Zocor Side Effects

Generic Name: simvastatin

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

In Summary

More frequent side effects include: eczema and increased creatine phosphokinase in blood specimen. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to simvastatin: oral suspension, oral tablet

Side effects requiring immediate medical attention

Along with its needed effects, simvastatin (the active ingredient contained in Zocor) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking simvastatin:

More common

Dizziness

fainting

fast or irregular heartbeat

Less common

Bladder pain

bloody or cloudy urine

blurred vision

body aches or pain

chills

cough

dark-colored urine

difficult, burning, or painful urination

difficulty with breathing

difficulty with moving

dry mouth

ear congestion

fever

flushed, dry skin

frequent urge to urinate

fruit-like breath odor

headache

increased hunger

increased thirst

increased urination

joint pain

loss of consciousness

lower back or side pain

muscle cramps, spasms, or stiffness

muscular pain, tenderness, wasting, or weakness

nasal congestion

nausea

runny nose

sneezing

sore throat

stomachache

sweating

swelling

swollen joints

troubled breathing

unexplained weight loss

unusual tiredness or weakness

vomiting

Incidence not known

Blistering, peeling, or loosening of the skin

bloating

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

constipation

diarrhea

difficulty with swallowing

general tiredness and weakness

indigestion

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

light-colored stools

loss of appetite

pains in the stomach, side, or abdomen, possibly radiating to the back

pale skin

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

red skin lesions, often with a purple center

red, irritated eyes

skin rash, hives, or itching

sores, ulcers, or white spots in the mouth or on the lips

tightness in the chest

troubled breathing with exertion

unusual bleeding or bruising

upper right abdominal or stomach pain

weakness in the arms, hands, legs, or feet

yellow eyes or skin

Side effects not requiring immediate medical attention

Some side effects of simvastatin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Acid or sour stomach

belching

burning feeling in the chest or stomach

dizziness or lightheadedness

excess air or gas in the stomach or intestines

feeling of constant movement of self or surroundings

full feeling

heartburn

lack or loss of strength

pain or tenderness around the eyes and cheekbones

passing gas

sensation of spinning

skin rash, encrusted, scaly, and oozing

stomach discomfort, upset, or pain

tenderness in the stomach area

trouble sleeping

Incidence not known

Being forgetful

depression

discoloration of the skin

hair loss or thinning of the hair

inability to have or keep an erection

loss in sexual ability, desire, drive, or performance

For Healthcare Professionals

Applies to simvastatin: oral suspension, oral tablet

General

The more commonly reported adverse effects have included upper respiratory infection, headache, abdominal pain, constipation, and nausea.[Ref]

Musculoskeletal

Common (1% to 10%): Myalgia

Uncommon (0.1% to 1%): Myopathy

Frequency not reported: Elevations in creatine kinase, myopathy, dermatomyositis, arthralgia, tendon rupture

Postmarketing reports: Muscle cramps, myalgia, rhabdomyolysis[Ref]

This drug causes dose-related myopathy which, in rare cases maybe severe and sometimes take the form of rhabdomyolysis with or without renal failure secondary to myoglobinuria; rarely fatalities have occurred. The incidence of myopathy with the 80 mg dose has been reported as disproportionately higher than that observed at lower doses and the risk of myopathy with simvastatin 80 mg/day is greater compared with other statins with similar or greater LDL-C lowering efficacy.[Ref]

Hepatic

Persistent elevations in transaminases of up to 3 times the upper limit of normal (3xULN) have been reported in 1% of patients. With therapy discontinuation or interruption, transaminase levels generally returned to pretreatment levels. There have been rare postmarketing reports of hepatic failure.[Ref]

Common (1% to 10%): Elevations in liver function tests

Frequency not reported: Hepatitis (including chronic active hepatitis), cholestatic jaundice, fatty changes in the liver, cirrhosis, hepatic failure, fulminant hepatic necrosis

Postmarketing reports: Hepatic failure, hepatitis, jaundice[Ref]

Gastrointestinal

Common (1% to 10%): Constipation, nausea, flatulence, diarrhea, dyspepsia, abdominal pain, gastritis

Frequency not reported: Anorexia

Postmarketing reports: Pancreatitis, vomiting[Ref]

Hematologic

Frequency not reported: Hemolytic anemia, thrombocytopenia, leucopenia, thrombotic thrombocytopenic purpura (TTP)

Postmarketing reports: Anemia[Ref]

Nervous system

Common (1% to 10%): Headache, vertigo

Frequency not reported: Cognitive impairment, cranial nerve dysfunction, tremor, vertigo, memory loss, paraesthesias, peripheral neuropathy, peripheral nerve palsy

Postmarketing reports: Dizziness, paresthesia, peripheral neuropathy, cognitive impairment (e.g., memory loss, forgetfulness, amnesia, memory impairment, confusion)[Ref]

Renal

Frequency not reported: Myoglobinuria, acute renal failure secondary to rhabdomyolysis[Ref]

Cardiovascular

Common (1% to 10%): Angina, edema, atrial fibrillation[Ref]

Dermatologic

Common (1% to 10%): Eczema

Frequency not reported: Pruritic rash, erythema multiform including Stevens-Johnson syndrome, toxic epidermal necrolysis, photosensitivity, purpura

Postmarketing reports: Pruritus, alopecia, a variety of skin changes (e.g., nodules, discoloration, dryness of skin/mucous membranes, changes to hair/nails)[Ref]

Hypersensitivity

Frequency not reported: Anaphylaxis, angioedema, urticaria, fever, chills, flushing, malaise, dyspnea

Postmarketing reports: Hypersensitivity syndrome which has included some of the follow features: anaphylaxis, angioedema, lupus erythematous-like syndrome, polymyalgia rheumatica, dermatomyositis, vasculitis, purpura, thrombocytopenia, leukopenia, hemolytic anemia, positive ANA, ESR increase, eosinophilia, arthritis, arthralgia, urticaria, asthenia, photosensitivity, fever, chills, flushing, malaise, dyspnea, toxic epidermal necrolysis, erythema multiforme including Stevens-Johnson syndrome[Ref]

Immunologic

Postmarketing reports: Immune-mediated necrotizing myopathy[Ref]

Ocular

Frequency not reported: Progression of cataracts, ophthalmoplegia[Ref]

Psychiatric

Common (1%to 10%): Insomnia

Postmarketing reports: Depression[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection

Frequency not reported: Impotence, testicular pain, proteinuria

Postmarketing reports: Erectile dysfunction[Ref]

Oncologic

Frequency not reported: Tumor growth, liver, thyroid, lung adenomas, carcinomas[Ref]

Metabolic

Common (1% to 10%): Diabetes mellitus

Frequency not reported: HbA1c and fasting serum glucose levels elevations

Respiratory

Common (1% to 10%): Respiratory tract infection, bronchitis, sinusitis

Postmarketing reports: Interstitial lung disease

Other

Frequency not reported: Asthenia

References 1. Halkin A, Lossos IS, Mevorach D "HMG-CoA reductase inhibitor-induced impotence." Ann Pharmacother 30 (1996): 192 2. Katznelson S "Immunosuppressive and antiproliferative effects of HMG-CoA reductase inhibitors." Transplant Proc 31 (1999): s22-4 3. Katznelson S "Effect of HMG-CoA reductase inhibitors on chronic allograft rejection." Kidney Int 56 (1999): s117-21 4. Plosker GL, Mctavish D "Simvastatin - a reappraisal of its pharmacology and therapeutic efficacy in hypercholesterolaemia." Drugs 50 (1995): 334-63 5. Bilheimer DW "Long-term clinical tolerance of lovastatin and simvastatin." Cardiology 77 (1990): 58-65 6. "Summaries for patients. Muscle abnormalities in four patients taking statins to treat unfavorable cholesterol levels." Ann Intern Med 137 (2002): I45 7. Khattak FH, Morris IM, Branford WA "Simvastatin-associated dermatomyositis." Br J Rheumatol 33 (1994): 199 8. Simons LA "Simvastatin in severe primary hypercholesterolemia: efficacy, safety, and tolerability in 595 patients over 18 weeks. The Principal Investigators." Clin Cardiol 16 (1993): 317-22 9. Weise WJ, Possidente CJ "Fatal rhabdomyolysis associated with simvastatin in a renal transplant patient." Am J Med 108 (2000): 351-2 10. McDonagh J, Winocour P, Walker DJ "Musculoskeletal manifestations during simvastatin therapy." Br J Rheumatol 32 (1993): 647-8 11. Graham DJ, Staffa JA, Shatin D, et al. "Incidence of hospitalized rhabdomyolysis in patients treated with lipid-lowering drugs." JAMA 292 (2004): 2585-90 12. Meier CR, Schlienger RG, Kraenzlin ME, Schlegel B, Jick H "HMG-CoA reductase inhibitors and the risk of fractures." JAMA 283 (2000): 3205-10 13. Sinzinger H, Wolfram R, Peskar BA "Muscular side effects of statins." J Cardiovasc Pharmacol 40 (2002): 163-71 14. Federman DG, Hussain F, Walters AB "Fatal rhabdomyolysis caused by lipid-lowering therapy." South Med J 94 (2001): 1023-6 15. Arora R, Liebo M, Maldonado F "Statin-induced myopathy: the two faces of Janus." J Cardiovasc Pharmacol Ther 11 (2006): 105-12 16. Itakura H, Vaughn D, Haller DG, O'Dwyer PJ "Rhabdomyolysis from cytochrome p-450 interaction of ketoconazole and simvastatin in prostate cancer." J Urol 169 (2003): 613 17. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0 18. Vanpuijenbroek EP, Dubufvereijken PWG, Spooren PFMJ, Vandoormaal JJ "Possible increased risk of rhabdomyolysis during concomitant use of simvastatin and gemfibrozil." J Intern Med 240 (1996): 403-4 19. "Product Information. Zocor (simvastatin)." Merck & Co, Inc, West Point, PA. 20. Omar MA, Wilson JP "FDA adverse event reports on statin-associated rhabdomyolysis." Ann Pharmacother 36 (2002): 288-95 21. Diaczok BJ, Shali R "Statins unmasking a mitochondrial myopathy: a case report and proposed mechanism of disease." South Med J 96 (2003): 318-20 22. Mukhtar RY, Reckless JP "Statin-induced myositis: a commonly encountered or rare side effect?" Curr Opin Lipidol 16 (2005): 640-7 23. Grundy SM "Can statins cause chronic low-grade myopathy?" Ann Intern Med 137 (2002): 617-8 24. Ramdass MJ, Singh G, Andrews B "Simvastatin-induced bilateral leg compartment syndrome and myonecrosis associated with hypothyroidism." Postgrad Med J 83 (2007): 152-3 25. 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 26. Gonyeau MJ "Statins and osteoporosis: a clinical review." Pharmacotherapy 25 (2005): 228-43 27. Alvarez JM, Rawdanowiz TJ, Goldstein J "Rhadbdomyolysis after coronary artery bypass grafting in a patient receiving simvastatin." J Thorac Cardiovasc Surg 116 (1998): 654-5 28. Walker JF "Simvastatin: the clinical profile." Am J Med 87 (1989): s44-6 29. ChoquetKastylevsky G, Kanitakis J, Dumas V, Descotes J, Faure M, Claudy A "Eosinophilic fasciitis and simvastatin." Arch Intern Med 161 (2001): 1456-7 30. Chan MH, Mak TW, Chiu RW, Chow CC, Chan IH, Lam CW "Simvastatin increases serum osteocalcin concentration in patients treated for hypercholesterolaemia." J Clin Endocrinol Metab 86 (2001): 4556-9 31. Finsterer J, Zuntner G "Rhabdomyolysis from Simvastatin triggered by infection and muscle exertion." South Med J 98 (2005): 827-9 32. Pedersen TR, Berg K, Cook TJ, Faergeman O, Haghfelt T, Kjekshus J, Miettinen T, Musliner TA, Olsson AG, Pyorala K, Thorgeirsso "Safety and tolerability of cholesterol lowering with simvastatin during 5 years in the scandinavian simvastatin survival study." Arch Intern Med 156 (1996): 2085-92 33. Molden E, Andersson KS "Simvastatin-associated rhabdomyolysis after coadministration of macrolide antibiotics in two patients." Pharmacotherapy 27 (2007): 603-7 34. Peces R, Pobes A "Rhabdomyolysis associated with concurrent use of simvastatin and diltiazem." Nephron 89 (2001): 117-8 35. van Puijenbroek EP, Du Buf-Vereijken PW, Spooren PF, van Doormaal JJ "Possible increased risk of rhabdomyolysis during concomitant use of simvastatin and gemfibrozil." J Intern Med 240 (1996): 403-4 36. Maxa JL, Melton LB, Ogu CC, Sills MN, Limanni A "Rhabdomyolysis after concomitant use of cyclosporine, simvastatin, gemfibrozil, and itraconazole." Ann Pharmacother 36 (2002): 820-3 37. Nakad A, Bataille L, Hamoir V, Sempoux C, Horsmans Y "Atorvastatin-induced acute hepatitis with absence of cross-toxicity with simvastatin." Lancet 353 (1999): 1763-4 38. Mauro VF, MacDonald JL "Simvastatin: a review of its pharmacology and clinical use." DICP 25 (1991): 257-64 39. Chagnon JP, Cerf M "Simvastatin-induced protein-losing enteropathy." Am J Gastroenterol 87 (1992): 257 40. Adverse Drug Reactions Advisory Committee (ADRAC) and the Adverse Drug Reactions Unit of the TGA "Australian Adverse Drug Reactions Bulletin. Available from: URL: http://www.tga.gov.au/adr/aadrb/aadr0612.htm." ([2006 Dec]): 41. Johnson JL, Loomis IB "A case of simvastatin-associated pancreatitis and review of statin-associated pancreatitis." Pharmacotherapy 26 (2006): 414-22 42. Sundram F, Roberts P, Kennedy B, Pavord S "Thrombotic thrombocytopenic purpura associated with statin treatment." Postgrad Med J 80 (2004): 551-2 43. Phan T, Mcleod JG, Pollard JD, Peiris O, Rohan A, Halpern JP "Peripheral neuropathy associated with simvastatin." J Neurol Neurosurg Psychiatry 58 (1995): 625-8 44. Morales K, Wittink M, Datto C, et al. "Simvastatin causes changes in affective processes in elderly volunteers." J Am Geriatr Soc 54 (2006): 70-6 45. 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 46. Gregoor PJ "Atorvastatin may cause nightmares." BMJ 332 (2006): 950 47. Orsi A, Sherman O, Woldeselassie "Simvastatin-associated memory loss." Pharmacotherapy 21 (2001): 767-9 48. Muldoon MF, Ryan CM, Sereika SM, Flory JD, Manuck SB "Randomized trial of the effects of simvastatin on cognitive functioning in hypercholesterolemic adults." Am J Med 117 (2004): 823-9 49. Galatti L, Polimeni G, Salvo F, Romani M, Sessa A, Spina E "Short-term memory loss associated with rosuvastatin." Pharmacotherapy 26 (2006): 1190-2 50. Padala KP, Padala PR, Potter JF "Simvastatin-induced decline in cognition." Ann Pharmacother 40 (2006): 1880-3 51. Pedersen TR, Kjekshus J, Berg K, Haghfelt T, Faergeman O, Thorgeirsson G, Pyorala K, Miettinen T, Wilhelmsen L, Olsson AG, Wedel "Randomised trial of cholesterol lowering in 4444 patients with coronary heart disease: the Scandinavian Simvastatin Survival Study (4S)." Lancet 344 (1994): 1383-9 52. Krasovec M, Elsner P, Burg G "Generalized eczematous skin rash possibly due to HMG-CoA reductase inhibitors." Dermatology 186 (1993): 248-52 53. Feldmann R, Mainetti C, Saurat JH "Skin lesions due to treatment with simvastatin (Zocor)." Dermatology 186 (1993): 272 54. Bannwarth B, Miremont G, Papapietro PM "Lupuslike syndrome associated with simvastatin." Arch Intern Med 152 (1992): 1093 55. Rudski L, Rabinovitch MA, Danoff D "Systemic immune reactions to HMG-CoA reductase inhibitors - Report of 4 cases and review of the literature." Medicine 77 (1998): 378-83 56. Duits N, Bos FM "Depressive symptoms and cholesterol-lowering drugs." Lancet 341 (1993): 114 57. Linnebur SA, Hiatt WH "Probable Statin-Induced Testicular Pain (January)." Ann Pharmacother (2007): 58. Bjerre LM, LeLorier J "Do statins cause cancer? A meta-analysis of large randomized clinical trials." Am J Med 110 (2001): 716-23 59. 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.

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