FDA label
What is rosuvastatin used for?
The FDA-approved uses of rosuvastatin, quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “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...”
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Rosuvastatin, tablet, film coated
Indications and Usage, quoted from the label by Accord Healthcare Inc. (ANDA206434). Cross-references to other label sections are left out.
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.
Source: DailyMed label, set id 3ffe0294-3997-2755-e054-00144ff8d46c, version 11, effective November 14, 2025. NDC 16729-284, one of 200 listings for this product.
Rosuvastatin Calcium, tablet
Indications and Usage, quoted from the label by TORRENT PHARMACEUTICALS LIMITED (ANDA207626). Cross-references to other label sections are left out.
Rosuvastatin tablets is 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 at increased risk for CV events.
- As an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C):
- in adults with primary hypercholesterolemia.
- and slow the progression of atherosclerosis in adults.
- in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH).
- 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.
Source: DailyMed label, set id 6985e729-d963-4f32-89a1-727472b86daa, version 9, effective September 2, 2026. NDC 13668-720, one of 34 listings for this product.
Rosuvastatin, tablet, film coated
Indications and Usage, quoted from the label by ScieGen Pharmaceuticals, Inc. (ANDA206381). Cross-references to other label sections are left out.
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 at increased risk for CV events.
- As an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C):
- in adults with hypercholesterolemia.
- and slow the progression of atherosclerosis in adults.
- in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH).
- 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.
Source: DailyMed label, set id ee4933c5-0d97-494d-ac0f-2083e0100836, version 10, effective September 4, 2026. NDC 50228-116, one of 33 listings for this product.
Questions
What is rosuvastatin used for?
The FDA label says: “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...”
What drug class is rosuvastatin?
FDA lists rosuvastatin in the HMG-CoA Reductase Inhibitor established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.
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