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Clofibrate Side Effects

Medically reviewed by Drugs.com. Last updated on Mar 20, 2023.

Applies to clofibrate: oral capsule.

Warning

Follow any diet or exercise plan outlined by your doctor. Diet and exercise are very important factors in controlling cholesterol.

Call your doctor immediately if you experience chest pain, shortness of breath, an irregular heartbeat, severe stomach pain with nausea and vomiting, fever and chills, a sore throat, a flulike feeling, blood in your urine, a decrease in urination, muscle cramps, muscle pain, muscle weakness, painful joints, swelling in your ankles or legs, or sudden weight gain. These could be early signs of serious side effects.

If you experience any of the following serious side effects, stop taking clofibrate and seek emergency medical attention:

Other, less serious side effects may be more likely to occur. Continue to take clofibrate and talk to your doctor if you experience

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

For Healthcare Professionals

Applies to clofibrate: oral capsule.

General

In general, the most common adverse effects due to clofibrate therapy are gastrointestinal in nature (especially nausea) and may subside over time or with a decreased dosage.[Ref]

Gastrointestinal

Cholelithiasis and cholecystitis (sometimes requiring surgery or resulting in pancreatitis) occur more frequently in patients receiving clofibrate than in patients receiving placebo.[Ref]

Gastrointestinal reactions may include nausea, vomiting, diarrhea, gastritis, weight loss or gain, and gallstones (during prolonged therapy).[Ref]

Musculoskeletal

Musculoskeletal effects (myopathy) typically occur as a "flu-like" syndrome (myalgia, cramps, muscle weakness, and arthralgia). Rhabdomyolysis with an accompanying increase in creatinine kinase and creatinine phosphokinase (CPK) has been reported in patients with renal disease.[Ref]

Patients diagnosed with rhabdomyolysis are usually asymptomatic clinically several days after discontinuing clofibrate, but the muscle enzymes may remain elevated for a more prolonged period. Severe renal disease may increase the risk of myopathies, perhaps because of accumulation of the active metabolite clofibric acid.[Ref]

Metabolic

Electrolyte disturbances like hyperkalemia have been reported in patients with renal insufficiency who receive clofibrate.[Ref]

Nervous system

Central nervous system depressant effects may include fatigue, weakness, drowsiness, and/or dizziness. Headache has also been reported.[Ref]

Hematologic

Hematologic adverse effects may include leukopenia, anemia, eosinophilia, agranulocytosis, and potentiation of anticoagulant effects. Because of these effects, some clinicians recommend periodic monitoring of blood counts.[Ref]

Cardiovascular

Cardiovascular complications may include various arrhythmias and altered angina pectoris. Swelling and phlebitis have occurred at xanthomata sites.[Ref]

Renal

Renal dysfunction (including dysuria, hematuria, proteinuria, and decreased urine output) has been reported. Acute renal failure and interstitial nephritis have also been reported.[Ref]

Genitourinary

Decreased libido (primarily in men) and impotence have been reported.[Ref]

Hepatic

Hepatic disorders may include elevated liver enzymes and/or hepatomegaly. (Liver biopsy, when performed in this setting, is usually normal.) Clofibrate should be used cautiously for patients with a history of jaundice or liver disease.[Ref]

Dermatologic

Dermatologic reactions which occur in about 2% of patients may include urticaria, rash, dry skin, and alopecia. Erythema multiforme, toxic epidermal necrolysis, and Stevens-Johnson syndrome have occurred rarely.[Ref]

Hypersensitivity

One case of a hypersensitivity reaction occurring as eosinophilic pneumonia has been reported.[Ref]

Other

Fever, which occurred on rechallenge with clofibrate, has been reported in one case.[Ref]

Oncologic

Oncologic effects of tumor growth in rodents have been associated with many lipid-lowering drugs. Clofibrate 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.[Ref]

References

1. Product Information. Atromid-S (clofibrate). Wyeth-Ayerst Laboratories. 2001;PROD.

2. Faergeman O. Effects and side-effects of treatment of hypercholesterolemia with cholestyramine and neomycin. Acta Med Scand. 1973;194:165-7.

3. Cayen MN. Disposition, metabolism and pharmacokinetics of antihyperlipidemic agents in laboratory animals and man. Pharmacol Ther. 1985;29:157-204.

4. Pokroy N, Ress S, Gregory MC. Clofibrate-induced complications in renal disease: a case report. S Afr Med J. 1977;52:806-8.

5. Abourizk N, Khalil BA, Bahuth N, Afifi AK. Clofibrate-induced muscular syndrome. Report of a case with clinical, electromyographic and pathologic observations. J Neurol Sci. 1979;42:1-9.

6. Rush P, Baron M, Kapusta M. Clofibrate myopathy: a case report and a review of the literature. Semin Arthritis Rheum. 1986;15:226-9.

7. Shepherd J. Fibrates and statins in the treatment of hyperlipidaemia: an appraisal of their efficacy and safety. Eur Heart J. 1995;16:5-13.

8. Duell PB, Connor WE, Illingworth DR. Rhabdomyolysis after taking atorvastatin with gemfibrozil. Am J Cardiol. 1998;81:368-9.

9. Cumming A. Acute renal failure and interstitial nephritis after clofibrate treatment. Br Med J. 1980;281:1529-30.

10. Murata Y, Tani M, Amano M. Erythema multiforme due to clofibrate . J Am Acad Dermatol. 1988;18:381-2.

11. Wong SS. Stevens-Johnson syndrome induced by clofibrate. Acta Derm Venereol. 1994;74:475.

12. Hendrickson RM, Simpson F. Clofibrate and eosinophilic pneumonia . JAMA. 1982;247:3082.

13. Beckner RR, Canada AT, Ockene IS. Fever due to clofibrate . N Engl J Med. 1979;301:1345-6.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.