Skip to main content

Cerivastatin Side Effects

Applies to cerivastatin: oral tablet.


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 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 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]


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]

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]


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


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


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


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 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


Related treatment guides


1. "Product Information. Baycol (cerivastatin)." Bayer (2001):

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

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

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

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

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

7. Grimbert S, Pessayre D, Degott C, Benhamou JP "Acute hepatitis induced by HMG-coa reductase inhibitor, lovastatin." Dig Dis Sci 39 (1994): 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 38 (1998): 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 94 (1993): 13-20

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

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

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

13. "Lovastatin 5-year safety and efficacy study. Lovastatin Study Groups I through IV." Arch Intern Med 153 (1993): 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 260 (1988): 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 318 (1988): 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 318 (1988): 46-7

17. Wallace CS, Mueller BA "Lovastatin-induced rhabdomyolysis in the absence of concomitant drugs." Ann Pharmacother 26 (1992): 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 94 (1993): 109-10

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

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

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

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

23. Rodriguez ML "Cerivastatin-induced rhabdomyolysis." Ann Intern Med 132 (2000): 598

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

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

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

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

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

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

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

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

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

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

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

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

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

37. Thompson PD, Clarkson P, Karas RH "Statin-associated myopathy." JAMA 289 (2003): 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 292 (2004): 2622-31

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

40. Arora R, Liebo M, Maldonado F "Statin-induced myopathy: the two faces of Janus." J Cardiovasc Pharmacol Ther 11 (2006): 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 50 (1991): 730-7

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

43. Ahmad S "Lovastatin and peripheral neuropathy." Am Heart J 130 (1995): 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 58 (2002): 1333-7

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

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

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

48. Bannwarth B, Miremont G, Papapietro PM "Lupuslike syndrome associated with simvastatin." Arch Intern Med 152 (1992): 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 67 (1991): 447-53

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

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

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

53. Newman TB, Hulley SB "Carcinogenicity of lipid-lowering drugs." JAMA 275 (1996): 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.