Omega-3-Acid Ethyl Esters: uses, dosing, side effects & brands
Omega-3-Acid Ethyl Esters is an omega-3 fatty acid sold in the U.S. under one brand. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Omega-3 Fatty Acid
- Available as
- Capsule
- Sold as
- Omega-3-Acid Ethyl Esters
- Prescription?
- Prescription only
- Generic available?
- Yes
- What the pharmacy pays
- about $5 for a 30-count supply — not your price
How omega-3-acid ethyl esters is dosed
From the FDA label for Omega-3-Acid Ethyl Esters (application ANDA210093). Other omega-3-acid ethyl esters products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Assess TG levels carefully before initiating therapy. Identify other causes (e.g., diabetes mellitus, hypothyroidism, medications) of high TG levels and manage as appropriate [see Indications and Usage (1) ]. Patients should be placed on an appropriate lipid-lowering diet before receiving omega-3-acid ethyl esters capsules, and should continue this diet during treatment with omega-3-acid ethyl esters capsules. In clinical studies, omega-3-acid ethyl esters capsules was administered with meals. The daily dose of omega-3-acid ethyl esters capsules is 4 grams per day. The daily dose may be taken as a single 4-gram dose (4 capsules) or as two 2-gram doses (2 capsules given twice daily). Patients should be advised to swallow omega-3-acid ethyl esters capsules whole. Do not break open, crush, dissolve, or chew omega-3-acid ethyl esters capsules. The daily dose of omega-3-acid ethyl esters capsules is 4 grams per day taken as a single 4-gram dose (4 capsules) or as two 2-gram doses (2 capsules given twice daily). ( 2 ) Patients should be advised to swallow omega-3-acid ethyl esters capsules whole. Do not break open, crush, dissolve, or chew omega-3-acid ethyl esters capsules. ( 2 )
Omega-3-Acid Ethyl Esters side effects
The most common adverse reactions (incidence >3% and greater than placebo) were eructation, dyspepsia, and taste perversion. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact [Epic Pharma LLC at 1-888-374-2791] or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse reactions reported in at least 3% of subjects treated with Omega-3-acid ethyl esters and at a greater rate than placebo based on pooled data across 23 clinical trials are listed in Table 1. Table 1. Adverse Reactions Occurring at Incidence ≥3% and Greater than Placebo in Clinical Trials of Omega-3-Acid Ethyl Esters Adverse Reaction * Omega-3-Acid Ethyl Esters (n = 655) Placebo (n = 370) n % n % Eructation 29 4 5 1 Dyspepsia 22 3 6 2 Taste perversion 27 4 1 <1 * Trials included subjects with hypertriglyceridemia and severe hypertriglyceridemia. Additional adverse reactions from clinical trials are listed below: Digestive System Constipation, gastrointestinal disorder and vomiting. Metabolic and Nutritional Disorders Increased ALT and increased AST. Skin Pruritus and rash. 6.2 Postmarketing Experience In addition to…
Who shouldn’t take omega-3-acid ethyl esters
Omega-3-acid ethyl esters capsules are contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to omega-3-acid ethyl esters or any of its components. Omega-3-acid ethyl esters capsules are contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to omega-3-acid ethyl esters or any of its components. ( 4 )
Omega-3-Acid Ethyl Esters drug interactions
Omega-3-acids may prolong bleeding time. Patients taking omega-3-acid ethyl esters and an anticoagulant or other drug affecting coagulation (e.g., anti-platelet agents) should be monitored periodically. ( 7.1 ) 7.1 Anticoagulants or Other Drugs Affecting Coagulation Some trials with omega-3-acids demonstrated prolongation of bleeding time. The prolongation of bleeding time reported in these trials has not exceeded normal limits and did not produce clinically significant bleeding episodes. Clinical trials have not been done to thoroughly examine the effect of omega-3-acid ethyl esters and concomitant anticoagulants. Patients receiving treatment with omega-3-acid ethyl esters and an anticoagulant or other drug affecting coagulation (e.g., anti-platelet agents) should be monitored periodically.
Every omega-3-acid ethyl esters product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Omega-3-Acid Ethyl Esters.
What omega-3-acid ethyl esters pills look like
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
Can you crush or split omega-3-acid ethyl esters?
At least one omega-3-acid ethyl estersproduct is labelled to be swallowed whole — crushing an extended-release tablet releases the whole day’s dose at once. Which applies depends on the form you were given.
What each omega-3-acid ethyl esters label says about crushing, splitting and chewingHow long omega-3-acid ethyl esters keeps
No omega-3-acid ethyl esters label we read sets a separate limit for after opening, but they do specify how it must be stored — and the stability behind any date assumes those conditions.
Does omega-3-acid ethyl esters expire? The in-use limits and storage rules from its labelsWhat people report to the FDA about omega-3-acid ethyl esters
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 2,164 reports naming omega-3-acid ethyl esters, and the FDA flagged 71% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- product odour abnormal175 reports
- diarrhoea104 reports
- nausea97 reports
- chest pain92 reports
- malaise78 reports
- dyspnoea68 reports
- fatigue68 reports
- abdominal discomfort63 reports
Read these as a signal, not a rate. A report does not mean omega-3-acid ethyl esters caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 25, 2026.
Related calculators
Frequently asked questions
What is omega-3-acid ethyl esters?
Omega-3-Acid Ethyl Esters is an omega-3 fatty acid.
What kind of drug is omega-3-acid ethyl esters?
The FDA classifies omega-3-acid ethyl esters as an omega-3 fatty acid. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take omega-3-acid ethyl esters with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run omega-3-acid ethyl esters against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does omega-3-acid ethyl esters come in?
Across the brands we track, omega-3-acid ethyl esters is currently marketed as capsule, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic omega-3-acid ethyl esters?
Yes. Our catalog lists 1 generic omega-3-acid ethyl esters product alongside the brand versions. A generic has the same active ingredient and must meet the FDA's bioequivalence standard; it usually costs less. Ask your pharmacist which one your plan covers.
Cite this page
- APA
- pharmaranks. (2026, July 24). Omega-3-Acid Ethyl Esters: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/omega-3-acid-ethyl-esters
- MLA
- “Omega-3-Acid Ethyl Esters: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/omega-3-acid-ethyl-esters.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for omega-3-acid ethyl esters on DailyMed (NIH) ↗.