Lipofen Side Effects

Generic name: fenofibrate

Note: This document contains side effect information about fenofibrate. Some of the dosage forms listed on this page may not apply to the brand name Lipofen.

Some side effects of Lipofen may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to fenofibrate: oral capsule, oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking fenofibrate (the active ingredient contained in Lipofen) hives; difficult breathing; swelling of your face, lips, tongue, or throat.

In rare cases, fenofibrate 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 fenofibrate 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 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.

For Healthcare Professionals

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 Lipofen) 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 Lipofen) 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 Lipofen) 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 Lipofen) 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 Lipofen) 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 Lipofen) 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 Lipofen) 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 Lipofen) 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 Lipofen) 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.

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