FDA label
What is Nexletol used for?
Nexletol contains bempedoic acid. 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: “NEXLETOL is indicated: to reduce the risk of major adverse cardiovascular events (cardiovascular death, myocardial infarction, stroke, or coronary revascularization) in adults at increased risk for these events who are unable to take recommended statin therapy (including those not taking a statin); as an adjunct to diet and exercise, in combination with other low-density lipoprotein cholesterol...”
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Nexletol, tablet, film coated
Indications and Usage, quoted from the label by Esperion Therapeutics, Inc. (NDA211616). Cross-references to other label sections are left out.
NEXLETOL is indicated:
- to reduce the risk of major adverse cardiovascular events (cardiovascular death, myocardial infarction, stroke, or coronary revascularization) in adults at increased risk for these events who are unable to take recommended statin therapy (including those not taking a statin).
- as an adjunct to diet and exercise, in combination with other low-density lipoprotein cholesterol (LDL-C) lowering therapies, or alone when concomitant LDL-C lowering therapy is not possible, to reduce LDL-C in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH).
Source: DailyMed label, set id 88d06d89-a3da-40b4-b273-8f4f7d56c4c9, version 20, effective June 25, 2026. NDC 72426-118, one of 1 listing for this product.
Questions
What is Nexletol used for?
The FDA label says: “NEXLETOL is indicated: to reduce the risk of major adverse cardiovascular events (cardiovascular death, myocardial infarction, stroke, or coronary revascularization) in adults at increased risk for these events who are unable to take recommended statin therapy (including those not taking a statin); as an adjunct to diet and exercise, in combination with other low-density lipoprotein cholesterol...”
What drug class is Nexletol?
FDA lists bempedoic acid in the Adenosine Triphosphate-Citrate Lyase 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.