Consumer Drug Information

Fenofibrate

Generic Name: Fenofibrate Capsules and Tablets (FEN-oh-FYE-brate)
Brand Name: Examples include Antara and Tricor

Fenofibrate is used for:

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Controlling high cholesterol and triglyceride levels in the blood. It is used in combination with a diet low in cholesterol and saturated fat.

Fenofibrate is a lipid-lowering agent. It lowers elevated blood triglyceride levels by making the liver produce fewer triglycerides and increasing the elimination of triglycerides from the blood stream.

Do NOT use Fenofibrate if:

you are allergic to any ingredient in Fenofibrate
you have gallbladder problems, liver problems (including cirrhosis), or severe kidney problems
you are breast-feeding or pregnant

Contact your doctor or health care provider right away if any of these apply to you.

Before using Fenofibrate :

Some medical conditions may interact with Fenofibrate . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines or other substances
if you have diabetes, underactive thyroid, heart blood vessel problems, gallstones, kidney problems, or certain muscle problems (myopathy)
if you are very overweight, have an inactive lifestyle, or you drink large amounts of alcohol
if you are taking a beta-blocker (eg, propranolol), estrogen, or thiazide diuretic (eg, hydrochlorothiazide)

Some MEDICINES MAY INTERACT with Fenofibrate . Tell your health care provider if you are taking any other medicines, especially any of the following:

HMG-CoA reductase inhibitors (eg, simvastatin) because the risk of serious muscle problems leading to kidney failure may be increased
Immunosuppressants (eg, cyclosporine) or other medicines that may harm the kidney (eg, aminoglycoside antibiotics [eg, gentamicin], amphotericin B, nonsteroidal anti-inflammatory drugs [NSAIDs] [eg, ibuprofen] tacrolimus, vancomycin) because they may decrease Fenofibrate 's excretion and increase the risk of its side effects
Anticoagulants (eg, warfarin) or sulfonylureas (eg, glipizide) because the risk of their side effects may be increased by Fenofibrate

This may not be a complete list of all interactions that may occur. Ask your health care provider if Fenofibrate may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Fenofibrate :

Use Fenofibrate as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Fenofibrate by mouth with or without food.
Swallow Fenofibrate whole. Do not break, crush, or chew before swallowing. Do not take chipped or broken tablets.
If you also take a bile acid binding resin (eg, cholestyramine) do not take it within 4 to 6 hours before or 1 hour after taking Fenofibrate . Check with your doctor if you have any questions.
If you miss a dose of Fenofibrate , take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Fenofibrate .

Important safety information:

Fenofibrate may cause dizziness or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Fenofibrate with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
Follow the diet, exercise program, and weight reduction program given to you by your health care provider.
Lab tests, including liver function, kidney function, blood cholesterol, and other blood tests, may be performed while you use Fenofibrate . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
Use Fenofibrate with caution in the ELDERLY; they may be more sensitive to its effects.
Fenofibrate should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
PREGNANCY and BREAST-FEEDING: If you plan on becoming pregnant, contact your doctor. You will need to discuss the benefits and risks of using Fenofibrate while you are pregnant. It is not known if Fenofibrate is found in breast milk. Do not breast-feed while taking Fenofibrate .

Possible side effects of Fenofibrate :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Headache; nausea.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chills or sore throat; dark urine; fever; muscle pain, tenderness, or weakness; pale stools; red, swollen, blistered or peeling skin; severe or persistent nausea, vomiting, or stomach pain; unusual bruising or bleeding; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http: / / www.aapcc.org / dnn / Resources / FindLocalPoisonCenters / tabid / 130 / Default.aspx), or emergency room immediately.

Proper storage of Fenofibrate :

Store Fenofibrate between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Protect from moisture. Do not store in the bathroom. Keep Fenofibrate out of the reach of children and away from pets.

General information:

If you have any questions about Fenofibrate , please talk with your doctor, pharmacist, or other health care provider.
Fenofibrate is to be used only by the patient for whom it is prescribed. Do not share it with other people.
If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Fenofibrate . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: August 6, 2008

Database Edition 08.3.1.002