Irbesartan: adverse event reports filed with FDA

10,055

reports as suspect product

0.1% of all reports · about 447 a year

692

reports, 12 months to June 2026

925 in the 12 months before

93.7%

marked serious by the reporter

67.6% across the class

6.7%

record death among outcomes, as reported

674 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 Irbesartan reports recording the termmedian drug in angiotensin 2 receptor blocker

1. Acute kidney injurysudden loss of kidney function12.6%1,268
2. Falla fall8.1%817
3. Hypotensionlow blood pressure7.6%760
4. Nauseafeeling sick5.4%542
5. Hyponatraemialow blood sodium5.3%530
6. Malaisegeneral feeling of being unwell5%501
7. Fatiguetiredness5%500
8. Vomitingbeing sick4.6%464
9. Hyperkalaemiahigh blood potassium4.5%457
10. Drug interactionan interaction between medicines4.3%437
11. Drug ineffectivethe medicine did not work as expected4.2%427
12. Astheniaweakness or lack of energy4.2%425
13. Blood pressure increaseda raised blood pressure reading4.2%425
14. Confusional stateconfusion4.2%420
15. Headachehead pain4.1%414
16. Coughcough4.1%413
17. Dyspnoeashortness of breath3.8%385
18. Diarrhoealoose or frequent stools3.6%365
19. Dizzinesslight-headedness or unsteadiness3.6%359
20. Anxietyanxiety3.5%347
21. Muscular weaknessmuscle weakness3.4%340
22. Cerebrovascular accidentstroke3.3%333
23. Pyrexiafever3.2%324
24. Painpain, site not specified3.2%317
25. Chest discomfortchest discomfort3%304
26. Muscle spasticity3%304
27. Dysphagiadifficulty swallowing3%299
28. Aphasiadifficulty with language2.9%294
29. Dysarthria2.9%291
30. Hemiplegia2.9%288

Top 30 of 1,303 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. 10.1% 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 10,055 reports.

Drugs most often listed in the same reports

Other products listed in reports where Irbesartan 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 Irbesartan as a suspect or interacting product; reports listing it only as a concomitant medication (22,504) 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.