FDA label

What is atorvastatin used for?

The FDA-approved uses of atorvastatin, 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: “Atorvastatin calcium tablets are indicated: To reduce the risk of:; As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in:; 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 10 years and older with homozygous familial hypercholesterolemia (HoFH); As an adjunct to diet for t...”

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Atorvastatin Calcium, tablet, film coated

Indications and Usage, quoted from the label by Mylan Pharmaceuticals Inc. (ANDA091226). Cross-references to other label sections are left out.

Atorvastatin calcium tablets are indicated:

  • To reduce the risk of:
  • oMyocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD
  • oMI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD
  • oNon-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD
  • As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in:
  • oAdults with primary hyperlipidemia.
  • oAdults and pediatric patients aged 10 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 10 years and older with homozygous familial hypercholesterolemia (HoFH).
  • As an adjunct to diet for the treatment of adults with:
  • oPrimary dysbetalipoproteinemia
  • oHypertriglyceridemia

Source: DailyMed label, set id d0a0feb6-84f0-4693-a11f-eb4f7ae0a87d, version 28, effective June 15, 2026. NDC 0378-3950, one of 232 listings for this product.

Atorvastatin Calcium, tablet, film coated

Indications and Usage, quoted from the label by Apotex Corp. (ANDA090548). Cross-references to other label sections are left out.

Atorvastatin Calcium Tablets are indicated:

  • To reduce the risk of:
  • Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD
  • MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD
  • Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD
  • As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in:
  • Adults with primary hyperlipidemia.
  • Adults and pediatric patients aged 10 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 10 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 d9adb9e4-c495-9530-e5e3-7e3b01d53e4c, version 35, effective September 8, 2026. NDC 60505-2578, one of 67 listings for this product.

Questions

What is atorvastatin used for?

The FDA label says: “Atorvastatin calcium tablets are indicated: To reduce the risk of:; As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in:; 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 10 years and older with homozygous familial hypercholesterolemia (HoFH); As an adjunct to diet for t...”

What drug class is atorvastatin?

FDA lists atorvastatin 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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