No black box warning on record for Rosuvastatin

As of the latest FDA labeling reviewed, Rosuvastatin (rosuvastatin calcium) does not carry a black box warning. Standard warnings and precautions still apply — see the full Rosuvastatin medicine page for the complete safety profile.

Other warnings & precautions

Pregnancy Category X: Absolutely contraindicated in pregnancy and breastfeeding. Reliable contraception required for women of childbearing age on rosuvastatin.
Asian Patients: Studies show Asian patients have approximately 2-fold higher rosuvastatin plasma concentrations at the same dose. Start at 5mg/day in patients of Asian descent and titrate cautiously.
Renal Proteinuria: Dose-dependent proteinuria and hematuria have been observed with rosuvastatin, particularly at 40mg. Dipstick urinalysis before initiating 40mg and periodically during treatment is recommended. This may represent tubular dysfunction rather than glomerular damage.
Myopathy Risk: While lower than simvastatin, myopathy risk remains real — especially with interacting medicines (gemfibrozil, cyclosporine). Unexplained muscle pain, tenderness, or weakness warrants CK measurement. Rhabdomyolysis, though rare, can cause acute renal failure and is potentially fatal.
Diabetes Risk: High-intensity statins including rosuvastatin are associated with a small but statistically significant increase in new-onset type 2 diabetes (approximately 10–12% relative risk increase). For high cardiovascular risk patients, the cardiovascular benefit far exceeds this risk.

No black box warning on record for Rosuvastatin

Other warnings & precautions

Pregnancy Category X: Absolutely contraindicated in pregnancy and breastfeeding. Reliable contraception required for women of childbearing age on rosuvastatin.
Asian Patients: Studies show Asian patients have approximately 2-fold higher rosuvastatin plasma concentrations at the same dose. Start at 5mg/day in patients of Asian descent and titrate cautiously.
Renal Proteinuria: Dose-dependent proteinuria and hematuria have been observed with rosuvastatin, particularly at 40mg. Dipstick urinalysis before initiating 40mg and periodically during treatment is recommended. This may represent tubular dysfunction rather than glomerular damage.
Myopathy Risk: While lower than simvastatin, myopathy risk remains real — especially with interacting medicines (gemfibrozil, cyclosporine). Unexplained muscle pain, tenderness, or weakness warrants CK measurement. Rhabdomyolysis, though rare, can cause acute renal failure and is potentially fatal.
Diabetes Risk: High-intensity statins including rosuvastatin are associated with a small but statistically significant increase in new-onset type 2 diabetes (approximately 10–12% relative risk increase). For high cardiovascular risk patients, the cardiovascular benefit far exceeds this risk.

Rosuvastatin Black Box Warning

No black box warning on record for Rosuvastatin

Other warnings & precautions

Rosuvastatin Black Box Warning

No black box warning on record for Rosuvastatin

Other warnings & precautions