Omega-3-Acid Ethyl Esters side effects: what 1,919 FDA adverse event reports show

Omega-3-Acid Ethyl Esters · 55 reaction terms · 887 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Who reports

1,919 reports · 77% serious · 96 with death outcome · 44% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Omega-3-acid ethyl esters capsules are indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (greater than or equal to 500 mg/dL) hypertriglyceridemia. Usage Considerations: Patients should be placed on an appropriate lipid-lowering diet before receiving omega-3-acid ethyl esters and should continue this diet during treatment with omega-3-acid ethyl esters capsules.

FDA label, Indications and Usage

What it is

Omega-3-acid ethyl esters, USP, a lipid-regulating agent, is supplied as a liquid-filled gel capsule for oral administration. Each 1-gram capsule of omega-3-acid ethyl esters contains at least 900 mg of the ethyl esters of omega-3 fatty acids sourced from fish oils.

FDA label, Description section

Boxed warning

None in the current label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 31 strongest signals

Labeled adverse reaction 1Labeled (related wording) 1Reporting / coding artifact 6Lab value / disease marker 3Not in label — unassessed 20

What the badges mean

Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.

Strongest disproportionality signals

Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 24 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Product odour abnormal	96	102.0 83.8–124.1ROR 107.3 · χ² 9,414 / p <1e-300	99.1 EB05 83.5 · IC025 +5.7 3/3 methods agree	Reporting / coding artifact	79% consumer	no trial data cached
Poor quality product administered	51	54.8 41.8–71.9ROR 56.2 · χ² 2,627 / p <1e-300	53.5 EB05 42.3 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious n=3	no trial data cached
Product taste abnormal	32	26.1 18.5–36.8ROR 26.5 · χ² 745 / p 3e-164	25.6 EB05 19.0 · IC025 +3.6 3/3 methods agree	Reporting / coding artifact	72% consumer	no trial data cached
Eructation (belching)	32	18.4 13.1–26.0ROR 18.7 · χ² 509 / p 5e-113	18.2 EB05 13.4 · IC025 +3.3 3/3 methods agree	Labeled adverse reaction exact term	serious n=4	no trial data cached
Full blood count abnormal	15	15.6 9.4–25.8ROR 15.7 · χ² 190 / p 2e-43	14.7 EB05 8.8 · IC025 +2.5 3/3 methods agree	Lab value / disease marker	serious PRR 14.4	no trial data cached
Blood triglycerides increased	25	15.4 10.4–22.8ROR 15.6 · χ² 323 / p 2e-72	15.0 EB05 10.4 · IC025 +2.9 3/3 methods agree	Labeled (related wording) related wording	serious PRR 13.0	no trial data cached
Obstructive airways disorder	15	14.7 8.9–24.3ROR 14.8 · χ² 178 / p 7e-41	13.8 EB05 8.2 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 11.4	no trial data cached
Product physical issue	26	14.3 9.7–20.9ROR 14.5 · χ² 308 / p 4e-69	13.8 EB05 9.6 · IC025 +2.9 3/3 methods agree	Reporting / coding artifact	serious n=2 · 73% consumer	no trial data cached
Pneumonia aspiration	32	14.0 10.0–19.8ROR 14.3 · χ² 375 / p 8e-84	13.7 EB05 9.9 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 10.5 · ♀ 96% (drug 44%)	no trial data cached
Sputum discoloured	12	13.9 7.9–24.4ROR 14.0 · χ² 131 / p 1e-30	12.5 EB05 6.7 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 13.5	no trial data cached
Neoplasm	14	13.3 7.9–22.4ROR 13.4 · χ² 147 / p 4e-34	12.1 EB05 6.9 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 10.8	no trial data cached
Angina pectoris	34	12.9 9.2–18.0ROR 13.1 · χ² 361 / p 8e-81	12.5 EB05 9.1 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 9.9 · 94% clinician	no trial data cached
Hernia	21	11.9 7.8–18.3ROR 12.1 · χ² 200 / p 1e-45	11.1 EB05 7.2 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 10.0 · 95% clinician	no trial data cached
Clostridium difficile colitis	11	11.3 6.3–20.4ROR 11.4 · χ² 93 / p 2e-22	9.4 EB05 5.1 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 8.6	no trial data cached
Pulmonary mass	13	9.6 5.6–16.4ROR 9.6 · χ² 91 / p 6e-22	8.0 EB05 4.7 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 7.8	no trial data cached
Sleep disorder due to a general medical condition	14	9.5 5.6–16.0ROR 9.5 · χ² 98 / p 2e-23	8.0 EB05 4.8 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 12.0	no trial data cached
Incorrect route of product administration	14	9.1 5.4–15.4ROR 9.2 · χ² 93 / p 2e-22	7.6 EB05 4.6 · IC025 +1.9 3/3 methods agree	Reporting / coding artifact	serious PRR 13.6	no trial data cached
Cerebral infarction	19	8.5 5.4–13.3ROR 8.6 · χ² 118 / p 7e-28	7.4 EB05 4.9 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 6.3	no trial data cached
Gamma-glutamyltransferase increased	17	8.4 5.2–13.5ROR 8.4 · χ² 103 / p 1e-24	7.2 EB05 4.6 · IC025 +2.0 3/3 methods agree	Lab value / disease marker	serious PRR 6.5	no trial data cached
Coma	36	8.3 6.0–11.4ROR 8.4 · χ² 223 / p 1e-50	7.7 EB05 5.7 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 6.2 · ♀ 82% (drug 44%)	no trial data cached
Fracture	14	8.1 4.8–13.6ROR 8.1 · χ² 80 / p 2e-19	6.7 EB05 4.1 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 6.6	no trial data cached
Sciatica	10	6.9 3.7–12.8ROR 6.9 · χ² 45 / p 1e-11	5.4 EB05 3.1 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 6.9	no trial data cached
Cataract	34	6.3 4.5–8.7ROR 6.4 · χ² 146 / p 8e-34	5.8 EB05 4.3 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 5.3 · ♀ 21% (drug 44%)	no trial data cached
Rhabdomyolysis (muscle breakdown)	21	5.5 3.6–8.4ROR 5.6 · χ² 73 / p 6e-18	5.0 EB05 3.4 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 4.1 · 95% clinician	no trial data cached
Product substitution issue	24	4.6 3.1–6.8ROR 4.6 · χ² 63 / p 9e-16	4.2 EB05 3.0 · IC025 +1.4 3/3 methods agree	Reporting / coding artifact	serious PRR 1.5 · 78% consumer	no trial data cached
Underdose	30	4.5 3.1–6.4ROR 4.5 · χ² 78 / p 5e-19	4.2 EB05 3.1 · IC025 +1.5 3/3 methods agree	Reporting / coding artifact	serious PRR 12.3 · ♀ 93% (drug 44%)	no trial data cached
Blood creatine phosphokinase increased	12	4.5 2.6–7.9ROR 4.5 · χ² 29 / p 3e-8	3.9 EB05 2.4 · IC025 +1.0 3/3 methods agree	Lab value / disease marker	serious PRR 3.1	no trial data cached
Hepatic function abnormal	15	4.4 2.7–7.3ROR 4.5 · χ² 36 / p 8e-10	3.9 EB05 2.6 · IC025 +1.1 3/3 methods agree	Not in label — unassessed	serious PRR 3.6	no trial data cached
Eczema	18	3.9 2.5–6.2ROR 3.9 · χ² 36 / p 9e-10	3.6 EB05 2.4 · IC025 +1.1 3/3 methods agree	Not in label — unassessed	serious PRR 8.1	no trial data cached
Femur fracture	10	3.5 1.9–6.5ROR 3.5 · χ² 16 / p 4e-5	3.1 EB05 1.8 · IC025 +0.6	Not in label — unassessed	serious PRR 2.6	no trial data cached
Neoplasm malignant	19	3.1 2.0–4.9ROR 3.1 · χ² 25 / p 3e-7	2.9 EB05 2.0 · IC025 +0.8 3/3 methods agree	Not in label — unassessed	serious PRR 2.4	no trial data cached

Trial evidence (ClinicalTrials.gov)

Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).

Most frequently reported reactions

By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Product odour abnormal	96	102.0 83.8–124.1ROR 107.3 · χ² 9,414 / p <1e-300	99.1 EB05 83.5 · IC025 +5.7 3/3 methods agree	Reporting / coding artifact	79% consumer	no trial data cached
Poor quality product administered	51	54.8 41.8–71.9ROR 56.2 · χ² 2,627 / p <1e-300	53.5 EB05 42.3 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious n=3	no trial data cached
Coma	36	8.3 6.0–11.4ROR 8.4 · χ² 223 / p 1e-50	7.7 EB05 5.7 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 6.2 · ♀ 82% (drug 44%)	no trial data cached
Cataract	34	6.3 4.5–8.7ROR 6.4 · χ² 146 / p 8e-34	5.8 EB05 4.3 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 5.3 · ♀ 21% (drug 44%)	no trial data cached
Angina pectoris	34	12.9 9.2–18.0ROR 13.1 · χ² 361 / p 8e-81	12.5 EB05 9.1 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 9.9 · 94% clinician	no trial data cached
Pneumonia aspiration	32	14.0 10.0–19.8ROR 14.3 · χ² 375 / p 8e-84	13.7 EB05 9.9 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 10.5 · ♀ 96% (drug 44%)	no trial data cached
Eructation (belching)	32	18.4 13.1–26.0ROR 18.7 · χ² 509 / p 5e-113	18.2 EB05 13.4 · IC025 +3.3 3/3 methods agree	Labeled adverse reaction exact term	serious n=4	no trial data cached
Product taste abnormal	32	26.1 18.5–36.8ROR 26.5 · χ² 745 / p 3e-164	25.6 EB05 19.0 · IC025 +3.6 3/3 methods agree	Reporting / coding artifact	72% consumer	no trial data cached
Underdose	30	4.5 3.1–6.4ROR 4.5 · χ² 78 / p 5e-19	4.2 EB05 3.1 · IC025 +1.5 3/3 methods agree	Reporting / coding artifact	serious PRR 12.3 · ♀ 93% (drug 44%)	no trial data cached
Product physical issue	26	14.3 9.7–20.9ROR 14.5 · χ² 308 / p 4e-69	13.8 EB05 9.6 · IC025 +2.9 3/3 methods agree	Reporting / coding artifact	serious n=2 · 73% consumer	no trial data cached
Blood triglycerides increased	25	15.4 10.4–22.8ROR 15.6 · χ² 323 / p 2e-72	15.0 EB05 10.4 · IC025 +2.9 3/3 methods agree	Labeled (related wording) related wording	serious PRR 13.0	no trial data cached
Product quality issue	24	1.9 1.3–2.9ROR 2.0 · χ² 10 / p 7e-4	1.9 EB05 1.4 · IC025 +0.2	Reporting / coding artifact	serious PRR 0.8	no trial data cached
Product substitution issue	24	4.6 3.1–6.8ROR 4.6 · χ² 63 / p 9e-16	4.2 EB05 3.0 · IC025 +1.4 3/3 methods agree	Reporting / coding artifact	serious PRR 1.5 · 78% consumer	no trial data cached
Rhabdomyolysis (muscle breakdown)	21	5.5 3.6–8.4ROR 5.6 · χ² 73 / p 6e-18	5.0 EB05 3.4 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 4.1 · 95% clinician	no trial data cached
Hernia	21	11.9 7.8–18.3ROR 12.1 · χ² 200 / p 1e-45	11.1 EB05 7.2 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 10.0 · 95% clinician	no trial data cached

Unlabeled candidate signals

These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.

Poor quality product administered — n=51, PRR 54.8
Pneumonia aspiration — n=32, PRR 14.0
Angina pectoris — n=34, PRR 12.9
Hernia — n=21, PRR 11.9
Coma — n=36, PRR 8.3
Cataract — n=34, PRR 6.3
Rhabdomyolysis — n=21, PRR 5.5

✓ A hand-written Bradford Hill causality assessment exists for this drug: Zoledronic acid (bisphosphonates) ↔ Osteonecrosis of the jaw.

Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.

Common questions

What are the most reported side effects of Omega-3-Acid Ethyl Esters?

In FDA FAERS, the most frequently co-reported reaction terms for Omega-3-Acid Ethyl Esters are poor quality product administered, coma, cataract, angina pectoris, pneumonia aspiration, eructation. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.

Does Omega-3-Acid Ethyl Esters have an FDA boxed warning?

No. The FDA label retrieved for Omega-3-Acid Ethyl Esters has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Omega-3-Acid Ethyl Esters causes these side effects?

No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.

Sources & methods

FDA label via openFDA (set ID 034045d6-5308-4701-b97b-8873e053ec17, effective 20231006; matched on openfda.generic_name.exact:"OMEGA-3-ACID ETHYL ESTERS")
Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA count= aggregation, field patient.drug.openfda.generic_name.exact, 55 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction
Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
Seriousness and sex counts from openFDA count=serious, patient.patientsex, seriousnessdeath

Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.