Zocor/Zocor HP Adverse Reactions

SIMVASTATIN (ZOCOR) is generally well-tolerated; for the most part side effects have been mild and transient in nature. Less than 2% of patients were discontinued from controlled clinical studies due to side effects attributable to SIMVASTATIN (ZOCOR).
In the pre-marketing controlled clinical studies, adverse effects occurring with a frequency of 1% or more and considered by the investigator as possibly, probably or definitely drug related were: abdominal pain, constipation and flatulence. Other side effects occurring in 0.5-0.9% of patients were asthenia and headache.
Myopathy has been reported rarely. See Myopathy/Rhabdomyolysis under Precautions.
In HPS involving 20,536 patients treated with 40 mg/day of SIMVASTATIN (ZOCOR) (n=10,269) or placebo (n=10,267), the safety profiles were comparable between patients treated with SIMVASTATIN (ZOCOR) and patients treated with placebo over the mean 5 years of the study. In this mega-trial, only serious adverse effects and discontinuations due to any adverse effects were recorded. Discontinuation rates due to side effects were comparable (4.8% in patients treated with SIMVASTATIN (ZOCOR) compared with 5.1% in patients treated with placebo). The incidence of myopathy was <0.1% in patients treated with SIMVASTATIN (ZOCOR). Elevated transaminases (>3X ULN confirmed by repeat test) occurred in 0.21% (n=21) of patients treated with SIMVASTATIN (ZOCOR) compared with 0.09% (n=9) of patients treated with placebo.
In 4S involving 4,444 patients treated with 20-40 mg/day of SIMVASTATIN (ZOCOR) (n=2,221) or placebo (n=2,223), the safety and tolerability profiles were comparable between treatment groups over the median 5.4 years of the study.
The following additional side effects were reported either in uncontrolled clinical studies or in marketed use: nausea, diarrhea, rash, lichen planus, dyspepsia, pruritus, alopecia, dizziness, muscle cramps, myalgia, pancreatitis, paresthesia, peripheral neuropathy, insomnia, depression, vomiting, anemia, erectile dysfunction, and interstitial lung disease. Rarely rhabdomyolysis and hepatitis/jaundice, and very rarely fatal and non-fatal hepatic failure have occurred.
There have been very rare reports of immune-mediated necrotizing myopathy (IMNM), an autoimmune myopathy, associated with statin use. IMNM is characterized by: proximal muscle weakness and elevated serum creatine kinase, which persist despite discontinuation of statin treatment; muscle biopsy showing necrotizing myopathy without significant inflammation; improvement with immunosuppressive agents (see Myopathy/Rhabdomyolysis under Precautions).
An apparent hypersensitivity syndrome has been reported rarely which has included some of the following features: anaphylaxis, angioedema, lupus-like syndrome, polymyalgia rheumatica, dermatomyositis, vasculitis, thrombocytopenia, eosinophilia, ESR increased, arthritis, arthralgia, urticaria, photosensitivity, fever, flushing, dyspnea, and malaise.
There have been rare postmarketing reports of cognitive impairment (e.g., memory loss, forgetfulness, amnesia, memory impairment, confusion) associated with statin use. These cognitive issues have been reported for all statins. The reports are generally nonserious, and reversible upon statin discontinuation, with variable times to symptom onset (1 day to years) and symptom resolution (median of 3 weeks).
Myasthenia gravis or ocular myasthenia associated with statin use has been reported (see Myasthenia Gravis/Ocular Myasthenia under Precautions).
Laboratory Test Findings: Marked and persistent increases of serum transaminases have been reported infrequently. Elevated alkaline phosphatase and γ-glutamyl transpeptidase have been reported. Liver function test abnormalities generally have been mild and transient. Increases in serum CK levels, derived from skeletal muscle, have been reported (see Precautions).
Increases in HbA1c and fasting serum glucose levels have been reported with statins, including SIMVASTATIN (ZOCOR).
Pediatric Patients (Ages 10-17 Years): In a study involving pediatric patients 10-17 years of age with heterozygous familial hypercholesterolemia (n=175), the safety and tolerability profile of the group treated with SIMVASTATIN (ZOCOR) was generally similar to that of the group treated with placebo (see Use in Children under Precautions).