Icosapent Ethyl

• 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.ICD-10: E78.1

• 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.contraindicated

Assess lipid levels before initiating therapy. Identify other causes of high triglyceride levels and manage as appropriate. (2.1) Patients should engage in appropriate nutritional intake and physical activity before receiving icosapent ethyl capsules, which should continue during treatment. (2.1) The daily dose of icosapent ethyl capsules are 4 grams per day taken as either four 0.5 gram capsules twice daily with food or two 1 gram capsules twice daily with food. (2.2) Advise patients to swallow capsules whole. Do not break open, crush, dissolve, or chew icosapent ethyl capsules. (2.2) 2.1 Prior to Initiation of Icosapent Ethyl Capsules Assess lipid levels before initiating therapy. Identify other causes (e.g., diabetes mellitus, hypothyroidism, or medications) of high triglyceride levels and manage as appropriate. Patients should engage in appropriate nutritional intake and physical activity before receiving icosapent ethyl capsules, which should continue during treatment with icosapent ethyl capsules. 2.2 Dosage and Administration The daily dose of icosapent ethyl capsules are 4 grams per day taken as either: four 0.5 gram capsules twice daily with food; or as two 1 gram capsules twice daily with food. Advise patients to swallow icosapent ethyl capsules whole. Do not break open, crush, dissolve, or chew icosapent ethyl capsules.

Atrial Fibrillation/Flutter: Icosapent ethyl was associated with an increased risk of atrial fibrillation or atrial flutter requiring hospitalization in a double-blind, placebo-controlled trial. The incidence of atrial fibrillation was greater in patients with a previous history of atrial fibrillation or atrial flutter. (5.1) Potential for Allergic Reactions in Patients with Fish Allergy: Icosapent ethyl capsules contains ethyl esters of the omega-3 fatty acid, eicosapentaenoic acid (EPA), obtained from the oil of fish. It is not known whether patients with allergies to fish and/or shellfish are at increased risk of an allergic reaction to icosapent ethyl capsules. Inform patients with known hypersensitivity to fish and/or shellfish about the potential for allergic reactions and advise them to discontinue icosapent ethyl and seek medical attention if any reactions occur. (5.2) Bleeding: Icosapent ethyl was associated with an increased risk of bleeding in a double-blind, placebo-controlled trial. The incidence of bleeding was greater in patients receiving concomitant antithrombotic medications, such as aspirin, clopidogrel, or warfarin. (5.3) 5.1 Atrial Fibrillation/Flutter Icosapent ethyl is associated with an increased risk of atrial fibrillation or atrial flutter requiring hospitalization.

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) Common adverse reactions in the hypertriglyceridemia trials (incidence ≥1% more frequent than placebo): arthralgia and oropharyngeal pain. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact XLCare Pharmaceuticals, Inc. at 1-866-495-1995 or contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Common adverse reactions (incidence ≥3% on icosapent ethyl and ≥1% more frequent than placebo) included musculoskeletal pain, peripheral edema, constipation, gout, and atrial fibrillation. Hypertriglyceridemia Trials In two randomized, double-blind, placebo-controlled trials in patients with triglyceride levels between 200 and 2000 mg/dL treated for 12 weeks, adverse reactions reported with icosapent ethyl at an incidence ≥1% more frequent than placebo based on pooled data included arthralgia and oropharyngeal pain.

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 organogenesis at exposures that were equivalent to the clinical exposure at the human dose of 4 g/day, based on body surface area comparisons. In a study in pregnant rabbits orally administered icosapent ethyl during organogenesis, there were no clinically relevant adverse developmental effects at exposures that were 5 times the clinical exposure, based on body surface area comparisons ( see Data ). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

• Jul 26, 2012NDANDA202057Amarin Pharms
• May 21, 2020ANDAANDA209457Hikma
• Aug 7, 2020ANDAANDA209499Dr Reddys
• Sep 11, 2020ANDAANDA209525Teva Pharms Usa
• Jun 30, 2021ANDAANDA209437Apotex
• Apr 20, 2023ANDAANDA217656Zydus Lifesciences
• Sep 22, 2023ANDAANDA217844Onesource Specialty
• Dec 7, 2023ANDAANDA216811Ascent Pharms Inc

Reference statistics from the openFDA drug-shortage dataset. For a live view, consult the FDA database directly. Not clinical guidance.

• Icosapent Ethyl, Capsule, 1 g (NDC 60429-005-12)To be discontinued
  Sponsor: Apotex Corp.
  Updated Apr 1, 2026
• Icosapent Ethyl, Capsule, 1 g (NDC 61474-9711-1)To be discontinued
  Sponsor: Apotex Corp.
  Updated Apr 1, 2026

1. 1Product Odour Abnormal1,00512%
2. 2Product Physical Issue82310%
3. 3Off Label Use7619.3%
4. 4Poor Quality Product Administered5867.2%
5. 5Diarrhoea5737.0%
6. 6Drug Ineffective5506.7%
7. 7Nausea5126.3%
8. 8Arthralgia4845.9%
9. 9Product Taste Abnormal4345.3%
10. 10Fatigue4105.0%
11. 11Prescribed Underdose3063.7%
12. 12Blood Triglycerides Increased2913.6%
13. 13Headache2883.5%
14. 14Dizziness2833.5%
15. 15Eructation2723.3%

The 10 most recently updated of 73 ClinicalTrials.gov registrations naming Icosapent Ethyl as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Effects of Icosapent Ethyl on Coronary Plaque, Inflammation, and Ventricular Remodeling
  Not yet recruiting · Observational · 420 enrolled · Ruijin Hospital
  NCT07641257updated 2026-06-11
• Targeting Vascular INflammation in Patients With Community-Acquired Pneumonia
  Recruiting · Phase 3 · Interventional · 168 enrolled · Ottawa Heart Institute Research Corporation
  NCT06710080updated 2026-05-11
• Altering Lipids for Tolerance of Aromatase Inhibitor Therapy
  Completed · Phase 2 · Interventional · 77 enrolled · University of Michigan Rogel Cancer Center
  NCT04268134updated 2026-05-06
• IcoSApent ethyL to Slow Down Aortic VAlve Stenosis proGrEssion
  Active not recruiting · Phase 2 · Interventional · 110 enrolled · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  NCT06466278updated 2025-10-03
• Testing an Omega-3 Fatty Acid-Based Anti-Cancer Therapy for Patients With Triple-Negative Inflammatory Breast Cancer That Has Spread to Other Parts of the Body
  Terminated · Phase 1 · Phase 2 · Interventional · 1 enrolled · National Cancer Institute (NCI)
  NCT05198843updated 2025-10-03
• The Effect of E-EPA on Circulating LDL and Plasma Lipid Metabolism
  Completed · Interventional · 68 enrolled · Wihuri Research Institute
  NCT04152291updated 2025-09-22
• EPA for Metastasis Trial 2
  Active not recruiting · Phase 3 · Interventional · 418 enrolled · Mark A Hull, PhD FRCP
  NCT03428477updated 2025-04-18
• Aggressive Risk-Prevention Therapies for Coronary Atherosclerotic Plaque (ART-CAP)
  Withdrawn · Phase 4 · Interventional · 0 enrolled · University of Louisville
  NCT06280976updated 2025-03-17
• CreNeuroS™️CNS Fish Oil Plus Softgels Compared to Vascepa® Capsules and Deplin® Capsules in a Pharmacokinetic, Single Dose Evaluation on Healthy Adult Human Subjects Under Fasting Conditions
  Enrolling by invitation · Interventional · 14 enrolled · Sichuan Credit Pharmaceutical Co., Ltd.
  NCT06758778updated 2025-01-23
• Effect of Icosapent-ethyl Ester (IPE) to Reduce the Residual Risk Cardiovascular Disease.
  Not yet recruiting · Interventional · 294 enrolled · University of Sao Paulo
  NCT06720662updated 2024-12-13

Frequently asked questions

What is Icosapent Ethyl used for?

According to FDA labeling, Icosapent Ethyl carries indications including: 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What are the brand names for Icosapent Ethyl?

Icosapent Ethyl is marketed under brand names including Vascepa.

What are the contraindications for Icosapent Ethyl?

Icosapent Ethyl labeling lists contraindications including: 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.. Always consult the full prescribing information and a clinician.