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Omacor 1000mg

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Omacor 1000mg

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Treatment option:

Medically reviewed

Rosario Oropesa

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

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Overview of Omacor 1000mg

Quick Facts

Property Description
Active Ingredient Omega-3-acid ethyl esters 90
Form 1000 mg soft capsule (for oral use)
Pharmacological Class Lipid-modifying agents (Triglyceride-reducing)
Common Use Management of high blood triglyceride levels
Origin Highly purified natural-source derivative

What is Omacor 1000mg and What Type of Medicine is It?

Omacor 1000mg is a prescription-only medicine presented as a 1000 mg soft capsule intended for oral use. It is formally classified under the pharmacological class of Lipid-modifying agents, specifically as a Serum cholesterol and triglyceride reducing agent. This classification places it among medications used to manage specific types of elevated fats in the bloodstream, a function recognized across pharmacological studies. The medicine is utilized in clinical practice to address certain forms of hypertriglyceridaemia when dietary measures alone have proven inadequate.


Composition: Highly Purified Omega-3-Acid Ethyl Esters

The active ingredient in Omacor 1000mg is Omega-3-acid ethyl esters 90, which are natural-source derivatives obtained from the oil of fatty fish. This product undergoes extensive purification and synthesis to yield a high, standardized concentration of the ethyl esters of Eicosapentaenoic acid (EPA) and Docosahexaenoic acid (DHA). The highly purified nature ensures the delivery of a consistent therapeutic dose, which is a key factor differentiating it from general fish oil supplements. These specific ethyl esters have a known physiological mechanism to decrease triglyceride concentrations.


General Purpose of the Lipid-Modifying Agent

The general purpose of Omacor 1000mg is to function as an antihyperlipidaemic agent. It acts by influencing metabolic pathways in the liver, primarily by reducing the production of triglycerides (hepatic triglyceride synthesis) and promoting their breakdown. This established action allows the medicine to be used as an adjunct to diet and lifestyle modifications, specifically when managing severe hypertriglyceridemia, helping patients work toward a normalized blood lipid profile.

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What side effects are possible with Omacor 1000mg?

Possible Side Effects and Safety Information

The safety profile of Omacor 1000mg, based on official regulatory documentation, defines the known and potential adverse reactions and special warnings associated with its use.

Documented Adverse Reactions by Frequency

Adverse reactions are classified by regulatory frequency standards (e.g., from the SmPC):

Frequency Category Representative Adverse Reactions
Common (1/100) Gastrointestinal disorders (collective), Atrial fibrillation
Uncommon (1/1000) Hyperglycaemia, Gout, Dizziness, Dysgeusia (change in taste), Epistaxis, Gastrointestinal haemorrhage, Rash
Rare (1/10,000) Hypersensitivity, Liver disorders (including ALT/AST increases), Urticaria

Gastrointestinal disorders are the most frequent effects documented under the Common classification, including abdominal pain, diarrhoea, dyspepsia (indigestion), nausea, and eructation (burping).

Significant Safety Considerations

A specific concern highlighted in regulatory warnings is the dose-dependent increased risk of Atrial fibrillation in patients with established cardiovascular diseases or risk factors. The risk is highest with the 4 g/day dose, and official guidance recommends permanent discontinuation of treatment if this condition develops.

Safety Restrictions for Use: The medicine is contraindicated in cases of hypersensitivity to the active substance, soya (as it contains soya oil), or any other excipients. Caution is required when using Omacor alongside oral anticoagulants, as a slight prolongation of bleeding time is possible, necessitating the monitoring of coagulation parameters. Patients with hepatic impairment should have liver function ( ALT and AST levels) monitored, particularly at the high dosage. Use in the paediatric population is not recommended due to insufficient safety data.

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Overdose and Emergency Response

Overdose and when to seek help

Overdose Presentations and Required Actions

Official regulatory documents classify acute over-exposure to Omacor 1000mg as having minimal acute toxicity, stating it is unlikely to require special treatment. Non-severe symptoms may include gastrointestinal presentations, such as abdominal pain or nausea. The mandated immediate action for overdosage is to contact a doctor or pharmacist for further advice.

Serious Outcomes and When to Seek Help

For high-dose exposure, the primary regulatory concern is the dose-dependent risk of Atrial Fibrillation (AF), a serious cardiovascular outcome. Regulators explicitly mandate that immediate medical attention must be sought if any specific symptoms of Atrial Fibrillation are observed. These clinical signs include palpitations, light-headedness, asthenia (weakness), or shortness of breath.

Supportive Procedures

No specific antidote is listed in the official prescribing information. In the event that Atrial Fibrillation develops, the officially required management procedure is the permanent discontinuation of treatment, as described in regulatory constraints for this serious complication. The overall regulatory profile for this medicine emphasizes the required actions for high-dose complications rather than signs of acute toxicity.

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Therapeutic Uses of Omacor 1000mg

Omacor 1000mg is relevant for therapeutic support in managing lipid metabolism disorders when diet and lifestyle changes alone are insufficient. The medicine is commonly used for two therapeutic contexts.


The primary therapeutic use is for managing the laboratory finding of severe endogenous hypertriglyceridemia, where concentrations of blood triglycerides are abnormally elevated (e.g., 500 mg/dL). The primary benefit is the reduction of these very high blood fat levels, which contributes to easing the burden of systemic imbalance and may assist with maintaining functional stability of the lipid profile. The medicine is also relevant for long-term cardiovascular support, where it may be part of symptomatic management for patients following events like a heart attack, in contexts where additional lipid control is needed. This is commonly applied in clinical settings where additional lipid control is needed alongside other standard therapies (e.g., statins) to manage conditions like mixed dyslipidemia.

“This supportive therapy is relevant when the internal lipid profile presents an elevated health risk that has not responded adequately to lifestyle adjustments.”

Quick Fact: Lipid Disorder Support
Conditions Managed Severe hypertriglyceridemia, secondary prevention post-myocardial infarction, and mixed dyslipidemia.
Symptom Domain Asymptomatic biochemical risk factors and acute metabolic crisis risk.
Primary Benefit Reduction of very high triglyceride levels, supporting long-term cardiovascular health.

Regulatory References

  1. European Medicines Agency's Summary of Product Characteristics
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Eligibility and Restrictions for Use

Who Can and Cannot Use Omacor 1000mg?

The population eligibility for Omacor 1000mg is defined by specific criteria set forth in official regulatory documents, focusing on absolute contraindications and use limitations across various patient groups.

Absolute Contraindications

Omacor 1000mg must not be used by patients with a known hypersensitivity or allergy to the active substance (Omega-3-acid ethyl esters 90) or to any of the excipients. This includes patients with a known soya or peanut allergy, as the capsule contains soya derivatives which pose a risk of cross-reactivity.

Age-Group and Physiological Restrictions

Population Regulatory Status
Children and Adolescents (Under 18) Not Recommended. Safety and efficacy data are not established.
Older Adults (Over 70) Use with Caution. Clinical data regarding use in this age group are limited.
Lactation (Breastfeeding) Not Recommended. Use is prohibited due to a lack of data on excretion into human milk.
Pregnancy Conditional Use. Should only be used if deemed clearly necessary by a physician.

Conditional Eligibility

Caution and specific monitoring are required for patients with certain medical conditions: Hepatic impairment (liver problems) requires liver function monitoring, as data on severe impairment are limited. Renal impairment (kidney problems) also has limited clinical data. Use requires caution in patients at high risk of hemorrhage, such as those with severe trauma or recent surgery.

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What should I know about interactions with other medicines?

Interactions with other medicines and products

This section describes the officially documented interaction patterns for Omacor 1000mg based on government regulatory information. The interaction profile focuses primarily on pharmacodynamic effects and the expected absence of certain metabolic interactions.

Interacting Substance/Class Documented Interaction Pattern Regulatory Constraint
Oral Anticoagulants or Anti-platelet agents Additive effect that may prolong bleeding time. Requires periodic monitoring of coagulation parameters (e.g., Prothrombin Time/INR) and potential dosage adjustment of the anticoagulant.
HTG-Exacerbating Drugs (e.g., Thiazides, Estrogens, Beta blockers) The substance can counteract the triglyceride-lowering effect of Omacor. Potential for efficacy reduction noted in regulatory documents.
Excess Alcohol Intake Can increase blood triglyceride levels, opposing the intended therapeutic action. Noted as a restriction that counteracts the therapeutic goal.

The regulatory profile explicitly states that no clinically significant drug-drug interactions due to P450-mediated metabolism are expected in humans, characterizing a key aspect of the medicine's pharmacokinetic interaction profile. Furthermore, Omacor 1000mg has no mandatory time separation requirements for co-administration with other medicines. The core of the interaction profile centers on the required monitoring procedures for coagulation risk and the potential for certain substances to reduce the medicine's effectiveness.

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Mechanism of Action

The mechanism of Omacor 1000mg, driven by the highly purified Eicosapentaenoic acid (EPA) and Docosahexaenoic acid (DHA), operates through a coordinated, multi-target approach to alter core hepatic lipid metabolism.

Modulation of Hepatic Triglyceride Synthesis

The active components modulate the capacity of the liver to synthesize triglycerides by influencing regulatory targets. They inhibit enzymes such as DGAT and suppress the transcription factor SREBP-1c, which are crucial for the assembly of fat into VLDL (Very Low-Density Lipoprotein) particles. This action influences the quantity of VLDL released from the liver into the circulation.

Induction of Fatty Acid beta-oxidation and Lipoprotein Catabolism

The drug components function as ligands for the nuclear receptor PPAR-alpha, which promotes the genetic programming for beta-oxidation (fatty acid breakdown) within liver cells. Concurrently, the mechanism modifies the expression of Lipoprotein Lipase (LPL), an enzyme essential for the catabolism of fat-carrying lipoproteins already circulating in the blood. This multi-target activity modifies the consumption of fatty acid substrates and the systemic catabolism of fat particles.

Coordinated Multi-Target Mechanism

These core mechanistic domains—the modification of fat synthesis, the induction of fat breakdown, and the influence on systemic clearance—operate together to produce a comprehensive physiological adjustment. This coordinated activity modifies the balance of hepatic triglyceride production and the systemic catabolism of circulating lipids.

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Dosage and Administration Information

Omacor 1000mg is administered strictly via the oral route using a 1000 mg soft capsule. To ensure proper administration, the capsule must be swallowed whole with a drink of water and must not be opened, chewed, or crushed. The instructions require the medicine to be taken with food or at meal times; this administration condition helps to mitigate the potential for gastrointestinal disturbances.

The standard adult daily dose for the management of hypertriglyceridaemia varies by region but is typically between 2 g and 4 g (two to four capsules). The 4 g maximum daily dose may be taken as a single 4 g dose or divided into two 2 g doses administered twice daily. The medicine is generally intended for long-term administration as part of a sustained lipid management plan.

Regarding specific patient populations, Omacor is not recommended for use in children or adolescents under 18 years because its efficacy and safety in this age group have not been established. Older adults (over 70 years) should use the medicine with care due to limited clinical data. In procedural management, if a dose is missed, patients are instructed to not double the dose to compensate, but rather to return to their regular schedule at the next designated time.

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Recent Clinical Evidence

Omacor 1000mg: Recent Clinical Evidence

Omacor 1000mg, a prescription formulation of omega-3 polyunsaturated fatty acids (primarily ethyl esters of eicosapentaenoic acid [EPA] and docosahexaenoic acid [DHA]), is approved for use in specific patient populations. The clinical evidence base primarily supports its role in managing lipid disorders and reducing the risk of cardiovascular events.


A. Research on Hypertriglyceridemia

The primary established indication for Omacor 1000mg is the treatment of severe hypertriglyceridemia (high levels of triglycerides) in adults, when dietary measures alone have proven insufficient. Clinical trials have consistently documented that the daily administration of the product is associated with substantial reductions in serum triglyceride levels.

  • Reduction Range: Studies typically observe a 20% to 50% decrease in triglyceride concentrations following several weeks of treatment at the prescribed dosage.
  • Mechanism of Study: Research indicates that the omega-3 fatty acids in the formulation may inhibit the liver's synthesis of very-low-density lipoproteins (VLDL), which are precursors to triglycerides.

B. Cardiovascular Risk Reduction

Research has explored the potential of high-dose omega-3 fatty acids to reduce major adverse cardiovascular events (MACE), particularly in patients with existing cardiovascular disease or established risk factors. While findings across the broader category of omega-3 supplements have been mixed, specific high-purity formulations are being studied.

  • Post-Myocardial Infarction: Early trials examined the use of the prescription product in patients who had recently experienced a myocardial infarction (heart attack). These studies documented that long-term use was associated with a reduction in cardiovascular mortality and recurrent non-fatal events.
  • Tolerability: The formulation is generally well-tolerated, with the most commonly reported side effects being mild gastrointestinal disturbances, such as belching, indigestion, and altered taste perception.
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Frequently Asked Questions (FAQ)

Common questions about Omacor 1000mg (FAQ)

Q: Is Omacor 1000mg the same thing as a regular fish oil supplement?

A: Omacor 1000mg is not the same as a general over-the-counter fish oil supplement. Official documents state that Omacor is a highly purified, prescription-only medicine classified as a lipid-modifying agent, which places it within a formal pharmacological class. This high level of purity and specific regulatory classification is the core distinction from general supplements.


Q: Can Omacor 1000mg affect my bleeding or bruising?

A: Regulatory documents note that Omacor 1000mg can cause a slight increase in bleeding time. If the medicine is used alongside other medicines that affect blood clotting, such as anti-platelet agents or anticoagulants, official guidance requires the monitoring of blood clotting parameters.


Q: Can I open or chew the Omacor 1000mg capsule?

A: No. Regulatory information indicates the capsule must be swallowed whole and not opened, chewed, or crushed. This administration method is defined in official instructions and is intended to ensure the integrity of the medicine and mitigate the potential for gastrointestinal disturbances.


Q: Is Omacor 1000mg intended for lifelong use, or is it a short-term treatment?

A: Omacor 1000mg is generally intended for long-term administration as part of a sustained management plan for specific blood lipid levels. The duration of treatment is determined by the prescribing physician.


Q: What happens if I miss a scheduled amount of Omacor 1000mg?

A: Official instructions advise against taking a double dose to compensate for a missed one. Patients are instructed to simply return to their regular scheduled dose at the next designated time, without attempting to make up the missed amount.


Q: Is Omacor 1000mg prescribed for low-risk patients or only those with very high triglyceride levels?

A: The medicine is officially indicated for treating severe hypertriglyceridaemia (very high fat levels in the blood) when dietary measures alone have been insufficient. It also has an approved use as an additional treatment for patients after a heart attack.


Q: Can Omacor 1000mg cause changes in my sense of taste?

A: Yes, official safety documentation lists a change in taste perception, which is known as dysgeusia, as an uncommon adverse reaction. This means the effect has been observed in clinical studies but does not affect a large number of patients.


Q: What is the difference between prescription Omacor and over-the-counter omega-3 products?

A: Prescription Omacor 1000mg is a high-purity, standardized formulation of Omega-3-acid ethyl esters. It is licensed by regulatory bodies as a prescription drug (a lipid-modifying agent) with specific, studied therapeutic indications. This strict regulation and standardization is a key difference when compared to non-regulated over-the-counter supplements.


Q: Do I need to fast or take Omacor 1000mg at a specific time of day?

A: Regulatory information indicates the medicine should be taken at meal times (with food) to help reduce the potential for gastrointestinal side effects. The medicine is taken once or twice daily, as defined by the prescribed regimen.


Q: Does Omacor 1000mg help with cholesterol levels as well as triglycerides?

A: Omacor 1000mg is primarily studied and indicated for the management of high triglycerides. Official documents note that it may cause an increase in LDL-cholesterol (a type of 'bad' cholesterol) in some patients. Any change in HDL-cholesterol is generally reported as small and inconsistent in the clinical data.


Q: What are the most common stomach-related side effects reported for Omacor 1000mg?

A: Gastrointestinal disorders are the most frequently documented stomach-related effects, classified as common (affecting 1 in 100 to 1 in 10 patients). These common effects include burping (eructation), abdominal pain, nausea, indigestion (dyspepsia), diarrhea, and constipation.


Q: Why might a doctor prescribe Omacor 1000mg for high triglycerides?

A: The medicine is prescribed to influence metabolic pathways in the liver. Its mechanism of action involves the modification of hepatic triglyceride production and fat particle catabolism. This coordinated activity is intended to help manage very high triglyceride levels in the bloodstream.


Q: Are weight gain or weight loss listed as side effects of Omacor 1000mg?

A: Weight gain or weight loss are not listed among the commonly, uncommonly, or rarely documented adverse reactions in the official regulatory safety profile for Omacor 1000mg.


Q: Is Omacor 1000mg safe for people who have diabetes?

A: Official documents note that special care is required if a patient has uncontrolled diabetes. An increase in blood sugar, known as hyperglycaemia, is also listed as an uncommon adverse reaction in the safety profile.


Q: Can taking Omacor 1000mg affect the results of blood tests?

A: Yes, regulatory documents recommend monitoring certain parameters in blood tests, such as liver function and coagulation (blood clotting). This is because Omacor 1000mg may cause changes in the results related to these specific parameters.


Q: Has Omacor 1000mg been studied in children or adolescents?

A: Safety and efficacy in children and adolescents under 18 years have not been established in clinical studies. The medicine is consequently not recommended for use in this age group, according to regulatory guidance.


Q: Is Omacor 1000mg the only drug that contains omega-3-acid ethyl esters?

A: No. Regulatory documents reference Omacor as one product within a group known as 'Omega-3-acid ethyl ester medicines,' indicating that other licensed products containing this specific active substance are available.


Q: What if I experience gas or bloating after starting Omacor 1000mg?

A: Gas (flatulence) and bloating (abdominal distension) are part of the gastrointestinal disorders listed as common adverse reactions in the official safety documents. The official administration instructions state the medicine should be taken with food, which may help mitigate these gastrointestinal effects.


Q: Are there any specific lifestyle factors that can improve the benefits of Omacor 1000mg?

A: Omacor 1000mg is indicated for use as a supplement to diet and lifestyle changes. The official therapeutic indications require patients to continue relevant dietary measures alongside treatment for the management of high triglyceride levels.


Q: Is it normal if Omacor 1000mg causes mild nausea when first starting?

A: Nausea is classified as a common adverse reaction in official safety documentation. This means it is a known effect, but the typical timing or duration of onset (such as 'when first starting') can vary among patients.


Q: Does Omacor 1000mg have a listed interaction with oral contraceptives?

A: Official interaction documents note that certain drugs that contain Estrogens (a component often found in oral contraceptives) can counteract the triglyceride-lowering effect of Omacor 1000mg.


Q: Why is Omacor 1000mg sometimes prescribed after a heart event?

A: The medicine is approved for use as an additional treatment for secondary prevention after a myocardial infarction (heart attack). Research in this area has documented an association between its use and changes in cardiovascular mortality and recurrent non-fatal events.


Q: What are the possible allergic reactions associated with Omacor 1000mg?

A: Official safety documents list hypersensitivity as an uncommon reaction and urticaria (hives) as rare. The product is also contraindicated (must not be used) by those with known allergies to the active substance or excipients, which includes soya derivatives.


Q: Can Omacor 1000mg be used by people who have had a heart attack?

A: Official documents state that Omacor 1000mg is indicated for use as an additional treatment for secondary prevention in patients who have recently had a myocardial infarction (heart attack), alongside standard medical treatments.

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How should Omacor 1000mg be stored and disposed of?

Storage and Disposal Requirements

Omacor 1000mg soft capsules must be stored according to regulatory requirements to protect the active ingredient's stability. The medicine must be kept at room temperature, typically not above 25 C (77 F), with some regions permitting excursions up to 30 C. It is mandatory to protect Omacor from light and moisture and to not freeze or refrigerate the capsules.

Handling and Safety

The product must be stored out of the sight and reach of children.

Disposal of Unused Medicine

Expired or unused Omacor must be handled as pharmaceutical waste. Do not dispose of the medicine via wastewater or household waste (trash). Unused product should be disposed of in accordance with local regulatory requirements for the safe handling of medicines.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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