Valsartan: adverse event reports filed with FDA

16,935

reports as suspect product

0.1% of all reports · about 753 a year

923

reports, 12 months to June 2026

1,163 in the 12 months before

83.8%

marked serious by the reporter

67.6% across the class

7%

record death among outcomes, as reported

1,192 reports · not verified by FDA

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 Valsartan reports recording the termmedian drug in angiotensin 2 receptor blocker

1. Drug ineffectivethe medicine did not work as expected8.4%1,418
2. Acute kidney injurysudden loss of kidney function7.6%1,289
3. Dizzinesslight-headedness or unsteadiness7.1%1,203
4. Headachehead pain6.4%1,076
5. Dyspnoeashortness of breath5.7%959
6. Hypotensionlow blood pressure5.5%934
7. Hypertensionhigh blood pressure5.3%906
8. Blood pressure increaseda raised blood pressure reading5.1%871
9. Fatiguetiredness5.1%859
10. Drug interactionan interaction between medicines5%845
11. Nauseafeeling sick4.7%789
12. Diarrhoealoose or frequent stools4.4%751
13. Malaisegeneral feeling of being unwell4.2%707
14. Coughcough3.9%665
15. Weight decreasedweight loss3.6%606
16. Falla fall3.4%568
17. Astheniaweakness or lack of energy3.3%562
18. Painpain, site not specified3.2%534
19. Hyperkalaemiahigh blood potassium3%508
20. Hyponatraemialow blood sodium3%504
21. Chest painchest pain3%500
22. Arthralgiajoint pain2.8%482
23. Oedema peripheralswelling of the legs, ankles or hands2.8%467
24. Anaemialow red blood cells2.7%465
25. Vomitingbeing sick2.7%450
26. General physical health deteriorationgeneral decline in health2.5%423
27. Anxietyanxiety2.5%421
28. Pyrexiafever2.5%420
29. Off label useused for a purpose or in a way not on the label2.5%416
30. Myalgiamuscle pain2.4%411

Top 30 of 2,540 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 24 drugs in the angiotensin 2 receptor blocker 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 243,200 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

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 36.5% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 16,935 reports.

Drugs most often listed in the same reports

Other products listed in reports where Valsartan 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

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 angiotensin 2 receptor blocker class

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.

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 Valsartan as a suspect or interacting product; reports listing it only as a concomitant medication (37,981) 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.