Olmesartan medoxomil: adverse event reports filed with FDA

4,777

reports as suspect product

0% of all reports · about 216 a year

169

reports, 12 months to June 2026

136 in the 12 months before

90.6%

marked serious by the reporter

67.6% across the class

4.4%

record death among outcomes, as reported

209 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 Olmesartan medoxomil reports recording the termmedian drug in angiotensin 2 receptor blocker

1. Weight decreasedweight loss15.3%730
2. Diarrhoealoose or frequent stools10.6%504
3. Sprue-like enteropathy7.6%364
4. Hypotensionlow blood pressure6.7%318
5. Gastrointestinal disorder5.2%248
6. Acute kidney injurysudden loss of kidney function4.9%235
7. Hospitalisationadmission to hospital4.9%234
8. Drug ineffectivethe medicine did not work as expected4.6%222
9. Dizzinesslight-headedness or unsteadiness4.5%213
10. Vomitingbeing sick4%193
11. Nauseafeeling sick3.7%175
12. Dyspnoeashortness of breath3.5%169
13. Blood pressure increaseda raised blood pressure reading3.5%166
14. Dehydrationdehydration3.5%166
15. Syncopefainting3.2%153
16. Hyperkalaemiahigh blood potassium3.1%146
17. Hypertensionhigh blood pressure3%144
18. Coughcough3%141
19. Atrial fibrillationan irregular heart rhythm2.8%135
20. Hypokalaemialow blood potassium2.7%129
21. Drug interactionan interaction between medicines2.7%128
22. Renal impairmentreduced kidney function2.7%128
23. Fatiguetiredness2.6%126
24. Hyponatraemialow blood sodium2.6%122
25. Malabsorption2.6%122
26. Headachehead pain2.5%120
27. Renal failurekidney failure2.4%116
28. Astheniaweakness or lack of energy2.3%109
29. Metabolic acidosistoo much acid in the body fluids2.2%103
30. Decreased appetitereduced appetite2.1%99

Top 30 of 889 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. 33.1% 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 4,777 reports.

Drugs most often listed in the same reports

Other products listed in reports where Olmesartan medoxomil 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 Olmesartan medoxomil as a suspect or interacting product; reports listing it only as a concomitant medication (7,232) 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.