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Atromid-S Side Effects

Generic name: clofibrate

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

Applies to clofibrate: oral capsule

General

In general, the most common adverse effects due to clofibrate (the active ingredient contained in Atromid-S) 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 (the active ingredient contained in Atromid-S) 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 (the active ingredient contained in Atromid-S) [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 (the active ingredient contained in Atromid-S) 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 (the active ingredient contained in Atromid-S) has been reported in one case.[Ref]

Oncologic

Oncologic effects of tumor growth in rodents have been associated with many lipid-lowering drugs. Clofibrate (the active ingredient contained in Atromid-S) 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, Philadelphia, PA.

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

3. 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 42 (1979): 1-9

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

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

6. Duell PB, Connor WE, Illingworth DR "Rhabdomyolysis after taking atorvastatin with gemfibrozil." Am J Cardiol 81 (1998): 368-9

7. Cayen MN "Disposition, metabolism and pharmacokinetics of antihyperlipidemic agents in laboratory animals and man." Pharmacol Ther 29 (1985): 157-204

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

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

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

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

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

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

Medically reviewed by Drugs.com. Last updated on March 3, 2020.

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