FDA label
What is simvastatin used for?
The FDA-approved uses of simvastatin, 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: “Simvastatin tablets are indicated: To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary hea...”
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Simvastatin, tablet, film coated
Indications and Usage, quoted from the label by Aurobindo Pharma Limited (ANDA077691). Cross-references to other label sections are left out.
Simvastatin tablets are indicated:
- To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events.
- As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C):
- In adults with primary hyperlipidemia.
- In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).
- As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults with homozygous familial hypercholesterolemia (HoFH).
- As an adjunct to diet for the treatment of adults with:
- Primary dysbetalipoproteinemia.
- Hypertriglyceridemia.
Source: DailyMed label, set id 4724dbb4-3613-4e6a-948f-a43d34f97f06, version 29, effective May 11, 2026. NDC 65862-050, one of 156 listings for this product.
Questions
What is simvastatin used for?
The FDA label says: “Simvastatin tablets are indicated: To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary hea...”
What drug class is simvastatin?
FDA lists simvastatin 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.