Fenofibrate
Fenofibrate is a cholesterol and triglyceride medicine, taken by mouth along with a healthy diet, used for high triglycerides, high cholesterol and mixed dyslipidemia (a combination of lipid problems) in adults.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 144 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Fenofibrate is a fibrate, used with diet mainly to lower high triglycerides (and, for some products, LDL cholesterol) by activating PPAR alpha, a receptor that helps clear triglyceride-rich fats and raises HDL (“good”) cholesterol; it is usually an add-on rather than a first choice, on the market since about 2001 and available as a generic. Most people tolerate it well, and the usual complaints are mild nausea, constipation, belly ache or headache. Watch for unexplained muscle pain or weakness, more likely if you also take a statin, and get help fast for dark urine, yellowing skin or eyes, or swelling of the face or throat.
Clinical pearls
- Food rules differ between fenofibrate products, so check whether yours must be taken with a meal or not.
- If you take warfarin, expect extra INR checks when fenofibrate starts or changes, since it can strengthen the blood thinner.
- Take it at least 1 hour before or 4 to 6 hours after a bile acid resin such as cholestyramine.
- Plan on liver tests before and during treatment, kidney tests too, and an HDL recheck in the first few months.
Patient information guide A plain-language walkthrough of Fenofibrate, written from its FDA label.
What Fenofibrate is used for
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Fenofibrate is used with diet to improve blood fats in adults.
- Tricor and fenofibrate tablets: lower LDL cholesterol, total cholesterol, triglycerides and apolipoprotein B, and raise HDL cholesterol, in primary hypercholesterolemia or mixed dyslipidemia.
- Tricor and fenofibrate tablets: treat severe hypertriglyceridemia.
- Antara and Lipofen capsules: lower triglycerides in severe hypertriglyceridemia (500 mg/dL or higher).
- Antara and Lipofen capsules: lower LDL cholesterol in primary hyperlipidemia when recommended LDL-lowering therapy is not possible.
- Generic fenofibrate capsules: reduce LDL cholesterol, total cholesterol, triglycerides and apolipoprotein B in primary hypercholesterolemia or mixed dyslipidemia, and treat hypertriglyceridemia.
Fenofibrate did not reduce heart disease complications or death in people with type 2 diabetes in large trials.
How Fenofibrate works
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Fenofibrate is a prodrug (it is converted in the body to its active form). The active form, fenofibric acid, switches on a receptor called PPAR alpha. This boosts an enzyme called lipoprotein lipase, which breaks down and clears triglyceride-rich particles from the blood.
Lower triglycerides change LDL from small, dense particles into larger, more easily cleared ones. It also raises HDL cholesterol and lowers uric acid levels.
Fenofibrate dosage
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Fenofibrate is taken by mouth, generally once a day. Some products can be taken with or without food, and others work best with meals. Your dose depends on your condition, your response and your kidney function, so follow your prescriber and your product’s label.
- Stay on a lipid-lowering diet during treatment.
- Your doctor may recheck triglycerides after several weeks and stop it if there is not enough response after about two months.
Dosing details from the FDA-approved label
From the Fenofibrate prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Severe hypertriglyceridemia
- 30 mg to 90 mg orally once daily
- The dose should be adjusted according to patient response
- Recommended dosage is 30 mg or 90 mg orally once daily, individualized according to patient response and adjusted if necessary following repeat lipid determinations at 4 to 8 week intervals
- Administer as a single dose at any time of day, with or without food; discontinue in patients who do not have an adequate response after two months of treatment
- Primary hyperlipidemia
- 90 mg orally once daily
- Administer as a single dose at any time of day, with or without food; discontinue in patients who do not have an adequate response after two months of treatment
- Renal impairment (mild to moderately impaired renal function)
- Initial dosage of 30 mg orally once daily
- Assess renal function prior to initiation and periodically thereafter
- Geriatric patients
- Select the dosage on the basis of renal function
Read the label’s full dosing text
2 DOSAGE AND 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, USP, and should continue this diet during treatment with Fenofibrate Tablets, USP. Fenofibrate Tablets, USP 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 etiologic agent may obviate the need for specific drug therapy of hypertriglyceridemia. Lipid levels should be monitored periodically and consideration should be given to reducing the dosage of Fenofibrate Tablets, USP if lipid levels fall significantly below the targeted range. Therapy should be withdrawn in patients who do not have an adequate response after two months of treatment with the maximum recommended dose of 160 mg once daily. 2.2 Primary Hypercholesterolemia or Mixed Dyslipidemia The initial dose of Fenofibrate Tablets, USP is 160 mg once daily. 2.3 Severe Hypertriglyceridemia The initial dose is 54 to 160 mg per day. Dosage should be individualized according to patient response, and should be adjusted if necessary following repeat lipid determinations at 4 to 8 week intervals. The maximum dose is 160 mg once daily.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Fenofibrate side effects
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The most common effects seen in clinical trials were:
Common side effects
- Abnormal liver blood tests (raised AST or ALT)
- Increased CPK (a muscle enzyme) on blood tests
- Abdominal pain
- Back pain
- Headache
- Nausea
- Constipation
- Runny or stuffy nose (rhinitis)
When to get medical help
- Dark urine, yellow skin or eyes, belly pain, itching, nausea or unusual tiredness, which can signal liver injury
- Unexplained muscle pain, tenderness or weakness, especially with fever or feeling unwell
- Swelling of the face, lips or throat, trouble breathing, or a severe or blistering skin rash or fever with rash
- Severe upper belly pain, which can signal pancreatitis or gallstones
- Leg swelling or pain, sudden chest pain or shortness of breath, which can signal a blood clot
Get help right away for signs of liver injury, muscle damage, serious allergic or skin reactions, pancreatitis or blood clots.
Fenofibrate warnings and precautions
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- Liver injury: serious cases, including transplant and death, have been reported. Liver tests are checked before and during treatment.
- Muscle damage: myopathy and rhabdomyolysis (severe muscle breakdown) are more likely with statins, and in older adults and people with diabetes, kidney problems or low thyroid.
- Kidneys: fenofibrate can reversibly raise serum creatinine.
- Gallstones: it can increase cholesterol in bile.
- Allergic reactions: anaphylaxis, angioedema and severe skin reactions have been reported.
- Other: pancreatitis, lower blood counts, blood clots in the legs or lungs, and sharp drops in HDL cholesterol.
Fenofibrate interactions
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Tell your pharmacist about everything you take. Key interactions include:
- Statins: higher risk of muscle damage.
- Colchicine: muscle damage has been reported.
- Warfarin-type blood thinners: stronger effect and bleeding risk, so INR is monitored.
- Cyclosporine and tacrolimus: possible kidney harm.
- Bile acid resins: they can block absorption, so space doses at least 1 hour before or 4 to 6 hours after.
Interactions listed in the FDA-approved label
From the Fenofibrate prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Statins: Fibrates may cause myopathy when given alone, and the risk of myopathy and rhabdomyolysis is increased with concomitant use of fibrates with statins. Consider if the benefit 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: Cases of myopathy and rhabdomyolysis have been reported with concomitant use of colchicine with fenofibrates. Consider if the benefit 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: Fibrates may cause potentiation of coumarin-type anticoagulant effects with prolongation of the PT/INR. Exercise caution. Reduce the anticoagulant dosage to maintain the PT/INR at the desired level to prevent bleeding complications. Frequent PT/INR determinations are advisable until the PT/INR has stabilized.
- Immunosuppressants (e.g., cyclosporine, tacrolimus): Immunosuppressants can produce nephrotoxicity with decreases in creatinine clearance and rises in serum creatinine, and because renal excretion is the primary elimination route of fibrates, there is a risk of deterioration of renal function. Carefully consider the benefits and risks of using fenofibrate with immunosuppressants and other potentially nephrotoxic agents, use the lowest effective dosage and monitor renal function.
- Bile-acid binding resins: Bile-acid binding resins may bind other drugs given concurrently. Administer fenofibrate at least 1 hour before or 4 to 6 hours after the bile acid resin to avoid impeding its absorption.
Read the label’s full interactions text
7 DRUG INTERACTIONS Table 2 presents clinically important drug interactions with fenofibrate tablets. Table 2. Clinically Important Drug Interactions with Fenofibrate Tablets 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 tablets 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 tablets 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 tablets. 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.
Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Fenofibrate
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- Not for severe kidney disease or dialysis, active liver disease, or existing gallbladder disease.
- Not for anyone allergic to fenofibrate, fenofibric acid or its ingredients.
- Mild to moderate kidney problems call for a lower dose.
- Pregnancy: use only if the benefit justifies the risk.
- Do not breastfeed during treatment and for 5 days after the last dose.
- Not established as safe or effective in children.
- Older adults: dose is based on kidney function.
Fenofibrate overdose
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There is no specific treatment for fenofibrate overdose. Call Poison Help at 1-800-222-1222 or seek medical care. Treatment is supportive care, and dialysis is not expected to help because the drug is highly bound to proteins in the blood.
What Fenofibrate does in the body
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Fenofibric acid lowers total cholesterol, LDL cholesterol, apolipoprotein B, triglycerides and VLDL (triglyceride-rich particles). It raises HDL cholesterol and apolipoproteins A-I and A-II. Whether raising HDL or lowering triglycerides reduces heart risk has not been determined.
How your body processes Fenofibrate
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Fenofibrate is converted in the body to fenofibric acid, the active form. It is absorbed from the gut, and food can improve absorption of some products. Fenofibric acid is highly protein-bound and processed mainly by conjugation, not liver CYP enzymes. It is cleared mostly in urine, with a half-life of about 20 to 23 hours, which allows once-daily dosing. Severe kidney impairment causes the drug to build up.
How to store Fenofibrate
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Store at 20° to 25°C (68° to 77°F). Keep out of the reach of children. Protect from moisture.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Fenofibrate
59 supplements and herbal products have documented interactions with Fenofibrate in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 4
- Moderate · 46
- Minor · 9
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Fenofibrate: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Fenofibrate — the kind of thing our pharmacy team would talk through with you at the counter.
What is fenofibrate for?
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Do I take it with food?
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What side effects should I expect?
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When should I call my doctor?
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Can I take it with my other medicines?
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Is it safe in pregnancy or while breastfeeding?
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Is Fenofibrate available over the counter?
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When was Fenofibrate first available?
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Who makes Fenofibrate?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Fenofibrate on HelloPharmacist
Fenofibrate forms and strengths (how it comes)
Fenofibrate is available in 2 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Fenofibrate inactive ingredients by manufacturer.
Tablet
How this form is used
- Tricor is used with diet for primary hypercholesterolemia or mixed dyslipidemia, and for severe hypertriglyceridemia in adults.
- Tricor tablets can be taken without regard to meals.
- Fenofibrate tablets are taken once daily; some versions are taken with meals and others with or without food, so check your product label.
Capsule
How this form is used
- Antara and Lipofen are used with diet to lower triglycerides in severe hypertriglyceridemia (500 mg/dL or higher).
- Antara and Lipofen are used with diet to lower LDL cholesterol in primary hyperlipidemia when recommended LDL-lowering therapy is not possible.
- Antara capsules are taken once daily, at any time of day, with or without food.
- Lipofen capsules are taken once daily, at any time of day, with food.
- Fenofibrate capsules (generic) are taken once daily, with or without food.
Fenofibrate on the U.S. market: products, makers and brands
How Fenofibrate appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
50 companies list 211 Fenofibrate product records with the FDA, mostly as tablet, capsule; the earliest marketing or approval year on record is 1993. Brand names on the directory include Antara, Fenoglide, Tricor and 5 more; the rest are generics.
FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Powder (15) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
How widely Fenofibrate is used (Medicaid data)
A general measure of how commonly Fenofibrate is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Fenofibrate is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Fenofibrate prescribed? Of the 1,601 medications we measure, Fenofibrate ranks #165 by Medicaid prescriptions — more than 90% of them.
Utilization by Fenofibrate product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
fenofibrate 145 MG Oral Tablet Most dispensed
Summed across the 18 of 119 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 477560
fenofibrate 160 MG Oral Tablet
Summed across the 14 of 165 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 349287
fenofibrate 48 MG Oral Tablet
Summed across the 7 of 87 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 477562
fenofibrate 54 MG Oral Tablet
Summed across the 8 of 79 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 351133
fenofibrate 134 MG Oral Capsule
Summed across the 7 of 35 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 310288
fenofibrate 200 MG Oral Capsule
Summed across the 6 of 35 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 310289
fenofibrate 67 MG Oral Capsule
Summed across the 6 of 29 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 200311
fenofibric acid 135 MG Delayed Release Oral Capsule
Summed across the 5 of 27 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 828373
fenofibrate 120 MG Oral Tablet
Summed across the 2 of 9 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 749802
fenofibrate 130 MG Oral Capsule
Summed across the 2 of 18 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 483425
fenofibrate 40 MG Oral Tablet
Summed across the 1 of 8 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 749804
fenofibrate 43 MG Oral Capsule
Summed across the 3 of 10 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 483427
fenofibrate 150 MG Oral Capsule
Summed across the 2 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 616852
fenofibrate 50 MG Oral Capsule
Summed across the 1 of 5 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 616853
fenofibric acid 45 MG Delayed Release Oral Capsule
Summed across the 4 of 24 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 828379
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Fenofibrate, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 86 of 653 listed Fenofibrate NDCs with Medicaid activity.
Compare Fenofibrate products
A representative set of FDA-listed product records for Fenofibrate — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Capsule | ||||
| 134 mg | Oral | A-S Medication Solutions | ANDA | View NDC → |
| 200 mg | Oral | A-S Medication Solutions | ANDA | View NDC → |
| 67 mg | Oral | Ajanta Pharma USA Inc. | ANDA | View NDC → |
| 134 mg | Oral | Ajanta Pharma USA Inc. | ANDA | View NDC → |
| 200 mg | Oral | Ajanta Pharma USA Inc. | ANDA | View NDC → |
| 67 mg | Oral | Alembic Pharmaceuticals Inc. | ANDA | View NDC → |
| 134 mg | Oral | Alembic Pharmaceuticals Inc. | ANDA | View NDC → |
| 200 mg | Oral | Alembic Pharmaceuticals Inc. | ANDA | View NDC → |
| 67 mg | Oral | Alembic Pharmaceuticals Limited | ANDA | View NDC → |
| 134 mg | Oral | Alembic Pharmaceuticals Limited | ANDA | View NDC → |
| 200 mg | Oral | Alembic Pharmaceuticals Limited | ANDA | View NDC → |
| 200 mg | Oral | American Health Packaging | ANDA | View NDC → |
| 50 mg | Oral | ANI Pharmaceuticals, Inc. | NDA | View NDC → |
| 50 mg | Oral | ANI Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | View NDC → |
| 67 mg | Oral | ANI Pharmaceuticals, Inc. | ANDA | View NDC → |
| 134 mg | Oral | ANI Pharmaceuticals, Inc. | ANDA | View NDC → |
| 150 mg | Oral | ANI Pharmaceuticals, Inc. | NDA | View NDC → |
| 150 mg | Oral | ANI Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | View NDC → |
| 200 mg | Oral | ANI Pharmaceuticals, Inc. | ANDA | View NDC → |
| 43 mg | Oral | Apotex Corp. | ANDA | View NDC → |
| 130 mg | Oral | Apotex Corp. | ANDA | View NDC → |
| 67 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 134 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 200 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 67 mg | Oral | Bostal LLC | ANDA | View NDC → |
| 134 mg | Oral | Bostal LLC | ANDA | View NDC → |
| 200 mg | Oral | Bostal LLC | ANDA | View NDC → |
| 67 mg | Oral | Chartwell RX, LLC. | ANDA | View NDC → |
| 134 mg | Oral | Chartwell RX, LLC. | ANDA | View NDC → |
| 200 mg | Oral | Chartwell RX, LLC. | ANDA | View NDC → |
| 67 mg | Oral | Cipla USA Inc., | ANDA | View NDC → |
| 134 mg | Oral | Cipla USA Inc., | ANDA | View NDC → |
| 200 mg | Oral | Cipla USA Inc., | ANDA | View NDC → |
| 67 mg | Oral | Coupler LLC | ANDA | View NDC → |
| 43 mg | Oral | Dr. Reddy's Laboratories Limited | ANDA | View NDC → |
| 130 mg | Oral | Dr. Reddy's Laboratories Limited | ANDA | View NDC → |
| 67 mg | Oral | Glenmark Pharmaceuticals Inc., USA | ANDA | View NDC → |
| 134 mg | Oral | Glenmark Pharmaceuticals Inc., USA | ANDA | View NDC → |
| 200 mg | Oral | Glenmark Pharmaceuticals Inc., USA | ANDA | View NDC → |
| 30 mg | Oral | Lupin Pharmaceuticals, Inc. | NDA | View NDC → |
| 43 mg | Oral | Lupin Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | View NDC → |
| 43 mg | Oral | Lupin Pharmaceuticals, Inc. | NDA | View NDC → |
| 90 mg | Oral | Lupin Pharmaceuticals, Inc. | NDA | View NDC → |
| 130 mg | Oral | Lupin Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | View NDC → |
| 130 mg | Oral | Lupin Pharmaceuticals, Inc. | NDA | View NDC → |
| 130 mg | Oral | PD-Rx Pharmaceuticals, Inc. | ANDA | View NDC → |
| 43 mg | Oral | Sun Pharmaceutical Industries, Inc. | ANDA | View NDC → |
| 130 mg | Oral | Sun Pharmaceutical Industries, Inc. | ANDA | View NDC → |
| 67 mg | Oral | Torrent Pharmaceuticals Limited | ANDA | View NDC → |
| 134 mg | Oral | Torrent Pharmaceuticals Limited | ANDA | View NDC → |
| 200 mg | Oral | Torrent Pharmaceuticals Limited | ANDA | View NDC → |
| 💊Tablet | ||||
| 48 mg | Oral | A-S Medication Solutions × 3 listings | ANDA | View NDC → |
| 54 mg | Oral | A-S Medication Solutions × 3 listings | ANDA | View NDC → |
| 145 mg | Oral | A-S Medication Solutions | NDA | View NDC → |
| 145 mg | Oral | A-S Medication Solutions × 5 listings | ANDA | View NDC → |
| 160 mg | Oral | A-S Medication Solutions | ANDA | View NDC → |
| 54 mg | Oral | Ajanta Pharma USA Inc. | ANDA | View NDC → |
| 160 mg | Oral | Ajanta Pharma USA Inc. | ANDA | View NDC → |
| 48 mg | Oral | Alembic Pharmaceuticals Inc. | ANDA | View NDC → |
| 54 mg | Oral | Alembic Pharmaceuticals Inc. × 3 listings | ANDA | View NDC → |
| 145 mg | Oral | Alembic Pharmaceuticals Inc. | ANDA | View NDC → |
| 160 mg | Oral | Alembic Pharmaceuticals Inc. × 3 listings | ANDA | View NDC → |
| 48 mg | Oral | Alembic Pharmaceuticals Limited | ANDA | View NDC → |
| 54 mg | Oral | Alembic Pharmaceuticals Limited × 2 listings | ANDA | View NDC → |
| 145 mg | Oral | Alembic Pharmaceuticals Limited | ANDA | View NDC → |
| 160 mg | Oral | Alembic Pharmaceuticals Limited × 2 listings | ANDA | View NDC → |
| 48 mg | Oral | American Health Packaging | ANDA | View NDC → |
| 54 mg | Oral | American Health Packaging | ANDA | View NDC → |
| 145 mg | Oral | American Health Packaging | ANDA | View NDC → |
| 160 mg | Oral | American Health Packaging | ANDA | View NDC → |
| 54 mg | Oral | Amneal Pharmaceuticals LLC | ANDA | View NDC → |
| 160 mg | Oral | Amneal Pharmaceuticals LLC | ANDA | View NDC → |
| 48 mg | Oral | Amneal Pharmaceuticals NY LLC | ANDA | View NDC → |
| 54 mg | Oral | Amneal Pharmaceuticals NY LLC | ANDA | View NDC → |
| 145 mg | Oral | Amneal Pharmaceuticals NY LLC | ANDA | View NDC → |
| 160 mg | Oral | Amneal Pharmaceuticals NY LLC | ANDA | View NDC → |
| 54 mg | Oral | Amneal Pharmaceuticals of New York LLC | ANDA | View NDC → |
| 160 mg | Oral | Amneal Pharmaceuticals of New York LLC | ANDA | View NDC → |
| 48 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 54 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 145 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 160 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 48 mg | Oral | AvKARE | ANDA | View NDC → |
| 145 mg | Oral | AvKARE × 2 listings | ANDA | View NDC → |
| 160 mg | Oral | AvKARE | ANDA | View NDC → |
| 48 mg | Oral | AvPAK | ANDA | View NDC → |
| 54 mg | Oral | AvPAK | ANDA | View NDC → |
| 160 mg | Oral | AvPAK | ANDA | View NDC → |
| 48 mg | Oral | Bostal LLC | ANDA | View NDC → |
| 54 mg | Oral | Bostal LLC | ANDA | View NDC → |
| 145 mg | Oral | Bostal LLC | ANDA | View NDC → |
| 160 mg | Oral | Bostal LLC | ANDA | View NDC → |
| 40 mg | Oral | Bryant Ranch Prepack × 2 listings | ANDA | View NDC → |
| 48 mg | Oral | Bryant Ranch Prepack × 3 listings | ANDA | View NDC → |
| 120 mg | Oral | Bryant Ranch Prepack × 2 listings | ANDA | View NDC → |
| 145 mg | Oral | Bryant Ranch Prepack × 4 listings | ANDA | View NDC → |
| 160 mg | Oral | Bryant Ranch Prepack | ANDA | View NDC → |
| 48 mg | Oral | Camber Pharmaceuticals, Inc. | ANDA | View NDC → |
| 145 mg | Oral | Camber Pharmaceuticals, Inc. | ANDA | View NDC → |
| 54 mg | Oral | Chartwell RX, LLC | ANDA | View NDC → |
| 160 mg | Oral | Chartwell RX, LLC | ANDA | View NDC → |
| 48 mg | Oral | Cipla USA Inc. | ANDA | View NDC → |
| 145 mg | Oral | Cipla USA Inc. | ANDA | View NDC → |
| 40 mg | Oral | Creekwood Pharmaceuticals LLC | ANDA | View NDC → |
| 120 mg | Oral | Creekwood Pharmaceuticals LLC | ANDA | View NDC → |
| 54 mg | Oral | Dr. Reddy's Laboratories Inc. | ANDA | View NDC → |
| 160 mg | Oral | Dr. Reddy's Laboratories Inc. | ANDA | View NDC → |
| 48 mg | Oral | Golden State Medical Supply, Inc. | ANDA | View NDC → |
| 54 mg | Oral | Golden State Medical Supply, Inc. | ANDA | View NDC → |
| 145 mg | Oral | Golden State Medical Supply, Inc. | ANDA | View NDC → |
| 48 mg | Oral | Laurus Labs Limited | ANDA | View NDC → |
| 54 mg | Oral | Laurus Labs Limited | ANDA | View NDC → |
| 145 mg | Oral | Laurus Labs Limited | ANDA | View NDC → |
| 160 mg | Oral | Laurus Labs Limited | ANDA | View NDC → |
| 48 mg | Oral | Leading Pharma, LLC | ANDA | View NDC → |
| 54 mg | Oral | Leading Pharma, LLC | ANDA | View NDC → |
| 145 mg | Oral | Leading Pharma, LLC | ANDA | View NDC → |
| 160 mg | Oral | Leading Pharma, LLC | ANDA | View NDC → |
| 54 mg | Oral | Lifestar Pharma LLC | ANDA | View NDC → |
| 160 mg | Oral | Lifestar Pharma LLC | ANDA | View NDC → |
| 48 mg | Oral | Lupin Pharmaceuticals, Inc. | ANDA | View NDC → |
| 54 mg | Oral | Lupin Pharmaceuticals, Inc. | ANDA | View NDC → |
| 145 mg | Oral | Lupin Pharmaceuticals, Inc. | ANDA | View NDC → |
| 160 mg | Oral | Lupin Pharmaceuticals, Inc. | ANDA | View NDC → |
| 48 mg | Oral | Macleods Pharmaceuticals Limited | ANDA | View NDC → |
| 54 mg | Oral | Macleods Pharmaceuticals Limited | ANDA | View NDC → |
| 145 mg | Oral | Macleods Pharmaceuticals Limited | ANDA | View NDC → |
| 160 mg | Oral | Macleods Pharmaceuticals Limited | ANDA | View NDC → |
| 145 mg | Oral | Major Pharmaceuticals × 2 listings | ANDA | View NDC → |
| 160 mg | Oral | Major Pharmaceuticals | ANDA | View NDC → |
| 48 mg | Oral | Mylan Institutional Inc. | ANDA | View NDC → |
| 145 mg | Oral | Mylan Institutional Inc. | ANDA | View NDC → |
| 40 mg | Oral | Mylan Pharmaceuticals Inc. | ANDA | View NDC → |
| 48 mg | Oral | Mylan Pharmaceuticals Inc. | ANDA | View NDC → |
| 120 mg | Oral | Mylan Pharmaceuticals Inc. | ANDA | View NDC → |
| 145 mg | Oral | Mylan Pharmaceuticals Inc. | ANDA | View NDC → |
| 160 mg | Oral | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | View NDC → |
| 145 mg | Oral | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA | View NDC → |
| 54 mg | Oral | NorthStar RxLLC | ANDA | View NDC → |
| 160 mg | Oral | NorthStar RxLLC | ANDA | View NDC → |
| 48 mg | Oral | Northwind Health Company, LLC | ANDA | View NDC → |
| 145 mg | Oral | Northwind Health Company, LLC × 3 listings | ANDA | View NDC → |
| 160 mg | Oral | Northwind Health Company, LLC × 2 listings | ANDA | View NDC → |
| 48 mg | Oral | NuCare Pharmaceuticals,Inc. | ANDA | View NDC → |
| 145 mg | Oral | NuCare Pharmaceuticals,Inc. × 2 listings | ANDA | View NDC → |
| 160 mg | Oral | NuCare Pharmaceuticals,Inc. × 2 listings | ANDA | View NDC → |
| 160 mg | Oral | PD-Rx Pharmaceuticals, Inc. | ANDA | View NDC → |
| 145 mg | Oral | Preferred Pharmaceuticals, Inc. | ANDA | View NDC → |
| 145 mg | Oral | Preferred Pharmaceuticals Inc. | ANDA | View NDC → |
| 160 mg | Oral | Preferred Pharmaceuticals Inc. × 2 listings | ANDA | View NDC → |
| 54 mg | Oral | Proficient Rx LP | ANDA | View NDC → |
| 160 mg | Oral | Proficient Rx LP × 2 listings | ANDA | View NDC → |
| 160 mg | Oral | Quality Care Products, LLC | ANDA | View NDC → |
| 145 mg | Oral | Quallent Pharmaceuticals Health Llc | ANDA | View NDC → |
| 54 mg | Oral | Remedyrepack Inc. × 2 listings | ANDA | View NDC → |
| 145 mg | Oral | Remedyrepack Inc. | ANDA | View NDC → |
| 160 mg | Oral | Remedyrepack Inc. × 2 listings | ANDA | View NDC → |
| 54 mg | Oral | Rhodes Pharmaceuticals LLC | ANDA | View NDC → |
| 160 mg | Oral | Rhodes Pharmaceuticals LLC | ANDA | View NDC → |
| 48 mg | Oral | Safecor Health, LLC | ANDA | View NDC → |
| 145 mg | Oral | Safecor Health, LLC | ANDA | View NDC → |
| 48 mg | Oral | Solco Healthcare US, LLC | ANDA | View NDC → |
| 145 mg | Oral | Solco Healthcare US, LLC | ANDA | View NDC → |
| 160 mg | Oral | St. Mary's Medical Park Pharmacy | ANDA | View NDC → |
| 145 mg | Oral | Sun Pharmaceutical Industries, Inc. | ANDA | View NDC → |
| 40 mg | Oral | Trifluent Pharma LLC | ANDA | View NDC → |
| 120 mg | Oral | Trifluent Pharma LLC | ANDA | View NDC → |
| 160 mg | Oral | Westminster Pharmaceuticals, LLC | ANDA | View NDC → |
Showing 200 of 211 products — FDA National Drug Code Directory. See every product, package size and price: browse all 211 Fenofibrate NDCs →
Fenofibrate side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Fenofibrate — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Fenofibrate in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Fenofibrate FDA approval history
How Fenofibrate went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Fenofibrate recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list 2 Fenofibrate recalls since July 2021. Both are still ongoing or began in the last six months. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.
- Fenofibrate Capsules, USP 200 mg, Rx only, 100 Capsules, Manufactured by: Ajanta Pharma Limited, India, Marketed by: Ajanta Pharma USA Inc. Bridgewater, NJ 08807, NDC 27241-120-04. Lots: Lot # PA02216; Exp. 12/2029 FDA record D-0611-2026 →
- Fenofibrate Capsules 67 mg, USP, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc.… Lots: Lot # 17230834, exp. date Mar-25 17230835, exp. date Mar-25 FDA record D-0314-2025 →
Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 8703 3 dose forms · 23 strengths
-
Dose form (SCDF) Delayed Release Oral Capsule RxCUI 439656No current FDA listingClinical drug / strength (SCD) fenofibric acid 135 MGRxCUI 828373fenofibric acid 45 MGRxCUI 828379 -
Dose form (SCDF) Oral Capsule RxCUI 379815In current FDA listings -
Dose form (SCDF) Oral Tablet RxCUI 379818In current FDA listings
Look up RxCUI 8703 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Fenofibrate supply and shortage status
Whether Fenofibrate is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
💵 What Fenofibrate costs pharmacies (NADAC benchmark)
The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.
| Form | Strength | Pharmacy acquisition benchmark | |
|---|---|---|---|
| Tablet · Oral | 160 mg | $0.103 per tablet | NDC details & price history |
| Tablet · Oral | 54 mg | $0.073 per tablet | NDC details & price history |
| Tablet · Oral | 120 mg | $16.76 per tablet | NDC details & price history |
| Tablet · Oral | 40 mg | $5.54 per tablet | NDC details & price history |
| Tablet, Film Coated · Oral | 145 mg | $0.120 per tablet | NDC details & price history |
| Tablet, Film Coated · Oral | 48 mg | $0.079 per tablet | NDC details & price history |
| Capsule · Oral | 200 mg | $0.164 per capsule | NDC details & price history |
| Capsule · Oral | 134 mg | $0.119 per capsule | NDC details & price history |
| Capsule · Oral | 67 mg | $0.092 per capsule | NDC details & price history |
| Capsule · Oral | 90 mg | $16.23 per capsule | NDC details & price history |
Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.
Fenofibrate brand names
Fenofibrate is sold under 8 brand names in the FDA directory — Antara, Fenoglide, Tricor, Triglide and others. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Fenofibrate: manufacturers and labelers
50 companies list Fenofibrate products with the FDA. By number of product records, the largest are A-S Medication Solutions, Bryant Ranch Prepack, Alembic Pharmaceuticals Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
…and 26 more on the FDA NDC directory.
Fenofibrate drug class (RxNorm)
Fenofibrate belongs to the Peroxisome Proliferator-activated Receptor alpha Agonist class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Fenofibrate page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Lupin Pharmaceuticals, Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →