Drugs › Vasopressin V2 receptor antagonist
Generic name
Tolvaptan: adverse event reports filed with FDA
6,907 reports list it as a suspect or interacting product, 2011–2026. Class: Vasopressin V2 receptor antagonist. Also reported as Tolvaptan 30mg, Tolvaptan Tablet, Tolvaptan Tablets.
- 6,907
- reports as suspect product
- 0% of all reports · about 455 a year
- 2,232
- reports, 12 months to June 2026
- 971 in the 12 months before
- 75.1%
- marked serious by the reporter
- 76.5% across the class
- 15.8%
- record death among outcomes, as reported
- 1,089 reports · not verified by FDA
6,907 adverse event reports received by FDA list tolvaptan, a generic name as a suspect or interacting product, from May 2011 to June 2026. A further 1,176 reports list it only as a concomitant medication, and those are not counted in the figures on this page.
In the 12 months to June 2026, 2,232 reports listed it, up 130% from 971 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 455 reports a year and 0% of the 20,646,523 reports in the database, and 60% of the reports for the vasopressin V2 receptor antagonist class. How many people take it is not in the data, so a count is not a rate of occurrence.
The MedDRA terms listed most often are thirst (11.8%), product dose omission issue (10%) and death (7.7%). A report can list several reactions, so shares add to more than 100%; 769 different terms appear across these reports. Thirst is recorded in 11.8% of these reports, a larger share than in the median vasopressin V2 receptor antagonist drug (7.3%).
75.1% of the reports are marked serious by the reporter (76.5% across the class); 15.8% record death among the outcomes and 23.8% record hospitalisation, as reported. 43.8% of the reports came from consumers, and the largest patient age group is 45 to 64 (28.6%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
Reports by month, five years
Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.
By year received
2026 covers reports received through June 2026 only.
Reactions recorded in the reports
share of Tolvaptan reports recording the termmedian drug in vasopressin v2 receptor antagonist
- Thirst11.8%817
- Product dose omission issuea dose was missed10%692
- Deaththe patient died; cause not stated by this term7.7%532
- Pollakiuriapassing urine more often7.3%505
- Renal impairmentreduced kidney function6%412
- Polyuria5.6%388
- No adverse eventno adverse event was reported5.5%381
- Wrong technique in product usage processthe product was used in the wrong way5.4%373
- Fatiguetiredness5.1%351
- Inappropriate schedule of product administrationthe product was taken at the wrong times4.9%337
- Underdoseless than the intended dose4.9%336
- Product use in unapproved indicationused for a purpose not on the label4.4%302
- Blood creatinine increasedraised creatinine, a kidney test4.2%288
- Nauseafeeling sick3.8%262
- Nocturia3.8%260
- Product use issuea problem in how the product was used3.5%241
- Alanine aminotransferase increasedraised liver enzyme (ALT)3.2%219
- Dehydrationdehydration3.2%219
- Dizzinesslight-headedness or unsteadiness3.2%219
- Glomerular filtration rate decreasedreduced kidney filtering3%205
- Headachehead pain3%204
- Dry mouthdry mouth2.9%199
- Dialysisdialysis2.9%197
- Polydipsia2.8%193
- Vomitingbeing sick2.5%175
- Aspartate aminotransferase increasedraised liver enzyme (AST)2.5%173
- Diarrhoealoose or frequent stools2.4%168
- Decreased appetitereduced appetite2.4%163
- Off label useused for a purpose or in a way not on the label2.1%146
- Blood sodium decreased2.1%144
Top 30 of 769 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 2 drugs in the vasopressin v2 receptor antagonist class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Outcomes recorded
Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 11,505 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."
Patients and reporters
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 60.8% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Congenital cystic kidney disease | 3,811 | 55.2% |
| Hyponatraemia | 321 | 4.6% |
| Inappropriate antidiuretic hormone secretion | 133 | 1.9% |
| Cardiac failure | 113 | 1.6% |
| Fluid retention | 109 | 1.6% |
| Blood osmolarity decreased | 90 | 1.3% |
The indication field is filled in by the reporter and is often blank; shares are of all 6,907 reports.
Drugs most often listed in the same reports
| Drug (any role in the report) | Reports | Share of Tolvaptan reports |
|---|---|---|
| Furosemide | 386 | 5.6% |
| Amlodipine | 372 | 5.4% |
| Lisinopril | 340 | 4.9% |
| Spironolactone | 212 | 3.1% |
| Atorvastatin | 185 | 2.7% |
| Allopurinol | 159 | 2.3% |
| Aspirin | 142 | 2.1% |
| Ergocalciferol | 140 | 2% |
| Losartan | 136 | 2% |
| Carvedilol | 109 | 1.6% |
Other products listed in reports where Tolvaptan is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.
In context
| Measure | Tolvaptan | Vasopressin V2 receptor antagonist | All reports |
|---|---|---|---|
| Reports as suspect product | 6,907 | 11,505 | 20,646,523 |
| Share of that pool | — | 60% | 0% |
| Reports, latest 12 months | 2,232 | — | 1,332,454 |
| Marked serious | 75.1% | 76.5% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 158 | 188 | 91 |
| Hospitalisation recorded, per 1,000 reports | 238 | 252 | 213 |
| Consumer-filed share | 43.8% | 31.2% | 45.8% |
| Top term, share of reports | Thirst 11.8% | median 7.3% | 0.1% |
Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Other drugs in the vasopressin v2 receptor antagonist class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Samsca | brand | 4,598 | 41 | 78.6% |
Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.
Questions about Tolvaptan reports
How many adverse event reports has FDA received for Tolvaptan?
6,907 reports list Tolvaptan as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 2,232 of them arrived in the latest 12 months. Another 1,176 list it only as a concomitant medication.
What reactions are recorded in Tolvaptan reports?
thirst (11.8%), product dose omission issue (10%), death (7.7%), pollakiuria (7.3%) and renal impairment (6%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Tolvaptan was responsible.
How serious are the reports?
75.1% are marked serious by the reporter. Among the outcomes recorded, 15.8% of reports include death and 23.8% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
consumer or non-health professional (43.8%), physician (28.9%) and other health professional (17.6%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Tolvaptan rising?
2,232 reports in the 12 months to June 2026, up 130% from 971 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Tolvaptan was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Tolvaptan?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Tolvaptan as a suspect or interacting product; reports listing it only as a concomitant medication (1,176) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.