Icosapent Ethyl
Active ingredient
Sold as Vazkepa · VASCEPA
- Drug class
- -
- Availability
- Prescription only
- Routes
- Oral
- Markets covered
- 4
- Products on record
- 13
- FDA reports (12 mo)
- 954
Overview
Icosapent Ethyl is an active pharmaceutical ingredient. The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 7 | May 22, 2026 |
| US United States | FDA | 4 | April 30, 2026 |
| EU European Union | EMA | 1 | March 13, 2026 |
| CA Canada | Health Canada | 1 | July 5, 2025 |
GBUnited Kingdom· MHRA
7 products
Uses
7 mmol/l]) and • established cardiovascular disease, or • diabetes, and at least one other cardiovascular risk factor. 1.
How to take
USUnited States· FDA
4 products
Uses
1 INDICATIONS AND USAGE Icosapent ethyl capsules are 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 capsules on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined. Icosapent ethyl capsules are an ethyl ester of eicosapentaenoic acid (EPA) indicated: as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia.
(1) Limitations of Use: The effect of icosapent ethyl capsules on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined. (1)
EUEuropean Union· EMA
1 product
Uses
7 mmol/L]) and • established cardiovascular disease, or • diabetes, and at least one other cardiovascular risk factor. 1.
How to take
CACanada· Health Canada
1 product
Uses
VASCEPA® (icosapent ethyl) is indicated to reduce the risk of cardiovascular events (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularization or hospitalization for unstable angina) in statin-treated patients with elevated triglycerides, who are at high risk of cardiovascular events due to: established cardiovascular disease, or diabetes, and at least one other cardiovascular risk factor.
1 Pediatrics Pediatrics (<18 years): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use. 2 Geriatrics Geriatrics (≥65 years): VASCEPA may be used in patients ≥65 years of age.
Evidence from clinical studies and experience suggests that use in the geriatric population is not associated with differences in safety or effectiveness, but greater sensitivity of some older individuals cannot be ruled out.
Sources & citations
- [1]MHRA (UK) · PLGB512410002 · revised September 5, 2025
- [2]FDA DailyMed · 019cc0ac-0c2f-42… · revised April 30, 2026 [PDF]
- [3]European Medicines Agency · EMEA/H/C/005398 · revised March 13, 2026
- [4]Health Canada (DPD) · 02495244 · revised July 5, 2025
- [5]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.