What the label lists and what reports show
Gemfibrozil side effects
Gemfibrozil's FDA label lists its adverse reactions in its own words. FAERS holds 15,090 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is nausea (886 reports).
- Generic listed
- A presentation discontinued
- Boxed warning
Check it at the source: the gemfibrozil FDA label on DailyMed (effective April 10, 2026, Northstar RxLLC); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsIn the double-blind controlled phase of the primary prevention component of the Helsinki Heart Study, 2046 patients received gemfibrozil for up to five years. In that study, the following adverse reactions were statistically more frequent in subjects in the gemfibrozil group: Gemfibrozil PLACEBO (N = 2046) (N = 2035) Frequency in percent of subjects Gastrointestinal reactions 34.2 23.8 Dyspepsia 19.6 11.9 Abdominal pain 9.8 5.6 Acute appendicitis 1.2 0.6 (histologically confirmed in most cases where data were available) Atrial fibrillation 0.7 0.1 Adverse events reported by more than 1% of subjects, but without a significant difference between groups: Diarrhea 7.2 6.5 Fatigue 3.8 3.5 Nausea/Vomiting 2.5 2.1 Eczema 1.9 1.2 Rash 1.7 1.3 Vertigo 1.5 1.3 Constipation 1.4 1.3 Headache 1.2 1.1 Gallbladder surgery was performed in 0.9% of gemfibrozil and 0.5% of placebo subjects in the primary …
Source: FDA drug label, Northstar RxLLC, effective April 10, 2026 (SPL set 75cac02c-56e3-4dfe-b1e2-4ce166b28833), via openFDA; the full label on DailyMed
What do FAERS reports show?
15,090 reports list gemfibrozil among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1,220 are coded as a death and 5,332 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 23 reactions below, 10 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Gemfibrozil: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions