What the FDA labels say about taking them together
Fenofibrate and gemfibrozil
Fenofibrate's FDA label of April 29, 2024 names gemfibrozil in its warnings and precautions section, and gemfibrozil's label names fenofibrate too. The fenofibrate label: “Risks are increased during co-administration with a statin, particularly in elderly patients and patients with diabetes, renal failure, or hypothyroidism.”
Check it at the source: the fenofibrate FDA label on DailyMed (effective April 29, 2024, A-S Medication Solutions); the gemfibrozil FDA label on DailyMed (effective April 10, 2026, Northstar RxLLC).
What does the fenofibrate label say about gemfibrozil?
Fenofibrate label, warnings and precautionsRisks are increased during co-administration with a statin (with a significantly higher rate observed for gemfibrozil), particularly in elderly patients and patients with diabetes, renal failure, or hypothyroidism ( 5.3 ).
Antara label (Lupin Pharmaceuticals, Inc., October 1, 2025), warnings and precautionsBecause of chemical, pharmacological, and clinical similarities between fenofibrates, including Antara; pemafibrate; clofibrate; and gemfibrozil; the findings in 5 large randomized, placebo-controlled clinical trials with these other fibrate drugs may also apply to Antara.
Source: FDA drug label (Antara, NDA021695), Lupin Pharmaceuticals, Inc., effective October 1, 2025 (SPL set 24790a18-0291-4b88-a724-acac43b616ce), via openFDA
Source: FDA drug label (Lipofen, NDA021612), ANI Pharmaceuticals, Inc., effective May 12, 2026 (SPL set 78b789b9-854f-46b9-97f3-a48759a6ff89), via openFDA
Source: FDA drug label (Tricor), NDA021656 (Abbvie), as published by A-S Medication Solutions, effective April 29, 2024 (SPL set 84b2af1b-365e-4723-ac5f-bc826ec47772), via openFDA; the full label on DailyMed
What does the gemfibrozil label say about fenofibrate?
Gemfibrozil label, warningsPancreatic acinar adenomas were increased in males and females on fenofibrate; hepatocellular carcinoma and pancreatic acinar adenomas were increased in males and hepatic neoplastic nodules in females treated with clofibrate; hepatic neoplastic nodules were increased in males and females treated with clofibrate; hepatic neoplastic nodules were increased in males and females treated with gemfibrozil while testicular interstitial cell (Leydig cell) tumors were increased in males on all three drugs.
Source: FDA drug label (Gemfibrozil), Northstar RxLLC, effective April 10, 2026 (SPL set 75cac02c-56e3-4dfe-b1e2-4ce166b28833), via openFDA; the full label on DailyMed
These are the labels' own sentences. PlainMeds does not grade interactions; a pharmacist or prescriber can say what they mean for one person's medicines.
Both medicines on the record
| Fenofibrate | Gemfibrozil | |
|---|---|---|
| Labeled for | High cholesterol, High triglycerides | High cholesterol, Heart attack and coronary artery disease |
| Boxed warning | No | Yes |
| Pharmacy cost (NADAC) | $0.103 per tablet 160 mg tablet | $0.104 per tablet 600 mg tablet |
| Shortage now | No current entry | A presentation being discontinued |
Source: FDA NDC Directory, CMS NADAC of October 7, 2026 and the FDA Drug Shortage Database (FDA files October 8, 2026)
What next?
- Check more medicines together
- up to five at once