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:
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
Frequently asked questions
- When is the best time to take simvastatin?
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References
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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.