 3.7 0.2 1.5 0.4 Shivering 35.8 7.4 30.3 5.7 19.5 4.9 Shivering, Grade 3 e 6.8 0.2 4.5 0.3 2.2 0.3 Fever 27.8 3.0 23.9 3.4 14.3 2.7 Fever, Grade 3 f 0.4 0.2 0.5 0.2 0.1 0.1 GI g 24.3 10.7 16.7 8.7 13.5 7.6 GI, Grade 3 e 2.1 0.7 0.9 0.6 1.2 0.4 .\"\n },\n {\n \"VerbatimTerm\": \"Vaccination\",\n \"Probability\": \"0.0007508695\",\n \"SemanticContext\": \"Postmarketing Observational Study of the Risk of Guillain-Barré Syndrome following Vaccination with SHINGRIX The association between vaccination with SHINGRIX and GBS was evaluated among Medicare beneficiaries aged 65 years or older.\"\n },\n {\n \"VerbatimTerm\": \"Vaccination\",\n \"Probability\": \"0.0037438571\",\n \"SemanticContext\": \"Vaccination of female rats with SHINGRIX had no effect on fertility [see Use in Specific Populations 8.1 ] .\"\n },\n {\n \"VerbatimTerm\": \"vaccinations\",\n \"Probability\": \"0.0036821961\",\n \"SemanticContext\": \"Using Medicare claims data, from October 2017 through February 2020, vaccinations with SHINGRIX among beneficiaries were identified through National Drug Codes, and potential cases of hospitalized GBS among recipients of SHINGRIX were identified through International Classification of Diseases codes.\"\n }\n ]\n },\n {\n \"Term\": \"Dizziness\",\n \"MEDDRACode\": \"10013573\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"dizziness\",\n \"Probability\": \"0.9992892742\",\n \"SemanticContext\": \"Unsolicited adverse events that occurred in =1% of recipients of SHINGRIX and at a rate at least 1.5-fold higher than placebo included chills 3.5% versus 0.2% , injection site pruritus 2.2% versus 0.2% , malaise 1.7% versus 0.3% , arthralgia 1.7% versus 1.2% , nausea 1.4% versus 0.5% , and dizziness 1.2% versus 0.8% .\"\n }\n ]\n },\n {\n \"Term\": \"Rash\",\n \"MEDDRACode\": \"10037844\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"rash\",\n \"Probability\": \"0.9995014668\",\n \"SemanticContext\": \"Immune System Disorders Hypersensitivity reactions, including angioedema, rash, and urticaria.\"\n },\n {\n \"VerbatimTerm\": \"rash\",\n \"Probability\": \"0.9895662665\",\n \"SemanticContext\": \"Suspected HZ cases were followed prospectively for the development of PHN, an HZ-related complication defined as HZ-associated pain rated as 3 or greater on a 0- to 10-point scale by the study subject occurring or persisting at least 90 days following the onset of rash in confirmed cases of HZ.\"\n },\n {\n \"VerbatimTerm\": \"rash\",\n \"Probability\": \"0.9958084822\",\n \"SemanticContext\": \"c PHN = Postherpetic neuralgia defined as HZ-associated pain rated as 3 or greater on a 0- to 10 point scale occurring or persisting at least 90 days following the onset of rash using Zoster Brief Pain Inventory questionnaire.\"\n }\n ]\n },\n {\n \"Term\": \"Immune system disorder\",\n \"MEDDRACode\": \"10021425\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Immune System Disorders\",\n \"Probability\": \"0.0029853582\",\n \"SemanticContext\": \"Immune System Disorders Hypersensitivity reactions, including angioedema, rash, and urticaria.\"\n }\n ]\n },\n {\n \"Term\": \"Pregnancy\",\n \"MEDDRACode\": \"10036556\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"pregnant\",\n \"Probability\": \"0.001083076\",\n \"SemanticContext\": \"There are no available human data to establish whether there is vaccine-associated risk with SHINGRIX in pregnant women.\"\n }\n ]\n },\n {\n \"Term\": \"Erythema\",\n \"MEDDRACode\": \"10015150\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"redness\",\n \"Probability\": \"0.998662293\",\n \"SemanticContext\": \"5.2, 6.2 ADVERSE REACTIONS • Solicited local adverse reactions in subjects aged 50 years and older were pain 78.0% , redness 38.1% , and swelling 25.9% .\"\n },\n {\n \"VerbatimTerm\": \"redness\",\n \"Probability\": \"0.9994713664\",\n \"SemanticContext\": \"Across both studies, the percentages of subjects aged 50 years and older reporting each solicited local adverse reaction and each solicited general adverse event following administration of SHINGRIX both doses combined were pain 78.0% , redness 38.1% , and swelling 25.9% ; and myalgia 44.7% , fatigue 44.5% , headache 37.7% , shivering 26.8% , fever 20.5% , and gastrointestinal symptoms 17.3% , respectively.\"\n },\n {\n \"VerbatimTerm\": \"Redness\",\n \"Probability\": \"0.9971604943\",\n \"SemanticContext\": \"Percentage of Subjects with Solicited Local Adverse Reactions and General Adverse Events within 7 Days a of Vaccination in Adults Aged 50 to 59 Years, 60 to 69 Years, and 70 Years and Older b Total Vaccinated Cohort with 7-Day Diary Card Aged 50 - 59 Years Aged 60 - 69 Years Aged =70 Years SHINGRIX % Placebo c % SHINGRIX % Placebo c % SHINGRIX % Placebo c % Local Adverse Reactions n = 1,315 n = 1,312 n = 1,311 n = 1,305 n = 2,258 n = 2,263 Pain 88.4 14.4 82.8 11.1 69.2 8.8 Pain, Grade 3 d 10.3 0.5 6.9 0.5 4.0 0.2 Redness 38.7 1.2 38.4 1.6 37.7 1.2 Redness, >100 mm 2.8 0.0 2.6 0.0 3.1 0.0 Swelling 30.5 0.8 26.5 1.0 23.0 1.1 Swelling, >100 mm 1.1 0.0 0.5 0.0 1.3 0.0 General Adverse Events n = 1,315 n = 1,312 n = 1,309 n = 1,305 n =2,252 n = 2,264 Myalgia 56.9 15.2 49.0 11.2 35.1 9.9 Myalgia, Grade 3 e 8.9 0.9 5.3 0.8 2.8 0.4 Fatigue 57.0 19.8 45.7 16.8 36.6 14.4 Fatigue, Grade 3 e 8.5 1.8 5.0 0.8 3.5 0.8 Headache 50.6 21.6 39.6 15.6 29.0 11.8 Headache, Grade 3 e 6.0 1.7 3.7 0.2 1.5 0.4 Shivering 35.8 7.4 30.3 5.7 19.5 4.9 Shivering, Grade 3 e 6.8 0.2 4.5 0.3 2.2 0.3 Fever 27.8 3.0 23.9 3.4 14.3 2.7 Fever, Grade 3 f 0.4 0.2 0.5 0.2 0.1 0.1 GI g 24.3 10.7 16.7 8.7 13.5 7.6 GI, Grade 3 e 2.1 0.7 0.9 0.6 1.2 0.4 .\"\n },\n {\n \"VerbatimTerm\": \"Redness\",\n \"Probability\": \"0.9712846279\",\n \"SemanticContext\": \"Percentage of Subjects with Solicited Local Adverse Reactions and General Adverse Events within 7 Days a of Vaccination in Adults Aged 50 to 59 Years, 60 to 69 Years, and 70 Years and Older b Total Vaccinated Cohort with 7-Day Diary Card Aged 50 - 59 Years Aged 60 - 69 Years Aged =70 Years SHINGRIX % Placebo c % SHINGRIX % Placebo c % SHINGRIX % Placebo c % Local Adverse Reactions n = 1,315 n = 1,312 n = 1,311 n = 1,305 n = 2,258 n = 2,263 Pain 88.4 14.4 82.8 11.1 69.2 8.8 Pain, Grade 3 d 10.3 0.5 6.9 0.5 4.0 0.2 Redness 38.7 1.2 38.4 1.6 37.7 1.2 Redness, >100 mm 2.8 0.0 2.6 0.0 3.1 0.0 Swelling 30.5 0.8 26.5 1.0 23.0 1.1 Swelling, >100 mm 1.1 0.0 0.5 0.0 1.3 0.0 General Adverse Events n = 1,315 n = 1,312 n = 1,309 n = 1,305 n =2,252 n = 2,264 Myalgia 56.9 15.2 49.0 11.2 35.1 9.9 Myalgia, Grade 3 e 8.9 0.9 5.3 0.8 2.8 0.4 Fatigue 57.0 19.8 45.7 16.8 36.6 14.4 Fatigue, Grade 3 e 8.5 1.8 5.0 0.8 3.5 0.8 Headache 50.6 21.6 39.6 15.6 29.0 11.8 Headache, Grade 3 e 6.0 1.7 3.7 0.2 1.5 0.4 Shivering 35.8 7.4 30.3 5.7 19.5 4.9 Shivering, Grade 3 e 6.8 0.2 4.5 0.3 2.2 0.3 Fever 27.8 3.0 23.9 3.4 14.3 2.7 Fever, Grade 3 f 0.4 0.2 0.5 0.2 0.1 0.1 GI g 24.3 10.7 16.7 8.7 13.5 7.6 GI, Grade 3 e 2.1 0.7 0.9 0.6 1.2 0.4 .\"\n }\n ]\n },\n {\n \"Term\": \"Local reaction\",\n \"MEDDRACode\": \"10024769\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"local reactions\",\n \"Probability\": \"0.0022811294\",\n \"SemanticContext\": \"There were no differences in the proportions of subjects reporting any or Grade 3 solicited local reactions between Dose 1 and Dose 2.\"\n }\n ]\n },\n {\n \"Term\": \"Gait disturbance\",\n \"MEDDRACode\": \"10017577\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"steps\",\n \"Probability\": \"0.0754784346\",\n \"SemanticContext\": \"The gE protein is purified by several chromatographic steps, formulated with excipients, filled into vials, and lyophilized.\"\n }\n ]\n },\n {\n \"Term\": \"Immunology test\",\n \"MEDDRACode\": \"10062297\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"ELISA\",\n \"Probability\": \"8.42358E-05\",\n \"SemanticContext\": \"Anti-gE antibody levels were measured by anti-gE enzyme-linked immunosorbent assay gE ELISA and were used to support the dosing schedule.\"\n },\n {\n \"VerbatimTerm\": \"ELISA\",\n \"Probability\": \"0.000181824\",\n \"SemanticContext\": \"Non-inferiority of the 0- and 6-month schedule compared with the 0- and 2-month schedule based on anti-gE ELISA GMCs 1 month after the second dose was demonstrated.\"\n }\n ]\n },\n {\n \"Term\": \"Blood chloride\",\n \"MEDDRACode\": \"10005416\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"chloride\",\n \"Probability\": \"0.0056106746\",\n \"SemanticContext\": \"The liposomes are composed of dioleoyl phosphatidylcholine DOPC and cholesterol in phosphate-buffered saline solution containing disodium phosphate anhydrous, potassium dihydrogen phosphate, sodium chloride, and water for injection.\"\n },\n {\n \"VerbatimTerm\": \"chloride\",\n \"Probability\": \"3.73544E-05\",\n \"SemanticContext\": \"Each dose also contains 20 mg of sucrose as stabilizer , 4.385 mg of sodium chloride, 1 mg of DOPC, 0.54 mg of potassium dihydrogen phosphate, 0.25 mg of cholesterol, 0.160 mg of sodium dihydrogen phosphate dihydrate, 0.15 mg of disodium phosphate anhydrous, 0.116 mg of dipotassium phosphate, and 0.08 mg of polysorbate 80.\"\n }\n ]\n },\n {\n \"Term\": \"Mobility decreased\",\n \"MEDDRACode\": \"10048334\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Decreased mobility\",\n \"Probability\": \"0.2333418131\",\n \"SemanticContext\": \"General Disorders and Administration Site Conditions Decreased mobility of the injected arm which may persist for 1 or more weeks.\"\n }\n ]\n },\n {\n \"Term\": \"Fatigue\",\n \"MEDDRACode\": \"10016256\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"fatigue\",\n \"Probability\": \"0.9995365739\",\n \"SemanticContext\": \"6.1 • Solicited general adverse reactions in subjects aged 50 years and older were myalgia 44.7% , fatigue 44.5% , headache 37.7% , shivering 26.8% , fever 20.5% , and gastrointestinal symptoms 17.3% .\"\n },\n {\n \"VerbatimTerm\": \"fatigue\",\n \"Probability\": \"0.9994075298\",\n \"SemanticContext\": \"Across both studies, the percentages of subjects aged 50 years and older reporting each solicited local adverse reaction and each solicited general adverse event following administration of SHINGRIX both doses combined were pain 78.0% , redness 38.1% , and swelling 25.9% ; and myalgia 44.7% , fatigue 44.5% , headache 37.7% , shivering 26.8% , fever 20.5% , and gastrointestinal symptoms 17.3% , respectively.\"\n },\n {\n \"VerbatimTerm\": \"fatigue\",\n \"Probability\": \"0.9904481173\",\n \"SemanticContext\": \"e Grade 3 myalgia, fatigue, headache, shivering, GI: Defined as preventing normal activity.\"\n },\n {\n \"VerbatimTerm\": \"fatigue\",\n \"Probability\": \"0.9932388067\",\n \"SemanticContext\": \"Grade 3 solicited general adverse events headache, shivering, myalgia, and fatigue were reported more frequently by subjects after Dose 2 2.3%, 3.1%, 3.6%, and 3.5%, respectively compared with Dose 1 1.4%, 1.4%, 2.3%, and 2.4%, respectively .\"\n },\n {\n \"VerbatimTerm\": \"Fatigue\",\n \"Probability\": \"0.9989528656\",\n \"SemanticContext\": \"Percentage of Subjects with Solicited Local Adverse Reactions and General Adverse Events within 7 Days a of Vaccination in Adults Aged 50 to 59 Years, 60 to 69 Years, and 70 Years and Older b Total Vaccinated Cohort with 7-Day Diary Card Aged 50 - 59 Years Aged 60 - 69 Years Aged =70 Years SHINGRIX % Placebo c % SHINGRIX % Placebo c % SHINGRIX % Placebo c % Local Adverse Reactions n = 1,315 n = 1,312 n = 1,311 n = 1,305 n = 2,258 n = 2,263 Pain 88.4 14.4 82.8 11.1 69.2 8.8 Pain, Grade 3 d 10.3 0.5 6.9 0.5 4.0 0.2 Redness 38.7 1.2 38.4 1.6 37.7 1.2 Redness, >100 mm 2.8 0.0 2.6 0.0 3.1 0.0 Swelling 30.5 0.8 26.5 1.0 23.0 1.1 Swelling, >100 mm 1.1 0.0 0.5 0.0 1.3 0.0 General Adverse Events n = 1,315 n = 1,312 n = 1,309 n = 1,305 n =2,252 n = 2,264 Myalgia 56.9 15.2 49.0 11.2 35.1 9.9 Myalgia, Grade 3 e 8.9 0.9 5.3 0.8 2.8 0.4 Fatigue 57.0 19.8 45.7 16.8 36.6 14.4 Fatigue, Grade 3 e 8.5 1.8 5.0 0.8 3.5 0.8 Headache 50.6 21.6 39.6 15.6 29.0 11.8 Headache, Grade 3 e 6.0 1.7 3.7 0.2 1.5 0.4 Shivering 35.8 7.4 30.3 5.7 19.5 4.9 Shivering, Grade 3 e 6.8 0.2 4.5 0.3 2.2 0.3 Fever 27.8 3.0 23.9 3.4 14.3 2.7 Fever, Grade 3 f 0.4 0.2 0.5 0.2 0.1 0.1 GI g 24.3 10.7 16.7 8.7 13.5 7.6 GI, Grade 3 e 2.1 0.7 0.9 0.6 1.2 0.4 .\"\n },\n {\n \"VerbatimTerm\": \"Fatigue\",\n \"Probability\": \"0.8494515419\",\n \"SemanticContext\": \"Percentage of Subjects with Solicited Local Adverse Reactions and General Adverse Events within 7 Days a of Vaccination in Adults Aged 50 to 59 Years, 60 to 69 Years, and 70 Years and Older b Total Vaccinated Cohort with 7-Day Diary Card Aged 50 - 59 Years Aged 60 - 69 Years Aged =70 Years SHINGRIX % Placebo c % SHINGRIX % Placebo c % SHINGRIX % Placebo c % Local Adverse Reactions n = 1,315 n = 1,312 n = 1,311 n = 1,305 n = 2,258 n = 2,263 Pain 88.4 14.4 82.8 11.1 69.2 8.8 Pain, Grade 3 d 10.3 0.5 6.9 0.5 4.0 0.2 Redness 38.7 1.2 38.4 1.6 37.7 1.2 Redness, >100 mm 2.8 0.0 2.6 0.0 3.1 0.0 Swelling 30.5 0.8 26.5 1.0 23.0 1.1 Swelling, >100 mm 1.1 0.0 0.5 0.0 1.3 0.0 General Adverse Events n = 1,315 n = 1,312 n = 1,309 n = 1,305 n =2,252 n = 2,264 Myalgia 56.9 15.2 49.0 11.2 35.1 9.9 Myalgia, Grade 3 e 8.9 0.9 5.3 0.8 2.8 0.4 Fatigue 57.0 19.8 45.7 16.8 36.6 14.4 Fatigue, Grade 3 e 8.5 1.8 5.0 0.8 3.5 0.8 Headache 50.6 21.6 39.6 15.6 29.0 11.8 Headache, Grade 3 e 6.0 1.7 3.7 0.2 1.5 0.4 Shivering 35.8 7.4 30.3 5.7 19.5 4.9 Shivering, Grade 3 e 6.8 0.2 4.5 0.3 2.2 0.3 Fever 27.8 3.0 23.9 3.4 14.3 2.7 Fever, Grade 3 f 0.4 0.2 0.5 0.2 0.1 0.1 GI g 24.3 10.7 16.7 8.7 13.5 7.6 GI, Grade 3 e 2.1 0.7 0.9 0.6 1.2 0.4 .\"\n }\n ]\n },\n {\n \"Term\": \"Anaphylactic reaction\",\n \"MEDDRACode\": \"10002198\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": true,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"anaphylactic reactions\",\n \"Probability\": \"0.0004946291\",\n \"SemanticContext\": \"Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of SHINGRIX.\"\n }\n ]\n },\n {\n \"Term\": \"Breast feeding\",\n \"MEDDRACode\": \"10006247\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": true,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"breastfed\",\n \"Probability\": \"0.0001095341\",\n \"SemanticContext\": \"Data are not available to assess the effects of SHINGRIX on the breastfed infant or on milk production/excretion.\"\n },\n {\n \"VerbatimTerm\": \"breastfed\",\n \"Probability\": \"4.81279E-05\",\n \"SemanticContext\": \"The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for SHINGRIX and any potential adverse effects on the breastfed child from SHINGRIX or from the underlying maternal condition.\"\n },\n {\n \"VerbatimTerm\": \"breastfeeding\",\n \"Probability\": \"0.0001323223\",\n \"SemanticContext\": \"The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for SHINGRIX and any potential adverse effects on the breastfed child from SHINGRIX or from the underlying maternal condition.\"\n }\n ]\n },\n {\n \"Term\": \"Urticaria\",\n \"MEDDRACode\": \"10046735\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"urticaria\",\n \"Probability\": \"0.9990267754\",\n \"SemanticContext\": \"Immune System Disorders Hypersensitivity reactions, including angioedema, rash, and urticaria.\"\n }\n ]\n },\n {\n \"Term\": \"Blindness\",\n \"MEDDRACode\": \"10005169\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"blind\",\n \"Probability\": \"0.0065948963\",\n \"SemanticContext\": \"14 CLINICAL STUDIES 14.1 Efficacy in Subjects 50 Years and Older Study 1 was a randomized, placebo-controlled, observer-blind clinical study conducted in 18 countries.\"\n },\n {\n \"VerbatimTerm\": \"blind\",\n \"Probability\": \"0.0051788986\",\n \"SemanticContext\": \"14.2 Efficacy in Subjects 70 Years and Older Study 2 was a randomized, placebo-controlled, observer-blind clinical study conducted in 18 countries.\"\n }\n ]\n },\n {\n \"Term\": \"Blood cholesterol\",\n \"MEDDRACode\": \"10005422\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"cholesterol\",\n \"Probability\": \"8.72995E-05\",\n \"SemanticContext\": \"The liposomes are composed of dioleoyl phosphatidylcholine DOPC and cholesterol in phosphate-buffered saline solution containing disodium phosphate anhydrous, potassium dihydrogen phosphate, sodium chloride, and water for injection.\"\n },\n {\n \"VerbatimTerm\": \"cholesterol\",\n \"Probability\": \"5.247E-05\",\n \"SemanticContext\": \"Each dose also contains 20 mg of sucrose as stabilizer , 4.385 mg of sodium chloride, 1 mg of DOPC, 0.54 mg of potassium dihydrogen phosphate, 0.25 mg of cholesterol, 0.160 mg of sodium dihydrogen phosphate dihydrate, 0.15 mg of disodium phosphate anhydrous, 0.116 mg of dipotassium phosphate, and 0.08 mg of polysorbate 80.\"\n }\n ]\n },\n {\n \"Term\": \"Syringomyelia\",\n \"MEDDRACode\": \"10042928\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0007957816\",\n \"SemanticContext\": \"Using a sterile needle and sterile syringe, withdraw the entire contents of the vial containing the adjuvant suspension component liquid by slightly tilting the vial.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0056707263\",\n \"SemanticContext\": \"Slowly transfer entire contents of syringe into the lyophilized gE antigen component vial powder .\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.1345677674\",\n \"SemanticContext\": \"Use a separate sterile needle and sterile syringe for each individual.\"\n }\n ]\n },\n {\n \"Term\": \"Pyrexia\",\n \"MEDDRACode\": \"10037660\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"fever\",\n \"Probability\": \"0.9998801351\",\n \"SemanticContext\": \"6.1 • Solicited general adverse reactions in subjects aged 50 years and older were myalgia 44.7% , fatigue 44.5% , headache 37.7% , shivering 26.8% , fever 20.5% , and gastrointestinal symptoms 17.3% .\"\n },\n {\n \"VerbatimTerm\": \"fever\",\n \"Probability\": \"0.999879837\",\n \"SemanticContext\": \"Across both studies, the percentages of subjects aged 50 years and older reporting each solicited local adverse reaction and each solicited general adverse event following administration of SHINGRIX both doses combined were pain 78.0% , redness 38.1% , and swelling 25.9% ; and myalgia 44.7% , fatigue 44.5% , headache 37.7% , shivering 26.8% , fever 20.5% , and gastrointestinal symptoms 17.3% , respectively.\"\n },\n {\n \"VerbatimTerm\": \"fever\",\n \"Probability\": \"0.420519501\",\n \"SemanticContext\": \"f Fever defined as =37.5°C/99.5°F for oral, axillary, or tympanic route, or =38°C/100.4°F for rectal route; Grade 3 fever defined as >39.0°C/102.2°F.\"\n },\n {\n \"VerbatimTerm\": \"fever\",\n \"Probability\": \"0.8982678652\",\n \"SemanticContext\": \"One subject\\n <0.01% reported lymphadenitis and 1 subject \\n <0.01% reported fever greater than 39°C; there was a basis for a causal relationship with SHINGRIX.\"\n },\n {\n \"VerbatimTerm\": \"Fever\",\n \"Probability\": \"0.9996385574\",\n \"SemanticContext\": \"Percentage of Subjects with Solicited Local Adverse Reactions and General Adverse Events within 7 Days a of Vaccination in Adults Aged 50 to 59 Years, 60 to 69 Years, and 70 Years and Older b Total Vaccinated Cohort with 7-Day Diary Card Aged 50 - 59 Years Aged 60 - 69 Years Aged =70 Years SHINGRIX % Placebo c % SHINGRIX % Placebo c % SHINGRIX % Placebo c % Local Adverse Reactions n = 1,315 n = 1,312 n = 1,311 n = 1,305 n = 2,258 n = 2,263 Pain 88.4 14.4 82.8 11.1 69.2 8.8 Pain, Grade 3 d 10.3 0.5 6.9 0.5 4.0 0.2 Redness 38.7 1.2 38.4 1.6 37.7 1.2 Redness, >100 mm 2.8 0.0 2.6 0.0 3.1 0.0 Swelling 30.5 0.8 26.5 1.0 23.0 1.1 Swelling, >100 mm 1.1 0.0 0.5 0.0 1.3 0.0 General Adverse Events n = 1,315 n = 1,312 n = 1,309 n = 1,305 n =2,252 n = 2,264 Myalgia 56.9 15.2 49.0 11.2 35.1 9.9 Myalgia, Grade 3 e 8.9 0.9 5.3 0.8 2.8 0.4 Fatigue 57.0 19.8 45.7 16.8 36.6 14.4 Fatigue, Grade 3 e 8.5 1.8 5.0 0.8 3.5 0.8 Headache 50.6 21.6 39.6 15.6 29.0 11.8 Headache, Grade 3 e 6.0 1.7 3.7 0.2 1.5 0.4 Shivering 35.8 7.4 30.3 5.7 19.5 4.9 Shivering, Grade 3 e 6.8 0.2 4.5 0.3 2.2 0.3 Fever 27.8 3.0 23.9 3.4 14.3 2.7 Fever, Grade 3 f 0.4 0.2 0.5 0.2 0.1 0.1 GI g 24.3 10.7 16.7 8.7 13.5 7.6 GI, Grade 3 e 2.1 0.7 0.9 0.6 1.2 0.4 .\"\n },\n {\n \"VerbatimTerm\": \"Fever\",\n \"Probability\": \"0.9828311205\",\n \"SemanticContext\": \"Percentage of Subjects with Solicited Local Adverse Reactions and General Adverse Events within 7 Days a of Vaccination in Adults Aged 50 to 59 Years, 60 to 69 Years, and 70 Years and Older b Total Vaccinated Cohort with 7-Day Diary Card Aged 50 - 59 Years Aged 60 - 69 Years Aged =70 Years SHINGRIX % Placebo c % SHINGRIX % Placebo c % SHINGRIX % Placebo c % Local Adverse Reactions n = 1,315 n = 1,312 n = 1,311 n = 1,305 n = 2,258 n = 2,263 Pain 88.4 14.4 82.8 11.1 69.2 8.8 Pain, Grade 3 d 10.3 0.5 6.9 0.5 4.0 0.2 Redness 38.7 1.2 38.4 1.6 37.7 1.2 Redness, >100 mm 2.8 0.0 2.6 0.0 3.1 0.0 Swelling 30.5 0.8 26.5 1.0 23.0 1.1 Swelling, >100 mm 1.1 0.0 0.5 0.0 1.3 0.0 General Adverse Events n = 1,315 n = 1,312 n = 1,309 n = 1,305 n =2,252 n = 2,264 Myalgia 56.9 15.2 49.0 11.2 35.1 9.9 Myalgia, Grade 3 e 8.9 0.9 5.3 0.8 2.8 0.4 Fatigue 57.0 19.8 45.7 16.8 36.6 14.4 Fatigue, Grade 3 e 8.5 1.8 5.0 0.8 3.5 0.8 Headache 50.6 21.6 39.6 15.6 29.0 11.8 Headache, Grade 3 e 6.0 1.7 3.7 0.2 1.5 0.4 Shivering 35.8 7.4 30.3 5.7 19.5 4.9 Shivering, Grade 3 e 6.8 0.2 4.5 0.3 2.2 0.3 Fever 27.8 3.0 23.9 3.4 14.3 2.7 Fever, Grade 3 f 0.4 0.2 0.5 0.2 0.1 0.1 GI g 24.3 10.7 16.7 8.7 13.5 7.6 GI, Grade 3 e 2.1 0.7 0.9 0.6 1.2 0.4 .\"\n },\n {\n \"VerbatimTerm\": \"Fever\",\n \"Probability\": \"0.7310901284\",\n \"SemanticContext\": \"f Fever defined as =37.5°C/99.5°F for oral, axillary, or tympanic route, or =38°C/100.4°F for rectal route; Grade 3 fever defined as >39.0°C/102.2°F.\"\n }\n ]\n },\n {\n \"Term\": \"Myalgia\",\n \"MEDDRACode\": \"10028411\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"myalgia\",\n \"Probability\": \"0.999610126\",\n \"SemanticContext\": \"6.1 • Solicited general adverse reactions in subjects aged 50 years and older were myalgia 44.7% , fatigue 44.5% , headache 37.7% , shivering 26.8% , fever 20.5% , and gastrointestinal symptoms 17.3% .\"\n },\n {\n \"VerbatimTerm\": \"myalgia\",\n \"Probability\": \"0.9996606112\",\n \"SemanticContext\": \"Across both studies, the percentages of subjects aged 50 years and older reporting each solicited local adverse reaction and each solicited general adverse event following administration of SHINGRIX both doses combined were pain 78.0% , redness 38.1% , and swelling 25.9% ; and myalgia 44.7% , fatigue 44.5% , headache 37.7% , shivering 26.8% , fever 20.5% , and gastrointestinal symptoms 17.3% , respectively.\"\n },\n {\n \"VerbatimTerm\": \"myalgia\",\n \"Probability\": \"0.997608602\",\n \"SemanticContext\": \"e Grade 3 myalgia, fatigue, headache, shivering, GI: Defined as preventing normal activity.\"\n },\n {\n \"VerbatimTerm\": \"myalgia\",\n \"Probability\": \"0.9993927479\",\n \"SemanticContext\": \"Grade 3 solicited general adverse events headache, shivering, myalgia, and fatigue were reported more frequently by subjects after Dose 2 2.3%, 3.1%, 3.6%, and 3.5%, respectively compared with Dose 1 1.4%, 1.4%, 2.3%, and 2.4%, respectively .\"\n },\n {\n \"VerbatimTerm\": \"Myalgia\",\n \"Probability\": \"0.9996000528\",\n \"SemanticContext\": \"Percentage of Subjects with Solicited Local Adverse Reactions and General Adverse Events within 7 Days a of Vaccination in Adults Aged 50 to 59 Years, 60 to 69 Years, and 70 Years and Older b Total Vaccinated Cohort with 7-Day Diary Card Aged 50 - 59 Years Aged 60 - 69 Years Aged =70 Years SHINGRIX % Placebo c % SHINGRIX % Placebo c % SHINGRIX % Placebo c % Local Adverse Reactions n = 1,315 n = 1,312 n = 1,311 n = 1,305 n = 2,258 n = 2,263 Pain 88.4 14.4 82.8 11.1 69.2 8.8 Pain, Grade 3 d 10.3 0.5 6.9 0.5 4.0 0.2 Redness 38.7 1.2 38.4 1.6 37.7 1.2 Redness, >100 mm 2.8 0.0 2.6 0.0 3.1 0.0 Swelling 30.5 0.8 26.5 1.0 23.0 1.1 Swelling, >100 mm 1.1 0.0 0.5 0.0 1.3 0.0 General Adverse Events n = 1,315 n = 1,312 n = 1,309 n = 1,305 n =2,252 n = 2,264 Myalgia 56.9 15.2 49.0 11.2 35.1 9.9 Myalgia, Grade 3 e 8.9 0.9 5.3 0.8 2.8 0.4 Fatigue 57.0 19.8 45.7 16.8 36.6 14.4 Fatigue, Grade 3 e 8.5 1.8 5.0 0.8 3.5 0.8 Headache 50.6 21.6 39.6 15.6 29.0 11.8 Headache, Grade 3 e 6.0 1.7 3.7 0.2 1.5 0.4 Shivering 35.8 7.4 30.3 5.7 19.5 4.9 Shivering, Grade 3 e 6.8 0.2 4.5 0.3 2.2 0.3 Fever 27.8 3.0 23.9 3.4 14.3 2.7 Fever, Grade 3 f 0.4 0.2 0.5 0.2 0.1 0.1 GI g 24.3 10.7 16.7 8.7 13.5 7.6 GI, Grade 3 e 2.1 0.7 0.9 0.6 1.2 0.4 .\"\n },\n {\n \"VerbatimTerm\": \"Myalgia\",\n \"Probability\": \"0.9723286629\",\n \"SemanticContext\": \"Percentage of Subjects with Solicited Local Adverse Reactions and General Adverse Events within 7 Days a of Vaccination in Adults Aged 50 to 59 Years, 60 to 69 Years, and 70 Years and Older b Total Vaccinated Cohort with 7-Day Diary Card Aged 50 - 59 Years Aged 60 - 69 Years Aged =70 Years SHINGRIX % Placebo c % SHINGRIX % Placebo c % SHINGRIX % Placebo c % Local Adverse Reactions n = 1,315 n = 1,312 n = 1,311 n = 1,305 n = 2,258 n = 2,263 Pain 88.4 14.4 82.8 11.1 69.2 8.8 Pain, Grade 3 d 10.3 0.5 6.9 0.5 4.0 0.2 Redness 38.7 1.2 38.4 1.6 37.7 1.2 Redness, >100 mm 2.8 0.0 2.6 0.0 3.1 0.0 Swelling 30.5 0.8 26.5 1.0 23.0 1.1 Swelling, >100 mm 1.1 0.0 0.5 0.0 1.3 0.0 General Adverse Events n = 1,315 n = 1,312 n = 1,309 n = 1,305 n =2,252 n = 2,264 Myalgia 56.9 15.2 49.0 11.2 35.1 9.9 Myalgia, Grade 3 e 8.9 0.9 5.3 0.8 2.8 0.4 Fatigue 57.0 19.8 45.7 16.8 36.6 14.4 Fatigue, Grade 3 e 8.5 1.8 5.0 0.8 3.5 0.8 Headache 50.6 21.6 39.6 15.6 29.0 11.8 Headache, Grade 3 e 6.0 1.7 3.7 0.2 1.5 0.4 Shivering 35.8 7.4 30.3 5.7 19.5 4.9 Shivering, Grade 3 e 6.8 0.2 4.5 0.3 2.2 0.3 Fever 27.8 3.0 23.9 3.4 14.3 2.7 Fever, Grade 3 f 0.4 0.2 0.5 0.2 0.1 0.1 GI g 24.3 10.7 16.7 8.7 13.5 7.6 GI, Grade 3 e 2.1 0.7 0.9 0.6 1.2 0.4 .\"\n }\n ]\n },\n {\n \"Term\": \"Infection\",\n \"MEDDRACode\": \"10021789\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"infection\",\n \"Probability\": \"0.0003611147\",\n \"SemanticContext\": \"• SHINGRIX is not indicated for prevention of primary varicella infection chickenpox .\"\n },\n {\n \"VerbatimTerm\": \"infection\",\n \"Probability\": \"0.0005685389\",\n \"SemanticContext\": \"Limitations of Use : • SHINGRIX is not indicated for prevention of primary varicella infection chickenpox .\"\n },\n {\n \"VerbatimTerm\": \"infection\",\n \"Probability\": \"0.0008632541\",\n \"SemanticContext\": \"SHINGRIX is not indicated for prevention of primary varicella infection chickenpox .\"\n }\n ]\n },\n {\n \"Term\": \"Lipids\",\n \"MEDDRACode\": \"10024587\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"lipid\",\n \"Probability\": \"2.4374E-06\",\n \"SemanticContext\": \"The adjuvant suspension component is AS01 B which is composed of 3- O -desacyl-4’-monophosphoryl lipid A MPL from Salmonella minnesota and QS-21, a saponin purified from plant extract Quillaja saponaria Molina, combined in a liposomal formulation.\"\n }\n ]\n },\n {\n \"Term\": \"No adverse event\",\n \"MEDDRACode\": \"10067482\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"no adverse effects\",\n \"Probability\": \"0.0025804043\",\n \"SemanticContext\": \"This study revealed no adverse effects on fetal or pre-weaning development due to SHINGRIX see Data .\"\n },\n {\n \"VerbatimTerm\": \"No adverse effects\",\n \"Probability\": \"0.0043531656\",\n \"SemanticContext\": \"No adverse effects on pre-weaning development up to post-natal Day 25 were observed.\"\n }\n ]\n },\n {\n \"Term\": \"Varicella zoster virus infection\",\n \"MEDDRACode\": \"10075611\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"varicella zoster\",\n \"Probability\": \"0.0002133548\",\n \"SemanticContext\": \"DOSAGE FORMS AND STRENGTHS Suspension for injection supplied as a single-dose vial of lyophilized varicella zoster virus glycoprotein E gE antigen component to be reconstituted with the accompanying vial of AS01 B adjuvant suspension component.\"\n },\n {\n \"VerbatimTerm\": \"varicella zoster\",\n \"Probability\": \"4.30655E-05\",\n \"SemanticContext\": \"The vaccine is supplied as a vial of lyophilized recombinant varicella zoster virus surface glycoprotein E gE antigen component, which must be reconstituted at the time of use with the accompanying vial of AS01 B adjuvant suspension component.\"\n },\n {\n \"VerbatimTerm\": \"varicella zoster\",\n \"Probability\": \"3.46479E-05\",\n \"SemanticContext\": \"Prepare SHINGRIX by reconstituting the lyophilized varicella zoster virus glycoprotein E gE antigen component powder with the accompanying AS01 B adjuvant suspension component liquid .\"\n }\n ]\n },\n {\n \"Term\": \"Varicella\",\n \"MEDDRACode\": \"10046980\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"varicella\",\n \"Probability\": \"0.0008983314\",\n \"SemanticContext\": \"• SHINGRIX is not indicated for prevention of primary varicella infection chickenpox .\"\n },\n {\n \"VerbatimTerm\": \"varicella\",\n \"Probability\": \"0.7435947061\",\n \"SemanticContext\": \"The study excluded, among others, subjects who were immunocompromised, had a history of previous HZ, were vaccinated against varicella or HZ, and patients whose survival was not expected to be at least 4 years or with conditions that might interfere with study evaluations.\"\n },\n {\n \"VerbatimTerm\": \"varicella\",\n \"Probability\": \"0.0009151697\",\n \"SemanticContext\": \"Limitations of Use : • SHINGRIX is not indicated for prevention of primary varicella infection chickenpox .\"\n },\n {\n \"VerbatimTerm\": \"varicella\",\n \"Probability\": \"0.0016783774\",\n \"SemanticContext\": \"SHINGRIX is not indicated for prevention of primary varicella infection chickenpox .\"\n }\n ]\n },\n {\n \"Term\": \"Blood sodium\",\n \"MEDDRACode\": \"10005799\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0073271096\",\n \"SemanticContext\": \"The liposomes are composed of dioleoyl phosphatidylcholine DOPC and cholesterol in phosphate-buffered saline solution containing disodium phosphate anhydrous, potassium dihydrogen phosphate, sodium chloride, and water for injection.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"2.43168E-05\",\n \"SemanticContext\": \"Each dose also contains 20 mg of sucrose as stabilizer , 4.385 mg of sodium chloride, 1 mg of DOPC, 0.54 mg of potassium dihydrogen phosphate, 0.25 mg of cholesterol, 0.160 mg of sodium dihydrogen phosphate dihydrate, 0.15 mg of disodium phosphate anhydrous, 0.116 mg of dipotassium phosphate, and 0.08 mg of polysorbate 80.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"6.88381E-05\",\n \"SemanticContext\": \"Each dose also contains 20 mg of sucrose as stabilizer , 4.385 mg of sodium chloride, 1 mg of DOPC, 0.54 mg of potassium dihydrogen phosphate, 0.25 mg of cholesterol, 0.160 mg of sodium dihydrogen phosphate dihydrate, 0.15 mg of disodium phosphate anhydrous, 0.116 mg of dipotassium phosphate, and 0.08 mg of polysorbate 80.\"\n }\n ]\n },\n {\n \"Term\": \"Infant\",\n \"MEDDRACode\": \"10021731\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": true,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"infant\",\n \"Probability\": \"0.0002019405\",\n \"SemanticContext\": \"Data are not available to assess the effects of SHINGRIX on the breastfed infant or on milk production/excretion.\"\n }\n ]\n }\n ],\n \"IndicationTerms\": []\n }\n ]\n },\n {\n \"GenericName\": \"medroxyprogesterone acetate\",\n \"MeddraVersion\": \"24.0\",\n \"Labels\": [\n {\n \"Id\": \"US8524701e-5f25-4a0a-a923-5e34911827a4\",\n \"NDCCode\": \"62756-091\",\n \"UpdatedDate\": \"Jul 02, 2021\",\n \"LabelSource\": {\n \"Country\": \"us\",\n \"ProductId\": \"01e28bef-9758-40cf-a4ff-86ae9f4f5105\",\n \"FileId\": \"8524701e-5f25-4a0a-a923-5e34911827a4\",\n \"Version\": \"6\"\n },\n \"AdverseEventTerms\": [\n {\n \"Term\": \"Arthralgia\",\n \"MEDDRACode\": \"10003239\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Arthralgia\",\n \"Probability\": \"0.9977725148\",\n \"SemanticContext\": \"Table 2 Adverse Reactions that Were Reported by between 1 and 5% of Subjects Body System* Adverse Reactions [Incidence % ] Body as a Whole Asthenia/fatigue 4.2% Backache 2.2% Dysmenorrhea 1.7% Hot flashes 1.0% Digestive Nausea 3.3% Bloating 2.3% Metabolic/Nutritional Edema 2.2% Musculoskeletal Leg cramps 3.7% Arthralgia 1.0% Nervous Depression 1.5% Insomnia 1.0% Skin and Appendages Acne 1.2% No hair growth/alopecia 1.1% Rash 1.1% Urogenital Leukorrhea 2.9% Breast pain 2.8% Vaginitis 1.2% .\"\n }\n ]\n },\n {\n \"Term\": \"Acne\",\n \"MEDDRACode\": \"10000496\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Acne\",\n \"Probability\": \"0.930585146\",\n \"SemanticContext\": \"Table 2 Adverse Reactions that Were Reported by between 1 and 5% of Subjects Body System* Adverse Reactions [Incidence % ] Body as a Whole Asthenia/fatigue 4.2% Backache 2.2% Dysmenorrhea 1.7% Hot flashes 1.0% Digestive Nausea 3.3% Bloating 2.3% Metabolic/Nutritional Edema 2.2% Musculoskeletal Leg cramps 3.7% Arthralgia 1.0% Nervous Depression 1.5% Insomnia 1.0% Skin and Appendages Acne 1.2% No hair growth/alopecia 1.1% Rash 1.1% Urogenital Leukorrhea 2.9% Breast pain 2.8% Vaginitis 1.2% .\"\n }\n ]\n },\n {\n \"Term\": \"Alopecia\",\n \"MEDDRACode\": \"10001760\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"alopecia\",\n \"Probability\": \"0.9991275072\",\n \"SemanticContext\": \"Table 2 Adverse Reactions that Were Reported by between 1 and 5% of Subjects Body System* Adverse Reactions [Incidence % ] Body as a Whole Asthenia/fatigue 4.2% Backache 2.2% Dysmenorrhea 1.7% Hot flashes 1.0% Digestive Nausea 3.3% Bloating 2.3% Metabolic/Nutritional Edema 2.2% Musculoskeletal Leg cramps 3.7% Arthralgia 1.0% Nervous Depression 1.5% Insomnia 1.0% Skin and Appendages Acne 1.2% No hair growth/alopecia 1.1% Rash 1.1% Urogenital Leukorrhea 2.9% Breast pain 2.8% Vaginitis 1.2% .\"\n }\n ]\n },\n {\n \"Term\": \"Atrophy\",\n \"MEDDRACode\": \"10003694\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"atrophy\",\n \"Probability\": \"0.0366246104\",\n \"SemanticContext\": \", Injection site infection , Injection site nodule/lump, Injection site pain/tenderness, Injection site persistent atrophy/indentation/dimpling, Injection-site reaction, Lipodystrophy acquired, Chills, Axillary swelling Cardiovascular Syncope, Tachycardia, Thrombophlebitis, Deep vein thrombosis, Pulmonary embolus, Varicose veins Digestive Changes in appetite, Gastrointestinal disturbances, Jaundice, Excessive thirst, Rectal bleeding Hematologic and Lymphatic Anemia, Blood dyscrasia Musculoskeletal Osteoporosis Neoplasms Cervical cancer, Breast cancer Nervous Paralysis, Facial palsy, Paresthesia, Drowsiness Respiratory Dyspnea and asthma, Hoarseness Skin and Appendages Hirsutism, Excessive sweating and body odor, Dry skin, Scleroderma Urogenital Lack of return to fertility, Unexpected pregnancy, Prevention of lactation, Changes in breast size, Breast lumps or nipple bleeding, Galactorrhea, Melasma, Chloasma, Increased libido, Uterine hyperplasia, Genitourinary infections, Vaginal cysts, Dyspareunia .\"\n }\n ]\n },\n {\n \"Term\": \"Back pain\",\n \"MEDDRACode\": \"10003988\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Backache\",\n \"Probability\": \"0.9919945002\",\n \"SemanticContext\": \"Table 2 Adverse Reactions that Were Reported by between 1 and 5% of Subjects Body System* Adverse Reactions [Incidence % ] Body as a Whole Asthenia/fatigue 4.2% Backache 2.2% Dysmenorrhea 1.7% Hot flashes 1.0% Digestive Nausea 3.3% Bloating 2.3% Metabolic/Nutritional Edema 2.2% Musculoskeletal Leg cramps 3.7% Arthralgia 1.0% Nervous Depression 1.5% Insomnia 1.0% Skin and Appendages Acne 1.2% No hair growth/alopecia 1.1% Rash 1.1% Urogenital Leukorrhea 2.9% Breast pain 2.8% Vaginitis 1.2% .\"\n }\n ]\n },\n {\n \"Term\": \"Chest pain\",\n \"MEDDRACode\": \"10008479\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Chest pain\",\n \"Probability\": \"0.8911892176\",\n \"SemanticContext\": \"Adverse Reactions Body as a Whole Chest pain, Allergic reactions including angioedema, Fever, Injection site abscess Injection site abscess and injection site infections have been reported; therefore strict aseptic injection technique should be followed when administering medroxyprogesterone acetate injectable suspension in order to avoid injection site infections [see Dosage and Administration 2.1 ].\"\n }\n ]\n },\n {\n \"Term\": \"Blood disorder\",\n \"MEDDRACode\": \"10061590\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Blood dyscrasia\",\n \"Probability\": \"0.0392450094\",\n \"SemanticContext\": \", Injection site infection , Injection site nodule/lump, Injection site pain/tenderness, Injection site persistent atrophy/indentation/dimpling, Injection-site reaction, Lipodystrophy acquired, Chills, Axillary swelling Cardiovascular Syncope, Tachycardia, Thrombophlebitis, Deep vein thrombosis, Pulmonary embolus, Varicose veins Digestive Changes in appetite, Gastrointestinal disturbances, Jaundice, Excessive thirst, Rectal bleeding Hematologic and Lymphatic Anemia, Blood dyscrasia Musculoskeletal Osteoporosis Neoplasms Cervical cancer, Breast cancer Nervous Paralysis, Facial palsy, Paresthesia, Drowsiness Respiratory Dyspnea and asthma, Hoarseness Skin and Appendages Hirsutism, Excessive sweating and body odor, Dry skin, Scleroderma Urogenital Lack of return to fertility, Unexpected pregnancy, Prevention of lactation, Changes in breast size, Breast lumps or nipple bleeding, Galactorrhea, Melasma, Chloasma, Increased libido, Uterine hyperplasia, Genitourinary infections, Vaginal cysts, Dyspareunia .\"\n }\n ]\n },\n {\n \"Term\": \"Breast mass\",\n \"MEDDRACode\": \"10006272\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Breast lumps\",\n \"Probability\": \"0.0627239645\",\n \"SemanticContext\": \", Injection site infection , Injection site nodule/lump, Injection site pain/tenderness, Injection site persistent atrophy/indentation/dimpling, Injection-site reaction, Lipodystrophy acquired, Chills, Axillary swelling Cardiovascular Syncope, Tachycardia, Thrombophlebitis, Deep vein thrombosis, Pulmonary embolus, Varicose veins Digestive Changes in appetite, Gastrointestinal disturbances, Jaundice, Excessive thirst, Rectal bleeding Hematologic and Lymphatic Anemia, Blood dyscrasia Musculoskeletal Osteoporosis Neoplasms Cervical cancer, Breast cancer Nervous Paralysis, Facial palsy, Paresthesia, Drowsiness Respiratory Dyspnea and asthma, Hoarseness Skin and Appendages Hirsutism, Excessive sweating and body odor, Dry skin, Scleroderma Urogenital Lack of return to fertility, Unexpected pregnancy, Prevention of lactation, Changes in breast size, Breast lumps or nipple bleeding, Galactorrhea, Melasma, Chloasma, Increased libido, Uterine hyperplasia, Genitourinary infections, Vaginal cysts, Dyspareunia .\"\n }\n ]\n },\n {\n \"Term\": \"Breast pain\",\n \"MEDDRACode\": \"10006298\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Breast pain\",\n \"Probability\": \"0.9910093546\",\n \"SemanticContext\": \"Table 2 Adverse Reactions that Were Reported by between 1 and 5% of Subjects Body System* Adverse Reactions [Incidence % ] Body as a Whole Asthenia/fatigue 4.2% Backache 2.2% Dysmenorrhea 1.7% Hot flashes 1.0% Digestive Nausea 3.3% Bloating 2.3% Metabolic/Nutritional Edema 2.2% Musculoskeletal Leg cramps 3.7% Arthralgia 1.0% Nervous Depression 1.5% Insomnia 1.0% Skin and Appendages Acne 1.2% No hair growth/alopecia 1.1% Rash 1.1% Urogenital Leukorrhea 2.9% Breast pain 2.8% Vaginitis 1.2% .\"\n }\n ]\n },\n {\n \"Term\": \"Deep vein thrombosis\",\n \"MEDDRACode\": \"10051055\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Deep vein thrombosis\",\n \"Probability\": \"0.8165109754\",\n \"SemanticContext\": \", Injection site infection , Injection site nodule/lump, Injection site pain/tenderness, Injection site persistent atrophy/indentation/dimpling, Injection-site reaction, Lipodystrophy acquired, Chills, Axillary swelling Cardiovascular Syncope, Tachycardia, Thrombophlebitis, Deep vein thrombosis, Pulmonary embolus, Varicose veins Digestive Changes in appetite, Gastrointestinal disturbances, Jaundice, Excessive thirst, Rectal bleeding Hematologic and Lymphatic Anemia, Blood dyscrasia Musculoskeletal Osteoporosis Neoplasms Cervical cancer, Breast cancer Nervous Paralysis, Facial palsy, Paresthesia, Drowsiness Respiratory Dyspnea and asthma, Hoarseness Skin and Appendages Hirsutism, Excessive sweating and body odor, Dry skin, Scleroderma Urogenital Lack of return to fertility, Unexpected pregnancy, Prevention of lactation, Changes in breast size, Breast lumps or nipple bleeding, Galactorrhea, Melasma, Chloasma, Increased libido, Uterine hyperplasia, Genitourinary infections, Vaginal cysts, Dyspareunia .\"\n }\n ]\n },\n {\n \"Term\": \"Angioedema\",\n \"MEDDRACode\": \"10002424\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"angioedema\",\n \"Probability\": \"0.9822225571\",\n \"SemanticContext\": \"Adverse Reactions Body as a Whole Chest pain, Allergic reactions including angioedema, Fever, Injection site abscess Injection site abscess and injection site infections have been reported; therefore strict aseptic injection technique should be followed when administering medroxyprogesterone acetate injectable suspension in order to avoid injection site infections [see Dosage and Administration 2.1 ].\"\n }\n ]\n },\n {\n \"Term\": \"Chloasma\",\n \"MEDDRACode\": \"10008570\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Chloasma\",\n \"Probability\": \"0.9810640216\",\n \"SemanticContext\": \", Injection site infection , Injection site nodule/lump, Injection site pain/tenderness, Injection site persistent atrophy/indentation/dimpling, Injection-site reaction, Lipodystrophy acquired, Chills, Axillary swelling Cardiovascular Syncope, Tachycardia, Thrombophlebitis, Deep vein thrombosis, Pulmonary embolus, Varicose veins Digestive Changes in appetite, Gastrointestinal disturbances, Jaundice, Excessive thirst, Rectal bleeding Hematologic and Lymphatic Anemia, Blood dyscrasia Musculoskeletal Osteoporosis Neoplasms Cervical cancer, Breast cancer Nervous Paralysis, Facial palsy, Paresthesia, Drowsiness Respiratory Dyspnea and asthma, Hoarseness Skin and Appendages Hirsutism, Excessive sweating and body odor, Dry skin, Scleroderma Urogenital Lack of return to fertility, Unexpected pregnancy, Prevention of lactation, Changes in breast size, Breast lumps or nipple bleeding, Galactorrhea, Melasma, Chloasma, Increased libido, Uterine hyperplasia, Genitourinary infections, Vaginal cysts, Dyspareunia .\"\n }\n ]\n },\n {\n \"Term\": \"Injection site abscess\",\n \"MEDDRACode\": \"10022044\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"abscess Injection site\",\n \"Probability\": \"0.8668063879\",\n \"SemanticContext\": \"Adverse Reactions Body as a Whole Chest pain, Allergic reactions including angioedema, Fever, Injection site abscess Injection site abscess and injection site infections have been reported; therefore strict aseptic injection technique should be followed when administering medroxyprogesterone acetate injectable suspension in order to avoid injection site infections [see Dosage and Administration 2.1 ].\"\n },\n {\n \"VerbatimTerm\": \"Injection site abscess\",\n \"Probability\": \"0.9849588871\",\n \"SemanticContext\": \"Adverse Reactions Body as a Whole Chest pain, Allergic reactions including angioedema, Fever, Injection site abscess Injection site abscess and injection site infections have been reported; therefore strict aseptic injection technique should be followed when administering medroxyprogesterone acetate injectable suspension in order to avoid injection site infections [see Dosage and Administration 2.1 ].\"\n },\n {\n \"VerbatimTerm\": \"Injection site abscess\",\n \"Probability\": \"0.8047962189\",\n \"SemanticContext\": \"Adverse Reactions Body as a Whole Chest pain, Allergic reactions including angioedema, Fever, Injection site abscess Injection site abscess and injection site infections have been reported; therefore strict aseptic injection technique should be followed when administering medroxyprogesterone acetate injectable suspension in order to avoid injection site infections [see Dosage and Administration 2.1 ].\"\n },\n {\n \"VerbatimTerm\": \"site abscess Injection\",\n \"Probability\": \"0.9491738081\",\n \"SemanticContext\": \"Adverse Reactions Body as a Whole Chest pain, Allergic reactions including angioedema, Fever, Injection site abscess Injection site abscess and injection site infections have been reported; therefore strict aseptic injection technique should be followed when administering medroxyprogesterone acetate injectable suspension in order to avoid injection site infections [see Dosage and Administration 2.1 ].\"\n }\n ]\n },\n {\n \"Term\": \"Dyspnoea\",\n \"MEDDRACode\": \"10013968\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Dyspnea\",\n \"Probability\": \"0.9848220944\",\n \"SemanticContext\": \", Injection site infection , Injection site nodule/lump, Injection site pain/tenderness, Injection site persistent atrophy/indentation/dimpling, Injection-site reaction, Lipodystrophy acquired, Chills, Axillary swelling Cardiovascular Syncope, Tachycardia, Thrombophlebitis, Deep vein thrombosis, Pulmonary embolus, Varicose veins Digestive Changes in appetite, Gastrointestinal disturbances, Jaundice, Excessive thirst, Rectal bleeding Hematologic and Lymphatic Anemia, Blood dyscrasia Musculoskeletal Osteoporosis Neoplasms Cervical cancer, Breast cancer Nervous Paralysis, Facial palsy, Paresthesia, Drowsiness Respiratory Dyspnea and asthma, Hoarseness Skin and Appendages Hirsutism, Excessive sweating and body odor, Dry skin, Scleroderma Urogenital Lack of return to fertility, Unexpected pregnancy, Prevention of lactation, Changes in breast size, Breast lumps or nipple bleeding, Galactorrhea, Melasma, Chloasma, Increased libido, Uterine hyperplasia, Genitourinary infections, Vaginal cysts, Dyspareunia .\"\n }\n ]\n },\n {\n \"Term\": \"Fatigue\",\n \"MEDDRACode\": \"10016256\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"fatigue\",\n \"Probability\": \"0.9952222109\",\n \"SemanticContext\": \"Table 2 Adverse Reactions that Were Reported by between 1 and 5% of Subjects Body System* Adverse Reactions [Incidence % ] Body as a Whole Asthenia/fatigue 4.2% Backache 2.2% Dysmenorrhea 1.7% Hot flashes 1.0% Digestive Nausea 3.3% Bloating 2.3% Metabolic/Nutritional Edema 2.2% Musculoskeletal Leg cramps 3.7% Arthralgia 1.0% Nervous Depression 1.5% Insomnia 1.0% Skin and Appendages Acne 1.2% No hair growth/alopecia 1.1% Rash 1.1% Urogenital Leukorrhea 2.9% Breast pain 2.8% Vaginitis 1.2% .\"\n }\n ]\n },\n {\n \"Term\": \"Dyspareunia\",\n \"MEDDRACode\": \"10013941\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Dyspareunia\",\n \"Probability\": \"0.9481015205\",\n \"SemanticContext\": \", Injection site infection , Injection site nodule/lump, Injection site pain/tenderness, Injection site persistent atrophy/indentation/dimpling, Injection-site reaction, Lipodystrophy acquired, Chills, Axillary swelling Cardiovascular Syncope, Tachycardia, Thrombophlebitis, Deep vein thrombosis, Pulmonary embolus, Varicose veins Digestive Changes in appetite, Gastrointestinal disturbances, Jaundice, Excessive thirst, Rectal bleeding Hematologic and Lymphatic Anemia, Blood dyscrasia Musculoskeletal Osteoporosis Neoplasms Cervical cancer, Breast cancer Nervous Paralysis, Facial palsy, Paresthesia, Drowsiness Respiratory Dyspnea and asthma, Hoarseness Skin and Appendages Hirsutism, Excessive sweating and body odor, Dry skin, Scleroderma Urogenital Lack of return to fertility, Unexpected pregnancy, Prevention of lactation, Changes in breast size, Breast lumps or nipple bleeding, Galactorrhea, Melasma, Chloasma, Increased libido, Uterine hyperplasia, Genitourinary infections, Vaginal cysts, Dyspareunia .\"\n }\n ]\n },\n {\n \"Term\": \"Dysmenorrhoea\",\n \"MEDDRACode\": \"10013935\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Dysmenorrhea\",\n \"Probability\": \"0.9984272718\",\n \"SemanticContext\": \"Table 2 Adverse Reactions that Were Reported by between 1 and 5% of Subjects Body System* Adverse Reactions [Incidence % ] Body as a Whole Asthenia/fatigue 4.2% Backache 2.2% Dysmenorrhea 1.7% Hot flashes 1.0% Digestive Nausea 3.3% Bloating 2.3% Metabolic/Nutritional Edema 2.2% Musculoskeletal Leg cramps 3.7% Arthralgia 1.0% Nervous Depression 1.5% Insomnia 1.0% Skin and Appendages Acne 1.2% No hair growth/alopecia 1.1% Rash 1.1% Urogenital Leukorrhea 2.9% Breast pain 2.8% Vaginitis 1.2% .\"\n }\n ]\n },\n {\n \"Term\": \"Abdominal distension\",\n \"MEDDRACode\": \"10000060\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Bloating\",\n \"Probability\": \"0.9995775223\",\n \"SemanticContext\": \"Table 2 Adverse Reactions that Were Reported by between 1 and 5% of Subjects Body System* Adverse Reactions [Incidence % ] Body as a Whole Asthenia/fatigue 4.2% Backache 2.2% Dysmenorrhea 1.7% Hot flashes 1.0% Digestive Nausea 3.3% Bloating 2.3% Metabolic/Nutritional Edema 2.2% Musculoskeletal Leg cramps 3.7% Arthralgia 1.0% Nervous Depression 1.5% Insomnia 1.0% Skin and Appendages Acne 1.2% No hair growth/alopecia 1.1% Rash 1.1% Urogenital Leukorrhea 2.9% Breast pain 2.8% Vaginitis 1.2% .\"\n }\n ]\n },\n {\n \"Term\": \"Anaemia\",\n \"MEDDRACode\": \"10002034\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Anemia\",\n \"Probability\": \"0.9812781215\",\n \"SemanticContext\": \", Injection site infection , Injection site nodule/lump, Injection site pain/tenderness, Injection site persistent atrophy/indentation/dimpling, Injection-site reaction, Lipodystrophy acquired, Chills, Axillary swelling Cardiovascular Syncope, Tachycardia, Thrombophlebitis, Deep vein thrombosis, Pulmonary embolus, Varicose veins Digestive Changes in appetite, Gastrointestinal disturbances, Jaundice, Excessive thirst, Rectal bleeding Hematologic and Lymphatic Anemia, Blood dyscrasia Musculoskeletal Osteoporosis Neoplasms Cervical cancer, Breast cancer Nervous Paralysis, Facial palsy, Paresthesia, Drowsiness Respiratory Dyspnea and asthma, Hoarseness Skin and Appendages Hirsutism, Excessive sweating and body odor, Dry skin, Scleroderma Urogenital Lack of return to fertility, Unexpected pregnancy, Prevention of lactation, Changes in breast size, Breast lumps or nipple bleeding, Galactorrhea, Melasma, Chloasma, Increased libido, Uterine hyperplasia, Genitourinary infections, Vaginal cysts, Dyspareunia .\"\n }\n ]\n },\n {\n \"Term\": \"Hirsutism\",\n \"MEDDRACode\": \"10020112\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Hirsutism\",\n \"Probability\": \"0.8219954967\",\n \"SemanticContext\": \", Injection site infection , Injection site nodule/lump, Injection site pain/tenderness, Injection site persistent atrophy/indentation/dimpling, Injection-site reaction, Lipodystrophy acquired, Chills, Axillary swelling Cardiovascular Syncope, Tachycardia, Thrombophlebitis, Deep vein thrombosis, Pulmonary embolus, Varicose veins Digestive Changes in appetite, Gastrointestinal disturbances, Jaundice, Excessive thirst, Rectal bleeding Hematologic and Lymphatic Anemia, Blood dyscrasia Musculoskeletal Osteoporosis Neoplasms Cervical cancer, Breast cancer Nervous Paralysis, Facial palsy, Paresthesia, Drowsiness Respiratory Dyspnea and asthma, Hoarseness Skin and Appendages Hirsutism, Excessive sweating and body odor, Dry skin, Scleroderma Urogenital Lack of return to fertility, Unexpected pregnancy, Prevention of lactation, Changes in breast size, Breast lumps or nipple bleeding, Galactorrhea, Melasma, Chloasma, Increased libido, Uterine hyperplasia, Genitourinary infections, Vaginal cysts, Dyspareunia .\"\n }\n ]\n },\n {\n \"Term\": \"Dry skin\",\n \"MEDDRACode\": \"10013786\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Dry skin\",\n \"Probability\": \"0.9500162601\",\n \"SemanticContext\": \", Injection site infection , Injection site nodule/lump, Injection site pain/tenderness, Injection site persistent atrophy/indentation/dimpling, Injection-site reaction, Lipodystrophy acquired, Chills, Axillary swelling Cardiovascular Syncope, Tachycardia, Thrombophlebitis, Deep vein thrombosis, Pulmonary embolus, Varicose veins Digestive Changes in appetite, Gastrointestinal disturbances, Jaundice, Excessive thirst, Rectal bleeding Hematologic and Lymphatic Anemia, Blood dyscrasia Musculoskeletal Osteoporosis Neoplasms Cervical cancer, Breast cancer Nervous Paralysis, Facial palsy, Paresthesia, Drowsiness Respiratory Dyspnea and asthma, Hoarseness Skin and Appendages Hirsutism, Excessive sweating and body odor, Dry skin, Scleroderma Urogenital Lack of return to fertility, Unexpected pregnancy, Prevention of lactation, Changes in breast size, Breast lumps or nipple bleeding, Galactorrhea, Melasma, Chloasma, Increased libido, Uterine hyperplasia, Genitourinary infections, Vaginal cysts, Dyspareunia .\"\n }\n ]\n },\n {\n \"Term\": \"Facial paralysis\",\n \"MEDDRACode\": \"10016062\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Facial palsy\",\n \"Probability\": \"0.9882963896\",\n \"SemanticContext\": \", Injection site infection , Injection site nodule/lump, Injection site pain/tenderness, Injection site persistent atrophy/indentation/dimpling, Injection-site reaction, Lipodystrophy acquired, Chills, Axillary swelling Cardiovascular Syncope, Tachycardia, Thrombophlebitis, Deep vein thrombosis, Pulmonary embolus, Varicose veins Digestive Changes in appetite, Gastrointestinal disturbances, Jaundice, Excessive thirst, Rectal bleeding Hematologic and Lymphatic Anemia, Blood dyscrasia Musculoskeletal Osteoporosis Neoplasms Cervical cancer, Breast cancer Nervous Paralysis, Facial palsy, Paresthesia, Drowsiness Respiratory Dyspnea and asthma, Hoarseness Skin and Appendages Hirsutism, Excessive sweating and body odor, Dry skin, Scleroderma Urogenital Lack of return to fertility, Unexpected pregnancy, Prevention of lactation, Changes in breast size, Breast lumps or nipple bleeding, Galactorrhea, Melasma, Chloasma, Increased libido, Uterine hyperplasia, Genitourinary infections, Vaginal cysts, Dyspareunia .\"\n }\n ]\n },\n {\n \"Term\": \"Asthenia\",\n \"MEDDRACode\": \"10003549\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Asthenia\",\n \"Probability\": \"0.9753061533\",\n \"SemanticContext\": \"Table 2 Adverse Reactions that Were Reported by between 1 and 5% of Subjects Body System* Adverse Reactions [Incidence % ] Body as a Whole Asthenia/fatigue 4.2% Backache 2.2% Dysmenorrhea 1.7% Hot flashes 1.0% Digestive Nausea 3.3% Bloating 2.3% Metabolic/Nutritional Edema 2.2% Musculoskeletal Leg cramps 3.7% Arthralgia 1.0% Nervous Depression 1.5% Insomnia 1.0% Skin and Appendages Acne 1.2% No hair growth/alopecia 1.1% Rash 1.1% Urogenital Leukorrhea 2.9% Breast pain 2.8% Vaginitis 1.2% .\"\n }\n ]\n },\n {\n \"Term\": \"Injection site nodule\",\n \"MEDDRACode\": \"10057880\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Injection site nodule\",\n \"Probability\": \"0.7540705204\",\n \"SemanticContext\": \", Injection site infection , Injection site nodule/lump, Injection site pain/tenderness, Injection site persistent atrophy/indentation/dimpling, Injection-site reaction, Lipodystrophy acquired, Chills, Axillary swelling Cardiovascular Syncope, Tachycardia, Thrombophlebitis, Deep vein thrombosis, Pulmonary embolus, Varicose veins Digestive Changes in appetite, Gastrointestinal disturbances, Jaundice, Excessive thirst, Rectal bleeding Hematologic and Lymphatic Anemia, Blood dyscrasia Musculoskeletal Osteoporosis Neoplasms Cervical cancer, Breast cancer Nervous Paralysis, Facial palsy, Paresthesia, Drowsiness Respiratory Dyspnea and asthma, Hoarseness Skin and Appendages Hirsutism, Excessive sweating and body odor, Dry skin, Scleroderma Urogenital Lack of return to fertility, Unexpected pregnancy, Prevention of lactation, Changes in breast size, Breast lumps or nipple bleeding, Galactorrhea, Melasma, Chloasma, Increased libido, Uterine hyperplasia, Genitourinary infections, Vaginal cysts, Dyspareunia .\"\n }\n ]\n },\n {\n \"Term\": \"Lipodystrophy acquired\",\n \"MEDDRACode\": \"10049287\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Lipodystrophy acquired\",\n \"Probability\": \"0.8695557117\",\n \"SemanticContext\": \", Injection site infection , Injection site nodule/lump, Injection site pain/tenderness, Injection site persistent atrophy/indentation/dimpling, Injection-site reaction, Lipodystrophy acquired, Chills, Axillary swelling Cardiovascular Syncope, Tachycardia, Thrombophlebitis, Deep vein thrombosis, Pulmonary embolus, Varicose veins Digestive Changes in appetite, Gastrointestinal disturbances, Jaundice, Excessive thirst, Rectal bleeding Hematologic and Lymphatic Anemia, Blood dyscrasia Musculoskeletal Osteoporosis Neoplasms Cervical cancer, Breast cancer Nervous Paralysis, Facial palsy, Paresthesia, Drowsiness Respiratory Dyspnea and asthma, Hoarseness Skin and Appendages Hirsutism, Excessive sweating and body odor, Dry skin, Scleroderma Urogenital Lack of return to fertility, Unexpected pregnancy, Prevention of lactation, Changes in breast size, Breast lumps or nipple bleeding, Galactorrhea, Melasma, Chloasma, Increased libido, Uterine hyperplasia, Genitourinary infections, Vaginal cysts, Dyspareunia .\"\n }\n ]\n },\n {\n \"Term\": \"Hyperplasia\",\n \"MEDDRACode\": \"10020718\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hyperplasia\",\n \"Probability\": \"0.2465875745\",\n \"SemanticContext\": \", Injection site infection , Injection site nodule/lump, Injection site pain/tenderness, Injection site persistent atrophy/indentation/dimpling, Injection-site reaction, Lipodystrophy acquired, Chills, Axillary swelling Cardiovascular Syncope, Tachycardia, Thrombophlebitis, Deep vein thrombosis, Pulmonary embolus, Varicose veins Digestive Changes in appetite, Gastrointestinal disturbances, Jaundice, Excessive thirst, Rectal bleeding Hematologic and Lymphatic Anemia, Blood dyscrasia Musculoskeletal Osteoporosis Neoplasms Cervical cancer, Breast cancer Nervous Paralysis, Facial palsy, Paresthesia, Drowsiness Respiratory Dyspnea and asthma, Hoarseness Skin and Appendages Hirsutism, Excessive sweating and body odor, Dry skin, Scleroderma Urogenital Lack of return to fertility, Unexpected pregnancy, Prevention of lactation, Changes in breast size, Breast lumps or nipple bleeding, Galactorrhea, Melasma, Chloasma, Increased libido, Uterine hyperplasia, Genitourinary infections, Vaginal cysts, Dyspareunia .\"\n }\n ]\n },\n {\n \"Term\": \"Galactorrhoea\",\n \"MEDDRACode\": \"10017600\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Galactorrhea\",\n \"Probability\": \"0.5549114347\",\n \"SemanticContext\": \", Injection site infection , Injection site nodule/lump, Injection site pain/tenderness, Injection site persistent atrophy/indentation/dimpling, Injection-site reaction, Lipodystrophy acquired, Chills, Axillary swelling Cardiovascular Syncope, Tachycardia, Thrombophlebitis, Deep vein thrombosis, Pulmonary embolus, Varicose veins Digestive Changes in appetite, Gastrointestinal disturbances, Jaundice, Excessive thirst, Rectal bleeding Hematologic and Lymphatic Anemia, Blood dyscrasia Musculoskeletal Osteoporosis Neoplasms Cervical cancer, Breast cancer Nervous Paralysis, Facial palsy, Paresthesia, Drowsiness Respiratory Dyspnea and asthma, Hoarseness Skin and Appendages Hirsutism, Excessive sweating and body odor, Dry skin, Scleroderma Urogenital Lack of return to fertility, Unexpected pregnancy, Prevention of lactation, Changes in breast size, Breast lumps or nipple bleeding, Galactorrhea, Melasma, Chloasma, Increased libido, Uterine hyperplasia, Genitourinary infections, Vaginal cysts, Dyspareunia .\"\n }\n ]\n },\n {\n \"Term\": \"Muscle spasms\",\n \"MEDDRACode\": \"10028334\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Leg cramps\",\n \"Probability\": \"0.9951592684\",\n \"SemanticContext\": \"Table 2 Adverse Reactions that Were Reported by between 1 and 5% of Subjects Body System* Adverse Reactions [Incidence % ] Body as a Whole Asthenia/fatigue 4.2% Backache 2.2% Dysmenorrhea 1.7% Hot flashes 1.0% Digestive Nausea 3.3% Bloating 2.3% Metabolic/Nutritional Edema 2.2% Musculoskeletal Leg cramps 3.7% Arthralgia 1.0% Nervous Depression 1.5% Insomnia 1.0% Skin and Appendages Acne 1.2% No hair growth/alopecia 1.1% Rash 1.1% Urogenital Leukorrhea 2.9% Breast pain 2.8% Vaginitis 1.2% .\"\n }\n ]\n },\n {\n \"Term\": \"Gastrointestinal disorder\",\n \"MEDDRACode\": \"10017944\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Gastrointestinal disturbances\",\n \"Probability\": \"0.5910551548\",\n \"SemanticContext\": \", Injection site infection , Injection site nodule/lump, Injection site pain/tenderness, Injection site persistent atrophy/indentation/dimpling, Injection-site reaction, Lipodystrophy acquired, Chills, Axillary swelling Cardiovascular Syncope, Tachycardia, Thrombophlebitis, Deep vein thrombosis, Pulmonary embolus, Varicose veins Digestive Changes in appetite, Gastrointestinal disturbances, Jaundice, Excessive thirst, Rectal bleeding Hematologic and Lymphatic Anemia, Blood dyscrasia Musculoskeletal Osteoporosis Neoplasms Cervical cancer, Breast cancer Nervous Paralysis, Facial palsy, Paresthesia, Drowsiness Respiratory Dyspnea and asthma, Hoarseness Skin and Appendages Hirsutism, Excessive sweating and body odor, Dry skin, Scleroderma Urogenital Lack of return to fertility, Unexpected pregnancy, Prevention of lactation, Changes in breast size, Breast lumps or nipple bleeding, Galactorrhea, Melasma, Chloasma, Increased libido, Uterine hyperplasia, Genitourinary infections, Vaginal cysts, Dyspareunia .\"\n }\n ]\n },\n {\n \"Term\": \"Injection site infection\",\n \"MEDDRACode\": \"10022076\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"injection site infections\",\n \"Probability\": \"0.293731153\",\n \"SemanticContext\": \"Adverse Reactions Body as a Whole Chest pain, Allergic reactions including angioedema, Fever, Injection site abscess Injection site abscess and injection site infections have been reported; therefore strict aseptic injection technique should be followed when administering medroxyprogesterone acetate injectable suspension in order to avoid injection site infections [see Dosage and Administration 2.1 ].\"\n },\n {\n \"VerbatimTerm\": \"injection site infections\",\n \"Probability\": \"0.0021134317\",\n \"SemanticContext\": \"Adverse Reactions Body as a Whole Chest pain, Allergic reactions including angioedema, Fever, Injection site abscess Injection site abscess and injection site infections have been reported; therefore strict aseptic injection technique should be followed when administering medroxyprogesterone acetate injectable suspension in order to avoid injection site infections [see Dosage and Administration 2.1 ].\"\n },\n {\n \"VerbatimTerm\": \"Injection site infection\",\n \"Probability\": \"0.9760733843\",\n \"SemanticContext\": \", Injection site infection , Injection site nodule/lump, Injection site pain/tenderness, Injection site persistent atrophy/indentation/dimpling, Injection-site reaction, Lipodystrophy acquired, Chills, Axillary swelling Cardiovascular Syncope, Tachycardia, Thrombophlebitis, Deep vein thrombosis, Pulmonary embolus, Varicose veins Digestive Changes in appetite, Gastrointestinal disturbances, Jaundice, Excessive thirst, Rectal bleeding Hematologic and Lymphatic Anemia, Blood dyscrasia Musculoskeletal Osteoporosis Neoplasms Cervical cancer, Breast cancer Nervous Paralysis, Facial palsy, Paresthesia, Drowsiness Respiratory Dyspnea and asthma, Hoarseness Skin and Appendages Hirsutism, Excessive sweating and body odor, Dry skin, Scleroderma Urogenital Lack of return to fertility, Unexpected pregnancy, Prevention of lactation, Changes in breast size, Breast lumps or nipple bleeding, Galactorrhea, Melasma, Chloasma, Increased libido, Uterine hyperplasia, Genitourinary infections, Vaginal cysts, Dyspareunia .\"\n }\n ]\n },\n {\n \"Term\": \"Nervousness\",\n \"MEDDRACode\": \"10029216\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"nervousness\",\n \"Probability\": \"0.9948254824\",\n \"SemanticContext\": \"ADVERSE REACTIONS Most common adverse reactions incidence >5% are: menstrual irregularities bleeding or spotting 57% at 12 months, 32% at 24 months, abdominal pain/discomfort 11%, weight gain > 10 lbs at 24 months 38%, dizziness 6%, headache 17%, nervousness 11%, decreased libido 6%.\"\n },\n {\n \"VerbatimTerm\": \"Nervousness\",\n \"Probability\": \"0.8359353542\",\n \"SemanticContext\": \"Table 1 Adverse Reactions that Were Reported by More than 5% of Subjects Body System* Adverse Reactions [Incidence % ] Body as a Whole Headache 16.5% Abdominal pain/discomfort 11.2% Metabolic/Nutritional Increased weight> 10lbs at 24 months 37.7% Nervous Nervousness 10.8% Dizziness 5.6% Libido decreased 5.5% Urogenital Menstrual irregularities: bleeding 57.3% at 12 months, 32.1% at 24 months amenorrhea 55% at 12 months, 68% at 24 months .\"\n }\n ]\n },\n {\n \"Term\": \"Oedema\",\n \"MEDDRACode\": \"10030095\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Edema\",\n \"Probability\": \"0.9857736826\",\n \"SemanticContext\": \"Table 2 Adverse Reactions that Were Reported by between 1 and 5% of Subjects Body System* Adverse Reactions [Incidence % ] Body as a Whole Asthenia/fatigue 4.2% Backache 2.2% Dysmenorrhea 1.7% Hot flashes 1.0% Digestive Nausea 3.3% Bloating 2.3% Metabolic/Nutritional Edema 2.2% Musculoskeletal Leg cramps 3.7% Arthralgia 1.0% Nervous Depression 1.5% Insomnia 1.0% Skin and Appendages Acne 1.2% No hair growth/alopecia 1.1% Rash 1.1% Urogenital Leukorrhea 2.9% Breast pain 2.8% Vaginitis 1.2% .\"\n }\n ]\n },\n {\n \"Term\": \"Skin odour abnormal\",\n \"MEDDRACode\": \"10040904\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"body odor\",\n \"Probability\": \"0.5742846727\",\n \"SemanticContext\": \", Injection site infection , Injection site nodule/lump, Injection site pain/tenderness, Injection site persistent atrophy/indentation/dimpling, Injection-site reaction, Lipodystrophy acquired, Chills, Axillary swelling Cardiovascular Syncope, Tachycardia, Thrombophlebitis, Deep vein thrombosis, Pulmonary embolus, Varicose veins Digestive Changes in appetite, Gastrointestinal disturbances, Jaundice, Excessive thirst, Rectal bleeding Hematologic and Lymphatic Anemia, Blood dyscrasia Musculoskeletal Osteoporosis Neoplasms Cervical cancer, Breast cancer Nervous Paralysis, Facial palsy, Paresthesia, Drowsiness Respiratory Dyspnea and asthma, Hoarseness Skin and Appendages Hirsutism, Excessive sweating and body odor, Dry skin, Scleroderma Urogenital Lack of return to fertility, Unexpected pregnancy, Prevention of lactation, Changes in breast size, Breast lumps or nipple bleeding, Galactorrhea, Melasma, Chloasma, Increased libido, Uterine hyperplasia, Genitourinary infections, Vaginal cysts, Dyspareunia .\"\n }\n ]\n },\n {\n \"Term\": \"Rectal haemorrhage\",\n \"MEDDRACode\": \"10038063\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Rectal bleeding\",\n \"Probability\": \"0.9821777344\",\n \"SemanticContext\": \", Injection site infection , Injection site nodule/lump, Injection site pain/tenderness, Injection site persistent atrophy/indentation/dimpling, Injection-site reaction, Lipodystrophy acquired, Chills, Axillary swelling Cardiovascular Syncope, Tachycardia, Thrombophlebitis, Deep vein thrombosis, Pulmonary embolus, Varicose veins Digestive Changes in appetite, Gastrointestinal disturbances, Jaundice, Excessive thirst, Rectal bleeding Hematologic and Lymphatic Anemia, Blood dyscrasia Musculoskeletal Osteoporosis Neoplasms Cervical cancer, Breast cancer Nervous Paralysis, Facial palsy, Paresthesia, Drowsiness Respiratory Dyspnea and asthma, Hoarseness Skin and Appendages Hirsutism, Excessive sweating and body odor, Dry skin, Scleroderma Urogenital Lack of return to fertility, Unexpected pregnancy, Prevention of lactation, Changes in breast size, Breast lumps or nipple bleeding, Galactorrhea, Melasma, Chloasma, Increased libido, Uterine hyperplasia, Genitourinary infections, Vaginal cysts, Dyspareunia .\"\n }\n ]\n },\n {\n \"Term\": \"Tenderness\",\n \"MEDDRACode\": \"10043224\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"tenderness\",\n \"Probability\": \"0.129968524\",\n \"SemanticContext\": \", Injection site infection , Injection site nodule/lump, Injection site pain/tenderness, Injection site persistent atrophy/indentation/dimpling, Injection-site reaction, Lipodystrophy acquired, Chills, Axillary swelling Cardiovascular Syncope, Tachycardia, Thrombophlebitis, Deep vein thrombosis, Pulmonary embolus, Varicose veins Digestive Changes in appetite, Gastrointestinal disturbances, Jaundice, Excessive thirst, Rectal bleeding Hematologic and Lymphatic Anemia, Blood dyscrasia Musculoskeletal Osteoporosis Neoplasms Cervical cancer, Breast cancer Nervous Paralysis, Facial palsy, Paresthesia, Drowsiness Respiratory Dyspnea and asthma, Hoarseness Skin and Appendages Hirsutism, Excessive sweating and body odor, Dry skin, Scleroderma Urogenital Lack of return to fertility, Unexpected pregnancy, Prevention of lactation, Changes in breast size, Breast lumps or nipple bleeding, Galactorrhea, Melasma, Chloasma, Increased libido, Uterine hyperplasia, Genitourinary infections, Vaginal cysts, Dyspareunia .\"\n }\n ]\n },\n {\n \"Term\": \"Unintended pregnancy\",\n \"MEDDRACode\": \"10045542\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Unexpected pregnancy\",\n \"Probability\": \"0.5132997632\",\n \"SemanticContext\": \", Injection site infection , Injection site nodule/lump, Injection site pain/tenderness, Injection site persistent atrophy/indentation/dimpling, Injection-site reaction, Lipodystrophy acquired, Chills, Axillary swelling Cardiovascular Syncope, Tachycardia, Thrombophlebitis, Deep vein thrombosis, Pulmonary embolus, Varicose veins Digestive Changes in appetite, Gastrointestinal disturbances, Jaundice, Excessive thirst, Rectal bleeding Hematologic and Lymphatic Anemia, Blood dyscrasia Musculoskeletal Osteoporosis Neoplasms Cervical cancer, Breast cancer Nervous Paralysis, Facial palsy, Paresthesia, Drowsiness Respiratory Dyspnea and asthma, Hoarseness Skin and Appendages Hirsutism, Excessive sweating and body odor, Dry skin, Scleroderma Urogenital Lack of return to fertility, Unexpected pregnancy, Prevention of lactation, Changes in breast size, Breast lumps or nipple bleeding, Galactorrhea, Melasma, Chloasma, Increased libido, Uterine hyperplasia, Genitourinary infections, Vaginal cysts, Dyspareunia .\"\n }\n ]\n },\n {\n \"Term\": \"Vaginal infection\",\n \"MEDDRACode\": \"10046914\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Vaginitis\",\n \"Probability\": \"0.9574716091\",\n \"SemanticContext\": \"Table 2 Adverse Reactions that Were Reported by between 1 and 5% of Subjects Body System* Adverse Reactions [Incidence % ] Body as a Whole Asthenia/fatigue 4.2% Backache 2.2% Dysmenorrhea 1.7% Hot flashes 1.0% Digestive Nausea 3.3% Bloating 2.3% Metabolic/Nutritional Edema 2.2% Musculoskeletal Leg cramps 3.7% Arthralgia 1.0% Nervous Depression 1.5% Insomnia 1.0% Skin and Appendages Acne 1.2% No hair growth/alopecia 1.1% Rash 1.1% Urogenital Leukorrhea 2.9% Breast pain 2.8% Vaginitis 1.2% .\"\n }\n ]\n },\n {\n \"Term\": \"Thirst\",\n \"MEDDRACode\": \"10043458\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Excessive thirst\",\n \"Probability\": \"0.9994300008\",\n \"SemanticContext\": \", Injection site infection , Injection site nodule/lump, Injection site pain/tenderness, Injection site persistent atrophy/indentation/dimpling, Injection-site reaction, Lipodystrophy acquired, Chills, Axillary swelling Cardiovascular Syncope, Tachycardia, Thrombophlebitis, Deep vein thrombosis, Pulmonary embolus, Varicose veins Digestive Changes in appetite, Gastrointestinal disturbances, Jaundice, Excessive thirst, Rectal bleeding Hematologic and Lymphatic Anemia, Blood dyscrasia Musculoskeletal Osteoporosis Neoplasms Cervical cancer, Breast cancer Nervous Paralysis, Facial palsy, Paresthesia, Drowsiness Respiratory Dyspnea and asthma, Hoarseness Skin and Appendages Hirsutism, Excessive sweating and body odor, Dry skin, Scleroderma Urogenital Lack of return to fertility, Unexpected pregnancy, Prevention of lactation, Changes in breast size, Breast lumps or nipple bleeding, Galactorrhea, Melasma, Chloasma, Increased libido, Uterine hyperplasia, Genitourinary infections, Vaginal cysts, Dyspareunia .\"\n }\n ]\n },\n {\n \"Term\": \"Paraesthesia\",\n \"MEDDRACode\": \"10033775\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Paresthesia\",\n \"Probability\": \"0.9739602208\",\n \"SemanticContext\": \", Injection site infection , Injection site nodule/lump, Injection site pain/tenderness, Injection site persistent atrophy/indentation/dimpling, Injection-site reaction, Lipodystrophy acquired, Chills, Axillary swelling Cardiovascular Syncope, Tachycardia, Thrombophlebitis, Deep vein thrombosis, Pulmonary embolus, Varicose veins Digestive Changes in appetite, Gastrointestinal disturbances, Jaundice, Excessive thirst, Rectal bleeding Hematologic and Lymphatic Anemia, Blood dyscrasia Musculoskeletal Osteoporosis Neoplasms Cervical cancer, Breast cancer Nervous Paralysis, Facial palsy, Paresthesia, Drowsiness Respiratory Dyspnea and asthma, Hoarseness Skin and Appendages Hirsutism, Excessive sweating and body odor, Dry skin, Scleroderma Urogenital Lack of return to fertility, Unexpected pregnancy, Prevention of lactation, Changes in breast size, Breast lumps or nipple bleeding, Galactorrhea, Melasma, Chloasma, Increased libido, Uterine hyperplasia, Genitourinary infections, Vaginal cysts, Dyspareunia .\"\n }\n ]\n },\n {\n \"Term\": \"Paralysis\",\n \"MEDDRACode\": \"10033799\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Paralysis\",\n \"Probability\": \"0.7778753042\",\n \"SemanticContext\": \", Injection site infection , Injection site nodule/lump, Injection site pain/tenderness, Injection site persistent atrophy/indentation/dimpling, Injection-site reaction, Lipodystrophy acquired, Chills, Axillary swelling Cardiovascular Syncope, Tachycardia, Thrombophlebitis, Deep vein thrombosis, Pulmonary embolus, Varicose veins Digestive Changes in appetite, Gastrointestinal disturbances, Jaundice, Excessive thirst, Rectal bleeding Hematologic and Lymphatic Anemia, Blood dyscrasia Musculoskeletal Osteoporosis Neoplasms Cervical cancer, Breast cancer Nervous Paralysis, Facial palsy, Paresthesia, Drowsiness Respiratory Dyspnea and asthma, Hoarseness Skin and Appendages Hirsutism, Excessive sweating and body odor, Dry skin, Scleroderma Urogenital Lack of return to fertility, Unexpected pregnancy, Prevention of lactation, Changes in breast size, Breast lumps or nipple bleeding, Galactorrhea, Melasma, Chloasma, Increased libido, Uterine hyperplasia, Genitourinary infections, Vaginal cysts, Dyspareunia .\"\n }\n ]\n },\n {\n \"Term\": \"Blood sodium\",\n \"MEDDRACode\": \"10005799\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Sodium\",\n \"Probability\": \"0.0001907647\",\n \"SemanticContext\": \"For Medroxyprogesterone acetate injectable suspension prefilled syringe, each mL of sterile aqueous suspension contains: Medroxyprogesterone acetate 150 mg Polyethylene glycol 3350 28.90 mg Polysorbate 80 2.41 mg Sodium chloride 8.68 mg Methylparaben 1.37 mg Propylparaben 0.15 mg Water for injection quantity sufficient When necessary, pH is adjusted with sodium hydroxide or hydrochloric acid, or both.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"7.637E-07\",\n \"SemanticContext\": \"For Medroxyprogesterone acetate injectable suspension prefilled syringe, each mL of sterile aqueous suspension contains: Medroxyprogesterone acetate 150 mg Polyethylene glycol 3350 28.90 mg Polysorbate 80 2.41 mg Sodium chloride 8.68 mg Methylparaben 1.37 mg Propylparaben 0.15 mg Water for injection quantity sufficient When necessary, pH is adjusted with sodium hydroxide or hydrochloric acid, or both.\"\n }\n ]\n },\n {\n \"Term\": \"Injection site pain\",\n \"MEDDRACode\": \"10022086\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Injection site pain\",\n \"Probability\": \"0.3185116649\",\n \"SemanticContext\": \", Injection site infection , Injection site nodule/lump, Injection site pain/tenderness, Injection site persistent atrophy/indentation/dimpling, Injection-site reaction, Lipodystrophy acquired, Chills, Axillary swelling Cardiovascular Syncope, Tachycardia, Thrombophlebitis, Deep vein thrombosis, Pulmonary embolus, Varicose veins Digestive Changes in appetite, Gastrointestinal disturbances, Jaundice, Excessive thirst, Rectal bleeding Hematologic and Lymphatic Anemia, Blood dyscrasia Musculoskeletal Osteoporosis Neoplasms Cervical cancer, Breast cancer Nervous Paralysis, Facial palsy, Paresthesia, Drowsiness Respiratory Dyspnea and asthma, Hoarseness Skin and Appendages Hirsutism, Excessive sweating and body odor, Dry skin, Scleroderma Urogenital Lack of return to fertility, Unexpected pregnancy, Prevention of lactation, Changes in breast size, Breast lumps or nipple bleeding, Galactorrhea, Melasma, Chloasma, Increased libido, Uterine hyperplasia, Genitourinary infections, Vaginal cysts, Dyspareunia .\"\n }\n ]\n },\n {\n \"Term\": \"Swelling\",\n \"MEDDRACode\": \"10042674\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"swelling\",\n \"Probability\": \"0.1375507116\",\n \"SemanticContext\": \", Injection site infection , Injection site nodule/lump, Injection site pain/tenderness, Injection site persistent atrophy/indentation/dimpling, Injection-site reaction, Lipodystrophy acquired, Chills, Axillary swelling Cardiovascular Syncope, Tachycardia, Thrombophlebitis, Deep vein thrombosis, Pulmonary embolus, Varicose veins Digestive Changes in appetite, Gastrointestinal disturbances, Jaundice, Excessive thirst, Rectal bleeding Hematologic and Lymphatic Anemia, Blood dyscrasia Musculoskeletal Osteoporosis Neoplasms Cervical cancer, Breast cancer Nervous Paralysis, Facial palsy, Paresthesia, Drowsiness Respiratory Dyspnea and asthma, Hoarseness Skin and Appendages Hirsutism, Excessive sweating and body odor, Dry skin, Scleroderma Urogenital Lack of return to fertility, Unexpected pregnancy, Prevention of lactation, Changes in breast size, Breast lumps or nipple bleeding, Galactorrhea, Melasma, Chloasma, Increased libido, Uterine hyperplasia, Genitourinary infections, Vaginal cysts, Dyspareunia .\"\n }\n ]\n },\n {\n \"Term\": \"Tachycardia\",\n \"MEDDRACode\": \"10043071\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Tachycardia\",\n \"Probability\": \"0.9814822078\",\n \"SemanticContext\": \", Injection site infection , Injection site nodule/lump, Injection site pain/tenderness, Injection site persistent atrophy/indentation/dimpling, Injection-site reaction, Lipodystrophy acquired, Chills, Axillary swelling Cardiovascular Syncope, Tachycardia, Thrombophlebitis, Deep vein thrombosis, Pulmonary embolus, Varicose veins Digestive Changes in appetite, Gastrointestinal disturbances, Jaundice, Excessive thirst, Rectal bleeding Hematologic and Lymphatic Anemia, Blood dyscrasia Musculoskeletal Osteoporosis Neoplasms Cervical cancer, Breast cancer Nervous Paralysis, Facial palsy, Paresthesia, Drowsiness Respiratory Dyspnea and asthma, Hoarseness Skin and Appendages Hirsutism, Excessive sweating and body odor, Dry skin, Scleroderma Urogenital Lack of return to fertility, Unexpected pregnancy, Prevention of lactation, Changes in breast size, Breast lumps or nipple bleeding, Galactorrhea, Melasma, Chloasma, Increased libido, Uterine hyperplasia, Genitourinary infections, Vaginal cysts, Dyspareunia .\"\n }\n ]\n },\n {\n \"Term\": \"Prophylaxis\",\n \"MEDDRACode\": \"10036898\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Prevention\",\n \"Probability\": \"0.0209683478\",\n \"SemanticContext\": \", Injection site infection , Injection site nodule/lump, Injection site pain/tenderness, Injection site persistent atrophy/indentation/dimpling, Injection-site reaction, Lipodystrophy acquired, Chills, Axillary swelling Cardiovascular Syncope, Tachycardia, Thrombophlebitis, Deep vein thrombosis, Pulmonary embolus, Varicose veins Digestive Changes in appetite, Gastrointestinal disturbances, Jaundice, Excessive thirst, Rectal bleeding Hematologic and Lymphatic Anemia, Blood dyscrasia Musculoskeletal Osteoporosis Neoplasms Cervical cancer, Breast cancer Nervous Paralysis, Facial palsy, Paresthesia, Drowsiness Respiratory Dyspnea and asthma, Hoarseness Skin and Appendages Hirsutism, Excessive sweating and body odor, Dry skin, Scleroderma Urogenital Lack of return to fertility, Unexpected pregnancy, Prevention of lactation, Changes in breast size, Breast lumps or nipple bleeding, Galactorrhea, Melasma, Chloasma, Increased libido, Uterine hyperplasia, Genitourinary infections, Vaginal cysts, Dyspareunia .\"\n },\n {\n \"VerbatimTerm\": \"Prevention\",\n \"Probability\": \"0.0298595428\",\n \"SemanticContext\": \"2 DOSAGE AND ADMINISTRATION 2.1 Prevention of Pregnancy The 1 mL prefilled syringe of medroxyprogesterone acetate injectable suspension should be vigorously shaken just before use to ensure that the dose being administered represents a uniform suspension.\"\n }\n ]\n },\n {\n \"Term\": \"Infection\",\n \"MEDDRACode\": \"10021789\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"infections\",\n \"Probability\": \"0.4733048081\",\n \"SemanticContext\": \", Injection site infection , Injection site nodule/lump, Injection site pain/tenderness, Injection site persistent atrophy/indentation/dimpling, Injection-site reaction, Lipodystrophy acquired, Chills, Axillary swelling Cardiovascular Syncope, Tachycardia, Thrombophlebitis, Deep vein thrombosis, Pulmonary embolus, Varicose veins Digestive Changes in appetite, Gastrointestinal disturbances, Jaundice, Excessive thirst, Rectal bleeding Hematologic and Lymphatic Anemia, Blood dyscrasia Musculoskeletal Osteoporosis Neoplasms Cervical cancer, Breast cancer Nervous Paralysis, Facial palsy, Paresthesia, Drowsiness Respiratory Dyspnea and asthma, Hoarseness Skin and Appendages Hirsutism, Excessive sweating and body odor, Dry skin, Scleroderma Urogenital Lack of return to fertility, Unexpected pregnancy, Prevention of lactation, Changes in breast size, Breast lumps or nipple bleeding, Galactorrhea, Melasma, Chloasma, Increased libido, Uterine hyperplasia, Genitourinary infections, Vaginal cysts, Dyspareunia .\"\n }\n ]\n },\n {\n \"Term\": \"Cervix carcinoma\",\n \"MEDDRACode\": \"10008342\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Cervical cancer\",\n \"Probability\": \"0.4160869122\",\n \"SemanticContext\": \", Injection site infection , Injection site nodule/lump, Injection site pain/tenderness, Injection site persistent atrophy/indentation/dimpling, Injection-site reaction, Lipodystrophy acquired, Chills, Axillary swelling Cardiovascular Syncope, Tachycardia, Thrombophlebitis, Deep vein thrombosis, Pulmonary embolus, Varicose veins Digestive Changes in appetite, Gastrointestinal disturbances, Jaundice, Excessive thirst, Rectal bleeding Hematologic and Lymphatic Anemia, Blood dyscrasia Musculoskeletal Osteoporosis Neoplasms Cervical cancer, Breast cancer Nervous Paralysis, Facial palsy, Paresthesia, Drowsiness Respiratory Dyspnea and asthma, Hoarseness Skin and Appendages Hirsutism, Excessive sweating and body odor, Dry skin, Scleroderma Urogenital Lack of return to fertility, Unexpected pregnancy, Prevention of lactation, Changes in breast size, Breast lumps or nipple bleeding, Galactorrhea, Melasma, Chloasma, Increased libido, Uterine hyperplasia, Genitourinary infections, Vaginal cysts, Dyspareunia .\"\n },\n {\n \"VerbatimTerm\": \"Cervical Cancer\",\n \"Probability\": \"0.0928263962\",\n \"SemanticContext\": \"Cervical Cancer A statistically nonsignificant increase in RR estimates of invasive squamous-cell cervical cancer has been associated with the use of medroxyprogesterone acetate injectable suspension in women who were first exposed before the age of 35 years RR 1.22 to 1.28 and 95% CI 0.93 to 1.70 .\"\n },\n {\n \"VerbatimTerm\": \"cervical cancer\",\n \"Probability\": \"0.0982991457\",\n \"SemanticContext\": \"Cervical Cancer A statistically nonsignificant increase in RR estimates of invasive squamous-cell cervical cancer has been associated with the use of medroxyprogesterone acetate injectable suspension in women who were first exposed before the age of 35 years RR 1.22 to 1.28 and 95% CI 0.93 to 1.70 .\"\n },\n {\n \"VerbatimTerm\": \"cervical cancer\",\n \"Probability\": \"0.0186944306\",\n \"SemanticContext\": \"The overall, nonsignificant relative rate of invasive squamous-cell cervical cancer in women who ever used medroxyprogesterone acetate injectable suspension was estimated to be 1.11 95% CI 0.96 to 1.29 .\"\n }\n ]\n },\n {\n \"Term\": \"Weight increased\",\n \"MEDDRACode\": \"10047899\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Increased weight\",\n \"Probability\": \"0.9630659819\",\n \"SemanticContext\": \"Table 1 Adverse Reactions that Were Reported by More than 5% of Subjects Body System* Adverse Reactions [Incidence % ] Body as a Whole Headache 16.5% Abdominal pain/discomfort 11.2% Metabolic/Nutritional Increased weight> 10lbs at 24 months 37.7% Nervous Nervousness 10.8% Dizziness 5.6% Libido decreased 5.5% Urogenital Menstrual irregularities: bleeding 57.3% at 12 months, 32.1% at 24 months amenorrhea 55% at 12 months, 68% at 24 months .\"\n }\n ]\n },\n {\n \"Term\": \"Rash\",\n \"MEDDRACode\": \"10037844\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Rash\",\n \"Probability\": \"0.9997755885\",\n \"SemanticContext\": \"Table 2 Adverse Reactions that Were Reported by between 1 and 5% of Subjects Body System* Adverse Reactions [Incidence % ] Body as a Whole Asthenia/fatigue 4.2% Backache 2.2% Dysmenorrhea 1.7% Hot flashes 1.0% Digestive Nausea 3.3% Bloating 2.3% Metabolic/Nutritional Edema 2.2% Musculoskeletal Leg cramps 3.7% Arthralgia 1.0% Nervous Depression 1.5% Insomnia 1.0% Skin and Appendages Acne 1.2% No hair growth/alopecia 1.1% Rash 1.1% Urogenital Leukorrhea 2.9% Breast pain 2.8% Vaginitis 1.2% .\"\n }\n ]\n },\n {\n \"Term\": \"Oral contraception\",\n \"MEDDRACode\": \"10030970\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"oral contraceptives\",\n \"Probability\": \"0.0111148655\",\n \"SemanticContext\": \"2.2 Switching From Other Methods of Contraception When switching from other contraceptive methods, medroxyprogesterone acetate injectable suspension should be given in a manner that ensures continuous contraceptive coverage based upon the mechanism of action of both methods, e.g., patients switching from oral contraceptives should have their first injection of medroxyprogesterone acetate injectable suspension on the day after the last active tablet or at the latest, on the day following the final inactive tablet .\"\n },\n {\n \"VerbatimTerm\": \"oral contraceptive\",\n \"Probability\": \"0.0002444088\",\n \"SemanticContext\": \"Shapiro et al. 2000 : age, ethnic group, socioeconomic status, and any combined estrogen/progestogen oral contraceptive use.\"\n }\n ]\n },\n {\n \"Term\": \"Barbiturates\",\n \"MEDDRACode\": \"10063229\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"barbiturates\",\n \"Probability\": \"0.0003173053\",\n \"SemanticContext\": \"Some drugs or herbal products that may decrease the effectiveness of hormonal contraceptives include: barbiturates bosentan carbamazepine felbamate griseofulvin oxcarbazepine phenytoin rifampin St. John’s wort topiramate HIV protease inhibitors and non-nucleoside reverse transcriptase inhibitors : Significant changes increase or decrease in the plasma levels of progestin have been noted in some cases of coadministration of HIV protease inhibitors.\"\n }\n ]\n },\n {\n \"Term\": \"Fracture\",\n \"MEDDRACode\": \"10017076\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"fracture\",\n \"Probability\": \"0.693872571\",\n \"SemanticContext\": \"The incidence rates of fracture were compared between medroxyprogesterone acetate injectable suspension users and contraceptive users who had no recorded use of medroxyprogesterone acetate injectable suspension .\"\n },\n {\n \"VerbatimTerm\": \"fracture\",\n \"Probability\": \"0.0209124386\",\n \"SemanticContext\": \"The Incident Rate Ratio IRR for any fracture during the follow-up period mean = 5.5 years was 1.41 95% CI 1.35, 1.47 .\"\n },\n {\n \"VerbatimTerm\": \"fracture\",\n \"Probability\": \"0.0016288161\",\n \"SemanticContext\": \"It is not known if this is due to medroxyprogesterone acetate injectable suspension use or to other related lifestyle factors that have a bearing on fracture rate.\"\n },\n {\n \"VerbatimTerm\": \"fracture\",\n \"Probability\": \"0.1207832694\",\n \"SemanticContext\": \"In the study, when cumulative exposure to medroxyprogesterone acetate injectable suspension was calculated, the fracture rate in users who received fewer than 8 injections was higher than that in women who received 8 or more injections.\"\n },\n {\n \"VerbatimTerm\": \"fracture\",\n \"Probability\": \"0.0036620498\",\n \"SemanticContext\": \"There were very few osteoporotic fractures fracture sites known to be related to low BMD in the study overall, and the incidence of osteoporotic fractures was not found to be higher in medroxyprogesterone acetate injectable suspension users compared to non-users.\"\n },\n {\n \"VerbatimTerm\": \"fracture\",\n \"Probability\": \"0.0009063482\",\n \"SemanticContext\": \"Importantly, this study could not determine whether use of medroxyprogesterone acetate injectable suspension has an effect on fracture rate later in life.\"\n }\n ]\n },\n {\n \"Term\": \"Adolescence\",\n \"MEDDRACode\": \"10001318\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"adolescence\",\n \"Probability\": \"6.48791E-05\",\n \"SemanticContext\": \"It is unknown if use of medroxyprogesterone acetate injectable suspension during adolescence or early adulthood, a critical period of bone accretion, will reduce peak bone mass and increase the risk for osteoporotic fracture in later life.\"\n },\n {\n \"VerbatimTerm\": \"adolescence\",\n \"Probability\": \"0.0019311309\",\n \"SemanticContext\": \"This loss of BMD is of particular concern during adolescence and early adulthood, a critical period of bone accretion.\"\n },\n {\n \"VerbatimTerm\": \"adolescence\",\n \"Probability\": \"0.0002446175\",\n \"SemanticContext\": \"Neonates exposed to medroxyprogesterone acetate in-utero and followed to adolescence showed no evidence of any adverse effects on their health including their physical, intellectual, sexual or social development.\"\n },\n {\n \"VerbatimTerm\": \"adolescence\",\n \"Probability\": \"0.0019311309\",\n \"SemanticContext\": \"This loss of BMD is of particular concern during adolescence and early adulthood, a critical period of bone accretion.\"\n }\n ]\n },\n {\n \"Term\": \"Becker's muscular dystrophy\",\n \"MEDDRACode\": \"10059117\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"BMD\",\n \"Probability\": \"0.0074011087\",\n \"SemanticContext\": \"14.2 Bone Mineral Density Changes in Adult Women Treated with Medroxyprogesterone Acetate Injectable Suspension In a controlled, clinical study, adult women using medroxyprogesterone acetate injectable suspension 150 mg for up to 5 years showed spine and hip bone mineral density BMD mean decreases of 5 to 6%, compared to no significant change in BMD in the control group.\"\n },\n {\n \"VerbatimTerm\": \"BMD\",\n \"Probability\": \"0.002817452\",\n \"SemanticContext\": \"14.2 Bone Mineral Density Changes in Adult Women Treated with Medroxyprogesterone Acetate Injectable Suspension In a controlled, clinical study, adult women using medroxyprogesterone acetate injectable suspension 150 mg for up to 5 years showed spine and hip bone mineral density BMD mean decreases of 5 to 6%, compared to no significant change in BMD in the control group.\"\n },\n {\n \"VerbatimTerm\": \"BMD\",\n \"Probability\": \"0.0042527914\",\n \"SemanticContext\": \"The decline in BMD was more pronounced during the first two years of use, with smaller declines in subsequent years.\"\n },\n {\n \"VerbatimTerm\": \"BMD\",\n \"Probability\": \"0.0084472299\",\n \"SemanticContext\": \"Mean changes in lumbar spine BMD of -2.86%, -4.11%, -4.89%, -4.93% and -5.38% after 1, 2, 3, 4, and 5 years, respectively, were observed.\"\n },\n {\n \"VerbatimTerm\": \"BMD\",\n \"Probability\": \"0.0018084049\",\n \"SemanticContext\": \"Mean decreases in BMD of the total hip and femoral neck were similar.\"\n },\n {\n \"VerbatimTerm\": \"BMD\",\n \"Probability\": \"0.0007956624\",\n \"SemanticContext\": \"After stopping use of medroxyprogesterone acetate injectable suspension, there was partial recovery of BMD toward baseline values during the 2-year post-therapy period.\"\n },\n {\n \"VerbatimTerm\": \"BMD\",\n \"Probability\": \"0.0036416948\",\n \"SemanticContext\": \"Table 4 shows the change in BMD in women after 5 years of treatment with medroxyprogesterone acetate injectable suspension and in women in a control group, as well as the extent of recovery of BMD for the subset of the women for whom 2 year post-treatment data were available.\"\n },\n {\n \"VerbatimTerm\": \"BMD\",\n \"Probability\": \"0.0050142407\",\n \"SemanticContext\": \"Table 4 shows the change in BMD in women after 5 years of treatment with medroxyprogesterone acetate injectable suspension and in women in a control group, as well as the extent of recovery of BMD for the subset of the women for whom 2 year post-treatment data were available.\"\n },\n {\n \"VerbatimTerm\": \"BMD\",\n \"Probability\": \"0.0034164786\",\n \"SemanticContext\": \"Mean Percent Change from Baseline in BMD in Adults by Skeletal Site and Cohort 5 Years of Treatment and 2 Years of Follow-Up Time in Study Spine Total Hip Femoral Neck Medroxyprogesterone Acetate Injectable Suspension The treatment group consisted of women who received medroxyprogesterone acetate injectable suspension for 5 years and were then followed for 2 years post-use total time in study of 7 years .\"\n },\n {\n \"VerbatimTerm\": \"BMD\",\n \"Probability\": \"0.0022749007\",\n \"SemanticContext\": \"Use of medroxyprogesterone acetate injectable suspension was associated with a significant decline from baseline in BMD.\"\n },\n {\n \"VerbatimTerm\": \"BMD\",\n \"Probability\": \"0.0254455805\",\n \"SemanticContext\": \"The decline in BMD at total hip and femoral neck was greater with longer duration of use.\"\n },\n {\n \"VerbatimTerm\": \"BMD\",\n \"Probability\": \"0.0042289495\",\n \"SemanticContext\": \"The mean decrease in BMD at 240 weeks was more pronounced at total hip -6.4% and femoral neck -5.4% compared to lumbar spine -2.1% .\"\n },\n {\n \"VerbatimTerm\": \"BMD\",\n \"Probability\": \"0.0004737973\",\n \"SemanticContext\": \"Adolescents in the untreated cohort had an increase in BMD during the period of growth following menarche.\"\n },\n {\n \"VerbatimTerm\": \"BMD\",\n \"Probability\": \"0.0003839731\",\n \"SemanticContext\": \"However, the two cohorts were not matched at baseline for age, gynecologic age, race, BMD and other factors that influence the rate of acquisition of BMD.\"\n },\n {\n \"VerbatimTerm\": \"BMD\",\n \"Probability\": \"0.0118665695\",\n \"SemanticContext\": \"However, the two cohorts were not matched at baseline for age, gynecologic age, race, BMD and other factors that influence the rate of acquisition of BMD.\"\n },\n {\n \"VerbatimTerm\": \"BMD\",\n \"Probability\": \"0.0078336895\",\n \"SemanticContext\": \"BMD Mean Percent Change from Baseline in Adolescents Receiving =4 Injections per 60-week Period, by Skeletal Site and Cohort Duration of Treatment Medroxyprogesterone Acetate Injectable Suspension 150 mg IM Unmatched, Untreated Cohort N Mean % Change N Mean % Change Total Hip BMD Week 60 1.2 years Week 120 2.3 years Week 240 4.6 years 113 73 28 -2.75 -5.40 -6.40 166 109 84 1.22 2.19 1.71 Femoral Neck BMD Week 60 Week 120 Week 240 113 73 28 -2.96 -5.30 -5.40 166 108 84 1.75 2.83 1.94 Lumbar Spine BMD Week 60 Week 120 Week 240 114 73 27 -2.47 -2.74 -2.11 167 109 84 3.39 5.28 6.40 .\"\n },\n {\n \"VerbatimTerm\": \"BMD\",\n \"Probability\": \"0.0154575408\",\n \"SemanticContext\": \"BMD Mean Percent Change from Baseline in Adolescents Receiving =4 Injections per 60-week Period, by Skeletal Site and Cohort Duration of Treatment Medroxyprogesterone Acetate Injectable Suspension 150 mg IM Unmatched, Untreated Cohort N Mean % Change N Mean % Change Total Hip BMD Week 60 1.2 years Week 120 2.3 years Week 240 4.6 years 113 73 28 -2.75 -5.40 -6.40 166 109 84 1.22 2.19 1.71 Femoral Neck BMD Week 60 Week 120 Week 240 113 73 28 -2.96 -5.30 -5.40 166 108 84 1.75 2.83 1.94 Lumbar Spine BMD Week 60 Week 120 Week 240 114 73 27 -2.47 -2.74 -2.11 167 109 84 3.39 5.28 6.40 .\"\n },\n {\n \"VerbatimTerm\": \"BMD\",\n \"Probability\": \"0.0070530176\",\n \"SemanticContext\": \"BMD Mean Percent Change from Baseline in Adolescents Receiving =4 Injections per 60-week Period, by Skeletal Site and Cohort Duration of Treatment Medroxyprogesterone Acetate Injectable Suspension 150 mg IM Unmatched, Untreated Cohort N Mean % Change N Mean % Change Total Hip BMD Week 60 1.2 years Week 120 2.3 years Week 240 4.6 years 113 73 28 -2.75 -5.40 -6.40 166 109 84 1.22 2.19 1.71 Femoral Neck BMD Week 60 Week 120 Week 240 113 73 28 -2.96 -5.30 -5.40 166 108 84 1.75 2.83 1.94 Lumbar Spine BMD Week 60 Week 120 Week 240 114 73 27 -2.47 -2.74 -2.11 167 109 84 3.39 5.28 6.40 .\"\n },\n {\n \"VerbatimTerm\": \"BMD\",\n \"Probability\": \"0.0261407495\",\n \"SemanticContext\": \"BMD Mean Percent Change from Baseline in Adolescents Receiving =4 Injections per 60-week Period, by Skeletal Site and Cohort Duration of Treatment Medroxyprogesterone Acetate Injectable Suspension 150 mg IM Unmatched, Untreated Cohort N Mean % Change N Mean % Change Total Hip BMD Week 60 1.2 years Week 120 2.3 years Week 240 4.6 years 113 73 28 -2.75 -5.40 -6.40 166 109 84 1.22 2.19 1.71 Femoral Neck BMD Week 60 Week 120 Week 240 113 73 28 -2.96 -5.30 -5.40 166 108 84 1.75 2.83 1.94 Lumbar Spine BMD Week 60 Week 120 Week 240 114 73 27 -2.47 -2.74 -2.11 167 109 84 3.39 5.28 6.40 .\"\n },\n {\n \"VerbatimTerm\": \"BMD\",\n \"Probability\": \"0.0106063485\",\n \"SemanticContext\": \"BMD Recovery Post-Treatment in Adolescents Longer duration of treatment and smoking were associated with less recovery of BMD following the last injection of medroxyprogesterone acetate injectable suspension.\"\n },\n {\n \"VerbatimTerm\": \"BMD\",\n \"Probability\": \"0.0005838573\",\n \"SemanticContext\": \"BMD Recovery Post-Treatment in Adolescents Longer duration of treatment and smoking were associated with less recovery of BMD following the last injection of medroxyprogesterone acetate injectable suspension.\"\n },\n {\n \"VerbatimTerm\": \"BMD\",\n \"Probability\": \"0.0101103485\",\n \"SemanticContext\": \"Table 6 shows the extent of recovery of BMD up to 60 months post-treatment for adolescents who received medroxyprogesterone acetate injectable suspension for two years or less compared to more than two years.\"\n },\n {\n \"VerbatimTerm\": \"BMD\",\n \"Probability\": \"0.0367683172\",\n \"SemanticContext\": \"Post-treatment follow-up showed that, in women treated for more than two years, only lumbar spine BMD recovered to baseline levels after treatment was discontinued.\"\n },\n {\n \"VerbatimTerm\": \"BMD\",\n \"Probability\": \"0.0027620792\",\n \"SemanticContext\": \"Adolescents treated with medroxyprogesterone acetate injectable suspension for more than two years did not recover to their baseline BMD level at femoral neck and total hip even up to 60 months post-treatment.\"\n },\n {\n \"VerbatimTerm\": \"BMD\",\n \"Probability\": \"0.0024689436\",\n \"SemanticContext\": \"Adolescents in the untreated cohort gained BMD throughout the trial period data not shown [see Warnings and Precautions 5.1 ] .\"\n },\n {\n \"VerbatimTerm\": \"BMD\",\n \"Probability\": \"0.0601000786\",\n \"SemanticContext\": \"Table 6: BMD Recovery Months Post-Treatment in Adolescents by Years of Medroxyprogesterone Acetate Injectable Suspension Use 2 Years or Less vs. More than 2 Years Duration of Treatment 2 years or less More than 2 years N Mean % Change from baseline N Mean % Change from baseline Total Hip BMD End of Treatment 49 -1.5% 49 -6.2% 12 M post-treatment 33 -1.4% 24 -4.6% 24 M post-treatment 18 0.3% 17 -3.6% 36 M post-treatment 12 2.1% 11 -4.6% 48 M post-treatment 10 1.3% 9 -2.5% 60 M post-treatment 3 0.2% 2 -1.0% Femoral Neck BMD End of Treatment 49 -1.6% 49 -5.8% 12 M post-treatment 33 -1.4% 24 -4.3% 24 M post-treatment 18 0.5% 17 -3.8% 36 M post-treatment 12 1.2% 11 -3.8% 48 M post-treatment 10 2.0% 9 -1.7% 60 M post-treatment 3 1.0% 2 -1.9% Lumbar Spine BMD End of Treatment 49 -0.9% 49 -3.5% 12 M post-treatment 33 0.4% 23 -1.1% 24 M post-treatment 18 2.6% 17 1.9% 36 M post-treatment 12 2.4% 11 0.6% 48 M post-treatment 10 6.5% 9 3.5% 60 M post-treatment 3 6.2% 2 5.7% .\"\n },\n {\n \"VerbatimTerm\": \"BMD\",\n \"Probability\": \"0.0006925166\",\n \"SemanticContext\": \"Table 6: BMD Recovery Months Post-Treatment in Adolescents by Years of Medroxyprogesterone Acetate Injectable Suspension Use 2 Years or Less vs. More than 2 Years Duration of Treatment 2 years or less More than 2 years N Mean % Change from baseline N Mean % Change from baseline Total Hip BMD End of Treatment 49 -1.5% 49 -6.2% 12 M post-treatment 33 -1.4% 24 -4.6% 24 M post-treatment 18 0.3% 17 -3.6% 36 M post-treatment 12 2.1% 11 -4.6% 48 M post-treatment 10 1.3% 9 -2.5% 60 M post-treatment 3 0.2% 2 -1.0% Femoral Neck BMD End of Treatment 49 -1.6% 49 -5.8% 12 M post-treatment 33 -1.4% 24 -4.3% 24 M post-treatment 18 0.5% 17 -3.8% 36 M post-treatment 12 1.2% 11 -3.8% 48 M post-treatment 10 2.0% 9 -1.7% 60 M post-treatment 3 1.0% 2 -1.9% Lumbar Spine BMD End of Treatment 49 -0.9% 49 -3.5% 12 M post-treatment 33 0.4% 23 -1.1% 24 M post-treatment 18 2.6% 17 1.9% 36 M post-treatment 12 2.4% 11 0.6% 48 M post-treatment 10 6.5% 9 3.5% 60 M post-treatment 3 6.2% 2 5.7% .\"\n },\n {\n \"VerbatimTerm\": \"BMD\",\n \"Probability\": \"0.0006058216\",\n \"SemanticContext\": \"Table 6: BMD Recovery Months Post-Treatment in Adolescents by Years of Medroxyprogesterone Acetate Injectable Suspension Use 2 Years or Less vs. More than 2 Years Duration of Treatment 2 years or less More than 2 years N Mean % Change from baseline N Mean % Change from baseline Total Hip BMD End of Treatment 49 -1.5% 49 -6.2% 12 M post-treatment 33 -1.4% 24 -4.6% 24 M post-treatment 18 0.3% 17 -3.6% 36 M post-treatment 12 2.1% 11 -4.6% 48 M post-treatment 10 1.3% 9 -2.5% 60 M post-treatment 3 0.2% 2 -1.0% Femoral Neck BMD End of Treatment 49 -1.6% 49 -5.8% 12 M post-treatment 33 -1.4% 24 -4.3% 24 M post-treatment 18 0.5% 17 -3.8% 36 M post-treatment 12 1.2% 11 -3.8% 48 M post-treatment 10 2.0% 9 -1.7% 60 M post-treatment 3 1.0% 2 -1.9% Lumbar Spine BMD End of Treatment 49 -0.9% 49 -3.5% 12 M post-treatment 33 0.4% 23 -1.1% 24 M post-treatment 18 2.6% 17 1.9% 36 M post-treatment 12 2.4% 11 0.6% 48 M post-treatment 10 6.5% 9 3.5% 60 M post-treatment 3 6.2% 2 5.7% .\"\n },\n {\n \"VerbatimTerm\": \"BMD\",\n \"Probability\": \"0.0023917556\",\n \"SemanticContext\": \"Table 6: BMD Recovery Months Post-Treatment in Adolescents by Years of Medroxyprogesterone Acetate Injectable Suspension Use 2 Years or Less vs. More than 2 Years Duration of Treatment 2 years or less More than 2 years N Mean % Change from baseline N Mean % Change from baseline Total Hip BMD End of Treatment 49 -1.5% 49 -6.2% 12 M post-treatment 33 -1.4% 24 -4.6% 24 M post-treatment 18 0.3% 17 -3.6% 36 M post-treatment 12 2.1% 11 -4.6% 48 M post-treatment 10 1.3% 9 -2.5% 60 M post-treatment 3 0.2% 2 -1.0% Femoral Neck BMD End of Treatment 49 -1.6% 49 -5.8% 12 M post-treatment 33 -1.4% 24 -4.3% 24 M post-treatment 18 0.5% 17 -3.8% 36 M post-treatment 12 1.2% 11 -3.8% 48 M post-treatment 10 2.0% 9 -1.7% 60 M post-treatment 3 1.0% 2 -1.9% Lumbar Spine BMD End of Treatment 49 -0.9% 49 -3.5% 12 M post-treatment 33 0.4% 23 -1.1% 24 M post-treatment 18 2.6% 17 1.9% 36 M post-treatment 12 2.4% 11 0.6% 48 M post-treatment 10 6.5% 9 3.5% 60 M post-treatment 3 6.2% 2 5.7% .\"\n },\n {\n \"VerbatimTerm\": \"BMD\",\n \"Probability\": \"0.0012566149\",\n \"SemanticContext\": \"There were very few osteoporotic fractures fracture sites known to be related to low BMD in the study overall, and the incidence of osteoporotic fractures was not found to be higher in medroxyprogesterone acetate injectable suspension users compared to non-users.\"\n },\n {\n \"VerbatimTerm\": \"BMD\",\n \"Probability\": \"0.0038231611\",\n \"SemanticContext\": \"Use for longer than 2 years is not recommended unless other birth control methods are considered inadequate due to the impact of long-term medroxyprogesterone acetate injectable suspension treatment on bone mineral density BMD [see Warnings and Precautions 5.1 ] .\"\n },\n {\n \"VerbatimTerm\": \"BMD\",\n \"Probability\": \"0.0019326508\",\n \"SemanticContext\": \"5 WARNINGS AND PRECAUTIONS 5.1 Loss of Bone Mineral Density Use of medroxyprogesterone acetate injectable suspension reduces serum estrogen levels and is associated with significant loss of bone mineral density BMD .\"\n },\n {\n \"VerbatimTerm\": \"BMD\",\n \"Probability\": \"0.0011630058\",\n \"SemanticContext\": \"This loss of BMD is of particular concern during adolescence and early adulthood, a critical period of bone accretion.\"\n },\n {\n \"VerbatimTerm\": \"BMD\",\n \"Probability\": \"0.0001964271\",\n \"SemanticContext\": \"A study to assess the reversibility of loss of BMD in adolescents was conducted with medroxyprogesterone acetate injectable suspension.\"\n },\n {\n \"VerbatimTerm\": \"BMD\",\n \"Probability\": \"0.0004969239\",\n \"SemanticContext\": \"After discontinuing medroxyprogesterone acetate injectable suspension in these adolescents, mean BMD loss at the total hip and femoral neck did not fully recover by 5 years 60 months post-treatment in the sub-group of adolescents who were treated for more than 2 years [see Clinical Studies 14.3 ].\"\n },\n {\n \"VerbatimTerm\": \"BMD\",\n \"Probability\": \"0.0008450449\",\n \"SemanticContext\": \"Similarly, in adults, there was only partial recovery of mean BMD at the total hip, femoral neck, and lumbar spine towards baseline by 2 years post-treatment [See Clinical Studies 14.2 ].\"\n },\n {\n \"VerbatimTerm\": \"BMD\",\n \"Probability\": \"0.0008767545\",\n \"SemanticContext\": \"BMD should be evaluated when a woman needs to continue to use medroxyprogesterone acetate injectable suspension long-term.\"\n },\n {\n \"VerbatimTerm\": \"BMD\",\n \"Probability\": \"1.45113E-05\",\n \"SemanticContext\": \"In adolescents, interpretation of BMD results should take into account patient age and skeletal maturity.\"\n },\n {\n \"VerbatimTerm\": \"BMD\",\n \"Probability\": \"5.02598E-05\",\n \"SemanticContext\": \"Use of medroxyprogesterone acetate injectable suspension is associated with significant loss of BMD.\"\n },\n {\n \"VerbatimTerm\": \"BMD\",\n \"Probability\": \"0.0011630058\",\n \"SemanticContext\": \"This loss of BMD is of particular concern during adolescence and early adulthood, a critical period of bone accretion.\"\n },\n {\n \"VerbatimTerm\": \"BMD\",\n \"Probability\": \"8.67699E-05\",\n \"SemanticContext\": \"In adolescents, interpretation of BMD results should take into account patient age and skeletal maturity.\"\n },\n {\n \"VerbatimTerm\": \"BMD\",\n \"Probability\": \"0.0003115535\",\n \"SemanticContext\": \"Other than concerns about loss of BMD, the safety and effectiveness are expected to be the same for postmenarchal adolescents and adult women.\"\n }\n ]\n },\n {\n \"Term\": \"Progesterone\",\n \"MEDDRACode\": \"10063291\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"progesterone\",\n \"Probability\": \"0.0024991035\",\n \"SemanticContext\": \"11 DESCRIPTION Medroxyprogesterone acetate injectable suspension, USP, a contraceptive injection, contains medroxyprogesterone acetate, USP a derivative of progesterone, as its active ingredient.\"\n },\n {\n \"VerbatimTerm\": \"progesterone\",\n \"Probability\": \"0.0014027655\",\n \"SemanticContext\": \"The following laboratory tests may be affected by progestins including medroxyprogesterone acetate injectable suspension: a Plasma and urinary steroid levels are decreased e.g., progesterone, estradiol, pregnanediol, testosterone, cortisol .\"\n }\n ]\n },\n {\n \"Term\": \"Osteoporosis\",\n \"MEDDRACode\": \"10031282\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"osteoporosis\",\n \"Probability\": \"0.2073624432\",\n \"SemanticContext\": \"There have been cases of osteoporosis including osteoporotic fractures reported post-marketing in patients taking medroxyprogesterone acetate injectable suspension.\"\n },\n {\n \"VerbatimTerm\": \"osteoporosis\",\n \"Probability\": \"9.77796E-05\",\n \"SemanticContext\": \"Other birth control methods should be considered in the risk/benefit analysis for the use of medroxyprogesterone acetate injectable suspension in women with osteoporosis risk factors.\"\n },\n {\n \"VerbatimTerm\": \"osteoporosis\",\n \"Probability\": \"0.002709806\",\n \"SemanticContext\": \"Medroxyprogesterone acetate injectable suspension can pose an additional risk in patients with risk factors for osteoporosis e.g., metabolic bone disease, chronic alcohol and/or tobacco use, anorexia nervosa, strong family history of osteoporosis or chronic use of drugs that can reduce bone mass such as anticonvulsants or corticosteroids .\"\n },\n {\n \"VerbatimTerm\": \"osteoporosis\",\n \"Probability\": \"8.56172E-05\",\n \"SemanticContext\": \"Medroxyprogesterone acetate injectable suspension can pose an additional risk in patients with risk factors for osteoporosis e.g., metabolic bone disease, chronic alcohol and/or tobacco use, anorexia nervosa, strong family history of osteoporosis or chronic use of drugs that can reduce bone mass such as anticonvulsants or corticosteroids .\"\n },\n {\n \"VerbatimTerm\": \"Osteoporosis\",\n \"Probability\": \"0.0320436656\",\n \"SemanticContext\": \", Injection site infection , Injection site nodule/lump, Injection site pain/tenderness, Injection site persistent atrophy/indentation/dimpling, Injection-site reaction, Lipodystrophy acquired, Chills, Axillary swelling Cardiovascular Syncope, Tachycardia, Thrombophlebitis, Deep vein thrombosis, Pulmonary embolus, Varicose veins Digestive Changes in appetite, Gastrointestinal disturbances, Jaundice, Excessive thirst, Rectal bleeding Hematologic and Lymphatic Anemia, Blood dyscrasia Musculoskeletal Osteoporosis Neoplasms Cervical cancer, Breast cancer Nervous Paralysis, Facial palsy, Paresthesia, Drowsiness Respiratory Dyspnea and asthma, Hoarseness Skin and Appendages Hirsutism, Excessive sweating and body odor, Dry skin, Scleroderma Urogenital Lack of return to fertility, Unexpected pregnancy, Prevention of lactation, Changes in breast size, Breast lumps or nipple bleeding, Galactorrhea, Melasma, Chloasma, Increased libido, Uterine hyperplasia, Genitourinary infections, Vaginal cysts, Dyspareunia .\"\n }\n ]\n },\n {\n \"Term\": \"Depression\",\n \"MEDDRACode\": \"10012378\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Depression\",\n \"Probability\": \"0.9143756032\",\n \"SemanticContext\": \"Table 2 Adverse Reactions that Were Reported by between 1 and 5% of Subjects Body System* Adverse Reactions [Incidence % ] Body as a Whole Asthenia/fatigue 4.2% Backache 2.2% Dysmenorrhea 1.7% Hot flashes 1.0% Digestive Nausea 3.3% Bloating 2.3% Metabolic/Nutritional Edema 2.2% Musculoskeletal Leg cramps 3.7% Arthralgia 1.0% Nervous Depression 1.5% Insomnia 1.0% Skin and Appendages Acne 1.2% No hair growth/alopecia 1.1% Rash 1.1% Urogenital Leukorrhea 2.9% Breast pain 2.8% Vaginitis 1.2% .\"\n },\n {\n \"VerbatimTerm\": \"Depression\",\n \"Probability\": \"0.2297161222\",\n \"SemanticContext\": \"5.9 Depression Monitor patients who have a history of depression and do not re-administer medroxyprogesterone acetate injectable suspension if depression recurs.\"\n },\n {\n \"VerbatimTerm\": \"depression\",\n \"Probability\": \"0.0005587935\",\n \"SemanticContext\": \"5.9 Depression Monitor patients who have a history of depression and do not re-administer medroxyprogesterone acetate injectable suspension if depression recurs.\"\n },\n {\n \"VerbatimTerm\": \"depression\",\n \"Probability\": \"0.0037875772\",\n \"SemanticContext\": \"5.9 Depression Monitor patients who have a history of depression and do not re-administer medroxyprogesterone acetate injectable suspension if depression recurs.\"\n }\n ]\n },\n {\n \"Term\": \"Hot flush\",\n \"MEDDRACode\": \"10060800\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Hot flashes\",\n \"Probability\": \"0.9986914396\",\n \"SemanticContext\": \"Table 2 Adverse Reactions that Were Reported by between 1 and 5% of Subjects Body System* Adverse Reactions [Incidence % ] Body as a Whole Asthenia/fatigue 4.2% Backache 2.2% Dysmenorrhea 1.7% Hot flashes 1.0% Digestive Nausea 3.3% Bloating 2.3% Metabolic/Nutritional Edema 2.2% Musculoskeletal Leg cramps 3.7% Arthralgia 1.0% Nervous Depression 1.5% Insomnia 1.0% Skin and Appendages Acne 1.2% No hair growth/alopecia 1.1% Rash 1.1% Urogenital Leukorrhea 2.9% Breast pain 2.8% Vaginitis 1.2% .\"\n }\n ]\n },\n {\n \"Term\": \"Libido increased\",\n \"MEDDRACode\": \"10024421\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Increased libido\",\n \"Probability\": \"0.9117340446\",\n \"SemanticContext\": \", Injection site infection , Injection site nodule/lump, Injection site pain/tenderness, Injection site persistent atrophy/indentation/dimpling, Injection-site reaction, Lipodystrophy acquired, Chills, Axillary swelling Cardiovascular Syncope, Tachycardia, Thrombophlebitis, Deep vein thrombosis, Pulmonary embolus, Varicose veins Digestive Changes in appetite, Gastrointestinal disturbances, Jaundice, Excessive thirst, Rectal bleeding Hematologic and Lymphatic Anemia, Blood dyscrasia Musculoskeletal Osteoporosis Neoplasms Cervical cancer, Breast cancer Nervous Paralysis, Facial palsy, Paresthesia, Drowsiness Respiratory Dyspnea and asthma, Hoarseness Skin and Appendages Hirsutism, Excessive sweating and body odor, Dry skin, Scleroderma Urogenital Lack of return to fertility, Unexpected pregnancy, Prevention of lactation, Changes in breast size, Breast lumps or nipple bleeding, Galactorrhea, Melasma, Chloasma, Increased libido, Uterine hyperplasia, Genitourinary infections, Vaginal cysts, Dyspareunia .\"\n }\n ]\n },\n {\n \"Term\": \"Blood cholesterol\",\n \"MEDDRACode\": \"10005422\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"total cholesterol\",\n \"Probability\": \"0.0001732409\",\n \"SemanticContext\": \"Both increases and decreases in total cholesterol, triglycerides, low-density lipoprotein LDL cholesterol, and high-density lipoprotein HDL cholesterol have been observed in studies.\"\n }\n ]\n },\n {\n \"Term\": \"Oestradiol\",\n \"MEDDRACode\": \"10030227\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"estradiol\",\n \"Probability\": \"0.0008494556\",\n \"SemanticContext\": \"The following laboratory tests may be affected by progestins including medroxyprogesterone acetate injectable suspension: a Plasma and urinary steroid levels are decreased e.g., progesterone, estradiol, pregnanediol, testosterone, cortisol .\"\n }\n ]\n },\n {\n \"Term\": \"Progestin therapy\",\n \"MEDDRACode\": \"10036797\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"progestin therapy\",\n \"Probability\": \"3.8496E-06\",\n \"SemanticContext\": \"7.2 Laboratory Test Interactions The pathologist should be advised of progestin therapy when relevant specimens are submitted.\"\n }\n ]\n },\n {\n \"Term\": \"Tri-iodothyronine uptake\",\n \"MEDDRACode\": \"10044599\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"T3-uptake\",\n \"Probability\": \"0.0013377964\",\n \"SemanticContext\": \"T3-uptake values may decrease.\"\n }\n ]\n },\n {\n \"Term\": \"Discomfort\",\n \"MEDDRACode\": \"10013082\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"discomfort\",\n \"Probability\": \"0.9828912616\",\n \"SemanticContext\": \"ADVERSE REACTIONS Most common adverse reactions incidence >5% are: menstrual irregularities bleeding or spotting 57% at 12 months, 32% at 24 months, abdominal pain/discomfort 11%, weight gain > 10 lbs at 24 months 38%, dizziness 6%, headache 17%, nervousness 11%, decreased libido 6%.\"\n },\n {\n \"VerbatimTerm\": \"discomfort\",\n \"Probability\": \"0.9764465094\",\n \"SemanticContext\": \"Table 1 Adverse Reactions that Were Reported by More than 5% of Subjects Body System* Adverse Reactions [Incidence % ] Body as a Whole Headache 16.5% Abdominal pain/discomfort 11.2% Metabolic/Nutritional Increased weight> 10lbs at 24 months 37.7% Nervous Nervousness 10.8% Dizziness 5.6% Libido decreased 5.5% Urogenital Menstrual irregularities: bleeding 57.3% at 12 months, 32.1% at 24 months amenorrhea 55% at 12 months, 68% at 24 months .\"\n }\n ]\n },\n {\n \"Term\": \"Blood gonadotrophin\",\n \"MEDDRACode\": \"10005560\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"gonadotropins\",\n \"Probability\": \"0.0082066655\",\n \"SemanticContext\": \"spl-medroxy-structure 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Medroxyprogesterone acetate MPA injectable suspension, inhibits the secretion of gonadotropins which primarily prevents follicular maturation and ovulation and causes thickening of cervical mucus.\"\n },\n {\n \"VerbatimTerm\": \"Gonadotropin\",\n \"Probability\": \"0.0001799464\",\n \"SemanticContext\": \"b Gonadotropin levels are decreased.\"\n }\n ]\n },\n {\n \"Term\": \"Nausea\",\n \"MEDDRACode\": \"10028813\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Nausea\",\n \"Probability\": \"0.999587059\",\n \"SemanticContext\": \"Table 2 Adverse Reactions that Were Reported by between 1 and 5% of Subjects Body System* Adverse Reactions [Incidence % ] Body as a Whole Asthenia/fatigue 4.2% Backache 2.2% Dysmenorrhea 1.7% Hot flashes 1.0% Digestive Nausea 3.3% Bloating 2.3% Metabolic/Nutritional Edema 2.2% Musculoskeletal Leg cramps 3.7% Arthralgia 1.0% Nervous Depression 1.5% Insomnia 1.0% Skin and Appendages Acne 1.2% No hair growth/alopecia 1.1% Rash 1.1% Urogenital Leukorrhea 2.9% Breast pain 2.8% Vaginitis 1.2% .\"\n }\n ]\n },\n {\n \"Term\": \"Neoplasm\",\n \"MEDDRACode\": \"10028980\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Neoplasms\",\n \"Probability\": \"0.0074873865\",\n \"SemanticContext\": \", Injection site infection , Injection site nodule/lump, Injection site pain/tenderness, Injection site persistent atrophy/indentation/dimpling, Injection-site reaction, Lipodystrophy acquired, Chills, Axillary swelling Cardiovascular Syncope, Tachycardia, Thrombophlebitis, Deep vein thrombosis, Pulmonary embolus, Varicose veins Digestive Changes in appetite, Gastrointestinal disturbances, Jaundice, Excessive thirst, Rectal bleeding Hematologic and Lymphatic Anemia, Blood dyscrasia Musculoskeletal Osteoporosis Neoplasms Cervical cancer, Breast cancer Nervous Paralysis, Facial palsy, Paresthesia, Drowsiness Respiratory Dyspnea and asthma, Hoarseness Skin and Appendages Hirsutism, Excessive sweating and body odor, Dry skin, Scleroderma Urogenital Lack of return to fertility, Unexpected pregnancy, Prevention of lactation, Changes in breast size, Breast lumps or nipple bleeding, Galactorrhea, Melasma, Chloasma, Increased libido, Uterine hyperplasia, Genitourinary infections, Vaginal cysts, Dyspareunia .\"\n }\n ]\n },\n {\n \"Term\": \"Blood triglycerides\",\n \"MEDDRACode\": \"10005836\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"triglycerides\",\n \"Probability\": \"0.0001741052\",\n \"SemanticContext\": \"Both increases and decreases in total cholesterol, triglycerides, low-density lipoprotein LDL cholesterol, and high-density lipoprotein HDL cholesterol have been observed in studies.\"\n }\n ]\n },\n {\n \"Term\": \"Liver function test\",\n \"MEDDRACode\": \"10060105\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"liver function test\",\n \"Probability\": \"0.0010573268\",\n \"SemanticContext\": \"f Sulfobromophthalein and other liver function test values may be increased.\"\n }\n ]\n },\n {\n \"Term\": \"Scleroderma\",\n \"MEDDRACode\": \"10039710\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Scleroderma\",\n \"Probability\": \"0.547527492\",\n \"SemanticContext\": \", Injection site infection , Injection site nodule/lump, Injection site pain/tenderness, Injection site persistent atrophy/indentation/dimpling, Injection-site reaction, Lipodystrophy acquired, Chills, Axillary swelling Cardiovascular Syncope, Tachycardia, Thrombophlebitis, Deep vein thrombosis, Pulmonary embolus, Varicose veins Digestive Changes in appetite, Gastrointestinal disturbances, Jaundice, Excessive thirst, Rectal bleeding Hematologic and Lymphatic Anemia, Blood dyscrasia Musculoskeletal Osteoporosis Neoplasms Cervical cancer, Breast cancer Nervous Paralysis, Facial palsy, Paresthesia, Drowsiness Respiratory Dyspnea and asthma, Hoarseness Skin and Appendages Hirsutism, Excessive sweating and body odor, Dry skin, Scleroderma Urogenital Lack of return to fertility, Unexpected pregnancy, Prevention of lactation, Changes in breast size, Breast lumps or nipple bleeding, Galactorrhea, Melasma, Chloasma, Increased libido, Uterine hyperplasia, Genitourinary infections, Vaginal cysts, Dyspareunia .\"\n }\n ]\n },\n {\n \"Term\": \"Bone loss\",\n \"MEDDRACode\": \"10065687\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Bone loss\",\n \"Probability\": \"0.0036903024\",\n \"SemanticContext\": \"Bone loss is greater with increasing duration of use and may not be completely reversible.\"\n }\n ]\n },\n {\n \"Term\": \"Ultrasound scan\",\n \"MEDDRACode\": \"10045434\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"U.S.\",\n \"Probability\": \"0.0021006465\",\n \"SemanticContext\": \"MEDROXYPROGESTERONE ACETATE injectable suspension, for intramuscular use Initial U.S. Approval: 1959 WARNING: LOSS OF BONE MINERAL DENSITY See full prescribing information for complete boxed warning .\"\n },\n {\n \"VerbatimTerm\": \"U.S.\",\n \"Probability\": \"0.0004483461\",\n \"SemanticContext\": \"Based on the published SEER-18 2011 incidence rate age-adjusted to the 2000 U.S. Standard Population of breast cancer for U.S. women, all races, age 20 to 49 years, a doubling of risk would increase the incidence of breast cancer in women who use medroxyprogesterone acetate injectable suspension from about 72 to about 144 cases per 100,000 women.\"\n },\n {\n \"VerbatimTerm\": \"U.S.\",\n \"Probability\": \"4.95547E-05\",\n \"SemanticContext\": \"Based on the published SEER-18 2011 incidence rate age-adjusted to the 2000 U.S. Standard Population of breast cancer for U.S. women, all races, age 20 to 49 years, a doubling of risk would increase the incidence of breast cancer in women who use medroxyprogesterone acetate injectable suspension from about 72 to about 144 cases per 100,000 women.\"\n },\n {\n \"VerbatimTerm\": \"U.S.\",\n \"Probability\": \"3.9534E-05\",\n \"SemanticContext\": \"In a large U.S. study of women who discontinued use of medroxyprogesterone acetate injectable suspension to become pregnant, data are available for 61% of them.\"\n }\n ]\n },\n {\n \"Term\": \"Varicose vein\",\n \"MEDDRACode\": \"10046996\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Varicose veins\",\n \"Probability\": \"0.9363082647\",\n \"SemanticContext\": \", Injection site infection , Injection site nodule/lump, Injection site pain/tenderness, Injection site persistent atrophy/indentation/dimpling, Injection-site reaction, Lipodystrophy acquired, Chills, Axillary swelling Cardiovascular Syncope, Tachycardia, Thrombophlebitis, Deep vein thrombosis, Pulmonary embolus, Varicose veins Digestive Changes in appetite, Gastrointestinal disturbances, Jaundice, Excessive thirst, Rectal bleeding Hematologic and Lymphatic Anemia, Blood dyscrasia Musculoskeletal Osteoporosis Neoplasms Cervical cancer, Breast cancer Nervous Paralysis, Facial palsy, Paresthesia, Drowsiness Respiratory Dyspnea and asthma, Hoarseness Skin and Appendages Hirsutism, Excessive sweating and body odor, Dry skin, Scleroderma Urogenital Lack of return to fertility, Unexpected pregnancy, Prevention of lactation, Changes in breast size, Breast lumps or nipple bleeding, Galactorrhea, Melasma, Chloasma, Increased libido, Uterine hyperplasia, Genitourinary infections, Vaginal cysts, Dyspareunia .\"\n }\n ]\n },\n {\n \"Term\": \"Thrombosis\",\n \"MEDDRACode\": \"10043607\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"thrombosis\",\n \"Probability\": \"0.0400243104\",\n \"SemanticContext\": \"WARNINGS AND PRECAUTIONS Thromboembolic Disorders: Discontinue medroxyprogesterone acetate injectable suspension in patients who develop thrombosis.\"\n },\n {\n \"VerbatimTerm\": \"thrombosis\",\n \"Probability\": \"0.0013543665\",\n \"SemanticContext\": \"Any patient who develops thrombosis while undergoing therapy with medroxyprogesterone acetate injectable suspension should discontinue treatment unless she has no other acceptable options for birth control.\"\n }\n ]\n },\n {\n \"Term\": \"Breast cancer\",\n \"MEDDRACode\": \"10006187\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"breast cancer\",\n \"Probability\": \"0.0001501739\",\n \"SemanticContext\": \"Cancer Risks: Monitor women with a strong family history of breast cancer carefully.\"\n },\n {\n \"VerbatimTerm\": \"breast cancer\",\n \"Probability\": \"0.0280118883\",\n \"SemanticContext\": \"Counsel patients about the possible increased risk of breast cancer in women who use medroxyprogesterone acetate injectable suspension [ see Warnings and Precautions 5.3 ].\"\n },\n {\n \"VerbatimTerm\": \"breast cancer\",\n \"Probability\": \"0.0004915893\",\n \"SemanticContext\": \"5.3 Cancer Risks Breast Cancer Women who have or have had a history of breast cancer should not use hormonal contraceptives, including medroxyprogesterone acetate injectable suspension, because breast cancer may be hormonally sensitive [see Contraindications 4 ].\"\n },\n {\n \"VerbatimTerm\": \"breast cancer\",\n \"Probability\": \"0.001616925\",\n \"SemanticContext\": \"5.3 Cancer Risks Breast Cancer Women who have or have had a history of breast cancer should not use hormonal contraceptives, including medroxyprogesterone acetate injectable suspension, because breast cancer may be hormonally sensitive [see Contraindications 4 ].\"\n },\n {\n \"VerbatimTerm\": \"breast cancer\",\n \"Probability\": \"0.0008050799\",\n \"SemanticContext\": \"Women with a strong family history of breast cancer should be monitored with particular care.\"\n },\n {\n \"VerbatimTerm\": \"breast cancer\",\n \"Probability\": \"0.026068151\",\n \"SemanticContext\": \"The results of five large case-control studies 1, 2 assessing the association between depo-medroxyprogesterone acetate DMPA use and the risk of breast cancer are summarized in Figure 1.\"\n },\n {\n \"VerbatimTerm\": \"breast cancer\",\n \"Probability\": \"0.3376191854\",\n \"SemanticContext\": \"Three of the studies suggest a slightly increased risk of breast cancer in the overall population of users; these increased risks were statistically significant in one study.\"\n },\n {\n \"VerbatimTerm\": \"breast cancer\",\n \"Probability\": \"0.3336695433\",\n \"SemanticContext\": \"One recent US study 1 evaluated the recency and duration of use and found a statistically significantly increased risk of breast cancer in recent users defined as last use within the past five years who used DMPA for 12 months or longer; this is consistent with results of a previous study.\"\n },\n {\n \"VerbatimTerm\": \"breast cancer\",\n \"Probability\": \"0.0011171401\",\n \"SemanticContext\": \"Li et al. 2012 : age, year, BMI, duration of OC use, number of full-term pregnancies, family history of breast cancer, and history of screening mammography.\"\n },\n {\n \"VerbatimTerm\": \"breast cancer\",\n \"Probability\": \"0.0005778968\",\n \"SemanticContext\": \"Based on the published SEER-18 2011 incidence rate age-adjusted to the 2000 U.S. Standard Population of breast cancer for U.S. women, all races, age 20 to 49 years, a doubling of risk would increase the incidence of breast cancer in women who use medroxyprogesterone acetate injectable suspension from about 72 to about 144 cases per 100,000 women.\"\n },\n {\n \"VerbatimTerm\": \"breast cancer\",\n \"Probability\": \"0.4629985392\",\n \"SemanticContext\": \"Based on the published SEER-18 2011 incidence rate age-adjusted to the 2000 U.S. Standard Population of breast cancer for U.S. women, all races, age 20 to 49 years, a doubling of risk would increase the incidence of breast cancer in women who use medroxyprogesterone acetate injectable suspension from about 72 to about 144 cases per 100,000 women.\"\n },\n {\n \"VerbatimTerm\": \"Breast Cancer\",\n \"Probability\": \"0.6822158098\",\n \"SemanticContext\": \"6 ADVERSE REACTIONS The following important adverse reactions observed with the use of medroxyprogesterone acetate injectable suspension are discussed in greater detail in the Warnings and Precautions section 5 : Loss of Bone Mineral Density [ see Warnings and Precautions 5.1 ] Thromboembolic disease [ see Warnings and Precautions 5.2 ] Breast Cancer [ see Warnings and Precautions 5.3 ] Anaphylaxis and Anaphylactoid Reactions [ see Warnings and Precautions 5.5 ] Bleeding Irregularities [ see Warnings and Precautions 5.\"\n },\n {\n \"VerbatimTerm\": \"Breast Cancer\",\n \"Probability\": \"4.93167E-05\",\n \"SemanticContext\": \"5.3 Cancer Risks Breast Cancer Women who have or have had a history of breast cancer should not use hormonal contraceptives, including medroxyprogesterone acetate injectable suspension, because breast cancer may be hormonally sensitive [see Contraindications 4 ].\"\n },\n {\n \"VerbatimTerm\": \"Breast cancer\",\n \"Probability\": \"0.0305041671\",\n \"SemanticContext\": \", Injection site infection , Injection site nodule/lump, Injection site pain/tenderness, Injection site persistent atrophy/indentation/dimpling, Injection-site reaction, Lipodystrophy acquired, Chills, Axillary swelling Cardiovascular Syncope, Tachycardia, Thrombophlebitis, Deep vein thrombosis, Pulmonary embolus, Varicose veins Digestive Changes in appetite, Gastrointestinal disturbances, Jaundice, Excessive thirst, Rectal bleeding Hematologic and Lymphatic Anemia, Blood dyscrasia Musculoskeletal Osteoporosis Neoplasms Cervical cancer, Breast cancer Nervous Paralysis, Facial palsy, Paresthesia, Drowsiness Respiratory Dyspnea and asthma, Hoarseness Skin and Appendages Hirsutism, Excessive sweating and body odor, Dry skin, Scleroderma Urogenital Lack of return to fertility, Unexpected pregnancy, Prevention of lactation, Changes in breast size, Breast lumps or nipple bleeding, Galactorrhea, Melasma, Chloasma, Increased libido, Uterine hyperplasia, Genitourinary infections, Vaginal cysts, Dyspareunia .\"\n }\n ]\n },\n {\n \"Term\": \"Parity\",\n \"MEDDRACode\": \"10033997\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"parity\",\n \"Probability\": \"0.0051765442\",\n \"SemanticContext\": \"Odds ratio estimates were adjusted for the following covariates: Lee et al. 1987 : age, parity, and socioeconomic status.\"\n },\n {\n \"VerbatimTerm\": \"parity\",\n \"Probability\": \"0.0012106001\",\n \"SemanticContext\": \"Paul et al. 1989 : age, parity, ethnic group, and year of interview.\"\n }\n ]\n },\n {\n \"Term\": \"Blood albumin\",\n \"MEDDRACode\": \"10005285\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"serum albumin\",\n \"Probability\": \"0.0004282594\",\n \"SemanticContext\": \"MPA binding occurs primarily to serum albumin.\"\n }\n ]\n },\n {\n \"Term\": \"Seizure\",\n \"MEDDRACode\": \"10039906\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"convulsions\",\n \"Probability\": \"0.6872887611\",\n \"SemanticContext\": \"5.8 Convulsions There have been a few reported cases of convulsions in patients who were treated with medroxyprogesterone acetate injectable suspension.\"\n },\n {\n \"VerbatimTerm\": \"Convulsions\",\n \"Probability\": \"0.6858593225\",\n \"SemanticContext\": \"5.8 Convulsions There have been a few reported cases of convulsions in patients who were treated with medroxyprogesterone acetate injectable suspension.\"\n }\n ]\n },\n {\n \"Term\": \"Social avoidant behaviour\",\n \"MEDDRACode\": \"10041243\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"withdrew\",\n \"Probability\": \"0.006528765\",\n \"SemanticContext\": \"Two percent of women withdrew from a large-scale clinical trial because of excessive weight gain.\"\n }\n ]\n },\n {\n \"Term\": \"Jaundice\",\n \"MEDDRACode\": \"10023126\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"jaundice\",\n \"Probability\": \"0.3882668614\",\n \"SemanticContext\": \"Liver Function: Discontinue medroxyprogesterone acetate injectable suspension if jaundice or disturbances of liver function develop.\"\n },\n {\n \"VerbatimTerm\": \"jaundice\",\n \"Probability\": \"0.1052616537\",\n \"SemanticContext\": \"5.7 Liver Function Discontinue medroxyprogesterone acetate injectable suspension use if jaundice or acute or chronic disturbances of liver function develop.\"\n },\n {\n \"VerbatimTerm\": \"Jaundice\",\n \"Probability\": \"0.9900028706\",\n \"SemanticContext\": \", Injection site infection , Injection site nodule/lump, Injection site pain/tenderness, Injection site persistent atrophy/indentation/dimpling, Injection-site reaction, Lipodystrophy acquired, Chills, Axillary swelling Cardiovascular Syncope, Tachycardia, Thrombophlebitis, Deep vein thrombosis, Pulmonary embolus, Varicose veins Digestive Changes in appetite, Gastrointestinal disturbances, Jaundice, Excessive thirst, Rectal bleeding Hematologic and Lymphatic Anemia, Blood dyscrasia Musculoskeletal Osteoporosis Neoplasms Cervical cancer, Breast cancer Nervous Paralysis, Facial palsy, Paresthesia, Drowsiness Respiratory Dyspnea and asthma, Hoarseness Skin and Appendages Hirsutism, Excessive sweating and body odor, Dry skin, Scleroderma Urogenital Lack of return to fertility, Unexpected pregnancy, Prevention of lactation, Changes in breast size, Breast lumps or nipple bleeding, Galactorrhea, Melasma, Chloasma, Increased libido, Uterine hyperplasia, Genitourinary infections, Vaginal cysts, Dyspareunia .\"\n }\n ]\n },\n {\n \"Term\": \"Vaginal haemorrhage\",\n \"MEDDRACode\": \"10046910\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": true,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"vaginal bleeding\",\n \"Probability\": \"0.6739913225\",\n \"SemanticContext\": \"Undiagnosed vaginal bleeding.\"\n },\n {\n \"VerbatimTerm\": \"vaginal bleeding\",\n \"Probability\": \"0.5606259704\",\n \"SemanticContext\": \"Undiagnosed vaginal bleeding [ see Warnings and Precautions 5.\"\n }\n ]\n },\n {\n \"Term\": \"Contraception\",\n \"MEDDRACode\": \"10010808\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"contraception\",\n \"Probability\": \"2.97369E-05\",\n \"SemanticContext\": \"Counsel patients to use a back-up method or alternative method of contraception when enzyme inducers are used with medroxyprogesterone acetate injectable suspension.\"\n },\n {\n \"VerbatimTerm\": \"contraception\",\n \"Probability\": \"2.2223E-05\",\n \"SemanticContext\": \"7 DRUG INTERACTIONS 7.1 Changes in Contraceptive Effectiveness Associated With Co-Administration of Other Products If a woman on hormonal contraceptives takes a drug or herbal product that induces enzymes, including CYP3A4, that metabolize contraceptive hormones, counsel her to use additional contraception or a different method of contraception.\"\n },\n {\n \"VerbatimTerm\": \"contraception\",\n \"Probability\": \"0.0002737939\",\n \"SemanticContext\": \"7 DRUG INTERACTIONS 7.1 Changes in Contraceptive Effectiveness Associated With Co-Administration of Other Products If a woman on hormonal contraceptives takes a drug or herbal product that induces enzymes, including CYP3A4, that metabolize contraceptive hormones, counsel her to use additional contraception or a different method of contraception.\"\n },\n {\n \"VerbatimTerm\": \"contraception\",\n \"Probability\": \"2.97369E-05\",\n \"SemanticContext\": \"Counsel patients to use a back-up method or alternative method of contraception when enzyme inducers are used with medroxyprogesterone acetate injectable suspension.\"\n },\n {\n \"VerbatimTerm\": \"Contraception\",\n \"Probability\": \"0.4782785773\",\n \"SemanticContext\": \"14 CLINICAL STUDIES 14.1 Contraception In five clinical studies using medroxyprogesterone acetate injectable suspension, the 12-month failure rate for the group of women treated with medroxyprogesterone acetate injectable suspension was zero no pregnancies reported to 0.7 by Life-Table method.\"\n },\n {\n \"VerbatimTerm\": \"Contraception\",\n \"Probability\": \"0.0020893514\",\n \"SemanticContext\": \"2.2 Switching From Other Methods of Contraception When switching from other contraceptive methods, medroxyprogesterone acetate injectable suspension should be given in a manner that ensures continuous contraceptive coverage based upon the mechanism of action of both methods, e.g., patients switching from oral contraceptives should have their first injection of medroxyprogesterone acetate injectable suspension on the day after the last active tablet or at the latest, on the day following the final inactive tablet .\"\n }\n ]\n },\n {\n \"Term\": \"Euphoric mood\",\n \"MEDDRACode\": \"10015535\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"higher\",\n \"Probability\": \"0.0265987813\",\n \"SemanticContext\": \"In the study, when cumulative exposure to medroxyprogesterone acetate injectable suspension was calculated, the fracture rate in users who received fewer than 8 injections was higher than that in women who received 8 or more injections.\"\n },\n {\n \"VerbatimTerm\": \"higher\",\n \"Probability\": \"0.0481698811\",\n \"SemanticContext\": \"There were very few osteoporotic fractures fracture sites known to be related to low BMD in the study overall, and the incidence of osteoporotic fractures was not found to be higher in medroxyprogesterone acetate injectable suspension users compared to non-users.\"\n }\n ]\n },\n {\n \"Term\": \"Sex hormone binding globulin\",\n \"MEDDRACode\": \"10059654\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"sex-hormone-binding globulin\",\n \"Probability\": \"0.0028230548\",\n \"SemanticContext\": \"No binding of MPA occurs with sex-hormone-binding globulin SHBG .\"\n },\n {\n \"VerbatimTerm\": \"SHBG\",\n \"Probability\": \"0.0024396777\",\n \"SemanticContext\": \"No binding of MPA occurs with sex-hormone-binding globulin SHBG .\"\n },\n {\n \"VerbatimTerm\": \"Sex-hormone-binding-globulin\",\n \"Probability\": \"0.0007659197\",\n \"SemanticContext\": \"c Sex-hormone-binding-globulin concentrations are decreased.\"\n }\n ]\n },\n {\n \"Term\": \"Prothrombin level\",\n \"MEDDRACode\": \"10037047\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"prothrombin\",\n \"Probability\": \"0.0002483428\",\n \"SemanticContext\": \"e Coagulation test values for prothrombin Factor II , and Factors VII, VIII, IX, and X may increase.\"\n }\n ]\n },\n {\n \"Term\": \"High density lipoprotein\",\n \"MEDDRACode\": \"10020050\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"high-density lipoprotein\",\n \"Probability\": \"0.0020736456\",\n \"SemanticContext\": \"Both increases and decreases in total cholesterol, triglycerides, low-density lipoprotein LDL cholesterol, and high-density lipoprotein HDL cholesterol have been observed in studies.\"\n }\n ]\n },\n {\n \"Term\": \"Tremor\",\n \"MEDDRACode\": \"10044565\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"shaken\",\n \"Probability\": \"0.0590336919\",\n \"SemanticContext\": \"2 DOSAGE AND ADMINISTRATION 2.1 Prevention of Pregnancy The 1 mL prefilled syringe of medroxyprogesterone acetate injectable suspension should be vigorously shaken just before use to ensure that the dose being administered represents a uniform suspension.\"\n }\n ]\n },\n {\n \"Term\": \"Laboratory test\",\n \"MEDDRACode\": \"10059938\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Laboratory Test\",\n \"Probability\": \"4.0693E-06\",\n \"SemanticContext\": \"7.2 Laboratory Test Interactions The pathologist should be advised of progestin therapy when relevant specimens are submitted.\"\n },\n {\n \"VerbatimTerm\": \"laboratory tests\",\n \"Probability\": \"0.0002586842\",\n \"SemanticContext\": \"The following laboratory tests may be affected by progestins including medroxyprogesterone acetate injectable suspension: a Plasma and urinary steroid levels are decreased e.g., progesterone, estradiol, pregnanediol, testosterone, cortisol .\"\n },\n {\n \"VerbatimTerm\": \"laboratory tests\",\n \"Probability\": \"0.0005365312\",\n \"SemanticContext\": \"5.19 Interference With Laboratory Tests The use of medroxyprogesterone acetate injectable suspension may change the results of some laboratory tests, such as coagulation factors, lipids, glucose tolerance, and binding proteins.\"\n }\n ]\n },\n {\n \"Term\": \"Diabetes mellitus\",\n \"MEDDRACode\": \"10012601\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"diabetic\",\n \"Probability\": \"0.0287976265\",\n \"SemanticContext\": \"Carbohydrate Metabolism: Monitor diabetic patients carefully.\"\n },\n {\n \"VerbatimTerm\": \"diabetic\",\n \"Probability\": \"0.0004563034\",\n \"SemanticContext\": \"Monitor diabetic patients carefully while receiving medroxyprogesterone acetate injectable suspension.\"\n }\n ]\n },\n {\n \"Term\": \"Mass\",\n \"MEDDRACode\": \"10026865\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"mass\",\n \"Probability\": \"7.10827E-05\",\n \"SemanticContext\": \"It is unknown if use of medroxyprogesterone acetate injectable suspension during adolescence or early adulthood, a critical period of bone accretion, will reduce peak bone mass and increase the risk for osteoporotic fracture in later life.\"\n },\n {\n \"VerbatimTerm\": \"mass\",\n \"Probability\": \"9.9837E-06\",\n \"SemanticContext\": \"It is unknown if use of medroxyprogesterone acetate injectable suspension by younger women will reduce peak bone mass and increase the risk for osteoporotic fracture in later life.\"\n },\n {\n \"VerbatimTerm\": \"mass\",\n \"Probability\": \"3.09024E-05\",\n \"SemanticContext\": \"Medroxyprogesterone acetate injectable suspension can pose an additional risk in patients with risk factors for osteoporosis e.g., metabolic bone disease, chronic alcohol and/or tobacco use, anorexia nervosa, strong family history of osteoporosis or chronic use of drugs that can reduce bone mass such as anticonvulsants or corticosteroids .\"\n },\n {\n \"VerbatimTerm\": \"mass\",\n \"Probability\": \"6.8726E-06\",\n \"SemanticContext\": \"It is unknown if use of medroxyprogesterone acetate injectable suspension by younger women will reduce peak bone mass and increase the risk of osteoporotic fractures in later life.\"\n }\n ]\n },\n {\n \"Term\": \"Osteoporotic fracture\",\n \"MEDDRACode\": \"10031290\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"osteoporotic fracture\",\n \"Probability\": \"0.0023685098\",\n \"SemanticContext\": \"It is unknown if use of medroxyprogesterone acetate injectable suspension during adolescence or early adulthood, a critical period of bone accretion, will reduce peak bone mass and increase the risk for osteoporotic fracture in later life.\"\n },\n {\n \"VerbatimTerm\": \"osteoporotic fracture\",\n \"Probability\": \"0.0007470846\",\n \"SemanticContext\": \"It is unknown if use of medroxyprogesterone acetate injectable suspension by younger women will reduce peak bone mass and increase the risk for osteoporotic fracture in later life.\"\n },\n {\n \"VerbatimTerm\": \"osteoporotic fractures\",\n \"Probability\": \"0.1039592326\",\n \"SemanticContext\": \"There have been cases of osteoporosis including osteoporotic fractures reported post-marketing in patients taking medroxyprogesterone acetate injectable suspension.\"\n },\n {\n \"VerbatimTerm\": \"osteoporotic fractures\",\n \"Probability\": \"0.0095301569\",\n \"SemanticContext\": \"There were very few osteoporotic fractures fracture sites known to be related to low BMD in the study overall, and the incidence of osteoporotic fractures was not found to be higher in medroxyprogesterone acetate injectable suspension users compared to non-users.\"\n },\n {\n \"VerbatimTerm\": \"osteoporotic fractures\",\n \"Probability\": \"0.2922110558\",\n \"SemanticContext\": \"There were very few osteoporotic fractures fracture sites known to be related to low BMD in the study overall, and the incidence of osteoporotic fractures was not found to be higher in medroxyprogesterone acetate injectable suspension users compared to non-users.\"\n },\n {\n \"VerbatimTerm\": \"osteoporotic fractures\",\n \"Probability\": \"0.0008538961\",\n \"SemanticContext\": \"It is unknown if use of medroxyprogesterone acetate injectable suspension by younger women will reduce peak bone mass and increase the risk of osteoporotic fractures in later life.\"\n }\n ]\n },\n {\n \"Term\": \"Blood cortisol\",\n \"MEDDRACode\": \"10005455\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"cortisol\",\n \"Probability\": \"0.0007010102\",\n \"SemanticContext\": \"The following laboratory tests may be affected by progestins including medroxyprogesterone acetate injectable suspension: a Plasma and urinary steroid levels are decreased e.g., progesterone, estradiol, pregnanediol, testosterone, cortisol .\"\n }\n ]\n },\n {\n \"Term\": \"Blood testosterone\",\n \"MEDDRACode\": \"10005811\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"testosterone\",\n \"Probability\": \"0.0004066825\",\n \"SemanticContext\": \"The following laboratory tests may be affected by progestins including medroxyprogesterone acetate injectable suspension: a Plasma and urinary steroid levels are decreased e.g., progesterone, estradiol, pregnanediol, testosterone, cortisol .\"\n }\n ]\n },\n {\n \"Term\": \"Menstruation irregular\",\n \"MEDDRACode\": \"10027339\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"menstrual irregularities\",\n \"Probability\": \"0.9362635612\",\n \"SemanticContext\": \"ADVERSE REACTIONS Most common adverse reactions incidence >5% are: menstrual irregularities bleeding or spotting 57% at 12 months, 32% at 24 months, abdominal pain/discomfort 11%, weight gain > 10 lbs at 24 months 38%, dizziness 6%, headache 17%, nervousness 11%, decreased libido 6%.\"\n },\n {\n \"VerbatimTerm\": \"Menstrual irregularities\",\n \"Probability\": \"0.9708675146\",\n \"SemanticContext\": \"Table 1 Adverse Reactions that Were Reported by More than 5% of Subjects Body System* Adverse Reactions [Incidence % ] Body as a Whole Headache 16.5% Abdominal pain/discomfort 11.2% Metabolic/Nutritional Increased weight> 10lbs at 24 months 37.7% Nervous Nervousness 10.8% Dizziness 5.6% Libido decreased 5.5% Urogenital Menstrual irregularities: bleeding 57.3% at 12 months, 32.1% at 24 months amenorrhea 55% at 12 months, 68% at 24 months .\"\n }\n ]\n },\n {\n \"Term\": \"Drug interaction\",\n \"MEDDRACode\": \"10013710\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"interactions\",\n \"Probability\": \"4.93E-06\",\n \"SemanticContext\": \"Consult the labeling of all concurrently used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations.\"\n },\n {\n \"VerbatimTerm\": \"Interactions\",\n \"Probability\": \"1.05351E-05\",\n \"SemanticContext\": \"7.2 Laboratory Test Interactions The pathologist should be advised of progestin therapy when relevant specimens are submitted.\"\n }\n ]\n },\n {\n \"Term\": \"Menopause\",\n \"MEDDRACode\": \"10027308\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": true\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"menopausal\",\n \"Probability\": \"0.0015940964\",\n \"SemanticContext\": \"8.5 Geriatric Use This product has not been studied in post-menopausal women and is not indicated in this population.\"\n }\n ]\n },\n {\n \"Term\": \"Headache\",\n \"MEDDRACode\": \"10019211\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"headache\",\n \"Probability\": \"0.9999123812\",\n \"SemanticContext\": \"ADVERSE REACTIONS Most common adverse reactions incidence >5% are: menstrual irregularities bleeding or spotting 57% at 12 months, 32% at 24 months, abdominal pain/discomfort 11%, weight gain > 10 lbs at 24 months 38%, dizziness 6%, headache 17%, nervousness 11%, decreased libido 6%.\"\n },\n {\n \"VerbatimTerm\": \"Headache\",\n \"Probability\": \"0.9948391914\",\n \"SemanticContext\": \"Table 1 Adverse Reactions that Were Reported by More than 5% of Subjects Body System* Adverse Reactions [Incidence % ] Body as a Whole Headache 16.5% Abdominal pain/discomfort 11.2% Metabolic/Nutritional Increased weight> 10lbs at 24 months 37.7% Nervous Nervousness 10.8% Dizziness 5.6% Libido decreased 5.5% Urogenital Menstrual irregularities: bleeding 57.3% at 12 months, 32.1% at 24 months amenorrhea 55% at 12 months, 68% at 24 months .\"\n }\n ]\n },\n {\n \"Term\": \"Acquired immunodeficiency syndrome\",\n \"MEDDRACode\": \"10000565\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"AIDS\",\n \"Probability\": \"0.0008764267\",\n \"SemanticContext\": \"Counsel patients that this product does not protect against HIV infection AIDS and other sexually transmitted diseases.\"\n },\n {\n \"VerbatimTerm\": \"AIDS\",\n \"Probability\": \"0.0026349425\",\n \"SemanticContext\": \"5.16 Sexually Transmitted Diseases Patients should be counseled that medroxyprogesterone acetate injectable suspension does not protect against HIV infection AIDS and other sexually transmitted diseases.\"\n }\n ]\n },\n {\n \"Term\": \"Pregnancy\",\n \"MEDDRACode\": \"10036556\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": true,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"pregnancy\",\n \"Probability\": \"0.0004241467\",\n \"SemanticContext\": \"INDICATIONS AND USAGE Medroxyprogesterone acetate is a progestin indicated for use by females of reproductive potential to prevent pregnancy.\"\n },\n {\n \"VerbatimTerm\": \"pregnancy\",\n \"Probability\": \"0.002163887\",\n \"SemanticContext\": \"CONTRAINDICATIONS Known or suspected pregnancy or as a diagnostic test for pregnancy.\"\n },\n {\n \"VerbatimTerm\": \"pregnancy\",\n \"Probability\": \"0.0003015399\",\n \"SemanticContext\": \"CONTRAINDICATIONS Known or suspected pregnancy or as a diagnostic test for pregnancy.\"\n },\n {\n \"VerbatimTerm\": \"pregnancy\",\n \"Probability\": \"0.0001731515\",\n \"SemanticContext\": \"4 CONTRAINDICATIONS The use of medroxyprogesterone acetate injectable suspension is contraindicated in the following conditions: Known or suspected pregnancy or as a diagnostic test for pregnancy.\"\n },\n {\n \"VerbatimTerm\": \"pregnancy\",\n \"Probability\": \"9.44817E-05\",\n \"SemanticContext\": \"4 CONTRAINDICATIONS The use of medroxyprogesterone acetate injectable suspension is contraindicated in the following conditions: Known or suspected pregnancy or as a diagnostic test for pregnancy.\"\n },\n {\n \"VerbatimTerm\": \"pregnancy\",\n \"Probability\": \"0.0136636496\",\n \"SemanticContext\": \"Antibiotics : There have been reports of pregnancy while taking hormonal contraceptives and antibiotics, but clinical pharmacokinetic studies have not shown consistent effects of antibiotics on plasma concentrations of synthetic steroids.\"\n },\n {\n \"VerbatimTerm\": \"pregnancy\",\n \"Probability\": \"0.0007025898\",\n \"SemanticContext\": \"1 INDICATIONS AND USAGE Medroxyprogesterone acetate injectable suspension is indicated for use by females of reproductive potential to prevent pregnancy.\"\n },\n {\n \"VerbatimTerm\": \"pregnancy\",\n \"Probability\": \"0.0119650364\",\n \"SemanticContext\": \"8.1 Pregnancy Medroxyprogesterone acetate injectable suspension should not be administered during pregnancy.\"\n },\n {\n \"VerbatimTerm\": \"pregnancy\",\n \"Probability\": \"0.0012329221\",\n \"SemanticContext\": \"5.17 Pregnancy Although medroxyprogesterone acetate injectable suspension should not be used during pregnancy, there appears to be little or no increased risk of birth defects in women who have inadvertently been exposed to medroxyprogesterone acetate injections in early pregnancy.\"\n },\n {\n \"VerbatimTerm\": \"pregnancy\",\n \"Probability\": \"0.0008788407\",\n \"SemanticContext\": \"5.17 Pregnancy Although medroxyprogesterone acetate injectable suspension should not be used during pregnancy, there appears to be little or no increased risk of birth defects in women who have inadvertently been exposed to medroxyprogesterone acetate injections in early pregnancy.\"\n },\n {\n \"VerbatimTerm\": \"Pregnancy\",\n \"Probability\": \"0.0754004121\",\n \"SemanticContext\": \"2 DOSAGE AND ADMINISTRATION 2.1 Prevention of Pregnancy The 1 mL prefilled syringe of medroxyprogesterone acetate injectable suspension should be vigorously shaken just before use to ensure that the dose being administered represents a uniform suspension.\"\n },\n {\n \"VerbatimTerm\": \"Pregnancy\",\n \"Probability\": \"0.0584514737\",\n \"SemanticContext\": \"8.1 Pregnancy Medroxyprogesterone acetate injectable suspension should not be administered during pregnancy.\"\n },\n {\n \"VerbatimTerm\": \"Pregnancy\",\n \"Probability\": \"0.008915633\",\n \"SemanticContext\": \"5.17 Pregnancy Although medroxyprogesterone acetate injectable suspension should not be used during pregnancy, there appears to be little or no increased risk of birth defects in women who have inadvertently been exposed to medroxyprogesterone acetate injections in early pregnancy.\"\n },\n {\n \"VerbatimTerm\": \"pregnancies\",\n \"Probability\": \"0.2047817409\",\n \"SemanticContext\": \"14 CLINICAL STUDIES 14.1 Contraception In five clinical studies using medroxyprogesterone acetate injectable suspension, the 12-month failure rate for the group of women treated with medroxyprogesterone acetate injectable suspension was zero no pregnancies reported to 0.7 by Life-Table method.\"\n },\n {\n \"VerbatimTerm\": \"pregnancies\",\n \"Probability\": \"0.0002698302\",\n \"SemanticContext\": \"Li et al. 2012 : age, year, BMI, duration of OC use, number of full-term pregnancies, family history of breast cancer, and history of screening mammography.\"\n }\n ]\n },\n {\n \"Term\": \"Sexually transmitted disease\",\n \"MEDDRACode\": \"10040490\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"sexually transmitted diseases\",\n \"Probability\": \"0.0017573535\",\n \"SemanticContext\": \"Counsel patients that this product does not protect against HIV infection AIDS and other sexually transmitted diseases.\"\n },\n {\n \"VerbatimTerm\": \"sexually transmitted diseases\",\n \"Probability\": \"0.0017933846\",\n \"SemanticContext\": \"5.16 Sexually Transmitted Diseases Patients should be counseled that medroxyprogesterone acetate injectable suspension does not protect against HIV infection AIDS and other sexually transmitted diseases.\"\n },\n {\n \"VerbatimTerm\": \"Sexually Transmitted Diseases\",\n \"Probability\": \"0.0077948868\",\n \"SemanticContext\": \"5.16 Sexually Transmitted Diseases Patients should be counseled that medroxyprogesterone acetate injectable suspension does not protect against HIV infection AIDS and other sexually transmitted diseases.\"\n }\n ]\n },\n {\n \"Term\": \"Blood oestrogen\",\n \"MEDDRACode\": \"10005684\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"serum estrogen\",\n \"Probability\": \"0.0039409697\",\n \"SemanticContext\": \"5 WARNINGS AND PRECAUTIONS 5.1 Loss of Bone Mineral Density Use of medroxyprogesterone acetate injectable suspension reduces serum estrogen levels and is associated with significant loss of bone mineral density BMD .\"\n }\n ]\n },\n {\n \"Term\": \"Drug tolerance\",\n \"MEDDRACode\": \"10052804\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"tolerance\",\n \"Probability\": \"0.0026423335\",\n \"SemanticContext\": \"5.12 Carbohydrate Metabolism A decrease in glucose tolerance has been observed in some patients on medroxyprogesterone acetate injectable suspension treatment.\"\n },\n {\n \"VerbatimTerm\": \"tolerance\",\n \"Probability\": \"0.0004555583\",\n \"SemanticContext\": \"5.19 Interference With Laboratory Tests The use of medroxyprogesterone acetate injectable suspension may change the results of some laboratory tests, such as coagulation factors, lipids, glucose tolerance, and binding proteins.\"\n }\n ]\n },\n {\n \"Term\": \"Anaphylactoid reaction\",\n \"MEDDRACode\": \"10002216\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Anaphylactoid Reactions\",\n \"Probability\": \"0.0534238219\",\n \"SemanticContext\": \"Anaphylaxis and Anaphylactoid Reactions: Provide emergency medical treatment.\"\n },\n {\n \"VerbatimTerm\": \"Anaphylactoid Reactions\",\n \"Probability\": \"0.9931056499\",\n \"SemanticContext\": \"6 ADVERSE REACTIONS The following important adverse reactions observed with the use of medroxyprogesterone acetate injectable suspension are discussed in greater detail in the Warnings and Precautions section 5 : Loss of Bone Mineral Density [ see Warnings and Precautions 5.1 ] Thromboembolic disease [ see Warnings and Precautions 5.2 ] Breast Cancer [ see Warnings and Precautions 5.3 ] Anaphylaxis and Anaphylactoid Reactions [ see Warnings and Precautions 5.5 ] Bleeding Irregularities [ see Warnings and Precautions 5.\"\n },\n {\n \"VerbatimTerm\": \"anaphylactoid reaction\",\n \"Probability\": \"0.9119367599\",\n \"SemanticContext\": \"5.5 Anaphylaxis and Anaphylactoid Reaction Anaphylaxis and anaphylactoid reaction have been reported with the use of medroxyprogesterone acetate injectable suspension.\"\n },\n {\n \"VerbatimTerm\": \"Anaphylactoid Reaction\",\n \"Probability\": \"0.9529105425\",\n \"SemanticContext\": \"5.5 Anaphylaxis and Anaphylactoid Reaction Anaphylaxis and anaphylactoid reaction have been reported with the use of medroxyprogesterone acetate injectable suspension.\"\n }\n ]\n },\n {\n \"Term\": \"Neoplasm malignant\",\n \"MEDDRACode\": \"10028997\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Cancer\",\n \"Probability\": \"0.0067055821\",\n \"SemanticContext\": \"Cancer Risks: Monitor women with a strong family history of breast cancer carefully.\"\n },\n {\n \"VerbatimTerm\": \"Cancer\",\n \"Probability\": \"0.0033538938\",\n \"SemanticContext\": \"5.3 Cancer Risks Breast Cancer Women who have or have had a history of breast cancer should not use hormonal contraceptives, including medroxyprogesterone acetate injectable suspension, because breast cancer may be hormonally sensitive [see Contraindications 4 ].\"\n },\n {\n \"VerbatimTerm\": \"Cancers\",\n \"Probability\": \"0.0430918038\",\n \"SemanticContext\": \"Other Cancers Long-term case-controlled surveillance of users of medroxyprogesterone acetate injectable suspension found no overall increased risk of ovarian or liver cancer.\"\n }\n ]\n },\n {\n \"Term\": \"Syringomyelia\",\n \"MEDDRACode\": \"10042928\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.018864125\",\n \"SemanticContext\": \"DOSAGE FORMS AND STRENGTHS Prefilled syringe: prefilled syringe is available packaged with 22-gauge x 1 1/2 inch Terumo SurGuard ® Needles.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.5301625133\",\n \"SemanticContext\": \"DOSAGE FORMS AND STRENGTHS Prefilled syringe: prefilled syringe is available packaged with 22-gauge x 1 1/2 inch Terumo SurGuard ® Needles.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0004741848\",\n \"SemanticContext\": \"The structural formula is as follows: Medroxyprogesterone acetate injectable suspension, USP for IM injection is available in prefilled syringe containing 1 mL of medroxyprogesterone acetate sterile aqueous suspension 150 mg/mL.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.018060267\",\n \"SemanticContext\": \"For Medroxyprogesterone acetate injectable suspension prefilled syringe, each mL of sterile aqueous suspension contains: Medroxyprogesterone acetate 150 mg Polyethylene glycol 3350 28.90 mg Polysorbate 80 2.41 mg Sodium chloride 8.68 mg Methylparaben 1.37 mg Propylparaben 0.15 mg Water for injection quantity sufficient When necessary, pH is adjusted with sodium hydroxide or hydrochloric acid, or both.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0208078027\",\n \"SemanticContext\": \"2 DOSAGE AND ADMINISTRATION 2.1 Prevention of Pregnancy The 1 mL prefilled syringe of medroxyprogesterone acetate injectable suspension should be vigorously shaken just before use to ensure that the dose being administered represents a uniform suspension.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.086551249\",\n \"SemanticContext\": \"3 DOSAGE FORMS AND STRENGTHS Prefilled syringe is available packaged with 22-gauge x 1 1/2 inch Terumo SurGuard ® Needles.\"\n }\n ]\n },\n {\n \"Term\": \"Papilloedema\",\n \"MEDDRACode\": \"10033712\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"papilledema\",\n \"Probability\": \"0.0015304685\",\n \"SemanticContext\": \"Do not re-administer if examination reveals papilledema or retinal vascular lesions.\"\n }\n ]\n },\n {\n \"Term\": \"Pyrexia\",\n \"MEDDRACode\": \"10037660\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Fever\",\n \"Probability\": \"0.9983239174\",\n \"SemanticContext\": \"Adverse Reactions Body as a Whole Chest pain, Allergic reactions including angioedema, Fever, Injection site abscess Injection site abscess and injection site infections have been reported; therefore strict aseptic injection technique should be followed when administering medroxyprogesterone acetate injectable suspension in order to avoid injection site infections [see Dosage and Administration 2.1 ].\"\n }\n ]\n },\n {\n \"Term\": \"Somnolence\",\n \"MEDDRACode\": \"10041349\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Drowsiness\",\n \"Probability\": \"0.9616051316\",\n \"SemanticContext\": \", Injection site infection , Injection site nodule/lump, Injection site pain/tenderness, Injection site persistent atrophy/indentation/dimpling, Injection-site reaction, Lipodystrophy acquired, Chills, Axillary swelling Cardiovascular Syncope, Tachycardia, Thrombophlebitis, Deep vein thrombosis, Pulmonary embolus, Varicose veins Digestive Changes in appetite, Gastrointestinal disturbances, Jaundice, Excessive thirst, Rectal bleeding Hematologic and Lymphatic Anemia, Blood dyscrasia Musculoskeletal Osteoporosis Neoplasms Cervical cancer, Breast cancer Nervous Paralysis, Facial palsy, Paresthesia, Drowsiness Respiratory Dyspnea and asthma, Hoarseness Skin and Appendages Hirsutism, Excessive sweating and body odor, Dry skin, Scleroderma Urogenital Lack of return to fertility, Unexpected pregnancy, Prevention of lactation, Changes in breast size, Breast lumps or nipple bleeding, Galactorrhea, Melasma, Chloasma, Increased libido, Uterine hyperplasia, Genitourinary infections, Vaginal cysts, Dyspareunia .\"\n }\n ]\n },\n {\n \"Term\": \"Anorexia nervosa\",\n \"MEDDRACode\": \"10002649\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"anorexia nervosa\",\n \"Probability\": \"0.0002009571\",\n \"SemanticContext\": \"Medroxyprogesterone acetate injectable suspension can pose an additional risk in patients with risk factors for osteoporosis e.g., metabolic bone disease, chronic alcohol and/or tobacco use, anorexia nervosa, strong family history of osteoporosis or chronic use of drugs that can reduce bone mass such as anticonvulsants or corticosteroids .\"\n }\n ]\n },\n {\n \"Term\": \"Dysphonia\",\n \"MEDDRACode\": \"10013952\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Hoarseness\",\n \"Probability\": \"0.993224442\",\n \"SemanticContext\": \", Injection site infection , Injection site nodule/lump, Injection site pain/tenderness, Injection site persistent atrophy/indentation/dimpling, Injection-site reaction, Lipodystrophy acquired, Chills, Axillary swelling Cardiovascular Syncope, Tachycardia, Thrombophlebitis, Deep vein thrombosis, Pulmonary embolus, Varicose veins Digestive Changes in appetite, Gastrointestinal disturbances, Jaundice, Excessive thirst, Rectal bleeding Hematologic and Lymphatic Anemia, Blood dyscrasia Musculoskeletal Osteoporosis Neoplasms Cervical cancer, Breast cancer Nervous Paralysis, Facial palsy, Paresthesia, Drowsiness Respiratory Dyspnea and asthma, Hoarseness Skin and Appendages Hirsutism, Excessive sweating and body odor, Dry skin, Scleroderma Urogenital Lack of return to fertility, Unexpected pregnancy, Prevention of lactation, Changes in breast size, Breast lumps or nipple bleeding, Galactorrhea, Melasma, Chloasma, Increased libido, Uterine hyperplasia, Genitourinary infections, Vaginal cysts, Dyspareunia .\"\n }\n ]\n },\n {\n \"Term\": \"Epilepsy\",\n \"MEDDRACode\": \"10015037\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"epilepsy\",\n \"Probability\": \"0.0122069418\",\n \"SemanticContext\": \"5.14 Fluid Retention Because progestational drugs including medroxyprogesterone acetate injectable suspension may cause some degree of fluid retention, monitor patients with conditions that might be influenced by this condition, such as epilepsy, migraine, asthma, and cardiac or renal dysfunction.\"\n }\n ]\n },\n {\n \"Term\": \"Hepatic cancer\",\n \"MEDDRACode\": \"10073069\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"liver cancer\",\n \"Probability\": \"0.6047797203\",\n \"SemanticContext\": \"Other Cancers Long-term case-controlled surveillance of users of medroxyprogesterone acetate injectable suspension found no overall increased risk of ovarian or liver cancer.\"\n }\n ]\n },\n {\n \"Term\": \"Live birth\",\n \"MEDDRACode\": \"10049550\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"live birth\",\n \"Probability\": \"0.0042411685\",\n \"SemanticContext\": \"WHO 1991 : age, center, and age at first live birth.\"\n }\n ]\n },\n {\n \"Term\": \"Skin exfoliation\",\n \"MEDDRACode\": \"10040844\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"scale\",\n \"Probability\": \"0.6534203887\",\n \"SemanticContext\": \"Two percent of women withdrew from a large-scale clinical trial because of excessive weight gain.\"\n }\n ]\n },\n {\n \"Term\": \"Vaginal cyst\",\n \"MEDDRACode\": \"10046900\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Vaginal cysts\",\n \"Probability\": \"0.9868539572\",\n \"SemanticContext\": \", Injection site infection , Injection site nodule/lump, Injection site pain/tenderness, Injection site persistent atrophy/indentation/dimpling, Injection-site reaction, Lipodystrophy acquired, Chills, Axillary swelling Cardiovascular Syncope, Tachycardia, Thrombophlebitis, Deep vein thrombosis, Pulmonary embolus, Varicose veins Digestive Changes in appetite, Gastrointestinal disturbances, Jaundice, Excessive thirst, Rectal bleeding Hematologic and Lymphatic Anemia, Blood dyscrasia Musculoskeletal Osteoporosis Neoplasms Cervical cancer, Breast cancer Nervous Paralysis, Facial palsy, Paresthesia, Drowsiness Respiratory Dyspnea and asthma, Hoarseness Skin and Appendages Hirsutism, Excessive sweating and body odor, Dry skin, Scleroderma Urogenital Lack of return to fertility, Unexpected pregnancy, Prevention of lactation, Changes in breast size, Breast lumps or nipple bleeding, Galactorrhea, Melasma, Chloasma, Increased libido, Uterine hyperplasia, Genitourinary infections, Vaginal cysts, Dyspareunia .\"\n }\n ]\n },\n {\n \"Term\": \"Vaginal discharge\",\n \"MEDDRACode\": \"10046901\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Leukorrhea\",\n \"Probability\": \"0.9934228659\",\n \"SemanticContext\": \"Table 2 Adverse Reactions that Were Reported by between 1 and 5% of Subjects Body System* Adverse Reactions [Incidence % ] Body as a Whole Asthenia/fatigue 4.2% Backache 2.2% Dysmenorrhea 1.7% Hot flashes 1.0% Digestive Nausea 3.3% Bloating 2.3% Metabolic/Nutritional Edema 2.2% Musculoskeletal Leg cramps 3.7% Arthralgia 1.0% Nervous Depression 1.5% Insomnia 1.0% Skin and Appendages Acne 1.2% No hair growth/alopecia 1.1% Rash 1.1% Urogenital Leukorrhea 2.9% Breast pain 2.8% Vaginitis 1.2% .\"\n }\n ]\n },\n {\n \"Term\": \"Laboratory test interference\",\n \"MEDDRACode\": \"10023550\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Interference With Laboratory Tests\",\n \"Probability\": \"0.0045393109\",\n \"SemanticContext\": \"5.19 Interference With Laboratory Tests The use of medroxyprogesterone acetate injectable suspension may change the results of some laboratory tests, such as coagulation factors, lipids, glucose tolerance, and binding proteins.\"\n }\n ]\n },\n {\n \"Term\": \"Injection site reaction\",\n \"MEDDRACode\": \"10022095\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Injection-site reaction\",\n \"Probability\": \"0.8392066956\",\n \"SemanticContext\": \", Injection site infection , Injection site nodule/lump, Injection site pain/tenderness, Injection site persistent atrophy/indentation/dimpling, Injection-site reaction, Lipodystrophy acquired, Chills, Axillary swelling Cardiovascular Syncope, Tachycardia, Thrombophlebitis, Deep vein thrombosis, Pulmonary embolus, Varicose veins Digestive Changes in appetite, Gastrointestinal disturbances, Jaundice, Excessive thirst, Rectal bleeding Hematologic and Lymphatic Anemia, Blood dyscrasia Musculoskeletal Osteoporosis Neoplasms Cervical cancer, Breast cancer Nervous Paralysis, Facial palsy, Paresthesia, Drowsiness Respiratory Dyspnea and asthma, Hoarseness Skin and Appendages Hirsutism, Excessive sweating and body odor, Dry skin, Scleroderma Urogenital Lack of return to fertility, Unexpected pregnancy, Prevention of lactation, Changes in breast size, Breast lumps or nipple bleeding, Galactorrhea, Melasma, Chloasma, Increased libido, Uterine hyperplasia, Genitourinary infections, Vaginal cysts, Dyspareunia .\"\n },\n {\n \"VerbatimTerm\": \"Injection Site Reactions\",\n \"Probability\": \"0.9123144746\",\n \"SemanticContext\": \"5.6 Injection Site Reactions Injection site reactions have been reported with use of medroxyprogesterone acetate injectable suspension [see Adverse Reactions 6.2 ] .\"\n },\n {\n \"VerbatimTerm\": \"Site Reactions Injection\",\n \"Probability\": \"0.8436688185\",\n \"SemanticContext\": \"5.6 Injection Site Reactions Injection site reactions have been reported with use of medroxyprogesterone acetate injectable suspension [see Adverse Reactions 6.2 ] .\"\n },\n {\n \"VerbatimTerm\": \"Injection site reactions\",\n \"Probability\": \"0.8757202029\",\n \"SemanticContext\": \"5.6 Injection Site Reactions Injection site reactions have been reported with use of medroxyprogesterone acetate injectable suspension [see Adverse Reactions 6.2 ] .\"\n },\n {\n \"VerbatimTerm\": \"Reactions Injection site\",\n \"Probability\": \"0.6408555508\",\n \"SemanticContext\": \"5.6 Injection Site Reactions Injection site reactions have been reported with use of medroxyprogesterone acetate injectable suspension [see Adverse Reactions 6.2 ] .\"\n },\n {\n \"VerbatimTerm\": \"injection site reactions\",\n \"Probability\": \"0.4432887435\",\n \"SemanticContext\": \"Persistent injection site reactions may occur after administration of medroxyprogesterone acetate injectable suspension due to inadvertent subcutaneous administration or release of the drug into the subcutaneous space while removing the needle [see Dosage and Administration 2.1 ].\"\n }\n ]\n },\n {\n \"Term\": \"Infant\",\n \"MEDDRACode\": \"10021731\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Neonates\",\n \"Probability\": \"0.0096415877\",\n \"SemanticContext\": \"Neonates and infants exposed to medroxyprogesterone from breast milk have been studied for developmental and behavioral effects through puberty.\"\n },\n {\n \"VerbatimTerm\": \"Neonates\",\n \"Probability\": \"0.0050266683\",\n \"SemanticContext\": \"Neonates exposed to medroxyprogesterone acetate in-utero and followed to adolescence showed no evidence of any adverse effects on their health including their physical, intellectual, sexual or social development.\"\n }\n ]\n },\n {\n \"Term\": \"No adverse event\",\n \"MEDDRACode\": \"10067482\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"No adverse effects\",\n \"Probability\": \"0.0016008019\",\n \"SemanticContext\": \"No adverse effects have been noted.\"\n }\n ]\n },\n {\n \"Term\": \"Renal impairment\",\n \"MEDDRACode\": \"10062237\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"renal impairment\",\n \"Probability\": \"0.0006473362\",\n \"SemanticContext\": \"Specific Populations The effect of hepatic and/or renal impairment on the pharmacokinetics of medroxyprogesterone acetate injectable suspension is unknown.\"\n }\n ]\n },\n {\n \"Term\": \"Low density lipoprotein\",\n \"MEDDRACode\": \"10024900\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"low-density lipoprotein\",\n \"Probability\": \"0.0007102191\",\n \"SemanticContext\": \"Both increases and decreases in total cholesterol, triglycerides, low-density lipoprotein LDL cholesterol, and high-density lipoprotein HDL cholesterol have been observed in studies.\"\n }\n ]\n },\n {\n \"Term\": \"Exophthalmos\",\n \"MEDDRACode\": \"10015683\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"proptosis\",\n \"Probability\": \"0.0288926065\",\n \"SemanticContext\": \"Do not re-administer medroxyprogesterone acetate injectable suspension pending examination if there is a sudden partial or complete loss of vision or if there is a sudden onset of proptosis, diplopia, or migraine.\"\n }\n ]\n },\n {\n \"Term\": \"Diplopia\",\n \"MEDDRACode\": \"10013036\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"diplopia\",\n \"Probability\": \"0.0069024265\",\n \"SemanticContext\": \"Do not re-administer medroxyprogesterone acetate injectable suspension pending examination if there is a sudden partial or complete loss of vision or if there is a sudden onset of proptosis, diplopia, or migraine.\"\n }\n ]\n },\n {\n \"Term\": \"Puberty\",\n \"MEDDRACode\": \"10037280\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"puberty\",\n \"Probability\": \"0.0108719468\",\n \"SemanticContext\": \"Neonates and infants exposed to medroxyprogesterone from breast milk have been studied for developmental and behavioral effects through puberty.\"\n }\n ]\n },\n {\n \"Term\": \"Amenorrhoea\",\n \"MEDDRACode\": \"10001928\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"amenorrhea\",\n \"Probability\": \"0.9566178322\",\n \"SemanticContext\": \"Table 1 Adverse Reactions that Were Reported by More than 5% of Subjects Body System* Adverse Reactions [Incidence % ] Body as a Whole Headache 16.5% Abdominal pain/discomfort 11.2% Metabolic/Nutritional Increased weight> 10lbs at 24 months 37.7% Nervous Nervousness 10.8% Dizziness 5.6% Libido decreased 5.5% Urogenital Menstrual irregularities: bleeding 57.3% at 12 months, 32.1% at 24 months amenorrhea 55% at 12 months, 68% at 24 months .\"\n },\n {\n \"VerbatimTerm\": \"amenorrhea\",\n \"Probability\": \"0.998721242\",\n \"SemanticContext\": \"Adverse reactions leading to study discontinuation in = 2% of subjects: bleeding 8.2% , amenorrhea 2.1% , weight gain 2.0% 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of medroxyprogesterone acetate injectable suspension.\"\n },\n {\n \"VerbatimTerm\": \"amenorrhea\",\n \"Probability\": \"0.2103905678\",\n \"SemanticContext\": \"Advise patients at the beginning of treatment that their menstrual cycle may be disrupted and that irregular and unpredictable bleeding or spotting results, and that this usually decreases to the point of amenorrhea as treatment with medroxyprogesterone acetate injectable suspension continues, without other therapy being required.\"\n },\n {\n \"VerbatimTerm\": \"amenorrhea\",\n \"Probability\": \"0.8330312967\",\n \"SemanticContext\": \"Altered menstrual bleeding patterns include amenorrhea, irregular or unpredictable bleeding or spotting, prolonged spotting or bleeding, and heavy bleeding.\"\n },\n {\n \"VerbatimTerm\": \"amenorrhea\",\n \"Probability\": \"0.163269639\",\n \"SemanticContext\": \"As women continue using medroxyprogesterone acetate injectable suspension, fewer experience irregular bleeding and more experience amenorrhea.\"\n },\n {\n \"VerbatimTerm\": \"amenorrhea\",\n \"Probability\": \"0.8786634207\",\n \"SemanticContext\": \"In clinical studies of medroxyprogesterone acetate injectable suspension, by month 12 amenorrhea was reported by 55% of women, and by month 24, amenorrhea was reported by 68% of women using medroxyprogesterone acetate injectable suspension.\"\n },\n {\n \"VerbatimTerm\": \"amenorrhea\",\n \"Probability\": \"0.9405004978\",\n \"SemanticContext\": \"In clinical studies of medroxyprogesterone acetate injectable suspension, by month 12 amenorrhea was reported by 55% of women, and by month 24, amenorrhea was reported by 68% of women using medroxyprogesterone acetate injectable suspension.\"\n }\n ]\n },\n {\n \"Term\": \"Blood ketone body\",\n \"MEDDRACode\": \"10057593\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"acetone\",\n \"Probability\": \"4.27328E-05\",\n \"SemanticContext\": \"It is freely soluble in chloroform, soluble in acetone and dioxane, sparingly soluble in alcohol and methanol, slightly soluble in ether, and insoluble in water.\"\n }\n ]\n },\n {\n \"Term\": \"Blood methanol\",\n \"MEDDRACode\": \"10005663\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"methanol\",\n \"Probability\": \"0.0006054342\",\n \"SemanticContext\": \"It is freely soluble in chloroform, soluble in acetone and dioxane, sparingly soluble in alcohol and methanol, slightly soluble in ether, and insoluble in water.\"\n }\n ]\n },\n {\n \"Term\": \"Pulmonary embolism\",\n \"MEDDRACode\": \"10037377\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Pulmonary embolus\",\n \"Probability\": \"0.7553754449\",\n \"SemanticContext\": \", Injection site infection , Injection site nodule/lump, Injection site pain/tenderness, Injection site persistent atrophy/indentation/dimpling, Injection-site reaction, Lipodystrophy acquired, Chills, Axillary swelling Cardiovascular Syncope, Tachycardia, Thrombophlebitis, Deep vein thrombosis, Pulmonary embolus, Varicose veins Digestive Changes in appetite, Gastrointestinal disturbances, Jaundice, Excessive thirst, Rectal bleeding Hematologic and Lymphatic Anemia, Blood dyscrasia Musculoskeletal Osteoporosis Neoplasms Cervical cancer, Breast cancer Nervous Paralysis, Facial palsy, Paresthesia, Drowsiness Respiratory Dyspnea and asthma, Hoarseness Skin and Appendages Hirsutism, Excessive sweating and body odor, Dry skin, Scleroderma Urogenital Lack of return to fertility, Unexpected pregnancy, Prevention of lactation, Changes in breast size, Breast lumps or nipple bleeding, Galactorrhea, Melasma, Chloasma, Increased libido, Uterine hyperplasia, Genitourinary infections, Vaginal cysts, Dyspareunia .\"\n }\n ]\n },\n {\n \"Term\": \"Hypersensitivity\",\n \"MEDDRACode\": \"10020751\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": true,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Allergic reactions\",\n \"Probability\": \"0.7099017501\",\n \"SemanticContext\": \"Adverse Reactions Body as a Whole Chest pain, Allergic reactions including angioedema, Fever, Injection site abscess Injection site abscess and injection site infections have been reported; therefore strict aseptic injection technique should be followed when administering medroxyprogesterone acetate injectable suspension in order to avoid injection site infections [see Dosage and Administration 2.1 ].\"\n }\n ]\n },\n {\n \"Term\": \"Asthma\",\n \"MEDDRACode\": \"10003553\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"asthma\",\n \"Probability\": \"0.8936173916\",\n \"SemanticContext\": \", Injection site infection , Injection site nodule/lump, Injection site pain/tenderness, Injection site persistent atrophy/indentation/dimpling, Injection-site reaction, Lipodystrophy acquired, Chills, Axillary swelling Cardiovascular Syncope, Tachycardia, Thrombophlebitis, Deep vein thrombosis, Pulmonary embolus, Varicose veins Digestive Changes in appetite, Gastrointestinal disturbances, Jaundice, Excessive thirst, Rectal bleeding Hematologic and Lymphatic Anemia, Blood dyscrasia Musculoskeletal Osteoporosis Neoplasms Cervical cancer, Breast cancer Nervous Paralysis, Facial palsy, Paresthesia, Drowsiness Respiratory Dyspnea and asthma, Hoarseness Skin and Appendages Hirsutism, Excessive sweating and body odor, Dry skin, Scleroderma Urogenital Lack of return to fertility, Unexpected pregnancy, Prevention of lactation, Changes in breast size, Breast lumps or nipple bleeding, Galactorrhea, Melasma, Chloasma, Increased libido, Uterine hyperplasia, Genitourinary infections, Vaginal cysts, Dyspareunia .\"\n },\n {\n \"VerbatimTerm\": \"asthma\",\n \"Probability\": \"0.0211508572\",\n \"SemanticContext\": \"5.14 Fluid Retention Because progestational drugs including medroxyprogesterone acetate injectable suspension may cause some degree of fluid retention, monitor patients with conditions that might be influenced by this condition, such as epilepsy, migraine, asthma, and cardiac or renal dysfunction.\"\n }\n ]\n },\n {\n \"Term\": \"Protein total\",\n \"MEDDRACode\": \"10050537\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Plasma protein\",\n \"Probability\": \"0.0001881719\",\n \"SemanticContext\": \"Distribution Plasma protein binding of MPA averages 86%.\"\n }\n ]\n },\n {\n \"Term\": \"Protein bound iodine\",\n \"MEDDRACode\": \"10059913\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Protein-bound iodine\",\n \"Probability\": \"0.0001542866\",\n \"SemanticContext\": \"d Protein-bound iodine and butanol extractable protein-bound iodine may increase.\"\n },\n {\n \"VerbatimTerm\": \"protein-bound iodine\",\n \"Probability\": \"0.0004807413\",\n \"SemanticContext\": \"d Protein-bound iodine and butanol extractable protein-bound iodine may increase.\"\n }\n ]\n },\n {\n \"Term\": \"Dizziness\",\n \"MEDDRACode\": \"10013573\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"dizziness\",\n \"Probability\": \"0.999784708\",\n \"SemanticContext\": \"ADVERSE REACTIONS Most common adverse reactions incidence >5% are: menstrual irregularities bleeding or spotting 57% at 12 months, 32% at 24 months, abdominal pain/discomfort 11%, weight gain > 10 lbs at 24 months 38%, dizziness 6%, headache 17%, nervousness 11%, decreased libido 6%.\"\n },\n {\n \"VerbatimTerm\": \"Dizziness\",\n \"Probability\": \"0.9997609854\",\n \"SemanticContext\": \"Table 1 Adverse Reactions that Were Reported by More than 5% of Subjects Body System* Adverse Reactions [Incidence % ] Body as a Whole Headache 16.5% Abdominal pain/discomfort 11.2% Metabolic/Nutritional Increased weight> 10lbs at 24 months 37.7% Nervous Nervousness 10.8% Dizziness 5.6% Libido decreased 5.5% Urogenital Menstrual irregularities: bleeding 57.3% at 12 months, 32.1% at 24 months amenorrhea 55% at 12 months, 68% at 24 months .\"\n }\n ]\n },\n {\n \"Term\": \"Weight\",\n \"MEDDRACode\": \"10047890\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"weight\",\n \"Probability\": \"0.0003765225\",\n \"SemanticContext\": \"Dosage does not need to be adjusted for body weight [ see Clinical Studies 14.1 ] .\"\n },\n {\n \"VerbatimTerm\": \"weight\",\n \"Probability\": \"0.0003036261\",\n \"SemanticContext\": \"From an initial average body weight of 136 lb, women who completed 1 year of therapy with medroxyprogesterone acetate injectable suspension gained an average of 5.4 lb.\"\n }\n ]\n },\n {\n \"Term\": \"Coagulation test\",\n \"MEDDRACode\": \"10063556\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Coagulation test\",\n \"Probability\": \"0.001346916\",\n \"SemanticContext\": \"e Coagulation test values for prothrombin Factor II , and Factors VII, VIII, IX, and X may increase.\"\n }\n ]\n },\n {\n \"Term\": \"Drug level\",\n \"MEDDRACode\": \"10061823\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"pharmacokinetic studies\",\n \"Probability\": \"0.0001780093\",\n \"SemanticContext\": \"Antibiotics : There have been reports of pregnancy while taking hormonal contraceptives and antibiotics, but clinical pharmacokinetic studies have not shown consistent effects of antibiotics on plasma concentrations of synthetic steroids.\"\n }\n ]\n },\n {\n \"Term\": \"Libido decreased\",\n \"MEDDRACode\": \"10024419\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"decreased libido\",\n \"Probability\": \"0.9984976053\",\n \"SemanticContext\": \"ADVERSE REACTIONS Most common adverse reactions incidence >5% are: menstrual irregularities bleeding or spotting 57% at 12 months, 32% at 24 months, abdominal pain/discomfort 11%, weight gain > 10 lbs at 24 months 38%, dizziness 6%, headache 17%, nervousness 11%, decreased libido 6%.\"\n },\n {\n \"VerbatimTerm\": \"Libido decreased\",\n \"Probability\": \"0.9995839\",\n \"SemanticContext\": \"Table 1 Adverse Reactions that Were Reported by More than 5% of Subjects Body System* Adverse Reactions [Incidence % ] Body as a Whole Headache 16.5% Abdominal pain/discomfort 11.2% Metabolic/Nutritional Increased weight> 10lbs at 24 months 37.7% Nervous Nervousness 10.8% Dizziness 5.6% Libido decreased 5.5% Urogenital Menstrual irregularities: bleeding 57.3% at 12 months, 32.1% at 24 months amenorrhea 55% at 12 months, 68% at 24 months .\"\n }\n ]\n },\n {\n \"Term\": \"Lipids\",\n \"MEDDRACode\": \"10024587\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"lipid\",\n \"Probability\": \"7.1004E-06\",\n \"SemanticContext\": \"g The effects of medroxyprogesterone acetate on lipid metabolism are inconsistent.\"\n },\n {\n \"VerbatimTerm\": \"lipids\",\n \"Probability\": \"0.0007661879\",\n \"SemanticContext\": \"5.19 Interference With Laboratory Tests The use of medroxyprogesterone acetate injectable suspension may change the results of some laboratory tests, such as coagulation factors, lipids, glucose tolerance, and binding proteins.\"\n }\n ]\n },\n {\n \"Term\": \"Ectopic pregnancy\",\n \"MEDDRACode\": \"10014166\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Ectopic Pregnancy\",\n \"Probability\": \"0.3547293246\",\n \"SemanticContext\": \"Ectopic Pregnancy: Consider ectopic pregnancy if a woman using medroxyprogesterone acetate injectable suspension becomes pregnant or complains of severe abdominal pain.\"\n },\n {\n \"VerbatimTerm\": \"Ectopic Pregnancy\",\n \"Probability\": \"0.7040618658\",\n \"SemanticContext\": \"spl-medroxy-fig1 5.4 Ectopic Pregnancy Be alert to the possibility of an ectopic pregnancy among women using medroxyprogesterone acetate injectable suspension who become pregnant or complain of severe abdominal pain.\"\n },\n {\n \"VerbatimTerm\": \"ectopic pregnancy\",\n \"Probability\": \"0.0273045599\",\n \"SemanticContext\": \"Ectopic Pregnancy: Consider ectopic pregnancy if a woman using medroxyprogesterone acetate injectable suspension becomes pregnant or complains of severe abdominal pain.\"\n },\n {\n \"VerbatimTerm\": \"ectopic pregnancy\",\n \"Probability\": \"0.0260512829\",\n \"SemanticContext\": \"spl-medroxy-fig1 5.4 Ectopic Pregnancy Be alert to the possibility of an ectopic pregnancy among women using medroxyprogesterone acetate injectable suspension who become pregnant or complain of severe abdominal pain.\"\n }\n ]\n },\n {\n \"Term\": \"Anaphylactic reaction\",\n \"MEDDRACode\": \"10002198\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"anaphylactic reaction\",\n \"Probability\": \"0.0193089843\",\n \"SemanticContext\": \"Institute emergency medical treatment if an anaphylactic reaction occurs.\"\n }\n ]\n },\n {\n \"Term\": \"Haemorrhage\",\n \"MEDDRACode\": \"10055798\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": true,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"bleeding\",\n \"Probability\": \"0.9404574037\",\n \"SemanticContext\": \"ADVERSE REACTIONS Most common adverse reactions incidence >5% are: menstrual irregularities bleeding or spotting 57% at 12 months, 32% at 24 months, abdominal pain/discomfort 11%, weight gain > 10 lbs at 24 months 38%, dizziness 6%, headache 17%, nervousness 11%, decreased libido 6%.\"\n },\n {\n \"VerbatimTerm\": \"bleeding\",\n \"Probability\": \"0.9966931343\",\n \"SemanticContext\": \"Table 1 Adverse Reactions that Were Reported by More than 5% of Subjects Body System* Adverse Reactions [Incidence % ] Body as a Whole Headache 16.5% Abdominal pain/discomfort 11.2% Metabolic/Nutritional Increased weight> 10lbs at 24 months 37.7% Nervous Nervousness 10.8% Dizziness 5.6% Libido decreased 5.5% Urogenital Menstrual irregularities: bleeding 57.3% at 12 months, 32.1% at 24 months amenorrhea 55% at 12 months, 68% at 24 months .\"\n },\n {\n \"VerbatimTerm\": \"bleeding\",\n \"Probability\": \"0.9931640625\",\n \"SemanticContext\": \"Adverse reactions leading to study discontinuation in = 2% of subjects: bleeding 8.2% , amenorrhea 2.1% , weight gain 2.0% 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of medroxyprogesterone acetate injectable suspension.\"\n },\n {\n \"VerbatimTerm\": \"bleeding\",\n \"Probability\": \"0.0603440702\",\n \"SemanticContext\": \", Injection site infection , Injection site nodule/lump, Injection site pain/tenderness, Injection site persistent atrophy/indentation/dimpling, Injection-site reaction, Lipodystrophy acquired, Chills, Axillary swelling Cardiovascular Syncope, Tachycardia, Thrombophlebitis, Deep vein thrombosis, Pulmonary embolus, Varicose veins Digestive Changes in appetite, Gastrointestinal disturbances, Jaundice, Excessive thirst, Rectal bleeding Hematologic and Lymphatic Anemia, Blood dyscrasia Musculoskeletal Osteoporosis Neoplasms Cervical cancer, Breast cancer Nervous Paralysis, Facial palsy, Paresthesia, Drowsiness Respiratory Dyspnea and asthma, Hoarseness Skin and Appendages Hirsutism, Excessive sweating and body odor, Dry skin, Scleroderma Urogenital Lack of return to fertility, Unexpected pregnancy, Prevention of lactation, Changes in breast size, Breast lumps or nipple bleeding, Galactorrhea, Melasma, Chloasma, Increased libido, Uterine hyperplasia, Genitourinary infections, Vaginal cysts, Dyspareunia .\"\n },\n {\n \"VerbatimTerm\": \"bleeding\",\n \"Probability\": \"0.0096607208\",\n \"SemanticContext\": \"Advise patients at the beginning of treatment that their menstrual cycle may be disrupted and that irregular and unpredictable bleeding or spotting results, and that this usually decreases to the point of amenorrhea as treatment with medroxyprogesterone acetate injectable suspension continues, without other therapy being required.\"\n },\n {\n \"VerbatimTerm\": \"bleeding\",\n \"Probability\": \"0.3292019963\",\n \"SemanticContext\": \"5.10 Bleeding Irregularities Most women using medroxyprogesterone acetate injectable suspension experience disruption of menstrual bleeding patterns.\"\n },\n {\n \"VerbatimTerm\": \"bleeding\",\n \"Probability\": \"0.1266883314\",\n \"SemanticContext\": \"Altered menstrual bleeding patterns include amenorrhea, irregular or unpredictable bleeding or spotting, prolonged spotting or bleeding, and heavy bleeding.\"\n },\n {\n \"VerbatimTerm\": \"bleeding\",\n \"Probability\": \"0.5511844158\",\n \"SemanticContext\": \"Altered menstrual bleeding patterns include amenorrhea, irregular or unpredictable bleeding or spotting, prolonged spotting or bleeding, and heavy bleeding.\"\n },\n {\n \"VerbatimTerm\": \"bleeding\",\n \"Probability\": \"0.582652092\",\n \"SemanticContext\": \"Altered menstrual bleeding patterns include amenorrhea, irregular or unpredictable bleeding or spotting, prolonged spotting or bleeding, and heavy bleeding.\"\n },\n {\n \"VerbatimTerm\": \"bleeding\",\n \"Probability\": \"0.8051506281\",\n \"SemanticContext\": \"Altered menstrual bleeding patterns include amenorrhea, irregular or unpredictable bleeding or spotting, prolonged spotting or bleeding, and heavy bleeding.\"\n },\n {\n \"VerbatimTerm\": \"bleeding\",\n \"Probability\": \"0.0237819254\",\n \"SemanticContext\": \"Rule out the possibility of organic pathology if abnormal bleeding persists or is severe, and institute appropriate treatment.\"\n },\n {\n \"VerbatimTerm\": \"bleeding\",\n \"Probability\": \"0.3804681301\",\n \"SemanticContext\": \"As women continue using medroxyprogesterone acetate injectable suspension, fewer experience irregular bleeding and more experience amenorrhea.\"\n },\n {\n \"VerbatimTerm\": \"Bleeding\",\n \"Probability\": \"0.9286276698\",\n \"SemanticContext\": \"6 ADVERSE REACTIONS The following important adverse reactions observed with the use of medroxyprogesterone acetate injectable suspension are discussed in greater detail in the Warnings and Precautions section 5 : Loss of Bone Mineral Density [ see Warnings and Precautions 5.1 ] Thromboembolic disease [ see Warnings and Precautions 5.2 ] Breast Cancer [ see Warnings and Precautions 5.3 ] Anaphylaxis and Anaphylactoid Reactions [ see Warnings and Precautions 5.5 ] Bleeding Irregularities [ see Warnings and Precautions 5.\"\n },\n {\n \"VerbatimTerm\": \"Bleeding\",\n \"Probability\": \"0.0030300617\",\n \"SemanticContext\": \"5.10 Bleeding Irregularities Most women using medroxyprogesterone acetate injectable suspension experience disruption of menstrual bleeding patterns.\"\n }\n ]\n },\n {\n \"Term\": \"Coagulation factor\",\n \"MEDDRACode\": \"10059744\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"coagulation factors\",\n \"Probability\": \"0.0262556374\",\n \"SemanticContext\": \"5.19 Interference With Laboratory Tests The use of medroxyprogesterone acetate injectable suspension may change the results of some laboratory tests, such as coagulation factors, lipids, glucose tolerance, and binding proteins.\"\n }\n ]\n },\n {\n \"Term\": \"Abdominal pain\",\n \"MEDDRACode\": \"10000081\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"abdominal pain\",\n \"Probability\": \"0.043584466\",\n \"SemanticContext\": \"Ectopic Pregnancy: Consider ectopic pregnancy if a woman using medroxyprogesterone acetate injectable suspension becomes pregnant or complains of severe abdominal pain.\"\n },\n {\n \"VerbatimTerm\": \"abdominal pain\",\n \"Probability\": \"0.9953714609\",\n \"SemanticContext\": \"ADVERSE REACTIONS Most common adverse reactions incidence >5% are: menstrual irregularities bleeding or spotting 57% at 12 months, 32% at 24 months, abdominal pain/discomfort 11%, weight gain > 10 lbs at 24 months 38%, dizziness 6%, headache 17%, nervousness 11%, decreased libido 6%.\"\n },\n {\n \"VerbatimTerm\": \"abdominal pain\",\n \"Probability\": \"0.0493853688\",\n \"SemanticContext\": \"spl-medroxy-fig1 5.4 Ectopic Pregnancy Be alert to the possibility of an ectopic pregnancy among women using medroxyprogesterone acetate injectable suspension who become pregnant or complain of severe abdominal pain.\"\n },\n {\n \"VerbatimTerm\": \"Abdominal pain\",\n \"Probability\": \"0.9910187721\",\n \"SemanticContext\": \"Table 1 Adverse Reactions that Were Reported by More than 5% of Subjects Body System* Adverse Reactions [Incidence % ] Body as a Whole Headache 16.5% Abdominal pain/discomfort 11.2% Metabolic/Nutritional Increased weight> 10lbs at 24 months 37.7% Nervous Nervousness 10.8% Dizziness 5.6% Libido decreased 5.5% Urogenital Menstrual irregularities: bleeding 57.3% at 12 months, 32.1% at 24 months amenorrhea 55% at 12 months, 68% at 24 months .\"\n }\n ]\n },\n {\n \"Term\": \"Blood chloride\",\n \"MEDDRACode\": \"10005416\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"chloride\",\n \"Probability\": \"0.0003679693\",\n \"SemanticContext\": \"For Medroxyprogesterone acetate injectable suspension prefilled syringe, each mL of sterile aqueous suspension contains: Medroxyprogesterone acetate 150 mg Polyethylene glycol 3350 28.90 mg Polysorbate 80 2.41 mg Sodium chloride 8.68 mg Methylparaben 1.37 mg Propylparaben 0.15 mg Water for injection quantity sufficient When necessary, pH is adjusted with sodium hydroxide or hydrochloric acid, or both.\"\n }\n ]\n },\n {\n \"Term\": \"Breast feeding\",\n \"MEDDRACode\": \"10006247\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"breast-feeding\",\n \"Probability\": \"0.0009113252\",\n \"SemanticContext\": \"To ensure the patient is not pregnant at the time of the first injection, the first injection should be given ONLY during the first 5 days of a normal menstrual period; ONLY within the first 5-days postpartum if not breast-feeding; and if exclusively breast-feeding, ONLY at the sixth postpartum week.\"\n },\n {\n \"VerbatimTerm\": \"breast-feeding\",\n \"Probability\": \"0.0044022501\",\n \"SemanticContext\": \"To ensure the patient is not pregnant at the time of the first injection, the first injection should be given ONLY during the first 5 days of a normal menstrual period; ONLY within the first 5-days postpartum if not breast-feeding; and if exclusively breast-feeding, ONLY at the sixth postpartum week.\"\n }\n ]\n },\n {\n \"Term\": \"Menarche\",\n \"MEDDRACode\": \"10027182\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"menarche\",\n \"Probability\": \"0.024430424\",\n \"SemanticContext\": \"Pediatric Patients : Medroxyprogesterone acetate injectable suspension is not indicated before menarche.\"\n },\n {\n \"VerbatimTerm\": \"menarche\",\n \"Probability\": \"0.0029656887\",\n \"SemanticContext\": \"Adolescents in the untreated cohort had an increase in BMD during the period of growth following menarche.\"\n },\n {\n \"VerbatimTerm\": \"menarche\",\n \"Probability\": \"0.0010522604\",\n \"SemanticContext\": \"8.4 Pediatric Use Medroxyprogesterone acetate injectable suspension is not indicated before menarche.\"\n }\n ]\n },\n {\n \"Term\": \"HIV infection\",\n \"MEDDRACode\": \"10020161\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"HIV infection\",\n \"Probability\": \"0.0002518296\",\n \"SemanticContext\": \"Counsel patients that this product does not protect against HIV infection AIDS and other sexually transmitted diseases.\"\n },\n {\n \"VerbatimTerm\": \"HIV infection\",\n \"Probability\": \"0.0008044243\",\n \"SemanticContext\": \"5.16 Sexually Transmitted Diseases Patients should be counseled that medroxyprogesterone acetate injectable suspension does not protect against HIV infection AIDS and other sexually transmitted diseases.\"\n }\n ]\n },\n {\n \"Term\": \"Blood pressure measurement\",\n \"MEDDRACode\": \"10076581\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"blood pressure\",\n \"Probability\": \"6.6727E-06\",\n \"SemanticContext\": \"5.18 Monitoring A woman who is taking hormonal contraceptive should have a yearly visit with her healthcare provider for a blood pressure check and for other indicated healthcare.\"\n }\n ]\n },\n {\n \"Term\": \"Thrombophlebitis\",\n \"MEDDRACode\": \"10043570\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": true,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"thrombophlebitis\",\n \"Probability\": \"0.0021627843\",\n \"SemanticContext\": \"Active thrombophlebitis, or current or past history of thromboembolic disorders, or cerebral vascular disease.\"\n },\n {\n \"VerbatimTerm\": \"thrombophlebitis\",\n \"Probability\": \"0.0238484144\",\n \"SemanticContext\": \"Active thrombophlebitis, or current or past history of thromboembolic disorders, or cerebral vascular disease [ see Warnings and Precautions 5.2 ].\"\n },\n {\n \"VerbatimTerm\": \"Thrombophlebitis\",\n \"Probability\": \"0.9516618252\",\n \"SemanticContext\": \", Injection site infection , Injection site nodule/lump, Injection site pain/tenderness, Injection site persistent atrophy/indentation/dimpling, Injection-site reaction, Lipodystrophy acquired, Chills, Axillary swelling Cardiovascular Syncope, Tachycardia, Thrombophlebitis, Deep vein thrombosis, Pulmonary embolus, Varicose veins Digestive Changes in appetite, Gastrointestinal disturbances, Jaundice, Excessive thirst, Rectal bleeding Hematologic and Lymphatic Anemia, Blood dyscrasia Musculoskeletal Osteoporosis Neoplasms Cervical cancer, Breast cancer Nervous Paralysis, Facial palsy, Paresthesia, Drowsiness Respiratory Dyspnea and asthma, Hoarseness Skin and Appendages Hirsutism, Excessive sweating and body odor, Dry skin, Scleroderma Urogenital Lack of return to fertility, Unexpected pregnancy, Prevention of lactation, Changes in breast size, Breast lumps or nipple bleeding, Galactorrhea, Melasma, Chloasma, Increased libido, Uterine hyperplasia, Genitourinary infections, Vaginal cysts, Dyspareunia .\"\n }\n ]\n },\n {\n \"Term\": \"Body mass index\",\n \"MEDDRACode\": \"10005894\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"BMI\",\n \"Probability\": \"0.0001577437\",\n \"SemanticContext\": \"Li et al. 2012 : age, year, BMI, duration of OC use, number of full-term pregnancies, family history of breast cancer, and history of screening mammography.\"\n }\n ]\n },\n {\n \"Term\": \"Fluid retention\",\n \"MEDDRACode\": \"10016807\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Fluid Retention\",\n \"Probability\": \"0.0895982683\",\n \"SemanticContext\": \"5.14 Fluid Retention Because progestational drugs including medroxyprogesterone acetate injectable suspension may cause some degree of fluid retention, monitor patients with conditions that might be influenced by this condition, such as epilepsy, migraine, asthma, and cardiac or renal dysfunction.\"\n },\n {\n \"VerbatimTerm\": \"fluid retention\",\n \"Probability\": \"0.0956957936\",\n \"SemanticContext\": \"5.14 Fluid Retention Because progestational drugs including medroxyprogesterone acetate injectable suspension may cause some degree of fluid retention, monitor patients with conditions that might be influenced by this condition, such as epilepsy, migraine, asthma, and cardiac or renal dysfunction.\"\n }\n ]\n },\n {\n \"Term\": \"Migraine\",\n \"MEDDRACode\": \"10027599\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"migraine\",\n \"Probability\": \"0.0222274661\",\n \"SemanticContext\": \"Do not re-administer medroxyprogesterone acetate injectable suspension pending examination if there is a sudden partial or complete loss of vision or if there is a sudden onset of proptosis, diplopia, or migraine.\"\n },\n {\n \"VerbatimTerm\": \"migraine\",\n \"Probability\": \"0.1327675879\",\n \"SemanticContext\": \"5.14 Fluid Retention Because progestational drugs including medroxyprogesterone acetate injectable suspension may cause some degree of fluid retention, monitor patients with conditions that might be influenced by this condition, such as epilepsy, migraine, asthma, and cardiac or renal dysfunction.\"\n }\n ]\n },\n {\n \"Term\": \"Blindness\",\n \"MEDDRACode\": \"10005169\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"loss of vision\",\n \"Probability\": \"0.0006526411\",\n \"SemanticContext\": \"Do not re-administer medroxyprogesterone acetate injectable suspension pending examination if there is a sudden partial or complete loss of vision or if there is a sudden onset of proptosis, diplopia, or migraine.\"\n }\n ]\n },\n {\n \"Term\": \"Blood glucose\",\n \"MEDDRACode\": \"10005553\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"glucose\",\n \"Probability\": \"0.0001075865\",\n \"SemanticContext\": \"5.19 Interference With Laboratory Tests The use of medroxyprogesterone acetate injectable suspension may change the results of some laboratory tests, such as coagulation factors, lipids, glucose tolerance, and binding proteins.\"\n }\n ]\n },\n {\n \"Term\": \"Congenital anomaly\",\n \"MEDDRACode\": \"10010356\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"birth defects\",\n \"Probability\": \"0.0449128449\",\n \"SemanticContext\": \"5.17 Pregnancy Although medroxyprogesterone acetate injectable suspension should not be used during pregnancy, there appears to be little or no increased risk of birth defects in women who have inadvertently been exposed to medroxyprogesterone acetate injections in early pregnancy.\"\n }\n ]\n },\n {\n \"Term\": \"Chills\",\n \"MEDDRACode\": \"10008531\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Chills\",\n \"Probability\": \"0.9799051285\",\n \"SemanticContext\": \", Injection site infection , Injection site nodule/lump, Injection site pain/tenderness, Injection site persistent atrophy/indentation/dimpling, Injection-site reaction, Lipodystrophy acquired, Chills, Axillary swelling Cardiovascular Syncope, Tachycardia, Thrombophlebitis, Deep vein thrombosis, Pulmonary embolus, Varicose veins Digestive Changes in appetite, Gastrointestinal disturbances, Jaundice, Excessive thirst, Rectal bleeding Hematologic and Lymphatic Anemia, Blood dyscrasia Musculoskeletal Osteoporosis Neoplasms Cervical cancer, Breast cancer Nervous Paralysis, Facial palsy, Paresthesia, Drowsiness Respiratory Dyspnea and asthma, Hoarseness Skin and Appendages Hirsutism, Excessive sweating and body odor, Dry skin, Scleroderma Urogenital Lack of return to fertility, Unexpected pregnancy, Prevention of lactation, Changes in breast size, Breast lumps or nipple bleeding, Galactorrhea, Melasma, Chloasma, Increased libido, Uterine hyperplasia, Genitourinary infections, Vaginal cysts, Dyspareunia .\"\n }\n ]\n },\n {\n \"Term\": \"Hyperhidrosis\",\n \"MEDDRACode\": \"10020642\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"sweating\",\n \"Probability\": \"0.4025501311\",\n \"SemanticContext\": \", Injection site infection , Injection site nodule/lump, Injection site pain/tenderness, Injection site persistent atrophy/indentation/dimpling, Injection-site reaction, Lipodystrophy acquired, Chills, Axillary swelling Cardiovascular Syncope, Tachycardia, Thrombophlebitis, Deep vein thrombosis, Pulmonary embolus, Varicose veins Digestive Changes in appetite, Gastrointestinal disturbances, Jaundice, Excessive thirst, Rectal bleeding Hematologic and Lymphatic Anemia, Blood dyscrasia Musculoskeletal Osteoporosis Neoplasms Cervical cancer, Breast cancer Nervous Paralysis, Facial palsy, Paresthesia, Drowsiness Respiratory Dyspnea and asthma, Hoarseness Skin and Appendages Hirsutism, Excessive sweating and body odor, Dry skin, Scleroderma Urogenital Lack of return to fertility, Unexpected pregnancy, Prevention of lactation, Changes in breast size, Breast lumps or nipple bleeding, Galactorrhea, Melasma, Chloasma, Increased libido, Uterine hyperplasia, Genitourinary infections, Vaginal cysts, Dyspareunia .\"\n }\n ]\n },\n {\n \"Term\": \"Insomnia\",\n \"MEDDRACode\": \"10022437\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Insomnia\",\n \"Probability\": \"0.9404554963\",\n \"SemanticContext\": \"Table 2 Adverse Reactions that Were Reported by between 1 and 5% of Subjects Body System* Adverse Reactions [Incidence % ] Body as a Whole Asthenia/fatigue 4.2% Backache 2.2% Dysmenorrhea 1.7% Hot flashes 1.0% Digestive Nausea 3.3% Bloating 2.3% Metabolic/Nutritional Edema 2.2% Musculoskeletal Leg cramps 3.7% Arthralgia 1.0% Nervous Depression 1.5% Insomnia 1.0% Skin and Appendages Acne 1.2% No hair growth/alopecia 1.1% Rash 1.1% Urogenital Leukorrhea 2.9% Breast pain 2.8% Vaginitis 1.2% .\"\n }\n ]\n },\n {\n \"Term\": \"Syncope\",\n \"MEDDRACode\": \"10042772\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Cardiovascular Syncope\",\n \"Probability\": \"0.346047163\",\n \"SemanticContext\": \", Injection site infection , Injection site nodule/lump, Injection site pain/tenderness, Injection site persistent atrophy/indentation/dimpling, Injection-site reaction, Lipodystrophy acquired, Chills, Axillary swelling Cardiovascular Syncope, Tachycardia, Thrombophlebitis, Deep vein thrombosis, Pulmonary embolus, Varicose veins Digestive Changes in appetite, Gastrointestinal disturbances, Jaundice, Excessive thirst, Rectal bleeding Hematologic and Lymphatic Anemia, Blood dyscrasia Musculoskeletal Osteoporosis Neoplasms Cervical cancer, Breast cancer Nervous Paralysis, Facial palsy, Paresthesia, Drowsiness Respiratory Dyspnea and asthma, Hoarseness Skin and Appendages Hirsutism, Excessive sweating and body odor, Dry skin, Scleroderma Urogenital Lack of return to fertility, Unexpected pregnancy, Prevention of lactation, Changes in breast size, Breast lumps or nipple bleeding, Galactorrhea, Melasma, Chloasma, Increased libido, Uterine hyperplasia, Genitourinary infections, Vaginal cysts, Dyspareunia .\"\n }\n ]\n },\n {\n \"Term\": \"Hormonal contraception\",\n \"MEDDRACode\": \"10073728\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hormonal contraception\",\n \"Probability\": \"0.0023842454\",\n \"SemanticContext\": \"Control The control group consisted of women who did not use hormonal contraception and were followed for 7 years.\"\n }\n ]\n },\n {\n \"Term\": \"Injection\",\n \"MEDDRACode\": \"10052995\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"injection\",\n \"Probability\": \"3.83048E-05\",\n \"SemanticContext\": \"DOSAGE AND ADMINISTRATION The recommended dose is 150 mg of medroxyprogesterone acetate injectable suspension every 3 months 13 weeks administered by deep, intramuscular IM injection in the gluteal or deltoid muscle.\"\n },\n {\n \"VerbatimTerm\": \"injection\",\n \"Probability\": \"0.0038065314\",\n \"SemanticContext\": \"Adverse Reactions Body as a Whole Chest pain, Allergic reactions including angioedema, Fever, Injection site abscess Injection site abscess and injection site infections have been reported; therefore strict aseptic injection technique should be followed when administering medroxyprogesterone acetate injectable suspension in order to avoid injection site infections [see Dosage and Administration 2.1 ].\"\n },\n {\n \"VerbatimTerm\": \"injection\",\n \"Probability\": \"0.0064840019\",\n \"SemanticContext\": \"11 DESCRIPTION Medroxyprogesterone acetate injectable suspension, USP, a contraceptive injection, contains medroxyprogesterone acetate, USP a derivative of progesterone, as its active ingredient.\"\n },\n {\n \"VerbatimTerm\": \"injection\",\n \"Probability\": \"0.0019175112\",\n \"SemanticContext\": \"The structural formula is as follows: Medroxyprogesterone acetate injectable suspension, USP for IM injection is available in prefilled syringe containing 1 mL of medroxyprogesterone acetate sterile aqueous suspension 150 mg/mL.\"\n },\n {\n \"VerbatimTerm\": \"injection\",\n \"Probability\": \"0.0002446771\",\n \"SemanticContext\": \"For Medroxyprogesterone acetate injectable suspension prefilled syringe, each mL of sterile aqueous suspension contains: Medroxyprogesterone acetate 150 mg Polyethylene glycol 3350 28.90 mg Polysorbate 80 2.41 mg Sodium chloride 8.68 mg Methylparaben 1.37 mg Propylparaben 0.15 mg Water for injection quantity sufficient When necessary, pH is adjusted with sodium hydroxide or hydrochloric acid, or both.\"\n },\n {\n \"VerbatimTerm\": \"injection\",\n \"Probability\": \"0.0037266612\",\n \"SemanticContext\": \"Excretion The concentrations of medroxyprogesterone acetate decrease exponentially until they become undetectable \\n <100 pg/mL between 120 to 200 days following injection.\"\n },\n {\n \"VerbatimTerm\": \"injection\",\n \"Probability\": \"0.0038946569\",\n \"SemanticContext\": \"Longer duration of treatment was associated with less complete recovery during this 2-year period following the last injection.\"\n },\n {\n \"VerbatimTerm\": \"injection\",\n \"Probability\": \"0.001712203\",\n \"SemanticContext\": \"BMD Recovery Post-Treatment in Adolescents Longer duration of treatment and smoking were associated with less recovery of BMD following the last injection of medroxyprogesterone acetate injectable suspension.\"\n },\n {\n \"VerbatimTerm\": \"injection\",\n \"Probability\": \"0.0001071159\",\n \"SemanticContext\": \"The recommended dose is 150 mg of medroxyprogesterone acetate injectable suspension every 3 months 13 weeks administered by deep intramuscular IM injection using strict aseptic technique in the gluteal or deltoid muscle, rotating the sites with every injection.\"\n },\n {\n \"VerbatimTerm\": \"injection\",\n \"Probability\": \"0.0042479336\",\n \"SemanticContext\": \"The recommended dose is 150 mg of medroxyprogesterone acetate injectable suspension every 3 months 13 weeks administered by deep intramuscular IM injection using strict aseptic technique in the gluteal or deltoid muscle, rotating the sites with every injection.\"\n },\n {\n \"VerbatimTerm\": \"injection\",\n \"Probability\": \"0.0001216807\",\n \"SemanticContext\": \"As with any IM injection, to avoid an inadvertent subcutaneous injection, body habitus should be assessed prior to each injection to determine if a longer needle is necessary particularly for gluteal IM injection.\"\n },\n {\n \"VerbatimTerm\": \"injection\",\n \"Probability\": \"5.10414E-05\",\n \"SemanticContext\": \"As with any IM injection, to avoid an inadvertent subcutaneous injection, body habitus should be assessed prior to each injection to determine if a longer needle is necessary particularly for gluteal IM injection.\"\n },\n {\n \"VerbatimTerm\": \"injection\",\n \"Probability\": \"1.6739E-06\",\n \"SemanticContext\": \"As with any IM injection, to avoid an inadvertent subcutaneous injection, body habitus should be assessed prior to each injection to determine if a longer needle is necessary particularly for gluteal IM injection.\"\n },\n {\n \"VerbatimTerm\": \"injection\",\n \"Probability\": \"0.0001042216\",\n \"SemanticContext\": \"As with any IM injection, to avoid an inadvertent subcutaneous injection, body habitus should be assessed prior to each injection to determine if a longer needle is necessary particularly for gluteal IM injection.\"\n },\n {\n \"VerbatimTerm\": \"injection\",\n \"Probability\": \"0.0002507567\",\n \"SemanticContext\": \"To ensure the patient is not pregnant at the time of the first injection, the first injection should be given ONLY during the first 5 days of a normal menstrual period; ONLY within the first 5-days postpartum if not breast-feeding; and if exclusively breast-feeding, ONLY at the sixth postpartum week.\"\n },\n {\n \"VerbatimTerm\": \"injection\",\n \"Probability\": \"0.0006554127\",\n \"SemanticContext\": \"To ensure the patient is not pregnant at the time of the first injection, the first injection should be given ONLY during the first 5 days of a normal menstrual period; ONLY within the first 5-days postpartum if not breast-feeding; and if exclusively breast-feeding, ONLY at the sixth postpartum week.\"\n },\n {\n \"VerbatimTerm\": \"injection\",\n \"Probability\": \"3.76954E-05\",\n \"SemanticContext\": \"2.2 Switching From Other Methods of Contraception When switching from other contraceptive methods, medroxyprogesterone acetate injectable suspension should be given in a manner that ensures continuous contraceptive coverage based upon the mechanism of action of both methods, e.g., patients switching from oral contraceptives should have their first injection of medroxyprogesterone acetate injectable suspension on the day after the last active tablet or at the latest, on the day following the final inactive tablet .\"\n },\n {\n \"VerbatimTerm\": \"injection\",\n \"Probability\": \"0.0025978684\",\n \"SemanticContext\": \"Based on Life-Table analysis of these data, it is expected that 68% of women who do become pregnant may conceive within 12 months, 83% may conceive within 15 months, and 93% may conceive within 18 months from the last injection.\"\n },\n {\n \"VerbatimTerm\": \"injection\",\n \"Probability\": \"0.0018393993\",\n \"SemanticContext\": \"The median time to conception for those who do conceive is 10 months following the last injection with a range of 4 to 31 months, and is unrelated to the duration of use.\"\n },\n {\n \"VerbatimTerm\": \"Injection\",\n \"Probability\": \"0.0089730322\",\n \"SemanticContext\": \", Injection site infection , Injection site nodule/lump, Injection site pain/tenderness, Injection site persistent atrophy/indentation/dimpling, Injection-site reaction, Lipodystrophy acquired, Chills, Axillary swelling Cardiovascular Syncope, Tachycardia, Thrombophlebitis, Deep vein thrombosis, Pulmonary embolus, Varicose veins Digestive Changes in appetite, Gastrointestinal disturbances, Jaundice, Excessive thirst, Rectal bleeding Hematologic and Lymphatic Anemia, Blood dyscrasia Musculoskeletal Osteoporosis Neoplasms Cervical cancer, Breast cancer Nervous Paralysis, Facial palsy, Paresthesia, Drowsiness Respiratory Dyspnea and asthma, Hoarseness Skin and Appendages Hirsutism, Excessive sweating and body odor, Dry skin, Scleroderma Urogenital Lack of return to fertility, Unexpected pregnancy, Prevention of lactation, Changes in breast size, Breast lumps or nipple bleeding, Galactorrhea, Melasma, Chloasma, Increased libido, Uterine hyperplasia, Genitourinary infections, Vaginal cysts, Dyspareunia .\"\n },\n {\n \"VerbatimTerm\": \"injections\",\n \"Probability\": \"0.0001015741\",\n \"SemanticContext\": \"The mean number of injections per medroxyprogesterone acetate injectable suspension user was 9.3.\"\n },\n {\n \"VerbatimTerm\": \"injections\",\n \"Probability\": \"0.0484894812\",\n \"SemanticContext\": \"In the study, when cumulative exposure to medroxyprogesterone acetate injectable suspension was calculated, the fracture rate in users who received fewer than 8 injections was higher than that in women who received 8 or more injections.\"\n },\n {\n \"VerbatimTerm\": \"injections\",\n \"Probability\": \"0.0187035203\",\n \"SemanticContext\": \"In the study, when cumulative exposure to medroxyprogesterone acetate injectable suspension was calculated, the fracture rate in users who received fewer than 8 injections was higher than that in women who received 8 or more injections.\"\n },\n {\n \"VerbatimTerm\": \"injections\",\n \"Probability\": \"2.15753E-05\",\n \"SemanticContext\": \"If the time interval between injections is greater than 13 weeks, the physician should determine that the patient is not pregnant before administering the drug.\"\n },\n {\n \"VerbatimTerm\": \"injections\",\n \"Probability\": \"9.98525E-05\",\n \"SemanticContext\": \"5.17 Pregnancy Although medroxyprogesterone acetate injectable suspension should not be used during pregnancy, there appears to be little or no increased risk of birth defects in women who have inadvertently been exposed to medroxyprogesterone acetate injections in early pregnancy.\"\n },\n {\n \"VerbatimTerm\": \"Injections\",\n \"Probability\": \"0.0051496625\",\n \"SemanticContext\": \"BMD Mean Percent Change from Baseline in Adolescents Receiving =4 Injections per 60-week Period, by Skeletal Site and Cohort Duration of Treatment Medroxyprogesterone Acetate Injectable Suspension 150 mg IM Unmatched, Untreated Cohort N Mean % Change N Mean % Change Total Hip BMD Week 60 1.2 years Week 120 2.3 years Week 240 4.6 years 113 73 28 -2.75 -5.40 -6.40 166 109 84 1.22 2.19 1.71 Femoral Neck BMD Week 60 Week 120 Week 240 113 73 28 -2.96 -5.30 -5.40 166 108 84 1.75 2.83 1.94 Lumbar Spine BMD Week 60 Week 120 Week 240 114 73 27 -2.47 -2.74 -2.11 167 109 84 3.39 5.28 6.40 .\"\n }\n ]\n }\n ],\n \"IndicationTerms\": []\n }\n ]\n },\n {\n \"GenericName\": \"tropicamide\",\n \"MeddraVersion\": \"24.0\",\n \"Labels\": [\n {\n \"Id\": \"US4bbce573-ec20-4d9f-b955-3ea0ab3f70dc\",\n \"NDCCode\": \"61314-355\",\n \"UpdatedDate\": \"Jun 29, 2021\",\n \"LabelSource\": {\n \"Country\": \"us\",\n \"ProductId\": \"0104ffe4-013d-4afa-996d-dcba4f08e93d\",\n \"FileId\": \"4bbce573-ec20-4d9f-b955-3ea0ab3f70dc\",\n \"Version\": \"3\"\n },\n \"AdverseEventTerms\": [\n {\n \"Term\": \"Arthropod sting\",\n \"MEDDRACode\": \"10003402\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"stinging\",\n \"Probability\": \"0.1875593215\",\n \"SemanticContext\": \"ADVERSE REACTIONS Ocular: Transient stinging, blurred vision, photophobia and superficial punctate keratitis have been reported with the use of tropicamide.\"\n }\n ]\n },\n {\n \"Term\": \"Headache\",\n \"MEDDRACode\": \"10019211\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"headache\",\n \"Probability\": \"0.9955286384\",\n \"SemanticContext\": \"Non-Ocular: Dryness of the mouth, tachycardia, headache, allergic reactions, nausea, vomiting, pallor, central nervous system disturbances and muscle rigidity have been reported with the use of tropicamide.\"\n }\n ]\n },\n {\n \"Term\": \"Hypersensitivity\",\n \"MEDDRACode\": \"10020751\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": true,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hypersensitivity\",\n \"Probability\": \"0.0072008814\",\n \"SemanticContext\": \"CONTRAINDICATIONS Contraindicated in persons showing hypersensitivity to any component of this preparation.\"\n },\n {\n \"VerbatimTerm\": \"hypersensitivity\",\n \"Probability\": \"0.0192233734\",\n \"SemanticContext\": \"The possibility of psychotic reactions and behavioral disturbances due to hypersensitivity to anticholinergic drugs should be considered.\"\n }\n ]\n },\n {\n \"Term\": \"Intraocular pressure increased\",\n \"MEDDRACode\": \"10022806\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Increased intraocular pressure\",\n \"Probability\": \"0.9802491069\",\n \"SemanticContext\": \"Increased intraocular pressure has been reported following the use of mydriatics.\"\n }\n ]\n },\n {\n \"Term\": \"Nervousness\",\n \"MEDDRACode\": \"10029216\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"nervous\",\n \"Probability\": \"0.7652410269\",\n \"SemanticContext\": \"Non-Ocular: Dryness of the mouth, tachycardia, headache, allergic reactions, nausea, vomiting, pallor, central nervous system disturbances and muscle rigidity have been reported with the use of tropicamide.\"\n }\n ]\n },\n {\n \"Term\": \"Punctate keratitis\",\n \"MEDDRACode\": \"10037508\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"superficial punctate keratitis\",\n \"Probability\": \"0.7195799351\",\n \"SemanticContext\": \"ADVERSE REACTIONS Ocular: Transient stinging, blurred vision, photophobia and superficial punctate keratitis have been reported with the use of tropicamide.\"\n }\n ]\n },\n {\n \"Term\": \"Pallor\",\n \"MEDDRACode\": \"10033546\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"pallor\",\n \"Probability\": \"0.9971906543\",\n \"SemanticContext\": \"Non-Ocular: Dryness of the mouth, tachycardia, headache, allergic reactions, nausea, vomiting, pallor, central nervous system disturbances and muscle rigidity have been reported with the use of tropicamide.\"\n }\n ]\n },\n {\n \"Term\": \"Pain\",\n \"MEDDRACode\": \"10033371\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"stinging\",\n \"Probability\": \"0.1875593215\",\n \"SemanticContext\": \"ADVERSE REACTIONS Ocular: Transient stinging, blurred vision, photophobia and superficial punctate keratitis have been reported with the use of tropicamide.\"\n }\n ]\n },\n {\n \"Term\": \"Vision blurred\",\n \"MEDDRACode\": \"10047513\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"blurred vision\",\n \"Probability\": \"0.9305568337\",\n \"SemanticContext\": \"ADVERSE REACTIONS Ocular: Transient stinging, blurred vision, photophobia and superficial punctate keratitis have been reported with the use of tropicamide.\"\n }\n ]\n },\n {\n \"Term\": \"Blood chloride\",\n \"MEDDRACode\": \"10005416\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"chloride\",\n \"Probability\": \"0.0018004152\",\n \"SemanticContext\": \"Preservative: benzalkonium chloride 0.01%.\"\n },\n {\n \"VerbatimTerm\": \"chloride\",\n \"Probability\": \"0.0003311135\",\n \"SemanticContext\": \"Inactives: sodium chloride, edetate disodium, hydrochloric acid and/or sodium hydroxide to adjust pH , purified water.\"\n }\n ]\n },\n {\n \"Term\": \"Muscle rigidity\",\n \"MEDDRACode\": \"10028330\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"muscle rigidity\",\n \"Probability\": \"0.7413128018\",\n \"SemanticContext\": \"Non-Ocular: Dryness of the mouth, tachycardia, headache, allergic reactions, nausea, vomiting, pallor, central nervous system disturbances and muscle rigidity have been reported with the use of tropicamide.\"\n }\n ]\n },\n {\n \"Term\": \"Tachycardia\",\n \"MEDDRACode\": \"10043071\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"tachycardia\",\n \"Probability\": \"0.9915485978\",\n \"SemanticContext\": \"Non-Ocular: Dryness of the mouth, tachycardia, headache, allergic reactions, nausea, vomiting, pallor, central nervous system disturbances and muscle rigidity have been reported with the use of tropicamide.\"\n }\n ]\n },\n {\n \"Term\": \"Accommodation disorder\",\n \"MEDDRACode\": \"10000389\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"paralyzes accommodation\",\n \"Probability\": \"0.0062525761\",\n \"SemanticContext\": \"The stronger preparation 1% also paralyzes accommodation.\"\n }\n ]\n },\n {\n \"Term\": \"Mydriasis\",\n \"MEDDRACode\": \"10028521\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"mydriasis\",\n \"Probability\": \"0.0222295672\",\n \"SemanticContext\": \"chemical CLINICAL PHARMACOLOGY This anticholinergic preparation blocks the responses of the sphincter muscle of the iris and the ciliary muscle to cholinergic stimulation, dilating the pupil mydriasis .\"\n },\n {\n \"VerbatimTerm\": \"mydriasis\",\n \"Probability\": \"0.1545134187\",\n \"SemanticContext\": \"Complete recovery from mydriasis in some individuals may require 24 hours.\"\n },\n {\n \"VerbatimTerm\": \"mydriasis\",\n \"Probability\": \"0.036945764\",\n \"SemanticContext\": \"The weaker strength may be useful in producing mydriasis with only slight cycloplegia.\"\n },\n {\n \"VerbatimTerm\": \"mydriasis\",\n \"Probability\": \"0.0531229153\",\n \"SemanticContext\": \"INDICATIONS AND USAGE For mydriasis and cycloplegia for diagnostic procedures.\"\n },\n {\n \"VerbatimTerm\": \"Mydriasis\",\n \"Probability\": \"0.0127698053\",\n \"SemanticContext\": \"Mydriasis will reverse spontaneously with time, typically in 4 to 8 hours.\"\n }\n ]\n },\n {\n \"Term\": \"Nausea\",\n \"MEDDRACode\": \"10028813\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"nausea\",\n \"Probability\": \"0.9967982173\",\n \"SemanticContext\": \"Non-Ocular: Dryness of the mouth, tachycardia, headache, allergic reactions, nausea, vomiting, pallor, central nervous system disturbances and muscle rigidity have been reported with the use of tropicamide.\"\n }\n ]\n },\n {\n \"Term\": \"Euphoric mood\",\n \"MEDDRACode\": \"10015535\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"higher\",\n \"Probability\": \"6.11053E-05\",\n \"SemanticContext\": \"Individuals with heavily pigmented irides may require higher strength or more doses.\"\n }\n ]\n },\n {\n \"Term\": \"Blood cholinesterase\",\n \"MEDDRACode\": \"10005428\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"cholinesterase\",\n \"Probability\": \"1.04867E-05\",\n \"SemanticContext\": \"Drug Interactions: Tropicamide may interfere with the antihypertensive action of carbachol, pilocarpine, or ophthalmic cholinesterase inhibitors.\"\n }\n ]\n },\n {\n \"Term\": \"Circulatory collapse\",\n \"MEDDRACode\": \"10009192\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"collapse\",\n \"Probability\": \"0.4552838206\",\n \"SemanticContext\": \"Psychotic reactions, behavioral disturbances, and vasomotor or cardio-respiratory collapse in children have been reported with the use of anticholinergic drugs.\"\n },\n {\n \"VerbatimTerm\": \"collapse\",\n \"Probability\": \"0.1737023741\",\n \"SemanticContext\": \"Psychotic reactions, behavioral disturbances, and vasomotor or cardiorespiratory collapse in children have been reported with the use of anticholinergic drugs See WARNINGS .\"\n }\n ]\n },\n {\n \"Term\": \"Pregnancy\",\n \"MEDDRACode\": \"10036556\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"pregnant\",\n \"Probability\": \"0.000619165\",\n \"SemanticContext\": \"It is also not known whether tropicamide can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.\"\n },\n {\n \"VerbatimTerm\": \"pregnant\",\n \"Probability\": \"3.4735E-06\",\n \"SemanticContext\": \"Tropicamide should be given to a pregnant woman only if clearly needed.\"\n }\n ]\n },\n {\n \"Term\": \"Therapy cessation\",\n \"MEDDRACode\": \"10065154\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"medications out of\",\n \"Probability\": \"0.0006699344\",\n \"SemanticContext\": \"Keep this and all medications out of the reach of children.\"\n }\n ]\n },\n {\n \"Term\": \"Cycloplegia\",\n \"MEDDRACode\": \"10011719\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"cycloplegia\",\n \"Probability\": \"0.0029977257\",\n \"SemanticContext\": \"The weaker strength may be useful in producing mydriasis with only slight cycloplegia.\"\n },\n {\n \"VerbatimTerm\": \"cycloplegia\",\n \"Probability\": \"0.010545224\",\n \"SemanticContext\": \"INDICATIONS AND USAGE For mydriasis and cycloplegia for diagnostic procedures.\"\n }\n ]\n },\n {\n \"Term\": \"Fundoscopy\",\n \"MEDDRACode\": \"10017519\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"fundus\",\n \"Probability\": \"0.0005586189\",\n \"SemanticContext\": \"For examination of fundus, instill one or two drops of 0.5% solution 15 or 20 minutes prior to examination.\"\n }\n ]\n },\n {\n \"Term\": \"Diagnostic procedure\",\n \"MEDDRACode\": \"10061816\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"diagnostic procedures\",\n \"Probability\": \"0.0008648257\",\n \"SemanticContext\": \"INDICATIONS AND USAGE For mydriasis and cycloplegia for diagnostic procedures.\"\n }\n ]\n },\n {\n \"Term\": \"Crigler-Najjar syndrome\",\n \"MEDDRACode\": \"10011386\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"CNS\",\n \"Probability\": \"0.0230494905\",\n \"SemanticContext\": \"This preparation may cause CNS disturbances which may be dangerous in pediatric patients.\"\n },\n {\n \"VerbatimTerm\": \"CNS\",\n \"Probability\": \"0.0125093395\",\n \"SemanticContext\": \"Pediatric Use: Tropicamide may rarely cause CNS disturbances which may be dangerous in pediatric patients.\"\n }\n ]\n },\n {\n \"Term\": \"Vomiting\",\n \"MEDDRACode\": \"10047700\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"vomiting\",\n \"Probability\": \"0.9961316586\",\n \"SemanticContext\": \"Non-Ocular: Dryness of the mouth, tachycardia, headache, allergic reactions, nausea, vomiting, pallor, central nervous system disturbances and muscle rigidity have been reported with the use of tropicamide.\"\n }\n ]\n },\n {\n \"Term\": \"Photophobia\",\n \"MEDDRACode\": \"10034960\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"photophobia\",\n \"Probability\": \"0.8327803612\",\n \"SemanticContext\": \"ADVERSE REACTIONS Ocular: Transient stinging, blurred vision, photophobia and superficial punctate keratitis have been reported with the use of tropicamide.\"\n }\n ]\n },\n {\n \"Term\": \"Discomfort\",\n \"MEDDRACode\": \"10013082\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"pressure\",\n \"Probability\": \"0.1218765974\",\n \"SemanticContext\": \"PRECAUTIONS General: The lacrimal sac should be compressed by digital pressure for two to three minutes after instillation to reduce excessive systemic absorption.\"\n }\n ]\n },\n {\n \"Term\": \"Exercise adequate\",\n \"MEDDRACode\": \"10015636\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"exercised\",\n \"Probability\": \"7.0633E-06\",\n \"SemanticContext\": \"Because many drugs are excreted in human milk, caution should be exercised when tropicamide is administered to a nursing woman.\"\n }\n ]\n },\n {\n \"Term\": \"Injection\",\n \"MEDDRACode\": \"10052995\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"injection\",\n \"Probability\": \"3.75551E-05\",\n \"SemanticContext\": \"Not for injection.\"\n }\n ]\n },\n {\n \"Term\": \"Blood sodium\",\n \"MEDDRACode\": \"10005799\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0005091587\",\n \"SemanticContext\": \"Inactives: sodium chloride, edetate disodium, hydrochloric acid and/or sodium hydroxide to adjust pH , purified water.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"8.23536E-05\",\n \"SemanticContext\": \"Inactives: sodium chloride, edetate disodium, hydrochloric acid and/or sodium hydroxide to adjust pH , purified water.\"\n }\n ]\n },\n {\n \"Term\": \"Psychotic disorder\",\n \"MEDDRACode\": \"10061920\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Psychotic\",\n \"Probability\": \"0.0286814421\",\n \"SemanticContext\": \"Psychotic reactions, behavioral disturbances, and vasomotor or cardio-respiratory collapse in children have been reported with the use of anticholinergic drugs.\"\n },\n {\n \"VerbatimTerm\": \"Psychotic\",\n \"Probability\": \"0.0221884809\",\n \"SemanticContext\": \"Psychotic reactions, behavioral disturbances, and vasomotor or cardiorespiratory collapse in children have been reported with the use of anticholinergic drugs See WARNINGS .\"\n },\n {\n \"VerbatimTerm\": \"psychotic\",\n \"Probability\": \"0.0330839343\",\n \"SemanticContext\": \"The possibility of psychotic reactions and behavioral disturbances due to hypersensitivity to anticholinergic drugs should be considered.\"\n }\n ]\n },\n {\n \"Term\": \"Intraocular pressure test\",\n \"MEDDRACode\": \"10060950\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"intraocular pressure\",\n \"Probability\": \"7.61626E-05\",\n \"SemanticContext\": \"Mydriatics may produce a transient elevation of intraocular pressure.\"\n }\n ]\n },\n {\n \"Term\": \"Congenital nephrotic syndrome\",\n \"MEDDRACode\": \"10060737\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"CNS\",\n \"Probability\": \"0.0230494905\",\n \"SemanticContext\": \"This preparation may cause CNS disturbances which may be dangerous in pediatric patients.\"\n },\n {\n \"VerbatimTerm\": \"CNS\",\n \"Probability\": \"0.0125093395\",\n \"SemanticContext\": \"Pediatric Use: Tropicamide may rarely cause CNS disturbances which may be dangerous in pediatric patients.\"\n }\n ]\n },\n {\n \"Term\": \"Drug interaction\",\n \"MEDDRACode\": \"10013710\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Drug Interactions\",\n \"Probability\": \"0.0011895768\",\n \"SemanticContext\": \"Drug Interactions: Tropicamide may interfere with the antihypertensive action of carbachol, pilocarpine, or ophthalmic cholinesterase inhibitors.\"\n }\n ]\n },\n {\n \"Term\": \"Elderly\",\n \"MEDDRACode\": \"10014348\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"elderly\",\n \"Probability\": \"0.0005791426\",\n \"SemanticContext\": \"Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly and younger patients.\"\n }\n ]\n }\n ],\n \"IndicationTerms\": []\n }\n ]\n },\n {\n \"GenericName\": \"glycopyrrolate\",\n \"MeddraVersion\": \"24.0\",\n \"Labels\": [\n {\n \"Id\": \"USb823ebc2-d57c-4efb-b787-623253c4be39\",\n \"NDCCode\": \"71288-414\",\n \"UpdatedDate\": \"Jul 10, 2021\",\n \"LabelSource\": {\n \"Country\": \"us\",\n \"ProductId\": \"02541cfd-b209-49b9-a73f-13ef18dce06d\",\n \"FileId\": \"b823ebc2-d57c-4efb-b787-623253c4be39\",\n \"Version\": \"4\"\n },\n \"AdverseEventTerms\": [\n {\n \"Term\": \"Abdominal distension\",\n \"MEDDRACode\": \"10000060\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"bloated feeling\",\n \"Probability\": \"0.9798291922\",\n \"SemanticContext\": \"Adverse reactions may include xerostomia dry mouth ; urinary hesitancy and retention; blurred vision and photophobia due to mydriasis dilation of the pupil ; cycloplegia; increased ocular tension; tachycardia; palpitation; decreased sweating; loss of taste; headache; nervousness; drowsiness; weakness; dizziness; insomnia; nausea; vomiting; impotence; suppression of lactation; constipation; bloated feeling; severe allergic reactions including anaphylactic/anaphylactoid reactions; hypersensitivity; urticaria, pruritus, dry skin, and other dermal manifestations; some degree of mental confusion and/or excitement, especially in elderly persons.\"\n }\n ]\n },\n {\n \"Term\": \"Dry skin\",\n \"MEDDRACode\": \"10013786\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"dry skin\",\n \"Probability\": \"0.8716669083\",\n \"SemanticContext\": \"Adverse reactions may include xerostomia dry mouth ; urinary hesitancy and retention; blurred vision and photophobia due to mydriasis dilation of the pupil ; cycloplegia; increased ocular tension; tachycardia; palpitation; decreased sweating; loss of taste; headache; nervousness; drowsiness; weakness; dizziness; insomnia; nausea; vomiting; impotence; suppression of lactation; constipation; bloated feeling; severe allergic reactions including anaphylactic/anaphylactoid reactions; hypersensitivity; urticaria, pruritus, dry skin, and other dermal manifestations; some degree of mental confusion and/or excitement, especially in elderly persons.\"\n }\n ]\n },\n {\n \"Term\": \"Atrioventricular block\",\n \"MEDDRACode\": \"10003671\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"heart block\",\n \"Probability\": \"0.0236064196\",\n \"SemanticContext\": \"Post-marketing reports have included cases of heart block and QTc interval prolongation associated with the combined use of glycopyrrolate and an anticholinesterase.\"\n }\n ]\n },\n {\n \"Term\": \"Confusional state\",\n \"MEDDRACode\": \"10010305\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"mental confusion\",\n \"Probability\": \"0.3334090114\",\n \"SemanticContext\": \"Adverse reactions may include xerostomia dry mouth ; urinary hesitancy and retention; blurred vision and photophobia due to mydriasis dilation of the pupil ; cycloplegia; increased ocular tension; tachycardia; palpitation; decreased sweating; loss of taste; headache; nervousness; drowsiness; weakness; dizziness; insomnia; nausea; vomiting; impotence; suppression of lactation; constipation; bloated feeling; severe allergic reactions including anaphylactic/anaphylactoid reactions; hypersensitivity; urticaria, pruritus, dry skin, and other dermal manifestations; some degree of mental confusion and/or excitement, especially in elderly persons.\"\n }\n ]\n },\n {\n \"Term\": \"Anaphylactoid reaction\",\n \"MEDDRACode\": \"10002216\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"anaphylactoid reactions\",\n \"Probability\": \"0.8956189752\",\n \"SemanticContext\": \"Adverse reactions may include xerostomia dry mouth ; urinary hesitancy and retention; blurred vision and photophobia due to mydriasis dilation of the pupil ; cycloplegia; increased ocular tension; tachycardia; palpitation; decreased sweating; loss of taste; headache; nervousness; drowsiness; weakness; dizziness; insomnia; nausea; vomiting; impotence; suppression of lactation; constipation; bloated feeling; severe allergic reactions including anaphylactic/anaphylactoid reactions; hypersensitivity; urticaria, pruritus, dry skin, and other dermal manifestations; some degree of mental confusion and/or excitement, especially in elderly persons.\"\n }\n ]\n },\n {\n \"Term\": \"Cycloplegia\",\n \"MEDDRACode\": \"10011719\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"cycloplegia\",\n \"Probability\": \"0.9703940153\",\n \"SemanticContext\": \"Adverse reactions may include xerostomia dry mouth ; urinary hesitancy and retention; blurred vision and photophobia due to mydriasis dilation of the pupil ; cycloplegia; increased ocular tension; tachycardia; palpitation; decreased sweating; loss of taste; headache; nervousness; drowsiness; weakness; dizziness; insomnia; nausea; vomiting; impotence; suppression of lactation; constipation; bloated feeling; severe allergic reactions including anaphylactic/anaphylactoid reactions; hypersensitivity; urticaria, pruritus, dry skin, and other dermal manifestations; some degree of mental confusion and/or excitement, especially in elderly persons.\"\n }\n ]\n },\n {\n \"Term\": \"Dry mouth\",\n \"MEDDRACode\": \"10013781\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"dry mouth\",\n \"Probability\": \"0.9994138479\",\n \"SemanticContext\": \"Adverse reactions may include xerostomia dry mouth ; urinary hesitancy and retention; blurred vision and photophobia due to mydriasis dilation of the pupil ; cycloplegia; increased ocular tension; tachycardia; palpitation; decreased sweating; loss of taste; headache; nervousness; drowsiness; weakness; dizziness; insomnia; nausea; vomiting; impotence; suppression of lactation; constipation; bloated feeling; severe allergic reactions including anaphylactic/anaphylactoid reactions; hypersensitivity; urticaria, pruritus, dry skin, and other dermal manifestations; some degree of mental confusion and/or excitement, especially in elderly persons.\"\n }\n ]\n },\n {\n \"Term\": \"Headache\",\n \"MEDDRACode\": \"10019211\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"headache\",\n \"Probability\": \"0.9962521791\",\n \"SemanticContext\": \"Adverse reactions may include xerostomia dry mouth ; urinary hesitancy and retention; blurred vision and photophobia due to mydriasis dilation of the pupil ; cycloplegia; increased ocular tension; tachycardia; palpitation; decreased sweating; loss of taste; headache; nervousness; drowsiness; weakness; dizziness; insomnia; nausea; vomiting; impotence; suppression of lactation; constipation; bloated feeling; severe allergic reactions including anaphylactic/anaphylactoid reactions; hypersensitivity; urticaria, pruritus, dry skin, and other dermal manifestations; some degree of mental confusion and/or excitement, especially in elderly persons.\"\n }\n ]\n },\n {\n \"Term\": \"Ageusia\",\n \"MEDDRACode\": \"10001480\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"loss of taste\",\n \"Probability\": \"0.9767450094\",\n \"SemanticContext\": \"Adverse reactions may include xerostomia dry mouth ; urinary hesitancy and retention; blurred vision and photophobia due to mydriasis dilation of the pupil ; cycloplegia; increased ocular tension; tachycardia; palpitation; decreased sweating; loss of taste; headache; nervousness; drowsiness; weakness; dizziness; insomnia; nausea; vomiting; impotence; suppression of lactation; constipation; bloated feeling; severe allergic reactions including anaphylactic/anaphylactoid reactions; hypersensitivity; urticaria, pruritus, dry skin, and other dermal manifestations; some degree of mental confusion and/or excitement, especially in elderly persons.\"\n }\n ]\n },\n {\n \"Term\": \"Cardiac arrest\",\n \"MEDDRACode\": \"10007515\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"cardiac arrest\",\n \"Probability\": \"0.9988723993\",\n \"SemanticContext\": \"In addition, the following adverse events have been reported from post-marketing experience with glycopyrrolate: malignant hyperthermia; cardiac arrhythmias including bradycardia, ventricular tachycardia, ventricular fibrillation ; cardiac arrest; hypertension; hypotension; seizures; and respiratory arrest.\"\n }\n ]\n },\n {\n \"Term\": \"Hyperthermia malignant\",\n \"MEDDRACode\": \"10020844\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"malignant hyperthermia\",\n \"Probability\": \"0.8419152498\",\n \"SemanticContext\": \"In addition, the following adverse events have been reported from post-marketing experience with glycopyrrolate: malignant hyperthermia; cardiac arrhythmias including bradycardia, ventricular tachycardia, ventricular fibrillation ; cardiac arrest; hypertension; hypotension; seizures; and respiratory arrest.\"\n }\n ]\n },\n {\n \"Term\": \"Erectile dysfunction\",\n \"MEDDRACode\": \"10061461\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"impotence\",\n \"Probability\": \"0.9871602058\",\n \"SemanticContext\": \"Adverse reactions may include xerostomia dry mouth ; urinary hesitancy and retention; blurred vision and photophobia due to mydriasis dilation of the pupil ; cycloplegia; increased ocular tension; tachycardia; palpitation; decreased sweating; loss of taste; headache; nervousness; drowsiness; weakness; dizziness; insomnia; nausea; vomiting; impotence; suppression of lactation; constipation; bloated feeling; severe allergic reactions including anaphylactic/anaphylactoid reactions; hypersensitivity; urticaria, pruritus, dry skin, and other dermal manifestations; some degree of mental confusion and/or excitement, especially in elderly persons.\"\n }\n ]\n },\n {\n \"Term\": \"Mydriasis\",\n \"MEDDRACode\": \"10028521\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"mydriasis\",\n \"Probability\": \"0.9744223356\",\n \"SemanticContext\": \"Adverse reactions may include xerostomia dry mouth ; urinary hesitancy and retention; blurred vision and photophobia due to mydriasis dilation of the pupil ; cycloplegia; increased ocular tension; tachycardia; palpitation; decreased sweating; loss of taste; headache; nervousness; drowsiness; weakness; dizziness; insomnia; nausea; vomiting; impotence; suppression of lactation; constipation; bloated feeling; severe allergic reactions including anaphylactic/anaphylactoid reactions; hypersensitivity; urticaria, pruritus, dry skin, and other dermal manifestations; some degree of mental confusion and/or excitement, especially in elderly persons.\"\n }\n ]\n },\n {\n \"Term\": \"Nausea\",\n \"MEDDRACode\": \"10028813\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"nausea\",\n \"Probability\": \"0.9975378513\",\n \"SemanticContext\": \"Adverse reactions may include xerostomia dry mouth ; urinary hesitancy and retention; blurred vision and photophobia due to mydriasis dilation of the pupil ; cycloplegia; increased ocular tension; tachycardia; palpitation; decreased sweating; loss of taste; headache; nervousness; drowsiness; weakness; dizziness; insomnia; nausea; vomiting; impotence; suppression of lactation; constipation; bloated feeling; severe allergic reactions including anaphylactic/anaphylactoid reactions; hypersensitivity; urticaria, pruritus, dry skin, and other dermal manifestations; some degree of mental confusion and/or excitement, especially in elderly persons.\"\n }\n ]\n },\n {\n \"Term\": \"Palpitations\",\n \"MEDDRACode\": \"10033557\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"palpitation\",\n \"Probability\": \"0.9978880286\",\n \"SemanticContext\": \"Adverse reactions may include xerostomia dry mouth ; urinary hesitancy and retention; blurred vision and photophobia due to mydriasis dilation of the pupil ; cycloplegia; increased ocular tension; tachycardia; palpitation; decreased sweating; loss of taste; headache; nervousness; drowsiness; weakness; dizziness; insomnia; nausea; vomiting; impotence; suppression of lactation; constipation; bloated feeling; severe allergic reactions including anaphylactic/anaphylactoid reactions; hypersensitivity; urticaria, pruritus, dry skin, and other dermal manifestations; some degree of mental confusion and/or excitement, especially in elderly persons.\"\n }\n ]\n },\n {\n \"Term\": \"Agitation\",\n \"MEDDRACode\": \"10001497\",\n \"Overdose\": true,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hyperexcitability\",\n \"Probability\": \"0.4651350975\",\n \"SemanticContext\": \"A paradoxical reaction characterized by hyperexcitability may occur in pediatric patients taking large doses of anticholinergics including glycopyrrolate injection.\"\n },\n {\n \"VerbatimTerm\": \"hyperexcitability\",\n \"Probability\": \"0.4651350975\",\n \"SemanticContext\": \"A paradoxical reaction characterized by hyperexcitability may occur in pediatric patients taking large doses of anticholinergics including glycopyrrolate injection.\"\n }\n ]\n },\n {\n \"Term\": \"Injection site reaction\",\n \"MEDDRACode\": \"10022095\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Injection site reactions\",\n \"Probability\": \"0.8718348742\",\n \"SemanticContext\": \"Injection site reactions including pruritus, edema, erythema, and pain have also been reported.\"\n }\n ]\n },\n {\n \"Term\": \"Insomnia\",\n \"MEDDRACode\": \"10022437\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"insomnia\",\n \"Probability\": \"0.9660773277\",\n \"SemanticContext\": \"Adverse reactions may include xerostomia dry mouth ; urinary hesitancy and retention; blurred vision and photophobia due to mydriasis dilation of the pupil ; cycloplegia; increased ocular tension; tachycardia; palpitation; decreased sweating; loss of taste; headache; nervousness; drowsiness; weakness; dizziness; insomnia; nausea; vomiting; impotence; suppression of lactation; constipation; bloated feeling; severe allergic reactions including anaphylactic/anaphylactoid reactions; hypersensitivity; urticaria, pruritus, dry skin, and other dermal manifestations; some degree of mental confusion and/or excitement, especially in elderly persons.\"\n }\n ]\n },\n {\n \"Term\": \"Oedema\",\n \"MEDDRACode\": \"10030095\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"edema\",\n \"Probability\": \"0.4129323363\",\n \"SemanticContext\": \"Injection site reactions including pruritus, edema, erythema, and pain have also been reported.\"\n }\n ]\n },\n {\n \"Term\": \"Hypotension\",\n \"MEDDRACode\": \"10021097\",\n \"Overdose\": true,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hypotension\",\n \"Probability\": \"0.9988083839\",\n \"SemanticContext\": \"In addition, the following adverse events have been reported from post-marketing experience with glycopyrrolate: malignant hyperthermia; cardiac arrhythmias including bradycardia, ventricular tachycardia, ventricular fibrillation ; cardiac arrest; hypertension; hypotension; seizures; and respiratory arrest.\"\n },\n {\n \"VerbatimTerm\": \"hypotension\",\n \"Probability\": \"0.02185148\",\n \"SemanticContext\": \"To combat hypotension, administer IV fluids and/or pressor agents along with supportive care.\"\n },\n {\n \"VerbatimTerm\": \"hypotension\",\n \"Probability\": \"0.202827394\",\n \"SemanticContext\": \"Exposure to excessive amounts of benzyl alcohol has been associated with toxicity hypotension, metabolic acidosis , particularly in neonates, and an increased incidence of kernicterus, particularly in small preterm infants.\"\n },\n {\n \"VerbatimTerm\": \"hypotension\",\n \"Probability\": \"0.9339661002\",\n \"SemanticContext\": \"Additional symptoms may include gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse.\"\n },\n {\n \"VerbatimTerm\": \"hypotension\",\n \"Probability\": \"0.9339661002\",\n \"SemanticContext\": \"Additional symptoms may include gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse.\"\n }\n ]\n },\n {\n \"Term\": \"Seizure\",\n \"MEDDRACode\": \"10039906\",\n \"Overdose\": true,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"seizures\",\n \"Probability\": \"0.9960566163\",\n \"SemanticContext\": \"In addition, the following adverse events have been reported from post-marketing experience with glycopyrrolate: malignant hyperthermia; cardiac arrhythmias including bradycardia, ventricular tachycardia, ventricular fibrillation ; cardiac arrest; hypertension; hypotension; seizures; and respiratory arrest.\"\n },\n {\n \"VerbatimTerm\": \"seizures\",\n \"Probability\": \"0.9485216141\",\n \"SemanticContext\": \"Additional symptoms may include gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse.\"\n },\n {\n \"VerbatimTerm\": \"seizures\",\n \"Probability\": \"0.9485216141\",\n \"SemanticContext\": \"Additional symptoms may include gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse.\"\n }\n ]\n },\n {\n \"Term\": \"Pruritus\",\n \"MEDDRACode\": \"10037087\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"pruritus\",\n \"Probability\": \"0.9708908796\",\n \"SemanticContext\": \"Adverse reactions may include xerostomia dry mouth ; urinary hesitancy and retention; blurred vision and photophobia due to mydriasis dilation of the pupil ; cycloplegia; increased ocular tension; tachycardia; palpitation; decreased sweating; loss of taste; headache; nervousness; drowsiness; weakness; dizziness; insomnia; nausea; vomiting; impotence; suppression of lactation; constipation; bloated feeling; severe allergic reactions including anaphylactic/anaphylactoid reactions; hypersensitivity; urticaria, pruritus, dry skin, and other dermal manifestations; some degree of mental confusion and/or excitement, especially in elderly persons.\"\n },\n {\n \"VerbatimTerm\": \"pruritus\",\n \"Probability\": \"0.6501894593\",\n \"SemanticContext\": \"Injection site reactions including pruritus, edema, erythema, and pain have also been reported.\"\n }\n ]\n },\n {\n \"Term\": \"Bronchospasm\",\n \"MEDDRACode\": \"10006482\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"bronchospasm\",\n \"Probability\": \"0.8803418875\",\n \"SemanticContext\": \"Glycopyrrolate antagonizes muscarinic symptoms e.g., bronchorrhea, bronchospasm, bradycardia, and intestinal hypermotility induced by cholinergic drugs such as the anticholinesterases.\"\n }\n ]\n },\n {\n \"Term\": \"Pain\",\n \"MEDDRACode\": \"10033371\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"pain\",\n \"Probability\": \"0.0327010453\",\n \"SemanticContext\": \"Injection site reactions including pruritus, edema, erythema, and pain have also been reported.\"\n }\n ]\n },\n {\n \"Term\": \"Urticaria\",\n \"MEDDRACode\": \"10046735\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"urticaria\",\n \"Probability\": \"0.9846569896\",\n \"SemanticContext\": \"Adverse reactions may include xerostomia dry mouth ; urinary hesitancy and retention; blurred vision and photophobia due to mydriasis dilation of the pupil ; cycloplegia; increased ocular tension; tachycardia; palpitation; decreased sweating; loss of taste; headache; nervousness; drowsiness; weakness; dizziness; insomnia; nausea; vomiting; impotence; suppression of lactation; constipation; bloated feeling; severe allergic reactions including anaphylactic/anaphylactoid reactions; hypersensitivity; urticaria, pruritus, dry skin, and other dermal manifestations; some degree of mental confusion and/or excitement, especially in elderly persons.\"\n }\n ]\n },\n {\n \"Term\": \"Hypertension\",\n \"MEDDRACode\": \"10020772\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hypertension\",\n \"Probability\": \"0.99811095\",\n \"SemanticContext\": \"In addition, the following adverse events have been reported from post-marketing experience with glycopyrrolate: malignant hyperthermia; cardiac arrhythmias including bradycardia, ventricular tachycardia, ventricular fibrillation ; cardiac arrest; hypertension; hypotension; seizures; and respiratory arrest.\"\n },\n {\n \"VerbatimTerm\": \"hypertension\",\n \"Probability\": \"0.0240854025\",\n \"SemanticContext\": \"Use with caution in patients with: coronary artery disease; congestive heart failure; cardiac arrhythmias; hypertension; hyperthyroidism.\"\n }\n ]\n },\n {\n \"Term\": \"Hypohidrosis\",\n \"MEDDRACode\": \"10021013\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"decreased sweating\",\n \"Probability\": \"0.9976541996\",\n \"SemanticContext\": \"Adverse reactions may include xerostomia dry mouth ; urinary hesitancy and retention; blurred vision and photophobia due to mydriasis dilation of the pupil ; cycloplegia; increased ocular tension; tachycardia; palpitation; decreased sweating; loss of taste; headache; nervousness; drowsiness; weakness; dizziness; insomnia; nausea; vomiting; impotence; suppression of lactation; constipation; bloated feeling; severe allergic reactions including anaphylactic/anaphylactoid reactions; hypersensitivity; urticaria, pruritus, dry skin, and other dermal manifestations; some degree of mental confusion and/or excitement, especially in elderly persons.\"\n },\n {\n \"VerbatimTerm\": \"decreased sweating\",\n \"Probability\": \"0.0758095682\",\n \"SemanticContext\": \"In addition, in the presence of fever, high environmental temperature and/or during physical exercise, heat prostration can occur with use of anticholinergic agents including glycopyrrolate due to decreased sweating , particularly in children and the elderly.\"\n }\n ]\n },\n {\n \"Term\": \"Vision blurred\",\n \"MEDDRACode\": \"10047513\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"blurred vision\",\n \"Probability\": \"0.9970407486\",\n \"SemanticContext\": \"Adverse reactions may include xerostomia dry mouth ; urinary hesitancy and retention; blurred vision and photophobia due to mydriasis dilation of the pupil ; cycloplegia; increased ocular tension; tachycardia; palpitation; decreased sweating; loss of taste; headache; nervousness; drowsiness; weakness; dizziness; insomnia; nausea; vomiting; impotence; suppression of lactation; constipation; bloated feeling; severe allergic reactions including anaphylactic/anaphylactoid reactions; hypersensitivity; urticaria, pruritus, dry skin, and other dermal manifestations; some degree of mental confusion and/or excitement, especially in elderly persons.\"\n },\n {\n \"VerbatimTerm\": \"blurred vision\",\n \"Probability\": \"0.0056580901\",\n \"SemanticContext\": \"Information for the Patient Because glycopyrrolate injection may produce drowsiness or blurred vision, the patient should be cautioned not to engage in activities requiring mental alertness and/or visual acuity such as operating a motor vehicle or other machinery, or performing hazardous work while taking this drug see WARNINGS .\"\n },\n {\n \"VerbatimTerm\": \"blurred vision\",\n \"Probability\": \"0.0234022141\",\n \"SemanticContext\": \"Glycopyrrolate injection may produce drowsiness or blurred vision.\"\n },\n {\n \"VerbatimTerm\": \"blurred vision\",\n \"Probability\": \"0.0056580901\",\n \"SemanticContext\": \"Information for the Patient Because glycopyrrolate injection may produce drowsiness or blurred vision, the patient should be cautioned not to engage in activities requiring mental alertness and/or visual acuity such as operating a motor vehicle or other machinery, or performing hazardous work while taking this drug see WARNINGS .\"\n }\n ]\n },\n {\n \"Term\": \"Congenital nephrotic syndrome\",\n \"MEDDRACode\": \"10060737\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"CNS\",\n \"Probability\": \"0.059417665\",\n \"SemanticContext\": \"For this reason the occurrence of CNS-related side effects is lower, in comparison to their incidence following administration of anticholinergics which are chemically tertiary amines that can cross this barrier readily.\"\n },\n {\n \"VerbatimTerm\": \"CNS\",\n \"Probability\": \"0.0202596486\",\n \"SemanticContext\": \"If CNS symptoms e.g., excitement, restlessness, convulsions, psychotic behavior occur, physostigmine which does cross the blood--brain barrier may be used.\"\n }\n ]\n },\n {\n \"Term\": \"Arrhythmia\",\n \"MEDDRACode\": \"10003119\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"cardiac arrhythmias\",\n \"Probability\": \"0.9893879294\",\n \"SemanticContext\": \"In addition, the following adverse events have been reported from post-marketing experience with glycopyrrolate: malignant hyperthermia; cardiac arrhythmias including bradycardia, ventricular tachycardia, ventricular fibrillation ; cardiac arrest; hypertension; hypotension; seizures; and respiratory arrest.\"\n },\n {\n \"VerbatimTerm\": \"cardiac arrhythmias\",\n \"Probability\": \"0.0095223188\",\n \"SemanticContext\": \"Use with caution in patients with: coronary artery disease; congestive heart failure; cardiac arrhythmias; hypertension; hyperthyroidism.\"\n }\n ]\n },\n {\n \"Term\": \"Blood chloride\",\n \"MEDDRACode\": \"10005416\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"chloride\",\n \"Probability\": \"1.32183E-05\",\n \"SemanticContext\": \"Concomitant administration of glycopyrrolate injection and potassium chloride in a wax matrix may increase the severity of potassium chloride-induced gastrointestinal lesions as a result of a slower gastrointestinal transit time.\"\n },\n {\n \"VerbatimTerm\": \"chloride\",\n \"Probability\": \"0.0003254414\",\n \"SemanticContext\": \"Concomitant administration of glycopyrrolate injection and potassium chloride in a wax matrix may increase the severity of potassium chloride-induced gastrointestinal lesions as a result of a slower gastrointestinal transit time.\"\n },\n {\n \"VerbatimTerm\": \"chloride\",\n \"Probability\": \"0.0102356076\",\n \"SemanticContext\": \"Diluent Compatibilities Dextrose 5% and 10% in water, or saline, dextrose 5% in sodium chloride 0.45%, sodium chloride 0.9%, and Ringer's Injection.\"\n },\n {\n \"VerbatimTerm\": \"chloride\",\n \"Probability\": \"0.0219759047\",\n \"SemanticContext\": \"Diluent Compatibilities Dextrose 5% and 10% in water, or saline, dextrose 5% in sodium chloride 0.45%, sodium chloride 0.9%, and Ringer's Injection.\"\n },\n {\n \"VerbatimTerm\": \"chloride\",\n \"Probability\": \"1.32183E-05\",\n \"SemanticContext\": \"Concomitant administration of glycopyrrolate injection and potassium chloride in a wax matrix may increase the severity of potassium chloride-induced gastrointestinal lesions as a result of a slower gastrointestinal transit time.\"\n },\n {\n \"VerbatimTerm\": \"chloride\",\n \"Probability\": \"0.0003254414\",\n \"SemanticContext\": \"Concomitant administration of glycopyrrolate injection and potassium chloride in a wax matrix may increase the severity of potassium chloride-induced gastrointestinal lesions as a result of a slower gastrointestinal transit time.\"\n }\n ]\n },\n {\n \"Term\": \"Tachycardia\",\n \"MEDDRACode\": \"10043071\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"tachycardia\",\n \"Probability\": \"0.9961069226\",\n \"SemanticContext\": \"Adverse reactions may include xerostomia dry mouth ; urinary hesitancy and retention; blurred vision and photophobia due to mydriasis dilation of the pupil ; cycloplegia; increased ocular tension; tachycardia; palpitation; decreased sweating; loss of taste; headache; nervousness; drowsiness; weakness; dizziness; insomnia; nausea; vomiting; impotence; suppression of lactation; constipation; bloated feeling; severe allergic reactions including anaphylactic/anaphylactoid reactions; hypersensitivity; urticaria, pruritus, dry skin, and other dermal manifestations; some degree of mental confusion and/or excitement, especially in elderly persons.\"\n },\n {\n \"VerbatimTerm\": \"tachycardia\",\n \"Probability\": \"0.0018488169\",\n \"SemanticContext\": \"PRECAUTIONS General Investigate any tachycardia before giving glycopyrrolate injection since an increase in the heart rate may occur.\"\n }\n ]\n },\n {\n \"Term\": \"Constipation\",\n \"MEDDRACode\": \"10010774\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"constipation\",\n \"Probability\": \"0.9888880253\",\n \"SemanticContext\": \"Adverse reactions may include xerostomia dry mouth ; urinary hesitancy and retention; blurred vision and photophobia due to mydriasis dilation of the pupil ; cycloplegia; increased ocular tension; tachycardia; palpitation; decreased sweating; loss of taste; headache; nervousness; drowsiness; weakness; dizziness; insomnia; nausea; vomiting; impotence; suppression of lactation; constipation; bloated feeling; severe allergic reactions including anaphylactic/anaphylactoid reactions; hypersensitivity; urticaria, pruritus, dry skin, and other dermal manifestations; some degree of mental confusion and/or excitement, especially in elderly persons.\"\n }\n ]\n },\n {\n \"Term\": \"Respiratory arrest\",\n \"MEDDRACode\": \"10038669\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"respiratory arrest\",\n \"Probability\": \"0.9968597889\",\n \"SemanticContext\": \"In addition, the following adverse events have been reported from post-marketing experience with glycopyrrolate: malignant hyperthermia; cardiac arrhythmias including bradycardia, ventricular tachycardia, ventricular fibrillation ; cardiac arrest; hypertension; hypotension; seizures; and respiratory arrest.\"\n }\n ]\n },\n {\n \"Term\": \"Oesophageal achalasia\",\n \"MEDDRACode\": \"10030136\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": true,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"achalasia\",\n \"Probability\": \"0.8338642716\",\n \"SemanticContext\": \"In addition, in the management of peptic ulcer patients, because of the longer duration of therapy, glycopyrrolate injection may be contraindicated in patients with the following concurrent conditions: glaucoma; obstructive uropathy for example, bladder neck obstruction due to prostatic hypertrophy ; obstructive disease of the gastrointestinal tract as in achalasia, pyloroduodenal stenosis, etc. ; paralytic ileus, intestinal atony of the elderly or debilitated patient; unstable cardiovascular status in acute hemorrhage; severe ulcerative colitis; toxic megacolon complicating ulcerative colitis; myasthenia gravis.\"\n }\n ]\n },\n {\n \"Term\": \"Urinary tract obstruction\",\n \"MEDDRACode\": \"10061574\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": true,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"obstructive uropathy\",\n \"Probability\": \"0.5022221208\",\n \"SemanticContext\": \"In addition, in the management of peptic ulcer patients, because of the longer duration of therapy, glycopyrrolate injection may be contraindicated in patients with the following concurrent conditions: glaucoma; obstructive uropathy for example, bladder neck obstruction due to prostatic hypertrophy ; obstructive disease of the gastrointestinal tract as in achalasia, pyloroduodenal stenosis, etc. ; paralytic ileus, intestinal atony of the elderly or debilitated patient; unstable cardiovascular status in acute hemorrhage; severe ulcerative colitis; toxic megacolon complicating ulcerative colitis; myasthenia gravis.\"\n }\n ]\n },\n {\n \"Term\": \"Elderly\",\n \"MEDDRACode\": \"10014348\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": true,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": true\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"elderly\",\n \"Probability\": \"0.0269657671\",\n \"SemanticContext\": \"Adverse reactions may include xerostomia dry mouth ; urinary hesitancy and retention; blurred vision and photophobia due to mydriasis dilation of the pupil ; cycloplegia; increased ocular tension; tachycardia; palpitation; decreased sweating; loss of taste; headache; nervousness; drowsiness; weakness; dizziness; insomnia; nausea; vomiting; impotence; suppression of lactation; constipation; bloated feeling; severe allergic reactions including anaphylactic/anaphylactoid reactions; hypersensitivity; urticaria, pruritus, dry skin, and other dermal manifestations; some degree of mental confusion and/or excitement, especially in elderly persons.\"\n },\n {\n \"VerbatimTerm\": \"elderly\",\n \"Probability\": \"0.0876133144\",\n \"SemanticContext\": \"In addition, in the management of peptic ulcer patients, because of the longer duration of therapy, glycopyrrolate injection may be contraindicated in patients with the following concurrent conditions: glaucoma; obstructive uropathy for example, bladder neck obstruction due to prostatic hypertrophy ; obstructive disease of the gastrointestinal tract as in achalasia, pyloroduodenal stenosis, etc. ; paralytic ileus, intestinal atony of the elderly or debilitated patient; unstable cardiovascular status in acute hemorrhage; severe ulcerative colitis; toxic megacolon complicating ulcerative colitis; myasthenia gravis.\"\n },\n {\n \"VerbatimTerm\": \"elderly\",\n \"Probability\": \"0.0008308887\",\n \"SemanticContext\": \"In addition, in the presence of fever, high environmental temperature and/or during physical exercise, heat prostration can occur with use of anticholinergic agents including glycopyrrolate due to decreased sweating , particularly in children and the elderly.\"\n },\n {\n \"VerbatimTerm\": \"elderly\",\n \"Probability\": \"6.75527E-05\",\n \"SemanticContext\": \"Use glycopyrrolate with caution in the elderly and in all patients with autonomic neuropathy, hepatic disease, ulcerative colitis, prostic hypertrophy, or hiatal hernia, since anticholinergic drugs may aggravate these conditions.\"\n },\n {\n \"VerbatimTerm\": \"elderly\",\n \"Probability\": \"0.0003799498\",\n \"SemanticContext\": \"Other reported clinical experience has not identified differences in responses between the elderly and younger patients.\"\n },\n {\n \"VerbatimTerm\": \"elderly\",\n \"Probability\": \"4.0322E-05\",\n \"SemanticContext\": \"In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other therapy.\"\n },\n {\n \"VerbatimTerm\": \"elderly\",\n \"Probability\": \"0.0003799498\",\n \"SemanticContext\": \"Other reported clinical experience has not identified differences in responses between the elderly and younger patients.\"\n },\n {\n \"VerbatimTerm\": \"elderly\",\n \"Probability\": \"4.0322E-05\",\n \"SemanticContext\": \"In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other therapy.\"\n }\n ]\n },\n {\n \"Term\": \"Peptic ulcer\",\n \"MEDDRACode\": \"10034341\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": true,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"peptic ulcer\",\n \"Probability\": \"0.0012613535\",\n \"SemanticContext\": \"In addition, in the management of peptic ulcer patients, because of the longer duration of therapy, glycopyrrolate injection may be contraindicated in patients with the following concurrent conditions: glaucoma; obstructive uropathy for example, bladder neck obstruction due to prostatic hypertrophy ; obstructive disease of the gastrointestinal tract as in achalasia, pyloroduodenal stenosis, etc. ; paralytic ileus, intestinal atony of the elderly or debilitated patient; unstable cardiovascular status in acute hemorrhage; severe ulcerative colitis; toxic megacolon complicating ulcerative colitis; myasthenia gravis.\"\n },\n {\n \"VerbatimTerm\": \"peptic ulcer\",\n \"Probability\": \"0.0064238906\",\n \"SemanticContext\": \"Glycopyrrolate injection is not recommended for the treatment of peptic ulcer in pediatric patients see PRECAUTIONS, Pediatric Use .\"\n },\n {\n \"VerbatimTerm\": \"peptic ulcer\",\n \"Probability\": \"0.0308408439\",\n \"SemanticContext\": \"PEPTIC ULCER Glycopyrrolate injection is not recommended for the treatment of peptic ulcer in pediatric patients see PRECAUTIONS, Pediatric Use .\"\n },\n {\n \"VerbatimTerm\": \"peptic ulcer\",\n \"Probability\": \"0.0021929443\",\n \"SemanticContext\": \"In Peptic Ulcer For use in adults as adjunctive therapy for the treatment of peptic ulcer when rapid anticholinergic effect is desired or when oral medication is not tolerated.\"\n },\n {\n \"VerbatimTerm\": \"peptic ulcer\",\n \"Probability\": \"0.0040938854\",\n \"SemanticContext\": \"Safety and effectiveness in pediatric patients have not been established for the management of peptic ulcer.\"\n },\n {\n \"VerbatimTerm\": \"peptic ulcer\",\n \"Probability\": \"0.0040938854\",\n \"SemanticContext\": \"Safety and effectiveness in pediatric patients have not been established for the management of peptic ulcer.\"\n },\n {\n \"VerbatimTerm\": \"PEPTIC ULCER\",\n \"Probability\": \"0.0661120713\",\n \"SemanticContext\": \"PEPTIC ULCER The usual recommended dose of glycopyrrolate injection is 0.1 mg administered at 4-hour intervals, 3 or 4 times daily intravenously or intramuscularly.\"\n },\n {\n \"VerbatimTerm\": \"PEPTIC ULCER\",\n \"Probability\": \"0.2849953771\",\n \"SemanticContext\": \"PEPTIC ULCER Glycopyrrolate injection is not recommended for the treatment of peptic ulcer in pediatric patients see PRECAUTIONS, Pediatric Use .\"\n },\n {\n \"VerbatimTerm\": \"Peptic Ulcer\",\n \"Probability\": \"0.1963258088\",\n \"SemanticContext\": \"In Peptic Ulcer For use in adults as adjunctive therapy for the treatment of peptic ulcer when rapid anticholinergic effect is desired or when oral medication is not tolerated.\"\n }\n ]\n },\n {\n \"Term\": \"Hypertrophy\",\n \"MEDDRACode\": \"10020880\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": true,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hypertrophy\",\n \"Probability\": \"0.0011050403\",\n \"SemanticContext\": \"Use glycopyrrolate with caution in the elderly and in all patients with autonomic neuropathy, hepatic disease, ulcerative colitis, prostic hypertrophy, or hiatal hernia, since anticholinergic drugs may aggravate these conditions.\"\n }\n ]\n },\n {\n \"Term\": \"Manipulation\",\n \"MEDDRACode\": \"10062053\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"manipulations\",\n \"Probability\": \"2.72366E-05\",\n \"SemanticContext\": \"The usual attempts should be made to determine the etiology of the arrhythmia, and the surgical or anesthetic manipulations necessary to correct parasympathetic imbalance should be performed.\"\n },\n {\n \"VerbatimTerm\": \"manipulations\",\n \"Probability\": \"2.72366E-05\",\n \"SemanticContext\": \"The usual attempts should be made to determine the etiology of the arrhythmia, and the surgical or anesthetic manipulations necessary to correct parasympathetic imbalance should be performed.\"\n }\n ]\n },\n {\n \"Term\": \"Increased bronchial secretion\",\n \"MEDDRACode\": \"10062530\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"bronchorrhea\",\n \"Probability\": \"0.6193447113\",\n \"SemanticContext\": \"Glycopyrrolate antagonizes muscarinic symptoms e.g., bronchorrhea, bronchospasm, bradycardia, and intestinal hypermotility induced by cholinergic drugs such as the anticholinesterases.\"\n }\n ]\n },\n {\n \"Term\": \"Injection\",\n \"MEDDRACode\": \"10052995\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": true,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": true,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": true\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"intramuscular injection\",\n \"Probability\": \"0.0013192594\",\n \"SemanticContext\": \"Adults PREANESTHETIC MEDICATION The recommended dose of glycopyrrolate injection is 0.004 mg/kg by intramuscular injection, given 30 to 60 minutes prior to the anticipated time of induction of anesthesia or at the time the preanesthetic narcotic and/or sedative are administered.\"\n }\n ]\n },\n {\n \"Term\": \"Hypersensitivity\",\n \"MEDDRACode\": \"10020751\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": true,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hypersensitivity\",\n \"Probability\": \"0.8994732499\",\n \"SemanticContext\": \"Adverse reactions may include xerostomia dry mouth ; urinary hesitancy and retention; blurred vision and photophobia due to mydriasis dilation of the pupil ; cycloplegia; increased ocular tension; tachycardia; palpitation; decreased sweating; loss of taste; headache; nervousness; drowsiness; weakness; dizziness; insomnia; nausea; vomiting; impotence; suppression of lactation; constipation; bloated feeling; severe allergic reactions including anaphylactic/anaphylactoid reactions; hypersensitivity; urticaria, pruritus, dry skin, and other dermal manifestations; some degree of mental confusion and/or excitement, especially in elderly persons.\"\n },\n {\n \"VerbatimTerm\": \"hypersensitivity\",\n \"Probability\": \"0.0112995505\",\n \"SemanticContext\": \"CONTRAINDICATIONS Known hypersensitivity to glycopyrrolate or any of its inactive ingredients.\"\n }\n ]\n },\n {\n \"Term\": \"Benign prostatic hyperplasia\",\n \"MEDDRACode\": \"10004446\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": true,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"prostatic hypertrophy\",\n \"Probability\": \"0.0190807581\",\n \"SemanticContext\": \"In addition, in the management of peptic ulcer patients, because of the longer duration of therapy, glycopyrrolate injection may be contraindicated in patients with the following concurrent conditions: glaucoma; obstructive uropathy for example, bladder neck obstruction due to prostatic hypertrophy ; obstructive disease of the gastrointestinal tract as in achalasia, pyloroduodenal stenosis, etc. ; paralytic ileus, intestinal atony of the elderly or debilitated patient; unstable cardiovascular status in acute hemorrhage; severe ulcerative colitis; toxic megacolon complicating ulcerative colitis; myasthenia gravis.\"\n }\n ]\n },\n {\n \"Term\": \"Drug interaction\",\n \"MEDDRACode\": \"10013710\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Drug Interactions\",\n \"Probability\": \"0.0003578663\",\n \"SemanticContext\": \"Drug Interactions The concurrent use of glycopyrrolate injection with other anticholinergics or medications with anticholinergic activity, such as phenothiazines, antiparkinson drugs, or tricyclic antidepressants, may intensify the antimuscarinic effects and may result in an increase in anticholinergic side effects.\"\n },\n {\n \"VerbatimTerm\": \"Drug Interactions\",\n \"Probability\": \"0.0003578663\",\n \"SemanticContext\": \"Drug Interactions The concurrent use of glycopyrrolate injection with other anticholinergics or medications with anticholinergic activity, such as phenothiazines, antiparkinson drugs, or tricyclic antidepressants, may intensify the antimuscarinic effects and may result in an increase in anticholinergic side effects.\"\n }\n ]\n },\n {\n \"Term\": \"Colitis ulcerative\",\n \"MEDDRACode\": \"10009900\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": true,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"ulcerative colitis\",\n \"Probability\": \"0.9480740428\",\n \"SemanticContext\": \"In addition, in the management of peptic ulcer patients, because of the longer duration of therapy, glycopyrrolate injection may be contraindicated in patients with the following concurrent conditions: glaucoma; obstructive uropathy for example, bladder neck obstruction due to prostatic hypertrophy ; obstructive disease of the gastrointestinal tract as in achalasia, pyloroduodenal stenosis, etc. ; paralytic ileus, intestinal atony of the elderly or debilitated patient; unstable cardiovascular status in acute hemorrhage; severe ulcerative colitis; toxic megacolon complicating ulcerative colitis; myasthenia gravis.\"\n },\n {\n \"VerbatimTerm\": \"ulcerative colitis\",\n \"Probability\": \"0.5007496476\",\n \"SemanticContext\": \"In addition, in the management of peptic ulcer patients, because of the longer duration of therapy, glycopyrrolate injection may be contraindicated in patients with the following concurrent conditions: glaucoma; obstructive uropathy for example, bladder neck obstruction due to prostatic hypertrophy ; obstructive disease of the gastrointestinal tract as in achalasia, pyloroduodenal stenosis, etc. ; paralytic ileus, intestinal atony of the elderly or debilitated patient; unstable cardiovascular status in acute hemorrhage; severe ulcerative colitis; toxic megacolon complicating ulcerative colitis; myasthenia gravis.\"\n },\n {\n \"VerbatimTerm\": \"ulcerative colitis\",\n \"Probability\": \"0.0196677744\",\n \"SemanticContext\": \"Use glycopyrrolate with caution in the elderly and in all patients with autonomic neuropathy, hepatic disease, ulcerative colitis, prostic hypertrophy, or hiatal hernia, since anticholinergic drugs may aggravate these conditions.\"\n }\n ]\n },\n {\n \"Term\": \"Photophobia\",\n \"MEDDRACode\": \"10034960\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"photophobia\",\n \"Probability\": \"0.9906499982\",\n \"SemanticContext\": \"Adverse reactions may include xerostomia dry mouth ; urinary hesitancy and retention; blurred vision and photophobia due to mydriasis dilation of the pupil ; cycloplegia; increased ocular tension; tachycardia; palpitation; decreased sweating; loss of taste; headache; nervousness; drowsiness; weakness; dizziness; insomnia; nausea; vomiting; impotence; suppression of lactation; constipation; bloated feeling; severe allergic reactions including anaphylactic/anaphylactoid reactions; hypersensitivity; urticaria, pruritus, dry skin, and other dermal manifestations; some degree of mental confusion and/or excitement, especially in elderly persons.\"\n }\n ]\n },\n {\n \"Term\": \"Crigler-Najjar syndrome\",\n \"MEDDRACode\": \"10011386\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"CNS\",\n \"Probability\": \"0.059417665\",\n \"SemanticContext\": \"For this reason the occurrence of CNS-related side effects is lower, in comparison to their incidence following administration of anticholinergics which are chemically tertiary amines that can cross this barrier readily.\"\n },\n {\n \"VerbatimTerm\": \"CNS\",\n \"Probability\": \"0.0202596486\",\n \"SemanticContext\": \"If CNS symptoms e.g., excitement, restlessness, convulsions, psychotic behavior occur, physostigmine which does cross the blood--brain barrier may be used.\"\n }\n ]\n },\n {\n \"Term\": \"Ventricular tachycardia\",\n \"MEDDRACode\": \"10047302\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"ventricular tachycardia\",\n \"Probability\": \"0.9982693195\",\n \"SemanticContext\": \"In addition, the following adverse events have been reported from post-marketing experience with glycopyrrolate: malignant hyperthermia; cardiac arrhythmias including bradycardia, ventricular tachycardia, ventricular fibrillation ; cardiac arrest; hypertension; hypotension; seizures; and respiratory arrest.\"\n }\n ]\n },\n {\n \"Term\": \"Bradycardia\",\n \"MEDDRACode\": \"10006093\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"bradycardia\",\n \"Probability\": \"0.9923388958\",\n \"SemanticContext\": \"In addition, the following adverse events have been reported from post-marketing experience with glycopyrrolate: malignant hyperthermia; cardiac arrhythmias including bradycardia, ventricular tachycardia, ventricular fibrillation ; cardiac arrest; hypertension; hypotension; seizures; and respiratory arrest.\"\n },\n {\n \"VerbatimTerm\": \"bradycardia\",\n \"Probability\": \"0.9648375511\",\n \"SemanticContext\": \"Glycopyrrolate antagonizes muscarinic symptoms e.g., bronchorrhea, bronchospasm, bradycardia, and intestinal hypermotility induced by cholinergic drugs such as the anticholinesterases.\"\n },\n {\n \"VerbatimTerm\": \"bradycardia\",\n \"Probability\": \"0.3986262977\",\n \"SemanticContext\": \"INTRAOPERATIVE MEDICATION Glycopyrrolate injection may be used during surgery to counteract drug-induced or vagal reflexes and their associated arrhythmias e.g., bradycardia .\"\n },\n {\n \"VerbatimTerm\": \"bradycardia\",\n \"Probability\": \"0.0072978735\",\n \"SemanticContext\": \"Glycopyrrolate protects against the peripheral muscarinic effects e.g., bradycardia and excessive secretions of cholinergic agents such as neostigmine and pyridostigmine given to reverse the neuromuscular blockade due to non-depolarizing muscle relaxants.\"\n },\n {\n \"VerbatimTerm\": \"bradycardia\",\n \"Probability\": \"0.921428442\",\n \"SemanticContext\": \"Additional symptoms may include gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse.\"\n },\n {\n \"VerbatimTerm\": \"bradycardia\",\n \"Probability\": \"0.921428442\",\n \"SemanticContext\": \"Additional symptoms may include gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse.\"\n }\n ]\n },\n {\n \"Term\": \"Psychotic behaviour\",\n \"MEDDRACode\": \"10037249\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"psychotic behavior\",\n \"Probability\": \"0.0355412364\",\n \"SemanticContext\": \"If CNS symptoms e.g., excitement, restlessness, convulsions, psychotic behavior occur, physostigmine which does cross the blood--brain barrier may be used.\"\n }\n ]\n },\n {\n \"Term\": \"Cardiac failure congestive\",\n \"MEDDRACode\": \"10007559\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"congestive heart failure\",\n \"Probability\": \"0.0010692179\",\n \"SemanticContext\": \"Use with caution in patients with: coronary artery disease; congestive heart failure; cardiac arrhythmias; hypertension; hyperthyroidism.\"\n }\n ]\n },\n {\n \"Term\": \"Ileostomy\",\n \"MEDDRACode\": \"10021321\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"ileostomy\",\n \"Probability\": \"8.88127E-05\",\n \"SemanticContext\": \"Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy.\"\n }\n ]\n },\n {\n \"Term\": \"Circulatory collapse\",\n \"MEDDRACode\": \"10009192\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"cardiovascular collapse\",\n \"Probability\": \"0.951546073\",\n \"SemanticContext\": \"Additional symptoms may include gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse.\"\n },\n {\n \"VerbatimTerm\": \"cardiovascular collapse\",\n \"Probability\": \"0.951546073\",\n \"SemanticContext\": \"Additional symptoms may include gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse.\"\n }\n ]\n },\n {\n \"Term\": \"Blood sodium\",\n \"MEDDRACode\": \"10005799\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0002929866\",\n \"SemanticContext\": \"Each 1 mL contains: Glycopyrrolate, USP 0.2 mg Water for Injection, USP q.s. Benzyl Alcohol, NF 0.9% preservative pH adjusted, when necessary, with hydrochloric acid and/or sodium hydroxide.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.002981782\",\n \"SemanticContext\": \"Diluent Compatibilities Dextrose 5% and 10% in water, or saline, dextrose 5% in sodium chloride 0.45%, sodium chloride 0.9%, and Ringer's Injection.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.005456984\",\n \"SemanticContext\": \"Diluent Compatibilities Dextrose 5% and 10% in water, or saline, dextrose 5% in sodium chloride 0.45%, sodium chloride 0.9%, and Ringer's Injection.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0008017123\",\n \"SemanticContext\": \"Admixture Incompatibilities PHYSICAL INCOMPATIBILITY Since the stability of glycopyrrolate is questionable above a pH of 6.0 do not combine glycopyrrolate injection in the same syringe with Brevital ® methohexital Na ; Chloromycetin ® chloramphenicol Na succinate ; Dramamine ® dimenhydrinate ; Nembutal ® pentobarbital Na ; Pentothal ® thiopental Na ; Seconal ® secobarbital Na ; sodium bicarbonate Abbott ; Valium ® diazepam ; Decadron ® dexamethasone Na phosphate ; or Talwin ® pentazocine lactate .\"\n }\n ]\n },\n {\n \"Term\": \"Induction of anaesthesia\",\n \"MEDDRACode\": \"10021724\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"induction of anesthesia\",\n \"Probability\": \"0.0002940893\",\n \"SemanticContext\": \"Adults PREANESTHETIC MEDICATION The recommended dose of glycopyrrolate injection is 0.004 mg/kg by intramuscular injection, given 30 to 60 minutes prior to the anticipated time of induction of anesthesia or at the time the preanesthetic narcotic and/or sedative are administered.\"\n },\n {\n \"VerbatimTerm\": \"induction of anesthesia\",\n \"Probability\": \"0.0002040863\",\n \"SemanticContext\": \"Pediatric Patients see PRECAUTIONS, Pediatric Use PREANESTHETIC MEDICATION The recommended dose of glycopyrrolate injection in pediatric patients is 0.004 mg/kg intramuscularly, given 30 to 60 minutes prior to the anticipated time of induction of anesthesia or at the time the preanesthetic narcotic and/or sedative are administered.\"\n },\n {\n \"VerbatimTerm\": \"induction of anesthesia\",\n \"Probability\": \"0.0018851757\",\n \"SemanticContext\": \"INDICATIONS AND USAGE In Anesthesia Glycopyrrolate Injection is indicated for use as a preoperative antimuscarinic to reduce salivary, tracheobronchial, and pharyngeal secretions; to reduce the volume and free acidity of gastric secretions; and to block cardiac vagal inhibitory reflexes during induction of anesthesia and intubation.\"\n }\n ]\n },\n {\n \"Term\": \"Coronary artery disease\",\n \"MEDDRACode\": \"10011078\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"coronary artery disease\",\n \"Probability\": \"0.0009235442\",\n \"SemanticContext\": \"Use with caution in patients with: coronary artery disease; congestive heart failure; cardiac arrhythmias; hypertension; hyperthyroidism.\"\n }\n ]\n },\n {\n \"Term\": \"Diarrhoea\",\n \"MEDDRACode\": \"10012735\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Diarrhea\",\n \"Probability\": \"0.1577562988\",\n \"SemanticContext\": \"Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy.\"\n }\n ]\n },\n {\n \"Term\": \"Heat stroke\",\n \"MEDDRACode\": \"10019345\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"heat stroke\",\n \"Probability\": \"0.0100356936\",\n \"SemanticContext\": \"The patient also should be cautioned about the use of this drug during exercise or hot weather since overheating may result in heat stroke.\"\n },\n {\n \"VerbatimTerm\": \"heat stroke\",\n \"Probability\": \"0.0100356936\",\n \"SemanticContext\": \"The patient also should be cautioned about the use of this drug during exercise or hot weather since overheating may result in heat stroke.\"\n }\n ]\n },\n {\n \"Term\": \"Stenosis\",\n \"MEDDRACode\": \"10076711\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": true,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"stenosis\",\n \"Probability\": \"0.9491351247\",\n \"SemanticContext\": \"In addition, in the management of peptic ulcer patients, because of the longer duration of therapy, glycopyrrolate injection may be contraindicated in patients with the following concurrent conditions: glaucoma; obstructive uropathy for example, bladder neck obstruction due to prostatic hypertrophy ; obstructive disease of the gastrointestinal tract as in achalasia, pyloroduodenal stenosis, etc. ; paralytic ileus, intestinal atony of the elderly or debilitated patient; unstable cardiovascular status in acute hemorrhage; severe ulcerative colitis; toxic megacolon complicating ulcerative colitis; myasthenia gravis.\"\n }\n ]\n },\n {\n \"Term\": \"Blood lactic acid\",\n \"MEDDRACode\": \"10005632\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Lactated\",\n \"Probability\": \"0.0001771152\",\n \"SemanticContext\": \"Diluent Incompatibilities Lactated Ringer's solution Admixture Compatibilities PHYSICAL COMPATIBILITY This list does not constitute an endorsement of the clinical utility or safety of co-administration of glycopyrrolate with these drugs.\"\n },\n {\n \"VerbatimTerm\": \"lactate\",\n \"Probability\": \"0.0018446743\",\n \"SemanticContext\": \"Admixture Incompatibilities PHYSICAL INCOMPATIBILITY Since the stability of glycopyrrolate is questionable above a pH of 6.0 do not combine glycopyrrolate injection in the same syringe with Brevital ® methohexital Na ; Chloromycetin ® chloramphenicol Na succinate ; Dramamine ® dimenhydrinate ; Nembutal ® pentobarbital Na ; Pentothal ® thiopental Na ; Seconal ® secobarbital Na ; sodium bicarbonate Abbott ; Valium ® diazepam ; Decadron ® dexamethasone Na phosphate ; or Talwin ® pentazocine lactate .\"\n }\n ]\n },\n {\n \"Term\": \"Skin disorder\",\n \"MEDDRACode\": \"10040831\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"skin breakdown\",\n \"Probability\": \"0.6160229445\",\n \"SemanticContext\": \"Additional symptoms may include gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse.\"\n },\n {\n \"VerbatimTerm\": \"skin breakdown\",\n \"Probability\": \"0.6160229445\",\n \"SemanticContext\": \"Additional symptoms may include gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse.\"\n }\n ]\n },\n {\n \"Term\": \"Blood potassium\",\n \"MEDDRACode\": \"10005721\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"potassium\",\n \"Probability\": \"1.87206E-05\",\n \"SemanticContext\": \"Concomitant administration of glycopyrrolate injection and potassium chloride in a wax matrix may increase the severity of potassium chloride-induced gastrointestinal lesions as a result of a slower gastrointestinal transit time.\"\n },\n {\n \"VerbatimTerm\": \"potassium\",\n \"Probability\": \"0.0002984703\",\n \"SemanticContext\": \"Concomitant administration of glycopyrrolate injection and potassium chloride in a wax matrix may increase the severity of potassium chloride-induced gastrointestinal lesions as a result of a slower gastrointestinal transit time.\"\n },\n {\n \"VerbatimTerm\": \"potassium\",\n \"Probability\": \"1.87206E-05\",\n \"SemanticContext\": \"Concomitant administration of glycopyrrolate injection and potassium chloride in a wax matrix may increase the severity of potassium chloride-induced gastrointestinal lesions as a result of a slower gastrointestinal transit time.\"\n },\n {\n \"VerbatimTerm\": \"potassium\",\n \"Probability\": \"0.0002984703\",\n \"SemanticContext\": \"Concomitant administration of glycopyrrolate injection and potassium chloride in a wax matrix may increase the severity of potassium chloride-induced gastrointestinal lesions as a result of a slower gastrointestinal transit time.\"\n }\n ]\n },\n {\n \"Term\": \"Megacolon\",\n \"MEDDRACode\": \"10027110\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": true,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"toxic megacolon\",\n \"Probability\": \"0.6550104618\",\n \"SemanticContext\": \"In addition, in the management of peptic ulcer patients, because of the longer duration of therapy, glycopyrrolate injection may be contraindicated in patients with the following concurrent conditions: glaucoma; obstructive uropathy for example, bladder neck obstruction due to prostatic hypertrophy ; obstructive disease of the gastrointestinal tract as in achalasia, pyloroduodenal stenosis, etc. ; paralytic ileus, intestinal atony of the elderly or debilitated patient; unstable cardiovascular status in acute hemorrhage; severe ulcerative colitis; toxic megacolon complicating ulcerative colitis; myasthenia gravis.\"\n }\n ]\n },\n {\n \"Term\": \"Renal failure\",\n \"MEDDRACode\": \"10038435\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"renal failure\",\n \"Probability\": \"0.1452351511\",\n \"SemanticContext\": \"These results suggest that the elimination of glycopyrrolate is severely impaired in patients with renal failure.\"\n },\n {\n \"VerbatimTerm\": \"renal failure\",\n \"Probability\": \"0.007900387\",\n \"SemanticContext\": \"Use with caution in patients with renal disease since the renal elimination of glycopyrrolate may be severely impaired in patients with renal failure.\"\n },\n {\n \"VerbatimTerm\": \"renal failure\",\n \"Probability\": \"0.9022892118\",\n \"SemanticContext\": \"Additional symptoms may include gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse.\"\n },\n {\n \"VerbatimTerm\": \"renal failure\",\n \"Probability\": \"0.9022892118\",\n \"SemanticContext\": \"Additional symptoms may include gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse.\"\n }\n ]\n },\n {\n \"Term\": \"Glaucoma\",\n \"MEDDRACode\": \"10018304\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": true,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"glaucoma\",\n \"Probability\": \"0.0561552942\",\n \"SemanticContext\": \"In addition, in the management of peptic ulcer patients, because of the longer duration of therapy, glycopyrrolate injection may be contraindicated in patients with the following concurrent conditions: glaucoma; obstructive uropathy for example, bladder neck obstruction due to prostatic hypertrophy ; obstructive disease of the gastrointestinal tract as in achalasia, pyloroduodenal stenosis, etc. ; paralytic ileus, intestinal atony of the elderly or debilitated patient; unstable cardiovascular status in acute hemorrhage; severe ulcerative colitis; toxic megacolon complicating ulcerative colitis; myasthenia gravis.\"\n },\n {\n \"VerbatimTerm\": \"glaucoma\",\n \"Probability\": \"9.3315E-06\",\n \"SemanticContext\": \"WARNINGS This drug should be used with great caution, if at all, in patients with glaucoma.\"\n }\n ]\n },\n {\n \"Term\": \"Blood phosphorus\",\n \"MEDDRACode\": \"10005717\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"phosphate\",\n \"Probability\": \"5.63887E-05\",\n \"SemanticContext\": \"Glycopyrrolate injection is compatible for mixing and injection with the following injectable dosage forms: atropine sulfate, USP; Antilirium ® physostigmine salicylate ; Benadryl ® diphenhydramine HCl ; codeine phosphate, USP; Emete-Con ® benzquinamide HCl ; hydromorphone HCl, USP; Inapsine ® droperidol ; Levo-Dromoran ® levorphanol tartrate ; lidocaine, USP; meperidine HCl, USP; Mestinon ® /Regonol ® pyridostigmine bromide ; morphine sulfate, USP; Nubain ® nalbuphine HCl ; Numorphan ® oxymorphone HCl ; procaine HCl, USP; promethazine HCl, USP; Prostigmin ® neostigmine methylsulfate, USP ; scopolamine HBr, USP; Stadol ® butorphanol tartrate ; Sublimaze ® fentanyl citrate ; Tigan ® trimethobenzamide HCl ; and Vistaril ® hydroxyzine HCl .\"\n },\n {\n \"VerbatimTerm\": \"phosphate\",\n \"Probability\": \"0.0001507998\",\n \"SemanticContext\": \"Admixture Incompatibilities PHYSICAL INCOMPATIBILITY Since the stability of glycopyrrolate is questionable above a pH of 6.0 do not combine glycopyrrolate injection in the same syringe with Brevital ® methohexital Na ; Chloromycetin ® chloramphenicol Na succinate ; Dramamine ® dimenhydrinate ; Nembutal ® pentobarbital Na ; Pentothal ® thiopental Na ; Seconal ® secobarbital Na ; sodium bicarbonate Abbott ; Valium ® diazepam ; Decadron ® dexamethasone Na phosphate ; or Talwin ® pentazocine lactate .\"\n }\n ]\n },\n {\n \"Term\": \"Infusion\",\n \"MEDDRACode\": \"10060345\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"infusion\",\n \"Probability\": \"2.5491E-06\",\n \"SemanticContext\": \"Glycopyrrolate injection may be administered via the tubing of a running infusion of normal saline.\"\n }\n ]\n },\n {\n \"Term\": \"Neuromuscular blockade\",\n \"MEDDRACode\": \"10029315\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"NEUROMUSCULAR BLOCKADE\",\n \"Probability\": \"0.0005155802\",\n \"SemanticContext\": \"REVERSAL OF NEUROMUSCULAR BLOCKADE The recommended dose of glycopyrrolate injection is 0.2 mg for each 1 mg of neostigmine or 5 mg of pyridostigmine.\"\n },\n {\n \"VerbatimTerm\": \"NEUROMUSCULAR BLOCKADE\",\n \"Probability\": \"0.000980705\",\n \"SemanticContext\": \"REVERSAL OF NEUROMUSCULAR BLOCKADE The recommended pediatric dose of glycopyrrolate injection is 0.2 mg for each 1 mg of neostigmine or 5 mg of pyridostigmine.\"\n },\n {\n \"VerbatimTerm\": \"neuromuscular blockade\",\n \"Probability\": \"0.0008072257\",\n \"SemanticContext\": \"Glycopyrrolate protects against the peripheral muscarinic effects e.g., bradycardia and excessive secretions of cholinergic agents such as neostigmine and pyridostigmine given to reverse the neuromuscular blockade due to non-depolarizing muscle relaxants.\"\n },\n {\n \"VerbatimTerm\": \"neuromuscular blockade\",\n \"Probability\": \"0.1520015895\",\n \"SemanticContext\": \"Following overdosage, a curare-like action may occur, i.e., neuromuscular blockade leading to muscular weakness and possible paralysis.\"\n }\n ]\n },\n {\n \"Term\": \"Condom\",\n \"MEDDRACode\": \"10010274\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"rubber\",\n \"Probability\": \"0.0015276074\",\n \"SemanticContext\": \"The container closure is not made with natural rubber latex.\"\n }\n ]\n },\n {\n \"Term\": \"Liver disorder\",\n \"MEDDRACode\": \"10024670\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hepatic disease\",\n \"Probability\": \"0.0110192299\",\n \"SemanticContext\": \"Use glycopyrrolate with caution in the elderly and in all patients with autonomic neuropathy, hepatic disease, ulcerative colitis, prostic hypertrophy, or hiatal hernia, since anticholinergic drugs may aggravate these conditions.\"\n }\n ]\n },\n {\n \"Term\": \"Depressed level of consciousness\",\n \"MEDDRACode\": \"10012373\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"central nervous system depression\",\n \"Probability\": \"0.2317569852\",\n \"SemanticContext\": \"The “gasping syndrome,” characterized by central nervous system depression, metabolic acidosis, gasping respirations, and high levels of benzyl alcohol and its metabolites found in the blood and urine has been associated with benzyl alcohol dosages >99 mg/kg/day in neonates and low-birth-weight neonates.\"\n },\n {\n \"VerbatimTerm\": \"central nervous system depression\",\n \"Probability\": \"0.2317569852\",\n \"SemanticContext\": \"The “gasping syndrome,” characterized by central nervous system depression, metabolic acidosis, gasping respirations, and high levels of benzyl alcohol and its metabolites found in the blood and urine has been associated with benzyl alcohol dosages >99 mg/kg/day in neonates and low-birth-weight neonates.\"\n }\n ]\n },\n {\n \"Term\": \"Haemorrhage intracranial\",\n \"MEDDRACode\": \"10018985\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"intracranial hemorrhage\",\n \"Probability\": \"0.8226063848\",\n \"SemanticContext\": \"Additional symptoms may include gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse.\"\n },\n {\n \"VerbatimTerm\": \"intracranial hemorrhage\",\n \"Probability\": \"0.8226063848\",\n \"SemanticContext\": \"Additional symptoms may include gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse.\"\n }\n ]\n },\n {\n \"Term\": \"Metabolic acidosis\",\n \"MEDDRACode\": \"10027417\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"metabolic acidosis\",\n \"Probability\": \"0.083945632\",\n \"SemanticContext\": \"Exposure to excessive amounts of benzyl alcohol has been associated with toxicity hypotension, metabolic acidosis , particularly in neonates, and an increased incidence of kernicterus, particularly in small preterm infants.\"\n },\n {\n \"VerbatimTerm\": \"metabolic acidosis\",\n \"Probability\": \"0.0823256671\",\n \"SemanticContext\": \"The “gasping syndrome,” characterized by central nervous system depression, metabolic acidosis, gasping respirations, and high levels of benzyl alcohol and its metabolites found in the blood and urine has been associated with benzyl alcohol dosages >99 mg/kg/day in neonates and low-birth-weight neonates.\"\n },\n {\n \"VerbatimTerm\": \"metabolic acidosis\",\n \"Probability\": \"0.0823256671\",\n \"SemanticContext\": \"The “gasping syndrome,” characterized by central nervous system depression, metabolic acidosis, gasping respirations, and high levels of benzyl alcohol and its metabolites found in the blood and urine has been associated with benzyl alcohol dosages >99 mg/kg/day in neonates and low-birth-weight neonates.\"\n }\n ]\n },\n {\n \"Term\": \"Paralysis\",\n \"MEDDRACode\": \"10033799\",\n \"Overdose\": true,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"paralysis\",\n \"Probability\": \"0.1058253944\",\n \"SemanticContext\": \"Following overdosage, a curare-like action may occur, i.e., neuromuscular blockade leading to muscular weakness and possible paralysis.\"\n }\n ]\n },\n {\n \"Term\": \"Dizziness\",\n \"MEDDRACode\": \"10013573\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"dizziness\",\n \"Probability\": \"0.9912759066\",\n \"SemanticContext\": \"Adverse reactions may include xerostomia dry mouth ; urinary hesitancy and retention; blurred vision and photophobia due to mydriasis dilation of the pupil ; cycloplegia; increased ocular tension; tachycardia; palpitation; decreased sweating; loss of taste; headache; nervousness; drowsiness; weakness; dizziness; insomnia; nausea; vomiting; impotence; suppression of lactation; constipation; bloated feeling; severe allergic reactions including anaphylactic/anaphylactoid reactions; hypersensitivity; urticaria, pruritus, dry skin, and other dermal manifestations; some degree of mental confusion and/or excitement, especially in elderly persons.\"\n }\n ]\n },\n {\n \"Term\": \"Intestinal obstruction\",\n \"MEDDRACode\": \"10022687\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"intestinal obstruction\",\n \"Probability\": \"0.1999718845\",\n \"SemanticContext\": \"Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy.\"\n }\n ]\n },\n {\n \"Term\": \"Kernicterus\",\n \"MEDDRACode\": \"10023376\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"kernicterus\",\n \"Probability\": \"0.7467460632\",\n \"SemanticContext\": \"Exposure to excessive amounts of benzyl alcohol has been associated with toxicity hypotension, metabolic acidosis , particularly in neonates, and an increased incidence of kernicterus, particularly in small preterm infants.\"\n }\n ]\n },\n {\n \"Term\": \"Lipids\",\n \"MEDDRACode\": \"10024587\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"lipid\",\n \"Probability\": \"0.0001793802\",\n \"SemanticContext\": \"Glycopyrrolate is chemically a quaternary ammonium compound; hence, its passage across lipid membranes, such as the blood-brain barrier is limited in contrast to atropine sulfate and scopolamine hydrobromide.\"\n },\n {\n \"VerbatimTerm\": \"lipid\",\n \"Probability\": \"0.0001320541\",\n \"SemanticContext\": \"The highly polar quaternary ammonium group of glycopyrrolate limits its passage across lipid membranes, such as the blood-brain barrier, in contrast to atropine sulfate and scopolamine hydrobromide, which are highly non-polar tertiary amines which penetrate lipid barriers easily.\"\n },\n {\n \"VerbatimTerm\": \"lipid\",\n \"Probability\": \"4.69125E-05\",\n \"SemanticContext\": \"The highly polar quaternary ammonium group of glycopyrrolate limits its passage across lipid membranes, such as the blood-brain barrier, in contrast to atropine sulfate and scopolamine hydrobromide, which are highly non-polar tertiary amines which penetrate lipid barriers easily.\"\n }\n ]\n },\n {\n \"Term\": \"Nervousness\",\n \"MEDDRACode\": \"10029216\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"nervousness\",\n \"Probability\": \"0.8601945639\",\n \"SemanticContext\": \"Adverse reactions may include xerostomia dry mouth ; urinary hesitancy and retention; blurred vision and photophobia due to mydriasis dilation of the pupil ; cycloplegia; increased ocular tension; tachycardia; palpitation; decreased sweating; loss of taste; headache; nervousness; drowsiness; weakness; dizziness; insomnia; nausea; vomiting; impotence; suppression of lactation; constipation; bloated feeling; severe allergic reactions including anaphylactic/anaphylactoid reactions; hypersensitivity; urticaria, pruritus, dry skin, and other dermal manifestations; some degree of mental confusion and/or excitement, especially in elderly persons.\"\n }\n ]\n },\n {\n \"Term\": \"Foetal heart rate\",\n \"MEDDRACode\": \"10051137\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"fetal heart rate\",\n \"Probability\": \"0.0017162859\",\n \"SemanticContext\": \"Unlike atropine, glycopyrrolate in normal doses 0.004 mg/kg does not appear to affect fetal heart rate or fetal heart rate variability to a significant degree.\"\n },\n {\n \"VerbatimTerm\": \"fetal heart rate\",\n \"Probability\": \"0.0004992485\",\n \"SemanticContext\": \"Unlike atropine, glycopyrrolate in normal doses 0.004 mg/kg does not appear to affect fetal heart rate or fetal heart rate variability to a significant degree.\"\n },\n {\n \"VerbatimTerm\": \"fetal heart rate\",\n \"Probability\": \"0.0017162859\",\n \"SemanticContext\": \"Unlike atropine, glycopyrrolate in normal doses 0.004 mg/kg does not appear to affect fetal heart rate or fetal heart rate variability to a significant degree.\"\n },\n {\n \"VerbatimTerm\": \"fetal heart rate\",\n \"Probability\": \"0.0004992485\",\n \"SemanticContext\": \"Unlike atropine, glycopyrrolate in normal doses 0.004 mg/kg does not appear to affect fetal heart rate or fetal heart rate variability to a significant degree.\"\n }\n ]\n },\n {\n \"Term\": \"Synovial cyst\",\n \"MEDDRACode\": \"10042858\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"ganglia\",\n \"Probability\": \"0.0849958658\",\n \"SemanticContext\": \"These peripheral cholinergic receptors are present in the autonomic effector cells of smooth muscle, cardiac muscle, the sinoatrial node, the atrioventricular node, exocrine glands and, to a limited degree, in the autonomic ganglia.\"\n }\n ]\n },\n {\n \"Term\": \"Ventricular fibrillation\",\n \"MEDDRACode\": \"10047290\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"ventricular fibrillation\",\n \"Probability\": \"0.9971285462\",\n \"SemanticContext\": \"In addition, the following adverse events have been reported from post-marketing experience with glycopyrrolate: malignant hyperthermia; cardiac arrhythmias including bradycardia, ventricular tachycardia, ventricular fibrillation ; cardiac arrest; hypertension; hypotension; seizures; and respiratory arrest.\"\n }\n ]\n },\n {\n \"Term\": \"Heart rate\",\n \"MEDDRACode\": \"10019299\",\n \"Overdose\": true,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"heart rate\",\n \"Probability\": \"0.002987355\",\n \"SemanticContext\": \"PRECAUTIONS General Investigate any tachycardia before giving glycopyrrolate injection since an increase in the heart rate may occur.\"\n }\n ]\n },\n {\n \"Term\": \"Flushing\",\n \"MEDDRACode\": \"10016825\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"flush\",\n \"Probability\": \"0.0008463264\",\n \"SemanticContext\": \"The amount of benzyl alcohol from medications is usually considered negligible compared to that received in flush solutions containing benzyl alcohol.\"\n }\n ]\n },\n {\n \"Term\": \"Gastric ulcer\",\n \"MEDDRACode\": \"10017822\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"gastric ulcer\",\n \"Probability\": \"0.0397187173\",\n \"SemanticContext\": \"The use of anticholinergetic drugs in the treatment of gastric ulcer may produce a delay in gastric emptying due to antral statis.\"\n }\n ]\n },\n {\n \"Term\": \"Bladder neck obstruction\",\n \"MEDDRACode\": \"10005053\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": true,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"bladder neck obstruction\",\n \"Probability\": \"0.1356220841\",\n \"SemanticContext\": \"In addition, in the management of peptic ulcer patients, because of the longer duration of therapy, glycopyrrolate injection may be contraindicated in patients with the following concurrent conditions: glaucoma; obstructive uropathy for example, bladder neck obstruction due to prostatic hypertrophy ; obstructive disease of the gastrointestinal tract as in achalasia, pyloroduodenal stenosis, etc. ; paralytic ileus, intestinal atony of the elderly or debilitated patient; unstable cardiovascular status in acute hemorrhage; severe ulcerative colitis; toxic megacolon complicating ulcerative colitis; myasthenia gravis.\"\n }\n ]\n },\n {\n \"Term\": \"Haemorrhage\",\n \"MEDDRACode\": \"10055798\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": true,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"acute hemorrhage\",\n \"Probability\": \"0.513140142\",\n \"SemanticContext\": \"In addition, in the management of peptic ulcer patients, because of the longer duration of therapy, glycopyrrolate injection may be contraindicated in patients with the following concurrent conditions: glaucoma; obstructive uropathy for example, bladder neck obstruction due to prostatic hypertrophy ; obstructive disease of the gastrointestinal tract as in achalasia, pyloroduodenal stenosis, etc. ; paralytic ileus, intestinal atony of the elderly or debilitated patient; unstable cardiovascular status in acute hemorrhage; severe ulcerative colitis; toxic megacolon complicating ulcerative colitis; myasthenia gravis.\"\n }\n ]\n },\n {\n \"Term\": \"Ileus paralytic\",\n \"MEDDRACode\": \"10021333\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": true,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"paralytic ileus\",\n \"Probability\": \"0.9959945083\",\n \"SemanticContext\": \"In addition, in the management of peptic ulcer patients, because of the longer duration of therapy, glycopyrrolate injection may be contraindicated in patients with the following concurrent conditions: glaucoma; obstructive uropathy for example, bladder neck obstruction due to prostatic hypertrophy ; obstructive disease of the gastrointestinal tract as in achalasia, pyloroduodenal stenosis, etc. ; paralytic ileus, intestinal atony of the elderly or debilitated patient; unstable cardiovascular status in acute hemorrhage; severe ulcerative colitis; toxic megacolon complicating ulcerative colitis; myasthenia gravis.\"\n }\n ]\n },\n {\n \"Term\": \"Hiatus hernia\",\n \"MEDDRACode\": \"10020028\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hiatal hernia\",\n \"Probability\": \"0.0003222525\",\n \"SemanticContext\": \"Use glycopyrrolate with caution in the elderly and in all patients with autonomic neuropathy, hepatic disease, ulcerative colitis, prostic hypertrophy, or hiatal hernia, since anticholinergic drugs may aggravate these conditions.\"\n }\n ]\n },\n {\n \"Term\": \"Gasping syndrome\",\n \"MEDDRACode\": \"10069162\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"gasping syndrome\",\n \"Probability\": \"0.8579488397\",\n \"SemanticContext\": \"The “gasping syndrome,” characterized by central nervous system depression, metabolic acidosis, gasping respirations, and high levels of benzyl alcohol and its metabolites found in the blood and urine has been associated with benzyl alcohol dosages >99 mg/kg/day in neonates and low-birth-weight neonates.\"\n },\n {\n \"VerbatimTerm\": \"gasping syndrome\",\n \"Probability\": \"0.010502398\",\n \"SemanticContext\": \"Although normal therapeutic doses of this product deliver amounts of benzyl alcohol that are substantially lower than those reported in association with the “gasping syndrome,” the minimum amount of benzyl alcohol at which toxicity may occur is not known.\"\n },\n {\n \"VerbatimTerm\": \"gasping syndrome\",\n \"Probability\": \"0.8579488397\",\n \"SemanticContext\": \"The “gasping syndrome,” characterized by central nervous system depression, metabolic acidosis, gasping respirations, and high levels of benzyl alcohol and its metabolites found in the blood and urine has been associated with benzyl alcohol dosages >99 mg/kg/day in neonates and low-birth-weight neonates.\"\n },\n {\n \"VerbatimTerm\": \"gasping syndrome\",\n \"Probability\": \"0.010502398\",\n \"SemanticContext\": \"Although normal therapeutic doses of this product deliver amounts of benzyl alcohol that are substantially lower than those reported in association with the “gasping syndrome,” the minimum amount of benzyl alcohol at which toxicity may occur is not known.\"\n }\n ]\n },\n {\n \"Term\": \"Infant\",\n \"MEDDRACode\": \"10021731\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"infants\",\n \"Probability\": \"0.0009815991\",\n \"SemanticContext\": \"Pediatrics Following IV administration 5 mcg/kg glycopyrrolate to infants and children, the mean T 1/2 values were reported to be between 21.6 and 130.0 minutes and between 19.2 and 99.2 minutes, respectively.\"\n },\n {\n \"VerbatimTerm\": \"infants\",\n \"Probability\": \"0.0206949115\",\n \"SemanticContext\": \"Exposure to excessive amounts of benzyl alcohol has been associated with toxicity hypotension, metabolic acidosis , particularly in neonates, and an increased incidence of kernicterus, particularly in small preterm infants.\"\n },\n {\n \"VerbatimTerm\": \"infants\",\n \"Probability\": \"0.0091663897\",\n \"SemanticContext\": \"There have been rare reports of deaths, primarily in preterm infants, associated with exposure to excessive amounts of benzyl alcohol.\"\n },\n {\n \"VerbatimTerm\": \"infants\",\n \"Probability\": \"0.0163268149\",\n \"SemanticContext\": \"Premature and low-birthweight infants, as well as patients receiving high dosages, may be more likely to develop toxicity.\"\n },\n {\n \"VerbatimTerm\": \"infants\",\n \"Probability\": \"0.0163268149\",\n \"SemanticContext\": \"Premature and low-birthweight infants, as well as patients receiving high dosages, may be more likely to develop toxicity.\"\n },\n {\n \"VerbatimTerm\": \"INFANTS\",\n \"Probability\": \"0.0002548099\",\n \"SemanticContext\": \"INFANTS 1 month to 2 years of age may require up to 0.009 mg/kg.\"\n },\n {\n \"VerbatimTerm\": \"Infants\",\n \"Probability\": \"0.0183884501\",\n \"SemanticContext\": \"Infants, patients with Down's syndrome, and pediatric patients with spastic paralysis or brain damage may experience an increased response to anticholinergics, thus increasing the potential for side effects.\"\n },\n {\n \"VerbatimTerm\": \"Infants\",\n \"Probability\": \"0.0001420677\",\n \"SemanticContext\": \"Infants and young children are especially susceptible to the toxic effects of anticholinergics.\"\n },\n {\n \"VerbatimTerm\": \"Infants\",\n \"Probability\": \"0.0183884501\",\n \"SemanticContext\": \"Infants, patients with Down's syndrome, and pediatric patients with spastic paralysis or brain damage may experience an increased response to anticholinergics, thus increasing the potential for side effects.\"\n },\n {\n \"VerbatimTerm\": \"Infants\",\n \"Probability\": \"0.0001420677\",\n \"SemanticContext\": \"Infants and young children are especially susceptible to the toxic effects of anticholinergics.\"\n }\n ]\n },\n {\n \"Term\": \"Exercise adequate\",\n \"MEDDRACode\": \"10015636\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": true,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"exercise\",\n \"Probability\": \"4.5023E-06\",\n \"SemanticContext\": \"The patient also should be cautioned about the use of this drug during exercise or hot weather since overheating may result in heat stroke.\"\n },\n {\n \"VerbatimTerm\": \"exercise\",\n \"Probability\": \"5.52453E-05\",\n \"SemanticContext\": \"In addition, in the presence of fever, high environmental temperature and/or during physical exercise, heat prostration can occur with use of anticholinergic agents including glycopyrrolate due to decreased sweating , particularly in children and the elderly.\"\n },\n {\n \"VerbatimTerm\": \"exercise\",\n \"Probability\": \"4.5023E-06\",\n \"SemanticContext\": \"The patient also should be cautioned about the use of this drug during exercise or hot weather since overheating may result in heat stroke.\"\n },\n {\n \"VerbatimTerm\": \"exercised\",\n \"Probability\": \"4.3568E-06\",\n \"SemanticContext\": \"Because many drugs are excreted in human milk, caution should be exercised when glycopyrrolate injection is administered to a nursing woman.\"\n },\n {\n \"VerbatimTerm\": \"exercised\",\n \"Probability\": \"4.3568E-06\",\n \"SemanticContext\": \"Because many drugs are excreted in human milk, caution should be exercised when glycopyrrolate injection is administered to a nursing woman.\"\n }\n ]\n },\n {\n \"Term\": \"Nephropathy\",\n \"MEDDRACode\": \"10029151\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"renal disease\",\n \"Probability\": \"0.0001343787\",\n \"SemanticContext\": \"Use with caution in patients with renal disease since the renal elimination of glycopyrrolate may be severely impaired in patients with renal failure.\"\n }\n ]\n },\n {\n \"Term\": \"Low birth weight baby\",\n \"MEDDRACode\": \"10067508\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"low-birthweight\",\n \"Probability\": \"0.0081751049\",\n \"SemanticContext\": \"Premature and low-birthweight infants, as well as patients receiving high dosages, may be more likely to develop toxicity.\"\n },\n {\n \"VerbatimTerm\": \"low-birthweight\",\n \"Probability\": \"0.0081751049\",\n \"SemanticContext\": \"Premature and low-birthweight infants, as well as patients receiving high dosages, may be more likely to develop toxicity.\"\n }\n ]\n },\n {\n \"Term\": \"Gastrointestinal hypermotility\",\n \"MEDDRACode\": \"10052402\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"intestinal hypermotility\",\n \"Probability\": \"0.52350384\",\n \"SemanticContext\": \"Glycopyrrolate antagonizes muscarinic symptoms e.g., bronchorrhea, bronchospasm, bradycardia, and intestinal hypermotility induced by cholinergic drugs such as the anticholinesterases.\"\n }\n ]\n },\n {\n \"Term\": \"Erythema\",\n \"MEDDRACode\": \"10015150\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"erythema\",\n \"Probability\": \"0.3902985156\",\n \"SemanticContext\": \"Injection site reactions including pruritus, edema, erythema, and pain have also been reported.\"\n }\n ]\n },\n {\n \"Term\": \"Hepatic function abnormal\",\n \"MEDDRACode\": \"10019670\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Hepatic Impairment\",\n \"Probability\": \"0.0344017446\",\n \"SemanticContext\": \"Hepatic Impairment Pharmacokinetic information in patients with hepatic impairment is unavailable.\"\n },\n {\n \"VerbatimTerm\": \"hepatic impairment\",\n \"Probability\": \"0.0081015229\",\n \"SemanticContext\": \"Hepatic Impairment Pharmacokinetic information in patients with hepatic impairment is unavailable.\"\n }\n ]\n },\n {\n \"Term\": \"Intraocular pressure increased\",\n \"MEDDRACode\": \"10022806\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"increased ocular tension\",\n \"Probability\": \"0.996978879\",\n \"SemanticContext\": \"Adverse reactions may include xerostomia dry mouth ; urinary hesitancy and retention; blurred vision and photophobia due to mydriasis dilation of the pupil ; cycloplegia; increased ocular tension; tachycardia; palpitation; decreased sweating; loss of taste; headache; nervousness; drowsiness; weakness; dizziness; insomnia; nausea; vomiting; impotence; suppression of lactation; constipation; bloated feeling; severe allergic reactions including anaphylactic/anaphylactoid reactions; hypersensitivity; urticaria, pruritus, dry skin, and other dermal manifestations; some degree of mental confusion and/or excitement, especially in elderly persons.\"\n }\n ]\n },\n {\n \"Term\": \"Muscle relaxant therapy\",\n \"MEDDRACode\": \"10058909\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"muscle relaxants\",\n \"Probability\": \"0.0001859665\",\n \"SemanticContext\": \"Glycopyrrolate protects against the peripheral muscarinic effects e.g., bradycardia and excessive secretions of cholinergic agents such as neostigmine and pyridostigmine given to reverse the neuromuscular blockade due to non-depolarizing muscle relaxants.\"\n }\n ]\n },\n {\n \"Term\": \"Somnolence\",\n \"MEDDRACode\": \"10041349\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"drowsiness\",\n \"Probability\": \"0.9806941748\",\n \"SemanticContext\": \"Adverse reactions may include xerostomia dry mouth ; urinary hesitancy and retention; blurred vision and photophobia due to mydriasis dilation of the pupil ; cycloplegia; increased ocular tension; tachycardia; palpitation; decreased sweating; loss of taste; headache; nervousness; drowsiness; weakness; dizziness; insomnia; nausea; vomiting; impotence; suppression of lactation; constipation; bloated feeling; severe allergic reactions including anaphylactic/anaphylactoid reactions; hypersensitivity; urticaria, pruritus, dry skin, and other dermal manifestations; some degree of mental confusion and/or excitement, especially in elderly persons.\"\n },\n {\n \"VerbatimTerm\": \"drowsiness\",\n \"Probability\": \"0.0672483146\",\n \"SemanticContext\": \"Information for the Patient Because glycopyrrolate injection may produce drowsiness or blurred vision, the patient should be cautioned not to engage in activities requiring mental alertness and/or visual acuity such as operating a motor vehicle or other machinery, or performing hazardous work while taking this drug see WARNINGS .\"\n },\n {\n \"VerbatimTerm\": \"drowsiness\",\n \"Probability\": \"0.1519555151\",\n \"SemanticContext\": \"Glycopyrrolate injection may produce drowsiness or blurred vision.\"\n },\n {\n \"VerbatimTerm\": \"drowsiness\",\n \"Probability\": \"0.0672483146\",\n \"SemanticContext\": \"Information for the Patient Because glycopyrrolate injection may produce drowsiness or blurred vision, the patient should be cautioned not to engage in activities requiring mental alertness and/or visual acuity such as operating a motor vehicle or other machinery, or performing hazardous work while taking this drug see WARNINGS .\"\n }\n ]\n },\n {\n \"Term\": \"Asthenia\",\n \"MEDDRACode\": \"10003549\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"weakness\",\n \"Probability\": \"0.9961344004\",\n \"SemanticContext\": \"Adverse reactions may include xerostomia dry mouth ; urinary hesitancy and retention; blurred vision and photophobia due to mydriasis dilation of the pupil ; cycloplegia; increased ocular tension; tachycardia; palpitation; decreased sweating; loss of taste; headache; nervousness; drowsiness; weakness; dizziness; insomnia; nausea; vomiting; impotence; suppression of lactation; constipation; bloated feeling; severe allergic reactions including anaphylactic/anaphylactoid reactions; hypersensitivity; urticaria, pruritus, dry skin, and other dermal manifestations; some degree of mental confusion and/or excitement, especially in elderly persons.\"\n }\n ]\n },\n {\n \"Term\": \"Vomiting\",\n \"MEDDRACode\": \"10047700\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"vomiting\",\n \"Probability\": \"0.9979300499\",\n \"SemanticContext\": \"Adverse reactions may include xerostomia dry mouth ; urinary hesitancy and retention; blurred vision and photophobia due to mydriasis dilation of the pupil ; cycloplegia; increased ocular tension; tachycardia; palpitation; decreased sweating; loss of taste; headache; nervousness; drowsiness; weakness; dizziness; insomnia; nausea; vomiting; impotence; suppression of lactation; constipation; bloated feeling; severe allergic reactions including anaphylactic/anaphylactoid reactions; hypersensitivity; urticaria, pruritus, dry skin, and other dermal manifestations; some degree of mental confusion and/or excitement, especially in elderly persons.\"\n }\n ]\n },\n {\n \"Term\": \"Dyspnoea\",\n \"MEDDRACode\": \"10013968\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"gasping\",\n \"Probability\": \"0.0507506132\",\n \"SemanticContext\": \"The “gasping syndrome,” characterized by central nervous system depression, metabolic acidosis, gasping respirations, and high levels of benzyl alcohol and its metabolites found in the blood and urine has been associated with benzyl alcohol dosages >99 mg/kg/day in neonates and low-birth-weight neonates.\"\n },\n {\n \"VerbatimTerm\": \"gasping\",\n \"Probability\": \"0.0507506132\",\n \"SemanticContext\": \"The “gasping syndrome,” characterized by central nervous system depression, metabolic acidosis, gasping respirations, and high levels of benzyl alcohol and its metabolites found in the blood and urine has been associated with benzyl alcohol dosages >99 mg/kg/day in neonates and low-birth-weight neonates.\"\n }\n ]\n },\n {\n \"Term\": \"Myasthenia gravis\",\n \"MEDDRACode\": \"10028417\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": true,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"myasthenia gravis\",\n \"Probability\": \"0.0096288621\",\n \"SemanticContext\": \"In addition, in the management of peptic ulcer patients, because of the longer duration of therapy, glycopyrrolate injection may be contraindicated in patients with the following concurrent conditions: glaucoma; obstructive uropathy for example, bladder neck obstruction due to prostatic hypertrophy ; obstructive disease of the gastrointestinal tract as in achalasia, pyloroduodenal stenosis, etc. ; paralytic ileus, intestinal atony of the elderly or debilitated patient; unstable cardiovascular status in acute hemorrhage; severe ulcerative colitis; toxic megacolon complicating ulcerative colitis; myasthenia gravis.\"\n }\n ]\n },\n {\n \"Term\": \"Blood pH increased\",\n \"MEDDRACode\": \"10005708\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"pH higher\",\n \"Probability\": \"0.9222848415\",\n \"SemanticContext\": \"These mixtures will result in a pH higher than 6.0 and may result in gas production or precipitation.\"\n }\n ]\n },\n {\n \"Term\": \"Analgesic drug level\",\n \"MEDDRACode\": \"10060090\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"salicylate\",\n \"Probability\": \"0.0026963651\",\n \"SemanticContext\": \"Glycopyrrolate injection is compatible for mixing and injection with the following injectable dosage forms: atropine sulfate, USP; Antilirium ® physostigmine salicylate ; Benadryl ® diphenhydramine HCl ; codeine phosphate, USP; Emete-Con ® benzquinamide HCl ; hydromorphone HCl, USP; Inapsine ® droperidol ; Levo-Dromoran ® levorphanol tartrate ; lidocaine, USP; meperidine HCl, USP; Mestinon ® /Regonol ® pyridostigmine bromide ; morphine sulfate, USP; Nubain ® nalbuphine HCl ; Numorphan ® oxymorphone HCl ; procaine HCl, USP; promethazine HCl, USP; Prostigmin ® neostigmine methylsulfate, USP ; scopolamine HBr, USP; Stadol ® butorphanol tartrate ; Sublimaze ® fentanyl citrate ; Tigan ® trimethobenzamide HCl ; and Vistaril ® hydroxyzine HCl .\"\n }\n ]\n },\n {\n \"Term\": \"Renal impairment\",\n \"MEDDRACode\": \"10062237\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Renal Impairment\",\n \"Probability\": \"0.3388841152\",\n \"SemanticContext\": \"Renal Impairment In one study glycopyrrolate was administered IV in uremic patients undergoing renal transplantation.\"\n },\n {\n \"VerbatimTerm\": \"Renal Impairment\",\n \"Probability\": \"0.0001334548\",\n \"SemanticContext\": \"Dosage adjustments may be necessary see Pharmacokinetics -- Renal Impairment .\"\n }\n ]\n },\n {\n \"Term\": \"Syringomyelia\",\n \"MEDDRACode\": \"10042928\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0006778836\",\n \"SemanticContext\": \"In order to minimize the appearance of cardiac side effects, the drugs may be administered simultaneously by intravenous injection and may be mixed in the same syringe.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0006778836\",\n \"SemanticContext\": \"In order to minimize the appearance of cardiac side effects, the drugs may be administered simultaneously by intravenous injection and may be mixed in the same syringe.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0006568134\",\n \"SemanticContext\": \"Admixture Incompatibilities PHYSICAL INCOMPATIBILITY Since the stability of glycopyrrolate is questionable above a pH of 6.0 do not combine glycopyrrolate injection in the same syringe with Brevital ® methohexital Na ; Chloromycetin ® chloramphenicol Na succinate ; Dramamine ® dimenhydrinate ; Nembutal ® pentobarbital Na ; Pentothal ® thiopental Na ; Seconal ® secobarbital Na ; sodium bicarbonate Abbott ; Valium ® diazepam ; Decadron ® dexamethasone Na phosphate ; or Talwin ® pentazocine lactate .\"\n }\n ]\n },\n {\n \"Term\": \"Anaesthesia\",\n \"MEDDRACode\": \"10002091\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"anesthesia\",\n \"Probability\": \"0.000667423\",\n \"SemanticContext\": \"Dysrhythmias associated with the use of glycopyrrolate intravenously as a premedicant or during anesthesia have been observed in pediatric patients.\"\n },\n {\n \"VerbatimTerm\": \"anesthesia\",\n \"Probability\": \"0.000667423\",\n \"SemanticContext\": \"Dysrhythmias associated with the use of glycopyrrolate intravenously as a premedicant or during anesthesia have been observed in pediatric patients.\"\n },\n {\n \"VerbatimTerm\": \"Anesthesia\",\n \"Probability\": \"0.0030552447\",\n \"SemanticContext\": \"INDICATIONS AND USAGE In Anesthesia Glycopyrrolate Injection is indicated for use as a preoperative antimuscarinic to reduce salivary, tracheobronchial, and pharyngeal secretions; to reduce the volume and free acidity of gastric secretions; and to block cardiac vagal inhibitory reflexes during induction of anesthesia and intubation.\"\n }\n ]\n },\n {\n \"Term\": \"Euphoric mood\",\n \"MEDDRACode\": \"10015535\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"high\",\n \"Probability\": \"9.91588E-05\",\n \"SemanticContext\": \"Administration of high dosages of medications containing this preservative must take into account the total amount of benzyl alcohol administered.\"\n },\n {\n \"VerbatimTerm\": \"high\",\n \"Probability\": \"0.0002324879\",\n \"SemanticContext\": \"In addition, in the presence of fever, high environmental temperature and/or during physical exercise, heat prostration can occur with use of anticholinergic agents including glycopyrrolate due to decreased sweating , particularly in children and the elderly.\"\n },\n {\n \"VerbatimTerm\": \"high\",\n \"Probability\": \"0.0007050335\",\n \"SemanticContext\": \"Other studies in dogs suggest that this may be due to diminished seminal secretion which is evident at high doses of glycopyrrolate.\"\n },\n {\n \"VerbatimTerm\": \"high\",\n \"Probability\": \"0.0010203123\",\n \"SemanticContext\": \"The “gasping syndrome,” characterized by central nervous system depression, metabolic acidosis, gasping respirations, and high levels of benzyl alcohol and its metabolites found in the blood and urine has been associated with benzyl alcohol dosages >99 mg/kg/day in neonates and low-birth-weight neonates.\"\n },\n {\n \"VerbatimTerm\": \"high\",\n \"Probability\": \"0.0001207923\",\n \"SemanticContext\": \"Premature and low-birthweight infants, as well as patients receiving high dosages, may be more likely to develop toxicity.\"\n },\n {\n \"VerbatimTerm\": \"high\",\n \"Probability\": \"0.0010203123\",\n \"SemanticContext\": \"The “gasping syndrome,” characterized by central nervous system depression, metabolic acidosis, gasping respirations, and high levels of benzyl alcohol and its metabolites found in the blood and urine has been associated with benzyl alcohol dosages >99 mg/kg/day in neonates and low-birth-weight neonates.\"\n },\n {\n \"VerbatimTerm\": \"high\",\n \"Probability\": \"0.0001207923\",\n \"SemanticContext\": \"Premature and low-birthweight infants, as well as patients receiving high dosages, may be more likely to develop toxicity.\"\n }\n ]\n },\n {\n \"Term\": \"Psychomotor hyperactivity\",\n \"MEDDRACode\": \"10037211\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"overactivity\",\n \"Probability\": \"0.0001398027\",\n \"SemanticContext\": \"This dosage may be repeated every five to ten minutes until anticholinergic overactivity is reversed or up to a maximum of 2.5 mg.\"\n }\n ]\n },\n {\n \"Term\": \"Hyperthyroidism\",\n \"MEDDRACode\": \"10020850\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hyperthyroidism\",\n \"Probability\": \"0.0368310809\",\n \"SemanticContext\": \"Use with caution in patients with: coronary artery disease; congestive heart failure; cardiac arrhythmias; hypertension; hyperthyroidism.\"\n }\n ]\n },\n {\n \"Term\": \"Blood bromide\",\n \"MEDDRACode\": \"10005373\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"bromide\",\n \"Probability\": \"0.000813961\",\n \"SemanticContext\": \"Glycopyrrolate is a quaternary ammonium salt with the following chemical name: 3[ cyclopentylhydroxyphenylacetyl oxy]-1,1-dimethyl pyrrolidinium bromide.\"\n },\n {\n \"VerbatimTerm\": \"bromide\",\n \"Probability\": \"0.0002941191\",\n \"SemanticContext\": \"Glycopyrrolate injection is compatible for mixing and injection with the following injectable dosage forms: atropine sulfate, USP; Antilirium ® physostigmine salicylate ; Benadryl ® diphenhydramine HCl ; codeine phosphate, USP; Emete-Con ® benzquinamide HCl ; hydromorphone HCl, USP; Inapsine ® droperidol ; Levo-Dromoran ® levorphanol tartrate ; lidocaine, USP; meperidine HCl, USP; Mestinon ® /Regonol ® pyridostigmine bromide ; morphine sulfate, USP; Nubain ® nalbuphine HCl ; Numorphan ® oxymorphone HCl ; procaine HCl, USP; promethazine HCl, USP; Prostigmin ® neostigmine methylsulfate, USP ; scopolamine HBr, USP; Stadol ® butorphanol tartrate ; Sublimaze ® fentanyl citrate ; Tigan ® trimethobenzamide HCl ; and Vistaril ® hydroxyzine HCl .\"\n }\n ]\n },\n {\n \"Term\": \"Weight\",\n \"MEDDRACode\": \"10047890\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"weight\",\n \"Probability\": \"0.005499512\",\n \"SemanticContext\": \"The molecular formula is C 19 H 28 BrNO 3 and the molecular weight is 398.34.\"\n }\n ]\n },\n {\n \"Term\": \"Flatulence\",\n \"MEDDRACode\": \"10016766\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"gas\",\n \"Probability\": \"0.2258955538\",\n \"SemanticContext\": \"These mixtures will result in a pH higher than 6.0 and may result in gas production or precipitation.\"\n }\n ]\n },\n {\n \"Term\": \"Pregnancy\",\n \"MEDDRACode\": \"10036556\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Pregnancy\",\n \"Probability\": \"0.0019910634\",\n \"SemanticContext\": \"Pregnancy TERATOGENIC EFFECTS Reproduction studies with glycopyrrolate were performed in rats at a dietary dose of approximately 65 mg/kg/day exposure was approximately 320 times the maximum recommended daily human dose of 2 mg on a mg/m 2 basis and rabbits at intramuscular doses of up to 0.5 mg/kg/day exposure was approximately 5 times the maximum recommended daily human dose on a mg/m 2 basis .\"\n },\n {\n \"VerbatimTerm\": \"Pregnancy\",\n \"Probability\": \"0.0019910634\",\n \"SemanticContext\": \"Pregnancy TERATOGENIC EFFECTS Reproduction studies with glycopyrrolate were performed in rats at a dietary dose of approximately 65 mg/kg/day exposure was approximately 320 times the maximum recommended daily human dose of 2 mg on a mg/m 2 basis and rabbits at intramuscular doses of up to 0.5 mg/kg/day exposure was approximately 5 times the maximum recommended daily human dose on a mg/m 2 basis .\"\n },\n {\n \"VerbatimTerm\": \"pregnancy\",\n \"Probability\": \"0.0001883507\",\n \"SemanticContext\": \"Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.\"\n },\n {\n \"VerbatimTerm\": \"pregnancy\",\n \"Probability\": \"0.0001978576\",\n \"SemanticContext\": \"NONTERATOGENIC EFFECTS Published literature suggest the following regarding the use of glycopyrrolate during pregnancy.\"\n },\n {\n \"VerbatimTerm\": \"pregnancy\",\n \"Probability\": \"0.0001883507\",\n \"SemanticContext\": \"Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.\"\n },\n {\n \"VerbatimTerm\": \"pregnancy\",\n \"Probability\": \"0.0001978576\",\n \"SemanticContext\": \"NONTERATOGENIC EFFECTS Published literature suggest the following regarding the use of glycopyrrolate during pregnancy.\"\n }\n ]\n },\n {\n \"Term\": \"Autonomic neuropathy\",\n \"MEDDRACode\": \"10061666\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"autonomic neuropathy\",\n \"Probability\": \"0.0143336356\",\n \"SemanticContext\": \"Use glycopyrrolate with caution in the elderly and in all patients with autonomic neuropathy, hepatic disease, ulcerative colitis, prostic hypertrophy, or hiatal hernia, since anticholinergic drugs may aggravate these conditions.\"\n }\n ]\n },\n {\n \"Term\": \"Colostomy\",\n \"MEDDRACode\": \"10010041\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"colostomy\",\n \"Probability\": \"5.6929E-05\",\n \"SemanticContext\": \"Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy.\"\n }\n ]\n },\n {\n \"Term\": \"Muscular weakness\",\n \"MEDDRACode\": \"10028372\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"muscular weakness\",\n \"Probability\": \"0.1612734199\",\n \"SemanticContext\": \"Following overdosage, a curare-like action may occur, i.e., neuromuscular blockade leading to muscular weakness and possible paralysis.\"\n }\n ]\n },\n {\n \"Term\": \"Supportive care\",\n \"MEDDRACode\": \"10068369\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"supportive care\",\n \"Probability\": \"6.174E-07\",\n \"SemanticContext\": \"To combat hypotension, administer IV fluids and/or pressor agents along with supportive care.\"\n }\n ]\n },\n {\n \"Term\": \"Cholinergic syndrome\",\n \"MEDDRACode\": \"10008674\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"muscarinic effects\",\n \"Probability\": \"0.020375222\",\n \"SemanticContext\": \"Glycopyrrolate protects against the peripheral muscarinic effects e.g., bradycardia and excessive secretions of cholinergic agents such as neostigmine and pyridostigmine given to reverse the neuromuscular blockade due to non-depolarizing muscle relaxants.\"\n }\n ]\n },\n {\n \"Term\": \"Pyrexia\",\n \"MEDDRACode\": \"10037660\",\n \"Overdose\": true,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Fever\",\n \"Probability\": \"0.0097416043\",\n \"SemanticContext\": \"Fever should be treated symptomatically.\"\n },\n {\n \"VerbatimTerm\": \"fever\",\n \"Probability\": \"0.0348789096\",\n \"SemanticContext\": \"In addition, in the presence of fever, high environmental temperature and/or during physical exercise, heat prostration can occur with use of anticholinergic agents including glycopyrrolate due to decreased sweating , particularly in children and the elderly.\"\n }\n ]\n },\n {\n \"Term\": \"Trisomy 21\",\n \"MEDDRACode\": \"10044688\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Down's syndrome\",\n \"Probability\": \"0.0180939138\",\n \"SemanticContext\": \"Infants, patients with Down's syndrome, and pediatric patients with spastic paralysis or brain damage may experience an increased response to anticholinergics, thus increasing the potential for side effects.\"\n },\n {\n \"VerbatimTerm\": \"Down's syndrome\",\n \"Probability\": \"0.0180939138\",\n \"SemanticContext\": \"Infants, patients with Down's syndrome, and pediatric patients with spastic paralysis or brain damage may experience an increased response to anticholinergics, thus increasing the potential for side effects.\"\n }\n ]\n },\n {\n \"Term\": \"Electrocardiogram QT interval\",\n \"MEDDRACode\": \"10014385\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"QTc\",\n \"Probability\": \"0.0003266633\",\n \"SemanticContext\": \"Post-marketing reports have included cases of heart block and QTc interval prolongation associated with the combined use of glycopyrrolate and an anticholinesterase.\"\n }\n ]\n },\n {\n \"Term\": \"Urinary hesitation\",\n \"MEDDRACode\": \"10046542\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"urinary hesitancy\",\n \"Probability\": \"0.9254028797\",\n \"SemanticContext\": \"Adverse reactions may include xerostomia dry mouth ; urinary hesitancy and retention; blurred vision and photophobia due to mydriasis dilation of the pupil ; cycloplegia; increased ocular tension; tachycardia; palpitation; decreased sweating; loss of taste; headache; nervousness; drowsiness; weakness; dizziness; insomnia; nausea; vomiting; impotence; suppression of lactation; constipation; bloated feeling; severe allergic reactions including anaphylactic/anaphylactoid reactions; hypersensitivity; urticaria, pruritus, dry skin, and other dermal manifestations; some degree of mental confusion and/or excitement, especially in elderly persons.\"\n }\n ]\n },\n {\n \"Term\": \"Intestinal atony\",\n \"MEDDRACode\": \"10068577\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": true,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"intestinal atony\",\n \"Probability\": \"0.9856381416\",\n \"SemanticContext\": \"In addition, in the management of peptic ulcer patients, because of the longer duration of therapy, glycopyrrolate injection may be contraindicated in patients with the following concurrent conditions: glaucoma; obstructive uropathy for example, bladder neck obstruction due to prostatic hypertrophy ; obstructive disease of the gastrointestinal tract as in achalasia, pyloroduodenal stenosis, etc. ; paralytic ileus, intestinal atony of the elderly or debilitated patient; unstable cardiovascular status in acute hemorrhage; severe ulcerative colitis; toxic megacolon complicating ulcerative colitis; myasthenia gravis.\"\n }\n ]\n },\n {\n \"Term\": \"Blood bicarbonate\",\n \"MEDDRACode\": \"10005357\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"bicarbonate\",\n \"Probability\": \"0.0008160472\",\n \"SemanticContext\": \"Admixture Incompatibilities PHYSICAL INCOMPATIBILITY Since the stability of glycopyrrolate is questionable above a pH of 6.0 do not combine glycopyrrolate injection in the same syringe with Brevital ® methohexital Na ; Chloromycetin ® chloramphenicol Na succinate ; Dramamine ® dimenhydrinate ; Nembutal ® pentobarbital Na ; Pentothal ® thiopental Na ; Seconal ® secobarbital Na ; sodium bicarbonate Abbott ; Valium ® diazepam ; Decadron ® dexamethasone Na phosphate ; or Talwin ® pentazocine lactate .\"\n }\n ]\n },\n {\n \"Term\": \"Endotracheal intubation\",\n \"MEDDRACode\": \"10067450\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"intubation\",\n \"Probability\": \"0.0015663207\",\n \"SemanticContext\": \"INDICATIONS AND USAGE In Anesthesia Glycopyrrolate Injection is indicated for use as a preoperative antimuscarinic to reduce salivary, tracheobronchial, and pharyngeal secretions; to reduce the volume and free acidity of gastric secretions; and to block cardiac vagal inhibitory reflexes during induction of anesthesia and intubation.\"\n }\n ]\n },\n {\n \"Term\": \"Restlessness\",\n \"MEDDRACode\": \"10038743\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"restlessness\",\n \"Probability\": \"0.0086043179\",\n \"SemanticContext\": \"If CNS symptoms e.g., excitement, restlessness, convulsions, psychotic behavior occur, physostigmine which does cross the blood--brain barrier may be used.\"\n }\n ]\n },\n {\n \"Term\": \"Brain injury\",\n \"MEDDRACode\": \"10067967\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"brain damage\",\n \"Probability\": \"0.0043599606\",\n \"SemanticContext\": \"Infants, patients with Down's syndrome, and pediatric patients with spastic paralysis or brain damage may experience an increased response to anticholinergics, thus increasing the potential for side effects.\"\n },\n {\n \"VerbatimTerm\": \"brain damage\",\n \"Probability\": \"0.0043599606\",\n \"SemanticContext\": \"Infants, patients with Down's syndrome, and pediatric patients with spastic paralysis or brain damage may experience an increased response to anticholinergics, thus increasing the potential for side effects.\"\n }\n ]\n }\n ],\n \"IndicationTerms\": []\n }\n ]\n },\n {\n \"GenericName\": \"allopurinol\",\n \"MeddraVersion\": \"24.0\",\n \"Labels\": [\n {\n \"Id\": \"US2acff21e-7d8f-4b03-b7b7-9400f54f66ac\",\n \"NDCCode\": \"67457-978\",\n \"UpdatedDate\": \"Feb 06, 2021\",\n \"LabelSource\": {\n \"Country\": \"us\",\n \"ProductId\": \"018525b1-e37d-4ff2-9dc3-36b3d90ac3e0\",\n \"FileId\": \"2acff21e-7d8f-4b03-b7b7-9400f54f66ac\",\n \"Version\": \"2\"\n },\n \"AdverseEventTerms\": [\n {\n \"Term\": \"Acute respiratory distress syndrome\",\n \"MEDDRACode\": \"10001052\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"ARDS\",\n \"Probability\": \"0.9892326593\",\n \"SemanticContext\": \"A listing of the adverse reactions regardless of causality reported from clinical trials follows: Incidence Greater Than 1%: Cutaneous/Dermatologic: rash 1.5% Genitourinary: renal failure/insufficiency 1.2% Gastrointestinal: nausea 1.3% , vomiting 1.2% Incidence Less Than 1%: Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECG abnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea Musculoskeletal: arthralgia Other: hypotonia, diaphoresis, tumor lysis syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Alopecia\",\n \"MEDDRACode\": \"10001760\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"alopecia\",\n \"Probability\": \"0.974013567\",\n \"SemanticContext\": \"A listing of the adverse reactions regardless of causality reported from clinical trials follows: Incidence Greater Than 1%: Cutaneous/Dermatologic: rash 1.5% Genitourinary: renal failure/insufficiency 1.2% Gastrointestinal: nausea 1.3% , vomiting 1.2% Incidence Less Than 1%: Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECG abnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea Musculoskeletal: arthralgia Other: hypotonia, diaphoresis, tumor lysis syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Anaemia\",\n \"MEDDRACode\": \"10002034\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"anemia\",\n \"Probability\": \"0.9973264933\",\n \"SemanticContext\": \"A listing of the adverse reactions regardless of causality reported from clinical trials follows: Incidence Greater Than 1%: Cutaneous/Dermatologic: rash 1.5% Genitourinary: renal failure/insufficiency 1.2% Gastrointestinal: nausea 1.3% , vomiting 1.2% Incidence Less Than 1%: Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECG abnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea Musculoskeletal: arthralgia Other: hypotonia, diaphoresis, tumor lysis syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Arthralgia\",\n \"MEDDRACode\": \"10003239\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"arthralgia\",\n \"Probability\": \"0.9907821417\",\n \"SemanticContext\": \"A listing of the adverse reactions regardless of causality reported from clinical trials follows: Incidence Greater Than 1%: Cutaneous/Dermatologic: rash 1.5% Genitourinary: renal failure/insufficiency 1.2% Gastrointestinal: nausea 1.3% , vomiting 1.2% Incidence Less Than 1%: Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECG abnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea Musculoskeletal: arthralgia Other: hypotonia, diaphoresis, tumor lysis syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Cardiac failure\",\n \"MEDDRACode\": \"10007554\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"heart failure\",\n \"Probability\": \"0.9848833084\",\n \"SemanticContext\": \"A listing of the adverse reactions regardless of causality reported from clinical trials follows: Incidence Greater Than 1%: Cutaneous/Dermatologic: rash 1.5% Genitourinary: renal failure/insufficiency 1.2% Gastrointestinal: nausea 1.3% , vomiting 1.2% Incidence Less Than 1%: Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECG abnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea Musculoskeletal: arthralgia Other: hypotonia, diaphoresis, tumor lysis syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Coma\",\n \"MEDDRACode\": \"10010071\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"coma\",\n \"Probability\": \"0.996800065\",\n \"SemanticContext\": \"A listing of the adverse reactions regardless of causality reported from clinical trials follows: Incidence Greater Than 1%: Cutaneous/Dermatologic: rash 1.5% Genitourinary: renal failure/insufficiency 1.2% Gastrointestinal: nausea 1.3% , vomiting 1.2% Incidence Less Than 1%: Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECG abnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea Musculoskeletal: arthralgia Other: hypotonia, diaphoresis, tumor lysis syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Cardio-respiratory arrest\",\n \"MEDDRACode\": \"10007617\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"cardiorespiratory arrest\",\n \"Probability\": \"0.9955924749\",\n \"SemanticContext\": \"A listing of the adverse reactions regardless of causality reported from clinical trials follows: Incidence Greater Than 1%: Cutaneous/Dermatologic: rash 1.5% Genitourinary: renal failure/insufficiency 1.2% Gastrointestinal: nausea 1.3% , vomiting 1.2% Incidence Less Than 1%: Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECG abnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea Musculoskeletal: arthralgia Other: hypotonia, diaphoresis, tumor lysis syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Cellulitis\",\n \"MEDDRACode\": \"10007882\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"cellulitis\",\n \"Probability\": \"0.9886650443\",\n \"SemanticContext\": \"A listing of the adverse reactions regardless of causality reported from clinical trials follows: Incidence Greater Than 1%: Cutaneous/Dermatologic: rash 1.5% Genitourinary: renal failure/insufficiency 1.2% Gastrointestinal: nausea 1.3% , vomiting 1.2% Incidence Less Than 1%: Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECG abnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea Musculoskeletal: arthralgia Other: hypotonia, diaphoresis, tumor lysis syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Disseminated intravascular coagulation\",\n \"MEDDRACode\": \"10013442\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"disseminated intravascular coagulation\",\n \"Probability\": \"0.619956851\",\n \"SemanticContext\": \"A listing of the adverse reactions regardless of causality reported from clinical trials follows: Incidence Greater Than 1%: Cutaneous/Dermatologic: rash 1.5% Genitourinary: renal failure/insufficiency 1.2% Gastrointestinal: nausea 1.3% , vomiting 1.2% Incidence Less Than 1%: Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECG abnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea Musculoskeletal: arthralgia Other: hypotonia, diaphoresis, tumor lysis syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Bradycardia\",\n \"MEDDRACode\": \"10006093\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"bradycardia\",\n \"Probability\": \"0.9989444017\",\n \"SemanticContext\": \"A listing of the adverse reactions regardless of causality reported from clinical trials follows: Incidence Greater Than 1%: Cutaneous/Dermatologic: rash 1.5% Genitourinary: renal failure/insufficiency 1.2% Gastrointestinal: nausea 1.3% , vomiting 1.2% Incidence Less Than 1%: Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECG abnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea Musculoskeletal: arthralgia Other: hypotonia, diaphoresis, tumor lysis syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Haematuria\",\n \"MEDDRACode\": \"10018867\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hematuria\",\n \"Probability\": \"0.9931617975\",\n \"SemanticContext\": \"A listing of the adverse reactions regardless of causality reported from clinical trials follows: Incidence Greater Than 1%: Cutaneous/Dermatologic: rash 1.5% Genitourinary: renal failure/insufficiency 1.2% Gastrointestinal: nausea 1.3% , vomiting 1.2% Incidence Less Than 1%: Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECG abnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea Musculoskeletal: arthralgia Other: hypotonia, diaphoresis, tumor lysis syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Chills\",\n \"MEDDRACode\": \"10008531\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"chills\",\n \"Probability\": \"0.9819316864\",\n \"SemanticContext\": \"A listing of the adverse reactions regardless of causality reported from clinical trials follows: Incidence Greater Than 1%: Cutaneous/Dermatologic: rash 1.5% Genitourinary: renal failure/insufficiency 1.2% Gastrointestinal: nausea 1.3% , vomiting 1.2% Incidence Less Than 1%: Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECG abnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea Musculoskeletal: arthralgia Other: hypotonia, diaphoresis, tumor lysis syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Electrocardiogram\",\n \"MEDDRACode\": \"10014362\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"ECG\",\n \"Probability\": \"0.825920701\",\n \"SemanticContext\": \"A listing of the adverse reactions regardless of causality reported from clinical trials follows: Incidence Greater Than 1%: Cutaneous/Dermatologic: rash 1.5% Genitourinary: renal failure/insufficiency 1.2% Gastrointestinal: nausea 1.3% , vomiting 1.2% Incidence Less Than 1%: Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECG abnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea Musculoskeletal: arthralgia Other: hypotonia, diaphoresis, tumor lysis syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Flushing\",\n \"MEDDRACode\": \"10016825\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"flushing\",\n \"Probability\": \"0.9969593883\",\n \"SemanticContext\": \"A listing of the adverse reactions regardless of causality reported from clinical trials follows: Incidence Greater Than 1%: Cutaneous/Dermatologic: rash 1.5% Genitourinary: renal failure/insufficiency 1.2% Gastrointestinal: nausea 1.3% , vomiting 1.2% Incidence Less Than 1%: Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECG abnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea Musculoskeletal: arthralgia Other: hypotonia, diaphoresis, tumor lysis syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Agitation\",\n \"MEDDRACode\": \"10001497\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"agitation\",\n \"Probability\": \"0.9878342152\",\n \"SemanticContext\": \"A listing of the adverse reactions regardless of causality reported from clinical trials follows: Incidence Greater Than 1%: Cutaneous/Dermatologic: rash 1.5% Genitourinary: renal failure/insufficiency 1.2% Gastrointestinal: nausea 1.3% , vomiting 1.2% Incidence Less Than 1%: Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECG abnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea Musculoskeletal: arthralgia Other: hypotonia, diaphoresis, tumor lysis syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Hypervolaemia\",\n \"MEDDRACode\": \"10020919\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hypervolemia\",\n \"Probability\": \"0.9825322628\",\n \"SemanticContext\": \"A listing of the adverse reactions regardless of causality reported from clinical trials follows: Incidence Greater Than 1%: Cutaneous/Dermatologic: rash 1.5% Genitourinary: renal failure/insufficiency 1.2% Gastrointestinal: nausea 1.3% , vomiting 1.2% Incidence Less Than 1%: Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECG abnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea Musculoskeletal: arthralgia Other: hypotonia, diaphoresis, tumor lysis syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Hypocalcaemia\",\n \"MEDDRACode\": \"10020947\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hypocalcemia\",\n \"Probability\": \"0.9962221384\",\n \"SemanticContext\": \"A listing of the adverse reactions regardless of causality reported from clinical trials follows: Incidence Greater Than 1%: Cutaneous/Dermatologic: rash 1.5% Genitourinary: renal failure/insufficiency 1.2% Gastrointestinal: nausea 1.3% , vomiting 1.2% Incidence Less Than 1%: Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECG abnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea Musculoskeletal: arthralgia Other: hypotonia, diaphoresis, tumor lysis syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Hyperphosphataemia\",\n \"MEDDRACode\": \"10020711\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hyperphosphatemia\",\n \"Probability\": \"0.991492033\",\n \"SemanticContext\": \"A listing of the adverse reactions regardless of causality reported from clinical trials follows: Incidence Greater Than 1%: Cutaneous/Dermatologic: rash 1.5% Genitourinary: renal failure/insufficiency 1.2% Gastrointestinal: nausea 1.3% , vomiting 1.2% Incidence Less Than 1%: Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECG abnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea Musculoskeletal: arthralgia Other: hypotonia, diaphoresis, tumor lysis syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Hypokalaemia\",\n \"MEDDRACode\": \"10021015\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hypokalemia\",\n \"Probability\": \"0.9985771179\",\n \"SemanticContext\": \"A listing of the adverse reactions regardless of causality reported from clinical trials follows: Incidence Greater Than 1%: Cutaneous/Dermatologic: rash 1.5% Genitourinary: renal failure/insufficiency 1.2% Gastrointestinal: nausea 1.3% , vomiting 1.2% Incidence Less Than 1%: Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECG abnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea Musculoskeletal: arthralgia Other: hypotonia, diaphoresis, tumor lysis syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Apnoea\",\n \"MEDDRACode\": \"10002974\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"apnea\",\n \"Probability\": \"0.99490273\",\n \"SemanticContext\": \"A listing of the adverse reactions regardless of causality reported from clinical trials follows: Incidence Greater Than 1%: Cutaneous/Dermatologic: rash 1.5% Genitourinary: renal failure/insufficiency 1.2% Gastrointestinal: nausea 1.3% , vomiting 1.2% Incidence Less Than 1%: Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECG abnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea Musculoskeletal: arthralgia Other: hypotonia, diaphoresis, tumor lysis syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Cerebral infarction\",\n \"MEDDRACode\": \"10008118\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"cerebral infarction\",\n \"Probability\": \"0.9936599731\",\n \"SemanticContext\": \"A listing of the adverse reactions regardless of causality reported from clinical trials follows: Incidence Greater Than 1%: Cutaneous/Dermatologic: rash 1.5% Genitourinary: renal failure/insufficiency 1.2% Gastrointestinal: nausea 1.3% , vomiting 1.2% Incidence Less Than 1%: Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECG abnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea Musculoskeletal: arthralgia Other: hypotonia, diaphoresis, tumor lysis syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Hypernatraemia\",\n \"MEDDRACode\": \"10020679\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hypernatremia\",\n \"Probability\": \"0.9939175248\",\n \"SemanticContext\": \"A listing of the adverse reactions regardless of causality reported from clinical trials follows: Incidence Greater Than 1%: Cutaneous/Dermatologic: rash 1.5% Genitourinary: renal failure/insufficiency 1.2% Gastrointestinal: nausea 1.3% , vomiting 1.2% Incidence Less Than 1%: Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECG abnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea Musculoskeletal: arthralgia Other: hypotonia, diaphoresis, tumor lysis syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Aplasia\",\n \"MEDDRACode\": \"10002961\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"aplasia\",\n \"Probability\": \"0.9798099399\",\n \"SemanticContext\": \"A listing of the adverse reactions regardless of causality reported from clinical trials follows: Incidence Greater Than 1%: Cutaneous/Dermatologic: rash 1.5% Genitourinary: renal failure/insufficiency 1.2% Gastrointestinal: nausea 1.3% , vomiting 1.2% Incidence Less Than 1%: Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECG abnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea Musculoskeletal: arthralgia Other: hypotonia, diaphoresis, tumor lysis syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Haemorrhage\",\n \"MEDDRACode\": \"10055798\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hemorrhage\",\n \"Probability\": \"0.9960540533\",\n \"SemanticContext\": \"A listing of the adverse reactions regardless of causality reported from clinical trials follows: Incidence Greater Than 1%: Cutaneous/Dermatologic: rash 1.5% Genitourinary: renal failure/insufficiency 1.2% Gastrointestinal: nausea 1.3% , vomiting 1.2% Incidence Less Than 1%: Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECG abnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea Musculoskeletal: arthralgia Other: hypotonia, diaphoresis, tumor lysis syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Hyponatraemia\",\n \"MEDDRACode\": \"10021036\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hyponatremia\",\n \"Probability\": \"0.9975528717\",\n \"SemanticContext\": \"A listing of the adverse reactions regardless of causality reported from clinical trials follows: Incidence Greater Than 1%: Cutaneous/Dermatologic: rash 1.5% Genitourinary: renal failure/insufficiency 1.2% Gastrointestinal: nausea 1.3% , vomiting 1.2% Incidence Less Than 1%: Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECG abnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea Musculoskeletal: arthralgia Other: hypotonia, diaphoresis, tumor lysis syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Abdominal distension\",\n \"MEDDRACode\": \"10000060\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"enlarged abdomen\",\n \"Probability\": \"0.993304193\",\n \"SemanticContext\": \"A listing of the adverse reactions regardless of causality reported from clinical trials follows: Incidence Greater Than 1%: Cutaneous/Dermatologic: rash 1.5% Genitourinary: renal failure/insufficiency 1.2% Gastrointestinal: nausea 1.3% , vomiting 1.2% Incidence Less Than 1%: Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECG abnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea Musculoskeletal: arthralgia Other: hypotonia, diaphoresis, tumor lysis syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Diarrhoea\",\n \"MEDDRACode\": \"10012735\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"diarrhea\",\n \"Probability\": \"0.9815238118\",\n \"SemanticContext\": \"One adverse experience of severe diarrhea and one incidence of nausea were also reported as being possibly attributable to ALOPRIM allopurinol for Injection.\"\n },\n {\n \"VerbatimTerm\": \"diarrhea\",\n \"Probability\": \"0.9986451268\",\n \"SemanticContext\": \"A listing of the adverse reactions regardless of causality reported from clinical trials follows: Incidence Greater Than 1%: Cutaneous/Dermatologic: rash 1.5% Genitourinary: renal failure/insufficiency 1.2% Gastrointestinal: nausea 1.3% , vomiting 1.2% Incidence Less Than 1%: Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECG abnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea Musculoskeletal: arthralgia Other: hypotonia, diaphoresis, tumor lysis syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Cerebrovascular accident\",\n \"MEDDRACode\": \"10008190\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"stroke\",\n \"Probability\": \"0.9870914221\",\n \"SemanticContext\": \"A listing of the adverse reactions regardless of causality reported from clinical trials follows: Incidence Greater Than 1%: Cutaneous/Dermatologic: rash 1.5% Genitourinary: renal failure/insufficiency 1.2% Gastrointestinal: nausea 1.3% , vomiting 1.2% Incidence Less Than 1%: Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECG abnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea Musculoskeletal: arthralgia Other: hypotonia, diaphoresis, tumor lysis syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Hepatic failure\",\n \"MEDDRACode\": \"10019663\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"liver failure\",\n \"Probability\": \"0.9963355064\",\n \"SemanticContext\": \"A listing of the adverse reactions regardless of causality reported from clinical trials follows: Incidence Greater Than 1%: Cutaneous/Dermatologic: rash 1.5% Genitourinary: renal failure/insufficiency 1.2% Gastrointestinal: nausea 1.3% , vomiting 1.2% Incidence Less Than 1%: Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECG abnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea Musculoskeletal: arthralgia Other: hypotonia, diaphoresis, tumor lysis syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Headache\",\n \"MEDDRACode\": \"10019211\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"headache\",\n \"Probability\": \"0.9980645776\",\n \"SemanticContext\": \"A listing of the adverse reactions regardless of causality reported from clinical trials follows: Incidence Greater Than 1%: Cutaneous/Dermatologic: rash 1.5% Genitourinary: renal failure/insufficiency 1.2% Gastrointestinal: nausea 1.3% , vomiting 1.2% Incidence Less Than 1%: Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECG abnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea Musculoskeletal: arthralgia Other: hypotonia, diaphoresis, tumor lysis syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Gastrointestinal haemorrhage\",\n \"MEDDRACode\": \"10017955\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"gastrointestinal bleeding\",\n \"Probability\": \"0.9949218035\",\n \"SemanticContext\": \"A listing of the adverse reactions regardless of causality reported from clinical trials follows: Incidence Greater Than 1%: Cutaneous/Dermatologic: rash 1.5% Genitourinary: renal failure/insufficiency 1.2% Gastrointestinal: nausea 1.3% , vomiting 1.2% Incidence Less Than 1%: Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECG abnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea Musculoskeletal: arthralgia Other: hypotonia, diaphoresis, tumor lysis syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Lactic acidosis\",\n \"MEDDRACode\": \"10023676\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"lactic acidosis\",\n \"Probability\": \"0.9787368178\",\n \"SemanticContext\": \"A listing of the adverse reactions regardless of causality reported from clinical trials follows: Incidence Greater Than 1%: Cutaneous/Dermatologic: rash 1.5% Genitourinary: renal failure/insufficiency 1.2% Gastrointestinal: nausea 1.3% , vomiting 1.2% Incidence Less Than 1%: Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECG abnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea Musculoskeletal: arthralgia Other: hypotonia, diaphoresis, tumor lysis syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Hyperbilirubinaemia\",\n \"MEDDRACode\": \"10020578\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hyperbilirubinemia\",\n \"Probability\": \"0.9982037544\",\n \"SemanticContext\": \"A listing of the adverse reactions regardless of causality reported from clinical trials follows: Incidence Greater Than 1%: Cutaneous/Dermatologic: rash 1.5% Genitourinary: renal failure/insufficiency 1.2% Gastrointestinal: nausea 1.3% , vomiting 1.2% Incidence Less Than 1%: Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECG abnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea Musculoskeletal: arthralgia Other: hypotonia, diaphoresis, tumor lysis syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Respiratory failure\",\n \"MEDDRACode\": \"10038695\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"respiratory failure\",\n \"Probability\": \"0.9814435244\",\n \"SemanticContext\": \"A listing of the adverse reactions regardless of causality reported from clinical trials follows: Incidence Greater Than 1%: Cutaneous/Dermatologic: rash 1.5% Genitourinary: renal failure/insufficiency 1.2% Gastrointestinal: nausea 1.3% , vomiting 1.2% Incidence Less Than 1%: Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECG abnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea Musculoskeletal: arthralgia Other: hypotonia, diaphoresis, tumor lysis syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Respiratory rate increased\",\n \"MEDDRACode\": \"10038712\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"increased respiration rate\",\n \"Probability\": \"0.9976735711\",\n \"SemanticContext\": \"A listing of the adverse reactions regardless of causality reported from clinical trials follows: Incidence Greater Than 1%: Cutaneous/Dermatologic: rash 1.5% Genitourinary: renal failure/insufficiency 1.2% Gastrointestinal: nausea 1.3% , vomiting 1.2% Incidence Less Than 1%: Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECG abnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea Musculoskeletal: arthralgia Other: hypotonia, diaphoresis, tumor lysis syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Proctitis\",\n \"MEDDRACode\": \"10036774\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"proctitis\",\n \"Probability\": \"0.9920524955\",\n \"SemanticContext\": \"A listing of the adverse reactions regardless of causality reported from clinical trials follows: Incidence Greater Than 1%: Cutaneous/Dermatologic: rash 1.5% Genitourinary: renal failure/insufficiency 1.2% Gastrointestinal: nausea 1.3% , vomiting 1.2% Incidence Less Than 1%: Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECG abnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea Musculoskeletal: arthralgia Other: hypotonia, diaphoresis, tumor lysis syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Pyrexia\",\n \"MEDDRACode\": \"10037660\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"fever\",\n \"Probability\": \"0.9978833795\",\n \"SemanticContext\": \"A listing of the adverse reactions regardless of causality reported from clinical trials follows: Incidence Greater Than 1%: Cutaneous/Dermatologic: rash 1.5% Genitourinary: renal failure/insufficiency 1.2% Gastrointestinal: nausea 1.3% , vomiting 1.2% Incidence Less Than 1%: Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECG abnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea Musculoskeletal: arthralgia Other: hypotonia, diaphoresis, tumor lysis syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Injection site reaction\",\n \"MEDDRACode\": \"10022095\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"injection site reaction\",\n \"Probability\": \"0.9415088892\",\n \"SemanticContext\": \"Fifteen of these adverse experiences were allergic in nature rash, eosinophilia, local injection site reaction .\"\n },\n {\n \"VerbatimTerm\": \"injection site reaction\",\n \"Probability\": \"0.992401123\",\n \"SemanticContext\": \"A listing of the adverse reactions regardless of causality reported from clinical trials follows: Incidence Greater Than 1%: Cutaneous/Dermatologic: rash 1.5% Genitourinary: renal failure/insufficiency 1.2% Gastrointestinal: nausea 1.3% , vomiting 1.2% Incidence Less Than 1%: Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECG abnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea Musculoskeletal: arthralgia Other: hypotonia, diaphoresis, tumor lysis syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Leukopenia\",\n \"MEDDRACode\": \"10024384\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"leukopenia\",\n \"Probability\": \"0.9997218847\",\n \"SemanticContext\": \"A listing of the adverse reactions regardless of causality reported from clinical trials follows: Incidence Greater Than 1%: Cutaneous/Dermatologic: rash 1.5% Genitourinary: renal failure/insufficiency 1.2% Gastrointestinal: nausea 1.3% , vomiting 1.2% Incidence Less Than 1%: Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECG abnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea Musculoskeletal: arthralgia Other: hypotonia, diaphoresis, tumor lysis syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Seizure\",\n \"MEDDRACode\": \"10039906\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"seizure\",\n \"Probability\": \"0.935611248\",\n \"SemanticContext\": \"Two patients had serious adverse experiences decreased renal function and generalized seizure reported as being possibly attributable to ALOPRIM allopurinol for Injection.\"\n },\n {\n \"VerbatimTerm\": \"seizure\",\n \"Probability\": \"0.9923551083\",\n \"SemanticContext\": \"A listing of the adverse reactions regardless of causality reported from clinical trials follows: Incidence Greater Than 1%: Cutaneous/Dermatologic: rash 1.5% Genitourinary: renal failure/insufficiency 1.2% Gastrointestinal: nausea 1.3% , vomiting 1.2% Incidence Less Than 1%: Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECG abnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea Musculoskeletal: arthralgia Other: hypotonia, diaphoresis, tumor lysis syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Urticaria\",\n \"MEDDRACode\": \"10046735\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"urticarial\",\n \"Probability\": \"0.973472774\",\n \"SemanticContext\": \"Other serious hypersensitivity reactions that have been reported include exfoliative, urticarial and purpuric lesions; generalized vasculitis; and irreversible hepatotoxicity.\"\n }\n ]\n },\n {\n \"Term\": \"Intestinal obstruction\",\n \"MEDDRACode\": \"10022687\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"intestinal obstruction\",\n \"Probability\": \"0.9965773225\",\n \"SemanticContext\": \"A listing of the adverse reactions regardless of causality reported from clinical trials follows: Incidence Greater Than 1%: Cutaneous/Dermatologic: rash 1.5% Genitourinary: renal failure/insufficiency 1.2% Gastrointestinal: nausea 1.3% , vomiting 1.2% Incidence Less Than 1%: Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECG abnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea Musculoskeletal: arthralgia Other: hypotonia, diaphoresis, tumor lysis syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Neutropenia\",\n \"MEDDRACode\": \"10029354\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"neutropenia\",\n \"Probability\": \"0.9972655773\",\n \"SemanticContext\": \"A listing of the adverse reactions regardless of causality reported from clinical trials follows: Incidence Greater Than 1%: Cutaneous/Dermatologic: rash 1.5% Genitourinary: renal failure/insufficiency 1.2% Gastrointestinal: nausea 1.3% , vomiting 1.2% Incidence Less Than 1%: Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECG abnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea Musculoskeletal: arthralgia Other: hypotonia, diaphoresis, tumor lysis syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Oedema\",\n \"MEDDRACode\": \"10030095\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"edema\",\n \"Probability\": \"0.9738371372\",\n \"SemanticContext\": \"A listing of the adverse reactions regardless of causality reported from clinical trials follows: Incidence Greater Than 1%: Cutaneous/Dermatologic: rash 1.5% Genitourinary: renal failure/insufficiency 1.2% Gastrointestinal: nausea 1.3% , vomiting 1.2% Incidence Less Than 1%: Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECG abnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea Musculoskeletal: arthralgia Other: hypotonia, diaphoresis, tumor lysis syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Eosinophilia\",\n \"MEDDRACode\": \"10014950\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"eosinophilia\",\n \"Probability\": \"0.9963283539\",\n \"SemanticContext\": \"Fifteen of these adverse experiences were allergic in nature rash, eosinophilia, local injection site reaction .\"\n },\n {\n \"VerbatimTerm\": \"eosinophilia\",\n \"Probability\": \"0.9909427166\",\n \"SemanticContext\": \"A listing of the adverse reactions regardless of causality reported from clinical trials follows: Incidence Greater Than 1%: Cutaneous/Dermatologic: rash 1.5% Genitourinary: renal failure/insufficiency 1.2% Gastrointestinal: nausea 1.3% , vomiting 1.2% Incidence Less Than 1%: Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECG abnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea Musculoskeletal: arthralgia Other: hypotonia, diaphoresis, tumor lysis syndrome .\"\n },\n {\n \"VerbatimTerm\": \"eosinophilia\",\n \"Probability\": \"0.4574880004\",\n \"SemanticContext\": \"Serious and sometimes fatal dermatologic reactions, including toxic epidermal necrolysis TEN , Stevens-Johnson syndrome SJS , and drug reaction with eosinophilia and systemic symptoms DRESS have been reported in patients taking allopurinol.\"\n }\n ]\n },\n {\n \"Term\": \"Hypertension\",\n \"MEDDRACode\": \"10020772\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hypertension\",\n \"Probability\": \"0.997330904\",\n \"SemanticContext\": \"A listing of the adverse reactions regardless of causality reported from clinical trials follows: Incidence Greater Than 1%: Cutaneous/Dermatologic: rash 1.5% Genitourinary: renal failure/insufficiency 1.2% Gastrointestinal: nausea 1.3% , vomiting 1.2% Incidence Less Than 1%: Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECG abnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea Musculoskeletal: arthralgia Other: hypotonia, diaphoresis, tumor lysis syndrome .\"\n },\n {\n \"VerbatimTerm\": \"hypertension\",\n \"Probability\": \"0.0010468066\",\n \"SemanticContext\": \"In patients with decreased renal function, or who have concurrent illnesses which can affect renal function such as hypertension and diabetes mellitus, periodic laboratory parameters of renal function, particularly BUN and serum creatinine or creatinine clearance, should be performed and the patient’s allopurinol dosage reassessed.\"\n }\n ]\n },\n {\n \"Term\": \"Tremor\",\n \"MEDDRACode\": \"10044565\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"tremor\",\n \"Probability\": \"0.9778693914\",\n \"SemanticContext\": \"A listing of the adverse reactions regardless of causality reported from clinical trials follows: Incidence Greater Than 1%: Cutaneous/Dermatologic: rash 1.5% Genitourinary: renal failure/insufficiency 1.2% Gastrointestinal: nausea 1.3% , vomiting 1.2% Incidence Less Than 1%: Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECG abnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea Musculoskeletal: arthralgia Other: hypotonia, diaphoresis, tumor lysis syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Paralysis\",\n \"MEDDRACode\": \"10033799\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"paralysis\",\n \"Probability\": \"0.9900040627\",\n \"SemanticContext\": \"A listing of the adverse reactions regardless of causality reported from clinical trials follows: Incidence Greater Than 1%: Cutaneous/Dermatologic: rash 1.5% Genitourinary: renal failure/insufficiency 1.2% Gastrointestinal: nausea 1.3% , vomiting 1.2% Incidence Less Than 1%: Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECG abnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea Musculoskeletal: arthralgia Other: hypotonia, diaphoresis, tumor lysis syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Pruritus\",\n \"MEDDRACode\": \"10037087\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"pruritus\",\n \"Probability\": \"0.9990013838\",\n \"SemanticContext\": \"A listing of the adverse reactions regardless of causality reported from clinical trials follows: Incidence Greater Than 1%: Cutaneous/Dermatologic: rash 1.5% Genitourinary: renal failure/insufficiency 1.2% Gastrointestinal: nausea 1.3% , vomiting 1.2% Incidence Less Than 1%: Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECG abnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea Musculoskeletal: arthralgia Other: hypotonia, diaphoresis, tumor lysis syndrome .\"\n },\n {\n \"VerbatimTerm\": \"pruritus\",\n \"Probability\": \"0.1071986258\",\n \"SemanticContext\": \"If anorexia, weight loss, or pruritus develop in patients on allopurinol, evaluation of liver function should be part of their diagnostic workup.\"\n }\n ]\n },\n {\n \"Term\": \"Nausea\",\n \"MEDDRACode\": \"10028813\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"nausea\",\n \"Probability\": \"0.9968652725\",\n \"SemanticContext\": \"One adverse experience of severe diarrhea and one incidence of nausea were also reported as being possibly attributable to ALOPRIM allopurinol for Injection.\"\n },\n {\n \"VerbatimTerm\": \"nausea\",\n \"Probability\": \"0.9998202324\",\n \"SemanticContext\": \"A listing of the adverse reactions regardless of causality reported from clinical trials follows: Incidence Greater Than 1%: Cutaneous/Dermatologic: rash 1.5% Genitourinary: renal failure/insufficiency 1.2% Gastrointestinal: nausea 1.3% , vomiting 1.2% Incidence Less Than 1%: Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECG abnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea Musculoskeletal: arthralgia Other: hypotonia, diaphoresis, tumor lysis syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Septic shock\",\n \"MEDDRACode\": \"10040070\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"septic shock\",\n \"Probability\": \"0.9910261631\",\n \"SemanticContext\": \"A listing of the adverse reactions regardless of causality reported from clinical trials follows: Incidence Greater Than 1%: Cutaneous/Dermatologic: rash 1.5% Genitourinary: renal failure/insufficiency 1.2% Gastrointestinal: nausea 1.3% , vomiting 1.2% Incidence Less Than 1%: Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECG abnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea Musculoskeletal: arthralgia Other: hypotonia, diaphoresis, tumor lysis syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Status epilepticus\",\n \"MEDDRACode\": \"10041962\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"status epilepticus\",\n \"Probability\": \"0.9896459579\",\n \"SemanticContext\": \"A listing of the adverse reactions regardless of causality reported from clinical trials follows: Incidence Greater Than 1%: Cutaneous/Dermatologic: rash 1.5% Genitourinary: renal failure/insufficiency 1.2% Gastrointestinal: nausea 1.3% , vomiting 1.2% Incidence Less Than 1%: Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECG abnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea Musculoskeletal: arthralgia Other: hypotonia, diaphoresis, tumor lysis syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Ultrasound scan\",\n \"MEDDRACode\": \"10045434\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"U.S.\",\n \"Probability\": \"4.87882E-05\",\n \"SemanticContext\": \"Clinical Trials A compassionate plea trial was conducted from 1977 through 1989 in which 718 evaluable patients with malignancies requiring treatment with cytotoxic chemotherapy, but who were unable to ingest or retain oral medication, received i.v. ALOPRIM allopurinol for Injection in the U.S. Of these patients, 411 had established hyperuricemia and 307 had normal serum urate levels at the time that treatment was initiated.\"\n }\n ]\n },\n {\n \"Term\": \"Blood chloride\",\n \"MEDDRACode\": \"10005416\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Chloride\",\n \"Probability\": \"9.46359E-05\",\n \"SemanticContext\": \"It should be diluted to the desired concentration with 0.9% Sodium Chloride Injection or 5% Dextrose for Injection.\"\n }\n ]\n },\n {\n \"Term\": \"Venous pressure decreased\",\n \"MEDDRACode\": \"10047235\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"decreased venous pressure\",\n \"Probability\": \"0.9989339113\",\n \"SemanticContext\": \"A listing of the adverse reactions regardless of causality reported from clinical trials follows: Incidence Greater Than 1%: Cutaneous/Dermatologic: rash 1.5% Genitourinary: renal failure/insufficiency 1.2% Gastrointestinal: nausea 1.3% , vomiting 1.2% Incidence Less Than 1%: Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECG abnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea Musculoskeletal: arthralgia Other: hypotonia, diaphoresis, tumor lysis syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Oliguria\",\n \"MEDDRACode\": \"10030302\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"oliguria\",\n \"Probability\": \"0.9998319149\",\n \"SemanticContext\": \"A listing of the adverse reactions regardless of causality reported from clinical trials follows: Incidence Greater Than 1%: Cutaneous/Dermatologic: rash 1.5% Genitourinary: renal failure/insufficiency 1.2% Gastrointestinal: nausea 1.3% , vomiting 1.2% Incidence Less Than 1%: Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECG abnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea Musculoskeletal: arthralgia Other: hypotonia, diaphoresis, tumor lysis syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Thrombophlebitis\",\n \"MEDDRACode\": \"10043570\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"thrombophlebitis\",\n \"Probability\": \"0.9985886812\",\n \"SemanticContext\": \"A listing of the adverse reactions regardless of causality reported from clinical trials follows: Incidence Greater Than 1%: Cutaneous/Dermatologic: rash 1.5% Genitourinary: renal failure/insufficiency 1.2% Gastrointestinal: nausea 1.3% , vomiting 1.2% Incidence Less Than 1%: Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECG abnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea Musculoskeletal: arthralgia Other: hypotonia, diaphoresis, tumor lysis syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Ventricular fibrillation\",\n \"MEDDRACode\": \"10047290\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"ventricular fibrillation\",\n \"Probability\": \"0.9947715402\",\n \"SemanticContext\": \"A listing of the adverse reactions regardless of causality reported from clinical trials follows: Incidence Greater Than 1%: Cutaneous/Dermatologic: rash 1.5% Genitourinary: renal failure/insufficiency 1.2% Gastrointestinal: nausea 1.3% , vomiting 1.2% Incidence Less Than 1%: Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECG abnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea Musculoskeletal: arthralgia Other: hypotonia, diaphoresis, tumor lysis syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Urinary tract infection\",\n \"MEDDRACode\": \"10046571\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"urinary tract infection\",\n \"Probability\": \"0.9922440052\",\n \"SemanticContext\": \"A listing of the adverse reactions regardless of causality reported from clinical trials follows: Incidence Greater Than 1%: Cutaneous/Dermatologic: rash 1.5% Genitourinary: renal failure/insufficiency 1.2% Gastrointestinal: nausea 1.3% , vomiting 1.2% Incidence Less Than 1%: Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECG abnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea Musculoskeletal: arthralgia Other: hypotonia, diaphoresis, tumor lysis syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Neoplasm\",\n \"MEDDRACode\": \"10028980\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"solid tumor\",\n \"Probability\": \"8.5635E-05\",\n \"SemanticContext\": \"INDICATIONS AND USAGE ALOPRIM allopurinol for Injection is indicated for the management of patients with leukemia, lymphoma, and solid tumor malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels and who cannot tolerate oral therapy.\"\n }\n ]\n },\n {\n \"Term\": \"Hypoglycaemia\",\n \"MEDDRACode\": \"10020993\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hypoglycemia\",\n \"Probability\": \"0.0683658421\",\n \"SemanticContext\": \"The risk of hypoglycemia secondary to this mechanism may be increased if allopurinol and chlorpropamide are given concomitantly in the presence of renal insufficiency.\"\n },\n {\n \"VerbatimTerm\": \"hypoglycemia\",\n \"Probability\": \"0.0683658421\",\n \"SemanticContext\": \"The risk of hypoglycemia secondary to this mechanism may be increased if allopurinol and chlorpropamide are given concomitantly in the presence of renal insufficiency.\"\n }\n ]\n },\n {\n \"Term\": \"Blood sodium\",\n \"MEDDRACode\": \"10005799\",\n \"Overdose\": true,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": true,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": true,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"1.64402E-05\",\n \"SemanticContext\": \"Each vial contains 500 mg of allopurinol equivalent to 580.7 mg of allopurinol sodium and 148 mg of sodium hydroxide as a solubilizer.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"8.98525E-05\",\n \"SemanticContext\": \"Each vial contains 500 mg of allopurinol equivalent to 580.7 mg of allopurinol sodium and 148 mg of sodium hydroxide as a solubilizer.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"2.4977E-05\",\n \"SemanticContext\": \"The chemical name for allopurinol sodium is 1,5-dihydro-4 H -pyrazolo[3,4- d ]pyrimidin-4-one monosodium salt.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0003026724\",\n \"SemanticContext\": \"The structural formula is: The pKa of allopurinol sodium is 9.31.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0006832778\",\n \"SemanticContext\": \"Drugs That Are Physically Incompatible in Solution with ALOPRIM ® allopurinol for Injection Amikacin sulfate Hydroxyzine HCl Amphotericin B Idarubicin HCl Carmustine Imipenem-cilastatin sodium Cefotaxime sodium Mechlorethamine HCl Chlorpromazine HCl Meperidine HCl Cimetidine HCl Metoclopramide HCl Clindamycin phosphate Methylprednisolone sodium succinate Cytarabine Minocycline HCl Dacarbazine Nalbuphine HCl Daunorubicin HCl Netilmicin sulfate Diphenhydramine HCl Ondansetron HCl Doxorubicin HCl Prochlorperazine edisylate Doxycycline hyclate Promethazine HCl Droperidol Sodium bicarbonate Floxuridine Streptozocin Gentamicin sulfate Tobramycin sulfate Haloperidol lactate Vinorelbine tartrate .\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0079203844\",\n \"SemanticContext\": \"Drugs That Are Physically Incompatible in Solution with ALOPRIM ® allopurinol for Injection Amikacin sulfate Hydroxyzine HCl Amphotericin B Idarubicin HCl Carmustine Imipenem-cilastatin sodium Cefotaxime sodium Mechlorethamine HCl Chlorpromazine HCl Meperidine HCl Cimetidine HCl Metoclopramide HCl Clindamycin phosphate Methylprednisolone sodium succinate Cytarabine Minocycline HCl Dacarbazine Nalbuphine HCl Daunorubicin HCl Netilmicin sulfate Diphenhydramine HCl Ondansetron HCl Doxorubicin HCl Prochlorperazine edisylate Doxycycline hyclate Promethazine HCl Droperidol Sodium bicarbonate Floxuridine Streptozocin Gentamicin sulfate Tobramycin sulfate Haloperidol lactate Vinorelbine tartrate .\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0005155206\",\n \"SemanticContext\": \"Drugs That Are Physically Incompatible in Solution with ALOPRIM ® allopurinol for Injection Amikacin sulfate Hydroxyzine HCl Amphotericin B Idarubicin HCl Carmustine Imipenem-cilastatin sodium Cefotaxime sodium Mechlorethamine HCl Chlorpromazine HCl Meperidine HCl Cimetidine HCl Metoclopramide HCl Clindamycin phosphate Methylprednisolone sodium succinate Cytarabine Minocycline HCl Dacarbazine Nalbuphine HCl Daunorubicin HCl Netilmicin sulfate Diphenhydramine HCl Ondansetron HCl Doxorubicin HCl Prochlorperazine edisylate Doxycycline hyclate Promethazine HCl Droperidol Sodium bicarbonate Floxuridine Streptozocin Gentamicin sulfate Tobramycin sulfate Haloperidol lactate Vinorelbine tartrate .\"\n },\n {\n \"VerbatimTerm\": \"Sodium\",\n \"Probability\": \"8.57397E-05\",\n \"SemanticContext\": \"Sodium hydroxide is also used as a pH adjuster.\"\n },\n {\n \"VerbatimTerm\": \"Sodium\",\n \"Probability\": \"0.0001749396\",\n \"SemanticContext\": \"Allopurinol Sodium Structural Formula CLINICAL PHARMACOLOGY Allopurinol acts on purine catabolism without disrupting the biosynthesis of purines.\"\n },\n {\n \"VerbatimTerm\": \"Sodium\",\n \"Probability\": \"7.34274E-05\",\n \"SemanticContext\": \"It should be diluted to the desired concentration with 0.9% Sodium Chloride Injection or 5% Dextrose for Injection.\"\n },\n {\n \"VerbatimTerm\": \"Sodium\",\n \"Probability\": \"0.00016132\",\n \"SemanticContext\": \"Sodium bicarbonate-containing solutions should not be used.\"\n },\n {\n \"VerbatimTerm\": \"Sodium\",\n \"Probability\": \"0.0022670925\",\n \"SemanticContext\": \"Drugs That Are Physically Incompatible in Solution with ALOPRIM ® allopurinol for Injection Amikacin sulfate Hydroxyzine HCl Amphotericin B Idarubicin HCl Carmustine Imipenem-cilastatin sodium Cefotaxime sodium Mechlorethamine HCl Chlorpromazine HCl Meperidine HCl Cimetidine HCl Metoclopramide HCl Clindamycin phosphate Methylprednisolone sodium succinate Cytarabine Minocycline HCl Dacarbazine Nalbuphine HCl Daunorubicin HCl Netilmicin sulfate Diphenhydramine HCl Ondansetron HCl Doxorubicin HCl Prochlorperazine edisylate Doxycycline hyclate Promethazine HCl Droperidol Sodium bicarbonate Floxuridine Streptozocin Gentamicin sulfate Tobramycin sulfate Haloperidol lactate Vinorelbine tartrate .\"\n }\n ]\n },\n {\n \"Term\": \"Muscle twitching\",\n \"MEDDRACode\": \"10028347\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"twitching\",\n \"Probability\": \"0.9952607155\",\n \"SemanticContext\": \"A listing of the adverse reactions regardless of causality reported from clinical trials follows: Incidence Greater Than 1%: Cutaneous/Dermatologic: rash 1.5% Genitourinary: renal failure/insufficiency 1.2% Gastrointestinal: nausea 1.3% , vomiting 1.2% Incidence Less Than 1%: Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECG abnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea Musculoskeletal: arthralgia Other: hypotonia, diaphoresis, tumor lysis syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Pancytopenia\",\n \"MEDDRACode\": \"10033661\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"pancytopenia\",\n \"Probability\": \"0.9892234206\",\n \"SemanticContext\": \"A listing of the adverse reactions regardless of causality reported from clinical trials follows: Incidence Greater Than 1%: Cutaneous/Dermatologic: rash 1.5% Genitourinary: renal failure/insufficiency 1.2% Gastrointestinal: nausea 1.3% , vomiting 1.2% Incidence Less Than 1%: Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECG abnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea Musculoskeletal: arthralgia Other: hypotonia, diaphoresis, tumor lysis syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Skin reaction\",\n \"MEDDRACode\": \"10040914\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Skin reactions\",\n \"Probability\": \"0.6196264029\",\n \"SemanticContext\": \"Skin reactions can be severe and sometimes fatal.\"\n },\n {\n \"VerbatimTerm\": \"skin reactions\",\n \"Probability\": \"0.0031479895\",\n \"SemanticContext\": \"The HLA-B*58:01 allele is a genetic marker for severe skin reactions indicative of hypersensitivity to allopurinol.\"\n }\n ]\n },\n {\n \"Term\": \"Blood lactic acid\",\n \"MEDDRACode\": \"10005632\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"lactate\",\n \"Probability\": \"0.0014545321\",\n \"SemanticContext\": \"Drugs That Are Physically Incompatible in Solution with ALOPRIM ® allopurinol for Injection Amikacin sulfate Hydroxyzine HCl Amphotericin B Idarubicin HCl Carmustine Imipenem-cilastatin sodium Cefotaxime sodium Mechlorethamine HCl Chlorpromazine HCl Meperidine HCl Cimetidine HCl Metoclopramide HCl Clindamycin phosphate Methylprednisolone sodium succinate Cytarabine Minocycline HCl Dacarbazine Nalbuphine HCl Daunorubicin HCl Netilmicin sulfate Diphenhydramine HCl Ondansetron HCl Doxorubicin HCl Prochlorperazine edisylate Doxycycline hyclate Promethazine HCl Droperidol Sodium bicarbonate Floxuridine Streptozocin Gentamicin sulfate Tobramycin sulfate Haloperidol lactate Vinorelbine tartrate .\"\n }\n ]\n },\n {\n \"Term\": \"Overdose\",\n \"MEDDRACode\": \"10033295\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"doses over\",\n \"Probability\": \"0.0978157222\",\n \"SemanticContext\": \"In adults, in one clinical trial, doses over 600 mg a day did not appear to be more effective.\"\n },\n {\n \"VerbatimTerm\": \"overdosing\",\n \"Probability\": \"0.0940291286\",\n \"SemanticContext\": \"OVERDOSAGE Massive overdosing or acute poisoning by ALOPRIM allopurinol for Injection has not been reported.\"\n },\n {\n \"VerbatimTerm\": \"overdose\",\n \"Probability\": \"0.0043109655\",\n \"SemanticContext\": \"Both allopurinol and oxypurinol are dialyzable; however, the usefulness of hemodialysis or peritoneal dialysis in the management of an overdose of ALOPRIM allopurinol for Injection is unknown.\"\n }\n ]\n },\n {\n \"Term\": \"Tumour lysis syndrome\",\n \"MEDDRACode\": \"10045170\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"tumor lysis syndrome\",\n \"Probability\": \"0.9594166279\",\n \"SemanticContext\": \"A listing of the adverse reactions regardless of causality reported from clinical trials follows: Incidence Greater Than 1%: Cutaneous/Dermatologic: rash 1.5% Genitourinary: renal failure/insufficiency 1.2% Gastrointestinal: nausea 1.3% , vomiting 1.2% Incidence Less Than 1%: Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECG abnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea Musculoskeletal: arthralgia Other: hypotonia, diaphoresis, tumor lysis syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Vomiting\",\n \"MEDDRACode\": \"10047700\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"vomiting\",\n \"Probability\": \"0.9997322559\",\n \"SemanticContext\": \"A listing of the adverse reactions regardless of causality reported from clinical trials follows: Incidence Greater Than 1%: Cutaneous/Dermatologic: rash 1.5% Genitourinary: renal failure/insufficiency 1.2% Gastrointestinal: nausea 1.3% , vomiting 1.2% Incidence Less Than 1%: Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECG abnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea Musculoskeletal: arthralgia Other: hypotonia, diaphoresis, tumor lysis syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Ecchymosis\",\n \"MEDDRACode\": \"10014080\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"ecchymosis\",\n \"Probability\": \"0.9745848179\",\n \"SemanticContext\": \"A listing of the adverse reactions regardless of causality reported from clinical trials follows: Incidence Greater Than 1%: Cutaneous/Dermatologic: rash 1.5% Genitourinary: renal failure/insufficiency 1.2% Gastrointestinal: nausea 1.3% , vomiting 1.2% Incidence Less Than 1%: Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECG abnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea Musculoskeletal: arthralgia Other: hypotonia, diaphoresis, tumor lysis syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Electrolyte imbalance\",\n \"MEDDRACode\": \"10014418\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"electrolyte abnormality\",\n \"Probability\": \"0.9367923737\",\n \"SemanticContext\": \"A listing of the adverse reactions regardless of causality reported from clinical trials follows: Incidence Greater Than 1%: Cutaneous/Dermatologic: rash 1.5% Genitourinary: renal failure/insufficiency 1.2% Gastrointestinal: nausea 1.3% , vomiting 1.2% Incidence Less Than 1%: Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECG abnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea Musculoskeletal: arthralgia Other: hypotonia, diaphoresis, tumor lysis syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Flatulence\",\n \"MEDDRACode\": \"10016766\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"flatulence\",\n \"Probability\": \"0.9972864389\",\n \"SemanticContext\": \"A listing of the adverse reactions regardless of causality reported from clinical trials follows: Incidence Greater Than 1%: Cutaneous/Dermatologic: rash 1.5% Genitourinary: renal failure/insufficiency 1.2% Gastrointestinal: nausea 1.3% , vomiting 1.2% Incidence Less Than 1%: Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECG abnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea Musculoskeletal: arthralgia Other: hypotonia, diaphoresis, tumor lysis syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Rash\",\n \"MEDDRACode\": \"10037844\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"rash\",\n \"Probability\": \"0.9980365038\",\n \"SemanticContext\": \"Fifteen of these adverse experiences were allergic in nature rash, eosinophilia, local injection site reaction .\"\n },\n {\n \"VerbatimTerm\": \"rash\",\n \"Probability\": \"0.9997340441\",\n \"SemanticContext\": \"A listing of the adverse reactions regardless of causality reported from clinical trials follows: Incidence Greater Than 1%: Cutaneous/Dermatologic: rash 1.5% Genitourinary: renal failure/insufficiency 1.2% Gastrointestinal: nausea 1.3% , vomiting 1.2% Incidence Less Than 1%: Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECG abnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea Musculoskeletal: arthralgia Other: hypotonia, diaphoresis, tumor lysis syndrome .\"\n },\n {\n \"VerbatimTerm\": \"rash\",\n \"Probability\": \"0.0334119201\",\n \"SemanticContext\": \"Therefore, treatment with ALOPRIM allopurinol for Injection should be discontinued immediately if a rash develops see WARNINGS .\"\n }\n ]\n },\n {\n \"Term\": \"Blood uric acid\",\n \"MEDDRACode\": \"10005858\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"serum uric acid\",\n \"Probability\": \"2.55455E-05\",\n \"SemanticContext\": \"The action of oral allopurinol differs from that of uricosuric agents, which lower the serum uric acid level by increasing urinary excretion of uric acid.\"\n },\n {\n \"VerbatimTerm\": \"serum uric acid\",\n \"Probability\": \"9.59696E-05\",\n \"SemanticContext\": \"Normal serum uric acid levels were achieved in 68% reduction of serum uric acid was documented in 93% of the former, and were maintained throughout chemotherapy in 97% of the latter.\"\n },\n {\n \"VerbatimTerm\": \"serum uric acid\",\n \"Probability\": \"0.0005298555\",\n \"SemanticContext\": \"Normal serum uric acid levels were achieved in 68% reduction of serum uric acid was documented in 93% of the former, and were maintained throughout chemotherapy in 97% of the latter.\"\n },\n {\n \"VerbatimTerm\": \"serum uric acid\",\n \"Probability\": \"4.7246E-06\",\n \"SemanticContext\": \"DOSAGE AND ADMINISTRATION Children and Adults The dosage of ALOPRIM allopurinol for Injection to lower serum uric acid to normal or near-normal varies with the severity of the disease.\"\n },\n {\n \"VerbatimTerm\": \"serum uric acid\",\n \"Probability\": \"2.9261E-06\",\n \"SemanticContext\": \"The amount and frequency of dosage for maintaining the serum uric acid just within the normal range is best determined by using the serum uric acid level as an index.\"\n },\n {\n \"VerbatimTerm\": \"serum uric acid\",\n \"Probability\": \"0.0002392828\",\n \"SemanticContext\": \"The amount and frequency of dosage for maintaining the serum uric acid just within the normal range is best determined by using the serum uric acid level as an index.\"\n },\n {\n \"VerbatimTerm\": \"serum uric acid\",\n \"Probability\": \"1.1818E-06\",\n \"SemanticContext\": \"Laboratory Tests The correct dosage and schedule for maintaining the serum uric acid within the normal range is best determined by using the serum uric acid as an index.\"\n },\n {\n \"VerbatimTerm\": \"serum uric acid\",\n \"Probability\": \"0.0003017485\",\n \"SemanticContext\": \"Laboratory Tests The correct dosage and schedule for maintaining the serum uric acid within the normal range is best determined by using the serum uric acid as an index.\"\n }\n ]\n },\n {\n \"Term\": \"Euphoric mood\",\n \"MEDDRACode\": \"10015535\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"high\",\n \"Probability\": \"0.000477165\",\n \"SemanticContext\": \"A maximum of 0.9 mg/dL of these oxypurines has been reported when the serum urate was lowered to less than 2 mg/dL by high doses of allopurinol.\"\n },\n {\n \"VerbatimTerm\": \"higher\",\n \"Probability\": \"0.000105419\",\n \"SemanticContext\": \"Oxypurinol was present in systemic circulation in much higher concentrations and for a much longer period than allopurinol; thus, it is generally believed that the pharmacological action of allopurinol is mediated via oxypurinol.\"\n },\n {\n \"VerbatimTerm\": \"higher\",\n \"Probability\": \"0.002040118\",\n \"SemanticContext\": \"Patients who carry the HLA-B*58:01 allele are at a higher risk of allopurinol hypersensitivity syndrome AHS , but hypersensitivity reactions have been reported in patients who do not carry this allele.\"\n },\n {\n \"VerbatimTerm\": \"higher\",\n \"Probability\": \"0.0004381537\",\n \"SemanticContext\": \"The frequency of this allele is higher in individuals of African, Asian e.g., Han Chinese, Korean, Thai , and Native Hawaiian/Pacific Islander ancestry.\"\n }\n ]\n },\n {\n \"Term\": \"Hypersensitivity\",\n \"MEDDRACode\": \"10020751\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hypersensitivity reactions\",\n \"Probability\": \"0.0074883103\",\n \"SemanticContext\": \"For further details on hypersensitivity reactions to treatment with oral allopurinol, refer to the package insert for allopurinol tablets.\"\n },\n {\n \"VerbatimTerm\": \"hypersensitivity reactions\",\n \"Probability\": \"0.9255208373\",\n \"SemanticContext\": \"Other serious hypersensitivity reactions that have been reported include exfoliative, urticarial and purpuric lesions; generalized vasculitis; and irreversible hepatotoxicity.\"\n },\n {\n \"VerbatimTerm\": \"hypersensitivity reactions\",\n \"Probability\": \"0.6089010835\",\n \"SemanticContext\": \"Patients who carry the HLA-B*58:01 allele are at a higher risk of allopurinol hypersensitivity syndrome AHS , but hypersensitivity reactions have been reported in patients who do not carry this allele.\"\n },\n {\n \"VerbatimTerm\": \"hypersensitivity reactions\",\n \"Probability\": \"0.6948317885\",\n \"SemanticContext\": \"The occurrence of hypersensitivity reactions may be increased in patients with renal impairment, especially in patients who are receiving thiazide diuretics.\"\n },\n {\n \"VerbatimTerm\": \"hypersensitivity reactions\",\n \"Probability\": \"0.0149936676\",\n \"SemanticContext\": \"Renal failure is rarely associated with hypersensitivity reactions to allopurinol.\"\n },\n {\n \"VerbatimTerm\": \"HYPERSENSITIVITY REACTION\",\n \"Probability\": \"0.8950374126\",\n \"SemanticContext\": \"WARNINGS DISCONTINUE ALOPRIM AT THE FIRST APPEARANCE OF SKIN RASH OR OTHER SIGNS WHICH MAY INDICATE A HYPERSENSITIVITY REACTION.\"\n }\n ]\n },\n {\n \"Term\": \"Hypercalcaemia\",\n \"MEDDRACode\": \"10020583\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hypercalcemia\",\n \"Probability\": \"0.9886374474\",\n \"SemanticContext\": \"A listing of the adverse reactions regardless of causality reported from clinical trials follows: Incidence Greater Than 1%: Cutaneous/Dermatologic: rash 1.5% Genitourinary: renal failure/insufficiency 1.2% Gastrointestinal: nausea 1.3% , vomiting 1.2% Incidence Less Than 1%: Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECG abnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea Musculoskeletal: arthralgia Other: hypotonia, diaphoresis, tumor lysis syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Hypomagnesaemia\",\n \"MEDDRACode\": \"10021027\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hypomagnesemia\",\n \"Probability\": \"0.9988144636\",\n \"SemanticContext\": \"A listing of the adverse reactions regardless of causality reported from clinical trials follows: Incidence Greater Than 1%: Cutaneous/Dermatologic: rash 1.5% Genitourinary: renal failure/insufficiency 1.2% Gastrointestinal: nausea 1.3% , vomiting 1.2% Incidence Less Than 1%: Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECG abnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea Musculoskeletal: arthralgia Other: hypotonia, diaphoresis, tumor lysis syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Metabolic acidosis\",\n \"MEDDRACode\": \"10027417\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"metabolic acidosis\",\n \"Probability\": \"0.992393136\",\n \"SemanticContext\": \"A listing of the adverse reactions regardless of causality reported from clinical trials follows: Incidence Greater Than 1%: Cutaneous/Dermatologic: rash 1.5% Genitourinary: renal failure/insufficiency 1.2% Gastrointestinal: nausea 1.3% , vomiting 1.2% Incidence Less Than 1%: Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECG abnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea Musculoskeletal: arthralgia Other: hypotonia, diaphoresis, tumor lysis syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Renal impairment\",\n \"MEDDRACode\": \"10062237\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Impaired Renal Function\",\n \"Probability\": \"0.0102248788\",\n \"SemanticContext\": \"Impaired Renal Function The dose of ALOPRIM allopurinol for Injection should be reduced in patients with impaired renal function to avoid accumulation of allopurinol and its metabolites: Creatinine Clearance Recommended Daily Dose 10 to 20 mL/min 200 mg/day 3 to 10 mL/min 100 mg/day < 3 mL/min 100 mg/day at extended intervals .\"\n },\n {\n \"VerbatimTerm\": \"Impaired Renal Function\",\n \"Probability\": \"0.2859163582\",\n \"SemanticContext\": \"Reduce the dose of ALOPRIM in patients with impaired renal function see DOSAGE AND ADMINISTRATION: Impaired Renal Function .\"\n },\n {\n \"VerbatimTerm\": \"impaired renal function\",\n \"Probability\": \"0.0003357828\",\n \"SemanticContext\": \"Impaired Renal Function The dose of ALOPRIM allopurinol for Injection should be reduced in patients with impaired renal function to avoid accumulation of allopurinol and its metabolites: Creatinine Clearance Recommended Daily Dose 10 to 20 mL/min 200 mg/day 3 to 10 mL/min 100 mg/day < 3 mL/min 100 mg/day at extended intervals .\"\n },\n {\n \"VerbatimTerm\": \"impaired renal function\",\n \"Probability\": \"0.0008074641\",\n \"SemanticContext\": \"Reduce the dose of ALOPRIM in patients with impaired renal function see DOSAGE AND ADMINISTRATION: Impaired Renal Function .\"\n },\n {\n \"VerbatimTerm\": \"impaired renal function\",\n \"Probability\": \"0.0085410476\",\n \"SemanticContext\": \"In patients with severely impaired renal function or decreased urate clearance, the half-life of oxypurinol in the plasma is greatly prolonged.\"\n }\n ]\n },\n {\n \"Term\": \"Drug interaction\",\n \"MEDDRACode\": \"10013710\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Interactions\",\n \"Probability\": \"9.9067E-06\",\n \"SemanticContext\": \"Drug/Laboratory Test Interactions Allopurinol is not known to alter the accuracy of laboratory tests.\"\n },\n {\n \"VerbatimTerm\": \"Interactions\",\n \"Probability\": \"1.49069E-05\",\n \"SemanticContext\": \"Drug/Laboratory Test Interactions Allopurinol is not known to alter the accuracy of laboratory tests.\"\n }\n ]\n },\n {\n \"Term\": \"Splenomegaly\",\n \"MEDDRACode\": \"10041660\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"splenomegaly\",\n \"Probability\": \"0.9984333515\",\n \"SemanticContext\": \"A listing of the adverse reactions regardless of causality reported from clinical trials follows: Incidence Greater Than 1%: Cutaneous/Dermatologic: rash 1.5% Genitourinary: renal failure/insufficiency 1.2% Gastrointestinal: nausea 1.3% , vomiting 1.2% Incidence Less Than 1%: Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECG abnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea Musculoskeletal: arthralgia Other: hypotonia, diaphoresis, tumor lysis syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Injection\",\n \"MEDDRACode\": \"10052995\",\n \"Overdose\": true,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": true\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Injection\",\n \"Probability\": \"0.0089977682\",\n \"SemanticContext\": \"ADVERSE REACTIONS In an uncontrolled, compassionate plea protocol, 125 of 1,378 patients reported a total of 301 adverse reactions while receiving ALOPRIM allopurinol for Injection.\"\n },\n {\n \"VerbatimTerm\": \"Injection\",\n \"Probability\": \"0.004152596\",\n \"SemanticContext\": \"Side effects directly attributable to ALOPRIM allopurinol for Injection were reported in 19 patients.\"\n },\n {\n \"VerbatimTerm\": \"Injection\",\n \"Probability\": \"0.0579518676\",\n \"SemanticContext\": \"One adverse experience of severe diarrhea and one incidence of nausea were also reported as being possibly attributable to ALOPRIM allopurinol for Injection.\"\n },\n {\n \"VerbatimTerm\": \"Injection\",\n \"Probability\": \"0.1355061233\",\n \"SemanticContext\": \"Two patients had serious adverse experiences decreased renal function and generalized seizure reported as being possibly attributable to ALOPRIM allopurinol for Injection.\"\n },\n {\n \"VerbatimTerm\": \"Injection\",\n \"Probability\": \"0.0070950091\",\n \"SemanticContext\": \"Therefore, treatment with ALOPRIM allopurinol for Injection should be discontinued immediately if a rash develops see WARNINGS .\"\n },\n {\n \"VerbatimTerm\": \"Injection\",\n \"Probability\": \"0.0037591457\",\n \"SemanticContext\": \"DESCRIPTION\\n ALOPRIM allopurinol for Injection is a sterile, white, lyophilized powder or cake, in a single-dose vial for reconstitution.\"\n },\n {\n \"VerbatimTerm\": \"Injection\",\n \"Probability\": \"0.0008282065\",\n \"SemanticContext\": \"ALOPRIM allopurinol for Injection contains no preservatives.\"\n },\n {\n \"VerbatimTerm\": \"Injection\",\n \"Probability\": \"6.06738E-05\",\n \"SemanticContext\": \"To compare the pharmacokinetics of allopurinol and oxypurinol between intravenous i.v. and oral p.o. administration of ALOPRIM allopurinol for Injection, a well-controlled, four-way crossover study was conducted in 16 male healthy volunteers.\"\n },\n {\n \"VerbatimTerm\": \"Injection\",\n \"Probability\": \"0.0349749923\",\n \"SemanticContext\": \"ALOPRIM allopurinol for Injection was administered via an intravenous infusion over 30 minutes.\"\n },\n {\n \"VerbatimTerm\": \"Injection\",\n \"Probability\": \"0.0012831688\",\n \"SemanticContext\": \"Pharmacokinetic parameter estimates of allopurinol mean ± S.D. following single i.v. and p.o. administration of ALOPRIM allopurinol for Injection are summarized as follows: Administration of ALOPRIM ® allopurinol for Injection Allopurinol Parameters 100 mg i.v. 300 mg i.v. 100 mg p.o. n = 7 300 mg p.o. C max µg/mL 1.58 ± 0.22 5.12 ± 0.82 0.53 ± 0.10 1.35 ± 0.49 T max hr 0.50 0.50 1.00 ± 0.39 1.67 ± 0.96 T 1/2 hr 1.00 ± 0.46 1.21 ± 0.33 0.98 ± 0.43 1.32 ± 0.32 AUC 0 ->8 hr·µg/mL 1.99 ± 0.63 7.10 ± 1.28 1.03 ± 0.24 3.69 ± 0.96 CL mL/min/kg 12.2 ± 3.11 9.94 ± 2.36 V ss L/kg Volume of Distribution Steady-State 0.84 ± 0.13 0.87 ± 0.13 F absolute % Absolute Bioavailability 48.8 ± 19.7 52.7 ± 13.1 .\"\n },\n {\n \"VerbatimTerm\": \"Injection\",\n \"Probability\": \"0.0001133333\",\n \"SemanticContext\": \"Pharmacokinetic parameter estimates of allopurinol mean ± S.D. following single i.v. and p.o. administration of ALOPRIM allopurinol for Injection are summarized as follows: Administration of ALOPRIM ® allopurinol for Injection Allopurinol Parameters 100 mg i.v. 300 mg i.v. 100 mg p.o. n = 7 300 mg p.o. C max µg/mL 1.58 ± 0.22 5.12 ± 0.82 0.53 ± 0.10 1.35 ± 0.49 T max hr 0.50 0.50 1.00 ± 0.39 1.67 ± 0.96 T 1/2 hr 1.00 ± 0.46 1.21 ± 0.33 0.98 ± 0.43 1.32 ± 0.32 AUC 0 ->8 hr·µg/mL 1.99 ± 0.63 7.10 ± 1.28 1.03 ± 0.24 3.69 ± 0.96 CL mL/min/kg 12.2 ± 3.11 9.94 ± 2.36 V ss L/kg Volume of Distribution Steady-State 0.84 ± 0.13 0.87 ± 0.13 F absolute % Absolute Bioavailability 48.8 ± 19.7 52.7 ± 13.1 .\"\n },\n {\n \"VerbatimTerm\": \"Injection\",\n \"Probability\": \"0.0020208061\",\n \"SemanticContext\": \"Oxypurinol was measurable in the plasma within 10 to 15 minutes following the administration of ALOPRIM allopurinol for Injection.\"\n },\n {\n \"VerbatimTerm\": \"Injection\",\n \"Probability\": \"7.49338E-05\",\n \"SemanticContext\": \"Pharmacokinetic parameter estimates of oxypurinol following i.v. and p.o. administration of ALOPRIM allopurinol for Injection are shown below: Administration of ALOPRIM ® allopurinol for Injection Oxypurinol Parameters 100 mg i.v. 300 mg i.v. 100 mg p.o. 300 mg p.o. C max µg/mL 2.20 ± 0.31 6.18 ± 0.78 2.36 ± 0.30 6.36 ± 0.83 T max hr 3.89 ± 1.41 4.16 ± 1.2 3.10 ± 1.49 4.13 ± 1.35 T 1/2 hr 24.1 ± 5.4 23.5 ± 4.5 24.9 ± 8.4 23.7 ± 3.4 AUC 0 ->8 hr·µg/mL 80 ± 24 231 ± 54 83 ± 22 245 ± 49 F relative % Relative Bioavailability 107 ± 25 108 ± 9 .\"\n },\n {\n \"VerbatimTerm\": \"Injection\",\n \"Probability\": \"3.45478E-05\",\n \"SemanticContext\": \"Pharmacokinetic parameter estimates of oxypurinol following i.v. and p.o. administration of ALOPRIM allopurinol for Injection are shown below: Administration of ALOPRIM ® allopurinol for Injection Oxypurinol Parameters 100 mg i.v. 300 mg i.v. 100 mg p.o. 300 mg p.o. C max µg/mL 2.20 ± 0.31 6.18 ± 0.78 2.36 ± 0.30 6.36 ± 0.83 T max hr 3.89 ± 1.41 4.16 ± 1.2 3.10 ± 1.49 4.13 ± 1.35 T 1/2 hr 24.1 ± 5.4 23.5 ± 4.5 24.9 ± 8.4 23.7 ± 3.4 AUC 0 ->8 hr·µg/mL 80 ± 24 231 ± 54 83 ± 22 245 ± 49 F relative % Relative Bioavailability 107 ± 25 108 ± 9 .\"\n },\n {\n \"VerbatimTerm\": \"Injection\",\n \"Probability\": \"0.0002244711\",\n \"SemanticContext\": \"The C max and AUC 0->8 for both allopurinol and oxypurinol following i.v. administration of ALOPRIM allopurinol for Injection were dose proportional in the dose range of 100 to 300 mg.\"\n },\n {\n \"VerbatimTerm\": \"Injection\",\n \"Probability\": \"0.0004929304\",\n \"SemanticContext\": \"The half-life of allopurinol and oxypurinol was not influenced by the route of ALOPRIM allopurinol for Injection administration.\"\n },\n {\n \"VerbatimTerm\": \"Injection\",\n \"Probability\": \"3.94514E-05\",\n \"SemanticContext\": \"Oral and intravenous administration of ALOPRIM allopurinol for Injection at equal doses produced nearly superimposable oxypurinol plasma concentration vs time profiles, and the relative bioavailability of oxypurinol F relative was approximately 100%.\"\n },\n {\n \"VerbatimTerm\": \"Injection\",\n \"Probability\": \"0.0008125603\",\n \"SemanticContext\": \"Thus, the pharmacokinetics and plasma profiles of oxypurinol, the major pharmacological component derived from allopurinol, are similar after intravenous and oral administration of ALOPRIM allopurinol for Injection.\"\n },\n {\n \"VerbatimTerm\": \"Injection\",\n \"Probability\": \"0.0005811751\",\n \"SemanticContext\": \"Clinical Trials A compassionate plea trial was conducted from 1977 through 1989 in which 718 evaluable patients with malignancies requiring treatment with cytotoxic chemotherapy, but who were unable to ingest or retain oral medication, received i.v. ALOPRIM allopurinol for Injection in the U.S. Of these patients, 411 had established hyperuricemia and 307 had normal serum urate levels at the time that treatment was initiated.\"\n },\n {\n \"VerbatimTerm\": \"Injection\",\n \"Probability\": \"0.0001246631\",\n \"SemanticContext\": \"\\n \\n Cyclosporine\\n \\n \\n Reports indicate that cyclosporine levels may be increased during concomitant treatment with ALOPRIM allopurinol for Injection.\"\n },\n {\n \"VerbatimTerm\": \"Injection\",\n \"Probability\": \"2.28034E-05\",\n \"SemanticContext\": \"DOSAGE AND ADMINISTRATION Children and Adults The dosage of ALOPRIM allopurinol for Injection to lower serum uric acid to normal or near-normal varies with the severity of the disease.\"\n },\n {\n \"VerbatimTerm\": \"Injection\",\n \"Probability\": \"0.0001278818\",\n \"SemanticContext\": \"The recommended daily dose of ALOPRIM allopurinol for Injection is as follows: Recommended Daily Dose Adult: 200 to 400 mg/m 2 /day Maximum 600 mg/day Child: Starting Dose 200 mg/m 2 /day .\"\n },\n {\n \"VerbatimTerm\": \"Injection\",\n \"Probability\": \"0.0027423501\",\n \"SemanticContext\": \"Impaired Renal Function The dose of ALOPRIM allopurinol for Injection should be reduced in patients with impaired renal function to avoid accumulation of allopurinol and its metabolites: Creatinine Clearance Recommended Daily Dose 10 to 20 mL/min 200 mg/day 3 to 10 mL/min 100 mg/day< 3 mL/min 100 mg/day at extended intervals .\"\n },\n {\n \"VerbatimTerm\": \"Injection\",\n \"Probability\": \"9.29366E-05\",\n \"SemanticContext\": \"Whenever possible, therapy with ALOPRIM allopurinol for Injection should be initiated 24 to 48 hours before the start of chemotherapy known to cause tumor cell lysis including adrenocorticosteroids .\"\n },\n {\n \"VerbatimTerm\": \"Injection\",\n \"Probability\": \"0.004430294\",\n \"SemanticContext\": \"ALOPRIM allopurinol for Injection should not be mixed with or administered through the same intravenous port with agents which are incompatible in solution with ALOPRIM allopurinol for Injection see Preparation of Solution .\"\n },\n {\n \"VerbatimTerm\": \"Injection\",\n \"Probability\": \"0.0025672615\",\n \"SemanticContext\": \"ALOPRIM allopurinol for Injection should not be mixed with or administered through the same intravenous port with agents which are incompatible in solution with ALOPRIM allopurinol for Injection see Preparation of Solution .\"\n },\n {\n \"VerbatimTerm\": \"Injection\",\n \"Probability\": \"0.003698349\",\n \"SemanticContext\": \"Preparation of Solution ALOPRIM allopurinol for Injection must be reconstituted and diluted.\"\n },\n {\n \"VerbatimTerm\": \"Injection\",\n \"Probability\": \"0.000708133\",\n \"SemanticContext\": \"The contents of each 30 mL vial should be dissolved with 25 mL of Sterile Water for Injection.\"\n },\n {\n \"VerbatimTerm\": \"Injection\",\n \"Probability\": \"0.0093335211\",\n \"SemanticContext\": \"It should be diluted to the desired concentration with 0.9% Sodium Chloride Injection or 5% Dextrose for Injection.\"\n },\n {\n \"VerbatimTerm\": \"Injection\",\n \"Probability\": \"0.0102210939\",\n \"SemanticContext\": \"It should be diluted to the desired concentration with 0.9% Sodium Chloride Injection or 5% Dextrose for Injection.\"\n },\n {\n \"VerbatimTerm\": \"Injection\",\n \"Probability\": \"0.0044134855\",\n \"SemanticContext\": \"The following table lists drugs that are physically incompatible in solution with ALOPRIM allopurinol for Injection.\"\n },\n {\n \"VerbatimTerm\": \"Injection\",\n \"Probability\": \"6.17315E-05\",\n \"SemanticContext\": \"Drugs That Are Physically Incompatible in Solution with ALOPRIM ® allopurinol for Injection Amikacin sulfate Hydroxyzine HCl Amphotericin B Idarubicin HCl Carmustine Imipenem-cilastatin sodium Cefotaxime sodium Mechlorethamine HCl Chlorpromazine HCl Meperidine HCl Cimetidine HCl Metoclopramide HCl Clindamycin phosphate Methylprednisolone sodium succinate Cytarabine Minocycline HCl Dacarbazine Nalbuphine HCl Daunorubicin HCl Netilmicin sulfate Diphenhydramine HCl Ondansetron HCl Doxorubicin HCl Prochlorperazine edisylate Doxycycline hyclate Promethazine HCl Droperidol Sodium bicarbonate Floxuridine Streptozocin Gentamicin sulfate Tobramycin sulfate Haloperidol lactate Vinorelbine tartrate .\"\n },\n {\n \"VerbatimTerm\": \"Injection\",\n \"Probability\": \"0.0536156893\",\n \"SemanticContext\": \"INDICATIONS AND USAGE ALOPRIM allopurinol for Injection is indicated for the management of patients with leukemia, lymphoma, and solid tumor malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels and who cannot tolerate oral therapy.\"\n },\n {\n \"VerbatimTerm\": \"Injection\",\n \"Probability\": \"0.0068391562\",\n \"SemanticContext\": \"OVERDOSAGE Massive overdosing or acute poisoning by ALOPRIM allopurinol for Injection has not been reported.\"\n },\n {\n \"VerbatimTerm\": \"Injection\",\n \"Probability\": \"0.0002939105\",\n \"SemanticContext\": \"In the management of overdosage, there is no specific antidote for ALOPRIM allopurinol for Injection.\"\n },\n {\n \"VerbatimTerm\": \"Injection\",\n \"Probability\": \"0.0009177029\",\n \"SemanticContext\": \"Both allopurinol and oxypurinol are dialyzable; however, the usefulness of hemodialysis or peritoneal dialysis in the management of an overdose of ALOPRIM allopurinol for Injection is unknown.\"\n },\n {\n \"VerbatimTerm\": \"Injection\",\n \"Probability\": \"0.0006771982\",\n \"SemanticContext\": \"There have been no pregnancies reported in patients receiving ALOPRIM allopurinol for Injection, but it is assumed that the same risks would apply.\"\n },\n {\n \"VerbatimTerm\": \"Injection\",\n \"Probability\": \"9.74452E-05\",\n \"SemanticContext\": \"In patients receiving mercaptopurine or azathioprine, the concomitant administration of 300 to 600 mg of ALOPRIM allopurinol for Injection per day will require a reduction in dose to approximately one-third to one-fourth of the usual dose of mercaptopurine or azathioprine.\"\n },\n {\n \"VerbatimTerm\": \"Injection\",\n \"Probability\": \"0.000384897\",\n \"SemanticContext\": \"The appropriate dose of ALOPRIM allopurinol for Injection for patients with a creatinine clearance = 10 mL/min is 100 mg per day.\"\n },\n {\n \"VerbatimTerm\": \"Injection\",\n \"Probability\": \"0.0001246631\",\n \"SemanticContext\": \"\\n \\n Cyclosporine\\n \\n \\n Reports indicate that cyclosporine levels may be increased during concomitant treatment with ALOPRIM allopurinol for Injection.\"\n },\n {\n \"VerbatimTerm\": \"Injection\",\n \"Probability\": \"0.0006771982\",\n \"SemanticContext\": \"There have been no pregnancies reported in patients receiving ALOPRIM allopurinol for Injection, but it is assumed that the same risks would apply.\"\n },\n {\n \"VerbatimTerm\": \"Injection\",\n \"Probability\": \"0.0031149387\",\n \"SemanticContext\": \"Pediatric Use Clinical data are available on approximately 200 pediatric patients treated with ALOPRIM allopurinol for Injection.\"\n },\n {\n \"VerbatimTerm\": \"Injection\",\n \"Probability\": \"0.0002239347\",\n \"SemanticContext\": \"Geriatric Use Clinical studies of ALOPRIM allopurinol for Injection did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently than younger patients.\"\n },\n {\n \"VerbatimTerm\": \"Injection\",\n \"Probability\": \"0.0347729027\",\n \"SemanticContext\": \"Pediatric Use Clinical data are available on approximately 200 pediatric patients treated with ALOPRIM allopurinol for Injection.\"\n },\n {\n \"VerbatimTerm\": \"Injection\",\n \"Probability\": \"0.0002239347\",\n \"SemanticContext\": \"Geriatric Use Clinical studies of ALOPRIM allopurinol for Injection did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently than younger patients.\"\n }\n ]\n },\n {\n \"Term\": \"Nephrolithiasis\",\n \"MEDDRACode\": \"10029148\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"nephrolithiasis\",\n \"Probability\": \"0.0997959077\",\n \"SemanticContext\": \"The increased xanthine and hypoxanthine in the urine have not been accompanied by problems of nephrolithiasis.\"\n }\n ]\n },\n {\n \"Term\": \"Prothrombin time\",\n \"MEDDRACode\": \"10037056\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"prothrombin time\",\n \"Probability\": \"0.0003436506\",\n \"SemanticContext\": \"Consequently, prothrombin time should be reassessed periodically in patients receiving both drugs.\"\n },\n {\n \"VerbatimTerm\": \"prothrombin time\",\n \"Probability\": \"0.0004563928\",\n \"SemanticContext\": \"The prothrombin time should be reassessed periodically in the patients receiving dicumarol who are given allopurinol.\"\n },\n {\n \"VerbatimTerm\": \"prothrombin time\",\n \"Probability\": \"0.0003436506\",\n \"SemanticContext\": \"Consequently, prothrombin time should be reassessed periodically in patients receiving both drugs.\"\n }\n ]\n },\n {\n \"Term\": \"Hyperuricaemia\",\n \"MEDDRACode\": \"10020903\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hyperuricemia\",\n \"Probability\": \"0.9970003366\",\n \"SemanticContext\": \"A listing of the adverse reactions regardless of causality reported from clinical trials follows: Incidence Greater Than 1%: Cutaneous/Dermatologic: rash 1.5% Genitourinary: renal failure/insufficiency 1.2% Gastrointestinal: nausea 1.3% , vomiting 1.2% Incidence Less Than 1%: Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECG abnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea Musculoskeletal: arthralgia Other: hypotonia, diaphoresis, tumor lysis syndrome .\"\n },\n {\n \"VerbatimTerm\": \"hyperuricemia\",\n \"Probability\": \"0.0029704571\",\n \"SemanticContext\": \"As a result of xanthine oxidase inhibition, the serum concentration of hypoxanthine plus xanthine in patients receiving allopurinol for treatment of hyperuricemia is usually in the range of 0.3 to 0.4 mg/dL compared to a normal level of approximately 0.15 mg/dL.\"\n },\n {\n \"VerbatimTerm\": \"hyperuricemia\",\n \"Probability\": \"0.2562770247\",\n \"SemanticContext\": \"Clinical Trials A compassionate plea trial was conducted from 1977 through 1989 in which 718 evaluable patients with malignancies requiring treatment with cytotoxic chemotherapy, but who were unable to ingest or retain oral medication, received i.v. ALOPRIM allopurinol for Injection in the U.S. Of these patients, 411 had established hyperuricemia and 307 had normal serum urate levels at the time that treatment was initiated.\"\n },\n {\n \"VerbatimTerm\": \"hyperuricemia\",\n \"Probability\": \"0.0265547335\",\n \"SemanticContext\": \"In patients with hyperuricemia due to malignancy, the vast majority of changes in renal function are attributable to the underlying malignancy rather than to therapy with allopurinol.\"\n }\n ]\n },\n {\n \"Term\": \"Cleft lip\",\n \"MEDDRACode\": \"10009259\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"harelip\",\n \"Probability\": \"0.1086635888\",\n \"SemanticContext\": \"However, there is a published report in pregnant mice that single intraperitoneal doses of 50 or 100 mg/kg about 1/3 or 3/4 the human dose on a mg/m 2 basis of allopurinol on gestation days 10 or 13 produced significant increases in fetal deaths and teratogenic effects cleft palate, harelip, and digital defects .\"\n },\n {\n \"VerbatimTerm\": \"harelip\",\n \"Probability\": \"0.1086635888\",\n \"SemanticContext\": \"However, there is a published report in pregnant mice that single intraperitoneal doses of 50 or 100 mg/kg about 1/3 or 3/4 the human dose on a mg/m 2 basis of allopurinol on gestation days 10 or 13 produced significant increases in fetal deaths and teratogenic effects cleft palate, harelip, and digital defects .\"\n }\n ]\n },\n {\n \"Term\": \"Peritoneal dialysis\",\n \"MEDDRACode\": \"10034660\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"peritoneal dialysis\",\n \"Probability\": \"1.14538E-05\",\n \"SemanticContext\": \"Both allopurinol and oxypurinol are dialyzable; however, the usefulness of hemodialysis or peritoneal dialysis in the management of an overdose of ALOPRIM allopurinol for Injection is unknown.\"\n }\n ]\n },\n {\n \"Term\": \"Foetal death\",\n \"MEDDRACode\": \"10055690\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"fetal deaths\",\n \"Probability\": \"0.2845059931\",\n \"SemanticContext\": \"However, there is a published report in pregnant mice that single intraperitoneal doses of 50 or 100 mg/kg about 1/3 or 3/4 the human dose on a mg/m 2 basis of allopurinol on gestation days 10 or 13 produced significant increases in fetal deaths and teratogenic effects cleft palate, harelip, and digital defects .\"\n },\n {\n \"VerbatimTerm\": \"fetal deaths\",\n \"Probability\": \"0.2845059931\",\n \"SemanticContext\": \"However, there is a published report in pregnant mice that single intraperitoneal doses of 50 or 100 mg/kg about 1/3 or 3/4 the human dose on a mg/m 2 basis of allopurinol on gestation days 10 or 13 produced significant increases in fetal deaths and teratogenic effects cleft palate, harelip, and digital defects .\"\n }\n ]\n },\n {\n \"Term\": \"Blood bicarbonate\",\n \"MEDDRACode\": \"10005357\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"bicarbonate\",\n \"Probability\": \"0.0001090443\",\n \"SemanticContext\": \"Sodium bicarbonate-containing solutions should not be used.\"\n },\n {\n \"VerbatimTerm\": \"bicarbonate\",\n \"Probability\": \"0.0006941259\",\n \"SemanticContext\": \"Drugs That Are Physically Incompatible in Solution with ALOPRIM ® allopurinol for Injection Amikacin sulfate Hydroxyzine HCl Amphotericin B Idarubicin HCl Carmustine Imipenem-cilastatin sodium Cefotaxime sodium Mechlorethamine HCl Chlorpromazine HCl Meperidine HCl Cimetidine HCl Metoclopramide HCl Clindamycin phosphate Methylprednisolone sodium succinate Cytarabine Minocycline HCl Dacarbazine Nalbuphine HCl Daunorubicin HCl Netilmicin sulfate Diphenhydramine HCl Ondansetron HCl Doxorubicin HCl Prochlorperazine edisylate Doxycycline hyclate Promethazine HCl Droperidol Sodium bicarbonate Floxuridine Streptozocin Gentamicin sulfate Tobramycin sulfate Haloperidol lactate Vinorelbine tartrate .\"\n }\n ]\n },\n {\n \"Term\": \"Creatinine renal clearance\",\n \"MEDDRACode\": \"10011371\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Creatinine Clearance\",\n \"Probability\": \"2.38851E-05\",\n \"SemanticContext\": \"Impaired Renal Function The dose of ALOPRIM allopurinol for Injection should be reduced in patients with impaired renal function to avoid accumulation of allopurinol and its metabolites: Creatinine Clearance Recommended Daily Dose 10 to 20 mL/min 200 mg/day 3 to 10 mL/min 100 mg/day< 3 mL/min 100 mg/day at extended intervals .\"\n },\n {\n \"VerbatimTerm\": \"creatinine clearance\",\n \"Probability\": \"0.0001252592\",\n \"SemanticContext\": \"The appropriate dose of ALOPRIM allopurinol for Injection for patients with a creatinine clearance = 10 mL/min is 100 mg per day.\"\n },\n {\n \"VerbatimTerm\": \"creatinine clearance\",\n \"Probability\": \"0.00022313\",\n \"SemanticContext\": \"For patients with a creatinine clearance between 10 and 20 mL/min, a dose of 200 mg per day is recommended.\"\n },\n {\n \"VerbatimTerm\": \"creatinine clearance\",\n \"Probability\": \"0.0010219514\",\n \"SemanticContext\": \"With extreme renal impairment creatinine clearance less than 3 mL/min , the interval between doses may also need to be extended.\"\n },\n {\n \"VerbatimTerm\": \"creatinine clearance\",\n \"Probability\": \"0.0001526177\",\n \"SemanticContext\": \"In patients with decreased renal function, or who have concurrent illnesses which can affect renal function such as hypertension and diabetes mellitus, periodic laboratory parameters of renal function, particularly BUN and serum creatinine or creatinine clearance, should be performed and the patient’s allopurinol dosage reassessed.\"\n }\n ]\n },\n {\n \"Term\": \"Weight\",\n \"MEDDRACode\": \"10047890\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"weight\",\n \"Probability\": \"0.0001793206\",\n \"SemanticContext\": \"It is a white amorphous mass with a molecular weight of 158.09 and molecular formula C 5 H 3 N 4 NaO.\"\n }\n ]\n },\n {\n \"Term\": \"Crystalluria\",\n \"MEDDRACode\": \"10011509\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"crystalluria\",\n \"Probability\": \"0.1131501198\",\n \"SemanticContext\": \"There are isolated case reports of xanthine crystalluria in patients who were treated with oral allopurinol.\"\n }\n ]\n },\n {\n \"Term\": \"Lithiasis\",\n \"MEDDRACode\": \"10081111\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"calculi\",\n \"Probability\": \"0.002061516\",\n \"SemanticContext\": \"PRECAUTIONS General A fluid intake sufficient to yield a daily urinary output of at least two liters in adults and the maintenance of a neutral or, preferably, slightly alkaline urine are desirable to 1 avoid the theoretical possibility of formation of xanthine calculi under the influence of allopurinol therapy and 2 help prevent renal precipitation of urates in patients receiving concomitant uricosuric agents.\"\n }\n ]\n },\n {\n \"Term\": \"Renal failure\",\n \"MEDDRACode\": \"10038435\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"renal failure\",\n \"Probability\": \"0.9568727016\",\n \"SemanticContext\": \"A listing of the adverse reactions regardless of causality reported from clinical trials follows: Incidence Greater Than 1%: Cutaneous/Dermatologic: rash 1.5% Genitourinary: renal failure/insufficiency 1.2% Gastrointestinal: nausea 1.3% , vomiting 1.2% Incidence Less Than 1%: Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECG abnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea Musculoskeletal: arthralgia Other: hypotonia, diaphoresis, tumor lysis syndrome .\"\n },\n {\n \"VerbatimTerm\": \"Renal failure\",\n \"Probability\": \"0.2455421984\",\n \"SemanticContext\": \"Renal failure is rarely associated with hypersensitivity reactions to allopurinol.\"\n }\n ]\n },\n {\n \"Term\": \"Chemotherapy\",\n \"MEDDRACode\": \"10061758\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"chemotherapy\",\n \"Probability\": \"0.0002497137\",\n \"SemanticContext\": \"Clinical Trials A compassionate plea trial was conducted from 1977 through 1989 in which 718 evaluable patients with malignancies requiring treatment with cytotoxic chemotherapy, but who were unable to ingest or retain oral medication, received i.v. ALOPRIM allopurinol for Injection in the U.S. Of these patients, 411 had established hyperuricemia and 307 had normal serum urate levels at the time that treatment was initiated.\"\n },\n {\n \"VerbatimTerm\": \"chemotherapy\",\n \"Probability\": \"0.0038253367\",\n \"SemanticContext\": \"Normal serum uric acid levels were achieved in 68% reduction of serum uric acid was documented in 93% of the former, and were maintained throughout chemotherapy in 97% of the latter.\"\n },\n {\n \"VerbatimTerm\": \"chemotherapy\",\n \"Probability\": \"2.78635E-05\",\n \"SemanticContext\": \"Whenever possible, therapy with ALOPRIM allopurinol for Injection should be initiated 24 to 48 hours before the start of chemotherapy known to cause tumor cell lysis including adrenocorticosteroids .\"\n }\n ]\n },\n {\n \"Term\": \"Blood creatinine\",\n \"MEDDRACode\": \"10005480\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"serum creatinine\",\n \"Probability\": \"3.4336E-06\",\n \"SemanticContext\": \"In patients with decreased renal function, or who have concurrent illnesses which can affect renal function such as hypertension and diabetes mellitus, periodic laboratory parameters of renal function, particularly BUN and serum creatinine or creatinine clearance, should be performed and the patient’s allopurinol dosage reassessed.\"\n }\n ]\n },\n {\n \"Term\": \"Pregnancy\",\n \"MEDDRACode\": \"10036556\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"pregnant\",\n \"Probability\": \"0.0013705194\",\n \"SemanticContext\": \"However, there is a published report in pregnant mice that single intraperitoneal doses of 50 or 100 mg/kg about 1/3 or 3/4 the human dose on a mg/m 2 basis of allopurinol on gestation days 10 or 13 produced significant increases in fetal deaths and teratogenic effects cleft palate, harelip, and digital defects .\"\n },\n {\n \"VerbatimTerm\": \"pregnant\",\n \"Probability\": \"0.000515908\",\n \"SemanticContext\": \"There are, however, no adequate or well-controlled studies in pregnant women.\"\n },\n {\n \"VerbatimTerm\": \"pregnant\",\n \"Probability\": \"0.0013705194\",\n \"SemanticContext\": \"However, there is a published report in pregnant mice that single intraperitoneal doses of 50 or 100 mg/kg about 1/3 or 3/4 the human dose on a mg/m 2 basis of allopurinol on gestation days 10 or 13 produced significant increases in fetal deaths and teratogenic effects cleft palate, harelip, and digital defects .\"\n },\n {\n \"VerbatimTerm\": \"pregnant\",\n \"Probability\": \"0.000515908\",\n \"SemanticContext\": \"There are, however, no adequate or well-controlled studies in pregnant women.\"\n }\n ]\n },\n {\n \"Term\": \"MacLeod's syndrome\",\n \"MEDDRACode\": \"10025375\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"SJS\",\n \"Probability\": \"0.8129615784\",\n \"SemanticContext\": \"Serious and sometimes fatal dermatologic reactions, including toxic epidermal necrolysis TEN , Stevens-Johnson syndrome SJS , and drug reaction with eosinophilia and systemic symptoms DRESS have been reported in patients taking allopurinol.\"\n }\n ]\n },\n {\n \"Term\": \"Haemodialysis\",\n \"MEDDRACode\": \"10018875\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hemodialysis\",\n \"Probability\": \"0.0001114415\",\n \"SemanticContext\": \"Both allopurinol and oxypurinol are dialyzable; however, the usefulness of hemodialysis or peritoneal dialysis in the management of an overdose of ALOPRIM allopurinol for Injection is unknown.\"\n }\n ]\n },\n {\n \"Term\": \"Pulmonary embolism\",\n \"MEDDRACode\": \"10037377\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"pulmonary embolus\",\n \"Probability\": \"0.9855472445\",\n \"SemanticContext\": \"A listing of the adverse reactions regardless of causality reported from clinical trials follows: Incidence Greater Than 1%: Cutaneous/Dermatologic: rash 1.5% Genitourinary: renal failure/insufficiency 1.2% Gastrointestinal: nausea 1.3% , vomiting 1.2% Incidence Less Than 1%: Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECG abnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea Musculoskeletal: arthralgia Other: hypotonia, diaphoresis, tumor lysis syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Thrombocytopenia\",\n \"MEDDRACode\": \"10043554\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"thrombocytopenia\",\n \"Probability\": \"0.9889231324\",\n \"SemanticContext\": \"A listing of the adverse reactions regardless of causality reported from clinical trials follows: Incidence Greater Than 1%: Cutaneous/Dermatologic: rash 1.5% Genitourinary: renal failure/insufficiency 1.2% Gastrointestinal: nausea 1.3% , vomiting 1.2% Incidence Less Than 1%: Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECG abnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea Musculoskeletal: arthralgia Other: hypotonia, diaphoresis, tumor lysis syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Blood alkaline phosphatase\",\n \"MEDDRACode\": \"10005298\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"alkaline phosphatase\",\n \"Probability\": \"0.0002133548\",\n \"SemanticContext\": \"A few cases of reversible clinical hepatotoxicity have been noted in patients taking oral allopurinol, and in some patients asymptomatic rises in serum alkaline phosphatase or serum transaminase have been observed.\"\n }\n ]\n },\n {\n \"Term\": \"Blood urea\",\n \"MEDDRACode\": \"10005845\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"BUN\",\n \"Probability\": \"0.0001785159\",\n \"SemanticContext\": \"A few patients with pre-existing renal disease or poor urate clearance have shown a rise in BUN during allopurinol administration, although a decrease in BUN has also been observed.\"\n },\n {\n \"VerbatimTerm\": \"BUN\",\n \"Probability\": \"2.3512E-06\",\n \"SemanticContext\": \"In patients with decreased renal function, or who have concurrent illnesses which can affect renal function such as hypertension and diabetes mellitus, periodic laboratory parameters of renal function, particularly BUN and serum creatinine or creatinine clearance, should be performed and the patient’s allopurinol dosage reassessed.\"\n }\n ]\n },\n {\n \"Term\": \"Hypotension\",\n \"MEDDRACode\": \"10021097\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hypotension\",\n \"Probability\": \"0.9992523193\",\n \"SemanticContext\": \"A listing of the adverse reactions regardless of causality reported from clinical trials follows: Incidence Greater Than 1%: Cutaneous/Dermatologic: rash 1.5% Genitourinary: renal failure/insufficiency 1.2% Gastrointestinal: nausea 1.3% , vomiting 1.2% Incidence Less Than 1%: Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECG abnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea Musculoskeletal: arthralgia Other: hypotonia, diaphoresis, tumor lysis syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Water intoxication\",\n \"MEDDRACode\": \"10047837\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"water intoxication\",\n \"Probability\": \"0.9890418053\",\n \"SemanticContext\": \"A listing of the adverse reactions regardless of causality reported from clinical trials follows: Incidence Greater Than 1%: Cutaneous/Dermatologic: rash 1.5% Genitourinary: renal failure/insufficiency 1.2% Gastrointestinal: nausea 1.3% , vomiting 1.2% Incidence Less Than 1%: Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECG abnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea Musculoskeletal: arthralgia Other: hypotonia, diaphoresis, tumor lysis syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Constipation\",\n \"MEDDRACode\": \"10010774\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"constipation\",\n \"Probability\": \"0.9994630218\",\n \"SemanticContext\": \"A listing of the adverse reactions regardless of causality reported from clinical trials follows: Incidence Greater Than 1%: Cutaneous/Dermatologic: rash 1.5% Genitourinary: renal failure/insufficiency 1.2% Gastrointestinal: nausea 1.3% , vomiting 1.2% Incidence Less Than 1%: Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECG abnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea Musculoskeletal: arthralgia Other: hypotonia, diaphoresis, tumor lysis syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Dystonia\",\n \"MEDDRACode\": \"10013983\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"dystonia\",\n \"Probability\": \"0.9951182008\",\n \"SemanticContext\": \"A listing of the adverse reactions regardless of causality reported from clinical trials follows: Incidence Greater Than 1%: Cutaneous/Dermatologic: rash 1.5% Genitourinary: renal failure/insufficiency 1.2% Gastrointestinal: nausea 1.3% , vomiting 1.2% Incidence Less Than 1%: Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECG abnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea Musculoskeletal: arthralgia Other: hypotonia, diaphoresis, tumor lysis syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Carcinogenicity\",\n \"MEDDRACode\": \"10007269\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"carcinogenicity\",\n \"Probability\": \"0.0009374619\",\n \"SemanticContext\": \"No evidence of carcinogenicity was seen in either mice or rats at doses about 1/6 or 1/3 the recommended human dose on a mg/m 2 basis, respectively .\"\n }\n ]\n },\n {\n \"Term\": \"Gastrointestinal disorder\",\n \"MEDDRACode\": \"10017944\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"reaction Gastrointestinal\",\n \"Probability\": \"0.7290763259\",\n \"SemanticContext\": \"A listing of the adverse reactions regardless of causality reported from clinical trials follows: Incidence Greater Than 1%: Cutaneous/Dermatologic: rash 1.5% Genitourinary: renal failure/insufficiency 1.2% Gastrointestinal: nausea 1.3% , vomiting 1.2% Incidence Less Than 1%: Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECG abnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea Musculoskeletal: arthralgia Other: hypotonia, diaphoresis, tumor lysis syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Hepatomegaly\",\n \"MEDDRACode\": \"10019842\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hepatomegaly\",\n \"Probability\": \"0.9995492697\",\n \"SemanticContext\": \"A listing of the adverse reactions regardless of causality reported from clinical trials follows: Incidence Greater Than 1%: Cutaneous/Dermatologic: rash 1.5% Genitourinary: renal failure/insufficiency 1.2% Gastrointestinal: nausea 1.3% , vomiting 1.2% Incidence Less Than 1%: Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECG abnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea Musculoskeletal: arthralgia Other: hypotonia, diaphoresis, tumor lysis syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Hyperglycaemia\",\n \"MEDDRACode\": \"10020635\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hyperglycemia\",\n \"Probability\": \"0.9834791422\",\n \"SemanticContext\": \"A listing of the adverse reactions regardless of causality reported from clinical trials follows: Incidence Greater Than 1%: Cutaneous/Dermatologic: rash 1.5% Genitourinary: renal failure/insufficiency 1.2% Gastrointestinal: nausea 1.3% , vomiting 1.2% Incidence Less Than 1%: Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECG abnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea Musculoskeletal: arthralgia Other: hypotonia, diaphoresis, tumor lysis syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Hyperhidrosis\",\n \"MEDDRACode\": \"10020642\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"diaphoresis\",\n \"Probability\": \"0.9972603321\",\n \"SemanticContext\": \"A listing of the adverse reactions regardless of causality reported from clinical trials follows: Incidence Greater Than 1%: Cutaneous/Dermatologic: rash 1.5% Genitourinary: renal failure/insufficiency 1.2% Gastrointestinal: nausea 1.3% , vomiting 1.2% Incidence Less Than 1%: Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECG abnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea Musculoskeletal: arthralgia Other: hypotonia, diaphoresis, tumor lysis syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Hyperkalaemia\",\n \"MEDDRACode\": \"10020646\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hyperkalemia\",\n \"Probability\": \"0.9833505154\",\n \"SemanticContext\": \"A listing of the adverse reactions regardless of causality reported from clinical trials follows: Incidence Greater Than 1%: Cutaneous/Dermatologic: rash 1.5% Genitourinary: renal failure/insufficiency 1.2% Gastrointestinal: nausea 1.3% , vomiting 1.2% Incidence Less Than 1%: Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECG abnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea Musculoskeletal: arthralgia Other: hypotonia, diaphoresis, tumor lysis syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Blood creatinine increased\",\n \"MEDDRACode\": \"10005483\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"increased creatinine\",\n \"Probability\": \"0.998925209\",\n \"SemanticContext\": \"A listing of the adverse reactions regardless of causality reported from clinical trials follows: Incidence Greater Than 1%: Cutaneous/Dermatologic: rash 1.5% Genitourinary: renal failure/insufficiency 1.2% Gastrointestinal: nausea 1.3% , vomiting 1.2% Incidence Less Than 1%: Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECG abnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea Musculoskeletal: arthralgia Other: hypotonia, diaphoresis, tumor lysis syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Liver function test\",\n \"MEDDRACode\": \"10060105\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"liver function tests\",\n \"Probability\": \"0.0001690686\",\n \"SemanticContext\": \"In patients with pre-existing liver disease, periodic liver function tests are recommended during the early stages of therapy.\"\n },\n {\n \"VerbatimTerm\": \"liver function tests\",\n \"Probability\": \"0.0001092941\",\n \"SemanticContext\": \"In patients with pre-existing liver disease, periodic liver function tests are recommended during the early stages of therapy see WARNINGS .\"\n }\n ]\n },\n {\n \"Term\": \"Laboratory test\",\n \"MEDDRACode\": \"10059938\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Laboratory Test\",\n \"Probability\": \"2.2118E-06\",\n \"SemanticContext\": \"Drug/Laboratory Test Interactions Allopurinol is not known to alter the accuracy of laboratory tests.\"\n },\n {\n \"VerbatimTerm\": \"Laboratory Test\",\n \"Probability\": \"4.1724E-06\",\n \"SemanticContext\": \"Drug/Laboratory Test Interactions Allopurinol is not known to alter the accuracy of laboratory tests.\"\n },\n {\n \"VerbatimTerm\": \"laboratory tests\",\n \"Probability\": \"0.0003636777\",\n \"SemanticContext\": \"Drug/Laboratory Test Interactions Allopurinol is not known to alter the accuracy of laboratory tests.\"\n },\n {\n \"VerbatimTerm\": \"laboratory tests\",\n \"Probability\": \"0.0001744032\",\n \"SemanticContext\": \"Drug/Laboratory Test Interactions Allopurinol is not known to alter the accuracy of laboratory tests.\"\n },\n {\n \"VerbatimTerm\": \"Laboratory Tests\",\n \"Probability\": \"0.0001148161\",\n \"SemanticContext\": \"Laboratory Tests The correct dosage and schedule for maintaining the serum uric acid within the normal range is best determined by using the serum uric acid as an index.\"\n }\n ]\n },\n {\n \"Term\": \"Stevens-Johnson syndrome\",\n \"MEDDRACode\": \"10042033\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Stevens-Johnson syndrome\",\n \"Probability\": \"0.8440971971\",\n \"SemanticContext\": \"Serious and sometimes fatal dermatologic reactions, including toxic epidermal necrolysis TEN , Stevens-Johnson syndrome SJS , and drug reaction with eosinophilia and systemic symptoms DRESS have been reported in patients taking allopurinol.\"\n },\n {\n \"VerbatimTerm\": \"SJS\",\n \"Probability\": \"0.8129615784\",\n \"SemanticContext\": \"Serious and sometimes fatal dermatologic reactions, including toxic epidermal necrolysis TEN , Stevens-Johnson syndrome SJS , and drug reaction with eosinophilia and systemic symptoms DRESS have been reported in patients taking allopurinol.\"\n }\n ]\n },\n {\n \"Term\": \"Hypotonia\",\n \"MEDDRACode\": \"10021118\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hypotonia\",\n \"Probability\": \"0.9961255789\",\n \"SemanticContext\": \"A listing of the adverse reactions regardless of causality reported from clinical trials follows: Incidence Greater Than 1%: Cutaneous/Dermatologic: rash 1.5% Genitourinary: renal failure/insufficiency 1.2% Gastrointestinal: nausea 1.3% , vomiting 1.2% Incidence Less Than 1%: Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECG abnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea Musculoskeletal: arthralgia Other: hypotonia, diaphoresis, tumor lysis syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Jaundice\",\n \"MEDDRACode\": \"10023126\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"jaundice\",\n \"Probability\": \"0.9966931343\",\n \"SemanticContext\": \"A listing of the adverse reactions regardless of causality reported from clinical trials follows: Incidence Greater Than 1%: Cutaneous/Dermatologic: rash 1.5% Genitourinary: renal failure/insufficiency 1.2% Gastrointestinal: nausea 1.3% , vomiting 1.2% Incidence Less Than 1%: Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECG abnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea Musculoskeletal: arthralgia Other: hypotonia, diaphoresis, tumor lysis syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Myoclonus\",\n \"MEDDRACode\": \"10028622\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"myoclonus\",\n \"Probability\": \"0.9939953089\",\n \"SemanticContext\": \"A listing of the adverse reactions regardless of causality reported from clinical trials follows: Incidence Greater Than 1%: Cutaneous/Dermatologic: rash 1.5% Genitourinary: renal failure/insufficiency 1.2% Gastrointestinal: nausea 1.3% , vomiting 1.2% Incidence Less Than 1%: Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECG abnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea Musculoskeletal: arthralgia Other: hypotonia, diaphoresis, tumor lysis syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Drug reaction with eosinophilia and systemic symptoms\",\n \"MEDDRACode\": \"10073508\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hypersensitivity syndrome\",\n \"Probability\": \"0.0141527951\",\n \"SemanticContext\": \"Patients who carry the HLA-B*58:01 allele are at a higher risk of allopurinol hypersensitivity syndrome AHS , but hypersensitivity reactions have been reported in patients who do not carry this allele.\"\n }\n ]\n },\n {\n \"Term\": \"Illness\",\n \"MEDDRACode\": \"10080284\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"illnesses\",\n \"Probability\": \"0.0041811466\",\n \"SemanticContext\": \"In patients with decreased renal function, or who have concurrent illnesses which can affect renal function such as hypertension and diabetes mellitus, periodic laboratory parameters of renal function, particularly BUN and serum creatinine or creatinine clearance, should be performed and the patient’s allopurinol dosage reassessed.\"\n }\n ]\n },\n {\n \"Term\": \"Plasma cell myeloma\",\n \"MEDDRACode\": \"10035226\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"multiple myeloma\",\n \"Probability\": \"0.0118037164\",\n \"SemanticContext\": \"Concurrent conditions such as multiple myeloma and congestive myocardial disease were present among those patients whose renal function deteriorated after allopurinol was begun.\"\n }\n ]\n },\n {\n \"Term\": \"Decreased appetite\",\n \"MEDDRACode\": \"10061428\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"anorexia\",\n \"Probability\": \"0.0202777982\",\n \"SemanticContext\": \"If anorexia, weight loss, or pruritus develop in patients on allopurinol, evaluation of liver function should be part of their diagnostic workup.\"\n }\n ]\n },\n {\n \"Term\": \"Vasculitis\",\n \"MEDDRACode\": \"10047115\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"vasculitis\",\n \"Probability\": \"0.4819927514\",\n \"SemanticContext\": \"Other serious hypersensitivity reactions that have been reported include exfoliative, urticarial and purpuric lesions; generalized vasculitis; and irreversible hepatotoxicity.\"\n }\n ]\n },\n {\n \"Term\": \"Mucosal inflammation\",\n \"MEDDRACode\": \"10028116\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"mucositis\",\n \"Probability\": \"0.9148837924\",\n \"SemanticContext\": \"A listing of the adverse reactions regardless of causality reported from clinical trials follows: Incidence Greater Than 1%: Cutaneous/Dermatologic: rash 1.5% Genitourinary: renal failure/insufficiency 1.2% Gastrointestinal: nausea 1.3% , vomiting 1.2% Incidence Less Than 1%: Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECG abnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea Musculoskeletal: arthralgia Other: hypotonia, diaphoresis, tumor lysis syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Teratogenicity\",\n \"MEDDRACode\": \"10043275\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"teratogenicity\",\n \"Probability\": \"0.0003704429\",\n \"SemanticContext\": \"Pregnancy There was no evidence of fetotoxicity or teratogenicity in rats or rabbits treated during the period of organogenesis with oral allopurinol at doses up to 200 mg/kg/day and up to 100 mg/kg/day, respectively about three times the human dose on a mg/m 2 basis .\"\n },\n {\n \"VerbatimTerm\": \"teratogenicity\",\n \"Probability\": \"0.0003704429\",\n \"SemanticContext\": \"Pregnancy There was no evidence of fetotoxicity or teratogenicity in rats or rabbits treated during the period of organogenesis with oral allopurinol at doses up to 200 mg/kg/day and up to 100 mg/kg/day, respectively about three times the human dose on a mg/m 2 basis .\"\n }\n ]\n },\n {\n \"Term\": \"Mass\",\n \"MEDDRACode\": \"10026865\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"mass\",\n \"Probability\": \"9.352E-05\",\n \"SemanticContext\": \"It is a white amorphous mass with a molecular weight of 158.09 and molecular formula C 5 H 3 N 4 NaO.\"\n }\n ]\n },\n {\n \"Term\": \"Infection\",\n \"MEDDRACode\": \"10021789\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"infection\",\n \"Probability\": \"0.9611544609\",\n \"SemanticContext\": \"A listing of the adverse reactions regardless of causality reported from clinical trials follows: Incidence Greater Than 1%: Cutaneous/Dermatologic: rash 1.5% Genitourinary: renal failure/insufficiency 1.2% Gastrointestinal: nausea 1.3% , vomiting 1.2% Incidence Less Than 1%: Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECG abnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea Musculoskeletal: arthralgia Other: hypotonia, diaphoresis, tumor lysis syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Pain\",\n \"MEDDRACode\": \"10033371\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"pain\",\n \"Probability\": \"0.9823862314\",\n \"SemanticContext\": \"A listing of the adverse reactions regardless of causality reported from clinical trials follows: Incidence Greater Than 1%: Cutaneous/Dermatologic: rash 1.5% Genitourinary: renal failure/insufficiency 1.2% Gastrointestinal: nausea 1.3% , vomiting 1.2% Incidence Less Than 1%: Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECG abnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea Musculoskeletal: arthralgia Other: hypotonia, diaphoresis, tumor lysis syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Weight decreased\",\n \"MEDDRACode\": \"10047895\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"weight loss\",\n \"Probability\": \"0.0619781613\",\n \"SemanticContext\": \"If anorexia, weight loss, or pruritus develop in patients on allopurinol, evaluation of liver function should be part of their diagnostic workup.\"\n }\n ]\n },\n {\n \"Term\": \"Exercise adequate\",\n \"MEDDRACode\": \"10015636\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": true,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"exercised\",\n \"Probability\": \"2.6965E-06\",\n \"SemanticContext\": \"Since the effect of allopurinol on the nursing infant is unknown, caution should be exercised when allopurinol is administered to a nursing woman.\"\n },\n {\n \"VerbatimTerm\": \"exercised\",\n \"Probability\": \"2.6965E-06\",\n \"SemanticContext\": \"Since the effect of allopurinol on the nursing infant is unknown, caution should be exercised when allopurinol is administered to a nursing woman.\"\n }\n ]\n },\n {\n \"Term\": \"Mental status changes\",\n \"MEDDRACode\": \"10048294\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"mental status changes\",\n \"Probability\": \"0.8362580538\",\n \"SemanticContext\": \"A listing of the adverse reactions regardless of causality reported from clinical trials follows: Incidence Greater Than 1%: Cutaneous/Dermatologic: rash 1.5% Genitourinary: renal failure/insufficiency 1.2% Gastrointestinal: nausea 1.3% , vomiting 1.2% Incidence Less Than 1%: Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECG abnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea Musculoskeletal: arthralgia Other: hypotonia, diaphoresis, tumor lysis syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Sepsis\",\n \"MEDDRACode\": \"10040047\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"sepsis\",\n \"Probability\": \"0.9945378304\",\n \"SemanticContext\": \"A listing of the adverse reactions regardless of causality reported from clinical trials follows: Incidence Greater Than 1%: Cutaneous/Dermatologic: rash 1.5% Genitourinary: renal failure/insufficiency 1.2% Gastrointestinal: nausea 1.3% , vomiting 1.2% Incidence Less Than 1%: Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECG abnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea Musculoskeletal: arthralgia Other: hypotonia, diaphoresis, tumor lysis syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Pharyngitis\",\n \"MEDDRACode\": \"10034835\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"pharyngitis\",\n \"Probability\": \"0.9928842783\",\n \"SemanticContext\": \"A listing of the adverse reactions regardless of causality reported from clinical trials follows: Incidence Greater Than 1%: Cutaneous/Dermatologic: rash 1.5% Genitourinary: renal failure/insufficiency 1.2% Gastrointestinal: nausea 1.3% , vomiting 1.2% Incidence Less Than 1%: Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECG abnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea Musculoskeletal: arthralgia Other: hypotonia, diaphoresis, tumor lysis syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Neoplasm malignant\",\n \"MEDDRACode\": \"10028997\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"cancer\",\n \"Probability\": \"0.0002043545\",\n \"SemanticContext\": \"INDICATIONS AND USAGE ALOPRIM allopurinol for Injection is indicated for the management of patients with leukemia, lymphoma, and solid tumor malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels and who cannot tolerate oral therapy.\"\n }\n ]\n },\n {\n \"Term\": \"Infusion\",\n \"MEDDRACode\": \"10060345\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"infusion\",\n \"Probability\": \"0.0121459961\",\n \"SemanticContext\": \"ALOPRIM allopurinol for Injection was administered via an intravenous infusion over 30 minutes.\"\n },\n {\n \"VerbatimTerm\": \"infusion\",\n \"Probability\": \"2.65617E-05\",\n \"SemanticContext\": \"Administration In both adults and children, the daily dose can be given as single infusion or in equally divided infusions at 6-, 8-, or 12-hour intervals at the recommended final concentration of not greater than 6 mg/mL see Preparation of Solution .\"\n },\n {\n \"VerbatimTerm\": \"infusion\",\n \"Probability\": \"0.000299871\",\n \"SemanticContext\": \"The rate of infusion depends on the volume of infusate.\"\n },\n {\n \"VerbatimTerm\": \"infusions\",\n \"Probability\": \"7.05476E-05\",\n \"SemanticContext\": \"Administration In both adults and children, the daily dose can be given as single infusion or in equally divided infusions at 6-, 8-, or 12-hour intervals at the recommended final concentration of not greater than 6 mg/mL see Preparation of Solution .\"\n }\n ]\n },\n {\n \"Term\": \"Leukaemia\",\n \"MEDDRACode\": \"10024288\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"leukemia\",\n \"Probability\": \"0.0044489503\",\n \"SemanticContext\": \"\\n \\n Cytotoxic Agents\\n \\n \\n Enhanced bone marrow suppression by cyclophosphamide and other cytotoxic agents has been reported among patients with neoplastic disease, except leukemia, in the presence of allopurinol.\"\n },\n {\n \"VerbatimTerm\": \"leukemia\",\n \"Probability\": \"0.0001383424\",\n \"SemanticContext\": \"INDICATIONS AND USAGE ALOPRIM allopurinol for Injection is indicated for the management of patients with leukemia, lymphoma, and solid tumor malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels and who cannot tolerate oral therapy.\"\n },\n {\n \"VerbatimTerm\": \"leukemia\",\n \"Probability\": \"0.0044489503\",\n \"SemanticContext\": \"\\n \\n Cytotoxic Agents\\n \\n \\n Enhanced bone marrow suppression by cyclophosphamide and other cytotoxic agents has been reported among patients with neoplastic disease, except leukemia, in the presence of allopurinol.\"\n }\n ]\n },\n {\n \"Term\": \"Lymphoma\",\n \"MEDDRACode\": \"10025310\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"lymphoma\",\n \"Probability\": \"0.0015421212\",\n \"SemanticContext\": \"However, in a well-controlled study of patients with lymphoma on combination therapy, allopurinol did not increase the marrow toxicity of patients treated with cyclophosphamide, doxorubicin, bleomycin, procarbazine, and/or mechlorethamine.\"\n },\n {\n \"VerbatimTerm\": \"lymphoma\",\n \"Probability\": \"0.0002238452\",\n \"SemanticContext\": \"INDICATIONS AND USAGE ALOPRIM allopurinol for Injection is indicated for the management of patients with leukemia, lymphoma, and solid tumor malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels and who cannot tolerate oral therapy.\"\n },\n {\n \"VerbatimTerm\": \"lymphoma\",\n \"Probability\": \"0.0015421212\",\n \"SemanticContext\": \"However, in a well-controlled study of patients with lymphoma on combination therapy, allopurinol did not increase the marrow toxicity of patients treated with cyclophosphamide, doxorubicin, bleomycin, procarbazine, and/or mechlorethamine.\"\n }\n ]\n },\n {\n \"Term\": \"Gout\",\n \"MEDDRACode\": \"10018627\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"gout\",\n \"Probability\": \"0.0080515444\",\n \"SemanticContext\": \"Although the pattern of use for oral allopurinol includes longer term therapy, particularly for gout and renal calculi, the experience gained may be relevant.\"\n },\n {\n \"VerbatimTerm\": \"gout\",\n \"Probability\": \"0.0080515444\",\n \"SemanticContext\": \"Although the pattern of use for oral allopurinol includes longer term therapy, particularly for gout and renal calculi, the experience gained may be relevant.\"\n }\n ]\n },\n {\n \"Term\": \"Schwartz Jampel syndrome\",\n \"MEDDRACode\": \"10082378\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"SJS\",\n \"Probability\": \"0.8129615784\",\n \"SemanticContext\": \"Serious and sometimes fatal dermatologic reactions, including toxic epidermal necrolysis TEN , Stevens-Johnson syndrome SJS , and drug reaction with eosinophilia and systemic symptoms DRESS have been reported in patients taking allopurinol.\"\n }\n ]\n },\n {\n \"Term\": \"Drug therapy\",\n \"MEDDRACode\": \"10063370\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": true\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"drug therapy\",\n \"Probability\": \"0.0006140172\",\n \"SemanticContext\": \"In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.\"\n },\n {\n \"VerbatimTerm\": \"drug therapy\",\n \"Probability\": \"0.0006140172\",\n \"SemanticContext\": \"In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.\"\n }\n ]\n },\n {\n \"Term\": \"Infant\",\n \"MEDDRACode\": \"10021731\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": true,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"infant\",\n \"Probability\": \"3.96492E-05\",\n \"SemanticContext\": \"Since the effect of allopurinol on the nursing infant is unknown, caution should be exercised when allopurinol is administered to a nursing woman.\"\n },\n {\n \"VerbatimTerm\": \"infant\",\n \"Probability\": \"3.96492E-05\",\n \"SemanticContext\": \"Since the effect of allopurinol on the nursing infant is unknown, caution should be exercised when allopurinol is administered to a nursing woman.\"\n }\n ]\n },\n {\n \"Term\": \"Decreased activity\",\n \"MEDDRACode\": \"10011953\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Hypoactivity\",\n \"Probability\": \"0.1021557152\",\n \"SemanticContext\": \"Hypoactivity was observed with these doses.\"\n }\n ]\n },\n {\n \"Term\": \"Somnolence\",\n \"MEDDRACode\": \"10041349\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"drowsiness\",\n \"Probability\": \"0.0508775115\",\n \"SemanticContext\": \"Due to the occasional occurrence of drowsiness, patients should be alerted to the need for due precaution when engaging in activities where alertness is mandatory.\"\n }\n ]\n },\n {\n \"Term\": \"Toxic epidermal necrolysis\",\n \"MEDDRACode\": \"10044223\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"toxic epidermal necrolysis\",\n \"Probability\": \"0.8835817575\",\n \"SemanticContext\": \"Serious and sometimes fatal dermatologic reactions, including toxic epidermal necrolysis TEN , Stevens-Johnson syndrome SJS , and drug reaction with eosinophilia and systemic symptoms DRESS have been reported in patients taking allopurinol.\"\n }\n ]\n },\n {\n \"Term\": \"Transaminases\",\n \"MEDDRACode\": \"10054888\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"transaminase\",\n \"Probability\": \"0.0067349076\",\n \"SemanticContext\": \"A few cases of reversible clinical hepatotoxicity have been noted in patients taking oral allopurinol, and in some patients asymptomatic rises in serum alkaline phosphatase or serum transaminase have been observed.\"\n }\n ]\n },\n {\n \"Term\": \"Elderly\",\n \"MEDDRACode\": \"10014348\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": true\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"elderly\",\n \"Probability\": \"0.0003377199\",\n \"SemanticContext\": \"Other reported clinical experience has not identified differences in responses between the elderly and younger patients.\"\n },\n {\n \"VerbatimTerm\": \"elderly\",\n \"Probability\": \"4.0322E-05\",\n \"SemanticContext\": \"In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.\"\n },\n {\n \"VerbatimTerm\": \"elderly\",\n \"Probability\": \"0.0003377199\",\n \"SemanticContext\": \"Other reported clinical experience has not identified differences in responses between the elderly and younger patients.\"\n },\n {\n \"VerbatimTerm\": \"elderly\",\n \"Probability\": \"4.0322E-05\",\n \"SemanticContext\": \"In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.\"\n }\n ]\n },\n {\n \"Term\": \"Hepatotoxicity\",\n \"MEDDRACode\": \"10019851\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hepatotoxicity\",\n \"Probability\": \"0.9395298958\",\n \"SemanticContext\": \"Other serious hypersensitivity reactions that have been reported include exfoliative, urticarial and purpuric lesions; generalized vasculitis; and irreversible hepatotoxicity.\"\n },\n {\n \"VerbatimTerm\": \"hepatotoxicity\",\n \"Probability\": \"0.6486697197\",\n \"SemanticContext\": \"A few cases of reversible clinical hepatotoxicity have been noted in patients taking oral allopurinol, and in some patients asymptomatic rises in serum alkaline phosphatase or serum transaminase have been observed.\"\n }\n ]\n },\n {\n \"Term\": \"Cardiovascular disorder\",\n \"MEDDRACode\": \"10007649\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"cardiovascular disorder\",\n \"Probability\": \"0.8801230192\",\n \"SemanticContext\": \"A listing of the adverse reactions regardless of causality reported from clinical trials follows: Incidence Greater Than 1%: Cutaneous/Dermatologic: rash 1.5% Genitourinary: renal failure/insufficiency 1.2% Gastrointestinal: nausea 1.3% , vomiting 1.2% Incidence Less Than 1%: Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECG abnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea Musculoskeletal: arthralgia Other: hypotonia, diaphoresis, tumor lysis syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Glycosuria\",\n \"MEDDRACode\": \"10018473\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"glycosuria\",\n \"Probability\": \"0.9021183252\",\n \"SemanticContext\": \"A listing of the adverse reactions regardless of causality reported from clinical trials follows: Incidence Greater Than 1%: Cutaneous/Dermatologic: rash 1.5% Genitourinary: renal failure/insufficiency 1.2% Gastrointestinal: nausea 1.3% , vomiting 1.2% Incidence Less Than 1%: Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECG abnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea Musculoskeletal: arthralgia Other: hypotonia, diaphoresis, tumor lysis syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Poisoning\",\n \"MEDDRACode\": \"10061355\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"poisoning\",\n \"Probability\": \"0.0080267191\",\n \"SemanticContext\": \"OVERDOSAGE Massive overdosing or acute poisoning by ALOPRIM allopurinol for Injection has not been reported.\"\n }\n ]\n },\n {\n \"Term\": \"Diabetes mellitus\",\n \"MEDDRACode\": \"10012601\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"diabetes mellitus\",\n \"Probability\": \"0.0020055771\",\n \"SemanticContext\": \"In patients with decreased renal function, or who have concurrent illnesses which can affect renal function such as hypertension and diabetes mellitus, periodic laboratory parameters of renal function, particularly BUN and serum creatinine or creatinine clearance, should be performed and the patient’s allopurinol dosage reassessed.\"\n }\n ]\n },\n {\n \"Term\": \"Lymphocyte count\",\n \"MEDDRACode\": \"10025251\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"lymphocytes\",\n \"Probability\": \"0.0001679063\",\n \"SemanticContext\": \"No evidence of clastogenicity was observed in an in vivo micronucleus test in rats, or in lymphocytes taken from patients treated with allopurinol mean duration of treatment 40 months , or in an in vitro assay with human lymphocytes.\"\n },\n {\n \"VerbatimTerm\": \"lymphocytes\",\n \"Probability\": \"0.0003265142\",\n \"SemanticContext\": \"No evidence of clastogenicity was observed in an in vivo micronucleus test in rats, or in lymphocytes taken from patients treated with allopurinol mean duration of treatment 40 months , or in an in vitro assay with human lymphocytes.\"\n }\n ]\n },\n {\n \"Term\": \"Nephropathy\",\n \"MEDDRACode\": \"10029151\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"renal disease\",\n \"Probability\": \"0.204803288\",\n \"SemanticContext\": \"A few patients with pre-existing renal disease or poor urate clearance have shown a rise in BUN during allopurinol administration, although a decrease in BUN has also been observed.\"\n }\n ]\n }\n ],\n \"IndicationTerms\": []\n }\n ]\n }\n ]\n}"}],"_postman_id":"d36b1e4d-8fdf-4708-8a99-2a92a0bb53a1"},{"name":"Annotation details for the given generic names","id":"581805e7-8083-48ca-ad9c-e26ca8f5cdff","protocolProfileBehavior":{"disableBodyPruning":true},"request":{"auth":{"type":"basic","basic":{"basicConfig":[{"key":"username","value":""},{"key":"password","value":""}]},"isInherited":false},"method":"POST","header":[],"body":{"mode":"formdata","formdata":[{"key":"filtertype","value":"genericname","type":"text","description":"

Option is \"genericname\" (string)

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Option is semi-colon separated genericnames (string)

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Value for Number of records to skip (integer). Defaults to 0

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Value for number of records to fetch (integer). Defaults to 100

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Options are \"us\", \"uk\", \"ca\", \"eu\", \"all\" (string). Defaults to \"us\"

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Returns label annotation details matching a given set of generic names.
User can pass generic names retrieved from endpoint \"annotation/genericnames\", as up to a 100 semi-colon separated values .
Multiple generic names are treated as \"OR\" queries.
This will return a maximum of 100 annotation details.

Returns all Generic Names (Semi-colon separated) for which annotated product labels are available.

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Can be used to monitor a specific product label
Returns label details for a single label using the label id
The label id can be found as the value of the \"Id\" property for each specific label that is returned using any API endpoint.

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Label Id fetched during imports (string)

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charset=utf-8"},{"key":"Vary","value":"Accept"},{"key":"Server","value":"Microsoft-IIS/8.5"},{"key":"X-StackifyID","value":"V2|769a6663-d1dc-436a-ae74-7104fa5a27fc|C57775|CD6"},{"key":"X-Powered-By","value":"ServiceStack/5.10 NET45 Win32NT/.NET"},{"key":"Access-Control-Allow-Methods","value":"GET, POST, PUT, DELETE, OPTIONS"},{"key":"Access-Control-Allow-Headers","value":"Content-Type, Allow, Authorization, Wait, Accept, X-Requested-With, Put-Default-Position, Put-Before, If-Match, If-None-Match, Content-Range"},{"key":"Access-Control-Allow-Credentials","value":"true"},{"key":"Access-Control-Expose-Headers","value":"Content-Range"},{"key":"X-AspNet-Version","value":"4.0.30319"},{"key":"Set-Cookie","value":"ss-id=Ja23Y8GTrbRALEYQulFS; path=/; HttpOnly"},{"key":"Set-Cookie","value":"ss-pid=C0fyEYGLnKohYbIG1Gz6; expires=Fri, 26-Jul-2041 05:29:36 GMT; path=/; HttpOnly"},{"key":"Set-Cookie","value":"ss-opt=temp; expires=Fri, 26-Jul-2041 05:29:36 GMT; path=/; HttpOnly"},{"key":"strict-transport-security","value":"max-age=31536000; includeSubdomains"},{"key":"Date","value":"Mon, 26 Jul 2021 05:29:51 GMT"},{"key":"Content-Length","value":"267303"}],"cookie":[],"responseTime":null,"body":"{\n \"GenericName\": \"betamethasone sodium phosphate and betamethasone acetate\",\n \"MeddraVersion\": \"24.0\",\n \"Labels\": [\n {\n \"Id\": \"US304627ab-6caa-40f1-813f-70805bb35b39\",\n \"NDCCode\": \"51754-5060\",\n \"UpdatedDate\": \"Jun 02, 2021\",\n \"LabelSource\": {\n \"Country\": \"us\",\n \"ProductId\": \"024cd444-04e2-441a-9863-9e5db741e657\",\n \"FileId\": \"304627ab-6caa-40f1-813f-70805bb35b39\",\n \"Version\": \"3\"\n },\n \"AdverseEventTerms\": [\n {\n \"Term\": \"Abdominal distension\",\n \"MEDDRACode\": \"10000060\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Abdominal distention\",\n \"Probability\": \"0.9220182896\",\n \"SemanticContext\": \"Gastrointestinal Abdominal distention, bowel/bladder dysfunction after intrathecal administration , elevation in serum liver enzyme levels usually reversible upon discontinuation , hepatomegaly, increased appetite, nausea, pancreatitis, peptic ulcer with possible perforation and hemorrhage, perforation of the small and large intestine particularly in patients with inflammatory bowel disease , ulcerative esophagitis.\"\n }\n ]\n },\n {\n \"Term\": \"Abscess sterile\",\n \"MEDDRACode\": \"10000317\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"sterile abscess\",\n \"Probability\": \"0.9173126221\",\n \"SemanticContext\": \"Dermatologic Acne, allergic dermatitis, cutaneous and subcutaneous atrophy, dry scaly skin, ecchymoses and petechiae, edema, erythema, hyperpigmentation, hypopigmentation, impaired wound healing, increased sweating, rash, sterile abscess, striae, suppressed reactions to skin tests, thin fragile skin, thinning scalp hair, urticaria.\"\n }\n ]\n },\n {\n \"Term\": \"Acne\",\n \"MEDDRACode\": \"10000496\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Acne\",\n \"Probability\": \"0.8490418196\",\n \"SemanticContext\": \"Dermatologic Acne, allergic dermatitis, cutaneous and subcutaneous atrophy, dry scaly skin, ecchymoses and petechiae, edema, erythema, hyperpigmentation, hypopigmentation, impaired wound healing, increased sweating, rash, sterile abscess, striae, suppressed reactions to skin tests, thin fragile skin, thinning scalp hair, urticaria.\"\n }\n ]\n },\n {\n \"Term\": \"Alkalosis hypokalaemic\",\n \"MEDDRACode\": \"10001684\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hypokalemic alkalosis\",\n \"Probability\": \"0.9928042889\",\n \"SemanticContext\": \"Fluid and Electrolyte Disturbances Congestive heart failure in susceptible patients, fluid retention, hypokalemic alkalosis, potassium loss, sodium retention.\"\n }\n ]\n },\n {\n \"Term\": \"Anaphylactoid reaction\",\n \"MEDDRACode\": \"10002216\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Reactions Anaphylactoid\",\n \"Probability\": \"0.9314328432\",\n \"SemanticContext\": \"ADVERSE REACTIONS listed alphabetically, under each subsection Allergic Reactions Anaphylactoid reaction, anaphylaxis, angioedema.\"\n },\n {\n \"VerbatimTerm\": \"Anaphylactoid reaction\",\n \"Probability\": \"0.9212471247\",\n \"SemanticContext\": \"ADVERSE REACTIONS listed alphabetically, under each subsection Allergic Reactions Anaphylactoid reaction, anaphylaxis, angioedema.\"\n }\n ]\n },\n {\n \"Term\": \"Angioedema\",\n \"MEDDRACode\": \"10002424\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"angioedema\",\n \"Probability\": \"0.985330224\",\n \"SemanticContext\": \"ADVERSE REACTIONS listed alphabetically, under each subsection Allergic Reactions Anaphylactoid reaction, anaphylaxis, angioedema.\"\n }\n ]\n },\n {\n \"Term\": \"Arachnoiditis\",\n \"MEDDRACode\": \"10003074\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Arachnoiditis\",\n \"Probability\": \"0.8410742879\",\n \"SemanticContext\": \"Arachnoiditis, meningitis, paraparesis/paraplegia, and sensory disturbances have occurred after intrathecal administration see WARNINGS, Neurologic section .\"\n }\n ]\n },\n {\n \"Term\": \"Arrhythmia\",\n \"MEDDRACode\": \"10003119\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"arrhythmias\",\n \"Probability\": \"0.2166510224\",\n \"SemanticContext\": \"\\nDigitalis Glycosides Patients on digitalis glycosides may be at increased risk of arrhythmias due to hypokalemia.\"\n },\n {\n \"VerbatimTerm\": \"arrhythmias\",\n \"Probability\": \"0.2166510224\",\n \"SemanticContext\": \"\\nDigitalis Glycosides Patients on digitalis glycosides may be at increased risk of arrhythmias due to hypokalemia.\"\n }\n ]\n },\n {\n \"Term\": \"Arthropathy\",\n \"MEDDRACode\": \"10003285\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"arthropathy\",\n \"Probability\": \"0.362228483\",\n \"SemanticContext\": \"Musculoskeletal Aseptic necrosis of femoral and humeral heads, calcinosis following intra-articular or intralesional use , Charcot-like arthropathy, loss of muscle mass, muscle weakness, osteoporosis, pathologic fracture of long bones, postinjection flare following intra-articular use , steroid myopathy, tendon rupture, vertebral compression fractures.\"\n }\n ]\n },\n {\n \"Term\": \"Atrophy\",\n \"MEDDRACode\": \"10003694\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"atrophy\",\n \"Probability\": \"0.9240896702\",\n \"SemanticContext\": \"Dermatologic Acne, allergic dermatitis, cutaneous and subcutaneous atrophy, dry scaly skin, ecchymoses and petechiae, edema, erythema, hyperpigmentation, hypopigmentation, impaired wound healing, increased sweating, rash, sterile abscess, striae, suppressed reactions to skin tests, thin fragile skin, thinning scalp hair, urticaria.\"\n }\n ]\n },\n {\n \"Term\": \"Bladder dysfunction\",\n \"MEDDRACode\": \"10069632\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"bladder dysfunction\",\n \"Probability\": \"0.1721846163\",\n \"SemanticContext\": \"Gastrointestinal Abdominal distention, bowel/bladder dysfunction after intrathecal administration , elevation in serum liver enzyme levels usually reversible upon discontinuation , hepatomegaly, increased appetite, nausea, pancreatitis, peptic ulcer with possible perforation and hemorrhage, perforation of the small and large intestine particularly in patients with inflammatory bowel disease , ulcerative esophagitis.\"\n }\n ]\n },\n {\n \"Term\": \"Blood insulin\",\n \"MEDDRACode\": \"10005605\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"insulin\",\n \"Probability\": \"0.0001421571\",\n \"SemanticContext\": \"Endocrine Decreased carbohydrate and glucose tolerance, development of cushingoid state, glucosuria, hirsutism, hypertrichosis, increased requirements for insulin or oral hypoglycemic adrenocortical and pituitary unresponsiveness particularly in times of stress, as in trauma, surgery, or illness , suppression of growth in pediatric patients.\"\n }\n ]\n },\n {\n \"Term\": \"Bradycardia\",\n \"MEDDRACode\": \"10006093\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Bradycardia\",\n \"Probability\": \"0.9474010468\",\n \"SemanticContext\": \"Cardiovascular Bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure, fat embolism, hypertension, hypertrophic cardiomyopathy in premature infants, myocardial rupture following recent myocardial infarction see WARNINGS , pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis.\"\n }\n ]\n },\n {\n \"Term\": \"Calcinosis\",\n \"MEDDRACode\": \"10006938\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"calcinosis\",\n \"Probability\": \"0.1928986311\",\n \"SemanticContext\": \"Musculoskeletal Aseptic necrosis of femoral and humeral heads, calcinosis following intra-articular or intralesional use , Charcot-like arthropathy, loss of muscle mass, muscle weakness, osteoporosis, pathologic fracture of long bones, postinjection flare following intra-articular use , steroid myopathy, tendon rupture, vertebral compression fractures.\"\n }\n ]\n },\n {\n \"Term\": \"Cardiac arrest\",\n \"MEDDRACode\": \"10007515\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"cardiac arrest\",\n \"Probability\": \"0.9751826525\",\n \"SemanticContext\": \"Cardiovascular Bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure, fat embolism, hypertension, hypertrophic cardiomyopathy in premature infants, myocardial rupture following recent myocardial infarction see WARNINGS , pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis.\"\n }\n ]\n },\n {\n \"Term\": \"Circulatory collapse\",\n \"MEDDRACode\": \"10009192\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"circulatory collapse\",\n \"Probability\": \"0.9471425414\",\n \"SemanticContext\": \"Cardiovascular Bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure, fat embolism, hypertension, hypertrophic cardiomyopathy in premature infants, myocardial rupture following recent myocardial infarction see WARNINGS , pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis.\"\n }\n ]\n },\n {\n \"Term\": \"Compression fracture\",\n \"MEDDRACode\": \"10010214\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"compression fractures\",\n \"Probability\": \"0.0764600933\",\n \"SemanticContext\": \"Musculoskeletal Aseptic necrosis of femoral and humeral heads, calcinosis following intra-articular or intralesional use , Charcot-like arthropathy, loss of muscle mass, muscle weakness, osteoporosis, pathologic fracture of long bones, postinjection flare following intra-articular use , steroid myopathy, tendon rupture, vertebral compression fractures.\"\n }\n ]\n },\n {\n \"Term\": \"Cushingoid\",\n \"MEDDRACode\": \"10011655\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"moon face\",\n \"Probability\": \"0.5865163803\",\n \"SemanticContext\": \"Other Abnormal fat deposits, decreased resistance to infection, hiccups, increased or decreased motility and number of spermatozoa, malaise, moon face, weight gain.\"\n }\n ]\n },\n {\n \"Term\": \"Drug tolerance\",\n \"MEDDRACode\": \"10052804\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"tolerance\",\n \"Probability\": \"0.0068207681\",\n \"SemanticContext\": \"Endocrine Decreased carbohydrate and glucose tolerance, development of cushingoid state, glucosuria, hirsutism, hypertrichosis, increased requirements for insulin or oral hypoglycemic adrenocortical and pituitary unresponsiveness particularly in times of stress, as in trauma, surgery, or illness , suppression of growth in pediatric patients.\"\n }\n ]\n },\n {\n \"Term\": \"Ecchymosis\",\n \"MEDDRACode\": \"10014080\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"ecchymoses\",\n \"Probability\": \"0.878459692\",\n \"SemanticContext\": \"Dermatologic Acne, allergic dermatitis, cutaneous and subcutaneous atrophy, dry scaly skin, ecchymoses and petechiae, edema, erythema, hyperpigmentation, hypopigmentation, impaired wound healing, increased sweating, rash, sterile abscess, striae, suppressed reactions to skin tests, thin fragile skin, thinning scalp hair, urticaria.\"\n }\n ]\n },\n {\n \"Term\": \"Electrolyte imbalance\",\n \"MEDDRACode\": \"10014418\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Electrolyte Disturbances\",\n \"Probability\": \"0.0702655315\",\n \"SemanticContext\": \"Fluid and Electrolyte Disturbances Congestive heart failure in susceptible patients, fluid retention, hypokalemic alkalosis, potassium loss, sodium retention.\"\n }\n ]\n },\n {\n \"Term\": \"Exophthalmos\",\n \"MEDDRACode\": \"10015683\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Exophthalmos\",\n \"Probability\": \"0.7306218147\",\n \"SemanticContext\": \"Ophthalmic Exophthalmos, glaucoma, increased intraocular pressure, posterior subcapsular cataracts, rare instances of blindness associated with periocular injections, vision blurred.\"\n }\n ]\n },\n {\n \"Term\": \"Fat embolism\",\n \"MEDDRACode\": \"10016246\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"fat embolism\",\n \"Probability\": \"0.9359493256\",\n \"SemanticContext\": \"Cardiovascular Bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure, fat embolism, hypertension, hypertrophic cardiomyopathy in premature infants, myocardial rupture following recent myocardial infarction see WARNINGS , pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis.\"\n }\n ]\n },\n {\n \"Term\": \"Flatulence\",\n \"MEDDRACode\": \"10016766\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"wound\",\n \"Probability\": \"0.7914398909\",\n \"SemanticContext\": \"Dermatologic Acne, allergic dermatitis, cutaneous and subcutaneous atrophy, dry scaly skin, ecchymoses and petechiae, edema, erythema, hyperpigmentation, hypopigmentation, impaired wound healing, increased sweating, rash, sterile abscess, striae, suppressed reactions to skin tests, thin fragile skin, thinning scalp hair, urticaria.\"\n }\n ]\n },\n {\n \"Term\": \"Fracture\",\n \"MEDDRACode\": \"10017076\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"fracture\",\n \"Probability\": \"0.1648706198\",\n \"SemanticContext\": \"Musculoskeletal Aseptic necrosis of femoral and humeral heads, calcinosis following intra-articular or intralesional use , Charcot-like arthropathy, loss of muscle mass, muscle weakness, osteoporosis, pathologic fracture of long bones, postinjection flare following intra-articular use , steroid myopathy, tendon rupture, vertebral compression fractures.\"\n }\n ]\n },\n {\n \"Term\": \"Glycosuria\",\n \"MEDDRACode\": \"10018473\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"glucosuria\",\n \"Probability\": \"0.3521543741\",\n \"SemanticContext\": \"Endocrine Decreased carbohydrate and glucose tolerance, development of cushingoid state, glucosuria, hirsutism, hypertrichosis, increased requirements for insulin or oral hypoglycemic adrenocortical and pituitary unresponsiveness particularly in times of stress, as in trauma, surgery, or illness , suppression of growth in pediatric patients.\"\n }\n ]\n },\n {\n \"Term\": \"Haemorrhage\",\n \"MEDDRACode\": \"10055798\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hemorrhage\",\n \"Probability\": \"0.0100172162\",\n \"SemanticContext\": \"Gastrointestinal Abdominal distention, bowel/bladder dysfunction after intrathecal administration , elevation in serum liver enzyme levels usually reversible upon discontinuation , hepatomegaly, increased appetite, nausea, pancreatitis, peptic ulcer with possible perforation and hemorrhage, perforation of the small and large intestine particularly in patients with inflammatory bowel disease , ulcerative esophagitis.\"\n }\n ]\n },\n {\n \"Term\": \"Headache\",\n \"MEDDRACode\": \"10019211\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"headache\",\n \"Probability\": \"0.9994540215\",\n \"SemanticContext\": \"Neurologic/Psychiatric Convulsions, depression, emotional instability, euphoria, headache, increased intracranial pressure with papilledema pseudotumor cerebri usually following discontinuation of treatment, insomnia, mood swings, neuritis, neuropathy, paresthesia, personality changes, psychic disorders, vertigo.\"\n }\n ]\n },\n {\n \"Term\": \"Hepatomegaly\",\n \"MEDDRACode\": \"10019842\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hepatomegaly\",\n \"Probability\": \"0.9734054804\",\n \"SemanticContext\": \"Gastrointestinal Abdominal distention, bowel/bladder dysfunction after intrathecal administration , elevation in serum liver enzyme levels usually reversible upon discontinuation , hepatomegaly, increased appetite, nausea, pancreatitis, peptic ulcer with possible perforation and hemorrhage, perforation of the small and large intestine particularly in patients with inflammatory bowel disease , ulcerative esophagitis.\"\n }\n ]\n },\n {\n \"Term\": \"Hiccups\",\n \"MEDDRACode\": \"10020039\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hiccups\",\n \"Probability\": \"0.9896069765\",\n \"SemanticContext\": \"Other Abnormal fat deposits, decreased resistance to infection, hiccups, increased or decreased motility and number of spermatozoa, malaise, moon face, weight gain.\"\n }\n ]\n },\n {\n \"Term\": \"Hirsutism\",\n \"MEDDRACode\": \"10020112\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hirsutism\",\n \"Probability\": \"0.2953276932\",\n \"SemanticContext\": \"Endocrine Decreased carbohydrate and glucose tolerance, development of cushingoid state, glucosuria, hirsutism, hypertrichosis, increased requirements for insulin or oral hypoglycemic adrenocortical and pituitary unresponsiveness particularly in times of stress, as in trauma, surgery, or illness , suppression of growth in pediatric patients.\"\n }\n ]\n },\n {\n \"Term\": \"Hyperhidrosis\",\n \"MEDDRACode\": \"10020642\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"increased sweating\",\n \"Probability\": \"0.9847165346\",\n \"SemanticContext\": \"Dermatologic Acne, allergic dermatitis, cutaneous and subcutaneous atrophy, dry scaly skin, ecchymoses and petechiae, edema, erythema, hyperpigmentation, hypopigmentation, impaired wound healing, increased sweating, rash, sterile abscess, striae, suppressed reactions to skin tests, thin fragile skin, thinning scalp hair, urticaria.\"\n }\n ]\n },\n {\n \"Term\": \"Hypertrichosis\",\n \"MEDDRACode\": \"10020864\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hypertrichosis\",\n \"Probability\": \"0.0435546935\",\n \"SemanticContext\": \"Endocrine Decreased carbohydrate and glucose tolerance, development of cushingoid state, glucosuria, hirsutism, hypertrichosis, increased requirements for insulin or oral hypoglycemic adrenocortical and pituitary unresponsiveness particularly in times of stress, as in trauma, surgery, or illness , suppression of growth in pediatric patients.\"\n }\n ]\n },\n {\n \"Term\": \"Hypertrophic cardiomyopathy\",\n \"MEDDRACode\": \"10020871\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hypertrophic cardiomyopathy\",\n \"Probability\": \"0.9198092222\",\n \"SemanticContext\": \"Cardiovascular Bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure, fat embolism, hypertension, hypertrophic cardiomyopathy in premature infants, myocardial rupture following recent myocardial infarction see WARNINGS , pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis.\"\n }\n ]\n },\n {\n \"Term\": \"Idiopathic intracranial hypertension\",\n \"MEDDRACode\": \"10078904\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"pseudotumor cerebri\",\n \"Probability\": \"0.9905838966\",\n \"SemanticContext\": \"Neurologic/Psychiatric Convulsions, depression, emotional instability, euphoria, headache, increased intracranial pressure with papilledema pseudotumor cerebri usually following discontinuation of treatment, insomnia, mood swings, neuritis, neuropathy, paresthesia, personality changes, psychic disorders, vertigo.\"\n }\n ]\n },\n {\n \"Term\": \"Illness\",\n \"MEDDRACode\": \"10080284\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"illness\",\n \"Probability\": \"0.0265882611\",\n \"SemanticContext\": \"Endocrine Decreased carbohydrate and glucose tolerance, development of cushingoid state, glucosuria, hirsutism, hypertrichosis, increased requirements for insulin or oral hypoglycemic adrenocortical and pituitary unresponsiveness particularly in times of stress, as in trauma, surgery, or illness , suppression of growth in pediatric patients.\"\n }\n ]\n },\n {\n \"Term\": \"Increased appetite\",\n \"MEDDRACode\": \"10021654\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"increased appetite\",\n \"Probability\": \"0.9850496054\",\n \"SemanticContext\": \"Gastrointestinal Abdominal distention, bowel/bladder dysfunction after intrathecal administration , elevation in serum liver enzyme levels usually reversible upon discontinuation , hepatomegaly, increased appetite, nausea, pancreatitis, peptic ulcer with possible perforation and hemorrhage, perforation of the small and large intestine particularly in patients with inflammatory bowel disease , ulcerative esophagitis.\"\n }\n ]\n },\n {\n \"Term\": \"Inflammatory bowel disease\",\n \"MEDDRACode\": \"10021972\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"inflammatory bowel disease\",\n \"Probability\": \"0.1555013657\",\n \"SemanticContext\": \"Gastrointestinal Abdominal distention, bowel/bladder dysfunction after intrathecal administration , elevation in serum liver enzyme levels usually reversible upon discontinuation , hepatomegaly, increased appetite, nausea, pancreatitis, peptic ulcer with possible perforation and hemorrhage, perforation of the small and large intestine particularly in patients with inflammatory bowel disease , ulcerative esophagitis.\"\n }\n ]\n },\n {\n \"Term\": \"Intracranial pressure increased\",\n \"MEDDRACode\": \"10022773\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"increased intracranial pressure\",\n \"Probability\": \"0.9971914887\",\n \"SemanticContext\": \"Neurologic/Psychiatric Convulsions, depression, emotional instability, euphoria, headache, increased intracranial pressure with papilledema pseudotumor cerebri usually following discontinuation of treatment, insomnia, mood swings, neuritis, neuropathy, paresthesia, personality changes, psychic disorders, vertigo.\"\n }\n ]\n },\n {\n \"Term\": \"Mental disorder\",\n \"MEDDRACode\": \"10061284\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"psychic disorders\",\n \"Probability\": \"0.7727022171\",\n \"SemanticContext\": \"Neurologic/Psychiatric Convulsions, depression, emotional instability, euphoria, headache, increased intracranial pressure with papilledema pseudotumor cerebri usually following discontinuation of treatment, insomnia, mood swings, neuritis, neuropathy, paresthesia, personality changes, psychic disorders, vertigo.\"\n }\n ]\n },\n {\n \"Term\": \"Muscle mass\",\n \"MEDDRACode\": \"10056720\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"muscle mass\",\n \"Probability\": \"0.2707986832\",\n \"SemanticContext\": \"Musculoskeletal Aseptic necrosis of femoral and humeral heads, calcinosis following intra-articular or intralesional use , Charcot-like arthropathy, loss of muscle mass, muscle weakness, osteoporosis, pathologic fracture of long bones, postinjection flare following intra-articular use , steroid myopathy, tendon rupture, vertebral compression fractures.\"\n }\n ]\n },\n {\n \"Term\": \"Muscular weakness\",\n \"MEDDRACode\": \"10028372\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"muscle weakness\",\n \"Probability\": \"0.62056458\",\n \"SemanticContext\": \"Musculoskeletal Aseptic necrosis of femoral and humeral heads, calcinosis following intra-articular or intralesional use , Charcot-like arthropathy, loss of muscle mass, muscle weakness, osteoporosis, pathologic fracture of long bones, postinjection flare following intra-articular use , steroid myopathy, tendon rupture, vertebral compression fractures.\"\n }\n ]\n },\n {\n \"Term\": \"Myocardial rupture\",\n \"MEDDRACode\": \"10028604\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"myocardial rupture\",\n \"Probability\": \"0.9622409344\",\n \"SemanticContext\": \"Cardiovascular Bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure, fat embolism, hypertension, hypertrophic cardiomyopathy in premature infants, myocardial rupture following recent myocardial infarction see WARNINGS , pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis.\"\n }\n ]\n },\n {\n \"Term\": \"Myopathy\",\n \"MEDDRACode\": \"10028641\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"acute myopathy\",\n \"Probability\": \"0.7324115038\",\n \"SemanticContext\": \"An acute myopathy has been observed with the use of high doses of corticosteroids, most often occurring in patients with disorders of neuromuscular transmission eg, myasthenia gravis , or in patients receiving concomitant therapy with neuromuscular blocking drugs eg, pancuronium .\"\n },\n {\n \"VerbatimTerm\": \"acute myopathy\",\n \"Probability\": \"0.8456045389\",\n \"SemanticContext\": \"This acute myopathy is generalized, may involve ocular and respiratory muscles, and may result in quadriparesis.\"\n }\n ]\n },\n {\n \"Term\": \"Nausea\",\n \"MEDDRACode\": \"10028813\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"nausea\",\n \"Probability\": \"0.9926043749\",\n \"SemanticContext\": \"Gastrointestinal Abdominal distention, bowel/bladder dysfunction after intrathecal administration , elevation in serum liver enzyme levels usually reversible upon discontinuation , hepatomegaly, increased appetite, nausea, pancreatitis, peptic ulcer with possible perforation and hemorrhage, perforation of the small and large intestine particularly in patients with inflammatory bowel disease , ulcerative esophagitis.\"\n }\n ]\n },\n {\n \"Term\": \"Neuropathy peripheral\",\n \"MEDDRACode\": \"10029331\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"neuropathy\",\n \"Probability\": \"0.9886909723\",\n \"SemanticContext\": \"Neurologic/Psychiatric Convulsions, depression, emotional instability, euphoria, headache, increased intracranial pressure with papilledema pseudotumor cerebri usually following discontinuation of treatment, insomnia, mood swings, neuritis, neuropathy, paresthesia, personality changes, psychic disorders, vertigo.\"\n }\n ]\n },\n {\n \"Term\": \"Nitrogen balance negative\",\n \"MEDDRACode\": \"10029425\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Negative nitrogen balance\",\n \"Probability\": \"0.0774745941\",\n \"SemanticContext\": \"Metabolic Negative nitrogen balance due to protein catabolism.\"\n }\n ]\n },\n {\n \"Term\": \"Oesophagitis ulcerative\",\n \"MEDDRACode\": \"10049098\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"ulcerative esophagitis\",\n \"Probability\": \"0.1189861596\",\n \"SemanticContext\": \"Gastrointestinal Abdominal distention, bowel/bladder dysfunction after intrathecal administration , elevation in serum liver enzyme levels usually reversible upon discontinuation , hepatomegaly, increased appetite, nausea, pancreatitis, peptic ulcer with possible perforation and hemorrhage, perforation of the small and large intestine particularly in patients with inflammatory bowel disease , ulcerative esophagitis.\"\n }\n ]\n },\n {\n \"Term\": \"Osteonecrosis\",\n \"MEDDRACode\": \"10031264\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Aseptic necrosis\",\n \"Probability\": \"0.0380903184\",\n \"SemanticContext\": \"Musculoskeletal Aseptic necrosis of femoral and humeral heads, calcinosis following intra-articular or intralesional use , Charcot-like arthropathy, loss of muscle mass, muscle weakness, osteoporosis, pathologic fracture of long bones, postinjection flare following intra-articular use , steroid myopathy, tendon rupture, vertebral compression fractures.\"\n }\n ]\n },\n {\n \"Term\": \"Pancreatitis\",\n \"MEDDRACode\": \"10033645\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"pancreatitis\",\n \"Probability\": \"0.9878380299\",\n \"SemanticContext\": \"Gastrointestinal Abdominal distention, bowel/bladder dysfunction after intrathecal administration , elevation in serum liver enzyme levels usually reversible upon discontinuation , hepatomegaly, increased appetite, nausea, pancreatitis, peptic ulcer with possible perforation and hemorrhage, perforation of the small and large intestine particularly in patients with inflammatory bowel disease , ulcerative esophagitis.\"\n }\n ]\n },\n {\n \"Term\": \"Papilloedema\",\n \"MEDDRACode\": \"10033712\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"papilledema\",\n \"Probability\": \"0.9876710773\",\n \"SemanticContext\": \"Neurologic/Psychiatric Convulsions, depression, emotional instability, euphoria, headache, increased intracranial pressure with papilledema pseudotumor cerebri usually following discontinuation of treatment, insomnia, mood swings, neuritis, neuropathy, paresthesia, personality changes, psychic disorders, vertigo.\"\n }\n ]\n },\n {\n \"Term\": \"Paraesthesia\",\n \"MEDDRACode\": \"10033775\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"paresthesia\",\n \"Probability\": \"0.991415143\",\n \"SemanticContext\": \"Neurologic/Psychiatric Convulsions, depression, emotional instability, euphoria, headache, increased intracranial pressure with papilledema pseudotumor cerebri usually following discontinuation of treatment, insomnia, mood swings, neuritis, neuropathy, paresthesia, personality changes, psychic disorders, vertigo.\"\n }\n ]\n },\n {\n \"Term\": \"Paraparesis\",\n \"MEDDRACode\": \"10033885\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"paraparesis\",\n \"Probability\": \"0.9797343016\",\n \"SemanticContext\": \"Arachnoiditis, meningitis, paraparesis/paraplegia, and sensory disturbances have occurred after intrathecal administration see WARNINGS, Neurologic section .\"\n }\n ]\n },\n {\n \"Term\": \"Periocular injection\",\n \"MEDDRACode\": \"10071199\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"periocular injections\",\n \"Probability\": \"0.8666328192\",\n \"SemanticContext\": \"Ophthalmic Exophthalmos, glaucoma, increased intraocular pressure, posterior subcapsular cataracts, rare instances of blindness associated with periocular injections, vision blurred.\"\n }\n ]\n },\n {\n \"Term\": \"Petechiae\",\n \"MEDDRACode\": \"10034754\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"petechiae\",\n \"Probability\": \"0.9535653591\",\n \"SemanticContext\": \"Dermatologic Acne, allergic dermatitis, cutaneous and subcutaneous atrophy, dry scaly skin, ecchymoses and petechiae, edema, erythema, hyperpigmentation, hypopigmentation, impaired wound healing, increased sweating, rash, sterile abscess, striae, suppressed reactions to skin tests, thin fragile skin, thinning scalp hair, urticaria.\"\n }\n ]\n },\n {\n \"Term\": \"Pulmonary oedema\",\n \"MEDDRACode\": \"10037423\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"pulmonary edema\",\n \"Probability\": \"0.9963120222\",\n \"SemanticContext\": \"Cardiovascular Bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure, fat embolism, hypertension, hypertrophic cardiomyopathy in premature infants, myocardial rupture following recent myocardial infarction see WARNINGS , pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis.\"\n }\n ]\n },\n {\n \"Term\": \"Rash\",\n \"MEDDRACode\": \"10037844\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"rash\",\n \"Probability\": \"0.9927941561\",\n \"SemanticContext\": \"Dermatologic Acne, allergic dermatitis, cutaneous and subcutaneous atrophy, dry scaly skin, ecchymoses and petechiae, edema, erythema, hyperpigmentation, hypopigmentation, impaired wound healing, increased sweating, rash, sterile abscess, striae, suppressed reactions to skin tests, thin fragile skin, thinning scalp hair, urticaria.\"\n }\n ]\n },\n {\n \"Term\": \"Sensory disturbance\",\n \"MEDDRACode\": \"10040026\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"sensory disturbances\",\n \"Probability\": \"0.9903715849\",\n \"SemanticContext\": \"Arachnoiditis, meningitis, paraparesis/paraplegia, and sensory disturbances have occurred after intrathecal administration see WARNINGS, Neurologic section .\"\n }\n ]\n },\n {\n \"Term\": \"Skin exfoliation\",\n \"MEDDRACode\": \"10040844\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"scaly skin\",\n \"Probability\": \"0.9725744724\",\n \"SemanticContext\": \"Dermatologic Acne, allergic dermatitis, cutaneous and subcutaneous atrophy, dry scaly skin, ecchymoses and petechiae, edema, erythema, hyperpigmentation, hypopigmentation, impaired wound healing, increased sweating, rash, sterile abscess, striae, suppressed reactions to skin tests, thin fragile skin, thinning scalp hair, urticaria.\"\n }\n ]\n },\n {\n \"Term\": \"Skin striae\",\n \"MEDDRACode\": \"10040925\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"striae\",\n \"Probability\": \"0.9901443124\",\n \"SemanticContext\": \"Dermatologic Acne, allergic dermatitis, cutaneous and subcutaneous atrophy, dry scaly skin, ecchymoses and petechiae, edema, erythema, hyperpigmentation, hypopigmentation, impaired wound healing, increased sweating, rash, sterile abscess, striae, suppressed reactions to skin tests, thin fragile skin, thinning scalp hair, urticaria.\"\n }\n ]\n },\n {\n \"Term\": \"Syncope\",\n \"MEDDRACode\": \"10042772\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"syncope\",\n \"Probability\": \"0.9975394011\",\n \"SemanticContext\": \"Cardiovascular Bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure, fat embolism, hypertension, hypertrophic cardiomyopathy in premature infants, myocardial rupture following recent myocardial infarction see WARNINGS , pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis.\"\n }\n ]\n },\n {\n \"Term\": \"Tachycardia\",\n \"MEDDRACode\": \"10043071\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"tachycardia\",\n \"Probability\": \"0.9980987906\",\n \"SemanticContext\": \"Cardiovascular Bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure, fat embolism, hypertension, hypertrophic cardiomyopathy in premature infants, myocardial rupture following recent myocardial infarction see WARNINGS , pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis.\"\n }\n ]\n },\n {\n \"Term\": \"Tendon rupture\",\n \"MEDDRACode\": \"10043248\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"tendon rupture\",\n \"Probability\": \"0.462841779\",\n \"SemanticContext\": \"Musculoskeletal Aseptic necrosis of femoral and humeral heads, calcinosis following intra-articular or intralesional use , Charcot-like arthropathy, loss of muscle mass, muscle weakness, osteoporosis, pathologic fracture of long bones, postinjection flare following intra-articular use , steroid myopathy, tendon rupture, vertebral compression fractures.\"\n }\n ]\n },\n {\n \"Term\": \"Thrombophlebitis\",\n \"MEDDRACode\": \"10043570\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"thrombophlebitis\",\n \"Probability\": \"0.990190506\",\n \"SemanticContext\": \"Cardiovascular Bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure, fat embolism, hypertension, hypertrophic cardiomyopathy in premature infants, myocardial rupture following recent myocardial infarction see WARNINGS , pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis.\"\n }\n ]\n },\n {\n \"Term\": \"Urticaria\",\n \"MEDDRACode\": \"10046735\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"urticaria\",\n \"Probability\": \"0.249610126\",\n \"SemanticContext\": \"Dermatologic Acne, allergic dermatitis, cutaneous and subcutaneous atrophy, dry scaly skin, ecchymoses and petechiae, edema, erythema, hyperpigmentation, hypopigmentation, impaired wound healing, increased sweating, rash, sterile abscess, striae, suppressed reactions to skin tests, thin fragile skin, thinning scalp hair, urticaria.\"\n }\n ]\n },\n {\n \"Term\": \"Vasculitis\",\n \"MEDDRACode\": \"10047115\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"vasculitis\",\n \"Probability\": \"0.9850702286\",\n \"SemanticContext\": \"Cardiovascular Bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure, fat embolism, hypertension, hypertrophic cardiomyopathy in premature infants, myocardial rupture following recent myocardial infarction see WARNINGS , pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis.\"\n }\n ]\n },\n {\n \"Term\": \"Vertigo\",\n \"MEDDRACode\": \"10047340\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"vertigo\",\n \"Probability\": \"0.9880939722\",\n \"SemanticContext\": \"Neurologic/Psychiatric Convulsions, depression, emotional instability, euphoria, headache, increased intracranial pressure with papilledema pseudotumor cerebri usually following discontinuation of treatment, insomnia, mood swings, neuritis, neuropathy, paresthesia, personality changes, psychic disorders, vertigo.\"\n }\n ]\n },\n {\n \"Term\": \"Vision blurred\",\n \"MEDDRACode\": \"10047513\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"vision blurred\",\n \"Probability\": \"0.9673128724\",\n \"SemanticContext\": \"Ophthalmic Exophthalmos, glaucoma, increased intraocular pressure, posterior subcapsular cataracts, rare instances of blindness associated with periocular injections, vision blurred.\"\n }\n ]\n },\n {\n \"Term\": \"Weight increased\",\n \"MEDDRACode\": \"10047899\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"weight gain\",\n \"Probability\": \"0.7207409739\",\n \"SemanticContext\": \"Other Abnormal fat deposits, decreased resistance to infection, hiccups, increased or decreased motility and number of spermatozoa, malaise, moon face, weight gain.\"\n }\n ]\n },\n {\n \"Term\": \"Wound\",\n \"MEDDRACode\": \"10052428\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"wound\",\n \"Probability\": \"0.7914398909\",\n \"SemanticContext\": \"Dermatologic Acne, allergic dermatitis, cutaneous and subcutaneous atrophy, dry scaly skin, ecchymoses and petechiae, edema, erythema, hyperpigmentation, hypopigmentation, impaired wound healing, increased sweating, rash, sterile abscess, striae, suppressed reactions to skin tests, thin fragile skin, thinning scalp hair, urticaria.\"\n }\n ]\n },\n {\n \"Term\": \"Weight\",\n \"MEDDRACode\": \"10047890\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"weight\",\n \"Probability\": \"0.0043830574\",\n \"SemanticContext\": \"The formula for betamethasone sodium phosphate is C 22 H 28 FNa 2 0 8 P and it has a molecular weight of 516.40.\"\n },\n {\n \"VerbatimTerm\": \"weight\",\n \"Probability\": \"0.0027593374\",\n \"SemanticContext\": \"The formula for betamethasone acetate is C 24 H 31 FO 6 and it has a molecular weight of 434.50.\"\n },\n {\n \"VerbatimTerm\": \"weight\",\n \"Probability\": \"1.75551E-05\",\n \"SemanticContext\": \"Like adults, pediatric patients should be carefully observed with frequent measurements of blood pressure, weight, height, intraocular pressure, and clinical evaluation for the presence of infection, psychosocial disturbances, thromboembolism, peptic ulcers, cataracts, and osteoporosis.\"\n },\n {\n \"VerbatimTerm\": \"weight\",\n \"Probability\": \"1.75551E-05\",\n \"SemanticContext\": \"Like adults, pediatric patients should be carefully observed with frequent measurements of blood pressure, weight, height, intraocular pressure, and clinical evaluation for the presence of infection, psychosocial disturbances, thromboembolism, peptic ulcers, cataracts, and osteoporosis.\"\n }\n ]\n },\n {\n \"Term\": \"Premature baby\",\n \"MEDDRACode\": \"10036590\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"premature infants\",\n \"Probability\": \"0.8951079845\",\n \"SemanticContext\": \"Cardiovascular Bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure, fat embolism, hypertension, hypertrophic cardiomyopathy in premature infants, myocardial rupture following recent myocardial infarction see WARNINGS , pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis.\"\n },\n {\n \"VerbatimTerm\": \"premature infants\",\n \"Probability\": \"0.067655772\",\n \"SemanticContext\": \"DOSAGE AND ADMINISTRATION Benzyl alcohol as a preservative has been associated with a fatal \\\"Gasping Syndrome\\\" in premature infants and infants of low birth weight.\"\n },\n {\n \"VerbatimTerm\": \"premature infant\",\n \"Probability\": \"0.0024376214\",\n \"SemanticContext\": \"Solutions used for further dilution of this product should be preservative-free when used in the neonate, especially the premature infant.\"\n }\n ]\n },\n {\n \"Term\": \"Infant\",\n \"MEDDRACode\": \"10021731\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"neonate\",\n \"Probability\": \"0.0002295375\",\n \"SemanticContext\": \"Solutions used for further dilution of this product should be preservative-free when used in the neonate, especially the premature infant.\"\n }\n ]\n },\n {\n \"Term\": \"Asthenia\",\n \"MEDDRACode\": \"10003549\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"weakness\",\n \"Probability\": \"0.0763281584\",\n \"SemanticContext\": \"\\nAnticholinesterases Concomitant use of anticholinesterase agents and corticosteroids may produce severe weakness in patients with myasthenia gravis.\"\n },\n {\n \"VerbatimTerm\": \"weakness\",\n \"Probability\": \"0.0763281584\",\n \"SemanticContext\": \"\\nAnticholinesterases Concomitant use of anticholinesterase agents and corticosteroids may produce severe weakness in patients with myasthenia gravis.\"\n }\n ]\n },\n {\n \"Term\": \"Blood glucose\",\n \"MEDDRACode\": \"10005553\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"glucose\",\n \"Probability\": \"0.0010493994\",\n \"SemanticContext\": \"Endocrine Decreased carbohydrate and glucose tolerance, development of cushingoid state, glucosuria, hirsutism, hypertrichosis, increased requirements for insulin or oral hypoglycemic adrenocortical and pituitary unresponsiveness particularly in times of stress, as in trauma, surgery, or illness , suppression of growth in pediatric patients.\"\n }\n ]\n },\n {\n \"Term\": \"Cardiac failure congestive\",\n \"MEDDRACode\": \"10007559\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \", congestive heart failure\",\n \"Probability\": \"0.9454057217\",\n \"SemanticContext\": \"Cardiovascular Bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure, fat embolism, hypertension, hypertrophic cardiomyopathy in premature infants, myocardial rupture following recent myocardial infarction see WARNINGS , pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis.\"\n },\n {\n \"VerbatimTerm\": \"congestive heart failure,\",\n \"Probability\": \"0.9648900032\",\n \"SemanticContext\": \"Cardiovascular Bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure, fat embolism, hypertension, hypertrophic cardiomyopathy in premature infants, myocardial rupture following recent myocardial infarction see WARNINGS , pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis.\"\n },\n {\n \"VerbatimTerm\": \"congestive heart failure,\",\n \"Probability\": \"0.0003021359\",\n \"SemanticContext\": \"Cardio-renal As sodium retention with resultant edema and potassium loss may occur in patients receiving corticosteroids, these agents should be used with caution in patients with congestive heart failure, hypertension, or renal insufficiency.\"\n },\n {\n \"VerbatimTerm\": \"Congestive heart failure\",\n \"Probability\": \"0.6931449175\",\n \"SemanticContext\": \"Fluid and Electrolyte Disturbances Congestive heart failure in susceptible patients, fluid retention, hypokalemic alkalosis, potassium loss, sodium retention.\"\n },\n {\n \"VerbatimTerm\": \"congestive heart failure\",\n \"Probability\": \"0.0397903919\",\n \"SemanticContext\": \"There have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure.\"\n },\n {\n \"VerbatimTerm\": \"congestive heart failure\",\n \"Probability\": \"0.0585443377\",\n \"SemanticContext\": \"There have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure see PRECAUTIONS, Drug Interactions, Amphotericin B Injection and Potassium-Depleting Agents section .\"\n },\n {\n \"VerbatimTerm\": \"congestive heart failure\",\n \"Probability\": \"0.0397903919\",\n \"SemanticContext\": \"There have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure.\"\n }\n ]\n },\n {\n \"Term\": \"Seizure\",\n \"MEDDRACode\": \"10039906\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Convulsions\",\n \"Probability\": \"0.9118654132\",\n \"SemanticContext\": \"Neurologic/Psychiatric Convulsions, depression, emotional instability, euphoria, headache, increased intracranial pressure with papilledema pseudotumor cerebri usually following discontinuation of treatment, insomnia, mood swings, neuritis, neuropathy, paresthesia, personality changes, psychic disorders, vertigo.\"\n },\n {\n \"VerbatimTerm\": \"Convulsions\",\n \"Probability\": \"0.28859514000000003\",\n \"SemanticContext\": \"Convulsions have been reported with this concurrent use.\"\n },\n {\n \"VerbatimTerm\": \"Convulsions\",\n \"Probability\": \"0.28859514000000003\",\n \"SemanticContext\": \"Convulsions have been reported with this concurrent use.\"\n }\n ]\n },\n {\n \"Term\": \"Skin test\",\n \"MEDDRACode\": \"10040929\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"skin tests\",\n \"Probability\": \"0.4890305996\",\n \"SemanticContext\": \"Dermatologic Acne, allergic dermatitis, cutaneous and subcutaneous atrophy, dry scaly skin, ecchymoses and petechiae, edema, erythema, hyperpigmentation, hypopigmentation, impaired wound healing, increased sweating, rash, sterile abscess, striae, suppressed reactions to skin tests, thin fragile skin, thinning scalp hair, urticaria.\"\n },\n {\n \"VerbatimTerm\": \"skin tests\",\n \"Probability\": \"0.0017348826\",\n \"SemanticContext\": \"\\nSkin Tests Corticosteroids may suppress reactions to skin tests.\"\n },\n {\n \"VerbatimTerm\": \"skin tests\",\n \"Probability\": \"0.0017348826\",\n \"SemanticContext\": \"\\nSkin Tests Corticosteroids may suppress reactions to skin tests.\"\n },\n {\n \"VerbatimTerm\": \"Skin Tests\",\n \"Probability\": \"8.4429E-05\",\n \"SemanticContext\": \"\\nSkin Tests Corticosteroids may suppress reactions to skin tests.\"\n },\n {\n \"VerbatimTerm\": \"Skin Tests\",\n \"Probability\": \"8.4429E-05\",\n \"SemanticContext\": \"\\nSkin Tests Corticosteroids may suppress reactions to skin tests.\"\n }\n ]\n },\n {\n \"Term\": \"Injection\",\n \"MEDDRACode\": \"10052995\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"injections\",\n \"Probability\": \"0.0023337007\",\n \"SemanticContext\": \"Several intrabursal injections of corticosteroids are usually required in recurrent acute bursitis and in acute exacerbations of chronic bursitis.\"\n },\n {\n \"VerbatimTerm\": \"injections\",\n \"Probability\": \"0.0041358471\",\n \"SemanticContext\": \"Partial relief of pain and some increase in mobility can be expected in both conditions after one or two injections.\"\n },\n {\n \"VerbatimTerm\": \"injections\",\n \"Probability\": \"0.0143804252\",\n \"SemanticContext\": \"In tenosynovitis and tendinitis, three or four local injections at intervals of 1 to 2 weeks between injections are given in most cases.\"\n },\n {\n \"VerbatimTerm\": \"injections\",\n \"Probability\": \"0.0100973248\",\n \"SemanticContext\": \"In tenosynovitis and tendinitis, three or four local injections at intervals of 1 to 2 weeks between injections are given in most cases.\"\n },\n {\n \"VerbatimTerm\": \"injections\",\n \"Probability\": \"0.0005225837\",\n \"SemanticContext\": \"Disorders of the Foot A tuberculin syringe with a 25-gauge, 3/4-inch needle is suitable for most injections into the foot.\"\n },\n {\n \"VerbatimTerm\": \"Injection\",\n \"Probability\": \"0.0001057766\",\n \"SemanticContext\": \"\\nAmphotericin B Injection and Potassium-Depleting Agents When corticosteroids are administered concomitantly with potassium-depleting agents ie, amphotericin B, diuretics , patients should be observed closely for development of hypokalemia.\"\n },\n {\n \"VerbatimTerm\": \"Injection\",\n \"Probability\": \"0.0031567216\",\n \"SemanticContext\": \"Intra-articular Injection of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is well tolerated in joints and periarticular tissues.\"\n },\n {\n \"VerbatimTerm\": \"Injection\",\n \"Probability\": \"4.94146E-05\",\n \"SemanticContext\": \"Recommended Doses for Intra-articular Injection Size of joint Location Dose mL Very large Hip 1.0-2.0 Large Knee, ankle, shoulder 1.0 Medium Elbow, wrist 0.5-1.0 Small metacarpophalangeal, interphalangeal sternoclavicular Hand, chest 0.25-0.5 .\"\n },\n {\n \"VerbatimTerm\": \"Injection\",\n \"Probability\": \"0.0023193061\",\n \"SemanticContext\": \"There have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure see PRECAUTIONS, Drug Interactions, Amphotericin B Injection and Potassium-Depleting Agents section .\"\n },\n {\n \"VerbatimTerm\": \"Injection\",\n \"Probability\": \"0.0003004372\",\n \"SemanticContext\": \"Injection of a steroid into an infected site is to be avoided.\"\n },\n {\n \"VerbatimTerm\": \"Injection\",\n \"Probability\": \"0.0001057766\",\n \"SemanticContext\": \"\\nAmphotericin B Injection and Potassium-Depleting Agents When corticosteroids are administered concomitantly with potassium-depleting agents ie, amphotericin B, diuretics , patients should be observed closely for development of hypokalemia.\"\n },\n {\n \"VerbatimTerm\": \"injection\",\n \"Probability\": \"0.4555534422\",\n \"SemanticContext\": \"Bursitis, Tenosynovitis, Peritendinitis In acute subdeltoid, subacromial, olecranon, and prepatellar bursitis, one intrabursal injection of 1.0 mL Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension can relieve pain and restore full range of movement.\"\n },\n {\n \"VerbatimTerm\": \"injection\",\n \"Probability\": \"0.0003508031\",\n \"SemanticContext\": \"In ganglions of joint capsules and tendon sheaths, injection of 0.5 mL directly into the ganglion cysts has produced marked reduction in the size of the lesions.\"\n },\n {\n \"VerbatimTerm\": \"injection\",\n \"Probability\": \"0.1375828981\",\n \"SemanticContext\": \"There is virtually no pain on injection, and the \\\"secondary flare\\\" that sometimes occurs a few hours after intra-articular injection of corticosteroids has not been reported with Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension.\"\n },\n {\n \"VerbatimTerm\": \"injection\",\n \"Probability\": \"0.0096125007\",\n \"SemanticContext\": \"There is virtually no pain on injection, and the \\\"secondary flare\\\" that sometimes occurs a few hours after intra-articular injection of corticosteroids has not been reported with Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension.\"\n },\n {\n \"VerbatimTerm\": \"injection\",\n \"Probability\": \"0.0008165836\",\n \"SemanticContext\": \"The aspirating syringe is replaced by a syringe containing Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension and injection is then made into the joint.\"\n },\n {\n \"VerbatimTerm\": \"injection\",\n \"Probability\": \"0.001773417\",\n \"SemanticContext\": \"A portion of the administered dose of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is absorbed systemically following intra-articular injection.\"\n },\n {\n \"VerbatimTerm\": \"injection\",\n \"Probability\": \"0.0003313422\",\n \"SemanticContext\": \"Local injection of a steroid into a previously injected joint is not usually recommended.\"\n },\n {\n \"VerbatimTerm\": \"injection\",\n \"Probability\": \"0.000412643\",\n \"SemanticContext\": \"Corticosteroid injection into unstable joints is generally not recommended.\"\n },\n {\n \"VerbatimTerm\": \"injection\",\n \"Probability\": \"0.0107664168\",\n \"SemanticContext\": \"Intra-articular injection may result in damage to joint tissues see ADVERSE REACTIONS, Musculoskeletal section .\"\n },\n {\n \"VerbatimTerm\": \"Injections\",\n \"Probability\": \"0.0035157204\",\n \"SemanticContext\": \"Injections should be made into the affected tendon sheaths rather than into the tendons themselves.\"\n }\n ]\n },\n {\n \"Term\": \"Infection\",\n \"MEDDRACode\": \"10021789\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"infection\",\n \"Probability\": \"0.9585197568\",\n \"SemanticContext\": \"Other Abnormal fat deposits, decreased resistance to infection, hiccups, increased or decreased motility and number of spermatozoa, malaise, moon face, weight gain.\"\n },\n {\n \"VerbatimTerm\": \"infection\",\n \"Probability\": \"0.0003484488\",\n \"SemanticContext\": \"Information for Patients Patients should be warned not to discontinue the use of corticosteroids abruptly or without medical supervision, to advise any medical attendants that they are taking corticosteroids and to seek medical advice at once should they develop fever or other signs of infection.\"\n },\n {\n \"VerbatimTerm\": \"infection\",\n \"Probability\": \"0.006968081\",\n \"SemanticContext\": \"Corticosteroids may also mask some signs of current infection.\"\n },\n {\n \"VerbatimTerm\": \"infection\",\n \"Probability\": \"0.0003484488\",\n \"SemanticContext\": \"Information for Patients Patients should be warned not to discontinue the use of corticosteroids abruptly or without medical supervision, to advise any medical attendants that they are taking corticosteroids and to seek medical advice at once should they develop fever or other signs of infection.\"\n },\n {\n \"VerbatimTerm\": \"infection\",\n \"Probability\": \"0.0496386588\",\n \"SemanticContext\": \"Like adults, pediatric patients should be carefully observed with frequent measurements of blood pressure, weight, height, intraocular pressure, and clinical evaluation for the presence of infection, psychosocial disturbances, thromboembolism, peptic ulcers, cataracts, and osteoporosis.\"\n },\n {\n \"VerbatimTerm\": \"infection\",\n \"Probability\": \"0.0496386588\",\n \"SemanticContext\": \"Like adults, pediatric patients should be carefully observed with frequent measurements of blood pressure, weight, height, intraocular pressure, and clinical evaluation for the presence of infection, psychosocial disturbances, thromboembolism, peptic ulcers, cataracts, and osteoporosis.\"\n },\n {\n \"VerbatimTerm\": \"Infections\",\n \"Probability\": \"0.0002012551\",\n \"SemanticContext\": \"Route administration of vaccines or toxoids should be deferred until corticosteroid therapy is discontinued if possible see WARNINGS, Infections, Vaccination section .\"\n },\n {\n \"VerbatimTerm\": \"Infections\",\n \"Probability\": \"0.0199725032\",\n \"SemanticContext\": \"Infections\\nGeneral Patients who are on corticosteroids are more susceptible to infections than are healthy individuals.\"\n },\n {\n \"VerbatimTerm\": \"Infections\",\n \"Probability\": \"0.0002012551\",\n \"SemanticContext\": \"Route administration of vaccines or toxoids should be deferred until corticosteroid therapy is discontinued if possible see WARNINGS, Infections, Vaccination section .\"\n },\n {\n \"VerbatimTerm\": \"infections\",\n \"Probability\": \"0.0062551498\",\n \"SemanticContext\": \"Infections\\nGeneral Patients who are on corticosteroids are more susceptible to infections than are healthy individuals.\"\n },\n {\n \"VerbatimTerm\": \"infections\",\n \"Probability\": \"0.0172864199\",\n \"SemanticContext\": \"These infections may be mild to severe.\"\n },\n {\n \"VerbatimTerm\": \"infections\",\n \"Probability\": \"0.0025751591\",\n \"SemanticContext\": \"\\nFungal Infections Corticosteroids may exacerbate systemic fungal infections and therefore should not be used in the presence of such infections unless they are needed to control drug reactions.\"\n },\n {\n \"VerbatimTerm\": \"infections\",\n \"Probability\": \"0.0399692357\",\n \"SemanticContext\": \"\\nSpecial Pathogens Latent disease may be activated or there may be an exacerbation of intercurrent infections due to pathogens, including those caused by Amoeba, Candida, Cryptococcus, Mycobacterium, Nocardia, Pneumocystis, and Toxoplasma.\"\n },\n {\n \"VerbatimTerm\": \"infections\",\n \"Probability\": \"0.0026830435\",\n \"SemanticContext\": \"Ophthalmic Use of corticosteroids may produce posterior subcapsular cataracts, increased intraocular pressure, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to bacteria, fungi, or viruses.\"\n },\n {\n \"VerbatimTerm\": \"Infection\",\n \"Probability\": \"0.045684129\",\n \"SemanticContext\": \"Infection with any pathogen viral, bacterial, fungal, protozoan, or helminthic in any location of the body may be associated with the use of corticosteroids alone or in combination with other immunosuppressive agents.\"\n }\n ]\n },\n {\n \"Term\": \"Dermatitis allergic\",\n \"MEDDRACode\": \"10012434\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"allergic dermatitis\",\n \"Probability\": \"0.9705027342\",\n \"SemanticContext\": \"Dermatologic Acne, allergic dermatitis, cutaneous and subcutaneous atrophy, dry scaly skin, ecchymoses and petechiae, edema, erythema, hyperpigmentation, hypopigmentation, impaired wound healing, increased sweating, rash, sterile abscess, striae, suppressed reactions to skin tests, thin fragile skin, thinning scalp hair, urticaria.\"\n }\n ]\n },\n {\n \"Term\": \"Dermatitis atopic\",\n \"MEDDRACode\": \"10012438\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"atopic dermatitis\",\n \"Probability\": \"0.1745997667\",\n \"SemanticContext\": \"INDICATIONS AND USAGE When oral therapy is not feasible, the intramuscular use of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is indicated as follows: Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions.\"\n }\n ]\n },\n {\n \"Term\": \"Erythema\",\n \"MEDDRACode\": \"10015150\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"erythema\",\n \"Probability\": \"0.9973179102\",\n \"SemanticContext\": \"Dermatologic Acne, allergic dermatitis, cutaneous and subcutaneous atrophy, dry scaly skin, ecchymoses and petechiae, edema, erythema, hyperpigmentation, hypopigmentation, impaired wound healing, increased sweating, rash, sterile abscess, striae, suppressed reactions to skin tests, thin fragile skin, thinning scalp hair, urticaria.\"\n }\n ]\n },\n {\n \"Term\": \"Meningitis\",\n \"MEDDRACode\": \"10027199\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"meningitis\",\n \"Probability\": \"0.9676510096\",\n \"SemanticContext\": \"Arachnoiditis, meningitis, paraparesis/paraplegia, and sensory disturbances have occurred after intrathecal administration see WARNINGS, Neurologic section .\"\n }\n ]\n },\n {\n \"Term\": \"Oedema\",\n \"MEDDRACode\": \"10030095\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"edema\",\n \"Probability\": \"0.9890325069\",\n \"SemanticContext\": \"Dermatologic Acne, allergic dermatitis, cutaneous and subcutaneous atrophy, dry scaly skin, ecchymoses and petechiae, edema, erythema, hyperpigmentation, hypopigmentation, impaired wound healing, increased sweating, rash, sterile abscess, striae, suppressed reactions to skin tests, thin fragile skin, thinning scalp hair, urticaria.\"\n },\n {\n \"VerbatimTerm\": \"edema\",\n \"Probability\": \"0.7782428265\",\n \"SemanticContext\": \"Cardio-renal As sodium retention with resultant edema and potassium loss may occur in patients receiving corticosteroids, these agents should be used with caution in patients with congestive heart failure, hypertension, or renal insufficiency.\"\n }\n ]\n },\n {\n \"Term\": \"Affect lability\",\n \"MEDDRACode\": \"10054196\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"emotional instability\",\n \"Probability\": \"0.9832019806\",\n \"SemanticContext\": \"Neurologic/Psychiatric Convulsions, depression, emotional instability, euphoria, headache, increased intracranial pressure with papilledema pseudotumor cerebri usually following discontinuation of treatment, insomnia, mood swings, neuritis, neuropathy, paresthesia, personality changes, psychic disorders, vertigo.\"\n },\n {\n \"VerbatimTerm\": \"emotional instability\",\n \"Probability\": \"0.0597355664\",\n \"SemanticContext\": \"Also, existing emotional instability or psychotic tendencies may be aggravated by corticosteroids.\"\n }\n ]\n },\n {\n \"Term\": \"Anaphylactic reaction\",\n \"MEDDRACode\": \"10002198\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"anaphylaxis\",\n \"Probability\": \"0.97471416\",\n \"SemanticContext\": \"ADVERSE REACTIONS listed alphabetically, under each subsection Allergic Reactions Anaphylactoid reaction, anaphylaxis, angioedema.\"\n }\n ]\n },\n {\n \"Term\": \"Blindness\",\n \"MEDDRACode\": \"10005169\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"blindness\",\n \"Probability\": \"0.943292141\",\n \"SemanticContext\": \"Ophthalmic Exophthalmos, glaucoma, increased intraocular pressure, posterior subcapsular cataracts, rare instances of blindness associated with periocular injections, vision blurred.\"\n }\n ]\n },\n {\n \"Term\": \"Cataract subcapsular\",\n \"MEDDRACode\": \"10007764\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"posterior subcapsular cataracts\",\n \"Probability\": \"0.9602507353\",\n \"SemanticContext\": \"Ophthalmic Exophthalmos, glaucoma, increased intraocular pressure, posterior subcapsular cataracts, rare instances of blindness associated with periocular injections, vision blurred.\"\n },\n {\n \"VerbatimTerm\": \"posterior subcapsular cataracts\",\n \"Probability\": \"0.0417295992\",\n \"SemanticContext\": \"Ophthalmic Use of corticosteroids may produce posterior subcapsular cataracts, increased intraocular pressure, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to bacteria, fungi, or viruses.\"\n }\n ]\n },\n {\n \"Term\": \"Depression\",\n \"MEDDRACode\": \"10012378\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"depression\",\n \"Probability\": \"0.9991014004\",\n \"SemanticContext\": \"Neurologic/Psychiatric Convulsions, depression, emotional instability, euphoria, headache, increased intracranial pressure with papilledema pseudotumor cerebri usually following discontinuation of treatment, insomnia, mood swings, neuritis, neuropathy, paresthesia, personality changes, psychic disorders, vertigo.\"\n },\n {\n \"VerbatimTerm\": \"depression\",\n \"Probability\": \"0.8945868015\",\n \"SemanticContext\": \"Psychic derangements may appear when corticosteroids are used, ranging from euphoria, insomnia, mood swings, personality changes, and severe depression to frank psychotic manifestations.\"\n }\n ]\n },\n {\n \"Term\": \"Euphoric mood\",\n \"MEDDRACode\": \"10015535\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"High\",\n \"Probability\": \"0.0023848414\",\n \"SemanticContext\": \"High doses of corticosteroids, including Betamethasone Sodium Phosphate and Betamethasone Acetate, should not be used for the treatment of traumatic brain injury.\"\n },\n {\n \"VerbatimTerm\": \"high\",\n \"Probability\": \"0.000518918\",\n \"SemanticContext\": \"The studies do show that relatively high doses of corticosteroids are necessary to demonstrate a significant effect see DOSAGE AND ADMINISTRATION .\"\n },\n {\n \"VerbatimTerm\": \"high\",\n \"Probability\": \"0.0005062521\",\n \"SemanticContext\": \"An acute myopathy has been observed with the use of high doses of corticosteroids, most often occurring in patients with disorders of neuromuscular transmission eg, myasthenia gravis , or in patients receiving concomitant therapy with neuromuscular blocking drugs eg, pancuronium .\"\n }\n ]\n },\n {\n \"Term\": \"Fluid retention\",\n \"MEDDRACode\": \"10016807\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"water retention\",\n \"Probability\": \"0.3459350467\",\n \"SemanticContext\": \"Cardio-renal Average and large doses of corticosteroids can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium.\"\n }\n ]\n },\n {\n \"Term\": \"Glaucoma\",\n \"MEDDRACode\": \"10018304\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"glaucoma\",\n \"Probability\": \"0.8367315531\",\n \"SemanticContext\": \"Ophthalmic Exophthalmos, glaucoma, increased intraocular pressure, posterior subcapsular cataracts, rare instances of blindness associated with periocular injections, vision blurred.\"\n },\n {\n \"VerbatimTerm\": \"glaucoma\",\n \"Probability\": \"0.0019948184\",\n \"SemanticContext\": \"Ophthalmic Use of corticosteroids may produce posterior subcapsular cataracts, increased intraocular pressure, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to bacteria, fungi, or viruses.\"\n }\n ]\n },\n {\n \"Term\": \"Hypersensitivity\",\n \"MEDDRACode\": \"10020751\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hypersensitivity reactions\",\n \"Probability\": \"0.5334290266\",\n \"SemanticContext\": \"INDICATIONS AND USAGE When oral therapy is not feasible, the intramuscular use of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is indicated as follows: Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions.\"\n }\n ]\n },\n {\n \"Term\": \"Hypertension\",\n \"MEDDRACode\": \"10020772\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hypertension\",\n \"Probability\": \"0.9820815325\",\n \"SemanticContext\": \"Cardiovascular Bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure, fat embolism, hypertension, hypertrophic cardiomyopathy in premature infants, myocardial rupture following recent myocardial infarction see WARNINGS , pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis.\"\n },\n {\n \"VerbatimTerm\": \"hypertension\",\n \"Probability\": \"0.0003859103\",\n \"SemanticContext\": \"Cardio-renal As sodium retention with resultant edema and potassium loss may occur in patients receiving corticosteroids, these agents should be used with caution in patients with congestive heart failure, hypertension, or renal insufficiency.\"\n }\n ]\n },\n {\n \"Term\": \"Injury\",\n \"MEDDRACode\": \"10022116\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"trauma\",\n \"Probability\": \"0.0567143857\",\n \"SemanticContext\": \"Endocrine Decreased carbohydrate and glucose tolerance, development of cushingoid state, glucosuria, hirsutism, hypertrichosis, increased requirements for insulin or oral hypoglycemic adrenocortical and pituitary unresponsiveness particularly in times of stress, as in trauma, surgery, or illness , suppression of growth in pediatric patients.\"\n },\n {\n \"VerbatimTerm\": \"trauma\",\n \"Probability\": \"0.0063321888\",\n \"SemanticContext\": \"Results from one multicenter, randomized, placebo-controlled study with methylprednisolone hemisuccinate, an IV corticosteroid, showed an increase in early mortality at 2 weeks and late mortality at 6 months in patients with cranial trauma who were determined not to have other clear indications for corticosteroid treatment.\"\n }\n ]\n },\n {\n \"Term\": \"Insomnia\",\n \"MEDDRACode\": \"10022437\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"insomnia\",\n \"Probability\": \"0.9912691712\",\n \"SemanticContext\": \"Neurologic/Psychiatric Convulsions, depression, emotional instability, euphoria, headache, increased intracranial pressure with papilledema pseudotumor cerebri usually following discontinuation of treatment, insomnia, mood swings, neuritis, neuropathy, paresthesia, personality changes, psychic disorders, vertigo.\"\n },\n {\n \"VerbatimTerm\": \"insomnia\",\n \"Probability\": \"0.7756026387\",\n \"SemanticContext\": \"Psychic derangements may appear when corticosteroids are used, ranging from euphoria, insomnia, mood swings, personality changes, and severe depression to frank psychotic manifestations.\"\n }\n ]\n },\n {\n \"Term\": \"Intraocular pressure increased\",\n \"MEDDRACode\": \"10022806\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"increased intraocular pressure\",\n \"Probability\": \"0.9504164457\",\n \"SemanticContext\": \"Ophthalmic Exophthalmos, glaucoma, increased intraocular pressure, posterior subcapsular cataracts, rare instances of blindness associated with periocular injections, vision blurred.\"\n },\n {\n \"VerbatimTerm\": \"increased intraocular pressure\",\n \"Probability\": \"0.0126463771\",\n \"SemanticContext\": \"Ophthalmic Use of corticosteroids may produce posterior subcapsular cataracts, increased intraocular pressure, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to bacteria, fungi, or viruses.\"\n }\n ]\n },\n {\n \"Term\": \"Malaise\",\n \"MEDDRACode\": \"10025482\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"malaise\",\n \"Probability\": \"0.4331051707\",\n \"SemanticContext\": \"Other Abnormal fat deposits, decreased resistance to infection, hiccups, increased or decreased motility and number of spermatozoa, malaise, moon face, weight gain.\"\n },\n {\n \"VerbatimTerm\": \"malaise\",\n \"Probability\": \"0.3105759621\",\n \"SemanticContext\": \"A marked increase in pain accompanied by local swelling, further restriction of joint motion, fever, and malaise are suggestive of septic arthritis.\"\n }\n ]\n },\n {\n \"Term\": \"Mood swings\",\n \"MEDDRACode\": \"10027951\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"mood swings\",\n \"Probability\": \"0.8343330622\",\n \"SemanticContext\": \"Neurologic/Psychiatric Convulsions, depression, emotional instability, euphoria, headache, increased intracranial pressure with papilledema pseudotumor cerebri usually following discontinuation of treatment, insomnia, mood swings, neuritis, neuropathy, paresthesia, personality changes, psychic disorders, vertigo.\"\n },\n {\n \"VerbatimTerm\": \"mood swings\",\n \"Probability\": \"0.2920098901\",\n \"SemanticContext\": \"Psychic derangements may appear when corticosteroids are used, ranging from euphoria, insomnia, mood swings, personality changes, and severe depression to frank psychotic manifestations.\"\n }\n ]\n },\n {\n \"Term\": \"Myocardial infarction\",\n \"MEDDRACode\": \"10028596\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"myocardial infarction\",\n \"Probability\": \"0.9729269743\",\n \"SemanticContext\": \"Cardiovascular Bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure, fat embolism, hypertension, hypertrophic cardiomyopathy in premature infants, myocardial rupture following recent myocardial infarction see WARNINGS , pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis.\"\n },\n {\n \"VerbatimTerm\": \"myocardial infarction\",\n \"Probability\": \"0.0201148987\",\n \"SemanticContext\": \"Literature reports suggest an apparent association between use of corticosteroids and left ventricular free wall rupture after a recent myocardial infarction; therefore, therapy with corticosteroids should be used with great caution in these patients.\"\n }\n ]\n },\n {\n \"Term\": \"Neuritis\",\n \"MEDDRACode\": \"10029240\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"neuritis\",\n \"Probability\": \"0.9945985079\",\n \"SemanticContext\": \"Neurologic/Psychiatric Convulsions, depression, emotional instability, euphoria, headache, increased intracranial pressure with papilledema pseudotumor cerebri usually following discontinuation of treatment, insomnia, mood swings, neuritis, neuropathy, paresthesia, personality changes, psychic disorders, vertigo.\"\n }\n ]\n },\n {\n \"Term\": \"Paraplegia\",\n \"MEDDRACode\": \"10033892\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"paraplegia\",\n \"Probability\": \"0.9867712259\",\n \"SemanticContext\": \"Arachnoiditis, meningitis, paraparesis/paraplegia, and sensory disturbances have occurred after intrathecal administration see WARNINGS, Neurologic section .\"\n },\n {\n \"VerbatimTerm\": \"paraplegia\",\n \"Probability\": \"0.4716084898\",\n \"SemanticContext\": \"Specific events reported include, but are not limited to, spinal cord infarction, paraplegia, quadriplegia, cortical blindness, and stroke.\"\n }\n ]\n },\n {\n \"Term\": \"Perforation\",\n \"MEDDRACode\": \"10076705\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"perforation\",\n \"Probability\": \"0.00783512\",\n \"SemanticContext\": \"Gastrointestinal Abdominal distention, bowel/bladder dysfunction after intrathecal administration , elevation in serum liver enzyme levels usually reversible upon discontinuation , hepatomegaly, increased appetite, nausea, pancreatitis, peptic ulcer with possible perforation and hemorrhage, perforation of the small and large intestine particularly in patients with inflammatory bowel disease , ulcerative esophagitis.\"\n },\n {\n \"VerbatimTerm\": \"perforation\",\n \"Probability\": \"0.0098355711\",\n \"SemanticContext\": \"Gastrointestinal Abdominal distention, bowel/bladder dysfunction after intrathecal administration , elevation in serum liver enzyme levels usually reversible upon discontinuation , hepatomegaly, increased appetite, nausea, pancreatitis, peptic ulcer with possible perforation and hemorrhage, perforation of the small and large intestine particularly in patients with inflammatory bowel disease , ulcerative esophagitis.\"\n },\n {\n \"VerbatimTerm\": \"perforation\",\n \"Probability\": \"0.3528776169\",\n \"SemanticContext\": \"Gastrointestinal Steroids should be used with caution in active or latent peptic ulcers, diverticulitis, fresh intestinal anastomoses, and nonspecific ulcerative colitis, since they may increase the risk of a perforation.\"\n }\n ]\n },\n {\n \"Term\": \"Personality change\",\n \"MEDDRACode\": \"10034719\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"personality changes\",\n \"Probability\": \"0.8840609789\",\n \"SemanticContext\": \"Neurologic/Psychiatric Convulsions, depression, emotional instability, euphoria, headache, increased intracranial pressure with papilledema pseudotumor cerebri usually following discontinuation of treatment, insomnia, mood swings, neuritis, neuropathy, paresthesia, personality changes, psychic disorders, vertigo.\"\n },\n {\n \"VerbatimTerm\": \"personality changes\",\n \"Probability\": \"0.3702911735\",\n \"SemanticContext\": \"Psychic derangements may appear when corticosteroids are used, ranging from euphoria, insomnia, mood swings, personality changes, and severe depression to frank psychotic manifestations.\"\n }\n ]\n },\n {\n \"Term\": \"Protein total\",\n \"MEDDRACode\": \"10050537\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"protein\",\n \"Probability\": \"0.0006082356\",\n \"SemanticContext\": \"Metabolic Negative nitrogen balance due to protein catabolism.\"\n },\n {\n \"VerbatimTerm\": \"protein\",\n \"Probability\": \"9.80571E-05\",\n \"SemanticContext\": \"This, together with a decrease in the protein matrix of the bone secondary to an increase in protein catabolism, and reduced sex hormone production, may lead to inhibition of bone growth in pediatric patients and the development of osteoporosis at any age.\"\n },\n {\n \"VerbatimTerm\": \"protein\",\n \"Probability\": \"4.50235E-05\",\n \"SemanticContext\": \"This, together with a decrease in the protein matrix of the bone secondary to an increase in protein catabolism, and reduced sex hormone production, may lead to inhibition of bone growth in pediatric patients and the development of osteoporosis at any age.\"\n }\n ]\n },\n {\n \"Term\": \"Sodium retention\",\n \"MEDDRACode\": \"10041277\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"sodium retention\",\n \"Probability\": \"0.9046910405\",\n \"SemanticContext\": \"Fluid and Electrolyte Disturbances Congestive heart failure in susceptible patients, fluid retention, hypokalemic alkalosis, potassium loss, sodium retention.\"\n },\n {\n \"VerbatimTerm\": \"sodium retention\",\n \"Probability\": \"0.4755086899\",\n \"SemanticContext\": \"Cardio-renal As sodium retention with resultant edema and potassium loss may occur in patients receiving corticosteroids, these agents should be used with caution in patients with congestive heart failure, hypertension, or renal insufficiency.\"\n }\n ]\n },\n {\n \"Term\": \"Stress\",\n \"MEDDRACode\": \"10042209\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"stress\",\n \"Probability\": \"0.0246864855\",\n \"SemanticContext\": \"Endocrine Decreased carbohydrate and glucose tolerance, development of cushingoid state, glucosuria, hirsutism, hypertrichosis, increased requirements for insulin or oral hypoglycemic adrenocortical and pituitary unresponsiveness particularly in times of stress, as in trauma, surgery, or illness , suppression of growth in pediatric patients.\"\n },\n {\n \"VerbatimTerm\": \"stress\",\n \"Probability\": \"0.0001570582\",\n \"SemanticContext\": \"In patients on corticosteroid therapy subjected to any unusual stress, hydrocortisone or cortisone is the drug of choice as a supplement during and after the event.\"\n },\n {\n \"VerbatimTerm\": \"stress\",\n \"Probability\": \"7.95044E-05\",\n \"SemanticContext\": \"Therefore, in any situation of stress occurring during that period, naturally occurring glucocorticoids hydrocortisone cortisone , which also have salt-retaining properties, rather than betamethasone, are the appropriate choices as replacement therapy in adrenocortical deficiency states.\"\n }\n ]\n },\n {\n \"Term\": \"Blood sodium\",\n \"MEDDRACode\": \"10005799\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": true,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"2.97322E-05\",\n \"SemanticContext\": \"DESCRIPTION Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is a sterile aqueous suspension containing 3 mg per milliliter betamethasone, as betamethasone sodium phosphate, and 3 mg per milliliter betamethasone acetate.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0005223453\",\n \"SemanticContext\": \"Inactive ingredients per mL: 8.9 mg dibasic sodium phosphate dihydrate; 3.8 mg monobasic sodium phosphate dihydrate; 0.1 mg edetate disodium; and 0.2 mg benzalkonium chloride as preservative.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.000304848\",\n \"SemanticContext\": \"Inactive ingredients per mL: 8.9 mg dibasic sodium phosphate dihydrate; 3.8 mg monobasic sodium phosphate dihydrate; 0.1 mg edetate disodium; and 0.2 mg benzalkonium chloride as preservative.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"2.55551E-05\",\n \"SemanticContext\": \"The formula for betamethasone sodium phosphate is C 22 H 28 FNa 2 0 8 P and it has a molecular weight of 516.40.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0001307428\",\n \"SemanticContext\": \"The chemical structures for betamethasone sodium phosphate and betamethasone acetate are as follows: Betamethasone sodium phosphate is a white to practically white, odorless powder, and is hygroscopic.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"3.14241E-05\",\n \"SemanticContext\": \"The chemical structures for betamethasone sodium phosphate and betamethasone acetate are as follows: Betamethasone sodium phosphate is a white to practically white, odorless powder, and is hygroscopic.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"0.0001794994\",\n \"SemanticContext\": \"A derivative of prednisolone, betamethasone has a 16ß-methyl group that enhances the anti-inflammatory action of the molecule and reduces the sodium- and water-retaining properties of the fluorine atom bound at carbon 9.\"\n },\n {\n \"VerbatimTerm\": \"sodium\",\n \"Probability\": \"4.07215E-05\",\n \"SemanticContext\": \"Betamethasone sodium phosphate, a soluble ester, provides prompt activity, while betamethasone acetate is only slightly soluble and affords sustained activity.\"\n },\n {\n \"VerbatimTerm\": \"Sodium\",\n \"Probability\": \"0.0008715093\",\n \"SemanticContext\": \"DESCRIPTION Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is a sterile aqueous suspension containing 3 mg per milliliter betamethasone, as betamethasone sodium phosphate, and 3 mg per milliliter betamethasone acetate.\"\n },\n {\n \"VerbatimTerm\": \"Sodium\",\n \"Probability\": \"0.00126037\",\n \"SemanticContext\": \"CONTRAINDICATIONS Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is contraindicated in patients who are hypersensitive to any components of this product see DESCRIPTION .\"\n },\n {\n \"VerbatimTerm\": \"Sodium\",\n \"Probability\": \"5.12198E-05\",\n \"SemanticContext\": \"The initial dosage of parenterally administered Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension may vary from 0.25 to 9.0 mg per day depending on the specific disease entity being treated.\"\n },\n {\n \"VerbatimTerm\": \"Sodium\",\n \"Probability\": \"2.93331E-05\",\n \"SemanticContext\": \"If coadministration of a local anesthetic is desired, Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension may be mixed with 1% or 2% lidocaine hydrochloride, using the formulations which do not contain parabens.\"\n },\n {\n \"VerbatimTerm\": \"Sodium\",\n \"Probability\": \"0.0004365742\",\n \"SemanticContext\": \"The required dose of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is first withdrawn from the vial into the syringe.\"\n },\n {\n \"VerbatimTerm\": \"Sodium\",\n \"Probability\": \"7.2664E-06\",\n \"SemanticContext\": \"Do not inject local anesthetics into the vial of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension .\"\n },\n {\n \"VerbatimTerm\": \"Sodium\",\n \"Probability\": \"0.0014873147\",\n \"SemanticContext\": \"Bursitis, Tenosynovitis, Peritendinitis In acute subdeltoid, subacromial, olecranon, and prepatellar bursitis, one intrabursal injection of 1.0 mL Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension can relieve pain and restore full range of movement.\"\n },\n {\n \"VerbatimTerm\": \"Sodium\",\n \"Probability\": \"0.0003788769\",\n \"SemanticContext\": \"Rheumatoid Arthritis and Osteoarthritis Following intra-articular administration of 0.5 to 2.0 mL of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension, relief of pain, soreness, and stiffness may be experienced.\"\n },\n {\n \"VerbatimTerm\": \"Sodium\",\n \"Probability\": \"0.0001123659\",\n \"SemanticContext\": \"Intra-articular Injection of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is well tolerated in joints and periarticular tissues.\"\n },\n {\n \"VerbatimTerm\": \"Sodium\",\n \"Probability\": \"0.0003017485\",\n \"SemanticContext\": \"There is virtually no pain on injection, and the \\\"secondary flare\\\" that sometimes occurs a few hours after intra-articular injection of corticosteroids has not been reported with Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension.\"\n },\n {\n \"VerbatimTerm\": \"Sodium\",\n \"Probability\": \"9.2707E-05\",\n \"SemanticContext\": \"The aspirating syringe is replaced by a syringe containing Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension and injection is then made into the joint.\"\n },\n {\n \"VerbatimTerm\": \"Sodium\",\n \"Probability\": \"0.0002496243\",\n \"SemanticContext\": \"A portion of the administered dose of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is absorbed systemically following intra-articular injection.\"\n },\n {\n \"VerbatimTerm\": \"Sodium\",\n \"Probability\": \"0.0006137788\",\n \"SemanticContext\": \"Dermatologic Conditions In intralesional treatment, 0.2 mL/cm 2 of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is injected intradermally not subcutaneously using a tuberculin syringe with a 25-gauge, 1/2-inch needle.\"\n },\n {\n \"VerbatimTerm\": \"Sodium\",\n \"Probability\": \"0.0001061985\",\n \"SemanticContext\": \"Diagnosis Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension Dose mL Bursitis under heloma durum or heloma molle 0.25-0.5 under calcaneal spur 0.5 over hallux rigidus or digiti quinti varus 0.5 Tenosynovitis, periostitis of cuboid 0.5 Acute gouty arthritis 0.5-1.0 .\"\n },\n {\n \"VerbatimTerm\": \"Sodium\",\n \"Probability\": \"3.09731E-05\",\n \"SemanticContext\": \"INDICATIONS AND USAGE When oral therapy is not feasible, the intramuscular use of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is indicated as follows: Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions.\"\n },\n {\n \"VerbatimTerm\": \"Sodium\",\n \"Probability\": \"0.0002723932\",\n \"SemanticContext\": \"The intra-articular or soft tissue administration of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is indicated as adjunctive therapy for short-term administration to tide the patient over an acute episode or exacerbation in acute gouty arthritis, acute and subacute bursitis, acute nonspecific tenosynovitis, epicondylitis, rheumatoid arthritis, synovitis of osteoarthritis.\"\n },\n {\n \"VerbatimTerm\": \"Sodium\",\n \"Probability\": \"0.0001842082\",\n \"SemanticContext\": \"The intralesional administration of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is indicated for alopecia areata; discoid lupus erythematosus; keloids; localized hypertrophic, infiltrated, inflammatory lesions of granuloma annulare, lichen planus, lichen simplex chronicus neurodermatitis , and psoriatic plaques; necrobiosis lipoidica diabeticorum.\"\n },\n {\n \"VerbatimTerm\": \"Sodium\",\n \"Probability\": \"0.0002279878\",\n \"SemanticContext\": \"Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension may also be useful in cystic tumors of an aponeurosis or tendon ganglia .\"\n },\n {\n \"VerbatimTerm\": \"Sodium\",\n \"Probability\": \"0.001940161\",\n \"SemanticContext\": \"WARNINGS Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension should not be administered intravenously.\"\n },\n {\n \"VerbatimTerm\": \"Sodium\",\n \"Probability\": \"3.54269E-05\",\n \"SemanticContext\": \"High doses of corticosteroids, including Betamethasone Sodium Phosphate and Betamethasone Acetate, should not be used for the treatment of traumatic brain injury.\"\n }\n ]\n },\n {\n \"Term\": \"Blood potassium\",\n \"MEDDRACode\": \"10005721\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"potassium\",\n \"Probability\": \"0.5004429221\",\n \"SemanticContext\": \"Fluid and Electrolyte Disturbances Congestive heart failure in susceptible patients, fluid retention, hypokalemic alkalosis, potassium loss, sodium retention.\"\n },\n {\n \"VerbatimTerm\": \"potassium\",\n \"Probability\": \"1.5906E-06\",\n \"SemanticContext\": \"\\nAmphotericin B Injection and Potassium-Depleting Agents When corticosteroids are administered concomitantly with potassium-depleting agents ie, amphotericin B, diuretics , patients should be observed closely for development of hypokalemia.\"\n },\n {\n \"VerbatimTerm\": \"potassium\",\n \"Probability\": \"0.0042815804\",\n \"SemanticContext\": \"Cardio-renal Average and large doses of corticosteroids can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium.\"\n },\n {\n \"VerbatimTerm\": \"potassium\",\n \"Probability\": \"0.0043652952\",\n \"SemanticContext\": \"Cardio-renal As sodium retention with resultant edema and potassium loss may occur in patients receiving corticosteroids, these agents should be used with caution in patients with congestive heart failure, hypertension, or renal insufficiency.\"\n },\n {\n \"VerbatimTerm\": \"potassium\",\n \"Probability\": \"1.5906E-06\",\n \"SemanticContext\": \"\\nAmphotericin B Injection and Potassium-Depleting Agents When corticosteroids are administered concomitantly with potassium-depleting agents ie, amphotericin B, diuretics , patients should be observed closely for development of hypokalemia.\"\n },\n {\n \"VerbatimTerm\": \"Potassium\",\n \"Probability\": \"1.16859E-05\",\n \"SemanticContext\": \"\\nAmphotericin B Injection and Potassium-Depleting Agents When corticosteroids are administered concomitantly with potassium-depleting agents ie, amphotericin B, diuretics , patients should be observed closely for development of hypokalemia.\"\n },\n {\n \"VerbatimTerm\": \"Potassium\",\n \"Probability\": \"0.0005347729\",\n \"SemanticContext\": \"There have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure see PRECAUTIONS, Drug Interactions, Amphotericin B Injection and Potassium-Depleting Agents section .\"\n },\n {\n \"VerbatimTerm\": \"Potassium\",\n \"Probability\": \"1.16859E-05\",\n \"SemanticContext\": \"\\nAmphotericin B Injection and Potassium-Depleting Agents When corticosteroids are administered concomitantly with potassium-depleting agents ie, amphotericin B, diuretics , patients should be observed closely for development of hypokalemia.\"\n }\n ]\n },\n {\n \"Term\": \"Cataract\",\n \"MEDDRACode\": \"10007739\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"cataracts\",\n \"Probability\": \"0.0275354087\",\n \"SemanticContext\": \"Like adults, pediatric patients should be carefully observed with frequent measurements of blood pressure, weight, height, intraocular pressure, and clinical evaluation for the presence of infection, psychosocial disturbances, thromboembolism, peptic ulcers, cataracts, and osteoporosis.\"\n },\n {\n \"VerbatimTerm\": \"cataracts\",\n \"Probability\": \"0.0275354087\",\n \"SemanticContext\": \"Like adults, pediatric patients should be carefully observed with frequent measurements of blood pressure, weight, height, intraocular pressure, and clinical evaluation for the presence of infection, psychosocial disturbances, thromboembolism, peptic ulcers, cataracts, and osteoporosis.\"\n }\n ]\n },\n {\n \"Term\": \"Embolism\",\n \"MEDDRACode\": \"10061169\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"thromboembolism\",\n \"Probability\": \"0.9893396497\",\n \"SemanticContext\": \"Cardiovascular Bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure, fat embolism, hypertension, hypertrophic cardiomyopathy in premature infants, myocardial rupture following recent myocardial infarction see WARNINGS , pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis.\"\n },\n {\n \"VerbatimTerm\": \"thromboembolism\",\n \"Probability\": \"0.2168209255\",\n \"SemanticContext\": \"Like adults, pediatric patients should be carefully observed with frequent measurements of blood pressure, weight, height, intraocular pressure, and clinical evaluation for the presence of infection, psychosocial disturbances, thromboembolism, peptic ulcers, cataracts, and osteoporosis.\"\n },\n {\n \"VerbatimTerm\": \"thromboembolism\",\n \"Probability\": \"0.2168209255\",\n \"SemanticContext\": \"Like adults, pediatric patients should be carefully observed with frequent measurements of blood pressure, weight, height, intraocular pressure, and clinical evaluation for the presence of infection, psychosocial disturbances, thromboembolism, peptic ulcers, cataracts, and osteoporosis.\"\n }\n ]\n },\n {\n \"Term\": \"Intraocular pressure test\",\n \"MEDDRACode\": \"10060950\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"intraocular pressure\",\n \"Probability\": \"1.92508E-05\",\n \"SemanticContext\": \"Like adults, pediatric patients should be carefully observed with frequent measurements of blood pressure, weight, height, intraocular pressure, and clinical evaluation for the presence of infection, psychosocial disturbances, thromboembolism, peptic ulcers, cataracts, and osteoporosis.\"\n },\n {\n \"VerbatimTerm\": \"intraocular pressure\",\n \"Probability\": \"1.92508E-05\",\n \"SemanticContext\": \"Like adults, pediatric patients should be carefully observed with frequent measurements of blood pressure, weight, height, intraocular pressure, and clinical evaluation for the presence of infection, psychosocial disturbances, thromboembolism, peptic ulcers, cataracts, and osteoporosis.\"\n }\n ]\n },\n {\n \"Term\": \"Osteoporosis\",\n \"MEDDRACode\": \"10031282\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"osteoporosis\",\n \"Probability\": \"0.221250236\",\n \"SemanticContext\": \"Musculoskeletal Aseptic necrosis of femoral and humeral heads, calcinosis following intra-articular or intralesional use , Charcot-like arthropathy, loss of muscle mass, muscle weakness, osteoporosis, pathologic fracture of long bones, postinjection flare following intra-articular use , steroid myopathy, tendon rupture, vertebral compression fractures.\"\n },\n {\n \"VerbatimTerm\": \"osteoporosis\",\n \"Probability\": \"0.0007471144\",\n \"SemanticContext\": \"This, together with a decrease in the protein matrix of the bone secondary to an increase in protein catabolism, and reduced sex hormone production, may lead to inhibition of bone growth in pediatric patients and the development of osteoporosis at any age.\"\n },\n {\n \"VerbatimTerm\": \"osteoporosis\",\n \"Probability\": \"0.0002445281\",\n \"SemanticContext\": \"Special consideration should be given to patients at increased risk of osteoporosis ie, postmenopausal women before initiating corticosteroid therapy.\"\n },\n {\n \"VerbatimTerm\": \"osteoporosis\",\n \"Probability\": \"0.0227037072\",\n \"SemanticContext\": \"Like adults, pediatric patients should be carefully observed with frequent measurements of blood pressure, weight, height, intraocular pressure, and clinical evaluation for the presence of infection, psychosocial disturbances, thromboembolism, peptic ulcers, cataracts, and osteoporosis.\"\n },\n {\n \"VerbatimTerm\": \"osteoporosis\",\n \"Probability\": \"0.0227037072\",\n \"SemanticContext\": \"Like adults, pediatric patients should be carefully observed with frequent measurements of blood pressure, weight, height, intraocular pressure, and clinical evaluation for the presence of infection, psychosocial disturbances, thromboembolism, peptic ulcers, cataracts, and osteoporosis.\"\n }\n ]\n },\n {\n \"Term\": \"Peptic ulcer\",\n \"MEDDRACode\": \"10034341\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": true,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"peptic ulcer\",\n \"Probability\": \"0.3271082044\",\n \"SemanticContext\": \"Gastrointestinal Abdominal distention, bowel/bladder dysfunction after intrathecal administration , elevation in serum liver enzyme levels usually reversible upon discontinuation , hepatomegaly, increased appetite, nausea, pancreatitis, peptic ulcer with possible perforation and hemorrhage, perforation of the small and large intestine particularly in patients with inflammatory bowel disease , ulcerative esophagitis.\"\n },\n {\n \"VerbatimTerm\": \"peptic ulcers\",\n \"Probability\": \"0.0030171871\",\n \"SemanticContext\": \"Gastrointestinal Steroids should be used with caution in active or latent peptic ulcers, diverticulitis, fresh intestinal anastomoses, and nonspecific ulcerative colitis, since they may increase the risk of a perforation.\"\n },\n {\n \"VerbatimTerm\": \"peptic ulcers\",\n \"Probability\": \"0.1322284937\",\n \"SemanticContext\": \"Like adults, pediatric patients should be carefully observed with frequent measurements of blood pressure, weight, height, intraocular pressure, and clinical evaluation for the presence of infection, psychosocial disturbances, thromboembolism, peptic ulcers, cataracts, and osteoporosis.\"\n },\n {\n \"VerbatimTerm\": \"peptic ulcers\",\n \"Probability\": \"0.1322284937\",\n \"SemanticContext\": \"Like adults, pediatric patients should be carefully observed with frequent measurements of blood pressure, weight, height, intraocular pressure, and clinical evaluation for the presence of infection, psychosocial disturbances, thromboembolism, peptic ulcers, cataracts, and osteoporosis.\"\n }\n ]\n },\n {\n \"Term\": \"Blood chloride\",\n \"MEDDRACode\": \"10005416\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"chloride\",\n \"Probability\": \"0.0002238452\",\n \"SemanticContext\": \"Inactive ingredients per mL: 8.9 mg dibasic sodium phosphate dihydrate; 3.8 mg monobasic sodium phosphate dihydrate; 0.1 mg edetate disodium; and 0.2 mg benzalkonium chloride as preservative.\"\n }\n ]\n },\n {\n \"Term\": \"Blood ketone body\",\n \"MEDDRACode\": \"10057593\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"acetone\",\n \"Probability\": \"0.0002208948\",\n \"SemanticContext\": \"It is freely soluble in water and in methanol, but is practically insoluble in acetone and in chloroform.\"\n },\n {\n \"VerbatimTerm\": \"acetone\",\n \"Probability\": \"6.59293E-05\",\n \"SemanticContext\": \"It is practically insoluble in water, but freely soluble in acetone, and is soluble in alcohol and in chloroform.\"\n }\n ]\n },\n {\n \"Term\": \"Blood methanol\",\n \"MEDDRACode\": \"10005663\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"methanol\",\n \"Probability\": \"0.0001775324\",\n \"SemanticContext\": \"It is freely soluble in water and in methanol, but is practically insoluble in acetone and in chloroform.\"\n }\n ]\n },\n {\n \"Term\": \"Blood phosphorus\",\n \"MEDDRACode\": \"10005717\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": true,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Phosphate\",\n \"Probability\": \"0.0018841326\",\n \"SemanticContext\": \"DESCRIPTION Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is a sterile aqueous suspension containing 3 mg per milliliter betamethasone, as betamethasone sodium phosphate, and 3 mg per milliliter betamethasone acetate.\"\n },\n {\n \"VerbatimTerm\": \"Phosphate\",\n \"Probability\": \"0.0016702712\",\n \"SemanticContext\": \"CONTRAINDICATIONS Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is contraindicated in patients who are hypersensitive to any components of this product see DESCRIPTION .\"\n },\n {\n \"VerbatimTerm\": \"Phosphate\",\n \"Probability\": \"7.84435E-05\",\n \"SemanticContext\": \"The initial dosage of parenterally administered Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension may vary from 0.25 to 9.0 mg per day depending on the specific disease entity being treated.\"\n },\n {\n \"VerbatimTerm\": \"Phosphate\",\n \"Probability\": \"4.62551E-05\",\n \"SemanticContext\": \"If coadministration of a local anesthetic is desired, Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension may be mixed with 1% or 2% lidocaine hydrochloride, using the formulations which do not contain parabens.\"\n },\n {\n \"VerbatimTerm\": \"Phosphate\",\n \"Probability\": \"0.0007407665\",\n \"SemanticContext\": \"The required dose of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is first withdrawn from the vial into the syringe.\"\n },\n {\n \"VerbatimTerm\": \"Phosphate\",\n \"Probability\": \"1.78292E-05\",\n \"SemanticContext\": \"Do not inject local anesthetics into the vial of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension .\"\n },\n {\n \"VerbatimTerm\": \"Phosphate\",\n \"Probability\": \"0.0027849674\",\n \"SemanticContext\": \"Bursitis, Tenosynovitis, Peritendinitis In acute subdeltoid, subacromial, olecranon, and prepatellar bursitis, one intrabursal injection of 1.0 mL Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension can relieve pain and restore full range of movement.\"\n },\n {\n \"VerbatimTerm\": \"Phosphate\",\n \"Probability\": \"0.000951767\",\n \"SemanticContext\": \"Rheumatoid Arthritis and Osteoarthritis Following intra-articular administration of 0.5 to 2.0 mL of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension, relief of pain, soreness, and stiffness may be experienced.\"\n },\n {\n \"VerbatimTerm\": \"Phosphate\",\n \"Probability\": \"0.0001305044\",\n \"SemanticContext\": \"Intra-articular Injection of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is well tolerated in joints and periarticular tissues.\"\n },\n {\n \"VerbatimTerm\": \"Phosphate\",\n \"Probability\": \"0.000316292\",\n \"SemanticContext\": \"There is virtually no pain on injection, and the \\\"secondary flare\\\" that sometimes occurs a few hours after intra-articular injection of corticosteroids has not been reported with Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension.\"\n },\n {\n \"VerbatimTerm\": \"Phosphate\",\n \"Probability\": \"0.0002126098\",\n \"SemanticContext\": \"The aspirating syringe is replaced by a syringe containing Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension and injection is then made into the joint.\"\n },\n {\n \"VerbatimTerm\": \"Phosphate\",\n \"Probability\": \"0.0003962517\",\n \"SemanticContext\": \"A portion of the administered dose of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is absorbed systemically following intra-articular injection.\"\n },\n {\n \"VerbatimTerm\": \"Phosphate\",\n \"Probability\": \"0.0008839667\",\n \"SemanticContext\": \"Dermatologic Conditions In intralesional treatment, 0.2 mL/cm 2 of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is injected intradermally not subcutaneously using a tuberculin syringe with a 25-gauge, 1/2-inch needle.\"\n },\n {\n \"VerbatimTerm\": \"Phosphate\",\n \"Probability\": \"0.0001143761\",\n \"SemanticContext\": \"Diagnosis Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension Dose mL Bursitis under heloma durum or heloma molle 0.25-0.5 under calcaneal spur 0.5 over hallux rigidus or digiti quinti varus 0.5 Tenosynovitis, periostitis of cuboid 0.5 Acute gouty arthritis 0.5-1.0 .\"\n },\n {\n \"VerbatimTerm\": \"Phosphate\",\n \"Probability\": \"5.47399E-05\",\n \"SemanticContext\": \"INDICATIONS AND USAGE When oral therapy is not feasible, the intramuscular use of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is indicated as follows: Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions.\"\n },\n {\n \"VerbatimTerm\": \"Phosphate\",\n \"Probability\": \"0.0005810857\",\n \"SemanticContext\": \"The intra-articular or soft tissue administration of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is indicated as adjunctive therapy for short-term administration to tide the patient over an acute episode or exacerbation in acute gouty arthritis, acute and subacute bursitis, acute nonspecific tenosynovitis, epicondylitis, rheumatoid arthritis, synovitis of osteoarthritis.\"\n },\n {\n \"VerbatimTerm\": \"Phosphate\",\n \"Probability\": \"0.0004518628\",\n \"SemanticContext\": \"The intralesional administration of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is indicated for alopecia areata; discoid lupus erythematosus; keloids; localized hypertrophic, infiltrated, inflammatory lesions of granuloma annulare, lichen planus, lichen simplex chronicus neurodermatitis , and psoriatic plaques; necrobiosis lipoidica diabeticorum.\"\n },\n {\n \"VerbatimTerm\": \"Phosphate\",\n \"Probability\": \"0.0001576841\",\n \"SemanticContext\": \"Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension may also be useful in cystic tumors of an aponeurosis or tendon ganglia .\"\n },\n {\n \"VerbatimTerm\": \"Phosphate\",\n \"Probability\": \"0.0031431615\",\n \"SemanticContext\": \"WARNINGS Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension should not be administered intravenously.\"\n },\n {\n \"VerbatimTerm\": \"Phosphate\",\n \"Probability\": \"3.98965E-05\",\n \"SemanticContext\": \"High doses of corticosteroids, including Betamethasone Sodium Phosphate and Betamethasone Acetate, should not be used for the treatment of traumatic brain injury.\"\n },\n {\n \"VerbatimTerm\": \"phosphate\",\n \"Probability\": \"2.44964E-05\",\n \"SemanticContext\": \"DESCRIPTION Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is a sterile aqueous suspension containing 3 mg per milliliter betamethasone, as betamethasone sodium phosphate, and 3 mg per milliliter betamethasone acetate.\"\n },\n {\n \"VerbatimTerm\": \"phosphate\",\n \"Probability\": \"0.000279963\",\n \"SemanticContext\": \"Inactive ingredients per mL: 8.9 mg dibasic sodium phosphate dihydrate; 3.8 mg monobasic sodium phosphate dihydrate; 0.1 mg edetate disodium; and 0.2 mg benzalkonium chloride as preservative.\"\n },\n {\n \"VerbatimTerm\": \"phosphate\",\n \"Probability\": \"0.0002626181\",\n \"SemanticContext\": \"Inactive ingredients per mL: 8.9 mg dibasic sodium phosphate dihydrate; 3.8 mg monobasic sodium phosphate dihydrate; 0.1 mg edetate disodium; and 0.2 mg benzalkonium chloride as preservative.\"\n },\n {\n \"VerbatimTerm\": \"phosphate\",\n \"Probability\": \"5.19532E-05\",\n \"SemanticContext\": \"The formula for betamethasone sodium phosphate is C 22 H 28 FNa 2 0 8 P and it has a molecular weight of 516.40.\"\n },\n {\n \"VerbatimTerm\": \"phosphate\",\n \"Probability\": \"0.0004613101\",\n \"SemanticContext\": \"Chemically, it is 9-Fluoro-11ß,17,21-trihydroxy-16ß-methylpregna-1,4-diene-3,20-dione 21- disodium phosphate .\"\n },\n {\n \"VerbatimTerm\": \"phosphate\",\n \"Probability\": \"7.94276E-05\",\n \"SemanticContext\": \"The chemical structures for betamethasone sodium phosphate and betamethasone acetate are as follows: Betamethasone sodium phosphate is a white to practically white, odorless powder, and is hygroscopic.\"\n },\n {\n \"VerbatimTerm\": \"phosphate\",\n \"Probability\": \"2.84038E-05\",\n \"SemanticContext\": \"The chemical structures for betamethasone sodium phosphate and betamethasone acetate are as follows: Betamethasone sodium phosphate is a white to practically white, odorless powder, and is hygroscopic.\"\n },\n {\n \"VerbatimTerm\": \"phosphate\",\n \"Probability\": \"2.99046E-05\",\n \"SemanticContext\": \"Betamethasone sodium phosphate, a soluble ester, provides prompt activity, while betamethasone acetate is only slightly soluble and affords sustained activity.\"\n }\n ]\n },\n {\n \"Term\": \"Blood cortisol\",\n \"MEDDRACode\": \"10005455\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"cortisol plasma\",\n \"Probability\": \"0.0002329946\",\n \"SemanticContext\": \"This negative impact of corticosteroids on growth has been observed at low systemic doses and in the absence of laboratory evidence of HPA axis suppression ie, cosyntropin stimulation and basal cortisol plasma levels .\"\n },\n {\n \"VerbatimTerm\": \"cortisol plasma\",\n \"Probability\": \"0.0002329946\",\n \"SemanticContext\": \"This negative impact of corticosteroids on growth has been observed at low systemic doses and in the absence of laboratory evidence of HPA axis suppression ie, cosyntropin stimulation and basal cortisol plasma levels .\"\n }\n ]\n },\n {\n \"Term\": \"Immune thrombocytopenia\",\n \"MEDDRACode\": \"10083842\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": true,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"idiopathic thrombocytopenic purpura\",\n \"Probability\": \"0.0010954142\",\n \"SemanticContext\": \"Intramuscular corticosteroid preparations are contraindicated for idiopathic thrombocytopenic purpura.\"\n }\n ]\n },\n {\n \"Term\": \"Bursitis\",\n \"MEDDRACode\": \"10006811\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"bursitis\",\n \"Probability\": \"0.0023572445\",\n \"SemanticContext\": \"Several intrabursal injections of corticosteroids are usually required in recurrent acute bursitis and in acute exacerbations of chronic bursitis.\"\n },\n {\n \"VerbatimTerm\": \"bursitis\",\n \"Probability\": \"0.0005310476\",\n \"SemanticContext\": \"Several intrabursal injections of corticosteroids are usually required in recurrent acute bursitis and in acute exacerbations of chronic bursitis.\"\n },\n {\n \"VerbatimTerm\": \"bursitis\",\n \"Probability\": \"0.0010944307\",\n \"SemanticContext\": \"Chronic bursitis may be treated with reduced dosage once the acute condition is controlled.\"\n },\n {\n \"VerbatimTerm\": \"bursitis\",\n \"Probability\": \"0.0007698536\",\n \"SemanticContext\": \"The intra-articular or soft tissue administration of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is indicated as adjunctive therapy for short-term administration to tide the patient over an acute episode or exacerbation in acute gouty arthritis, acute and subacute bursitis, acute nonspecific tenosynovitis, epicondylitis, rheumatoid arthritis, synovitis of osteoarthritis.\"\n },\n {\n \"VerbatimTerm\": \"Bursitis\",\n \"Probability\": \"0.1879604161\",\n \"SemanticContext\": \"Bursitis, Tenosynovitis, Peritendinitis In acute subdeltoid, subacromial, olecranon, and prepatellar bursitis, one intrabursal injection of 1.0 mL Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension can relieve pain and restore full range of movement.\"\n },\n {\n \"VerbatimTerm\": \"Bursitis\",\n \"Probability\": \"0.0007043183\",\n \"SemanticContext\": \"Diagnosis Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension Dose mL Bursitis under heloma durum or heloma molle 0.25-0.5 under calcaneal spur 0.5 over hallux rigidus or digiti quinti varus 0.5 Tenosynovitis, periostitis of cuboid 0.5 Acute gouty arthritis 0.5-1.0 .\"\n }\n ]\n },\n {\n \"Term\": \"Condom\",\n \"MEDDRACode\": \"10010274\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"sheaths\",\n \"Probability\": \"0.0001238286\",\n \"SemanticContext\": \"Injections should be made into the affected tendon sheaths rather than into the tendons themselves.\"\n },\n {\n \"VerbatimTerm\": \"sheaths\",\n \"Probability\": \"0.0003462434\",\n \"SemanticContext\": \"In ganglions of joint capsules and tendon sheaths, injection of 0.5 mL directly into the ganglion cysts has produced marked reduction in the size of the lesions.\"\n }\n ]\n },\n {\n \"Term\": \"Congenital foot malformation\",\n \"MEDDRACode\": \"10062332\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"digiti quinti varus\",\n \"Probability\": \"0.21388188\",\n \"SemanticContext\": \"Diagnosis Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension Dose mL Bursitis under heloma durum or heloma molle 0.25-0.5 under calcaneal spur 0.5 over hallux rigidus or digiti quinti varus 0.5 Tenosynovitis, periostitis of cuboid 0.5 Acute gouty arthritis 0.5-1.0 .\"\n }\n ]\n },\n {\n \"Term\": \"Dental caries\",\n \"MEDDRACode\": \"10012318\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"cavity\",\n \"Probability\": \"0.0012502074\",\n \"SemanticContext\": \"Using sterile technique, a 20- to 24-gauge needle on an empty syringe is inserted into the synovial cavity and a few drops of synovial fluid are withdrawn to confirm that the needle is in the joint.\"\n }\n ]\n },\n {\n \"Term\": \"Exostosis\",\n \"MEDDRACode\": \"10015688\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"calcaneal spur\",\n \"Probability\": \"0.8606539965\",\n \"SemanticContext\": \"Diagnosis Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension Dose mL Bursitis under heloma durum or heloma molle 0.25-0.5 under calcaneal spur 0.5 over hallux rigidus or digiti quinti varus 0.5 Tenosynovitis, periostitis of cuboid 0.5 Acute gouty arthritis 0.5-1.0 .\"\n }\n ]\n },\n {\n \"Term\": \"Gasping syndrome\",\n \"MEDDRACode\": \"10069162\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Gasping Syndrome\",\n \"Probability\": \"0.8540283442\",\n \"SemanticContext\": \"DOSAGE AND ADMINISTRATION Benzyl alcohol as a preservative has been associated with a fatal \\\"Gasping Syndrome\\\" in premature infants and infants of low birth weight.\"\n }\n ]\n },\n {\n \"Term\": \"Joint range of motion decreased\",\n \"MEDDRACode\": \"10048706\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hallux rigidus\",\n \"Probability\": \"0.92116189\",\n \"SemanticContext\": \"Diagnosis Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension Dose mL Bursitis under heloma durum or heloma molle 0.25-0.5 under calcaneal spur 0.5 over hallux rigidus or digiti quinti varus 0.5 Tenosynovitis, periostitis of cuboid 0.5 Acute gouty arthritis 0.5-1.0 .\"\n }\n ]\n },\n {\n \"Term\": \"Local anaesthesia\",\n \"MEDDRACode\": \"10024758\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"local anesthetic\",\n \"Probability\": \"0.0007935762\",\n \"SemanticContext\": \"If coadministration of a local anesthetic is desired, Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension may be mixed with 1% or 2% lidocaine hydrochloride, using the formulations which do not contain parabens.\"\n },\n {\n \"VerbatimTerm\": \"local anesthetic\",\n \"Probability\": \"0.0004024804\",\n \"SemanticContext\": \"The local anesthetic is then drawn in, and the syringe shaken briefly.\"\n },\n {\n \"VerbatimTerm\": \"local anesthetics\",\n \"Probability\": \"0.0006788969\",\n \"SemanticContext\": \"Similar local anesthetics may also be used.\"\n },\n {\n \"VerbatimTerm\": \"local anesthetics\",\n \"Probability\": \"9.4923E-06\",\n \"SemanticContext\": \"Do not inject local anesthetics into the vial of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension .\"\n }\n ]\n },\n {\n \"Term\": \"Low birth weight baby\",\n \"MEDDRACode\": \"10067508\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"low birth weight\",\n \"Probability\": \"0.0174386799\",\n \"SemanticContext\": \"DOSAGE AND ADMINISTRATION Benzyl alcohol as a preservative has been associated with a fatal \\\"Gasping Syndrome\\\" in premature infants and infants of low birth weight.\"\n }\n ]\n },\n {\n \"Term\": \"Musculoskeletal stiffness\",\n \"MEDDRACode\": \"10052904\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"stiffness\",\n \"Probability\": \"0.3236957788\",\n \"SemanticContext\": \"Rheumatoid Arthritis and Osteoarthritis Following intra-articular administration of 0.5 to 2.0 mL of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension, relief of pain, soreness, and stiffness may be experienced.\"\n }\n ]\n },\n {\n \"Term\": \"Periostitis\",\n \"MEDDRACode\": \"10034551\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"periostitis\",\n \"Probability\": \"0.6446253061\",\n \"SemanticContext\": \"Diagnosis Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension Dose mL Bursitis under heloma durum or heloma molle 0.25-0.5 under calcaneal spur 0.5 over hallux rigidus or digiti quinti varus 0.5 Tenosynovitis, periostitis of cuboid 0.5 Acute gouty arthritis 0.5-1.0 .\"\n }\n ]\n },\n {\n \"Term\": \"Synovial cyst\",\n \"MEDDRACode\": \"10042858\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"ganglia\",\n \"Probability\": \"0.0059722662\",\n \"SemanticContext\": \"Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension may also be useful in cystic tumors of an aponeurosis or tendon ganglia .\"\n }\n ]\n },\n {\n \"Term\": \"Syringomyelia\",\n \"MEDDRACode\": \"10042928\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0210611224\",\n \"SemanticContext\": \"The required dose of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is first withdrawn from the vial into the syringe.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0052629709\",\n \"SemanticContext\": \"The local anesthetic is then drawn in, and the syringe shaken briefly.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0006746352\",\n \"SemanticContext\": \"Using sterile technique, a 20- to 24-gauge needle on an empty syringe is inserted into the synovial cavity and a few drops of synovial fluid are withdrawn to confirm that the needle is in the joint.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0279426575\",\n \"SemanticContext\": \"The aspirating syringe is replaced by a syringe containing Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension and injection is then made into the joint.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0108411014\",\n \"SemanticContext\": \"The aspirating syringe is replaced by a syringe containing Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension and injection is then made into the joint.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0007407963\",\n \"SemanticContext\": \"Dermatologic Conditions In intralesional treatment, 0.2 mL/cm 2 of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is injected intradermally not subcutaneously using a tuberculin syringe with a 25-gauge, 1/2-inch needle.\"\n },\n {\n \"VerbatimTerm\": \"syringe\",\n \"Probability\": \"0.0063966215\",\n \"SemanticContext\": \"Disorders of the Foot A tuberculin syringe with a 25-gauge, 3/4-inch needle is suitable for most injections into the foot.\"\n }\n ]\n },\n {\n \"Term\": \"Tendonitis\",\n \"MEDDRACode\": \"10043255\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"tendinitis\",\n \"Probability\": \"0.0425513685\",\n \"SemanticContext\": \"In tenosynovitis and tendinitis, three or four local injections at intervals of 1 to 2 weeks between injections are given in most cases.\"\n }\n ]\n },\n {\n \"Term\": \"Tenosynovitis\",\n \"MEDDRACode\": \"10043261\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Tenosynovitis\",\n \"Probability\": \"0.9132003188\",\n \"SemanticContext\": \"Bursitis, Tenosynovitis, Peritendinitis In acute subdeltoid, subacromial, olecranon, and prepatellar bursitis, one intrabursal injection of 1.0 mL Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension can relieve pain and restore full range of movement.\"\n },\n {\n \"VerbatimTerm\": \"Tenosynovitis\",\n \"Probability\": \"0.868797183\",\n \"SemanticContext\": \"Diagnosis Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension Dose mL Bursitis under heloma durum or heloma molle 0.25-0.5 under calcaneal spur 0.5 over hallux rigidus or digiti quinti varus 0.5 Tenosynovitis, periostitis of cuboid 0.5 Acute gouty arthritis 0.5-1.0 .\"\n },\n {\n \"VerbatimTerm\": \"tenosynovitis\",\n \"Probability\": \"0.4887915254\",\n \"SemanticContext\": \"In tenosynovitis and tendinitis, three or four local injections at intervals of 1 to 2 weeks between injections are given in most cases.\"\n },\n {\n \"VerbatimTerm\": \"tenosynovitis\",\n \"Probability\": \"0.0029706955\",\n \"SemanticContext\": \"The intra-articular or soft tissue administration of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is indicated as adjunctive therapy for short-term administration to tide the patient over an acute episode or exacerbation in acute gouty arthritis, acute and subacute bursitis, acute nonspecific tenosynovitis, epicondylitis, rheumatoid arthritis, synovitis of osteoarthritis.\"\n }\n ]\n },\n {\n \"Term\": \"Tremor\",\n \"MEDDRACode\": \"10044565\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"shaken\",\n \"Probability\": \"0.0258416235\",\n \"SemanticContext\": \"The local anesthetic is then drawn in, and the syringe shaken briefly.\"\n }\n ]\n },\n {\n \"Term\": \"Gouty arthritis\",\n \"MEDDRACode\": \"10018634\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"gouty arthritis\",\n \"Probability\": \"0.1532896757\",\n \"SemanticContext\": \"Diagnosis Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension Dose mL Bursitis under heloma durum or heloma molle 0.25-0.5 under calcaneal spur 0.5 over hallux rigidus or digiti quinti varus 0.5 Tenosynovitis, periostitis of cuboid 0.5 Acute gouty arthritis 0.5-1.0 .\"\n },\n {\n \"VerbatimTerm\": \"gouty arthritis\",\n \"Probability\": \"0.0744909942\",\n \"SemanticContext\": \"Rheumatic Disorders As adjunctive therapy for short-term administration to tide the patient over an acute episode or exacerbation in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis selected cases may require low-dose maintenance therapy .\"\n },\n {\n \"VerbatimTerm\": \"gouty arthritis\",\n \"Probability\": \"0.0042401552\",\n \"SemanticContext\": \"The intra-articular or soft tissue administration of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is indicated as adjunctive therapy for short-term administration to tide the patient over an acute episode or exacerbation in acute gouty arthritis, acute and subacute bursitis, acute nonspecific tenosynovitis, epicondylitis, rheumatoid arthritis, synovitis of osteoarthritis.\"\n }\n ]\n },\n {\n \"Term\": \"Osteoarthritis\",\n \"MEDDRACode\": \"10031161\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Osteoarthritis\",\n \"Probability\": \"0.000841707\",\n \"SemanticContext\": \"Rheumatoid Arthritis and Osteoarthritis Following intra-articular administration of 0.5 to 2.0 mL of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension, relief of pain, soreness, and stiffness may be experienced.\"\n },\n {\n \"VerbatimTerm\": \"osteoarthritis\",\n \"Probability\": \"0.1333166361\",\n \"SemanticContext\": \"The intra-articular or soft tissue administration of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is indicated as adjunctive therapy for short-term administration to tide the patient over an acute episode or exacerbation in acute gouty arthritis, acute and subacute bursitis, acute nonspecific tenosynovitis, epicondylitis, rheumatoid arthritis, synovitis of osteoarthritis.\"\n }\n ]\n },\n {\n \"Term\": \"Rheumatoid arthritis\",\n \"MEDDRACode\": \"10039073\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Rheumatoid Arthritis\",\n \"Probability\": \"0.0207345784\",\n \"SemanticContext\": \"Rheumatoid Arthritis and Osteoarthritis Following intra-articular administration of 0.5 to 2.0 mL of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension, relief of pain, soreness, and stiffness may be experienced.\"\n },\n {\n \"VerbatimTerm\": \"rheumatoid arthritis\",\n \"Probability\": \"0.000122507\",\n \"SemanticContext\": \"Rheumatic Disorders As adjunctive therapy for short-term administration to tide the patient over an acute episode or exacerbation in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis selected cases may require low-dose maintenance therapy .\"\n },\n {\n \"VerbatimTerm\": \"rheumatoid arthritis\",\n \"Probability\": \"0.014891088\",\n \"SemanticContext\": \"The intra-articular or soft tissue administration of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is indicated as adjunctive therapy for short-term administration to tide the patient over an acute episode or exacerbation in acute gouty arthritis, acute and subacute bursitis, acute nonspecific tenosynovitis, epicondylitis, rheumatoid arthritis, synovitis of osteoarthritis.\"\n }\n ]\n },\n {\n \"Term\": \"Pain\",\n \"MEDDRACode\": \"10033371\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"pain\",\n \"Probability\": \"0.0262791514\",\n \"SemanticContext\": \"Bursitis, Tenosynovitis, Peritendinitis In acute subdeltoid, subacromial, olecranon, and prepatellar bursitis, one intrabursal injection of 1.0 mL Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension can relieve pain and restore full range of movement.\"\n },\n {\n \"VerbatimTerm\": \"pain\",\n \"Probability\": \"0.1884167194\",\n \"SemanticContext\": \"Partial relief of pain and some increase in mobility can be expected in both conditions after one or two injections.\"\n },\n {\n \"VerbatimTerm\": \"pain\",\n \"Probability\": \"0.6658216715\",\n \"SemanticContext\": \"Rheumatoid Arthritis and Osteoarthritis Following intra-articular administration of 0.5 to 2.0 mL of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension, relief of pain, soreness, and stiffness may be experienced.\"\n },\n {\n \"VerbatimTerm\": \"pain\",\n \"Probability\": \"0.2712846398\",\n \"SemanticContext\": \"There is virtually no pain on injection, and the \\\"secondary flare\\\" that sometimes occurs a few hours after intra-articular injection of corticosteroids has not been reported with Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension.\"\n },\n {\n \"VerbatimTerm\": \"pain\",\n \"Probability\": \"0.2470580935\",\n \"SemanticContext\": \"A marked increase in pain accompanied by local swelling, further restriction of joint motion, fever, and malaise are suggestive of septic arthritis.\"\n }\n ]\n },\n {\n \"Term\": \"Multiple sclerosis\",\n \"MEDDRACode\": \"10028245\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"multiple sclerosis\",\n \"Probability\": \"0.0001541376\",\n \"SemanticContext\": \"In the treatment of acute exacerbations of multiple sclerosis, daily doses of 30 mg of betamethasone for a week followed by 12 mg every other day for 1 month are recommended see PRECAUTIONS, Neuro-psychiatric section .\"\n },\n {\n \"VerbatimTerm\": \"multiple sclerosis\",\n \"Probability\": \"0.7853093147\",\n \"SemanticContext\": \"Nervous System Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor or craniotomy.\"\n },\n {\n \"VerbatimTerm\": \"multiple sclerosis\",\n \"Probability\": \"0.0160097182\",\n \"SemanticContext\": \"Neuro-psychiatric Although controlled clinical trials have shown corticosteroids to be effective in speeding the resolution of acute exacerbations of multiple sclerosis, they do not show that they affect the ultimate outcome or natural history of the disease.\"\n }\n ]\n },\n {\n \"Term\": \"Social avoidant behaviour\",\n \"MEDDRACode\": \"10041243\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"withdrawn\",\n \"Probability\": \"7.4647E-06\",\n \"SemanticContext\": \"If possible, anticholinesterase agents should be withdrawn at least 24 hours before initiating corticosteroid therapy.\"\n },\n {\n \"VerbatimTerm\": \"withdrawn\",\n \"Probability\": \"0.0001446605\",\n \"SemanticContext\": \"If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.\"\n },\n {\n \"VerbatimTerm\": \"withdrawn\",\n \"Probability\": \"0.0010358393\",\n \"SemanticContext\": \"The required dose of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is first withdrawn from the vial into the syringe.\"\n },\n {\n \"VerbatimTerm\": \"withdrawn\",\n \"Probability\": \"0.0002759099\",\n \"SemanticContext\": \"Using sterile technique, a 20- to 24-gauge needle on an empty syringe is inserted into the synovial cavity and a few drops of synovial fluid are withdrawn to confirm that the needle is in the joint.\"\n },\n {\n \"VerbatimTerm\": \"withdrawn\",\n \"Probability\": \"7.4647E-06\",\n \"SemanticContext\": \"If possible, anticholinesterase agents should be withdrawn at least 24 hours before initiating corticosteroid therapy.\"\n }\n ]\n },\n {\n \"Term\": \"Adrenal suppression\",\n \"MEDDRACode\": \"10001382\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"adrenal suppression\",\n \"Probability\": \"0.2117733359\",\n \"SemanticContext\": \"Drug Interactions\\nAminoglutethimide Aminoglutethimide may lead to a loss of corticosteroid-induced adrenal suppression.\"\n },\n {\n \"VerbatimTerm\": \"adrenal suppression\",\n \"Probability\": \"0.2563617527\",\n \"SemanticContext\": \"Drug Interactions\\nAminoglutethimide Aminoglutethimide may lead to a loss of corticosteroid-induced adrenal suppression.\"\n }\n ]\n },\n {\n \"Term\": \"Analgesic drug level\",\n \"MEDDRACode\": \"10060090\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"salicylates\",\n \"Probability\": \"0.0001884699\",\n \"SemanticContext\": \"The clearance of salicylates may be increased with concurrent use of corticosteroids.\"\n },\n {\n \"VerbatimTerm\": \"salicylates\",\n \"Probability\": \"0.0001884699\",\n \"SemanticContext\": \"The clearance of salicylates may be increased with concurrent use of corticosteroids.\"\n }\n ]\n },\n {\n \"Term\": \"Barbiturates\",\n \"MEDDRACode\": \"10063229\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"barbiturates\",\n \"Probability\": \"0.0132356882\",\n \"SemanticContext\": \"\\nHepatic Enzyme Inducers eg, barbiturates, phenytoin, carbamazepine, rifampin Drugs which induce hepatic microsomal drug-metabolizing enzyme activity may enhance the metabolism of corticosteroids and require that the dosage of the corticosteroid be increased.\"\n },\n {\n \"VerbatimTerm\": \"barbiturates\",\n \"Probability\": \"0.0132356882\",\n \"SemanticContext\": \"\\nHepatic Enzyme Inducers eg, barbiturates, phenytoin, carbamazepine, rifampin Drugs which induce hepatic microsomal drug-metabolizing enzyme activity may enhance the metabolism of corticosteroids and require that the dosage of the corticosteroid be increased.\"\n }\n ]\n },\n {\n \"Term\": \"Blood glucose increased\",\n \"MEDDRACode\": \"10005557\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"increase blood glucose\",\n \"Probability\": \"0.0001438558\",\n \"SemanticContext\": \"\\nAntidiabetics Because corticosteroids may increase blood glucose concentrations, dosage adjustments of antidiabetic agents may be required.\"\n },\n {\n \"VerbatimTerm\": \"increase blood glucose\",\n \"Probability\": \"0.0001438558\",\n \"SemanticContext\": \"\\nAntidiabetics Because corticosteroids may increase blood glucose concentrations, dosage adjustments of antidiabetic agents may be required.\"\n }\n ]\n },\n {\n \"Term\": \"Blood oestrogen\",\n \"MEDDRACode\": \"10005684\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Estrogens\",\n \"Probability\": \"0.0003915131\",\n \"SemanticContext\": \"\\nEstrogens, Including Oral Contraceptives Estrogens may decrease the hepatic metabolism of certain corticosteroids, thereby increasing their effect.\"\n },\n {\n \"VerbatimTerm\": \"Estrogens\",\n \"Probability\": \"9.2539E-06\",\n \"SemanticContext\": \"\\nEstrogens, Including Oral Contraceptives Estrogens may decrease the hepatic metabolism of certain corticosteroids, thereby increasing their effect.\"\n },\n {\n \"VerbatimTerm\": \"Estrogens\",\n \"Probability\": \"0.0003915131\",\n \"SemanticContext\": \"\\nEstrogens, Including Oral Contraceptives Estrogens may decrease the hepatic metabolism of certain corticosteroids, thereby increasing their effect.\"\n },\n {\n \"VerbatimTerm\": \"Estrogens\",\n \"Probability\": \"9.2539E-06\",\n \"SemanticContext\": \"\\nEstrogens, Including Oral Contraceptives Estrogens may decrease the hepatic metabolism of certain corticosteroids, thereby increasing their effect.\"\n }\n ]\n },\n {\n \"Term\": \"Drug interaction\",\n \"MEDDRACode\": \"10013710\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Interactions\",\n \"Probability\": \"5.71575E-05\",\n \"SemanticContext\": \"\\nInteractions with Strong CYP3A4 Inhibitors Corticosteroids including betamethasone are metabolized by CYP3A4.\"\n },\n {\n \"VerbatimTerm\": \"Interactions\",\n \"Probability\": \"5.71575E-05\",\n \"SemanticContext\": \"\\nInteractions with Strong CYP3A4 Inhibitors Corticosteroids including betamethasone are metabolized by CYP3A4.\"\n }\n ]\n },\n {\n \"Term\": \"Hepatic enzyme\",\n \"MEDDRACode\": \"10060793\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Hepatic Enzyme\",\n \"Probability\": \"0.0014983416\",\n \"SemanticContext\": \"\\nHepatic Enzyme Inducers eg, barbiturates, phenytoin, carbamazepine, rifampin Drugs which induce hepatic microsomal drug-metabolizing enzyme activity may enhance the metabolism of corticosteroids and require that the dosage of the corticosteroid be increased.\"\n },\n {\n \"VerbatimTerm\": \"Hepatic Enzyme\",\n \"Probability\": \"0.0014983416\",\n \"SemanticContext\": \"\\nHepatic Enzyme Inducers eg, barbiturates, phenytoin, carbamazepine, rifampin Drugs which induce hepatic microsomal drug-metabolizing enzyme activity may enhance the metabolism of corticosteroids and require that the dosage of the corticosteroid be increased.\"\n }\n ]\n },\n {\n \"Term\": \"Hypokalaemia\",\n \"MEDDRACode\": \"10021015\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hypokalemia\",\n \"Probability\": \"0.2461926341\",\n \"SemanticContext\": \"\\nAmphotericin B Injection and Potassium-Depleting Agents When corticosteroids are administered concomitantly with potassium-depleting agents ie, amphotericin B, diuretics , patients should be observed closely for development of hypokalemia.\"\n },\n {\n \"VerbatimTerm\": \"hypokalemia\",\n \"Probability\": \"0.3628238142\",\n \"SemanticContext\": \"\\nDigitalis Glycosides Patients on digitalis glycosides may be at increased risk of arrhythmias due to hypokalemia.\"\n },\n {\n \"VerbatimTerm\": \"hypokalemia\",\n \"Probability\": \"0.2461926341\",\n \"SemanticContext\": \"\\nAmphotericin B Injection and Potassium-Depleting Agents When corticosteroids are administered concomitantly with potassium-depleting agents ie, amphotericin B, diuretics , patients should be observed closely for development of hypokalemia.\"\n },\n {\n \"VerbatimTerm\": \"hypokalemia\",\n \"Probability\": \"0.3628238142\",\n \"SemanticContext\": \"\\nDigitalis Glycosides Patients on digitalis glycosides may be at increased risk of arrhythmias due to hypokalemia.\"\n }\n ]\n },\n {\n \"Term\": \"Hypoprothrombinaemia\",\n \"MEDDRACode\": \"10021085\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hypoprothrombinemia\",\n \"Probability\": \"2.90804E-05\",\n \"SemanticContext\": \"Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia.\"\n },\n {\n \"VerbatimTerm\": \"hypoprothrombinemia\",\n \"Probability\": \"2.90804E-05\",\n \"SemanticContext\": \"Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia.\"\n }\n ]\n },\n {\n \"Term\": \"Immunisation\",\n \"MEDDRACode\": \"10021430\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Immunization\",\n \"Probability\": \"0.0011593997\",\n \"SemanticContext\": \"Immunization procedures may be undertaken in patients who are receiving corticosteroids as replacement therapy, eg, for Addison's disease.\"\n }\n ]\n },\n {\n \"Term\": \"Myasthenia gravis\",\n \"MEDDRACode\": \"10028417\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"myasthenia gravis\",\n \"Probability\": \"0.000156492\",\n \"SemanticContext\": \"\\nAnticholinesterases Concomitant use of anticholinesterase agents and corticosteroids may produce severe weakness in patients with myasthenia gravis.\"\n },\n {\n \"VerbatimTerm\": \"myasthenia gravis\",\n \"Probability\": \"0.0157971382\",\n \"SemanticContext\": \"An acute myopathy has been observed with the use of high doses of corticosteroids, most often occurring in patients with disorders of neuromuscular transmission eg, myasthenia gravis , or in patients receiving concomitant therapy with neuromuscular blocking drugs eg, pancuronium .\"\n },\n {\n \"VerbatimTerm\": \"myasthenia gravis\",\n \"Probability\": \"0.000156492\",\n \"SemanticContext\": \"\\nAnticholinesterases Concomitant use of anticholinesterase agents and corticosteroids may produce severe weakness in patients with myasthenia gravis.\"\n }\n ]\n },\n {\n \"Term\": \"Oral contraception\",\n \"MEDDRACode\": \"10030970\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Oral Contraceptives\",\n \"Probability\": \"0.0005377531\",\n \"SemanticContext\": \"\\nEstrogens, Including Oral Contraceptives Estrogens may decrease the hepatic metabolism of certain corticosteroids, thereby increasing their effect.\"\n },\n {\n \"VerbatimTerm\": \"Oral Contraceptives\",\n \"Probability\": \"0.0005377531\",\n \"SemanticContext\": \"\\nEstrogens, Including Oral Contraceptives Estrogens may decrease the hepatic metabolism of certain corticosteroids, thereby increasing their effect.\"\n }\n ]\n },\n {\n \"Term\": \"Psychomotor hyperactivity\",\n \"MEDDRACode\": \"10037211\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": true,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Increased activity\",\n \"Probability\": \"0.0042690933\",\n \"SemanticContext\": \"\\nCyclosporine Increased activity of both cyclosporine and corticosteroids may occur when the two are used concurrently.\"\n },\n {\n \"VerbatimTerm\": \"Increased activity\",\n \"Probability\": \"0.0042690933\",\n \"SemanticContext\": \"\\nCyclosporine Increased activity of both cyclosporine and corticosteroids may occur when the two are used concurrently.\"\n }\n ]\n },\n {\n \"Term\": \"Adrenogenital syndrome\",\n \"MEDDRACode\": \"10061630\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Congenital adrenal hyperplasia\",\n \"Probability\": \"0.9850029945\",\n \"SemanticContext\": \"Endocrine Disorders Congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis.\"\n }\n ]\n },\n {\n \"Term\": \"Alopecia areata\",\n \"MEDDRACode\": \"10001761\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"alopecia areata\",\n \"Probability\": \"0.9339317083\",\n \"SemanticContext\": \"The intralesional administration of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is indicated for alopecia areata; discoid lupus erythematosus; keloids; localized hypertrophic, infiltrated, inflammatory lesions of granuloma annulare, lichen planus, lichen simplex chronicus neurodermatitis , and psoriatic plaques; necrobiosis lipoidica diabeticorum.\"\n }\n ]\n },\n {\n \"Term\": \"Ankylosing spondylitis\",\n \"MEDDRACode\": \"10002556\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"ankylosing spondylitis\",\n \"Probability\": \"0.1903775632\",\n \"SemanticContext\": \"Rheumatic Disorders As adjunctive therapy for short-term administration to tide the patient over an acute episode or exacerbation in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis selected cases may require low-dose maintenance therapy .\"\n }\n ]\n },\n {\n \"Term\": \"Aplasia pure red cell\",\n \"MEDDRACode\": \"10002965\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \", pure red cell aplasia\",\n \"Probability\": \"0.9681130648\",\n \"SemanticContext\": \"Hematologic Disorders Acquired autoimmune hemolytic anemia, Diamond-Blackfan anemia, pure red cell aplasia, selected cases of secondary thrombocytopenia.\"\n },\n {\n \"VerbatimTerm\": \"pure red cell aplasia,\",\n \"Probability\": \"0.9838365316\",\n \"SemanticContext\": \"Hematologic Disorders Acquired autoimmune hemolytic anemia, Diamond-Blackfan anemia, pure red cell aplasia, selected cases of secondary thrombocytopenia.\"\n }\n ]\n },\n {\n \"Term\": \"Autoimmune haemolytic anaemia\",\n \"MEDDRACode\": \"10073785\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"autoimmune hemolytic anemia\",\n \"Probability\": \"0.9908950329\",\n \"SemanticContext\": \"Hematologic Disorders Acquired autoimmune hemolytic anemia, Diamond-Blackfan anemia, pure red cell aplasia, selected cases of secondary thrombocytopenia.\"\n }\n ]\n },\n {\n \"Term\": \"Berylliosis\",\n \"MEDDRACode\": \"10004485\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Berylliosis\",\n \"Probability\": \"0.0167868137\",\n \"SemanticContext\": \"Respiratory Diseases Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis.\"\n }\n ]\n },\n {\n \"Term\": \"Blood disorder\",\n \"MEDDRACode\": \"10061590\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Hematologic Disorders\",\n \"Probability\": \"0.0125087798\",\n \"SemanticContext\": \"Hematologic Disorders Acquired autoimmune hemolytic anemia, Diamond-Blackfan anemia, pure red cell aplasia, selected cases of secondary thrombocytopenia.\"\n }\n ]\n },\n {\n \"Term\": \"Brain neoplasm\",\n \"MEDDRACode\": \"10061019\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"brain tumor\",\n \"Probability\": \"0.0975262523\",\n \"SemanticContext\": \"Nervous System Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor or craniotomy.\"\n }\n ]\n },\n {\n \"Term\": \"Brain oedema\",\n \"MEDDRACode\": \"10048962\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"cerebral edema\",\n \"Probability\": \"0.848790884\",\n \"SemanticContext\": \"Nervous System Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor or craniotomy.\"\n }\n ]\n },\n {\n \"Term\": \"Carditis\",\n \"MEDDRACode\": \"10062746\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"carditis\",\n \"Probability\": \"0.1682180166\",\n \"SemanticContext\": \"Rheumatic Disorders As adjunctive therapy for short-term administration to tide the patient over an acute episode or exacerbation in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis selected cases may require low-dose maintenance therapy .\"\n }\n ]\n },\n {\n \"Term\": \"Chemotherapy\",\n \"MEDDRACode\": \"10061758\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"chemotherapy\",\n \"Probability\": \"0.0083633363\",\n \"SemanticContext\": \"Miscellaneous Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy.\"\n },\n {\n \"VerbatimTerm\": \"chemotherapy\",\n \"Probability\": \"0.0070828795\",\n \"SemanticContext\": \"Respiratory Diseases Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis.\"\n }\n ]\n },\n {\n \"Term\": \"Congenital aplastic anaemia\",\n \"MEDDRACode\": \"10053138\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Diamond-Blackfan anemia\",\n \"Probability\": \"0.9970852733\",\n \"SemanticContext\": \"Hematologic Disorders Acquired autoimmune hemolytic anemia, Diamond-Blackfan anemia, pure red cell aplasia, selected cases of secondary thrombocytopenia.\"\n }\n ]\n },\n {\n \"Term\": \"Craniotomy\",\n \"MEDDRACode\": \"10011322\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"craniotomy\",\n \"Probability\": \"0.1861142814\",\n \"SemanticContext\": \"Nervous System Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor or craniotomy.\"\n }\n ]\n },\n {\n \"Term\": \"Crohn's disease\",\n \"MEDDRACode\": \"10011401\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"regional enteritis\",\n \"Probability\": \"0.1630475819\",\n \"SemanticContext\": \"Gastrointestinal Diseases To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis.\"\n }\n ]\n },\n {\n \"Term\": \"Cutaneous lupus erythematosus\",\n \"MEDDRACode\": \"10056509\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"discoid lupus erythematosus\",\n \"Probability\": \"0.6132032275\",\n \"SemanticContext\": \"The intralesional administration of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is indicated for alopecia areata; discoid lupus erythematosus; keloids; localized hypertrophic, infiltrated, inflammatory lesions of granuloma annulare, lichen planus, lichen simplex chronicus neurodermatitis , and psoriatic plaques; necrobiosis lipoidica diabeticorum.\"\n }\n ]\n },\n {\n \"Term\": \"Cutaneous T-cell lymphoma\",\n \"MEDDRACode\": \"10011677\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"mycosis fungoides\",\n \"Probability\": \"0.9239732027\",\n \"SemanticContext\": \"Dermatologic Diseases Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme Stevens-Johnson syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Dermatitis bullous\",\n \"MEDDRACode\": \"10012441\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Bullous dermatitis\",\n \"Probability\": \"0.9218941927\",\n \"SemanticContext\": \"Dermatologic Diseases Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme Stevens-Johnson syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Dermatitis contact\",\n \"MEDDRACode\": \"10012442\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"contact dermatitis\",\n \"Probability\": \"0.0338545442\",\n \"SemanticContext\": \"INDICATIONS AND USAGE When oral therapy is not feasible, the intramuscular use of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is indicated as follows: Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions.\"\n }\n ]\n },\n {\n \"Term\": \"Dermatitis exfoliative generalised\",\n \"MEDDRACode\": \"10012456\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"erythroderma\",\n \"Probability\": \"0.9552758932\",\n \"SemanticContext\": \"Dermatologic Diseases Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme Stevens-Johnson syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Dermatitis herpetiformis\",\n \"MEDDRACode\": \"10012468\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"dermatitis herpetiformis\",\n \"Probability\": \"0.7886803746\",\n \"SemanticContext\": \"Dermatologic Diseases Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme Stevens-Johnson syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Dermatomyositis\",\n \"MEDDRACode\": \"10012503\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"dermatomyositis\",\n \"Probability\": \"0.8715889454\",\n \"SemanticContext\": \"For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.\"\n }\n ]\n },\n {\n \"Term\": \"Drug hypersensitivity\",\n \"MEDDRACode\": \"10013700\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"drug hypersensitivity\",\n \"Probability\": \"0.0465348065\",\n \"SemanticContext\": \"INDICATIONS AND USAGE When oral therapy is not feasible, the intramuscular use of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is indicated as follows: Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions.\"\n }\n ]\n },\n {\n \"Term\": \"Endocrine disorder\",\n \"MEDDRACode\": \"10014695\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Endocrine Disorders\",\n \"Probability\": \"0.0909818709\",\n \"SemanticContext\": \"Endocrine Disorders Congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis.\"\n }\n ]\n },\n {\n \"Term\": \"Eosinophilic pneumonia\",\n \"MEDDRACode\": \"10014962\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"eosinophilic pneumonias\",\n \"Probability\": \"0.1809546351\",\n \"SemanticContext\": \"Respiratory Diseases Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis.\"\n }\n ]\n },\n {\n \"Term\": \"Epicondylitis\",\n \"MEDDRACode\": \"10014971\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"epicondylitis\",\n \"Probability\": \"0.0014092624\",\n \"SemanticContext\": \"The intra-articular or soft tissue administration of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is indicated as adjunctive therapy for short-term administration to tide the patient over an acute episode or exacerbation in acute gouty arthritis, acute and subacute bursitis, acute nonspecific tenosynovitis, epicondylitis, rheumatoid arthritis, synovitis of osteoarthritis.\"\n }\n ]\n },\n {\n \"Term\": \"Erythema multiforme\",\n \"MEDDRACode\": \"10015218\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"severe erythema multiforme\",\n \"Probability\": \"0.9751800299\",\n \"SemanticContext\": \"Dermatologic Diseases Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme Stevens-Johnson syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Giant cell arteritis\",\n \"MEDDRACode\": \"10018250\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"temporal arteritis\",\n \"Probability\": \"0.1124004126\",\n \"SemanticContext\": \"Ophthalmic Diseases Sympathetic ophthalmia, temporal arteritis, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids.\"\n }\n ]\n },\n {\n \"Term\": \"Granuloma annulare\",\n \"MEDDRACode\": \"10018692\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"granuloma annulare\",\n \"Probability\": \"0.7087999582\",\n \"SemanticContext\": \"The intralesional administration of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is indicated for alopecia areata; discoid lupus erythematosus; keloids; localized hypertrophic, infiltrated, inflammatory lesions of granuloma annulare, lichen planus, lichen simplex chronicus neurodermatitis , and psoriatic plaques; necrobiosis lipoidica diabeticorum.\"\n }\n ]\n },\n {\n \"Term\": \"Hypercalcaemia\",\n \"MEDDRACode\": \"10020583\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hypercalcemia\",\n \"Probability\": \"0.9642394185\",\n \"SemanticContext\": \"Endocrine Disorders Congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis.\"\n }\n ]\n },\n {\n \"Term\": \"Juvenile idiopathic arthritis\",\n \"MEDDRACode\": \"10059176\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"juvenile rheumatoid arthritis\",\n \"Probability\": \"0.0017668903\",\n \"SemanticContext\": \"Rheumatic Disorders As adjunctive therapy for short-term administration to tide the patient over an acute episode or exacerbation in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis selected cases may require low-dose maintenance therapy .\"\n }\n ]\n },\n {\n \"Term\": \"Keloid scar\",\n \"MEDDRACode\": \"10023330\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"keloids\",\n \"Probability\": \"0.7265982032\",\n \"SemanticContext\": \"The intralesional administration of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is indicated for alopecia areata; discoid lupus erythematosus; keloids; localized hypertrophic, infiltrated, inflammatory lesions of granuloma annulare, lichen planus, lichen simplex chronicus neurodermatitis , and psoriatic plaques; necrobiosis lipoidica diabeticorum.\"\n }\n ]\n },\n {\n \"Term\": \"Lichen planus\",\n \"MEDDRACode\": \"10024429\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"lichen planus\",\n \"Probability\": \"0.2711394429\",\n \"SemanticContext\": \"The intralesional administration of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is indicated for alopecia areata; discoid lupus erythematosus; keloids; localized hypertrophic, infiltrated, inflammatory lesions of granuloma annulare, lichen planus, lichen simplex chronicus neurodermatitis , and psoriatic plaques; necrobiosis lipoidica diabeticorum.\"\n }\n ]\n },\n {\n \"Term\": \"Meningitis tuberculous\",\n \"MEDDRACode\": \"10027259\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"tuberculous meningitis\",\n \"Probability\": \"0.3902463913\",\n \"SemanticContext\": \"Miscellaneous Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy.\"\n }\n ]\n },\n {\n \"Term\": \"Metastatic neoplasm\",\n \"MEDDRACode\": \"10061289\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"metastatic\",\n \"Probability\": \"0.2010820806\",\n \"SemanticContext\": \"Nervous System Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor or craniotomy.\"\n }\n ]\n },\n {\n \"Term\": \"Necrobiosis lipoidica diabeticorum\",\n \"MEDDRACode\": \"10056969\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"necrobiosis lipoidica diabeticorum\",\n \"Probability\": \"0.6191030741\",\n \"SemanticContext\": \"The intralesional administration of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is indicated for alopecia areata; discoid lupus erythematosus; keloids; localized hypertrophic, infiltrated, inflammatory lesions of granuloma annulare, lichen planus, lichen simplex chronicus neurodermatitis , and psoriatic plaques; necrobiosis lipoidica diabeticorum.\"\n }\n ]\n },\n {\n \"Term\": \"Neoplasm\",\n \"MEDDRACode\": \"10028980\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"tumors\",\n \"Probability\": \"0.000385493\",\n \"SemanticContext\": \"Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension may also be useful in cystic tumors of an aponeurosis or tendon ganglia .\"\n }\n ]\n },\n {\n \"Term\": \"Neoplasm malignant\",\n \"MEDDRACode\": \"10028997\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"cancer\",\n \"Probability\": \"0.3044053316\",\n \"SemanticContext\": \"Endocrine Disorders Congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis.\"\n }\n ]\n },\n {\n \"Term\": \"Nephropathy\",\n \"MEDDRACode\": \"10029151\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Renal Diseases\",\n \"Probability\": \"0.0666455328\",\n \"SemanticContext\": \"Renal Diseases To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus.\"\n }\n ]\n },\n {\n \"Term\": \"Nervousness\",\n \"MEDDRACode\": \"10029216\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Nervous\",\n \"Probability\": \"0.0716812611\",\n \"SemanticContext\": \"Nervous System Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor or craniotomy.\"\n }\n ]\n },\n {\n \"Term\": \"Neurodermatitis\",\n \"MEDDRACode\": \"10029263\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"lichen simplex chronicus\",\n \"Probability\": \"0.8569835424\",\n \"SemanticContext\": \"The intralesional administration of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is indicated for alopecia areata; discoid lupus erythematosus; keloids; localized hypertrophic, infiltrated, inflammatory lesions of granuloma annulare, lichen planus, lichen simplex chronicus neurodermatitis , and psoriatic plaques; necrobiosis lipoidica diabeticorum.\"\n }\n ]\n },\n {\n \"Term\": \"Pemphigus\",\n \"MEDDRACode\": \"10034280\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"pemphigus\",\n \"Probability\": \"0.7534125447\",\n \"SemanticContext\": \"Dermatologic Diseases Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme Stevens-Johnson syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Polymyositis\",\n \"MEDDRACode\": \"10036102\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"polymyositis\",\n \"Probability\": \"0.846999824\",\n \"SemanticContext\": \"For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.\"\n }\n ]\n },\n {\n \"Term\": \"Polyuria\",\n \"MEDDRACode\": \"10036142\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"diuresis\",\n \"Probability\": \"0.5409085751\",\n \"SemanticContext\": \"Renal Diseases To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus.\"\n }\n ]\n },\n {\n \"Term\": \"Proteinuria\",\n \"MEDDRACode\": \"10037032\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"proteinuria\",\n \"Probability\": \"0.6872887611\",\n \"SemanticContext\": \"Renal Diseases To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus.\"\n }\n ]\n },\n {\n \"Term\": \"Psoriasis\",\n \"MEDDRACode\": \"10037153\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"psoriatic plaques\",\n \"Probability\": \"0.9028086662\",\n \"SemanticContext\": \"The intralesional administration of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is indicated for alopecia areata; discoid lupus erythematosus; keloids; localized hypertrophic, infiltrated, inflammatory lesions of granuloma annulare, lichen planus, lichen simplex chronicus neurodermatitis , and psoriatic plaques; necrobiosis lipoidica diabeticorum.\"\n }\n ]\n },\n {\n \"Term\": \"Psoriatic arthropathy\",\n \"MEDDRACode\": \"10037162\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"psoriatic arthritis\",\n \"Probability\": \"9.00042E-05\",\n \"SemanticContext\": \"Rheumatic Disorders As adjunctive therapy for short-term administration to tide the patient over an acute episode or exacerbation in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis selected cases may require low-dose maintenance therapy .\"\n }\n ]\n },\n {\n \"Term\": \"Pulmonary tuberculosis\",\n \"MEDDRACode\": \"10037440\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"pulmonary tuberculosis\",\n \"Probability\": \"0.1883048713\",\n \"SemanticContext\": \"Respiratory Diseases Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis.\"\n }\n ]\n },\n {\n \"Term\": \"Rheumatic disorder\",\n \"MEDDRACode\": \"10072736\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Rheumatic Disorders\",\n \"Probability\": \"0.1034022272\",\n \"SemanticContext\": \"Rheumatic Disorders As adjunctive therapy for short-term administration to tide the patient over an acute episode or exacerbation in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis selected cases may require low-dose maintenance therapy .\"\n }\n ]\n },\n {\n \"Term\": \"Sarcoidosis\",\n \"MEDDRACode\": \"10039486\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"sarcoidosis\",\n \"Probability\": \"0.4187629521\",\n \"SemanticContext\": \"Respiratory Diseases Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis.\"\n }\n ]\n },\n {\n \"Term\": \"Seasonal allergy\",\n \"MEDDRACode\": \"10048908\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"seasonal allergic rhinitis\",\n \"Probability\": \"0.0007181764\",\n \"SemanticContext\": \"INDICATIONS AND USAGE When oral therapy is not feasible, the intramuscular use of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is indicated as follows: Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions.\"\n }\n ]\n },\n {\n \"Term\": \"Serum sickness\",\n \"MEDDRACode\": \"10040400\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"serum sickness\",\n \"Probability\": \"0.0081218183\",\n \"SemanticContext\": \"INDICATIONS AND USAGE When oral therapy is not feasible, the intramuscular use of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is indicated as follows: Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions.\"\n }\n ]\n },\n {\n \"Term\": \"Stevens-Johnson syndrome\",\n \"MEDDRACode\": \"10042033\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Stevens-Johnson syndrome\",\n \"Probability\": \"0.6234071255\",\n \"SemanticContext\": \"Dermatologic Diseases Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme Stevens-Johnson syndrome .\"\n }\n ]\n },\n {\n \"Term\": \"Sympathetic ophthalmia\",\n \"MEDDRACode\": \"10042742\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Sympathetic ophthalmia\",\n \"Probability\": \"0.1706544161\",\n \"SemanticContext\": \"Ophthalmic Diseases Sympathetic ophthalmia, temporal arteritis, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids.\"\n }\n ]\n },\n {\n \"Term\": \"Synovitis\",\n \"MEDDRACode\": \"10042868\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"synovitis\",\n \"Probability\": \"0.0329957306\",\n \"SemanticContext\": \"The intra-articular or soft tissue administration of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is indicated as adjunctive therapy for short-term administration to tide the patient over an acute episode or exacerbation in acute gouty arthritis, acute and subacute bursitis, acute nonspecific tenosynovitis, epicondylitis, rheumatoid arthritis, synovitis of osteoarthritis.\"\n }\n ]\n },\n {\n \"Term\": \"Systemic lupus erythematosus\",\n \"MEDDRACode\": \"10042945\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"systemic lupus erythematosus\",\n \"Probability\": \"0.8350071311\",\n \"SemanticContext\": \"For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.\"\n }\n ]\n },\n {\n \"Term\": \"Thrombocytopenia\",\n \"MEDDRACode\": \"10043554\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"secondary thrombocytopenia\",\n \"Probability\": \"0.9785981178\",\n \"SemanticContext\": \"Hematologic Disorders Acquired autoimmune hemolytic anemia, Diamond-Blackfan anemia, pure red cell aplasia, selected cases of secondary thrombocytopenia.\"\n }\n ]\n },\n {\n \"Term\": \"Thyroiditis\",\n \"MEDDRACode\": \"10043778\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"thyroiditis\",\n \"Probability\": \"0.9144436121\",\n \"SemanticContext\": \"Endocrine Disorders Congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis.\"\n }\n ]\n },\n {\n \"Term\": \"Transfusion reaction\",\n \"MEDDRACode\": \"10044359\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"transfusion reactions\",\n \"Probability\": \"0.001026541\",\n \"SemanticContext\": \"INDICATIONS AND USAGE When oral therapy is not feasible, the intramuscular use of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is indicated as follows: Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions.\"\n }\n ]\n },\n {\n \"Term\": \"Trichiniasis\",\n \"MEDDRACode\": \"10044608\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Trichinosis\",\n \"Probability\": \"0.0454051495\",\n \"SemanticContext\": \"Miscellaneous Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy.\"\n }\n ]\n },\n {\n \"Term\": \"Unresponsive to stimuli\",\n \"MEDDRACode\": \"10045555\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"unresponsive\",\n \"Probability\": \"0.0376680493\",\n \"SemanticContext\": \"Ophthalmic Diseases Sympathetic ophthalmia, temporal arteritis, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids.\"\n }\n ]\n },\n {\n \"Term\": \"Uveitis\",\n \"MEDDRACode\": \"10046851\",\n \"Overdose\": false,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"uveitis\",\n \"Probability\": \"0.3520230055\",\n \"SemanticContext\": \"Ophthalmic Diseases Sympathetic ophthalmia, temporal arteritis, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids.\"\n }\n ]\n },\n {\n \"Term\": \"Colitis ulcerative\",\n \"MEDDRACode\": \"10009900\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"ulcerative colitis\",\n \"Probability\": \"0.3862008154\",\n \"SemanticContext\": \"Gastrointestinal Diseases To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis.\"\n },\n {\n \"VerbatimTerm\": \"ulcerative colitis\",\n \"Probability\": \"0.0139125884\",\n \"SemanticContext\": \"Gastrointestinal Steroids should be used with caution in active or latent peptic ulcers, diverticulitis, fresh intestinal anastomoses, and nonspecific ulcerative colitis, since they may increase the risk of a perforation.\"\n }\n ]\n },\n {\n \"Term\": \"Secondary adrenocortical insufficiency\",\n \"MEDDRACode\": \"10039807\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"secondary adrenocortical insufficiency\",\n \"Probability\": \"0.0055174232\",\n \"SemanticContext\": \"Hydrocortisone or cortisone is the drug of choice in primary or secondary adrenocortical insufficiency.\"\n },\n {\n \"VerbatimTerm\": \"secondary adrenocortical insufficiency\",\n \"Probability\": \"0.0083829165\",\n \"SemanticContext\": \"Endocrine Drug-induced secondary adrenocortical insufficiency may be minimized by gradual reduction of dosage.\"\n }\n ]\n },\n {\n \"Term\": \"Tuberculosis\",\n \"MEDDRACode\": \"10044755\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"active tuberculosis\",\n \"Probability\": \"0.0002934635\",\n \"SemanticContext\": \"\\nTuberculosis The use of corticosteroids in active tuberculosis should be restricted to those cases of fulminating or disseminated tuberculosis in which the corticosteroid is used for the management of the disease in conjunction with an appropriate antituberculous regimen.\"\n }\n ]\n },\n {\n \"Term\": \"Asthma\",\n \"MEDDRACode\": \"10003553\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"asthma\",\n \"Probability\": \"0.0466814041\",\n \"SemanticContext\": \"INDICATIONS AND USAGE When oral therapy is not feasible, the intramuscular use of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is indicated as follows: Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions.\"\n },\n {\n \"VerbatimTerm\": \"asthma\",\n \"Probability\": \"0.0001035512\",\n \"SemanticContext\": \"Other indications for pediatric use of corticosteroids, eg, severe asthma and wheezing, are based on adequate and well-controlled trials conducted in adults, on the premises that the course of the diseases and their pathophysiology are considered to be substantially similar in both populations.\"\n },\n {\n \"VerbatimTerm\": \"asthma\",\n \"Probability\": \"0.0001035512\",\n \"SemanticContext\": \"Other indications for pediatric use of corticosteroids, eg, severe asthma and wheezing, are based on adequate and well-controlled trials conducted in adults, on the premises that the course of the diseases and their pathophysiology are considered to be substantially similar in both populations.\"\n }\n ]\n },\n {\n \"Term\": \"Leukaemia\",\n \"MEDDRACode\": \"10024288\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"leukemias\",\n \"Probability\": \"0.0145325661\",\n \"SemanticContext\": \"Neoplastic Diseases For palliative management of leukemias and lymphomas.\"\n },\n {\n \"VerbatimTerm\": \"leukemias\",\n \"Probability\": \"0.0010807216\",\n \"SemanticContext\": \"Published studies provide evidence of efficacy and safety in pediatric patients for the treatment of nephrotic syndrome >2 years of age , and aggressive lymphomas and leukemias >1 month of age .\"\n },\n {\n \"VerbatimTerm\": \"leukemias\",\n \"Probability\": \"0.0010807216\",\n \"SemanticContext\": \"Published studies provide evidence of efficacy and safety in pediatric patients for the treatment of nephrotic syndrome >2 years of age , and aggressive lymphomas and leukemias >1 month of age .\"\n }\n ]\n },\n {\n \"Term\": \"Lymphoma\",\n \"MEDDRACode\": \"10025310\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"lymphomas\",\n \"Probability\": \"0.0005052686\",\n \"SemanticContext\": \"Neoplastic Diseases For palliative management of leukemias and lymphomas.\"\n },\n {\n \"VerbatimTerm\": \"lymphomas\",\n \"Probability\": \"0.0014491677\",\n \"SemanticContext\": \"Published studies provide evidence of efficacy and safety in pediatric patients for the treatment of nephrotic syndrome >2 years of age , and aggressive lymphomas and leukemias >1 month of age .\"\n },\n {\n \"VerbatimTerm\": \"lymphomas\",\n \"Probability\": \"0.0014491677\",\n \"SemanticContext\": \"Published studies provide evidence of efficacy and safety in pediatric patients for the treatment of nephrotic syndrome >2 years of age , and aggressive lymphomas and leukemias >1 month of age .\"\n }\n ]\n },\n {\n \"Term\": \"Nephrotic syndrome\",\n \"MEDDRACode\": \"10029164\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"nephrotic syndrome\",\n \"Probability\": \"0.2895687819\",\n \"SemanticContext\": \"Renal Diseases To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus.\"\n },\n {\n \"VerbatimTerm\": \"nephrotic syndrome\",\n \"Probability\": \"0.0101575553\",\n \"SemanticContext\": \"Published studies provide evidence of efficacy and safety in pediatric patients for the treatment of nephrotic syndrome >2 years of age , and aggressive lymphomas and leukemias >1 month of age .\"\n },\n {\n \"VerbatimTerm\": \"nephrotic syndrome\",\n \"Probability\": \"0.0101575553\",\n \"SemanticContext\": \"Published studies provide evidence of efficacy and safety in pediatric patients for the treatment of nephrotic syndrome >2 years of age , and aggressive lymphomas and leukemias >1 month of age .\"\n }\n ]\n },\n {\n \"Term\": \"Measles\",\n \"MEDDRACode\": \"10027011\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"measles\",\n \"Probability\": \"1.31754E-05\",\n \"SemanticContext\": \"Persons who are on corticosteroids should be warned to avoid exposure to chickenpox or measles.\"\n },\n {\n \"VerbatimTerm\": \"measles\",\n \"Probability\": \"0.8368965387\",\n \"SemanticContext\": \"\\nViral Infections Chickenpox and measles can have a more serious or even fatal course in pediatric and adult patients on corticosteroids.\"\n },\n {\n \"VerbatimTerm\": \"measles\",\n \"Probability\": \"0.0004200339\",\n \"SemanticContext\": \"If exposed to measles, prophylaxis with immunoglobulin IG may be indicated.\"\n },\n {\n \"VerbatimTerm\": \"measles\",\n \"Probability\": \"1.39059E-05\",\n \"SemanticContext\": \"Persons who are on corticosteroids should be warned to avoid exposure to chickenpox or measles.\"\n }\n ]\n },\n {\n \"Term\": \"Pyrexia\",\n \"MEDDRACode\": \"10037660\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"fever\",\n \"Probability\": \"0.0002241731\",\n \"SemanticContext\": \"Information for Patients Patients should be warned not to discontinue the use of corticosteroids abruptly or without medical supervision, to advise any medical attendants that they are taking corticosteroids and to seek medical advice at once should they develop fever or other signs of infection.\"\n },\n {\n \"VerbatimTerm\": \"fever\",\n \"Probability\": \"0.6035419106\",\n \"SemanticContext\": \"A marked increase in pain accompanied by local swelling, further restriction of joint motion, fever, and malaise are suggestive of septic arthritis.\"\n },\n {\n \"VerbatimTerm\": \"fever\",\n \"Probability\": \"0.0002241731\",\n \"SemanticContext\": \"Information for Patients Patients should be warned not to discontinue the use of corticosteroids abruptly or without medical supervision, to advise any medical attendants that they are taking corticosteroids and to seek medical advice at once should they develop fever or other signs of infection.\"\n }\n ]\n },\n {\n \"Term\": \"Varicella\",\n \"MEDDRACode\": \"10046980\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": true,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"chickenpox\",\n \"Probability\": \"1.87264E-05\",\n \"SemanticContext\": \"Persons who are on corticosteroids should be warned to avoid exposure to chickenpox or measles.\"\n },\n {\n \"VerbatimTerm\": \"chickenpox\",\n \"Probability\": \"0.0142869055\",\n \"SemanticContext\": \"If exposed to chickenpox, prophylaxis with varicella zoster immune globulin VZIG may be indicated.\"\n },\n {\n \"VerbatimTerm\": \"chickenpox\",\n \"Probability\": \"0.0004098415\",\n \"SemanticContext\": \"If chickenpox develops, treatment with antiviral agents should be considered.\"\n },\n {\n \"VerbatimTerm\": \"chickenpox\",\n \"Probability\": \"1.92554E-05\",\n \"SemanticContext\": \"Persons who are on corticosteroids should be warned to avoid exposure to chickenpox or measles.\"\n },\n {\n \"VerbatimTerm\": \"Chickenpox\",\n \"Probability\": \"0.3868080676\",\n \"SemanticContext\": \"\\nViral Infections Chickenpox and measles can have a more serious or even fatal course in pediatric and adult patients on corticosteroids.\"\n }\n ]\n },\n {\n \"Term\": \"Overdose\",\n \"MEDDRACode\": \"10033295\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"acute overdose\",\n \"Probability\": \"0.0699537098\",\n \"SemanticContext\": \"OVERDOSAGE Treatment of acute overdose is by supportive and symptomatic therapy.\"\n }\n ]\n },\n {\n \"Term\": \"Steroid therapy\",\n \"MEDDRACode\": \"10062117\",\n \"Overdose\": true,\n \"Warnings\": false,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"steroid therapy\",\n \"Probability\": \"1.95673E-05\",\n \"SemanticContext\": \"For chronic overdosage in the face of severe disease requiring continuous steroid therapy, the dosage of the corticosteroid may be reduced only temporarily, or alternate day treatment may be introduced.\"\n }\n ]\n },\n {\n \"Term\": \"Adrenal insufficiency\",\n \"MEDDRACode\": \"10001367\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"hypoadrenalism\",\n \"Probability\": \"0.0015194118\",\n \"SemanticContext\": \"Infants born to mothers who have received corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism.\"\n },\n {\n \"VerbatimTerm\": \"hypoadrenalism\",\n \"Probability\": \"0.0004232228\",\n \"SemanticContext\": \"Infants born to mothers who have received corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism.\"\n }\n ]\n },\n {\n \"Term\": \"Cleft palate\",\n \"MEDDRACode\": \"10009269\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"cleft palate\",\n \"Probability\": \"0.107471168\",\n \"SemanticContext\": \"Animal studies in which corticosteroids have been given to pregnant mice, rats, and rabbits have yielded an increased incidence of cleft palate in the offspring.\"\n },\n {\n \"VerbatimTerm\": \"cleft palate\",\n \"Probability\": \"0.107471168\",\n \"SemanticContext\": \"Animal studies in which corticosteroids have been given to pregnant mice, rats, and rabbits have yielded an increased incidence of cleft palate in the offspring.\"\n }\n ]\n },\n {\n \"Term\": \"Pregnancy\",\n \"MEDDRACode\": \"10036556\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": true,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"pregnant\",\n \"Probability\": \"0.0004303157\",\n \"SemanticContext\": \"Animal studies in which corticosteroids have been given to pregnant mice, rats, and rabbits have yielded an increased incidence of cleft palate in the offspring.\"\n },\n {\n \"VerbatimTerm\": \"pregnant\",\n \"Probability\": \"0.0003803372\",\n \"SemanticContext\": \"There are no adequate and well-controlled studies in pregnant women.\"\n },\n {\n \"VerbatimTerm\": \"pregnant\",\n \"Probability\": \"0.0004303157\",\n \"SemanticContext\": \"Animal studies in which corticosteroids have been given to pregnant mice, rats, and rabbits have yielded an increased incidence of cleft palate in the offspring.\"\n },\n {\n \"VerbatimTerm\": \"pregnant\",\n \"Probability\": \"0.0003803372\",\n \"SemanticContext\": \"There are no adequate and well-controlled studies in pregnant women.\"\n }\n ]\n },\n {\n \"Term\": \"Addison's disease\",\n \"MEDDRACode\": \"10001130\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Addison's disease\",\n \"Probability\": \"0.0001981854\",\n \"SemanticContext\": \"Immunization procedures may be undertaken in patients who are receiving corticosteroids as replacement therapy, eg, for Addison's disease.\"\n }\n ]\n },\n {\n \"Term\": \"Amoebiasis\",\n \"MEDDRACode\": \"10001980\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"amebiasis\",\n \"Probability\": \"0.0001121461\",\n \"SemanticContext\": \"It is recommended that latent amebiasis or active amebiasis be ruled out before initiating corticosteroid therapy in any patient who has spent time in the tropics or in any patient with unexplained diarrhea.\"\n },\n {\n \"VerbatimTerm\": \"amebiasis\",\n \"Probability\": \"3.55436E-05\",\n \"SemanticContext\": \"It is recommended that latent amebiasis or active amebiasis be ruled out before initiating corticosteroid therapy in any patient who has spent time in the tropics or in any patient with unexplained diarrhea.\"\n }\n ]\n },\n {\n \"Term\": \"Arthritis bacterial\",\n \"MEDDRACode\": \"10053555\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"septic arthritis\",\n \"Probability\": \"0.0120142698\",\n \"SemanticContext\": \"A marked increase in pain accompanied by local swelling, further restriction of joint motion, fever, and malaise are suggestive of septic arthritis.\"\n }\n ]\n },\n {\n \"Term\": \"Bacterial sepsis\",\n \"MEDDRACode\": \"10053840\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"gram-negative septicemia\",\n \"Probability\": \"0.8683134317\",\n \"SemanticContext\": \"In such patients, corticosteroid-induced immunosuppression may lead to Strongyloides hyperinfection and dissemination with widespread larval migration, often accompanied by severe enterocolitis and potentially fatal gram-negative septicemia.\"\n }\n ]\n },\n {\n \"Term\": \"Blindness cortical\",\n \"MEDDRACode\": \"10005177\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"cortical blindness\",\n \"Probability\": \"0.9183953404\",\n \"SemanticContext\": \"Specific events reported include, but are not limited to, spinal cord infarction, paraplegia, quadriplegia, cortical blindness, and stroke.\"\n }\n ]\n },\n {\n \"Term\": \"Blood calcium\",\n \"MEDDRACode\": \"10005392\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"calcium\",\n \"Probability\": \"0.0001752377\",\n \"SemanticContext\": \"Musculoskeletal Corticosteroids decrease bone formation and increase bone resorption both through their effect on calcium regulation ie, decreasing absorption and increasing excretion and inhibition of osteoblast function.\"\n }\n ]\n },\n {\n \"Term\": \"Blood calcium increased\",\n \"MEDDRACode\": \"10005396\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"increase calcium\",\n \"Probability\": \"0.0015409291\",\n \"SemanticContext\": \"All corticosteroids increase calcium excretion.\"\n }\n ]\n },\n {\n \"Term\": \"Blood creatinine\",\n \"MEDDRACode\": \"10005480\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"creatinine\",\n \"Probability\": \"2.31214E-05\",\n \"SemanticContext\": \"Elevation of creatinine kinase may occur.\"\n }\n ]\n },\n {\n \"Term\": \"Bone formation decreased\",\n \"MEDDRACode\": \"10056809\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"decrease bone formation\",\n \"Probability\": \"0.1900968254\",\n \"SemanticContext\": \"Musculoskeletal Corticosteroids decrease bone formation and increase bone resorption both through their effect on calcium regulation ie, decreasing absorption and increasing excretion and inhibition of osteoblast function.\"\n }\n ]\n },\n {\n \"Term\": \"Cerebral malaria\",\n \"MEDDRACode\": \"10063094\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"cerebral malaria\",\n \"Probability\": \"0.0010203421\",\n \"SemanticContext\": \"Corticosteroids should not be used in cerebral malaria.\"\n }\n ]\n },\n {\n \"Term\": \"Cerebrovascular accident\",\n \"MEDDRACode\": \"10008190\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"stroke\",\n \"Probability\": \"0.9507777691\",\n \"SemanticContext\": \"Specific events reported include, but are not limited to, spinal cord infarction, paraplegia, quadriplegia, cortical blindness, and stroke.\"\n }\n ]\n },\n {\n \"Term\": \"Craniocerebral injury\",\n \"MEDDRACode\": \"10070976\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"traumatic brain injury\",\n \"Probability\": \"0.004729569\",\n \"SemanticContext\": \"High doses of corticosteroids, including Betamethasone Sodium Phosphate and Betamethasone Acetate, should not be used for the treatment of traumatic brain injury.\"\n }\n ]\n },\n {\n \"Term\": \"Diarrhoea\",\n \"MEDDRACode\": \"10012735\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"diarrhea\",\n \"Probability\": \"0.0157217383\",\n \"SemanticContext\": \"It is recommended that latent amebiasis or active amebiasis be ruled out before initiating corticosteroid therapy in any patient who has spent time in the tropics or in any patient with unexplained diarrhea.\"\n }\n ]\n },\n {\n \"Term\": \"Disseminated tuberculosis\",\n \"MEDDRACode\": \"10013453\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"disseminated tuberculosis\",\n \"Probability\": \"0.0014456213\",\n \"SemanticContext\": \"\\nTuberculosis The use of corticosteroids in active tuberculosis should be restricted to those cases of fulminating or disseminated tuberculosis in which the corticosteroid is used for the management of the disease in conjunction with an appropriate antituberculous regimen.\"\n }\n ]\n },\n {\n \"Term\": \"Diverticulitis\",\n \"MEDDRACode\": \"10013538\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"diverticulitis\",\n \"Probability\": \"0.0026333332\",\n \"SemanticContext\": \"Gastrointestinal Steroids should be used with caution in active or latent peptic ulcers, diverticulitis, fresh intestinal anastomoses, and nonspecific ulcerative colitis, since they may increase the risk of a perforation.\"\n }\n ]\n },\n {\n \"Term\": \"Enterobiasis\",\n \"MEDDRACode\": \"10014881\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"threadworm\",\n \"Probability\": \"3.1695E-06\",\n \"SemanticContext\": \"Similarly, corticosteroids should be used with great care in patients with known or suspected Strongyloides threadworm infestation.\"\n }\n ]\n },\n {\n \"Term\": \"Enterocolitis\",\n \"MEDDRACode\": \"10014893\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"enterocolitis\",\n \"Probability\": \"0.9283791184\",\n \"SemanticContext\": \"In such patients, corticosteroid-induced immunosuppression may lead to Strongyloides hyperinfection and dissemination with widespread larval migration, often accompanied by severe enterocolitis and potentially fatal gram-negative septicemia.\"\n }\n ]\n },\n {\n \"Term\": \"Epidural injection\",\n \"MEDDRACode\": \"10072041\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"epidural injection\",\n \"Probability\": \"0.0806579888\",\n \"SemanticContext\": \"Serious Neurologic Adverse Reactions with Epidural Administration Serious neurologic events, some resulting in death, have been reported with epidural injection of corticosteroids.\"\n }\n ]\n },\n {\n \"Term\": \"Fungal infection\",\n \"MEDDRACode\": \"10017533\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Fungal Infections\",\n \"Probability\": \"0.0591728687\",\n \"SemanticContext\": \"\\nFungal Infections Corticosteroids may exacerbate systemic fungal infections and therefore should not be used in the presence of such infections unless they are needed to control drug reactions.\"\n },\n {\n \"VerbatimTerm\": \"fungal infections\",\n \"Probability\": \"0.0039953887\",\n \"SemanticContext\": \"\\nFungal Infections Corticosteroids may exacerbate systemic fungal infections and therefore should not be used in the presence of such infections unless they are needed to control drug reactions.\"\n }\n ]\n },\n {\n \"Term\": \"Gastrointestinal perforation\",\n \"MEDDRACode\": \"10018001\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"gastrointestinal perforation\",\n \"Probability\": \"0.0660684109\",\n \"SemanticContext\": \"Signs of peritoneal irritation following gastrointestinal perforation in patients receiving corticosteroids may be minimal or absent.\"\n }\n ]\n },\n {\n \"Term\": \"Globulin\",\n \"MEDDRACode\": \"10018342\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"globulin\",\n \"Probability\": \"7.3308E-06\",\n \"SemanticContext\": \"If exposed to chickenpox, prophylaxis with varicella zoster immune globulin VZIG may be indicated.\"\n }\n ]\n },\n {\n \"Term\": \"Herpes ophthalmic\",\n \"MEDDRACode\": \"10062004\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"ocular herpes\",\n \"Probability\": \"0.0001932383\",\n \"SemanticContext\": \"Corticosteroids should not be used in active ocular herpes simplex.\"\n }\n ]\n },\n {\n \"Term\": \"Herpes simplex\",\n \"MEDDRACode\": \"10019948\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"herpes simplex\",\n \"Probability\": \"0.0076557696\",\n \"SemanticContext\": \"Corticosteroids should not be used in active ocular herpes simplex.\"\n }\n ]\n },\n {\n \"Term\": \"Immunoglobulins\",\n \"MEDDRACode\": \"10021496\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"immunoglobulin\",\n \"Probability\": \"1.30001E-05\",\n \"SemanticContext\": \"If exposed to measles, prophylaxis with immunoglobulin IG may be indicated.\"\n }\n ]\n },\n {\n \"Term\": \"Immunosuppression\",\n \"MEDDRACode\": \"10062016\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"immunosuppression\",\n \"Probability\": \"0.0673691928\",\n \"SemanticContext\": \"In such patients, corticosteroid-induced immunosuppression may lead to Strongyloides hyperinfection and dissemination with widespread larval migration, often accompanied by severe enterocolitis and potentially fatal gram-negative septicemia.\"\n }\n ]\n },\n {\n \"Term\": \"Infestation\",\n \"MEDDRACode\": \"10061217\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"infestation\",\n \"Probability\": \"1.85043E-05\",\n \"SemanticContext\": \"Similarly, corticosteroids should be used with great care in patients with known or suspected Strongyloides threadworm infestation.\"\n }\n ]\n },\n {\n \"Term\": \"Intestinal anastomosis\",\n \"MEDDRACode\": \"10057146\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"intestinal anastomoses\",\n \"Probability\": \"0.0007113516\",\n \"SemanticContext\": \"Gastrointestinal Steroids should be used with caution in active or latent peptic ulcers, diverticulitis, fresh intestinal anastomoses, and nonspecific ulcerative colitis, since they may increase the risk of a perforation.\"\n }\n ]\n },\n {\n \"Term\": \"Kaposi's sarcoma\",\n \"MEDDRACode\": \"10023284\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Kaposi's sarcoma\",\n \"Probability\": \"0.6447533965\",\n \"SemanticContext\": \"Kaposi's sarcoma has been reported to occur in patients receiving corticosteroid therapy, most often for chronic conditions.\"\n }\n ]\n },\n {\n \"Term\": \"Latent tuberculosis\",\n \"MEDDRACode\": \"10065048\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"latent tuberculosis\",\n \"Probability\": \"9.3484E-06\",\n \"SemanticContext\": \"If corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity, close observation is necessary as reactivation of the disease may occur.\"\n }\n ]\n },\n {\n \"Term\": \"Localised infection\",\n \"MEDDRACode\": \"10024774\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"localize infection\",\n \"Probability\": \"0.0579909086\",\n \"SemanticContext\": \"There may be decreased resistance and inability to localize infection when corticosteroids are used.\"\n }\n ]\n },\n {\n \"Term\": \"Mineral supplementation\",\n \"MEDDRACode\": \"10053963\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"potassium supplementation\",\n \"Probability\": \"7.20068E-05\",\n \"SemanticContext\": \"Dietary salt restriction and potassium supplementation may be necessary.\"\n }\n ]\n },\n {\n \"Term\": \"Neuromuscular blockade\",\n \"MEDDRACode\": \"10029315\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"neuromuscular blocking\",\n \"Probability\": \"2.50523E-05\",\n \"SemanticContext\": \"An acute myopathy has been observed with the use of high doses of corticosteroids, most often occurring in patients with disorders of neuromuscular transmission eg, myasthenia gravis , or in patients receiving concomitant therapy with neuromuscular blocking drugs eg, pancuronium .\"\n }\n ]\n },\n {\n \"Term\": \"Optic neuritis\",\n \"MEDDRACode\": \"10030942\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"optic neuritis\",\n \"Probability\": \"0.0068469644\",\n \"SemanticContext\": \"The use of oral corticosteroids is not recommended in the treatment of optic neuritis and may lead to an increase in the risk of new episodes.\"\n }\n ]\n },\n {\n \"Term\": \"Prophylaxis\",\n \"MEDDRACode\": \"10036898\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"prophylaxis\",\n \"Probability\": \"4.42576E-05\",\n \"SemanticContext\": \"If exposed to chickenpox, prophylaxis with varicella zoster immune globulin VZIG may be indicated.\"\n },\n {\n \"VerbatimTerm\": \"prophylaxis\",\n \"Probability\": \"5.9652E-05\",\n \"SemanticContext\": \"If exposed to measles, prophylaxis with immunoglobulin IG may be indicated.\"\n }\n ]\n },\n {\n \"Term\": \"Psychotic disorder\",\n \"MEDDRACode\": \"10061920\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"psychotic\",\n \"Probability\": \"0.1747502387\",\n \"SemanticContext\": \"Psychic derangements may appear when corticosteroids are used, ranging from euphoria, insomnia, mood swings, personality changes, and severe depression to frank psychotic manifestations.\"\n },\n {\n \"VerbatimTerm\": \"psychotic\",\n \"Probability\": \"0.4338344634\",\n \"SemanticContext\": \"Also, existing emotional instability or psychotic tendencies may be aggravated by corticosteroids.\"\n }\n ]\n },\n {\n \"Term\": \"Quadriparesis\",\n \"MEDDRACode\": \"10049680\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"quadriparesis\",\n \"Probability\": \"0.0258567631\",\n \"SemanticContext\": \"This acute myopathy is generalized, may involve ocular and respiratory muscles, and may result in quadriparesis.\"\n }\n ]\n },\n {\n \"Term\": \"Quadriplegia\",\n \"MEDDRACode\": \"10037714\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"quadriplegia\",\n \"Probability\": \"0.7614523768\",\n \"SemanticContext\": \"Specific events reported include, but are not limited to, spinal cord infarction, paraplegia, quadriplegia, cortical blindness, and stroke.\"\n }\n ]\n },\n {\n \"Term\": \"Renal failure\",\n \"MEDDRACode\": \"10038435\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"renal insufficiency\",\n \"Probability\": \"0.0040278435\",\n \"SemanticContext\": \"Cardio-renal As sodium retention with resultant edema and potassium loss may occur in patients receiving corticosteroids, these agents should be used with caution in patients with congestive heart failure, hypertension, or renal insufficiency.\"\n }\n ]\n },\n {\n \"Term\": \"Resorption bone increased\",\n \"MEDDRACode\": \"10038642\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"increase bone resorption\",\n \"Probability\": \"0.1071431041\",\n \"SemanticContext\": \"Musculoskeletal Corticosteroids decrease bone formation and increase bone resorption both through their effect on calcium regulation ie, decreasing absorption and increasing excretion and inhibition of osteoblast function.\"\n }\n ]\n },\n {\n \"Term\": \"Sepsis\",\n \"MEDDRACode\": \"10040047\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"sepsis\",\n \"Probability\": \"0.0037489235\",\n \"SemanticContext\": \"If this complication occurs and the diagnosis of sepsis is confirmed, appropriate antimicrobial therapy should be instituted.\"\n }\n ]\n },\n {\n \"Term\": \"Shock\",\n \"MEDDRACode\": \"10040560\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"shock\",\n \"Probability\": \"0.9884623289\",\n \"SemanticContext\": \"General Rare instances of anaphylactoid/anaphylactic reactions with a possibility of shock have occurred in patients receiving parenteral corticosteroid therapy see ADVERSE REACTIONS .\"\n }\n ]\n },\n {\n \"Term\": \"Spinal cord infarction\",\n \"MEDDRACode\": \"10058571\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"spinal cord infarction\",\n \"Probability\": \"0.8695024252\",\n \"SemanticContext\": \"Specific events reported include, but are not limited to, spinal cord infarction, paraplegia, quadriplegia, cortical blindness, and stroke.\"\n }\n ]\n },\n {\n \"Term\": \"Swelling\",\n \"MEDDRACode\": \"10042674\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"local swelling\",\n \"Probability\": \"0.1138755977\",\n \"SemanticContext\": \"A marked increase in pain accompanied by local swelling, further restriction of joint motion, fever, and malaise are suggestive of septic arthritis.\"\n }\n ]\n },\n {\n \"Term\": \"Varicella zoster virus infection\",\n \"MEDDRACode\": \"10075611\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"varicella zoster\",\n \"Probability\": \"0.0005417168\",\n \"SemanticContext\": \"If exposed to chickenpox, prophylaxis with varicella zoster immune globulin VZIG may be indicated.\"\n }\n ]\n },\n {\n \"Term\": \"Viral infection\",\n \"MEDDRACode\": \"10047461\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": false,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"Viral Infections\",\n \"Probability\": \"0.0239899755\",\n \"SemanticContext\": \"\\nViral Infections Chickenpox and measles can have a more serious or even fatal course in pediatric and adult patients on corticosteroids.\"\n }\n ]\n },\n {\n \"Term\": \"Elderly\",\n \"MEDDRACode\": \"10014348\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": true\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"elderly\",\n \"Probability\": \"0.0003065467\",\n \"SemanticContext\": \"Geriatric Use No overall differences in safety or effectiveness were observed between elderly subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and young patients, but greater sensitivity of some older individuals cannot be ruled out.\"\n },\n {\n \"VerbatimTerm\": \"elderly\",\n \"Probability\": \"0.0006117523\",\n \"SemanticContext\": \"Geriatric Use No overall differences in safety or effectiveness were observed between elderly subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and young patients, but greater sensitivity of some older individuals cannot be ruled out.\"\n },\n {\n \"VerbatimTerm\": \"elderly\",\n \"Probability\": \"0.0003065467\",\n \"SemanticContext\": \"Geriatric Use No overall differences in safety or effectiveness were observed between elderly subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and young patients, but greater sensitivity of some older individuals cannot be ruled out.\"\n },\n {\n \"VerbatimTerm\": \"elderly\",\n \"Probability\": \"0.0006117523\",\n \"SemanticContext\": \"Geriatric Use No overall differences in safety or effectiveness were observed between elderly subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and young patients, but greater sensitivity of some older individuals cannot be ruled out.\"\n }\n ]\n },\n {\n \"Term\": \"Exercise adequate\",\n \"MEDDRACode\": \"10015636\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": true,\n \"Lactation\": false,\n \"PediatricUse\": false,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"exercised\",\n \"Probability\": \"3.803E-06\",\n \"SemanticContext\": \"Caution should be exercised when corticosteroids are administered to a nursing woman.\"\n },\n {\n \"VerbatimTerm\": \"exercised\",\n \"Probability\": \"1.04144E-05\",\n \"SemanticContext\": \"Caution should be exercised when corticosteroids are administered to a nursing woman.\"\n }\n ]\n },\n {\n \"Term\": \"Blood pressure measurement\",\n \"MEDDRACode\": \"10076581\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"blood pressure\",\n \"Probability\": \"0.0005681515\",\n \"SemanticContext\": \"Cardio-renal Average and large doses of corticosteroids can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium.\"\n },\n {\n \"VerbatimTerm\": \"blood pressure\",\n \"Probability\": \"1.01429E-05\",\n \"SemanticContext\": \"Like adults, pediatric patients should be carefully observed with frequent measurements of blood pressure, weight, height, intraocular pressure, and clinical evaluation for the presence of infection, psychosocial disturbances, thromboembolism, peptic ulcers, cataracts, and osteoporosis.\"\n },\n {\n \"VerbatimTerm\": \"blood pressure\",\n \"Probability\": \"1.01429E-05\",\n \"SemanticContext\": \"Like adults, pediatric patients should be carefully observed with frequent measurements of blood pressure, weight, height, intraocular pressure, and clinical evaluation for the presence of infection, psychosocial disturbances, thromboembolism, peptic ulcers, cataracts, and osteoporosis.\"\n }\n ]\n },\n {\n \"Term\": \"Hyperphenylalaninaemia\",\n \"MEDDRACode\": \"10084106\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"HPA\",\n \"Probability\": \"0.0368575752\",\n \"SemanticContext\": \"Endocrine Corticosteroids can produce reversible hypothalamic pituitary adrenal HPA axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment.\"\n },\n {\n \"VerbatimTerm\": \"HPA\",\n \"Probability\": \"0.0050438046\",\n \"SemanticContext\": \"This negative impact of corticosteroids on growth has been observed at low systemic doses and in the absence of laboratory evidence of HPA axis suppression ie, cosyntropin stimulation and basal cortisol plasma levels .\"\n },\n {\n \"VerbatimTerm\": \"HPA\",\n \"Probability\": \"0.0018695891\",\n \"SemanticContext\": \"Growth velocity may therefore be a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly used tests of HPA axis function.\"\n },\n {\n \"VerbatimTerm\": \"HPA\",\n \"Probability\": \"0.0050438046\",\n \"SemanticContext\": \"This negative impact of corticosteroids on growth has been observed at low systemic doses and in the absence of laboratory evidence of HPA axis suppression ie, cosyntropin stimulation and basal cortisol plasma levels .\"\n },\n {\n \"VerbatimTerm\": \"HPA\",\n \"Probability\": \"0.0018695891\",\n \"SemanticContext\": \"Growth velocity may therefore be a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly used tests of HPA axis function.\"\n }\n ]\n },\n {\n \"Term\": \"Wheezing\",\n \"MEDDRACode\": \"10047924\",\n \"Overdose\": false,\n \"Warnings\": true,\n \"BoxedWarning\": false,\n \"AdverseReactions\": false,\n \"Contraindications\": false,\n \"DrugInteractions\": false,\n \"UseInSpecificPopulations\": {\n \"AnySection\": true,\n \"Pregnancy\": false,\n \"NursingMothers\": false,\n \"Lactation\": false,\n \"PediatricUse\": true,\n \"GeriatricUse\": false\n },\n \"Other\": false,\n \"Blacklisted\": false,\n \"Annotations\": [\n {\n \"VerbatimTerm\": \"wheezing\",\n \"Probability\": \"0.0007653832\",\n \"SemanticContext\": \"Other indications for pediatric use of corticosteroids, eg, severe asthma and wheezing, are based on adequate and well-controlled trials conducted in adults, on the premises that the course of the diseases and their pathophysiology are considered to be substantially similar in both populations.\"\n },\n {\n \"VerbatimTerm\": \"wheezing\",\n \"Probability\": \"0.0007653832\",\n \"SemanticContext\": \"Other indications for pediatric use of corticosteroids, eg, severe asthma and wheezing, are based on adequate and well-controlled trials conducted in adults, on the premises that the course of the diseases and their pathophysiology are considered to be substantially similar in both populations.\"\n }\n ]\n }\n ],\n \"IndicationTerms\": []\n }\n ]\n}"}],"_postman_id":"4ea9b635-f011-439c-88c6-824ef4c36fc4"}],"auth":{"type":"basic","basic":{"basicConfig":[{"key":"username","value":""},{"key":"password","value":""}]}},"event":[{"listen":"prerequest","script":{"id":"864fe197-4f8c-4686-b767-16059bdb88dc","type":"text/javascript","exec":[""]}},{"listen":"test","script":{"id":"a8445ed3-872e-40aa-ad3f-ec26a349bf28","type":"text/javascript","exec":[""]}}],"variable":[{"key":"uniquelabelid","value":"US3f5d8caf-a587-4c9f-85a7-f74935acc991"}]}