Rhea Rosuvastatin Adverse Reactions

Rosuvastatin is generally well tolerated. The adverse events seen with Rosuvastatin are generally mild and transient. In controlled clinical trials less than 4% of Rosuvastatin treated patients were withdrawn due to adverse events. This withdrawal rate was comparable to that reported in patients receiving placebo. (See Table 6.)

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As with other HMG CoA reductase inhibitors, the incidence of adverse drug reactions tends to increase with increasing dose.
Skeletal Muscle Effects: Rare cases of rhabdomyolysis, which were occasionally associated with impairment of renal function, have been reported with rosuvastatin and with other marketed statins.
Laboratory Effects: As with other HMG-CoA reductase inhibitors, a dose-related increase in liver transaminases and CK has been observed in a small number of patients taking rosuvastatin. Increases in HbA1c have also been observed in patients treated with rosuvastatin (see Precautions and Pharmacology: Pharmacodynamics under Actions). Abnormal urinalysis testing (dipstick-positive proteinuria) has been seen in a small number of patients taking Rosuvastatin and other HMG-CoA reductase inhibitors. The protein detected was mostly tubular in origin. In most cases, proteinuria decreases or disappears spontaneously on continued therapy, and is not predictive of acute or progressive renal disease.
Other effects: In a long-term controlled clinical trial Rosuvastatin was shown to have no harmful effects on the ocular lens.
In Rosuvastatin treated patients, there was no impairment of adrenocortical function.
Post Marketing Experience: In addition to the previously mentioned, the following adverse events have been reported during post marketing experience for Rosuvastatin: Haematological disorders: Frequency unknown: thrombocytopenia.
Hepatobiliary disorders: Very rare: jaundice, hepatitis; rare: increased hepatic transaminases.
Musculoskeletal disorders: Frequency unknown: immune-mediated necrotising myopathy; very rare: arthralgia.
As with other HMG-CoA reductase inhibitors, the reporting rate for rhabdomyolysis in post-marketing use is higher at the highest marketed dose.
Nervous system disorders: Very rare: memory loss; frequency unknown: peripheral neuropathy.
Psychiatric disorders: Frequency unknown: depression, sleep disorders (including insomnia and nightmares).
Reproductive system and breast disorders: Frequency unknown: gynaecomastia.
Children and adolescents 6 to 17 years of age: The safety profile of Rosuvastatin is similar in children or adolescent patients and adults although CK elevations > 10 x ULN and muscle symptoms following exercise or increased physical activity, 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 [see Precautions].