What the label lists and what reports show
Omega 3-acid ethyl esters side effects
Omega 3-acid ethyl esters's FDA label: “The most common adverse reactions (incidence >3% and greater than placebo) were eructation, dyspepsia, and taste perversion.” FAERS holds 1,919 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is product odour abnormal (96 reports).
- Generic listed
Check it at the source: the omega 3-acid ethyl esters FDA label on DailyMed (effective January 8, 2025, PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of omega-3-acid ethyl esters capsules?Omega-3-acid ethyl esters capsules may cause serious side effects, including: changes in certain blood tests.Omega-3-acid ethyl esters may cause an increase in the results of blood tests used to check your liver function and your bad cholesterol levels. increased risk of a heart rhythm problem in people who have a heart rhythm problem.Omega-3-acid ethyl esters may cause an increase in the frequency of a heart rhythm problem (atrial fibrillation or flutter), especially in the first few months of taking omega-3-acid ethyl esters, if you already have a heart rhythm problem. The most common side effects of omega-3-acid ethyl esters include: [common side effects] These are not all the possible side effects of omega-3-acid ethyl esters. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Source: FDA drug label (Omega-3-acid ethyl esters), REMEDYREPACK INC., effective September 3, 2026 (SPL set 9e041905-40a7-4d5b-af1c-6c544e0748b9), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (incidence >3% and greater than placebo) were eructation, dyspepsia, and taste perversion.
From the label: adverse reactions, continuedThe most common adverse reactions (incidence >3% and greater than placebo) were eructation, dyspepsia, and taste perversion. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact [PuraCap Laboratories, LLC DBA Blu Pharmaceuticals 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. …
Source: FDA drug label, PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS, effective January 8, 2025 (SPL set 52d4fc86-227a-4a74-9f42-50fd184714d8), via openFDA; the full label on DailyMed
What do FAERS reports show?
1,919 reports list omega 3-acid ethyl esters among the medicines taken, each a report of something that happened, not proof the medicine caused it; 96 are coded as a death and 970 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 22 reactions below, 2 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Omega 3-acid ethyl esters: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions