Fenofibrate
Fibrates
Sold as Antara · Cholib · Synordia · Pravafenix · AA-FENO-MICRO
- Drug class
- Fibrates
- Availability
- Prescription only
- Routes
- Oral
- Markets covered
- 4
- Products on record
- 60
- FDA reports (12 mo)
- 1,934
Overview
Plain-language summary, compiled from the cited regulatory records
Fenofibrate is a medication belonging to the fibrate drug class [1]. It is approved for use in adult patients as a supplement to diet to manage certain lipid disorders [1]. Specifically, it is indicated to lower elevated levels of LDL-C, total cholesterol, triglycerides, and Apo B, while also increasing HDL-C in adults with primary hypercholesterolemia or mixed dyslipidemia [1]. Additionally, fenofibrate is used for the treatment of adult patients who have severe hypertriglyceridemia [1].
Fenofibrate is available under various brand names, including Antara [1]. In the past 12 months, there have been 1934 adverse event reports associated with fenofibrate [2]. The most frequently reported events include off-label use, diarrhea, nausea, fatigue, and reports of the drug being ineffective [2].
This is not medical advice. Consult a qualified healthcare professional.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 24 | May 22, 2026 |
| CA Canada | Health Canada | 19 | February 6, 2026 |
| US United States | FDA | 15 | January 13, 2026 |
| EU European Union | EMA | 2 | December 16, 2025 |
GBUnited Kingdom· MHRA
24 products
Uses
g. exercise, weight reduction) for the following: - Treatment of severe hypertriglyceridaemia with or without low HDL cholesterol. - Mixed hyperlipidaemia when a statin is contraindicated or not tolerated. - Mixed hyperlipidaemia in patients at high cardiovascular risk in addition to a statin when triglycerides and HDL cholesterol are not adequately controlled.
How to take
CACanada· Health Canada
19 products
Uses
8 DRUG INTERACTIONS ........................................................................................................................................ 12 DOSAGE AND ADMINISTRATION ....................................................................................................................
16 OVERDOSAGE ...................................................................................................................................................... 16 ACTION AND CLINICAL PHARMACOLOGY ..................................................................................................
17 STORAGE AND STABILITY ................................................................................................................................ 18 DOSAGE FORMS, COMPOSITION AND PACKAGING ...................................................................................
18 PART II: SCIENTIFIC INFORMATION .............................................................................................................. 19 PHARMACEUTICAL INFORMATION ................................................................................................................
USUnited States· FDA
15 products
Uses
1 ). 2 ). 1 ). 1 Primary Hypercholesterolemia or Mixed Dyslipidemia Fenofibrate tablet USP is indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (Total-C), Triglycerides and apolipoprotein B (Apo B), and to increase high-density lipoprotein cholesterol (HDL-C) in adult patients with primary hypercholesterolemia or mixed dyslipidemia.
2 Severe Hypertriglyceridemia Fenofibrate tablet USP is also indicated as adjunctive therapy to diet for treatment of adult patients with severe hypertriglyceridemia. Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually obviate the need for pharmacologic intervention.
g. > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been adequately studied. 1 )] .
EUEuropean Union· EMA
2 products
Uses
Cholib is indicated as adjunctive therapy to diet and exercise in high cardiovascular risk adult patients with mixed dyslipidaemia to reduce triglycerides and increase HDL-C levels when LDL-C levels are adequately controlled with the corresponding dose of simvastatin monotherapy.
How to take
Drug interactions
Known interactions involving Fenofibrate. Select one for details. This list is informational and not a complete interaction checker.
Showing 240 of 433. Type above to find a specific drug.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]MHRA (UK) · PL148940369 · revised August 30, 2024
- [2]Health Canada (DPD) · 02246859 · revised March 22, 2025
- [3]FDA DailyMed · 00c2f942-e839-46… · revised April 29, 2024 [PDF]
- [4]European Medicines Agency · EMEA/H/C/002559 · revised December 16, 2025
- [5]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.