Two medicines, side by side
Fenofibrate vs gemfibrozil
Fenofibrate and gemfibrozil are both labeled for high cholesterol. Drugs@FDA records approvals of fenofibrate since 1993 and of gemfibrozil since 1981. Pharmacies paid $0.103 per fenofibrate 160 mg tablet and $0.104 per gemfibrozil 600 mg tablet (NADAC, October 7, 2026); the strengths differ, so the two prices are not like for like. Only the gemfibrozil label carries a boxed warning.
Check it at the source: the fenofibrate FDA label on DailyMed (effective April 29, 2024); the gemfibrozil FDA label on DailyMed (effective April 10, 2026).
Highlights of the fenofibrate record
Fenofibrate (Tricor) · label of April 29, 2024
Used for
From the label: indicationsTRICOR is a peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as an adjunct to diet: To reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia ( 1.1 ). For treatment of adult patients with severe hypertriglyceridemia ( 1.2 ). […]
On the market
- Earliest approval on file
- December 31, 1993
- Generic labelers
- 54 labelers
- Pharmacy cost
- $0.103 per tablet
Supply and safety
- Shortage
- No current entry
- Recalls
- 8
Highlights of the gemfibrozil record
Gemfibrozil (Lopid) · label of April 10, 2026
Used for
From the label: indicationsGemfibrozil Tablets are indicated as adjunctive therapy to diet for: 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. […]
On the market
- Earliest approval on file
- December 21, 1981
- Generic labelers
- 27 labelers
- Pharmacy cost
- $0.104 per tablet
Supply and safety
- Shortage
- A presentation being discontinued
- Recalls
- 0
Source: FDA drug labels via openFDA (Fenofibrate label of April 29, 2024, Gemfibrozil label of April 10, 2026); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do fenofibrate and gemfibrozil differ on the record?
Only the gemfibrozil label carries a boxed warning.
Both are in FDA's class peroxisome proliferator receptor alpha agonists.
Half-life, in each label's words: Fenofibrate, “Fenofibric acid is eliminated with a half-life of 20 hours, allowing once daily dosing.”; Gemfibrozil, “Peak plasma levels occur in 1 to 2 hours with a plasma half-life of 1.5 hours following multiple doses.”
Generics: fenofibrate since 2002; gemfibrozil since 1993 (Drugs@FDA).
| Fenofibrate | Gemfibrozil | |
|---|---|---|
| Labeled for | High cholesterol, High triglycerides | High cholesterol, Heart attack and coronary artery disease |
| Pharmacologic class | Peroxisome Proliferator Receptor alpha Agonist | Peroxisome Proliferator Receptor alpha Agonist |
| How it works (label) | The active moiety of TRICOR is fenofibric acid. The pharmacological effects of fenofibric acid in both animals and humans have been extensively studied through oral administration of fenofibrate. | n/a |
| Half-life (label) | Fenofibric acid is eliminated with a half-life of 20 hours, allowing once daily dosing. | Peak plasma levels occur in 1 to 2 hours with a plasma half-life of 1.5 hours following multiple doses. |
| Earliest approval on file (Drugs@FDA) | December 31, 1993 | December 21, 1981 |
| First generic approved | April 9, 2002 | January 25, 1993 |
| Generic labelers (NDC) | 54 labelers | 27 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.103 per tablet (Fenofibrate 160 mg tablet) | $0.104 per tablet (Gemfibrozil 600 mg tablet) |
| 12-month price change | -14% | +2% |
| Boxed warning | No | Yes |
| Shortage now | No current entry | A presentation being discontinued |
| Recalls recorded | 8 | 0 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 35,248 | 15,090 |
| DEA schedule | none | none |
Source: Drugs@FDA, FDA NDC Directory, CMS NADAC of October 7, 2026, FDA shortages and recalls, FAERS via openFDA (FDA files October 8, 2026)
Do their labels mention each other?
Fenofibrate label, 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.
Fenofibrate label, warnings and precautionsBecause of chemical, pharmacological, and clinical similarities between fenofibrates, including LIPOFEN; pemafibrate; clofibrate; and gemfibrozil; the findings in 5 large randomized, placebo-controlled clinical trials with these other fibrate drugs may also apply to LIPOFEN.
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; …
Source: FDA drug labels via openFDA
What next?
- Alternatives to fenofibrate
- every medicine labeled for the same conditions