Lipofen Side Effects

Generic Name: fenofibrate

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

Not all side effects for Lipofen may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to fenofibrate: oral capsule, oral tablet

In addition to its needed effects, some unwanted effects may be caused by fenofibrate (the active ingredient contained in Lipofen). In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when 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 of the side effects that can occur with fenofibrate may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

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

For Healthcare Professionals

Applies to fenofibrate: oral capsule, oral tablet

General

Body as a whole effects probably related to fenofibrate (the active ingredient contained in Lipofen) or where causality has not yet been established include weight loss and fever.

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

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 possibly related to fenofibrate (the active ingredient contained in Lipofen) or where causality has not yet been established have included: photosensitivity, eczema, lupus-like syndrome, ichthyosis, telangiectasis, and alopecia.

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

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 effects probably related to fenofibrate (the active ingredient contained in Lipofen) or where causality has not yet been established include dry mouth, vertigo, anxiety, sleep disorders, and confusion.

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

Respiratory

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

Respiratory effects probably related to fenofibrate or where causality has not yet been established include allergic pulmonary alveolitis and congestion.

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 effects occurring during fenofibrate (the active ingredient contained in Lipofen) where causality has not yet been established have included decreased male fertility and renal lithiasis.

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

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.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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