Skip to main content

Cerivastatin Side Effects

Applies to cerivastatin: oral tablet.

Warning

Cerivastatin was withdrawn from the U.S. market in 2001.

Contact your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness, especially if it is accompanied by a fever or flu-like symptoms or yellowing of your skin or eyes.

Do not take cerivastatin without first talking to your doctor if you have liver disease.

Alcohol and cerivastatin can both damage your liver. Discuss with your doctor the amount of alcohol that you drink so that it can be determined if cerivastatin is the best choice for lowering your cholesterol.

Do not take cerivastatin if you are pregnant, if you are planning a pregnancy, or if you are breast-feeding a baby.

If you experience any of the following serious side effects, stop taking cerivastatin and call your doctor immediately:

Other, less serious side effects may be more likely to occur. Continue to take cerivastatin 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 cerivastatin: oral tablet.

General

Evaluations of adverse events in more than 3,000 patients during clinical trials have shown cerivastatin to be well tolerated. Adverse effects that occurred were generally mild and transient and the percentage of patients discontinuing cerivastatin was similar to that of the placebo groups in U.S. placebo-controlled clinical trials.[Ref]

Hepatic

Hepatic adverse effects of cerivastatin consist primarily of elevations in liver function tests, however, hepatitis has been reported. Hepatic side effects reported with other HMG-CoA reductase inhibitors are hepatitis, including chronic active hepatitis, cholestatic jaundice, fatty change in the liver, cirrhosis, fulminant hepatic necrosis and hepatoma.[Ref]

According to the manufacturer, persistent elevations of serum transaminases to more than 3 times the upper limit of normal have been reported in less than 1% of U.S. patients given cerivastatin for an average duration of 11 months. Liver function test abnormalities generally occurred within the first 6 weeks of treatment, were asymptomatic, and resolved after withdrawal of the medication.[Ref]

Gastrointestinal

Gastrointestinal adverse effects include dyspepsia (less than 6%), diarrhea, abdominal pain, or flatulence (less than 4%), nausea (less than 3%), and constipation (less than 2%). Other gastrointestinal side effects of HMG-CoA reductase inhibitors include pancreatitis, anorexia, and vomiting.[Ref]

Musculoskeletal

Musculoskeletal adverse effects include arthralgia (less than 7%) and myalgia (less than 3%). Myopathy manifesting as muscle aches or muscle weakness with increases in plasma creatine kinase values to greater than 10 times the upper limit of normal occurred in less than 0.2% of patients in U.S. clinical trials. Cases of rhabdomyolysis with acute renal failure secondary to myoglobinuria have been associated with cerivastatin and other HMG-CoA reductase inhibitors.

In addition, some data have suggested that exposure to HMG-CoA reductase inhibitors is associated with a decreased risk of bone fractures in persons older than 50 years of age.[Ref]

HMG-CoA reductase inhibitors (statins) have been associated with rare cases of severe myopathy and rhabdomyolysis, accompanied by increases in creatine kinase, myoglobinuria, proteinuria, and renal failure. Concomitant use with gemfibrozil (fibric acid derivatives), niacin, cyclosporine, erythromycin (macrolides) or azole antifungals may increase the incidence and severity of musculoskeletal side effects. Other variables associated with an increased risk of statin-induced myopathy include, advanced age, small body stature, female gender, renal and/or hepatic dysfunction, perioperative periods, hypothyroidism, diabetes mellitus, and alcoholism.

Milder forms of myotoxicity (i.e., myalgia) are commonly reported and occur in approximately 5% to 7% of patients taking a statin drug.

Patients should be instructed to promptly report symptoms of muscle pain, weakness, or tenderness. If such symptoms develop, creatine kinase should be measured and if markedly elevated, cerivastatin should be discontinued. The value of routine monitoring of creatine kinase is not known.[Ref]

Hematologic

Hematologic side effects including hemolytic anemia, thrombocytopenia, and leukopenia have occurred with HMG-CoA reductase inhibitors. These effects may be manifestations of a hypersensitivity reaction.[Ref]

Nervous system

Nervous system adverse effects are primarily headaches (less than 12%), dizziness (less than 3%) and insomnia (less than 3%). HMG-CoA reductase inhibitors as a class have been associated with cranial nerve dysfunction, tremor, vertigo, memory loss, anxiety, paresthesias, peripheral neuropathy, and peripheral nerve palsy.[Ref]

Cardiovascular

Cardiovascular adverse effects of peripheral edema have been reported in 2% of patients in U.S. clinical trials.[Ref]

Dermatologic

Dermatologic adverse effects of rash have been reported in less than 3% of patients in U.S. clinical trials. Other dermatologic side effects reported with HMG-CoA reductase inhibitors include pruritus and alopecia.[Ref]

Endocrine

Endocrine adverse effects of HMG-CoA reductase inhibitors include gynecomastia and thyroid dysfunction.[Ref]

Hypersensitivity

Hypersensitivity syndrome has been reported rarely with HMG-CoA reductase inhibitors. Manifestations include anaphylaxis, angioedema, purpura, urticaria, erythema multiforme (including Stevens-Johnson syndrome), toxic epidermal necrolysis, photosensitivity, fever (including severe hyperthermia), chills, flushing, malaise and dyspnea. Urticaria and angioedema have occurred during cerivastatin therapy.[Ref]

Immunologic

Immunologic adverse effects of HMG-CoA reductase inhibitors include a lupus-like syndrome with positive ANA and elevated ESR, polymyalgia rheumatica, dermatomyositis and vasculitis. These effects may be manifestations of a hypersensitivity reaction.[Ref]

Ocular

Ocular adverse effects occurring during cerivastatin therapy include visual disturbances and blurred vision. Progression of cataracts and ophthalmoplegia has been associated with the use of other HMG-CoA reductase inhibitors.[Ref]

Psychiatric

Psychiatric adverse effects of HMG-CoA reductase inhibitors include loss of libido and depression.[Ref]

Genitourinary

Genitourinary adverse effects of erectile dysfunction have been reported with other HMG-CoA reductase inhibitors.[Ref]

Halkin, et al report a case in which use of both lovastatin and pravastatin (different occasions in the same patient) led to reversible impotence. The impotence resolved within 2 weeks following discontinuation of the HMG-CoA reductase inhibitor.[Ref]

Oncologic

Oncologic side effects including tumor growth in rodents has been associated with many lipid-lowering drugs. Cerivastatin has been specifically associated with hepatocellular carcinomas and adenomas. Long-term clinical trials are needed to define the risk of cancer in humans.[Ref]

More about cerivastatin

Patient resources

Other brands

Baycol

Related treatment guides

References

1. Product Information. Baycol (cerivastatin). Bayer. 2001;PROD.

2. Arnon R, Eisenberg S. Lovastatin-induced hepatitis. Isr J Med Sci. 1992;28:101-2.

3. McGovern ME, Mellies MJ. Long-term experience with pravastatin in clinical research trials. Clin Ther. 1993;15:57-64.

4. Geddes JA. Cholestatic jaundice associated with lovastatin (mevacor) therapy. Can Med Assoc J. 1990;143:13-4.

5. McQueen MJ. Cholestatic jaundice associated with lovastatin (Mevacor) therapy. Can Med Assoc J. 1990;142:841-2.

6. Bilheimer DW. Long-term clinical tolerance of lovastatin and simvastatin. Cardiology. 1990;77:58-65.

7. Grimbert S, Pessayre D, Degott C, Benhamou JP. Acute hepatitis induced by HMG-coa reductase inhibitor, lovastatin. Dig Dis Sci. 1994;39:2032-3.

8. Mazzu A, Lettieri J, Kaiser L, Mullican W, Heller AH. Influence of age on the safety, tolerability, and pharmacokinetics of the novel HMG-CoA reductase inhibitor cerivastatin in healthy male volunteers. J Clin Pharmacol. 1998;38:715-9.

9. Wiklund O, Angelin B, Bergman M, Berglund L, Bondjers G, Carlsson A, Linden T, Miettinen T, Odman B, Olofsson SO, et al. Pravastatin and gemfibrozil alone and in combination for the treatment of hypercholesterolemia. Am J Med. 1993;94:13-20.

10. Pierce LR, Wysowski DK, Gross TP. Myopathy and rhabdomyolysis associated with lovastatin-gemfibrozil combination therapy. JAMA. 1990;264:71-5.

11. Schalke BB, Schmidt B, Toyka K, Hartung HP. Pravastatin-associated inflammatory myopathy . N Engl J Med. 1992;327:649-50.

12. Reaven P, Witztum JL. Lovastatin, nicotinic acid, and rhabdomyolysis. Ann Intern Med. 1988;109:597-8.

13. Lovastatin 5-year safety and efficacy study. Lovastatin Study Groups I through IV. Arch Intern Med. 1993;153:1079-87.

14. Corpier CL, Jones PH, Suki WN, et al. Rhabdomyolysis and renal injury with lovastatin use. Report of two cases in cardiac transplant recipients. JAMA. 1988;260:239-41.

15. East C, Alivizatos PA, Grundy SM, Jones PH, Farmer JA. Rhabdomyolysis in patients receiving lovastatin after cardiac transplantation. N Engl J Med. 1988;318:47-8.

16. Norman DJ, Illingworth DR, Munson J, Hosenpud J. Myolysis and acute renal failure in a heart-transplant recipient receiving lovastatin. N Engl J Med. 1988;318:46-7.

17. Wallace CS, Mueller BA. Lovastatin-induced rhabdomyolysis in the absence of concomitant drugs. Ann Pharmacother. 1992;26:190-2.

18. Chariot P, Abadia R, Agnus D, Danan C, Charpentier C, Gherardi RK. Simvastatin-induced rhabdomyolysis followed by a MELAS syndrome. Am J Med. 1993;94:109-10.

19. McDonagh J, Winocour P, Walker DJ. Musculoskeletal manifestations during simvastatin therapy. Br J Rheumatol. 1993;32:647-8.

20. Fernandezzatarain G, Navarro V, Garcia H, Villatoro J, Calvo C. Rhabdomyolysis and acute renal failure associated with lovastatin. Nephron. 1994;66:483-4.

21. Lees RS, Lees AM. Rhabdomyolysis from the coadministration of lovastatin and the antifungal agent itraconazole. N Engl J Med. 1995;333:664-5.

22. Pogson GW, Kindred LH, Carper BG. Rhabdomyolysis and renal failure associated with cerivastatin-gemfibrozil combination therapy. Am J Cardiol. 1999;83:1146.

23. Rodriguez ML. Cerivastatin-induced rhabdomyolysis. Ann Intern Med. 2000;132:598.

24. Meier CR, Schlienger RG, Kraenzlin ME, Schlegel B, Jick H. HMG-CoA reductase inhibitors and the risk of fractures. JAMA. 2000;283:3205-10.

25. Alexandridis G, Pappas GA, Elisaf MS. Rhabdomyolysis due to combination therapy with cerivastatin and gemfibrozil. Am J Med. 2000;109:261-2.

26. Gemici G, Toprak A, Oktay A. Rhabdomyolysis due to cerivastatin monotherapy. Am J Med. 2001;110:742.

27. Bruno-Joyce J, Dugas JM, MacCausland OE. Cerivastatin and gemfibrozil-associated rhabdomyolysis. Ann Pharmacother. 2001;35:1016-9.

28. Hamilton-Craig I. Statin-associated myopathy. Med J Aust. 2001;175:486-9.

29. Simpson S. Case reports of rhabdomyolysis associated with cerivastatin therapy. Arch Intern Med. 2001;161:2630-1.

30. Milionis HJ, Tsapoga TG, Elisaf MS. Another report of acute rhabdomyolysis following cerivastatin monotherapy. Arch Intern Med. 2001;161:2629-30.

31. Gabay M, Lodolce A. Other reports of cerivastatin-induced rhabdomyolysis. Arch Intern Med. 2001;161:2629.

32. Omar MA, Wilson JP. FDA adverse event reports on statin-associated rhabdomyolysis. Ann Pharmacother. 2002;36:288-95.

33. Hyman DJ, Henry A, Taylor A. Severe rhabdomyolysis related to cerivastatin without gemfibrozil. Ann Intern Med. 2002;137:74.

34. Summaries for patients. Muscle abnormalities in four patients taking statins to treat unfavorable cholesterol levels. Ann Intern Med. 2002;137:I45.

35. Grundy SM. Can statins cause chronic low-grade myopathy? Ann Intern Med. 2002;137:617-8.

36. Sinzinger H, Wolfram R, Peskar BA. Muscular side effects of statins. J Cardiovasc Pharmacol. 2002;40:163-71.

37. Thompson PD, Clarkson P, Karas RH. Statin-associated myopathy. JAMA. 2003;289:1681-90.

38. Psaty BM, Furberg CD, Ray WA, Weiss NS. Potential for conflict of interest in the evaluation of suspected adverse drug reactions: use of cerivastatin and risk of rhabdomyolysis. JAMA. 2004;292:2622-31.

39. Graham DJ, Staffa JA, Shatin D, et al. Incidence of hospitalized rhabdomyolysis in patients treated with lipid-lowering drugs. JAMA. 2004;292:2585-90.

40. Arora R, Liebo M, Maldonado F. Statin-induced myopathy: the two faces of Janus. J Cardiovasc Pharmacol Ther. 2006;11:105-12.

41. Vgontzas AN, Kales A, Bixler EO, Manfredi RL, Tyson KL. Effects of lovastatin and pravastatin on sleep efficiency and sleep stages. Clin Pharmacol Ther. 1991;50:730-7.

42. Jacobs MB. HMG-CoA reductase inhibitor therapy and peripheral neuropathy. Ann Intern Med. 1994;120:970.

43. Ahmad S. Lovastatin and peripheral neuropathy. Am Heart J. 1995;130:1321.

44. Gaist D, Jeppesen U, Andersen M, Garcia Rodriguez LA, Hallas J, Sindrup SH. Statins and risk of polyneuropathy: a case-control study. Neurology. 2002;58:1333-7.

45. Krasovec M, Elsner P, Burg G. Generalized eczematous skin rash possibly due to HMG-CoA reductase inhibitors. Dermatology. 1993;186:248-52.

46. Vonpohle WR. Recurrent hyperthermia due to lovastatin. West J Med. 1994;161:427-8.

47. Ahmad S. Lovastatin-induced lupus erythematosus. Arch Intern Med. 1991;151:1667-8.

48. Bannwarth B, Miremont G, Papapietro PM. Lupuslike syndrome associated with simvastatin. Arch Intern Med. 1992;152:1093.

49. Laties AM, Shear CL, Lippa EA, Gould AL, Taylor HR, Hurley DP, Stephenson WP, Keates EU, Tupy-Visich MA, Chremos AN. Expanded clinical evaluation of lovastatin (EXCEL) study results. II. Assessment of the human lens after 48 weeks of treatment with lovastatin. Am J Cardiol. 1991;67:447-53.

50. Duits N, Bos FM. Depressive symptoms and cholesterol-lowering drugs. Lancet. 1993;341:114.

51. Rosenson RS, Goranson NL. Lovastatin-associated sleep and mood disturbances. Am J Med. 1993;95:548-9.

52. Halkin A, Lossos IS, Mevorach D. HMG-CoA reductase inhibitor-induced impotence. Ann Pharmacother. 1996;30:192.

53. Newman TB, Hulley SB. Carcinogenicity of lipid-lowering drugs. JAMA. 1996;275:55-60.

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.

Medical Disclaimer