Eicosapentaenoic acid (purified omega-3) Pregnancy: Available data from published case reports and the pharmacovigilance database in pregnant women are insufficient to identify a drug-associated risk for major birth defects, miscarriage or adverse maternal or fetal outcomes.

Icosapent ethyl

Brand names: Vazkepa

Icosapent ethyl is a highly purified ethyl ester of the omega-3 fatty acid eicosapentaenoic acid (EPA), used to reduce cardiovascular risk in statin-treated patients with raised triglycerides.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: 4 grams per day — either four 0.5 gram capsules twice daily, or two 1 gram capsules twice daily

Route: Oral, with food

Frequency: Twice daily with food

Assess lipid levels before initiating therapy. Identify other causes of high triglyceride levels (e.g. diabetes mellitus, hypothyroidism, or medicines) and manage as appropriate. Patients should engage in appropriate nutritional intake and physical activity before starting treatment and continue during treatment. Advise patients to swallow capsules whole — do not break open, crush, dissolve or chew. Available as 0.5 gram and 1 gram capsules. Paediatric: safety and effectiveness in paediatric patients have not been established — verify against a children's formulary.

Dose auto-extracted from US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

Known hypersensitivity (e.g. anaphylactic reaction) to icosapent ethyl or any of its components

Side effects

Musculoskeletal pain
Peripheral oedema
Constipation
Gout
Atrial fibrillation / atrial flutter (increased risk, including hospitalisation)
Arthralgia and oropharyngeal pain (hypertriglyceridaemia trials)

Interactions

Anticoagulants and/or antiplatelet agents — some published studies with omega-3 fatty acids have shown prolongation of bleeding time; monitor for bleeding (risk of bleeding was greater in patients on concomitant aspirin, clopidogrel or warfarin)

Clinical monograph

How it works

It provides purified EPA which lowers plasma triglycerides through reduced hepatic VLDL-triglyceride synthesis and increased clearance, with additional proposed anti-inflammatory and membrane-stabilising effects.

Prescribing in practice

It is indicated as an adjunct to statin therapy in high-cardiovascular-risk patients with elevated triglycerides and should be prescribed within the eligibility criteria in NICE technology appraisal guidance.
An increased incidence of atrial fibrillation or flutter has been reported, so be alert to new palpitations or arrhythmia.
There may be an increased bleeding risk, particularly with concurrent antiplatelet or anticoagulant therapy.

Monitoring

Monitor the lipid profile, and remain alert for new atrial fibrillation or signs of bleeding during treatment.

Counselling the patient

Continue your statin and a healthy diet alongside this medicine.
Report palpitations or an irregular heartbeat.
Report any unusual bruising or bleeding, especially if you take other blood-thinning medicines.

Evidence & guidelines

The REDUCE-IT trial showed that icosapent ethyl reduced cardiovascular events in statin-treated patients with raised triglycerides, and NICE recommends it within defined criteria.

Reference: NICE TA805; REDUCE-IT trial; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

Calculators

Pathways