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Tolvaptan Side Effects

The most commonly reported side effects of tolvaptan include death, off label use, and renal impairment, based on 13,491 FDA adverse event reports from 2005 to 2025.

Tolvaptan side effects

Percentages show how often each reaction appears relative to total reports for tolvaptan.

1
Death7.2%968
2
Off Label Use6.0%810
3
Renal Impairment5.9%794
4
Cardiac Failure5.7%770
5
Thirst5.6%761
6
Product Dose Omission Issue3.9%523
7
Product Use In Unapproved Indication3.6%488
8
Wrong Technique In Product Usage Process3.6%480
9
Underdose3.5%478
10
Dehydration3.2%433
11
Blood Creatinine Increased3.1%416
12
Polyuria3.0%409
13
Inappropriate Schedule Of Product Administration3.0%408
14
Nausea2.9%396
15
Diarrhoea2.8%377

These are voluntary reports and do not establish that tolvaptan caused these reactions.

Report severity

83.2%Serious11,219 reports
33.7%Hospitalizations4,543 reports
22.9%Fatal3,094 reports

Seriousness is determined by the reporter, not by OpenClaim.

Tolvaptan drug interactions

Other drugs that appear in adverse event reports alongside tolvaptan. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Furosemide4.2%565
2
Valsartan3.1%421
3
Sacubitril2.9%387
4
Selexipag2.5%340
5
Spironolactone2.4%322
6
Macitentan2.0%269
7
Tadalafil1.2%166
8
Treprostinil0.8%112
9
Dapagliflozin0.8%109
10
Amlodipine0.8%102
11
Apixaban0.7%98
12
Tafamidis0.7%91
13
Warfarin0.6%77
14
Prednisolone0.5%69
15
Epoprostenol-sodium0.5%62

Taken alongside

1
Furosemide20.3%2,741
2
Spironolactone13.8%1,862
3
Amlodipine6.5%875
4
Aspirin6.0%809
5
Bisoprolol-fumarate4.9%663
6
Carvedilol4.6%616
7
Warfarin4.5%612
8
Atorvastatin-calcium4.0%540
9
Esomeprazole3.7%504
10
Lansoprazole3.6%487
11
Febuxostat3.3%440
12
Rosuvastatin3.0%409
13
Acetaminophen2.9%396
14
Levothyroxine-sodium2.9%392
15
Lisinopril2.7%365

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports tolvaptan side effects

41.2% of tolvaptan adverse event reports involve female patients and 42.1% involve male patients. The largest age group is elderly at 50%. These figures reflect who reports side effects, not underlying risk.

Sex

Female41.2%
Male42.1%
Unknown16.7%

Age group

< 20.4%
2–110.6%
12–170.4%
18–6448.2%
65+50.4%

What is tolvaptan used for

Conditions and purposes for which patients were taking tolvaptan when the adverse event was reported.

Abdominal DiscomfortAccidental Exposure To ProductAcid Base BalanceAcidosisAcute Kidney InjuryAcute Myeloid LeukaemiaAdverse EventAlcoholic Liver DiseaseAnaemiaAngina PectorisAnuriaAortic DilatationAortic Valve IncompetenceAortic Valve StenosisArrhythmia

Showing 15 of 423 indications

Tolvaptan brand names and reporting trend

Tolvaptan is sold under the brand name Tolvaptan.

Brand names

Tolvaptan15,896

Quarterly reports (20052025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking tolvaptan with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.