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icosapent ethyl

Vazkepa · ATC code C10AX

Also known as: Icosapent-Ethyl, İkosapent etil

Key facts
Active substance
icosapent ethyl
ATC code
C10AX
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Vazkepa 998 mg soft capsules
Marketing authorisation holder
Recordati Industria Chimica e Farmaceutica S.p.A.
Information as of
2026-10-28

Key facts

Icosapent ethyl (Vazkepa) is an ethyl ester of eicosapentaenoic acid (EPA) derived from fish oil, used to reduce cardiovascular event risk in high-risk statin-treated patients with raised triglycerides.

What it is used for

  • Reduction of the risk of cardiovascular events in adult statin-treated patients at high cardiovascular risk with elevated triglycerides (≥ 150 mg/dL [≥ 1.7 mmol/L]) and either established cardiovascular disease or diabetes with at least one other cardiovascular risk factor.

Dosing

  • Recommended daily dose: 4 capsules, taken as two 998 mg capsules twice daily, with or following a meal.
  • Swallow capsules whole; do not break, crush, dissolve or chew.
  • A missed dose should be taken as soon as remembered; the next dose should not be doubled.
  • No dose adjustment in elderly patients or in renal or hepatic impairment.

Contraindications

  • Hypersensitivity to the active substance, soya or any excipient.

Important warnings

  • Use with caution in known fish and/or shellfish allergy.
  • Increased risk of atrial fibrillation or flutter requiring hospitalisation, especially with a relevant history; watch for palpitations, dyspnoea or irregular pulse.
  • Increased risk of bleeding, particularly with antiplatelet agents or anticoagulants.
  • In hepatic impairment, monitor ALT and AST before and during treatment.

Side effects

  • Most frequent: bleeding (11.8%), peripheral oedema (7.8%), atrial fibrillation (5.8%), constipation (5.4%), musculoskeletal pain (4.3%), gout (4.3%) and rash (3.0%).
  • Eructation is also common; hypersensitivity and dysgeusia are uncommon.

Interactions

  • No interactions observed with omeprazole, rosiglitazone, warfarin and atorvastatin.
  • Antithrombotic agents (antiplatelets including acetylsalicylic acid, anticoagulants) increase bleeding risk – monitor periodically.

Pregnancy and breastfeeding

  • As a precaution, preferably avoid use during pregnancy unless the benefit outweighs the potential risk to the foetus.

Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Package leaflet, verbatim

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

  • VazkepaRecordati Industria Chimica e Farmaceutica S.p.A. · EMEA/H/C/005398

Source: European Medicines Agency (EMA), product information

Brand names in 3 more European countries
Iceland
Vazkepa
Liechtenstein
Vazkepa
Norway
Vazkepa

EMA – Article 57 product data (EU/EEA), 2026-10-29

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

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Sources

  1. European Medicines Agency. Vazkepa – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/vazkepa-epar-product-information_en.pdf

Editorial: Medelix editorial team · last updated 2026-10-28 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.