Candesartan cilexetil: adverse event reports filed with FDA

5,311

reports as suspect product

0% of all reports · about 236 a year

622

reports, 12 months to June 2026

560 in the 12 months before

97.6%

marked serious by the reporter

67.6% across the class

9.9%

record death among outcomes, as reported

528 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 Candesartan cilexetil reports recording the termmedian drug in angiotensin 2 receptor blocker

1. Dyspnoeashortness of breath12.4%656
2. Headachehead pain12.1%642
3. Off label useused for a purpose or in a way not on the label11.7%624
4. Fatiguetiredness11.5%610
5. Drug ineffectivethe medicine did not work as expected10.7%570
6. Painpain, site not specified9.7%516
7. Acute kidney injurysudden loss of kidney function9.5%506
8. Nauseafeeling sick9.5%506
9. Dizzinesslight-headedness or unsteadiness9.5%503
10. Vomitingbeing sick8.9%472
11. Malaisegeneral feeling of being unwell8.7%460
12. Falla fall8.6%456
13. Anxietyanxiety8.3%439
14. Diarrhoealoose or frequent stools7.9%418
15. Pyrexiafever7.5%399
16. Migrainemigraine7.3%390
17. Condition aggravatedthe condition being treated got worse7.1%378
18. Muscular weaknessmuscle weakness6.9%368
19. Pneumonialung infection6.9%367
20. Hypotensionlow blood pressure6.9%365
21. Arthralgiajoint pain6.1%324
22. Abdominal pain upperupper stomach pain6%321
23. Palpitationsawareness of the heartbeat6%317
24. Product use in unapproved indicationused for a purpose not on the label5.9%311
25. Coughcough5.8%306
26. Astheniaweakness or lack of energy5.7%304
27. Insomniadifficulty sleeping5.6%297
28. Memory impairmentmemory problems5.5%290
29. Pain in extremitypain in an arm or leg5.3%283
30. Vasculitisinflammation of blood vessels5.3%281

Top 30 of 1,252 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. 2.7% 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 5,311 reports.

Drugs most often listed in the same reports

Other products listed in reports where Candesartan cilexetil 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 Candesartan cilexetil as a suspect or interacting product; reports listing it only as a concomitant medication (7,415) 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.