Gemfibrozil: Side Effects, Uses & Monitoring
Gemfibrozil Tablets, USP are indicated as adjunctive therapy to diet for: 1.
- Data source
- FDA labeling via NIH DailyMed (label 3ebb5947…)
- Label version
- current
- Last reviewed
- 2026
Reported adverse reactions
Reactions listed in current FDA labeling, with the highest frequency reported across summarized placebo-controlled trials.
| Adverse reaction (as reported in labeling) | Reported frequency* |
|---|---|
| Gastrointestinal reactions | 34.2% |
| Dyspepsia | 19.6% |
| Abdominal pain | 9.8% |
| Diarrhea | 7.2% |
| Fatigue | 3.8% |
| Nausea/vomiting | 2.5% |
| Eczema | 1.9% |
| Rash | 1.7% |
| Vertigo | 1.5% |
| Constipation | 1.4% |
| Acute appendicitis | 1.2% |
| Headache | 1.2% |
| Atrial fibrillation | 0.7% |
*Highest percentage reported for the active moiety across placebo-controlled trial tables in current FDA labeling. Values reflect trial reporting, not your individual risk.
Labeled uses (from FDA prescribing information)
Gemfibrozil Tablets, USP are indicated as adjunctive therapy to diet for: 1. Treatment of adult patients with very high elevations of serum triglyceride levels (Types IV and V hyperlipidemia) who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them. Patients who present such risk typically have serum triglycerides over 2,000 mg/dL and have elevations of VLDL-cholesterol as well as fasting chylomicrons (Type V hyperlipidemia). Subjects who consistently have total serum or plasma triglycerides below 1,000 mg/dL are unlikely to present a risk of pancreatitis. Gemfibrozil therapy may be considered for those subjects with triglyceride elevations between 1,000 and 2,000 mg/dL who have a history of pancreatitis or of recurrent abdominal pain typical of pancreatitis. It is recognized that some Type IV patients with triglycerides under 1,000 mg/dL may, through dietary or alcoholic indiscretion, convert to a Type V pattern with massive triglyceride elevations accompanying fasting chylomicronemia, but the influence of gemfibrozil therapy on the risk of pancreatitis in such situations has not been adequately studied. Drug therapy is no…
Conditions associated with Gemfibrozil in labeling
Coronary Artery Disease
Narrowing of the coronary arteries by plaque, reducing blood flow to the heart muscle and causing chest pain, ...
Hyperlipidemia
Elevated levels of cholesterol or triglycerides in the blood, a major risk factor for heart attack and stroke....
Pancreatitis
Inflammation of the pancreas that causes severe upper abdominal pain radiating to the back, nausea, and vomiti...
Frequently Asked Questions
What is Gemfibrozil used for?
FDA labeling lists the approved uses shown above under "Labeled uses." This summary is informational; only a qualified prescriber can determine whether a medication is appropriate for you.
What are the most commonly reported side effects of Gemfibrozil?
The table above shows adverse reactions and the highest frequencies reported in placebo-controlled trials summarized in current FDA labeling for Gemfibrozil. Individual risk varies.
Does Gemfibrozil require lab monitoring?
Monitoring needs vary. Ask your healthcare provider whether any lab tests apply while taking Gemfibrozil.
Where does this information come from?
All clinical facts on this page were extracted from the current FDA-registered product labeling for this ingredient, published by manufacturers through NIH DailyMed. See the source link below.
Medical disclaimer: Educational content extracted from public FDA labeling. Not medical advice. Always consult a qualified healthcare professional before starting, stopping, or changing any medication.