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.
From the FDA label for Fenofibrate (Micronized) (application ANDA207564). Other fenofibrate products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
2 DOSAGE & ADMINISTRATION • Primary hypercholesterolemia or mixed dyslipidemia: Initial dose of 160 mg once daily ( 2.2 ). • Severe hypertriglyceridemia: Initial dose of 54 to 160 mg once daily. Maximum dose is 160 mg ( 2.3 ). • Renally impaired patients: Initial dose of 54 mg once daily ( 2.4 ). • Geriatric patients: Select the dose on the basis of renal function ( 2.5 ). • Should be given with meals ( 2.1 ). 2.1 General Considerations Patients should be placed on an appropriate lipid-lowering diet before receiving fenofibrate tablets, and should continue this diet during treatment with fenofibrate tablets. Fenofibrate tablets should be given with meals, thereby optimizing the bioavailability of the medication. The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcoholic intake may be important factors in hypertriglyceridemia and should be addressed prior to any drug therapy. Physical exercise can be an important ancillary measure. Diseases contributory to hyperlipidemia, such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy, thiazide diuretics and beta-blockers, are sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of the specific…
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 ) ] • Hepatotoxicity [see Warnings and Precautions ( 5.2) ] • Pancreatitis [ see Warnings and Precautions ( 5.7 ) ] • Hypersensitivity reactions [ see Warnings and Precautions ( 5.9 ) ] • Venothromboembolic disease [ see Warnings and Precautions ( 5.10) ] Adverse reactions > 2% and at least 1% greater than placebo: Abnormal liver tests, increased AST, increased ALT, increased CPK, and rhinitis ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact Macleods Pharma USA, Inc. at 1-888-943-3210 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Adverse events reported by 2% or more of patients treated with fenofibrate (and greater than placebo) during the double-blind, placebo-controlled trials, regardless of causality, are listed in Table 1 below. Adverse events led to discontinuation of treatment in 5.0% of patients treated with fenofibrate and in 3.0% treated with placebo. Increases in liver function tests were…
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? | Typical price | |
|---|---|---|---|---|---|---|---|
| 1 | 72/100 | Prescription | Capsule | Generic | $4 | View → | |
| 2 | 70/100 | Prescription | Capsule | Generic |
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| LS;215 | 160 mg | white | oval | — |
| RG78 | 43 mg | white | capsule | — |
| RG79 | 130 mg | white | capsule | — |
| FN2 | 160 mg | white | oval | — |
| A319 | 200 mg | orange | capsule | — |
| 93;7330 | 54 mg | yellow |
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
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.
Fenofibrate tablets are contraindicated in: • patients with severe renal impairment, including those receiving dialysis [see Clinical Pharmacology ( 12.3 )]. • patients with active liver disease, including those with primary biliary cirrhosis and unexplained persistent liver function abnormalities [see Warnings and Precautions ( 5.2 )]. • patients with preexisting gallbladder disease [see Warnings and Precautions ( 5.5 )]. • nursing mothers [see Use in Specific Populations ( 8.2 )] • patients with known hypersensitivity to fenofibrate or fenofibric acid [see Warnings and Precautions ( 5.9 )]. • Severe renal dysfunction, including dialysis patients ( 4 , 8.6 , 12.3 ). • Active liver disease ( 4 , 5.2 ). • Gallbladder disease ( 4 , 5.5 ). • Known hypersensitivity to fenofibrate ( 4 ). • Nursing mothers ( 4, 8.2).
Coumarin anticoagulants: ( 7.1 ). • Immunosuppressants: ( 7.2 ). • Bile acid resins: ( 7.3 ). 7.1 Coumarin Anticoagulants Potentiation of coumarin-type anticoagulant effects has been observed with prolongation of the PT/INR. 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 [see Warnings and Precautions ( 5.6 )]. 7.2 Immunosuppressants Immunosuppessants 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. The benefits and risks of using fenofibrate with immunosuppressants and other potentially nephrotoxic agents should be carefully considered, and the lowest effective dose employed and renal function monitored. 7.3 Bile Acid Binding Resins Since bile acid binding resins may bind other drugs given concurrently, patients should take fenofibrate at least 1 hour before or 4 to 6 hours after a bile acid…
| $4 |
| View → |
| 3 | 70/100 | Prescription | Tablet | Generic | $4 | View → |
| 4 | 70/100 | Prescription | Capsule | Generic | $4 | View → |
| 5 | 60/100 | Prescription | Capsule | Generic | $4 | View → |
| 6 | Not yet rated | Prescription | Tablet | Generic | $4 | View → |
| 7 | Not yet rated | Prescription | Capsule | Generic | $4 | View → |
| 8 | Not yet rated | Prescription | Tablet | Generic | $4 | View → |
| round |
| — |
| 93;7331 | 160 mg | white | oval | — |
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