FDA label
What is icosapent ethyl used for?
The FDA-approved uses of icosapent ethyl, 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: “Icosapent ethyl is indicated: as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia.”
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Icosapent Ethyl, capsule
Indications and Usage, quoted from the label by Hikma Pharmaceuticals USA Inc. (ANDA209457). Cross-references to other label sections are left out.
Icosapent ethyl is indicated:
- as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia.
Limitations of Use
The effect of icosapent ethyl on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined.
Source: DailyMed label, set id e3d38d1d-fbe7-413d-849a-675e7dfa9b0a, version 5, effective July 9, 2026. NDC 0054-0508, one of 28 listings for this product.
Questions
What is icosapent ethyl used for?
The FDA label says: “Icosapent ethyl is indicated: as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia.”
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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