From the FDA Drug Label
Adverse reactions reported in ≥2% of patients in placebo-controlled clinical studies and at a rate greater than placebo are shown in Table 2.
The following adverse reactions have been identified during postapproval use of rosuvastatin.
There have been rare reports of new-onset or exacerbation of myasthenia gravis, including ocular myasthenia, and reports of recurrence when the same or a different statin was administered
The FDA drug label does not answer the question.
From the Research
Adverse Effects of Rosuvastatin and Simvastatin
- The adverse effects of rosuvastatin were similar to those of other statins, with the exception of renal adverse effects 1.
- Rosuvastatin treatment is associated with relatively low rates of severe myopathy, rhabdomyolysis, and renal failure, similar to other statins 2.
- Asymptomatic liver enzyme elevations occur with rosuvastatin at a similarly low incidence as with other statins 2.
- Proteinuria induced by rosuvastatin is likely to be associated with a statin-provoked inhibition of low-molecular-weight protein reabsorption by the renal tubules 2.
- Higher doses of rosuvastatin have been associated with cases of renal failure 2.
Comparison of Adverse Effects
- There is no direct comparison of the adverse effects of rosuvastatin and simvastatin in the provided studies.
- However, the studies suggest that rosuvastatin has a similar safety profile to other statins, including simvastatin 1, 2.
- Rosuvastatin has been shown to be more effective than simvastatin in lowering LDL-C and achieving NCEP ATP III LDL-C goals 3, 4, 5.
Renal Adverse Effects
- Rosuvastatin has been associated with renal adverse effects, including proteinuria and renal failure 1, 2.
- The co-administration of rosuvastatin with drugs that increase rosuvastatin blood levels may be deleterious for the kidney 2.
- Rhabdomyolysis, considered a class effect of statins, is known to involve renal damage 2.
Other Adverse Effects
- Rosuvastatin has been associated with adverse effects related to the gastrointestinal tract and central nervous system, which are also commonly observed with many other drugs 2.
- Concerns have been raised by findings from the JUPITER study suggesting that rosuvastatin may slightly increase the incidence of physician-reported diabetes mellitus, as well as the levels of glycated hemoglobin in older patients with multiple risk factors and low-grade inflammation 2.