Rosuvastatin Calcium

Hyperlipidemia

Hyperlipidemia (2)

Cardiovascular disease prevention

Cardiovascular disease prevention (2)

Headache

Incidence: ~5.5% in FDA clinical trial data

Muscle pain (myalgia)

Incidence: ~2.8% in FDA clinical trial data

Nausea

Incidence: ~3.4% in FDA clinical trial data

Abdominal pain

Incidence: Reported in the clinician-authored database and FDA labeling; specific frequency not established in the source reviewed

Weakness (asthenia)

Incidence: ~2.7% in FDA clinical trial data

Constipation

Incidence: ~2.4% in FDA clinical trial data

Increases in blood sugar (fasting glucose) and HbA1c

Incidence: Reported; in some cases increases have exceeded the diagnostic threshold for diabetes

Unexplained muscle pain, tenderness, or weakness, especially with fever or dark urine — possible rhabdomyolysis

Signs of liver problems: fatigue, loss of appetite, right upper abdominal pain, dark urine, or yellowing of the skin/eyes (jaundice)

Blood or protein noted in routine urine testing (proteinuria/hematuria), reported more often at the 40 mg dose and usually transient

May cause muscle problems, including rare but serious rhabdomyolysis — serious

Symptoms: May cause muscle problems, including rare but serious rhabdomyolysis. Can cause liver enzyme abnormalities; regular monitoring is required. Not recommended during pregnancy or breastfeeding. Use with caution in patients with kidney impairment. May interact with other cholesterol-lowering medications and certain antivirals.

Action: Follow the urgency stated and seek prompt or emergency care when indicated. (2)

Contraindications recorded in the clinician database — serious

Symptoms: Contraindications recorded in the clinician database: Contraindications include active liver disease, unexplained persistent elevations of serum transaminases, pregnancy, breastfeeding, and known hypersensitivity to rosuvastatin. Use with caution in patients with renal impairment, history of liver disease, or those at risk for myopathy/rhabdomyolysis (e.g., elderly, hypothyroidism, concomitant use of other lipid-lowering agents).

Action: Follow the urgency stated and seek prompt or emergency care when indicated. (2)

Pregnancy

Crestor is contraindicated in pregnancy. Based on the way statins work (reducing cholesterol synthesis, which is needed for normal fetal development), the FDA label states Crestor may cause fetal harm; the label notes treatment is typically stopped once pregnancy is recognized. If you become pregnant or think you may be pregnant while taking Crestor, contact your healthcare provider promptly for guidance. Human data across statins as a class have not shown a clear increased risk of major birth defects, though data on miscarriage risk are insufficient. (2)

Breastfeeding

Breastfeeding is not recommended during Crestor treatment, due to the potential for adverse effects in the infant and the drug's effect on cholesterol synthesis important for infant development. (2)

Children

General safety and effectiveness in pediatric hyperlipidemia have not been established. FDA labeling documents experience only in children aged 8 years and older with homozygous familial hypercholesterolemia, dosed and monitored by a specialist; safety has not been established in children under 8 years of age. (2)

Renal Impairment

Renal impairment: no dose adjustment is needed for mild or moderate renal impairment. For severe renal impairment (creatinine clearance under 30 mL/min/1.73m2) not on hemodialysis, the recommended starting dose is 5 mg once daily, not to exceed 10 mg once daily. Hepatic impairment: Crestor is contraindicated in acute liver failure or decompensated cirrhosis; in other liver disease, baseline liver enzyme testing is generally recommended and patients should be monitored for symptoms such as fatigue, jaundice, or dark urine, especially with substantial alcohol use or prior liver disease. (2)

Hepatic Impairment

Renal impairment: no dose adjustment is needed for mild or moderate renal impairment. For severe renal impairment (creatinine clearance under 30 mL/min/1.73m2) not on hemodialysis, the recommended starting dose is 5 mg once daily, not to exceed 10 mg once daily. Hepatic impairment: Crestor is contraindicated in acute liver failure or decompensated cirrhosis; in other liver disease, baseline liver enzyme testing is generally recommended and patients should be monitored for symptoms such as fatigue, jaundice, or dark urine, especially with substantial alcohol use or prior liver disease. (2)

United States

• Crestortablet, film coated · 5 mg, 40 mg, 20 mg, 10 mg · astrazeneca pharmaceuticals lpregulator source
• rosuvstatintablet, film coated · 5 mg, 20 mg, 40 mg, 10 mg · lifestar pharma llcregulator source
• Rosuvastain Calciumtablet, film coated · 10 mg, 40 mg, 20 mg, 5 mg · chartwell rx, llcregulator source

United Kingdom

• Crestorreference source

Canada

• CRESTOR -regulator source
• MED-ROSUVASTATINregulator source

Australia

• Crestorreference source
• Rosuvastatin Sandozreference source
• Rosuvastatin RBXreference source
• APO-ROSUVASTATINreference source
• Cavstatreference source
• Crosuvareference source
• Pharmacor Rosuvastatinreference source
• Rosuvastatin Lupinreference source

New Zealand

• Rosuvastatin Viatrisreference source
• Rosuvastatin - Sandozreference source
• Rosuvastatin Mylanreference source