Atromid-S Side Effects

Generic Name: clofibrate

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

Not all side effects for Atromid-S 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 clofibrate: oral capsule liquid filled

In addition to its needed effects, some unwanted effects may be caused by clofibrate (the active ingredient contained in Atromid-S). 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 clofibrate:

Rare
  • Chest pain
  • irregular heartbeat
  • shortness of breath
  • stomach pain (severe) with nausea and vomiting

If any of the following side effects occur while taking clofibrate, check with your doctor or nurse as soon as possible:

Rare
  • Blood in urine
  • cough or hoarseness
  • decrease in urination
  • fever or chills
  • lower back or side pain
  • painful or difficult urination
  • swelling of feet or lower legs

Some of the side effects that can occur with clofibrate 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
  • Diarrhea
  • nausea
Less common or rare
  • Decreased sexual ability
  • headache
  • increased appetite or weight gain (slight)
  • muscle aches or cramps
  • sores in mouth and on lips
  • stomach pain, gas, or heartburn
  • unusual tiredness or weakness
  • vomiting

For Healthcare Professionals

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

Patients diagnosed with rhabdomyolysis are usually asymptomatic clinically several days after discontinuing clofibrate (the active ingredient contained in Atromid-S) 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]

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]

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

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

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

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

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

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

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