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Rosuvastatin Calcium Tablets Rx Only HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ROSUVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for ROSUVASTATIN CALCIUM TABLETS. ROSUVASTATIN CALCIUM tablets, for oral use Initial U.S. Approval: 2003
Medication labelWhy this: Advisory · dailymed-prescription
Rosuvastatin tablets are indicated: • To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L, and at least one additional CV risk factor. • As an adjunct to diet to: • Reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. • Reduce LDL-C and slow the progression of atherosclerosis in adults. • Reduce LDL-C in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). • As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH). • As an adjunct to diet for the treatment of adults with: • Primary dysbetalipoproteinemia. • Hypertriglyceridemia.
- generic_name
- rosuvastatin
- product_names
- Rosuvastatin
- ndc
- 50268-709, 31722-883, 50268-709-11, 50268-709-15, 50268-710, 31722-884, 50268-710-11, 50268-710-15, 50268-711, 31722-885, 50268-711-11, 50268-711-15
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en