What is ICOSAPENT ETHYL used for?

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 pat

How does ICOSAPENT ETHYL work?

11 DESCRIPTION Icosapent ethyl capsules, a lipid-regulating agent, is supplied as either a 0.

What is the active ingredient in ICOSAPENT ETHYL?

Icosapent ethyl (Icosapentum ethylicum)

What pharmaceutical form is ICOSAPENT ETHYL available in?

ICOSAPENT ETHYL: Kapsułki miękkie 998 mg (doustna)

What are the side effects of ICOSAPENT ETHYL?

6 ADVERSE REACTIONS The following important adverse reactions are described below and elsewhere in the labeling: Atrial Fibrillation or Atrial Flutter [see Warnings and Precautions (5.1)] Potential for Allergic Reactions in Patients with Fish Allergy [see Warnings and Precautions (5.2)] Bleeding [see Warnings and Precautions (5.3)] Common adverse reactions (incidence ≥3% and ≥1% more frequent than placebo): musculoskeletal pain, peripheral edema, constipation, gout, and atrial fibrillation. (6.1

Who should NOT take ICOSAPENT ETHYL?

4 CONTRAINDICATIONS Icosapent ethyl capsules are contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to icosapent ethyl or any of its components. Icosapent ethyl capsules are contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to icosapent ethyl or any of its components. (4)

Does ICOSAPENT ETHYL interact with other medications?

7 DRUG INTERACTIONS Increased Bleeding Risk with Anticoagulants and Antiplatelet Agents: Some published studies with omega-3 fatty acids have demonstrated prolongation of bleeding time. Monitor patients receiving icosapent ethyl and concomitant anticoagulants and/or antiplatelet agents for bleeding. (7) 7.1 Increased Bleeding Risk with Anticoagulants and Antiplatelet Agents Some published studies with omega-3 fatty acids have demonstrated prolongation of bleeding time. The prolongation of bleedi

Can ICOSAPENT ETHYL be used during pregnancy?

8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary The available data from published case reports and the pharmacovigilance database on the use of icosapent ethyl in pregnant women are insufficient to identify a drug-associated risk for major birth defects, miscarriage or adverse maternal or fetal outcomes. In animal reproduction studies in pregnant rats, non-dose-related imbalances for some minor developmental findings were observed with oral administration of icosapent ethyl during organ

What precautions should be taken with ICOSAPENT ETHYL?

No special requirements for disposal.

Who manufactures ICOSAPENT ETHYL?

Amarin Pharmaceuticals Ireland Ltd (Irlandia)

What ATC class does ICOSAPENT ETHYL belong to?

ICOSAPENT ETHYL: ATC C10AX06. ATC is the WHO Anatomical Therapeutic Chemical classification — it groups drugs by organ system and pharmacological mechanism.

OTC

ICOSAPENT ETHYL

998 mg, Kapsułki miękkie

INN: Icosapent ethyl

Data updated: 2026-04-13

Available in:

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Form

Kapsułki miękkie

Dosage

998 mg

Route

doustna

Storage

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15 to 30 °C (59 to 86°F) [see USP Controlled Room Temperature]. Keep out of reach of children.

Used to treat:

High Cholesterol E78

User Reviews

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