Diovan: adverse event reports filed with FDA

17,179

reports as suspect product

0.1% of all reports · about 764 a year

133

reports, 12 months to June 2026

120 in the 12 months before

91.7%

marked serious by the reporter

67.6% across the class

15%

record death among outcomes, as reported

2,572 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 Diovan reports recording the termmedian drug in angiotensin 2 receptor blocker

1. Blood pressure increaseda raised blood pressure reading10.3%1,762
2. Hypertensionhigh blood pressure7.3%1,259
3. Dizzinesslight-headedness or unsteadiness6.2%1,065
4. Deaththe patient died; cause not stated by this term5.6%966
5. Malaisegeneral feeling of being unwell5.4%933
6. Drug ineffectivethe medicine did not work as expected5.1%869
7. Dyspnoeashortness of breath4.6%786
8. Diabetes mellitusdiabetes4.5%779
9. Cerebrovascular accidentstroke4.4%764
10. Headachehead pain4.3%742
11. Falla fall4.2%725
12. Fatiguetiredness4%686
13. Hypotensionlow blood pressure3.4%579
14. Blood pressure decreaseda low blood pressure reading3%523
15. Feeling abnormalfeeling odd or not right3%523
16. Coughcough3%522
17. Blood pressure inadequately controlled3%516
18. Pneumonialung infection2.9%495
19. Astheniaweakness or lack of energy2.9%494
20. Painpain, site not specified2.7%459
21. Myocardial infarctionheart attack2.5%435
22. Nauseafeeling sick2.5%434
23. Gait disturbancedifficulty walking2.4%414
24. Cardiac failureheart failure2.3%399
25. Oedema peripheralswelling of the legs, ankles or hands2.2%385
26. Blood pressure fluctuation2.2%380
27. Arrhythmia2.1%369
28. Weight decreasedweight loss2.1%363
29. Pain in extremitypain in an arm or leg2%344
30. Memory impairmentmemory problems2%341

Top 30 of 1,819 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. 27.2% 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 17,179 reports.

Drugs most often listed in the same reports

Other products listed in reports where Diovan 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 Diovan as a suspect or interacting product; reports listing it only as a concomitant medication (35,218) 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.