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Medical Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice.
Brand Name
Omega-3-acid Ethyl Ester
Generic Name
Omega-3-acid Ethyl Esters
Active Ingredient
Omega-3-acid Ethyl EstersCategory
Vitamin C [EPC]
Variants
2
Different strengths and dosage forms
| Strength | Form | Route | NDC |
|---|---|---|---|
| 900 mg/1 | CAPSULE, LIQUID FILLED | ORAL | 63629-2448 |
| 900 mg/1 | CAPSULE, LIQUID FILLED | ORAL | 69452-175 |
References used for this content
This page is for informational purposes only and does not replace medical advice. Before using any prescription or over-the-counter medication for Omega-3-acid Ethyl Ester, you must consult a qualified healthcare professional.
Detailed information about Omega-3-acid Ethyl Ester
Omega-3-acid ethyl esters are a prescription-grade lipid-regulating medication containing concentrated EPA and DHA, primarily used to reduce very high triglyceride levels (hypertriglyceridemia) in adults.
The standard adult dosage for omega-3-acid ethyl esters for the treatment of severe hypertriglyceridemia is 4 grams per day. This dosage can be administered in one of two ways:
Healthcare providers generally recommend the twice-daily regimen for patients who experience gastrointestinal side effects, as spreading the dose can improve tolerability.
The safety and effectiveness of omega-3-acid ethyl esters have not been established in pediatric patients (children under 18 years of age). Consequently, this medication is not approved for use in children. Parents should consult a pediatrician before giving any omega-3 supplements to a child, as the requirements and safety profiles differ significantly from adults.
No specific dosage adjustments are required for patients with renal (kidney) impairment. The medication is not primarily cleared by the kidneys. However, patients with end-stage renal disease should be monitored closely by their specialist.
No dosage adjustment is typically necessary for patients with hepatic (liver) impairment. However, because omega-3-acid ethyl esters can occasionally cause elevations in liver enzymes (ALT/AST), patients with known liver disease should have their liver function monitored periodically during treatment.
Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Generally, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function.
To ensure maximum efficacy and minimize side effects, follow these specific instructions:
If you miss a dose of omega-3-acid ethyl esters, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not double the dose to catch up, as this can increase the risk of gastrointestinal distress.
In the event of an overdose, the most likely symptoms are severe gastrointestinal upset, including nausea, vomiting, and diarrhea. While omega-3 fatty acids are generally non-toxic even in high amounts, an acute overdose should be managed by contacting a poison control center or seeking emergency medical attention if symptoms are severe. There is no specific antidote for omega-3-acid ethyl ester overdose; treatment is supportive.
> Important: Follow your healthcare provider's dosing instructions exactly. Do not adjust your dose or stop taking the medication without medical guidance, as your triglyceride levels may rise rapidly upon discontinuation.
Most patients tolerate omega-3-acid ethyl esters well, but some experience mild side effects, particularly when starting therapy. The most common side effect is eructation (fishy-tasting burps). This occurs because the fish oil is being broken down in the stomach.
Other common side effects include:
Omega-3-acid ethyl esters are a potent medical intervention and should be used only under the supervision of a healthcare professional. It is not a replacement for a heart-healthy diet. Patients should continue a standard cholesterol-lowering diet (such as the TLC diet) throughout treatment.
There are currently no FDA black box warnings for Omega-3-acid Ethyl Esters. The safety profile is generally considered favorable for the indicated population of adults with severe hypertriglyceridemia.
Omega-3-acid ethyl esters are derived from the oil of several fish species (such as sardines, anchovies, and mackerel). It is unknown whether patients with allergies to fish or shellfish are at increased risk of an allergic reaction to this medication. Patients with known hypersensitivity to fish should use this medication with extreme caution.
There are no absolute drug-drug contraindications listed for omega-3-acid ethyl esters. However, this does not mean interactions are impossible; it simply means no combinations have been identified that carry a risk of life-threatening toxicity when used as directed.
Omega-3 fatty acids may have a mild inhibitory effect on platelet aggregation. When combined with other medications that affect blood clotting, the risk of bleeding may theoretically increase. Drugs in this category include:
Omega-3-acid ethyl esters must NEVER be used in the following circumstances:
These are conditions where the medication may be used, but only after a careful risk-benefit analysis by a healthcare professional:
Omega-3-acid ethyl esters were previously classified as Pregnancy Category C. Under the newer Pregnancy and Lactation Labeling Rule (PLLR), the data suggests that there are no adequate and well-controlled studies in pregnant women.
Animal studies using doses much higher than the human equivalent have not shown evidence of fetal harm or teratogenicity (birth defects). However, because omega-3 fatty acids are essential for fetal brain and eye development, they are often supplemented in pregnancy. The concern with the prescription form is the high dosage and the ethyl ester carrier. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Talk to your OB/GYN before use.
Studies have shown that omega-3 fatty acids (EPA and DHA) are excreted in human milk. The effect of increased omega-3 levels in milk on the nursing infant is unknown. However, since omega-3s are a natural component of breast milk, the risk is generally considered low. Caution should be exercised, and nursing mothers should consult a pediatrician to monitor the infant for any changes in bowel habits or skin rashes.
Omega-3-acid ethyl esters work through multiple pathways to lower serum triglycerides. The primary molecular mechanism involves the inhibition of acyl-CoA:1,2-diacylglycerol acyltransferase. By inhibiting this enzyme, the liver is less efficient at 'assembling' triglyceride molecules. Furthermore, EPA and DHA act as 'false substrates' for the synthesis of triglycerides.
Additionally, these fatty acids are potent activators of Peroxisome Proliferator-Activated Receptor alpha (PPAR-α). Activation of PPAR-α leads to an increase in the expression of genes that promote fatty acid oxidation (breakdown) in the liver and muscles, thereby reducing the availability of fatty acids for triglyceride synthesis.
The onset of action for triglyceride lowering is typically seen within 2 to 4 weeks of starting the 4-gram daily dose. The maximum effect is usually achieved after 2 to 3 months of consistent therapy. There is a clear dose-response relationship; doses lower than 4 grams per day are significantly less effective at lowering triglycerides in patients with severe hypertriglyceridemia. No evidence of tolerance development has been observed with long-term use.
Common questions about Omega-3-acid Ethyl Ester
Omega-3-acid ethyl esters are a prescription medication used specifically to lower very high triglyceride levels in adults, typically defined as levels 500 mg/dL or higher. Triglycerides are a type of fat found in the blood, and having extremely high levels can increase the risk of developing acute pancreatitis, a painful and potentially dangerous inflammation of the pancreas. This medication is intended to be used as an 'adjunct' to therapy, meaning it must be combined with a low-fat and low-cholesterol diet to be effective. It is not a treatment for general heart health in the same way that over-the-counter fish oils are marketed. Your healthcare provider will determine if your levels warrant this high-potency prescription version.
The most frequently reported side effect of omega-3-acid ethyl esters is eructation, more commonly known as 'fishy burps' or a fishy aftertaste. Many patients also report mild gastrointestinal symptoms such as indigestion (dyspepsia), nausea, or a change in their sense of taste. These side effects are generally mild and often decrease over time as the body adjusts to the medication. Taking the capsules with a large meal can significantly reduce the occurrence of nausea and fishy burps. If these symptoms become bothersome, your doctor may suggest splitting the 4-gram dose into two 2-gram doses taken twice daily.
It is generally recommended that you avoid or strictly limit alcohol consumption while taking omega-3-acid ethyl esters. Alcohol is known to significantly increase triglyceride levels in the blood, which directly counteracts the purpose of the medication. For individuals with severe hypertriglyceridemia, even small amounts of alcohol can trigger a spike in fat levels that increases the risk of pancreatitis. Furthermore, alcohol can place additional strain on the liver, which is where the medication is metabolized. Discuss your alcohol intake honestly with your doctor to determine a safe approach for your specific health situation.
The safety of omega-3-acid ethyl esters during pregnancy has not been fully established through large-scale clinical trials in humans. While omega-3 fatty acids themselves are vital for fetal development, the high doses found in prescription products and the ethyl ester formulation require careful medical supervision. Animal studies have not shown a high risk of birth defects, but the medication should only be used if the potential benefit to the mother outweighs the potential risk to the developing fetus. If you are pregnant or planning to become pregnant, you must discuss this with your healthcare provider. They may recommend switching to a standard prenatal vitamin with lower doses of DHA/EPA instead.
You will not 'feel' omega-3-acid ethyl esters working, as they do not provide immediate symptom relief. However, they begin affecting your lipid metabolism shortly after the first few doses. Clinical studies show that a significant reduction in triglyceride levels can usually be measured in a blood test after 2 to 4 weeks of consistent use. The maximum lipid-lowering effect is typically reached after about 2 to 3 months of daily treatment. It is essential to continue taking the medication exactly as prescribed and to follow your recommended diet, as stopping the medication will cause your triglyceride levels to rise again within a few weeks.
While you can technically stop taking omega-3-acid ethyl esters without experiencing withdrawal symptoms, you should not do so without consulting your doctor. This medication is used to manage a chronic condition—severely high triglycerides. If you stop the medication, your triglyceride levels will likely return to their previous dangerous levels, increasing your risk of pancreatitis and cardiovascular issues. If you are experiencing side effects that make you want to stop, talk to your healthcare provider first. They may be able to adjust your dose or suggest a different formulation that is easier for you to tolerate.
If you miss a dose of omega-3-acid ethyl esters, take the missed dose as soon as you remember, provided it is taken with food. However, if it is nearly time for your next scheduled dose, you should skip the missed dose and simply take your next one at the regular time. Do not take two doses at once or 'double up' to make up for the one you missed, as this significantly increases the likelihood of stomach upset, nausea, and diarrhea. Consistency is important for managing triglyceride levels, so try to use a pillbox or phone reminder to help you stay on track with your daily 4-gram regimen.
Omega-3-acid ethyl esters are not typically associated with weight gain. In fact, because the medication is always prescribed alongside a low-fat, calorie-restricted diet and an exercise program, many patients actually lose weight while on the therapy. Each 1-gram capsule contains approximately 9 to 10 calories derived from fat. At the full 4-gram daily dose, this adds about 40 calories to your daily intake, which is negligible for most people. If you notice significant or rapid weight gain, it is more likely related to dietary choices or another underlying medical condition rather than the medication itself.
Omega-3-acid ethyl esters can be taken with many other medications, but there are important exceptions. They are frequently prescribed alongside statins (like atorvastatin) for comprehensive lipid management. However, you must be cautious if you are taking 'blood thinners' such as warfarin, aspirin, or clopidogrel, as omega-3s can slightly increase the risk of bleeding. Additionally, certain medications like beta-blockers or estrogens can raise triglycerides, potentially making the omega-3s less effective. Always provide your doctor with a full list of all prescriptions, over-the-counter drugs, and herbal supplements you use to ensure there are no conflicting interactions.
Yes, omega-3-acid ethyl esters are available as a generic medication, which is typically much more affordable than the brand-name version, Lovaza. The generic versions are required by the FDA to have the same active ingredients (EPA and DHA ethyl esters), the same strength, and the same effectiveness as the brand-name drug. When your doctor writes a prescription for 'Omega-3-acid ethyl esters,' the pharmacist will often fill it with the generic version unless your doctor specifically marks the prescription as 'Dispense as Written.' Both the brand and generic versions require a prescription and should not be replaced with over-the-counter fish oil supplements.
Other drugs with the same active ingredient (Omega-3-acid Ethyl Esters)
Rarely, patients may experience:
While rare, serious complications can occur. You should contact your healthcare provider immediately if you experience:
> Warning: Stop taking Omega-3-acid Ethyl Esters and call your doctor immediately if you experience chest pain, severe dizziness, or signs of a severe allergic reaction.
With prolonged use, the most significant long-term consideration is the potential for persistent elevations in LDL cholesterol. Because omega-3-acid ethyl esters contain DHA, they can shift the composition of VLDL particles into LDL particles. This requires long-term monitoring by a healthcare professional. Additionally, long-term effects on liver enzymes (ALT/AST) are monitored to ensure no hepatic strain is occurring.
No FDA black box warnings are currently issued for omega-3-acid ethyl esters. However, the FDA does require warnings regarding the risk of atrial fibrillation and the potential for increased LDL-C levels to be included in the prescribing information.
Report any unusual symptoms to your healthcare provider. You may also report side effects to the FDA at 1-800-FDA-1088.
There is an observed increase in the risk of atrial fibrillation (a type of irregular heartbeat) requiring hospitalization in some patients taking omega-3-acid ethyl esters. This risk appears to be higher in patients with a pre-existing history of atrial fibrillation or flutter. Patients should be monitored for clinical symptoms such as palpitations or fainting.
In some patients, increases in Alanine Aminotransferase (ALT) levels have been observed without a concurrent increase in Aspartate Aminotransferase (AST). While these elevations are usually mild, liver function tests should be performed periodically, especially in patients with known liver impairment.
Some studies suggest that omega-3 fatty acids may prolong bleeding time. While the increase in bleeding time typically does not exceed normal limits, patients taking other 'blood thinners' (anticoagulants or antiplatelets) should be monitored more frequently.
Patients taking omega-3-acid ethyl esters require regular laboratory monitoring to ensure safety and efficacy:
Omega-3-acid ethyl esters are not known to cause drowsiness or impair cognitive function. There are no specific restrictions on driving or operating heavy machinery while taking this medication.
Alcohol can significantly increase triglyceride levels and may interfere with the effectiveness of the medication. Patients with severe hypertriglyceridemia are generally advised to avoid or strictly limit alcohol consumption to prevent pancreatitis and ensure the medication works as intended.
There is no 'withdrawal syndrome' associated with stopping omega-3-acid ethyl esters. However, if the medication is stopped suddenly, triglyceride levels are likely to return to their pre-treatment baseline, which could increase the risk of pancreatitis. Do not stop the medication without a transition plan from your doctor.
> Important: Discuss all your medical conditions, including any history of heart rhythm problems or liver disease, with your healthcare provider before starting Omega-3-acid Ethyl Esters.
Certain medications like beta-blockers (e.g., Metoprolol) and thiazide diuretics (e.g., Hydrochlorothiazide) are known to increase triglyceride levels as a side effect. Taking these medications may reduce the apparent efficacy of omega-3-acid ethyl esters.
Oral contraceptives and hormone replacement therapies containing estrogen can increase triglyceride levels. If you start or stop an estrogen-containing medication while on omega-3-acid ethyl esters, your triglyceride levels may fluctuate, requiring a dose adjustment of your lipid-lowering therapy.
Unlike many medications where food is a hindrance, a high-fat meal actually improves the absorption of omega-3-acid ethyl esters. However, since the medication is used to treat high triglycerides, patients must balance this with the need for a low-fat diet. A 'moderate-fat' meal is usually sufficient to trigger the necessary digestive enzymes without counteracting the drug's purpose.
Alcohol consumption is a significant 'interaction' because it can cause a dramatic spike in triglycerides. Consuming alcohol while taking this medication is like 'taking one step forward and two steps back' in terms of lipid management.
Omega-3-acid ethyl esters may lower the concentration of Vitamin E in the blood. Some formulations include a small amount of Vitamin E (alpha-tocopherol) as an antioxidant to prevent the oil from going rancid, but patients should be aware of this potential effect if they are already Vitamin E deficient.
Caution should be exercised when combining omega-3s with herbal supplements known to have antiplatelet effects, such as:
Omega-3-acid ethyl esters do not typically interfere with common laboratory blood chemistry or hematology tests, other than the intended changes to the lipid profile and the potential slight increase in ALT levels.
> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking. Keep a current list and share it with every healthcare provider you visit.
There is no known cross-sensitivity between omega-3-acid ethyl esters and other classes of lipid-lowering drugs like statins (e.g., Atorvastatin) or fibrates (e.g., Fenofibrate). Patients who cannot tolerate statins due to muscle pain can typically take omega-3-acid ethyl esters safely.
> Important: Your healthcare provider will evaluate your complete medical history, including any previous reactions to fish or supplements, before prescribing Omega-3-acid Ethyl Esters.
Omega-3-acid ethyl esters are not approved for use in patients under the age of 18. The primary reason is a lack of clinical trial data in this population. Pediatric hypertriglyceridemia is usually managed through intensive dietary changes and, in some cases, other medications that have a longer history of use in children.
In clinical trials of Lovaza, approximately 25% of subjects were over the age of 65. No overall differences in safety or efficacy were observed between these subjects and younger subjects. However, elderly patients are more likely to have a history of atrial fibrillation and are more likely to be taking anticoagulants like warfarin, which increases the need for careful monitoring of heart rhythm and bleeding.
For patients with mild, moderate, or severe renal impairment, no dosage adjustment is necessary. Omega-3-acid ethyl esters do not rely on the kidneys for clearance. However, the underlying cause of renal impairment (such as diabetes or hypertension) should be managed concurrently.
Patients with hepatic impairment do not require a dose reduction, but they do require increased monitoring. Specifically, those with significant liver dysfunction should have their ALT and AST levels checked before starting therapy and periodically thereafter. If ALT levels rise significantly (e.g., >3x the upper limit of normal), the medication may need to be discontinued.
> Important: Special populations require individualized medical assessment. Always inform your doctor if you are pregnant, planning to become pregnant, or breastfeeding.
| Parameter | Value |
|---|---|
| Bioavailability | High (when taken with food) |
| Protein Binding | >99% |
| Half-life (EPA) | 37–89 hours |
| Half-life (DHA) | 48 hours |
| Tmax | 5–8 hours |
| Metabolism | Hepatic Beta-oxidation |
| Excretion | Primarily metabolic (minimal renal) |
Omega-3-acid ethyl esters are classified as Antihyperlipidemics within the subclass of Omega-3 Fatty Acids. Related medications include Icosapent Ethyl (Vascepa), which contains only EPA, and various fibrates (like Gemfibrozil) which also target triglycerides but through different primary mechanisms.