Rosmi Adverse Reactions

The adverse events seen are generally mild and transient. In controlled-trials, less than 4% of patients treated with Rosuvastatin were withdrawn due to adverse events. This withdrawal rate was comparable to that reported in patients receiving placebo. (See table.)

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As with other HMG-CoA reductase inhibitors, the incidence of adverse drug reactions tends to be dose dependent.
Renal effects: In the Rosuvastatin clinical trial program, dipstick-positive proteinuria and microscopic hematuria were observed among Rosuvastatin treated patients, predominantly in patients dosed above the recommended dose range (i.e., 80 mg). However, this finding was more frequent in patients taking Rosuvastatin 40 mg, when compared to lower doses of Rosuvastatin or comparator statins, though it was generally transient and was not associated with worsening renal function. An assessment of renal function should be considered during routine follow-up of patients treated with a dose of 40 mg.
Skeletal muscle effects: As with other HMG CoA-reductase inhibitors, effects on skeletal muscle e.g. myalgia and myopathy (including myositis), have been reported in Rosuvastatin-treated patients. Rare case of rhabdomyolysis, which were occasionally associated with impairment of renal function, have been reported with Rosuvastatin and with other marketed statins.
A dose-related increase in CK levels has been observed in a small number of patients taking Rosuvastatin; the majority of cases were mild, asymptomatic and transient. If CK levels are elevated (>5x upper limit of normal), treatment should be temporarily discontinued.
Liver effects: As with other HMG-CoA reductase inhibitors, a dose-related increase in transaminase has been observed in a small number of patients taking Rosuvastatin; the majority of cases were mild, asymptomatic and transient.
Children and adolescents 6 to 17 years of age: The safety profile of Rosuvastatin is similar in children or adolescent patients and adults although creatine kinase (CK) elevations > 10 x ULN and muscle symptoms following exercise or increased physical activities, which resolved with continued treatment, were observed more frequently in a clinical trial of children and adolescents. However, the same special warnings and special precautions for use in adults also apply to children and adolescents.