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Fenofibrate (fibrate, cholesterol-lowering agent)

Uses|Precautions & warnings|Side effects|Interactions|Dosage

Fenofibrate is part of a class of drugs known as antihyperlipidemics, specifically a fibrate. Together with a low-fat, low-cholesterol diet, fibrates help to lower total cholesterol and low-density lipoprotein (LDL) or “bad” cholesterol levels while improving high-density lipoprotein (HDL) or “good” cholesterol levels. This results in lowering the risk or formation of atherosclerotic plaques, which can cause hypertension and embolisms.

hypocholesterolemia

Uses

What is fenofibrate used for?

Fenofibrate is mainly indicated to treat the following conditions:

  • Hypertriglyceridemia
  • Mixed hyperlipidemia
  • Primary biliary cholangitis (off-label use)

How should I take fenofibrate?

Fenofibrate is available as oral tablets and capsules. Swallow it whole without chewing, crushing, or dissolving it in liquid. It is best taken with meals.

How do I store fenofibrate?

This drug should be stored at room temperature (15-30°C) and be protected from light and moisture. Always check the label before using this product. For safety, keep out of the reach of children and pets.

Do not use if the printed expiration date has passed, the product seal has been broken, or the product has changed in color, odor, or consistency.

Do not dispose of this product by pouring it down the drain, toilet, or into the environment. Ask your pharmacist regarding the proper way and location of disposal.

Precautions & warnings

What should I know before using fenofibrate?

Lipid-lowering agents, including fenofibrate, may be associated with an increased risk of muscle pain, weakness, and fatigue. This risk is further increased in patients taking other medications such as statins or certain antibiotics.

Before using this drug, tell your doctor if you are/have:

  • Pregnant or breastfeeding.
  • Taking any other medicines. This includes any prescription, OTC, and herbal remedies.
  • An allergy to any of the ingredients of this product.
  • Any other illnesses, disorders, or medical conditions.

Is it safe during pregnancy or breastfeeding?

Unfortunately, there isn’t enough information about the safety of using this drug during pregnancy and breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking any medication.

This medication is pregnancy risk category C according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk
  • B=No risk in some studies
  • C=There may be some risk
  • D=Positive evidence of risk
  • X=Contraindicated
  • N=Unknown

Side effects

What side effects can occur when using fenofibrate?

Like all drugs, this product may have side effects. If they occur, side effects are generally mild and resolve once treatment is finished or the dose is lowered. Some reported side effects include:

  • Nausea, vomiting, diarrhea
  • Fatigue
  • Myopathy
  • Muscle cramps
  • Headache
  • Dizziness
  • Rash
  • Photosensitivity
  • Hair loss
  • Sinusitis, rhinitis
  • Agranulocytosis, thrombocytopenia

Seek medical attention immediately if you experience any of these serious, potentially fatal drug reactions:

However, not everyone experiences these side effects. In addition, some people may experience other side effects. So, if you have any concerns about a side effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with fenofibrate?

This medication may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects.

To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs, and herbal products) and share it with your doctor and pharmacist.

Drugs with known interactions:

  • Colchicine, statins, and other fibrates
  • Ciclosporin
  • Oral anticoagulants
  • Ezetimibe
  • Bile acid sequestrants

If you experience an adverse drug interaction, inform your doctor immediately to reevaluate your treatment plan. Approaches include dose adjustment, drug substitution, or ending therapy.

Does food or alcohol interact with fenofibrate?

This drug may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. It should be taken with meals for optimal absorption and effect. Do not take it with alcohol as it increases the risk of liver damage. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with fenofibrate?

This drug may interact with underlying conditions. This interaction may worsen your health condition or alter the way the drug works. Therefore, it is important to always let your doctor and pharmacist know all the health conditions you currently have, especially:

  • Severe renal impairment
  • Active liver disease
  • Gallbladder disease
  • Pancreatitis

Dosage

The information provided is not a substitute for any medical advice. Therefore, you should always consult with your doctor or pharmacist before using any medication.

What is the dose for an adult?

For severe hypertriglyceridemia

  • Standard micronized formulation
    • Initial dose: take 67 mg three times a day or 200 mg once per day.
    • Maintenance dose: may be reduced to 67 mg two times per day or increased to 67 mg four times per day, or 267 mg once daily, depending on your response.
  • Non-micronized formulation
    • Initial dose: 200-300 mg per day, given in divided doses.
    • Maintenance dose: take 200-400 mg per day depending on your response.
  • Improved bioavailability formulation: take 40-160 mg per day.

For mixed hyperlipidemia

  • Standard micronized formulation
    • Initial dose: take 67 mg three times a day or 200 mg once per day.
    • Maintenance dose: may be reduced to 67 mg two times per day or increased to 67 mg four times per day, or 267 mg once daily, depending on your response.
  • Non-micronized formulation
    • Initial dose: 200-300 mg per day, given in divided doses.
    • Maintenance dose: take 200-400 mg per day depending on your response.
  • Improved bioavailability formulation: take 40-160 mg per day.

What is the dose for a child?

There is no established pediatric dose. It may be unsafe for your child. It is always important to fully understand the safety of the drug before using. Please consult with your doctor or pharmacist for more information.

How is fenofibrate available?

This drug is available in the following brands, dosage forms, and strengths:

  • Audra capsule 300 mg
  • Diafeno capsule 200 mg
  • Fenofast capsule 200 mg
  • Fenogal capsule 160 mg
  • Fenolit capsule 200 mg
  • Lipanthyl NT tablet 145 mg, Supra modified-release tablet 160 mg, 67M capsule 67 mg
  • Lipiduce film-coated tablet 160 mg
  • Lipway tablet 160 mg
  • Lipway SR modified-release capsule 250 mg
  • Nubrex capsule 300 mg
  • Trichek capsule 200 mg
  • Trolip capsule 300 mg
  • Zinof capsule 200 mg

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to the nearest emergency room.

What should I do if I miss a dose?

If you miss a dose, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

Hello Health Group does not provide medical advice, diagnosis or treatment.

Sources

Fenofibrate https://www.mims.com/philippines/drug/info/fenofibrate Accessed June 28, 2021

Fenofibrate (Oral Route) https://www.mayoclinic.org/drugs-supplements/fenofibrate-oral-route/proper-use/drg-20068427 Accessed June 28, 2021

Fenofibrate – Fenoflex https://assets.unilab.com.ph/uploads/Common/Products/Fenoflex/fenoflex.pdf Accessed June 28, 2021

Fenofibrate https://www.ncbi.nlm.nih.gov/books/NBK559219/ Accessed June 28, 2021

Fenofibrate and Derivatives. Lexi-Drugs. Lexicomp. Wolters Kluwer Health, Inc. Riverwoods, IL. Accessed June 28, 2021. http://online.lexi.com

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Written by Stephanie Nicole Nera, RPh, PharmD Updated Jun 28
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