Fenofibrate: uses, dosing, side effects & brands
Fenofibrate is a peroxisome proliferator receptor alpha agonist sold in the U.S. under 8 brand and generic names, for coronary artery disease, hypercholesterolemia and hyperlipoproteinemias. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Peroxisome Proliferator Receptor Alpha Agonist
- Treats (across its forms)
- Coronary Artery Disease, Hypercholesterolemia and Hyperlipoproteinemias
- Available as
- Capsule · Tablet
- Sold as
- 8 products — Lipidil, Tricor and Tricor (Micronized), and others
- Prescription?
- Prescription only
- Generic available?
- Yes
- Half-life
- about 20 hours — but that is the half-life of fenofibric acid, the active form, not of fenofibrate itself
- What the pharmacy pays
- about $3 for a 30-count supply — not your price
How Lipofen is dosed
From the FDA label for Lipofen (application NDA021612). Other fenofibrate products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Severe hypertriglyceridemia : 50 to 150 mg orally once daily; the dosage should be adjusted according to patient response ( 2.2 ) Primary hyperlipidemia: 150 mg orally once daily ( 2.2 ) Administer as a single dose, at any time of day, with food ( 2.2 ). Assess TG when clinically appropriate, as early as 4 to 8 weeks after initiating fenofibrate. Discontinue fenofibrate in patients who do not have an adequate response after 2 months of treatment ( 2.2 ) Renal impairment : Initial dosage of 50 mg orally once daily ( 2.3 ) Geriatric patients : Select the dosage on the basis of renal function ( 2.4 ) 2.1 Prior to Initiation of fenofibrate capsules Assess lipid levels before initiating therapy. Identify other causes (e.g., diabetes mellitus, hypothyroidism, or medications) of high TG levels and manage as appropriate. Patients should be placed on an appropriate lipid-lowering diet before receiving fenofibrate, and should continue this diet during treatment with fenofibrate. In patients with diabetes and fasting chylomicronemia, improve glycemic control prior to considering starting fenofibrate. 2.2 Recommended Dosage and Administration Severe hypertriglyceridemia: The recommended dosage of fenofibrate capsules is 50 mg or 150 mg orally once daily. Dosage should be individualized according to patient response, and should be adjusted if necessary following repeat lipid determinations…
Everything below is the FDA label for Lipofen (capsule). Fenofibrate is also sold as tablet, and those are different medicines to take — follow the label for the one you were prescribed.
Lipofen side effects
The following serious adverse reactions are described below and elsewhere in the labeling: Mortality and coronary heart disease morbidity [see Warnings and Precautions (5.1) ] Hepatoxicity [see Warnings and Precautions (5.2) ] Myopathy and Rhabdomyolysis [see Warnings and Precautions (5.3) ] Increases in Serum Creatinine [see Warnings and Precautions (5.4) ] Cholelithiasis [see Warnings and Precautions (5.5) ] Increased Bleeding Risk with Coumarin Anticoagulants [see Warnings and Precautions (5.6) ] Pancreatitis [see Warnings and Precautions (5.7) ] Hematologic Changes [see Warnings and Precautions (5.8) ] Hypersensitivity reactions [see Warnings and Precautions (5.9) ] Venothromboembolic disease [see Warnings and Precautions (5.10) ] Paradoxical Decreases in HDL Cholesterol Levels [see Warnings and Precautions (5.11) ] Adverse reactions (≥ 2% and greater than placebo): abnormal liver tests, increased AST, increased ALT, increased CPK, and rhinitis ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact ANI Pharmaceuticals, Inc. at 1-855-204-1431 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in…
Who shouldn’t take Lipofen
Fenofibrate capsules are contraindicated in patients with: Severe renal impairment, including those with end-stage renal disease (ESRD) and those receiving dialysis [see Clinical Pharmacology (12.3) ] . Active liver disease, including those with unexplained persistent liver function abnormalities [see Warnings and Precautions (5.2) ] . Pre-existing gallbladder disease [see Warnings and Precautions (5.5) ] . Hypersensitivity to fenofibrate, fenofibric acid, or any of the excipients in fenofibrate capsules. Serious hypersensitivity reactions including anaphylaxis and angioedema have been reported with fenofibrate [see Warnings and Precautions (5.9) ] . Severe renal impairment, including those with end-stage renal disease (ESRD) and those receiving dialysis ( 4 ) Active liver disease, including those with unexplained persistent liver function abnormalities ( 4 ) Pre-existing gallbladder disease ( 4 ) Hypersensitivity to fenofibrate, fenofibric acid, or any of the excipients in fenofibrate capsules ( 4 )
Lipofen drug interactions
Table 2 presents clinically important drug interactions with fenofibrate. Table 2: Clinically Important Drug Interactions with Fenofibrate Statins Clinical Impact: Fibrates may cause myopathy when given alone. The risk of myopathy and rhabdomyolysis is increased with concomitant use of fibrates with statins. Intervention: Consider if the benefit of using fenofibrate concomitantly with statin therapy outweighs the increased risk of myopathy and rhabdomyolysis. If concomitant use is decided, monitor patients for signs and symptoms of myopathy, particularly during initiation of therapy and during upward dosage titration of statin therapy. Colchicine Clinical Impact: Cases of myopathy and rhabdomyolysis have been reported with concomitant use of colchicine with fenofibrates. Intervention: Consider if the benefit of using colchicine concomitantly with fenofibrate outweighs the increased risk of myopathy and rhabdomyolysis. If concomitant use is decided, monitor patients for signs and symptoms of myopathy, particularly during initiation of therapy and during upward dosage titration of colchicine. Coumarin Anticoagulants Clinical Impact: Fibrates may cause potentiation of coumarin-type anticoagulant effects with prolongation of the PT/INR. Intervention: Caution should be exercised when coumarin anticoagulants are given in conjunction with fenofibrate. The dosage of the anticoagulants should be reduced to maintain the PT/INR at the desired level to prevent bleeding complications. Frequent PT/INR determinations are advisable until it has been definitely determined that the PT/INR has stabilized. Immunosuppressants Clinical Impact: Immunosuppressants such as cyclosporine and tacrolimus can produce nephrotoxicity with decreases in creatinine clearance and rises in serum creatinine, and because renal excretion is the primary elimination route of fibrate drugs including fenofibrate, there is a risk that an interaction will lead to deterioration of renal function. Intervention: The benefits and risks of using fenofibrate with immunosuppressants and other potentially nephrotoxic agents should be carefully considered, and the lowest effective dosage employed and renal function monitored. Bile-Acid Binding Resins Clinical Impact: Bile-acid binding resins may bind other drugs given concurrently. Intervention: In patients taking a bile acid resin, administer fenofibrate at least 1 hour before or 4 to 6 hours after the bile acid resin to avoid impeding its absorption. Consider if the benefit of concomitant use of statins or colchicine outweighs the increased risk of myopathy and rhabdomyolysis. Monitor patients for signs and symptoms of myopathy ( 7 ) Exercise caution in concomitant treatment with coumarin anticoagulants. Reduce the dosage of coumarin to maintain the PT/INR at the desired level to prevent bleeding complications ( 7 ). Consider the benefits and risks of concomitant use with immunosuppressants and other potentially nephrotoxic agents. Use the lowest effective dosage and monitor renal function ( 7 ). Administer fenofibrate at least 1 hour before or 4 to 6 hours after a bile acid resin to avoid impeding its absorption ( 7 ).
Every fenofibrate product we track (8)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Pharmacy pays | |
|---|---|---|---|---|---|---|---|
| 1 | 72/100 | Prescription | Capsule | Generic | $3 | View → | |
| 2 | 72/100 | Prescription | Tablet | Generic | $3 | View → | |
| 3 | 72/100 | Prescription | Capsule | Generic | $3 | View → | |
| 4 | 70/100 | Prescription | Capsule | Generic | $3 | View → | |
| 5 | 66/100 | Prescription | Capsule | Generic | $3 | View → | |
| 6 | Not yet rated | Prescription | Tablet | Generic | $3 | View → | |
| 7 | Not yet rated | Prescription | Capsule | Generic | $3 | View → | |
| 8 | Not yet rated | Prescription | Tablet | Generic | $3 | View → |
What fenofibrate pills look like
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
Fenofibrate recalls
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
Can you crush or split fenofibrate?
At least one fenofibrateproduct is labelled to be swallowed whole — crushing an extended-release tablet releases the whole day’s dose at once. Which applies depends on the form you were given.
What each fenofibrate label says about crushing, splitting and chewingHow long fenofibrate keeps
No fenofibrate label we read sets a separate limit for after opening, but they do specify how it must be stored — and the stability behind any date assumes those conditions.
Does fenofibrate expire? The in-use limits and storage rules from its labelsFenofibrate and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for fenofibrate: levels in milk, effects in breastfed infants, and the drugs it would consider insteadNo relevant published information exists on the use of fenofibrate during breastfeeding. Because of a concern with disruption of infant lipid metabolism, fenofibrate is best avoided during breastfeeding. An alternate drug is preferred, especially while nursing a newborn or preterm infant. The manufacturer recommends that breastfeeding be avoided during fenofibrate therapy and for 5 days after the final dose.
National Institute of Child Health and Human Development, record revised July 15, 2026. LactMed states its information is not a substitute for professional judgement.
What people report to the FDA about fenofibrate
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 36,351 reports naming fenofibrate, and the FDA flagged 69% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- fatigue2,237 reports
- diarrhoea2,180 reports
- nausea2,109 reports
- headache1,597 reports
- dyspnoea1,579 reports
- dizziness1,435 reports
- fall1,399 reports
- asthenia1,349 reports
Read these as a signal, not a rate. A report does not mean fenofibrate caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved August 25, 2026.
How long fenofibrate stays in your system
The elimination half-life of fenofibrate is about 20 hours — but that is the half-life of fenofibric acid, the active form, not of fenofibrate itself. Fenofibrate is a prodrug. The label states it "is a pro-drug of the active chemical moiety fenofibric acid" and that after an oral dose it is "rapidly hydrolyzed by esterases to the active metabolite, fenofibric acid; no unchanged fenofibrate is detected in plasma." So there is no parent half-life to report — the label gives only one figure: "Fenofibric acid is eliminated with a half-life of 20 hours, allowing once daily dosing." That 20 hours is the elimination (terminal) half-life of the active moiety; the label reports no separate distribution phase. Kidney function matters: the label says patients with mild to moderate renal impairment (eGFR 30–59 mL/min/1.73m2) had similar exposure but "an increase in the half-life for fenofibric acid" compared with healthy subjects (it does not say by how much), and severe impairment (eGFR under 30) showed a 2.7-fold increase in exposure with accumulation on chronic dosing — the label says to avoid fenofibrate in severe renal impairment and to reduce the dose in mild-to-moderate. Older adults: in volunteers aged 77–87 the oral clearance of fenofibric acid was 1.2 L/h versus 1.1 L/h in young adults, i.e. essentially unchanged, so no age-related prolongation is described in those with normal renal function. Liver impairment: the label states no pharmacokinetic studies have been conducted in hepatic impairment, so the half-life there is unknown.
FENOFIBRATE tablet — DailyMed label, §12.3 Pharmacokinetics ↗Half-life is how long the body takes to clear half a dose. It is not the same as how long a drug test can detect it, and it varies with age, kidney and liver function.
Related calculators
Frequently asked questions
What is Lipofen?
Lipofen (Fenofibrate) is a peroxisome proliferator receptor alpha agonist used to treat Coronary Artery Disease, Hypercholesterolemia, Hyperlipoproteinemias, Hypertriglyceridemia.
What kind of drug is fenofibrate?
The FDA classifies fenofibrate as a peroxisome proliferator receptor alpha agonist. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
How long does fenofibrate stay in your system?
The elimination half-life of fenofibrate is about 20 hours — but that is the half-life of fenofibric acid, the active form, not of fenofibrate itself — that is how long the body takes to clear half of a dose. Fenofibrate is a prodrug. The label states it "is a pro-drug of the active chemical moiety fenofibric acid" and that after an oral dose it is "rapidly hydrolyzed by esterases to the active metabolite, fenofibric acid; no unchanged fenofibrate is detected in plasma." So there is no parent half-life to report — the label gives only one figure: "Fenofibric acid is eliminated with a half-life of 20 hours, allowing once daily dosing." That 20 hours is the elimination (terminal) half-life of the active moiety; the label reports no separate distribution phase. Kidney function matters: the label says patients with mild to moderate renal impairment (eGFR 30–59 mL/min/1.73m2) had similar exposure but "an increase in the half-life for fenofibric acid" compared with healthy subjects (it does not say by how much), and severe impairment (eGFR under 30) showed a 2.7-fold increase in exposure with accumulation on chronic dosing — the label says to avoid fenofibrate in severe renal impairment and to reduce the dose in mild-to-moderate. Older adults: in volunteers aged 77–87 the oral clearance of fenofibric acid was 1.2 L/h versus 1.1 L/h in young adults, i.e. essentially unchanged, so no age-related prolongation is described in those with normal renal function. Liver impairment: the label states no pharmacokinetic studies have been conducted in hepatic impairment, so the half-life there is unknown. Half-life is not the same as how long a drug test can detect the drug, and it varies with age, kidney and liver function.
Can you take fenofibrate with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run fenofibrate against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is fenofibrate sold under?
We track 8 fenofibrate-containing products in the U.S.: Lipidil, Tricor, Tricor (Micronized), Fenofibrate (Micronized), Fenofibrate, Fenoglide, Lipofen and Triglide. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does fenofibrate come in?
Across the brands we track, fenofibrate is currently marketed as capsule and tablet, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic fenofibrate?
Yes. Our catalog lists 2 generic fenofibrate products alongside the brand versions. A generic has the same active ingredient and must meet the FDA's bioequivalence standard; it usually costs less. Ask your pharmacist which one your plan covers.
Has fenofibrate been recalled?
The FDA's Enforcement database lists 2 recall records whose product description mentions fenofibrate. The most recent: Fenofibrate Capsules (May 28, 2026). A recall applies to specific lots, not to the drug as a whole — check the record for the affected lot numbers.
Cite this page
- APA
- pharmaranks. (2026, July 24). Fenofibrate: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/fenofibrate
- MLA
- “Fenofibrate: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/fenofibrate.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for fenofibrate on DailyMed (NIH) ↗.