Drug information for SAMSCA

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
TABLET; ORAL 15MG Prescription   TOLVAPTAN tolvaptan OTSUKA AMERICA PHARM 22275
2012-02-03 Letter
2012-02-02 Label
2011-09-28 Letter
2010-12-02 Medication Guide
2009-12-18 Other
2009-07-21 Review
2009-07-21 Summary Review
2009-05-27 Letter
2009-05-25 Label
TABLET; ORAL 30MG Prescription  (Reference Drug) TOLVAPTAN tolvaptan OTSUKA AMERICA PHARM   "
TABLET; ORAL 60MG Discontinued   TOLVAPTAN tolvaptan OTSUKA AMERICA PHARM   "

Drug Adverse Effects information for SAMSCA

Role code Indications Reaction # Reports
PS CARDIAC FAILURE ABDOMINAL DISTENSION 1
PS CARDIAC FAILURE ALTERED STATE OF CONSCIOUSNESS 1
PS CARDIAC FAILURE ARTHRALGIA 1
PS CARDIAC FAILURE ATRIAL FLUTTER 1
PS CARDIAC FAILURE BLOOD CREATINE INCREASED 1
PS CARDIAC FAILURE BLOOD CREATININE INCREASED 1
PS CARDIAC FAILURE BLOOD PRESSURE DECREASED 2
PS CARDIAC FAILURE BLOOD UREA INCREASED 2
PS CARDIAC FAILURE CARDIAC FAILURE 4
PS CARDIAC FAILURE CARDIAC FAILURE ACUTE 1
PS CARDIAC FAILURE CONDITION AGGRAVATED 2
PS CARDIAC FAILURE DECREASED APPETITE 1
PS CARDIAC FAILURE DEPRESSED LEVEL OF CONSCIOUSNESS 2
PS CARDIAC FAILURE DEPRESSION 1
PS CARDIAC FAILURE DIZZINESS 1
PS CARDIAC FAILURE EXCORIATION 1
PS CARDIAC FAILURE EYE DISORDER 1
PS CARDIAC FAILURE FALL 1
PS CARDIAC FAILURE FATIGUE 1
PS CARDIAC FAILURE HYPERNATRAEMIA 6
PS CARDIAC FAILURE HYPOKALAEMIA 1
PS CARDIAC FAILURE HYPOVOLAEMIA 2
PS CARDIAC FAILURE JAUNDICE 1
PS CARDIAC FAILURE JOINT STIFFNESS 1
PS CARDIAC FAILURE MUSCULAR WEAKNESS 1
PS CARDIAC FAILURE MUSCULOSKELETAL STIFFNESS 1
PS CARDIAC FAILURE OSMOTIC DEMYELINATION SYNDROME 3
PS CARDIAC FAILURE PANCYTOPENIA 1
PS CARDIAC FAILURE THIRST 4
PS CARDIAC FAILURE URINE OUTPUT INCREASED 1
PS CARDIAC FAILURE VENTRICULAR FIBRILLATION 1
PS CARDIAC FAILURE VENTRICULAR TACHYCARDIA 2
PS CARDIAC FAILURE ACUTE BLOOD UREA INCREASED 1
PS CARDIAC FAILURE ACUTE HYPERNATRAEMIA 1
PS CARDIAC FAILURE CHRONIC ALANINE AMINOTRANSFERASE INCREASED 1
PS CARDIAC FAILURE CHRONIC ASPARTATE AMINOTRANSFERASE INCREASED 1
PS CARDIAC FAILURE CHRONIC BLOOD BILIRUBIN INCREASED 1
PS CARDIAC FAILURE CHRONIC BLOOD POTASSIUM DECREASED 1
PS CARDIAC FAILURE CHRONIC BLOOD SODIUM INCREASED 1
PS CARDIAC FAILURE CHRONIC CARDIAC FAILURE 1
PS CARDIAC FAILURE CHRONIC CONDITION AGGRAVATED 1
PS CARDIAC FAILURE CHRONIC HEPATIC FUNCTION ABNORMAL 1
PS CARDIAC FAILURE CHRONIC SUDDEN CARDIAC DEATH 1
PS CARDIAC FAILURE CHRONIC VENTRICULAR FIBRILLATION 2
PS CARDIAC FAILURE CHRONIC WHITE BLOOD CELL COUNT DECREASED 2
PS CHEMOTHERAPY DEHYDRATION 2
PS CHEMOTHERAPY DISEASE RECURRENCE 2
PS CHEMOTHERAPY DRUG INEFFECTIVE 2
PS CHEMOTHERAPY HYPOKALAEMIA 1
PS CHEMOTHERAPY HYPONATRAEMIA 2
PS CHEMOTHERAPY HYPOPHAGIA 2
PS CHEMOTHERAPY NEUTROPENIC SEPSIS 2
PS CHEMOTHERAPY NEUTROPHIL COUNT INCREASED 1
PS CHEMOTHERAPY PANCYTOPENIA 2
PS CHEMOTHERAPY VOMITING 2
PS CHEMOTHERAPY WHITE BLOOD CELL COUNT INCREASED 1
PS CONGENITAL CYSTIC KIDNEY DISEASE ABDOMINAL DISTENSION 1
PS CONGENITAL CYSTIC KIDNEY DISEASE ALANINE AMINOTRANSFERASE INCREASED 3
PS CONGENITAL CYSTIC KIDNEY DISEASE ASPARTATE AMINOTRANSFERASE INCREASED 3
PS CONGENITAL CYSTIC KIDNEY DISEASE BLOOD BILIRUBIN INCREASED 1
PS CONGENITAL CYSTIC KIDNEY DISEASE DECREASED APPETITE 1
PS CONGENITAL CYSTIC KIDNEY DISEASE GALLBLADDER OEDEMA 1
PS CONGENITAL CYSTIC KIDNEY DISEASE HEPATOTOXICITY 1
PS CONGENITAL CYSTIC KIDNEY DISEASE LIVER DISORDER 1
PS CONGENITAL CYSTIC KIDNEY DISEASE LIVER FUNCTION TEST ABNORMAL 1
PS CONGENITAL CYSTIC KIDNEY DISEASE PRURITUS GENERALISED 1
PS CONGENITAL CYSTIC KIDNEY DISEASE UMBILICAL HERNIA 1
PS CONGESTIVE CARDIOMYOPATHY BLOOD PRESSURE DECREASED 1
PS CONGESTIVE CARDIOMYOPATHY HYPOKALAEMIA 2
PS CONGESTIVE CARDIOMYOPATHY URINE OUTPUT INCREASED 1
PS CONGESTIVE CARDIOMYOPATHY VENTRICULAR TACHYCARDIA 2
PS DIURETIC THERAPY INTERSTITIAL LUNG DISEASE 2
PS DIURETIC THERAPY PULMONARY ALVEOLAR HAEMORRHAGE 1
PS FLUID RETENTION ASPARTATE AMINOTRANSFERASE INCREASED 2
PS FLUID RETENTION BLOOD PRESSURE DECREASED 1
PS FLUID RETENTION BLOOD UREA INCREASED 2
PS FLUID RETENTION BRADYCARDIA 1
PS FLUID RETENTION BURNING SENSATION 1
PS FLUID RETENTION CARDIAC ARREST 1
PS FLUID RETENTION CARDIAC FAILURE 1
PS FLUID RETENTION CONDITION AGGRAVATED 1
PS FLUID RETENTION FLUID RETENTION 1
PS FLUID RETENTION HYPERKALAEMIA 1
PS FLUID RETENTION HYPERNATRAEMIA 4
PS FLUID RETENTION HYPONATRAEMIA 1
PS FLUID RETENTION RENAL FAILURE ACUTE 1
PS FLUID RETENTION RESPIRATORY ARREST 1
PS FLUID RETENTION THIRST 4
PS FLUID RETENTION VENTRICULAR TACHYCARDIA 1
PS HYPONATRAEMIA ABDOMINAL PAIN UPPER 2
PS HYPONATRAEMIA ALANINE AMINOTRANSFERASE INCREASED 1
PS HYPONATRAEMIA ALKALOSIS HYPOKALAEMIC 2
PS HYPONATRAEMIA ASPARTATE AMINOTRANSFERASE INCREASED 1
PS HYPONATRAEMIA ASPIRATION 2
PS HYPONATRAEMIA AUTOIMMUNE DISORDER 1
PS HYPONATRAEMIA BRADYPHRENIA 3
PS HYPONATRAEMIA CARDIAC FAILURE ACUTE 2
PS HYPONATRAEMIA CHRONIC OBSTRUCTIVE PULMONARY DISEASE 1
PS HYPONATRAEMIA CONDITION AGGRAVATED 2
PS HYPONATRAEMIA CONFUSIONAL STATE 1
PS HYPONATRAEMIA CONVULSION 1
PS HYPONATRAEMIA CYSTITIS 2
PS HYPONATRAEMIA DEHYDRATION 3
PS HYPONATRAEMIA DEMYELINATION 3
PS HYPONATRAEMIA DISEASE RECURRENCE 2
PS HYPONATRAEMIA DRUG INEFFECTIVE 4
PS HYPONATRAEMIA DYSARTHRIA 2
PS HYPONATRAEMIA DYSPNOEA 1
PS HYPONATRAEMIA ENCEPHALOPATHY 1
PS HYPONATRAEMIA GENERAL PHYSICAL HEALTH DETERIORATION 2
PS HYPONATRAEMIA HAEMATEMESIS 2
PS HYPONATRAEMIA HEPATIC CONGESTION 2
PS HYPONATRAEMIA HYPERBILIRUBINAEMIA 2
PS HYPONATRAEMIA HYPERNATRAEMIA 3
PS HYPONATRAEMIA HYPOKALAEMIA 1
PS HYPONATRAEMIA HYPONATRAEMIA 4
PS HYPONATRAEMIA HYPONATRAEMIC ENCEPHALOPATHY 5
PS HYPONATRAEMIA HYPOPHAGIA 2
PS HYPONATRAEMIA INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION 1
PS HYPONATRAEMIA INCORRECT DRUG ADMINISTRATION DURATION 1
PS HYPONATRAEMIA INCORRECT DRUG ADMINISTRATION RATE 3
PS HYPONATRAEMIA INFECTION 1
PS HYPONATRAEMIA LETHARGY 1
PS HYPONATRAEMIA LEUKOCYTOSIS 2
PS HYPONATRAEMIA LIVER DISORDER 1
PS HYPONATRAEMIA MALAISE 2
PS HYPONATRAEMIA MALLORY-WEISS SYNDROME 2
PS HYPONATRAEMIA MENTAL IMPAIRMENT 2
PS HYPONATRAEMIA MYOCARDIAL INFARCTION 1
PS HYPONATRAEMIA NEOPLASM 1
PS HYPONATRAEMIA NEPHROTIC SYNDROME 1
PS HYPONATRAEMIA NERVOUS SYSTEM DISORDER 2
PS HYPONATRAEMIA NEUTROPENIC SEPSIS 2
PS HYPONATRAEMIA NEUTROPHIL COUNT INCREASED 1
PS HYPONATRAEMIA OSMOTIC DEMYELINATION SYNDROME 2
PS HYPONATRAEMIA PANCYTOPENIA 2
PS HYPONATRAEMIA PARAESTHESIA 2
PS HYPONATRAEMIA PLEURAL EFFUSION 2
PS HYPONATRAEMIA PNEUMONIA 2
PS HYPONATRAEMIA POLYURIA 8
PS HYPONATRAEMIA PYREXIA 2
PS HYPONATRAEMIA RAPID CORRECTION OF HYPONATRAEMIA 11
PS HYPONATRAEMIA RESPIRATORY FAILURE 2
PS HYPONATRAEMIA SARCOIDOSIS 1
PS HYPONATRAEMIA SEPSIS 1
PS HYPONATRAEMIA THERAPY REGIMEN CHANGED 1
PS HYPONATRAEMIA URINARY TRACT INFECTION 1
PS HYPONATRAEMIA VASCULITIS 1
PS HYPONATRAEMIA VOMITING 9
PS HYPONATRAEMIA WHITE BLOOD CELL COUNT INCREASED 1
PS HYPONATRAEMIA WRONG TECHNIQUE IN DRUG USAGE PROCESS 9
PS INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION ABDOMINAL PAIN 1
PS INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION ABDOMINAL PAIN UPPER 2
PS INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION ALKALOSIS HYPOKALAEMIC 2
PS INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION ASPIRATION 2
PS INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION AUTOIMMUNE DISORDER 1
PS INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION BLOOD SODIUM DECREASED 1
PS INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION BRADYPHRENIA 3
PS INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION BRONCHIAL CARCINOMA 2
PS INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION CARDIAC FAILURE ACUTE 2
PS INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION CHILLS 2
PS INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION CHRONIC OBSTRUCTIVE PULMONARY DISEASE 2
PS INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION CONDITION AGGRAVATED 1
PS INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION CYSTITIS 2
PS INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION DEHYDRATION 3
PS INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION DELIRIUM TREMENS 2
PS INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION DEMYELINATION 3
PS INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION DISEASE PROGRESSION 1
PS INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION DISEASE RECURRENCE 2
PS INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION DISTURBANCE IN ATTENTION 2
PS INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION DRUG INEFFECTIVE 3
PS INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION DYSARTHRIA 2
PS INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION DYSKINESIA 2
PS INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION DYSPHAGIA 2
PS INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION DYSPNOEA 1
PS INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION ENCEPHALITIS 1
PS INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION ENCEPHALOPATHY 1
PS INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION FALL 1
PS INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION GENERAL PHYSICAL HEALTH DETERIORATION 2
PS INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION HAEMATEMESIS 2
PS INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION HEPATIC CONGESTION 2
PS INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION HYPERBILIRUBINAEMIA 2
PS INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION HYPERNATRAEMIA 2
PS INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION HYPERTENSION 1
PS INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION HYPOKALAEMIA 1
PS INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION HYPONATRAEMIA 3
PS INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION HYPONATRAEMIC ENCEPHALOPATHY 3
PS INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION HYPOPHAGIA 2
PS INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION 1
PS INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION INCORRECT DRUG ADMINISTRATION RATE 2
PS INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION INSOMNIA 1
PS INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION LETHARGY 3
PS INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION LEUKOCYTOSIS 2
PS INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION MALLORY-WEISS SYNDROME 2
PS INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION MENTAL IMPAIRMENT 2
PS INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION MOOD ALTERED 2
PS INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION MUTISM 2
PS INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION NAUSEA 2
PS INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION NEOPLASM 1
PS INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION NEOPLASM MALIGNANT 1
PS INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION NEPHROGENIC DIABETES INSIPIDUS 1
PS INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION NEPHROPATHY 1
PS INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION NEPHROTIC SYNDROME 1
PS INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION NERVOUS SYSTEM DISORDER 1
PS INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION NEUTROPENIC SEPSIS 2
PS INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION NEUTROPHIL COUNT INCREASED 1
PS INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION OVERDOSE 1
PS INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION PANCYTOPENIA 2
PS INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION PLEURAL EFFUSION 2
PS INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION PNEUMONIA 3
PS INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION POLYURIA 3
PS INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION PYREXIA 2
PS INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION QUADRIPARESIS 2
PS INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION RAPID CORRECTION OF HYPONATRAEMIA 5
PS INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION RENAL FAILURE ACUTE 1
PS INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION RESPIRATORY FAILURE 2
PS INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION SARCOIDOSIS 1
PS INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION SEPSIS 1
PS INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION SOMNOLENCE 3
PS INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION STUPOR 2
PS INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION URINARY TRACT INFECTION 1
PS INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION VASCULITIS 1
PS INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION VENTRICULAR TACHYCARDIA 2
PS INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION VERTIGO 2
PS INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION VISUAL FIELD DEFECT 1
PS INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION VOMITING 9
PS INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION WHITE BLOOD CELL COUNT INCREASED 1
PS INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION WRONG TECHNIQUE IN DRUG USAGE PROCESS 9
PS NEOPLASM DEHYDRATION 1
PS NEOPLASM DISEASE RECURRENCE 1
PS NEOPLASM DRUG INEFFECTIVE 1
PS NEOPLASM HYPONATRAEMIA 1
PS NEOPLASM HYPOPHAGIA 1
PS NEOPLASM NEUTROPENIC SEPSIS 1
PS NEOPLASM NEUTROPHIL COUNT INCREASED 1
PS NEOPLASM PANCYTOPENIA 1
PS NEOPLASM VOMITING 1
PS NEOPLASM WHITE BLOOD CELL COUNT INCREASED 1
PS OFF LABEL USE WRONG TECHNIQUE IN DRUG USAGE PROCESS 1
PS PNEUMONIA INTERSTITIAL LUNG DISEASE 1
PS PNEUMONIA PULMONARY ALVEOLAR HAEMORRHAGE 1
PS POLYURIA BLOOD UREA INCREASED 1
PS POLYURIA INTERSTITIAL LUNG DISEASE 1
PS POLYURIA PULMONARY ALVEOLAR HAEMORRHAGE 1
PS RENAL FAILURE ABDOMINAL DISTENSION 1
PS RENAL FAILURE ARTHRALGIA 1
PS RENAL FAILURE DIZZINESS 1
PS RENAL FAILURE EXCORIATION 1
PS RENAL FAILURE EYE DISORDER 1
PS RENAL FAILURE FALL 1
PS RENAL FAILURE FATIGUE 1
PS RENAL FAILURE JOINT STIFFNESS 1
PS RENAL FAILURE MUSCULAR WEAKNESS 1
PS RENAL FAILURE MUSCULOSKELETAL STIFFNESS 1
PS THROMBOSIS PROPHYLAXIS INTERSTITIAL LUNG DISEASE 1
PS THROMBOSIS PROPHYLAXIS PULMONARY ALVEOLAR HAEMORRHAGE 1
SS INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION CHILLS 2
SS INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION DELIRIUM TREMENS 2
SS INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION DISTURBANCE IN ATTENTION 2
SS INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION DYSARTHRIA 2
SS INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION DYSKINESIA 2
SS INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION DYSPHAGIA 2
SS INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION LETHARGY 2
SS INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION MOOD ALTERED 2
SS INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION MUTISM 2
SS INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION NAUSEA 2
SS INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION QUADRIPARESIS 2
SS INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION SOMNOLENCE 2
SS INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION STUPOR 2
SS INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION VERTIGO 2
SS INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION VOMITING 2
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