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What is TriCor?

TriCor (fenofibrate) helps reduce cholesterol and triglycerides (fatty acids) in the blood. High levels of these types of fat in the blood are associated with an increased risk of atherosclerosis (clogged arteries).

TriCor is used to treat high cholesterol and high triglyceride levels.

TriCor may also be used for purposes not listed in this medication guide.

Important information about TriCor

You should not use TriCor if you are allergic to fenofibrate, or if you have liver disease, gallbladder disease, severe kidney disease, or if you are on dialysis.

Do not take fenofibrate if you are breast-feeding a baby.

Before taking TriCor

You should not use TriCor if you are allergic to fenofibrate, or if you have:

  • liver disease;

  • severe kidney disease (or if you are on dialysis);

  • gallbladder disease;

  • if you are breast-feeding a baby.

To make sure TriCor is safe for you, tell your doctor if you have:

  • kidney disease;

  • diabetes;

  • heart disease;

  • a thyroid disorder; or

  • a history of pancreatitis or liver disease.

FDA pregnancy category C. It is not known whether TriCor will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

Fenofibrate can pass into breast milk and may harm a nursing baby. Do not breast-feed while taking TriCor.

How should I take TriCor?

Take TriCor exactly as it was prescribed for you. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

TriCor may be taken with or without food. Follow the directions on your medicine label.

Use TriCor regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

If you also take cholestyramine, colesevelam, colestipol: these other medicines should be taken at least 1 hour after or 4 hours before you take TriCor.

TriCor is only part of a treatment program that may also include diet, exercise, and weight control. Follow your doctor's instructions very closely.

While using TriCor, you may need frequent blood tests at your doctor's office. Your liver and gallbladder function may also need to be tested.

Store at room temperature away from moisture, heat, and light. Keep the tablets in their original container, along with the packet or canister of moisture-absorbing preservative.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking TriCor?

If you also take cholestyramine, colesevelam, or colestipol: Wait 4 to 6 hours after taking any of these other medicines before you take TriCor. Avoid taking TriCor within 1 hour before taking the other medicine.

Avoid drinking alcohol. It can raise triglyceride levels, and may also damage your liver while you are taking TriCor.

TriCor side effects

Get emergency medical help if you have any of these signs of an allergic reaction to TriCor: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

In rare cases, TriCor can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored urine.

Stop using TriCor and call your doctor at once if you have:

  • severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;

  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

  • chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; or

  • pain, swelling, warmth, or redness in one or both legs.

Common TriCor side effects may include:

  • mild stomach pain;

  • back pain;

  • headache; or

  • runny or stuffy nose.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect TriCor?

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with TriCor, especially:

  • other cholesterol lowering medicines;

  • colchicine;

  • a blood thinner such as warfarin, Coumadin;

  • medicines to treat a bowel disorder;

  • drugs that weaken immune system such as cancer medicine, steroids, and medicines to prevent organ transplant rejection;

  • antiviral medications;

  • chemotherapy;

  • pain or arthritis medicines (including aspirin, Tylenol, Advil, and Aleve); or

  • any injected antibiotics.

This list is not complete. Other drugs may interact with TriCor, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

For the Consumer

Applies to fenofibrate: oral capsule, oral tablet

Along with its needed effects, fenofibrate (the active ingredient contained in TriCor) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking fenofibrate:

Less common
  • Chills or fever
  • hives or skin rash
  • itching
  • muscle aches and pains
  • nausea or vomiting
Rare
  • Chronic indigestion
  • dark urine
  • muscle cramps, pain, stiffness, swelling, or weakness
  • troubled breathing
  • unusual bleeding or bruising
  • unusual tiredness
  • yellow eyes or skin
Incidence not known
  • Agitation
  • bloating
  • bloody urine
  • decreased frequency or amount of urine
  • lower back or side pain
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • swelling of the face, fingers, or lower legs
  • swollen joints
  • upper right abdominal or stomach pain

Some side effects of fenofibrate may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Runny nose
  • sneezing
  • stuffy nose
Less common
  • Back pain
  • diarrhea
  • eye irritation
  • gas
  • increased sensitivity of the skin to sunlight
Incidence not known
  • Lack or loss of strength

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Applies to fenofibrate: oral capsule, oral tablet

General

General total body symptoms have included asthenia/fatigue or flu-like symptoms (5%) and infection (18%). During clinical studies, 6% of patients discontinued fenofibrate (the active ingredient contained in TriCor) because of drug-related adverse effects. The most common reason for discontinuation of fenofibrate was skin rash in 2% of patients.

Body as a whole effects probably related to fenofibrate or where causality has not yet been established include weight loss and fever.

Hepatic

In clinical studies, 6% of patients receiving 134 mg to 200 mg fenofibrate (the active ingredient contained in TriCor) daily experienced transaminase levels greater than 3 times the upper limits of normal. No such incidences occurred in patients receiving dosages of 34 mg to 67 mg daily. Hepatotoxicity can occur following weeks or years of therapy and is dose related. Cirrhosis associated with chronic active hepatitis has been reported.

Hepatic side effects have included significant increases in serum transaminase levels.

Musculoskeletal

Patients should be instructed to report symptoms of muscle pain, weakness, or tenderness. If such symptoms develop, creatine kinase should be measured, and, if elevated, fenofibrate (the active ingredient contained in TriCor) should be discontinued.

Gemfibrozil is associated with a higher incidence of myotoxicity (i.e., rhabdomyolysis) than fenofibrate when used in combination with any HMG CoA reductase inhibitor (statin). Fenofibrate is primarily metabolized by glucuronidation, whereas gemfibrozil undergoes extensive oxidative metabolism which results in higher plasma levels of statins. This pharmacokinetic difference may account for the differences in the rates of myotoxicity.

A patient with auto-immune thyroiditis induced hypothyroidism developed acute renal failure secondary to simvastatin/fenofibrate combination therapy induced rhabdomyolysis. Following discontinuation of simvastatin/fenofibrate therapy and thyroid replacement, symptoms (i.e., muscle pain, oliguria) resolved and renal function returned to normal within 14 days.

Musculoskeletal side effects have included arthralgias (3%). In addition, the use of fibrate derivatives, including fenofibrate occasionally has been associated with myositis. Rhabdomyolysis has occurred rarely and generally in association with impaired renal function. Myopathy should be considered in the presence of symptoms of diffuse myalgias, muscle tenderness or weakness, and/or significant increase in serum creatine kinase. Combination therapy with HMG-CoA reductase inhibitors may increase the potential for myositis. Elevations in serum creatinine have also been associated with fenofibrate therapy.

Gastrointestinal

Gastrointestinal side effects included dyspepsia (5%), nausea/vomiting (4%), flatulence, abdominal pain, constipation, or diarrhea (3%), and eructation (1%). In addition, an increased incidence of gallbladder disease/surgeries and pancreatitis occurred during clinical studies. Fibrate derivatives, including fenofibrate (the active ingredient contained in TriCor) may increase cholesterol excretion into bile and result in cholelithiasis.

Gastrointestinal side effects having occurred during fenofibrate therapy where causality has not yet been established have included hematemesis.

Dermatologic

Dermatologic side effects have included pruritus (3%) and rash (6%). During clinical studies, 2% of patients discontinued fenofibrate (the active ingredient contained in TriCor) therapy because of rashes.

Dermatologic side effects possibly related to fenofibrate or where causality has not yet been established have included: photosensitivity, eczema, lupus-like syndrome, ichthyosis, telangiectasis, and alopecia.

Renal

Renal side effects have included acute renal failure. The accumulation of fenofibric acid in the presence of preexisting renal dysfunction causes an increase in levels of fenofibric acid, the main metabolite of fenofibrate (the active ingredient contained in TriCor) Renal side effects of fenofibric acid accumulation include acute renal failure associated with myositis and rhabdomyolysis.

Cardiovascular

Cardiovascular effects which have occurred during fenofibrate (the active ingredient contained in TriCor) therapy where causality has not yet been established include facial and peripheral edema, angina, palpitations, tachycardia, migraine and epistaxis.

Cardiovascular side effects have included arrhythmia (1%) and pulmonary embolus (PE).

Nervous system

Nervous system side effects have included decreased libido (2%) and insomnia (1%).

Nervous system effects probably related to fenofibrate or where causality has not yet been established include dry mouth, vertigo, anxiety, sleep disorders, and confusion.

Respiratory

Respiratory effects probably related to fenofibrate (the active ingredient contained in TriCor) or where causality has not yet been established include allergic pulmonary alveolitis and congestion.

Respiratory side effects have included cough or sinusitis (1%) and rhinitis (4%).

Ocular

Ocular side effects have included eye irritation (2%), eye floaters, blurred vision, or conjunctivitis (1%).

Other

Otic side effects have included earache (1%).

Genitourinary

Genitourinary side effects have included polyuria or vaginitis (1%).

Genitourinary effects occurring during fenofibrate where causality has not yet been established have included decreased male fertility and renal lithiasis.

Hypersensitivity

Hypersensitivity side effects have included severe skin rashes (requiring hospitalization and steroid therapy), urticaria and less severe rashes.

Hematologic

Hematologic side effects have included mild to moderate decreases in hemoglobin and hematocrit and white blood cells, rare incidences of thrombocytopenia and agranulocytosis, and deep vein thrombosis (DVT).

Oncologic

Oncologic effects of tumor growth in rodents have been associated with many lipid-lowering drugs. Fenofibrate (the active ingredient contained in TriCor) has been associated with liver, pancreatic and testicular tumors in rats. Long-term clinical trials are needed to define the risk of cancer in humans.

Endocrine

Endocrine side effects include at least one case of fenofibrate-induced gynecomastia that resolved following discontinuation and recurred upon rechallenge.