Gemfibrozil: adverse event reports filed with FDA

1,807

reports as suspect product

0% of all reports · about 80 a year

43

reports, 12 months to June 2026

44 in the 12 months before

79%

marked serious by the reporter

85.1% across the class

12.9%

record death among outcomes, as reported

234 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 Gemfibrozil reports recording the termmedian drug in peroxisome proliferator receptor alpha agonist

1. Rhabdomyolysismuscle breakdown20.9%378
2. Drug interactionan interaction between medicines14%253
3. Myalgiamuscle pain8.4%152
4. Renal failure acute8%145
5. Drug hypersensitivityan allergic-type reaction to a medicine7%126
6. Completed suicidedeath by suicide6.4%116
7. Astheniaweakness or lack of energy5.5%99
8. Fatiguetiredness5.3%95
9. Blood creatine phosphokinase increased5.1%92
10. Nauseafeeling sick4.9%88
11. Drug ineffectivethe medicine did not work as expected4.5%82
12. Muscular weaknessmuscle weakness3.3%59
13. Vomitingbeing sick3.3%59
14. Diarrhoealoose or frequent stools3.2%57
15. Acute kidney injurysudden loss of kidney function2.8%50
16. Pain in extremitypain in an arm or leg2.8%50
17. Blood triglycerides increased2.6%47
18. Malaisegeneral feeling of being unwell2.5%46
19. Dizzinesslight-headedness or unsteadiness2.4%44
20. Blood cholesterol increasedraised cholesterol2.4%43
21. Muscle spasmsmuscle cramps2.4%43
22. Abdominal painstomach or belly pain2.3%42
23. Toxicity to various agentspoisoning or toxic effect of one or more substances2.3%41
24. Arthralgiajoint pain2.2%40
25. Aspartate aminotransferase increasedraised liver enzyme (AST)2.2%40
26. Deaththe patient died; cause not stated by this term2.2%40
27. Alanine aminotransferase increasedraised liver enzyme (ALT)2.2%39
28. Blood creatinine increasedraised creatinine, a kidney test2.1%38
29. Myopathy2%37
30. Treatment noncompliancethe treatment was not taken as directed2%37

Top 30 of 468 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 7 drugs in the peroxisome proliferator receptor alpha agonist 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 29,908 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. 68.1% 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 1,807 reports.

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 peroxisome proliferator receptor alpha agonist 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 Gemfibrozil as a suspect or interacting product; reports listing it only as a concomitant medication (9,645) 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.