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More frequently reported side effects include: eczema and increased creatine phosphokinase in blood specimen. See below for a comprehensive list of adverse effects.
For the ConsumerApplies to simvastatin: oral suspension, oral tablet
Along with its needed effects, simvastatin 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
Less common
Incidence not known
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
Incidence not known
For Healthcare Professionals
Applies to simvastatin: oral suspension, oral tablet
GeneralThe more commonly reported adverse effects have included upper respiratory infection, headache, abdominal pain, constipation, and nausea.
MusculoskeletalThis 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.
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
HepaticCommon (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
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.
GastrointestinalCommon (1% to 10%): Constipation, nausea, flatulence, diarrhea, dyspepsia, abdominal pain, gastritis
Frequency not reported: Anorexia
Postmarketing reports: Pancreatitis, vomiting
HematologicFrequency not reported: Hemolytic anemia, thrombocytopenia, leucopenia, thrombotic thrombocytopenic purpura (TTP)
Postmarketing reports: Anemia
Nervous systemCommon (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)
RenalFrequency not reported: Myoglobinuria, acute renal failure secondary to rhabdomyolysis
CardiovascularCommon (1% to 10%): Angina, edema, atrial fibrillation
DermatologicCommon (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)
HypersensitivityFrequency 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
ImmunologicPostmarketing reports: Immune-mediated necrotizing myopathy
OcularFrequency not reported: Progression of cataracts, ophthalmoplegia
PsychiatricCommon (1%to 10%): Insomnia
Postmarketing reports: Depression
GenitourinaryCommon (1% to 10%): Urinary tract infection
Frequency not reported: Impotence, testicular pain, proteinuria
Postmarketing reports: Erectile dysfunction
OncologicFrequency not reported: Tumor growth, liver, thyroid, lung adenomas, carcinomas
MetabolicCommon (1% to 10%): Diabetes mellitus
Frequency not reported: HbA1c and fasting serum glucose levels elevations
RespiratoryCommon (1% to 10%): Respiratory tract infection, bronchitis, sinusitis
Postmarketing reports: Interstitial lung disease
OtherFrequency not reported: Asthenia
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/3/2022.
Source: Drugs.com Simvastatin (www.drugs.com/simvastatin.html).
February 15, 2021
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