Rhabdomyolysis with acute renal failure secondary to myoglobinuria has occurred rarely with simvastatin and has required drug discontinuance.
Simvastatin was extremely well tolerated in controlled clinical trials. Only 1.4% of subjects were discontinued from therapy due to the adverse effects of simvastatin. Adverse reactions tend to be transient and mild. Constipation (2.3%), dyspepsia (1.1%) and flatulence (1.9%) were the only adverse reactions reported at a higher incidence than placebo.
The following adverse reactions were reported in >1% of patients receiving simvastatin during clinical trials: Pain, asthenia, diarrhea, nausea/vomiting and headache.
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