Summary

More frequently reported side effects include: eczema and increased creatine phosphokinase in blood specimen. Continue reading for a comprehensive list of adverse effects.

Applies to simvastatin: oral oral suspension, oral tablets.

Side effects include:

Upper respiratory tract infections, headache, abdominal pain, constipation, nausea.

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