TOLVAPTAN

N/A

Manufactured by Otsuka America Pharmaceutical, Inc.

24,584 FDA adverse event reports analyzed

Last updated: 2026-04-14

About TOLVAPTAN

TOLVAPTAN is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Otsuka America Pharmaceutical, Inc.. The most commonly reported adverse reactions for TOLVAPTAN include DEATH, OFF LABEL USE, RENAL IMPAIRMENT, CARDIAC FAILURE, THIRST. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for TOLVAPTAN.

Top Adverse Reactions

DEATH973 reports
OFF LABEL USE814 reports
RENAL IMPAIRMENT804 reports
CARDIAC FAILURE785 reports
THIRST775 reports
PRODUCT DOSE OMISSION ISSUE522 reports
PRODUCT USE IN UNAPPROVED INDICATION487 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS480 reports
UNDERDOSE477 reports
DEHYDRATION449 reports
BLOOD CREATININE INCREASED422 reports
POLYURIA419 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION408 reports
NAUSEA400 reports
DIARRHOEA376 reports
POLLAKIURIA376 reports
PNEUMONIA366 reports
BLOOD SODIUM DECREASED360 reports
HYPERNATRAEMIA359 reports
HEPATIC FUNCTION ABNORMAL346 reports
FATIGUE345 reports
NO ADVERSE EVENT338 reports
PRODUCT USE ISSUE332 reports
DYSPNOEA320 reports
HYPONATRAEMIA304 reports
DECREASED APPETITE303 reports
DIZZINESS297 reports
BLOOD UREA INCREASED289 reports
MALAISE282 reports
HEADACHE274 reports
PYREXIA273 reports
ACUTE KIDNEY INJURY272 reports
ALANINE AMINOTRANSFERASE INCREASED261 reports
GLOMERULAR FILTRATION RATE DECREASED261 reports
NOCTURIA249 reports
ANAEMIA248 reports
VOMITING246 reports
DRUG INEFFECTIVE234 reports
HYPOTENSION233 reports
CONDITION AGGRAVATED225 reports
ASPARTATE AMINOTRANSFERASE INCREASED221 reports
PLATELET COUNT DECREASED213 reports
DIALYSIS204 reports
RAPID CORRECTION OF HYPONATRAEMIA203 reports
POLYDIPSIA200 reports
BLOOD PRESSURE DECREASED197 reports
INCORRECT DRUG ADMINISTRATION DURATION196 reports
HOSPITALISATION186 reports
RENAL FAILURE182 reports
HYPERKALAEMIA181 reports
CONSTIPATION177 reports
INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION176 reports
FALL175 reports
WEIGHT DECREASED173 reports
CARDIAC FAILURE CONGESTIVE172 reports
PLEURAL EFFUSION171 reports
ASTHENIA169 reports
URINARY TRACT INFECTION166 reports
WEIGHT INCREASED166 reports
OEDEMA PERIPHERAL160 reports
LIVER DISORDER159 reports
BLOOD SODIUM INCREASED158 reports
DRY MOUTH158 reports
SEPSIS157 reports
CARDIAC FAILURE CHRONIC156 reports
HAEMOGLOBIN DECREASED150 reports
INCORRECT PRODUCT ADMINISTRATION DURATION148 reports
PRURITUS146 reports
OEDEMA145 reports
ATRIAL FIBRILLATION136 reports
ABDOMINAL PAIN135 reports
HEPATIC ENZYME INCREASED135 reports
HEPATIC ENCEPHALOPATHY134 reports
ASCITES130 reports
PULMONARY ARTERIAL HYPERTENSION128 reports
HYPERTENSION123 reports
HYPOKALAEMIA122 reports
INCORRECT DOSE ADMINISTERED121 reports
CEREBRAL INFARCTION120 reports
THERAPY CESSATION120 reports
LIVER INJURY119 reports
SYNCOPE119 reports
INSOMNIA118 reports
ALTERED STATE OF CONSCIOUSNESS117 reports
DRUG INTERACTION116 reports
ABDOMINAL DISTENSION114 reports
HEPATIC FAILURE113 reports
BLOOD GLUCOSE INCREASED108 reports
BACK PAIN107 reports
COUGH106 reports
THERAPY INTERRUPTED106 reports
RESPIRATORY FAILURE105 reports
RIGHT VENTRICULAR FAILURE105 reports
RASH102 reports
BLOOD POTASSIUM INCREASED98 reports
GASTROINTESTINAL HAEMORRHAGE98 reports
RENAL DISORDER96 reports
GENERAL PHYSICAL HEALTH DETERIORATION95 reports
PULMONARY HYPERTENSION95 reports
ABDOMINAL PAIN UPPER94 reports

Report Outcomes

Out of 13,151 classified reports for TOLVAPTAN:

Serious 83.6%Non-Serious 16.4%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Male5,544 (49.9%)
Female5,471 (49.3%)
Unknown87 (0.8%)

Reports by Age

Age 60196 reports
Age 61187 reports
Age 73181 reports
Age 75180 reports
Age 77180 reports
Age 64177 reports
Age 85176 reports
Age 76171 reports
Age 84168 reports
Age 70166 reports
Age 74165 reports
Age 78164 reports
Age 80164 reports
Age 50163 reports
Age 62163 reports
Age 67163 reports
Age 69163 reports
Age 58162 reports
Age 56160 reports
Age 83160 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with TOLVAPTAN?

This profile reflects 24,584 FDA FAERS reports that mention TOLVAPTAN. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for TOLVAPTAN?

Frequently reported terms in FAERS include DEATH, OFF LABEL USE, RENAL IMPAIRMENT, CARDIAC FAILURE, THIRST, PRODUCT DOSE OMISSION ISSUE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures TOLVAPTAN?

Labeling and FAERS entries often list Otsuka America Pharmaceutical, Inc. in connection with TOLVAPTAN. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.