Omacor

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Omacor on Prescriptsy

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Omacor is a prescription medicine containing omega-3-acid ethyl esters 90, a highly purified and concentrated source of the omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA).

Each 1 g soft capsule provides at least 460 mg EPA and 380 mg DHA.

Omacor is licensed in the United Kingdom for two indications: the treatment of endogenous hypertriglyceridaemia as an adjunct to diet when dietary measures alone are insufficient, and as adjunctive treatment to standard therapy following myocardial infarction (heart attack).

Omacor is a prescription-only medicine (POM), manufactured by Viatris (formerly Mylan/Abbott).

Hypertriglyceridaemia, defined as fasting triglyceride levels above 1.7 mmol/L, is a common lipid abnormality associated with an increased risk of cardiovascular disease and, at very high levels (above 10 mmol/L), acute pancreatitis.

The prevalence of hypertriglyceridaemia in the UK adult population is estimated at 15% to 20%.

Triglyceride levels are influenced by diet (particularly saturated fat, refined carbohydrates, and alcohol), physical activity, body weight, genetics, and underlying conditions such as diabetes mellitus, hypothyroidism, and metabolic syndrome.

This page provides a comprehensive clinical overview of Omacor, including how it works, dosage guidance, side effects, safety warnings, and how to obtain a prescription in the United Kingdom.

Important safety information about Omacor

Before reading further, please note these essential safety points.

• Omacor is a prescription-only medicine for specific clinical indications. Standard fish oil supplements are not a substitute.
• Do not take Omacor if you are allergic to fish, soya, or peanuts.
• Inform your prescriber if you take anticoagulants (blood thinners) or antiplatelet medicines, as omega-3 fatty acids may increase bleeding risk.
• Omacor is an adjunct to dietary and lifestyle modification, not a replacement. Continue following a heart-healthy diet.
• Your prescriber will monitor triglyceride levels, liver function, and LDL cholesterol during treatment.

Understanding hypertriglyceridaemia

Triglycerides are a type of fat (lipid) found in the blood.

After eating, the body converts calories it does not need immediately into triglycerides, which are stored in fat cells and released between meals for energy.

Persistently elevated triglyceride levels are associated with atherosclerosis (the build-up of fatty deposits in artery walls), increasing the risk of coronary heart disease, stroke, and peripheral arterial disease.

Very high triglyceride levels (above 10 mmol/L) can cause acute pancreatitis, a serious and potentially life-threatening inflammation of the pancreas.

The causes of hypertriglyceridaemia can be primary (genetic) or secondary (acquired).

Common secondary causes include obesity, poorly controlled type 2 diabetes, excessive alcohol intake, hypothyroidism, chronic kidney disease, metabolic syndrome, and medicines such as corticosteroids, thiazide diuretics, beta-blockers, retinoids, and some antiretrovirals.

Treatment begins with addressing modifiable risk factors: dietary modification, weight management, increased physical activity, reduced alcohol consumption, and optimisation of blood glucose in diabetic patients.

When these measures are insufficient, pharmacological treatment may be required.

How Omacor works: mechanism of action

The omega-3 fatty acids in Omacor (EPA and DHA) lower triglyceride levels through several complementary mechanisms.

They inhibit the hepatic enzymes diacylglycerol acyltransferase and phosphatidic acid phosphatase, which are involved in triglyceride synthesis in the liver.

They enhance mitochondrial and peroxisomal beta-oxidation of fatty acids in the liver, diverting fatty acids away from triglyceride production and towards energy generation.

They increase the activity of lipoprotein lipase, the enzyme responsible for clearing triglyceride-rich lipoproteins (chylomicrons and VLDL) from the blood.

They reduce hepatic secretion of VLDL, the primary carrier of triglycerides in fasting blood.

The net result is a significant reduction in circulating triglyceride levels.

In clinical trials, Omacor at a dose of 4 g daily reduced fasting triglycerides by approximately 20% to 50%, depending on baseline levels and the duration of treatment.

The reduction is typically dose-dependent, with higher doses producing greater effects.

Beyond triglyceride lowering, omega-3 fatty acids have anti-inflammatory effects (reducing the production of pro-inflammatory eicosanoids), anti-arrhythmic properties (stabilising cardiac cell membrane ion channels), and mild anti-platelet effects (reducing thromboxane A2 production).

These pleiotropic effects may contribute to the cardiovascular benefit observed in post-MI patients, though the evidence base for cardiovascular outcomes with omega-3 fatty acids has evolved in recent years.

Clinical evidence and UK prescribing guidance

The GISSI-Prevenzione trial (1999), the landmark study supporting Omacor's use post-MI, enrolled over 11,000 patients who had survived a myocardial infarction within the preceding 3 months.

Patients randomised to receive omega-3 fatty acids (1 g daily) in addition to standard care showed a 15% relative reduction in the primary endpoint (death, non-fatal MI, and non-fatal stroke) and a 20% reduction in all-cause mortality, driven primarily by a reduction in sudden cardiac death.

This trial led to the licensing of Omacor for post-MI use in Europe.

Subsequent trials have produced mixed results. The JELIS trial (2007, conducted in Japan) showed a reduction in major coronary events with EPA added to statin therapy.

However, the ORIGIN trial (2012), ASCEND trial (2018), and VITAL trial (2018) did not demonstrate significant cardiovascular benefit with lower doses of omega-3 fatty acids in broader populations.

The REDUCE-IT trial (2019) showed a 25% relative risk reduction in major adverse cardiovascular events with high-dose icosapent ethyl (Vazkepa, a purified EPA-only preparation at 4 g daily) in patients with elevated triglycerides already on statin therapy, though debate continues about the role of the mineral oil placebo used in that trial.

Current NICE guidance (CG181: cardiovascular disease risk assessment and reduction, and TA733 on icosapent ethyl) provides the framework for lipid management.

Statins remain the first-line pharmacological treatment for cardiovascular risk reduction. Omega-3 fatty acids (Omacor) are used primarily for hypertriglyceridaemia rather than primary cardiovascular prevention.

NICE recommends that omega-3 fatty acid capsules should not be prescribed routinely for primary prevention of cardiovascular disease, but they remain licensed and available for the treatment of hypertriglyceridaemia and post-MI adjunctive therapy.

Omacor compared with other treatments for hypertriglyceridaemia

Several pharmacological options exist for managing hypertriglyceridaemia. Fibrates (bezafibrate, fenofibrate, gemfibrozil) are the most established class of triglyceride-lowering medicines, reducing levels by 30% to 50%.

They also raise HDL cholesterol. Fibrates may be used alone or in combination with statins (with caution regarding myopathy risk).

Statins themselves have a modest triglyceride-lowering effect (10% to 20%), in addition to their primary LDL-lowering action.

Nicotinic acid (niacin) lowers triglycerides and raises HDL but has significant side effects (flushing) and is rarely used.

Icosapent ethyl (Vazkepa) is a purified EPA preparation that has been shown to reduce cardiovascular events in patients with elevated triglycerides on statins (REDUCE-IT trial); NICE has issued technology appraisal guidance (TA733) supporting its use in certain patients.

Omacor is often used as adjunctive therapy when triglyceride levels remain elevated despite lifestyle modification and statin therapy. The choice between Omacor, fibrates, and icosapent ethyl depends on the clinical context, triglyceride level, cardiovascular risk profile, and local formulary guidance.

Dosage and administration

For hypertriglyceridaemia, the usual starting dose is 2 capsules daily, taken with food.

If triglyceride levels remain above target after 2 months, the dose may be increased to 4 capsules daily. For post-MI adjunctive therapy, the dose is 1 capsule daily.

Capsules should be swallowed whole with water during or immediately after a meal.

Do not chew the capsules, as this may release the oil and cause a fishy taste. Refrigerating capsules before use can help reduce eructation (fishy burping).

Triglyceride levels should be measured fasting and monitored every 2 to 3 months initially.

If no meaningful reduction is achieved after 2 months at the maximum dose, the prescriber should reconsider the treatment.

Liver function tests and LDL cholesterol should also be monitored during treatment, especially when used alongside statins.

Dietary and lifestyle measures should be maintained throughout treatment. Reducing saturated fat, refined carbohydrates, and alcohol intake; increasing physical activity; maintaining a healthy weight; and optimising blood glucose in diabetic patients are all essential for effective triglyceride management.

Side effects of Omacor

Common side effects

Gastrointestinal disturbances are the most commonly reported side effects: nausea, dyspepsia, abdominal bloating, diarrhoea, and eructation (burping). These are generally mild.

A fishy aftertaste is common and may be reduced by taking capsules immediately before food, swallowing them whole, and refrigerating them.

Uncommon and rare side effects

Dizziness, taste disturbance, headache, and mild elevations in liver transaminases may occur.

A small increase in LDL cholesterol is possible, particularly at higher doses and in patients with severe hypertriglyceridaemia. Hyperglycaemia may be observed in diabetic patients.

Allergic reactions (rash, urticaria) are rare. Anaphylaxis is extremely rare but can occur in patients with fish allergy.

Bleeding risk

Omega-3 fatty acids have mild anti-platelet effects and may prolong bleeding time. In most patients, this is clinically insignificant.

However, when combined with anticoagulants or antiplatelet agents, the bleeding risk may be increased. INR should be monitored in patients on warfarin when starting or stopping Omacor.

Report any unusual bruising or bleeding to your prescriber.

When to seek medical advice

Contact your GP or call NHS 111 if you experience severe abdominal pain (which could indicate pancreatitis, especially in patients with very high triglycerides), signs of liver dysfunction (jaundice, dark urine, persistent nausea), or unusual bleeding.

Report suspected adverse reactions to the MHRA at yellowcard.mhra.gov.uk .

Warnings and precautions

Contraindications

Omacor is contraindicated in patients with a known allergy to the active substance, fish, soya, peanuts, or any excipient. It is also contraindicated in active bleeding disorders.

Anticoagulant and antiplatelet therapy

Omega-3 fatty acids may potentiate the effect of anticoagulants and antiplatelet agents. If you take warfarin, a DOAC, aspirin, clopidogrel, or other blood-thinning medicines, inform your prescriber. INR and bleeding time should be monitored as appropriate.

Liver function

Mild elevations in liver enzymes have been reported. Liver function tests should be performed before starting Omacor and at regular intervals during treatment, particularly when used with statins.

LDL cholesterol

High-dose omega-3 fatty acids may raise LDL cholesterol. This should be monitored, and statin therapy adjusted if necessary.

Diabetes

Omacor may affect glycaemic control. Blood glucose should be monitored more frequently when starting treatment. Dietary and lifestyle measures for both triglyceride management and diabetes should be maintained.

Allergy

Omacor is derived from fish oil. The capsule shell contains soya lecithin. Patients with fish, soya, or peanut allergy must not take this medicine.

If you experience signs of a severe allergic reaction (swelling of the face or throat, difficulty breathing), call 999 immediately.

How to get Omacor in the UK

Omacor is available on NHS prescription from your GP, cardiologist, or lipid clinic.

The standard NHS prescription charge in England is 9.90 pounds per item; prescriptions are free in Scotland, Wales, and Northern Ireland.

Omacor is distinct from over-the-counter fish oil supplements and must be prescribed by a healthcare professional for its licensed indications.

Sources

• Omacor Capsules, Summary of Product Characteristics (EMC)
• Omega-3-acid ethyl esters, British National Formulary (BNF)
• NICE CG181: Cardiovascular disease, risk assessment and reduction
• High cholesterol, NHS
• MHRA Yellow Card Scheme