Cozaar: adverse event reports filed with FDA

4,913

reports as suspect product

0% of all reports · about 218 a year

60

reports, 12 months to June 2026

78 in the 12 months before

70.2%

marked serious by the reporter

67.6% across the class

9.9%

record death among outcomes, as reported

486 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 Cozaar reports recording the termmedian drug in angiotensin 2 receptor blocker

1. Drug ineffectivethe medicine did not work as expected7%346
2. Dizzinesslight-headedness or unsteadiness6.1%299
3. Drug hypersensitivityan allergic-type reaction to a medicine5.8%287
4. Blood pressure increaseda raised blood pressure reading4.8%234
5. Hypotensionlow blood pressure4.6%228
6. Headachehead pain3.8%185
7. Dyspnoeashortness of breath3.6%179
8. Hypertensionhigh blood pressure3.6%178
9. Coughcough3.3%164
10. Fatiguetiredness3.3%162
11. Nauseafeeling sick3.2%156
12. Diarrhoealoose or frequent stools2.9%142
13. Malaisegeneral feeling of being unwell2.9%141
14. Renal failure acute2.9%141
15. Drug interactionan interaction between medicines2.6%126
16. Astheniaweakness or lack of energy2.5%124
17. Falla fall2.5%122
18. Rashskin rash2.5%122
19. Hyperkalaemiahigh blood potassium2.3%112
20. Pruritusitching2.1%104
21. Vomitingbeing sick2%97
22. Adverse eventan unwanted medical event, type not specified2%96
23. Painpain, site not specified2%96
24. Product use in unapproved indicationused for a purpose not on the label2%96
25. Blood creatinine increasedraised creatinine, a kidney test1.9%92
26. Palpitationsawareness of the heartbeat1.9%92
27. Feeling abnormalfeeling odd or not right1.8%90
28. Pain in extremitypain in an arm or leg1.8%89
29. Back painback pain1.8%88
30. Renal failurekidney failure1.8%87

Top 30 of 915 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. 55.2% 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 4,913 reports.

Drugs most often listed in the same reports

Other products listed in reports where Cozaar 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 Cozaar as a suspect or interacting product; reports listing it only as a concomitant medication (23,130) 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.