FDA label
What is Crestor used for?
Crestor contains rosuvastatin. The FDA-approved uses below are 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: “CRESTOR 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 these events; As an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C):; As an adjunct to diet for the treatment of adults with:.”
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Crestor, tablet, film coated
Indications and Usage, quoted from the label by AstraZeneca Pharmaceuticals LP (NDA021366). Cross-references to other label sections are left out.
CRESTOR 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 these 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 325a5d0e-9a72-4015-9fcd-1655fb504cee, version 19, effective September 23, 2026. NDC 0310-7560, one of 4 listings for this product.
Questions
What is Crestor used for?
The FDA label says: “CRESTOR 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 these events; As an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C):; As an adjunct to diet for the treatment of adults with:.”
What drug class is Crestor?
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.
More on Crestor
- Is Crestor a controlled substance?Federal schedule
- Generic for CrestorFDA Orange Book
- What is Rosuvastatin used for?FDA label uses
- Is Rosuvastatin a controlled substance?Federal schedule
- Statins listFDA drug class
- Crestor Medicare Part D coverageBy plan and state
- NDC 0310-7560Crestor NDC record
- NDC 0310-7570Crestor NDC record
- NDC 0310-7580Crestor NDC record