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
Plain-language summary, compiled from the cited regulatory records
Icosapent ethyl is an ethyl ester of eicosapentaenoic acid (EPA) [1].
Icosapent ethyl capsules are approved for use as an addition to diet to lower triglyceride levels in adult patients who have severe hypertriglyceridemia, defined as triglyceride levels of 500 mg/dL or greater [1]. The effect of icosapent ethyl capsules on the risk of pancreatitis in patients with severe hypertriglyceridemia has not been determined [1].
In the past 12 months, there have been 954 adverse event reports associated with this ingredient [2]. The most frequent adverse events reported include issues related to the physical quality of the product, such as abnormal odor, and instances of poor quality product being administered [2]. Other reported events include off-label use and aggravation of a pre-existing condition [2].
This is not medical advice. Consult a qualified healthcare professional.
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.