FloLipid Side Effects
Generic name: simvastatin
Medically reviewed by Drugs.com. Last updated on Dec 13, 2021.
Note: This document contains side effect information about simvastatin. Some dosage forms listed on this page may not apply to the brand name FloLipid.
Applies to simvastatin: oral oral suspension, oral tablets.
Side effects include:
For Healthcare Professionals
Applies to simvastatin: oral suspension, oral tablet.
The more commonly reported adverse effects have included upper respiratory infection, headache, abdominal pain, constipation, and nausea.[Ref]
Common (1% to 10%): Myalgia
Uncommon (0.1% to 1%): Myopathy
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]
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
Postmarketing reports: Hepatic failure, hepatitis, jaundice[Ref]
Frequency not reported: Anorexia
Common (1% to 10%): Headache, vertigo
Frequency not reported: Cognitive impairment, cranial nerve dysfunction, tremor, vertigo, memory loss, paraesthesias, peripheral neuropathy, peripheral nerve palsy
Frequency not reported: Myoglobinuria, acute renal failure secondary to rhabdomyolysis[Ref]
Common (1% to 10%): Eczema
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]
Postmarketing reports: Immune-mediated necrotizing myopathy[Ref]
Frequency not reported: Progression of cataracts, ophthalmoplegia[Ref]
Common (1%to 10%): Insomnia
Common (1% to 10%): Urinary tract infection
Frequency not reported: Impotence, testicular pain, proteinuria
Frequency not reported: Tumor growth, liver, thyroid, lung adenomas, carcinomas[Ref]
Common (1% to 10%): Diabetes mellitus
Frequency not reported: HbA1c and fasting serum glucose levels elevations
Common (1% to 10%): Respiratory tract infection, bronchitis, sinusitis
Postmarketing reports: Interstitial lung disease
Frequency not reported: Asthenia
Frequently asked questions
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More about FloLipid (simvastatin)
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Some side effects may not be reported. You may report them to the FDA.