FDA label
What is ezetimibe used for?
The FDA-approved uses of ezetimibe, 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: “Ezetimibe tablets are indicated: In combination with a statin, or alone when additional low-density lipoprotein cholesterol (LDL-C) lowering therapy is not possible, as an adjunct to diet to reduce elevated LDL-C in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH); In combination with a statin as an adjunct to diet to reduce elevated LDL-C in pedia...”
Run it in Rivvi
Which 2027 plans near you dropped or restricted ezetimibe?
Tier changes and new prior auth, step therapy or quantity limits, plan by plan.
Free to start. Opens Rivvi, the AI workspace for healthcare teams.
Ezetimibe, tablet
Indications and Usage, quoted from the label by Accord Healthcare Inc. (ANDA211550). Cross-references to other label sections are left out.
Ezetimibe tablets are indicated:
- In combination with a statin, or alone when additional low-density lipoprotein cholesterol (LDL-C) lowering therapy is not possible, as an adjunct to diet to reduce elevated LDL-C in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH).
- In combination with a statin as an adjunct to diet to reduce elevated LDL-C in pediatric patients 10 years of age and older with HeFH.
- In combination with fenofibrate as an adjunct to diet to reduce elevated LDL-C in adults with mixed hyperlipidemia.
- In combination with a statin, and other LDL-C lowering therapies, to reduce elevated LDL-C levels in adults and in pediatric patients 10 years of age and older with homozygous familial hypercholesterolemia (HoFH).
- As an adjunct to diet for the reduction of elevated sitosterol and campesterol levels in adults and in pediatric patients 9 years of age and older with homozygous familial sitosterolemia.
When ezetimibe tablets are used in combination with a statin, fenofibrate, or other LDL-C lowering therapies, refer to the Prescribing Information of these products for information on the safe and effective use.
Source: DailyMed label, set id ceecdbe9-5404-4a93-a488-9211cd103058, version 10, effective October 14, 2025. NDC 16729-433, one of 41 listings for this product.
Questions
What is ezetimibe used for?
The FDA label says: “Ezetimibe tablets are indicated: In combination with a statin, or alone when additional low-density lipoprotein cholesterol (LDL-C) lowering therapy is not possible, as an adjunct to diet to reduce elevated LDL-C in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH); In combination with a statin as an adjunct to diet to reduce elevated LDL-C in pedia...”
What drug class is ezetimibe?
FDA lists ezetimibe in the Dietary Cholesterol Absorption 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.