Ezetimibe: adverse event reports filed with FDA

11,443

reports as suspect product

0.1% of all reports · about 509 a year

1,943

reports, 12 months to June 2026

1,763 in the 12 months before

84.3%

marked serious by the reporter

69.7% across the class

7.1%

record death among outcomes, as reported

811 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 Ezetimibe reports recording the termmedian drug in dietary cholesterol absorption inhibitor

1. Myalgiamuscle pain16.4%1,880
2. Fatiguetiredness7%797
3. Arthralgiajoint pain6.3%722
4. Drug ineffectivethe medicine did not work as expected6.3%716
5. Dyspnoeashortness of breath6.3%716
6. Dizzinesslight-headedness or unsteadiness6.1%696
7. Nauseafeeling sick6%691
8. Diarrhoealoose or frequent stools5.8%668
9. Headachehead pain5.4%617
10. Malaisegeneral feeling of being unwell4.8%548
11. Drug interactionan interaction between medicines4.6%528
12. Muscle spasmsmuscle cramps4.5%512
13. Pruritusitching4.3%490
14. Astheniaweakness or lack of energy4.2%475
15. Abdominal painstomach or belly pain4%457
16. Drug intolerancethe medicine was not tolerated3.8%431
17. Rhabdomyolysismuscle breakdown3.6%416
18. Myocardial infarctionheart attack3.5%402
19. Coughcough3.4%394
20. Vomitingbeing sick3.4%385
21. Falla fall3.3%377
22. Pain in extremitypain in an arm or leg3.2%362
23. Muscular weaknessmuscle weakness3%346
24. Abdominal pain upperupper stomach pain3%343
25. Acute kidney injurysudden loss of kidney function3%339
26. Pyrexiafever2.9%334
27. Insomniadifficulty sleeping2.8%321
28. Decreased appetitereduced appetite2.7%314
29. Blood pressure increaseda raised blood pressure reading2.6%301
30. Painpain, site not specified2.6%299

Top 30 of 1,228 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 3 drugs in the dietary cholesterol absorption inhibitor 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 23,350 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. 10.5% 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 11,443 reports.

Drugs most often listed in the same reports

Other products listed in reports where Ezetimibe 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 dietary cholesterol absorption inhibitor 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 Ezetimibe as a suspect or interacting product; reports listing it only as a concomitant medication (26,708) 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.