FDA label
What is Vascepa used for?
Vascepa contains icosapent ethyl. 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: “VASCEPA® (icosapent ethyl) is indicated: as an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization in adult patients with elevated triglyceride (TG) levels (≥ 150 mg/dL) and; as an adjunct to diet to reduce TG levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceri...”
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Vascepa, capsule
Indications and Usage, quoted from the label by Amarin Pharma Inc. (NDA202057). Cross-references to other label sections are left out.
VASCEPA® (icosapent ethyl) is indicated:
- as an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization in adult patients with elevated triglyceride (TG) levels (≥ 150 mg/dL) and
- established cardiovascular disease or
- diabetes mellitus and 2 or more additional risk factors for cardiovascular disease.
- as an adjunct to diet to reduce TG levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia.
Limitations of Use:
The effect of VASCEPA on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined.
Source: DailyMed label, set id 9c1a2828-1583-4414-ab22-a60480e8e508, version 21, effective March 23, 2026. NDC 52937-001, one of 5 listings for this product.
Questions
What is Vascepa used for?
The FDA label says: “VASCEPA® (icosapent ethyl) is indicated: as an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization in adult patients with elevated triglyceride (TG) levels (≥ 150 mg/dL) and; as an adjunct to diet to reduce TG levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceri...”
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 Vascepa
- Is Vascepa a controlled substance?Federal schedule
- Generic for VascepaFDA Orange Book
- What is Icosapent Ethyl used for?FDA label uses
- Is Icosapent Ethyl a controlled substance?Federal schedule
- Vascepa Medicare Part D coverageBy plan and state
- NDC 52937-001Vascepa NDC record
- NDC 52937-003Vascepa NDC record
- NDC 52937-005Vascepa NDC record