Zetia: adverse event reports filed with FDA

8,262

reports as suspect product

0% of all reports · about 367 a year

45

reports, 12 months to June 2026

58 in the 12 months before

45.9%

marked serious by the reporter

69.7% across the class

2.4%

record death among outcomes, as reported

202 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 Zetia reports recording the termmedian drug in dietary cholesterol absorption inhibitor

1. Myalgiamuscle pain13%1,077
2. Pain in extremitypain in an arm or leg5%411
3. Arthralgiajoint pain4.8%398
4. Fatiguetiredness4.7%390
5. Blood creatine phosphokinase increased4.4%366
6. Drug hypersensitivityan allergic-type reaction to a medicine4.1%340
7. Muscle spasmsmuscle cramps3.8%317
8. Diarrhoealoose or frequent stools3.7%306
9. Drug ineffectivethe medicine did not work as expected3.7%306
10. Dizzinesslight-headedness or unsteadiness3.7%304
11. Astheniaweakness or lack of energy3.6%298
12. Nauseafeeling sick3.4%284
13. Rhabdomyolysismuscle breakdown3.2%268
14. Painpain, site not specified3.2%267
15. Muscular weaknessmuscle weakness2.9%243
16. Back painback pain2.9%239
17. Headachehead pain2.9%237
18. Hepatic enzyme increasedraised liver enzymes2.5%210
19. Rashskin rash2.5%205
20. Dyspnoeashortness of breath2.2%180
21. Abdominal painstomach or belly pain2.2%179
22. Blood cholesterol increasedraised cholesterol2.1%177
23. Abdominal pain upperupper stomach pain2%166
24. Aspartate aminotransferase increasedraised liver enzyme (AST)1.9%158
25. Pruritusitching1.9%158
26. Alanine aminotransferase increasedraised liver enzyme (ALT)1.9%157
27. Pancreatitisinflammation of the pancreas1.8%152
28. Liver function test abnormal1.8%146
29. Malaisegeneral feeling of being unwell1.7%140
30. Gait disturbancedifficulty walking1.7%139

Top 30 of 790 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. 56.9% 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 8,262 reports.

Drugs most often listed in the same reports

Other products listed in reports where Zetia 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 Zetia as a suspect or interacting product; reports listing it only as a concomitant medication (28,822) 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.