Icosapent Ethyl Capsules side effects: what 1,163 FDA adverse event reports show
Drug class
Not stated in label
Who reports
1,163 reports · 73% serious · 144 with death outcome · 43% female
Used for
Icosapent ethyl capsules are indicated: • as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. Limitations of Use: The effect of icosapent ethyl capsules on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined.
What it is
Icosapent ethyl, a lipid-regulating agent, is supplied as a 1 gram oblong, pale yellow or yellow transparent soft gelatin capsule for oral use. Each icosapent ethyl capsule contains 1 gram of icosapent ethyl. Icosapent ethyl is an ethyl ester of the omega-3 fatty acid eicosapentaenoic acid (EPA).
Boxed warning
None in the current label
Causality screen of the 29 strongest signals
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.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- 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. 8 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Poor quality product administered | 12 | 21.1 12.0–37.1ROR 21.3 · χ² 210 / p 6e-48 | 20.2 EB05 11.9 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=1 | no trial data cached |
| Hypomagnesaemia | 15 | 19.5 11.8–32.2ROR 19.7 · χ² 244 / p 2e-55 | 18.8 EB05 11.7 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 15.8 | no trial data cached |
| Product odour abnormal | 10 | 17.3 9.3–32.1ROR 17.5 · χ² 138 / p 4e-32 | 15.9 EB05 8.1 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious n=2 | no trial data cached |
| Blood triglycerides increased | 17 | 17.3 10.8–27.7ROR 17.5 · χ² 244 / p 2e-55 | 16.7 EB05 10.6 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.1 | no trial data cached |
| Myocarditis | 9 | 14.3 7.5–27.4ROR 14.4 · χ² 98 / p 2e-23 | 12.2 EB05 5.8 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 11.3 | no trial data cached |
| Gastric ulcer | 14 | 13.2 7.9–22.3ROR 13.4 · χ² 146 / p 5e-34 | 12.0 EB05 6.9 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 11.0 | no trial data cached |
| Iron deficiency anaemia | 6 | 11.8 5.3–26.1ROR 11.8 · χ² 49 / p 1e-12 | 8.2 EB05 3.5 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 9.8 | no trial data cached |
| Pulmonary arterial hypertension | 9 | 11.1 5.8–21.3ROR 11.2 · χ² 73 / p 6e-18 | 8.8 EB05 4.4 · IC025 +1.7 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 9.0 | no trial data cached |
| Maternal exposure during pregnancy | 52 | 10.6 8.1–13.8ROR 11.1 · χ² 445 / p 6e-99 | 10.3 EB05 8.0 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 10.5 · ♀ 100% (drug 43%) · 98% clinician | no trial data cached |
| Neuroleptic malignant syndrome | 7 | 10.6 5.1–22.2ROR 10.6 · χ² 52 / p 3e-13 | 7.7 EB05 3.6 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 8.4 | no trial data cached |
| Adrenal insufficiency | 7 | 10.5 5.0–22.0ROR 10.6 · χ² 51 / p 4e-13 | 7.6 EB05 3.5 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 8.4 | no trial data cached |
| Cerebral infarction | 14 | 10.3 6.1–17.3ROR 10.4 · χ² 109 / p 1e-25 | 8.8 EB05 5.2 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 8.1 | no trial data cached |
| Joint dislocation | 6 | 10.3 4.6–22.8ROR 10.3 · χ² 41 / p 7e-11 | 7.0 EB05 3.1 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 9.1 | no trial data cached |
| Hepatic function abnormal | 19 | 9.2 5.9–14.4ROR 9.4 · χ² 131 / p 1e-30 | 8.1 EB05 5.3 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 7.9 | no trial data cached |
| Prescribed underdose | 10 | 9.0 4.9–16.7ROR 9.1 · χ² 64 / p 8e-16 | 7.1 EB05 3.9 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 11.0 | no trial data cached |
| Helicobacter infection | 5 | 8.8 3.7–21.2ROR 8.9 · χ² 27 / p 9e-8 | 5.6 EB05 2.5 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | serious PRR 7.4 | no trial data cached |
| Folliculitis | 5 | 8.7 3.6–20.9ROR 8.7 · χ² 27 / p 1e-7 | 5.6 EB05 2.4 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | serious PRR 8.1 | no trial data cached |
| Interstitial lung disease | 23 | 8.6 5.7–12.8ROR 8.7 · χ² 146 / p 5e-34 | 7.7 EB05 5.2 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 · 91% clinician | no trial data cached |
| Product physical issue | 9 | 8.1 4.2–15.6ROR 8.2 · χ² 49 / p 1e-12 | 6.2 EB05 3.4 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Product taste abnormal | 6 | 8.0 3.6–17.8ROR 8.1 · χ² 30 / p 2e-8 | 5.5 EB05 2.6 · IC025 +1.0 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Lower limb fracture | 8 | 7.5 3.8–15.0ROR 7.6 · χ² 39 / p 2e-10 | 5.6 EB05 3.0 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 6.5 | no trial data cached |
| Hip arthroplasty | 6 | 7.1 3.2–15.8ROR 7.1 · χ² 26 / p 2e-7 | 4.9 EB05 2.4 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 | no trial data cached |
| Eructation (belching) | 7 | 6.6 3.2–13.9ROR 6.7 · χ² 28 / p 6e-8 | 4.9 EB05 2.5 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Cytokine release syndrome | 7 | 6.6 3.2–13.8ROR 6.6 · χ² 28 / p 6e-8 | 4.8 EB05 2.5 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 | no trial data cached |
| Serotonin syndrome | 7 | 6.6 3.1–13.8ROR 6.6 · χ² 28 / p 7e-8 | 4.8 EB05 2.5 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 | no trial data cached |
| Glycosylated haemoglobin increased | 7 | 5.0 2.4–10.5ROR 5.0 · χ² 19 / p 8e-6 | 3.9 EB05 2.1 · IC025 +0.7 3/3 methods agree | Lab value / disease marker | serious PRR 7.7 | no trial data cached |
| Diabetic ketoacidosis | 5 | 3.8 1.6–9.0ROR 3.8 · χ² 8 / p 0.003 | 3.0 EB05 1.4 · IC025 +0.0 | Not in label — unassessed | serious PRR 3.0 | no trial data cached |
| Osteonecrosis of jaw (jawbone death) | 5 | 3.6 1.5–8.7ROR 3.6 · χ² 7 / p 0.004 | 2.9 EB05 1.4 · IC025 -0.0 PRR-only: not supported by EBGM or IC | Not in label — unassessed | serious PRR 2.9 | no trial data cached |
| Psoriatic arthropathy | 7 | 3.1 1.5–6.6ROR 3.1 · χ² 8 / p 0.002 | 2.7 EB05 1.5 · IC025 +0.2 | Not in label — unassessed | serious PRR 2.7 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
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 |
|---|---|---|---|---|---|---|
| Maternal exposure during pregnancy | 52 | 10.6 8.1–13.8ROR 11.1 · χ² 445 / p 6e-99 | 10.3 EB05 8.0 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 10.5 · ♀ 100% (drug 43%) · 98% clinician | no trial data cached |
| Interstitial lung disease | 23 | 8.6 5.7–12.8ROR 8.7 · χ² 146 / p 5e-34 | 7.7 EB05 5.2 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 · 91% clinician | no trial data cached |
| Hepatic function abnormal | 19 | 9.2 5.9–14.4ROR 9.4 · χ² 131 / p 1e-30 | 8.1 EB05 5.3 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 7.9 | no trial data cached |
| Blood triglycerides increased | 17 | 17.3 10.8–27.7ROR 17.5 · χ² 244 / p 2e-55 | 16.7 EB05 10.6 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.1 | no trial data cached |
| Hypomagnesaemia | 15 | 19.5 11.8–32.2ROR 19.7 · χ² 244 / p 2e-55 | 18.8 EB05 11.7 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 15.8 | no trial data cached |
| Cerebral infarction | 14 | 10.3 6.1–17.3ROR 10.4 · χ² 109 / p 1e-25 | 8.8 EB05 5.2 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 8.1 | no trial data cached |
| Gastric ulcer | 14 | 13.2 7.9–22.3ROR 13.4 · χ² 146 / p 5e-34 | 12.0 EB05 6.9 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 11.0 | no trial data cached |
| Poor quality product administered | 12 | 21.1 12.0–37.1ROR 21.3 · χ² 210 / p 6e-48 | 20.2 EB05 11.9 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=1 | no trial data cached |
| Prescribed underdose | 10 | 9.0 4.9–16.7ROR 9.1 · χ² 64 / p 8e-16 | 7.1 EB05 3.9 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 11.0 | no trial data cached |
| Product odour abnormal | 10 | 17.3 9.3–32.1ROR 17.5 · χ² 138 / p 4e-32 | 15.9 EB05 8.1 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious n=2 | no trial data cached |
| Product physical issue | 9 | 8.1 4.2–15.6ROR 8.2 · χ² 49 / p 1e-12 | 6.2 EB05 3.4 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Pulmonary arterial hypertension | 9 | 11.1 5.8–21.3ROR 11.2 · χ² 73 / p 6e-18 | 8.8 EB05 4.4 · IC025 +1.7 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 9.0 | no trial data cached |
| Myocarditis | 9 | 14.3 7.5–27.4ROR 14.4 · χ² 98 / p 2e-23 | 12.2 EB05 5.8 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 11.3 | no trial data cached |
| Lower limb fracture | 8 | 7.5 3.8–15.0ROR 7.6 · χ² 39 / p 2e-10 | 5.6 EB05 3.0 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 6.5 | no trial data cached |
| Psoriatic arthropathy | 7 | 3.1 1.5–6.6ROR 3.1 · χ² 8 / p 0.002 | 2.7 EB05 1.5 · IC025 +0.2 | Not in label — unassessed | serious PRR 2.7 | 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.
- Interstitial lung disease — n=23, PRR 8.6
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 Icosapent Ethyl?
In FDA FAERS, the most frequently co-reported reaction terms for Icosapent Ethyl are interstitial lung disease, hepatic function abnormal, blood triglycerides increased, hypomagnesaemia, cerebral infarction, gastric ulcer. 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 Icosapent Ethyl have an FDA boxed warning?
No. The FDA label retrieved for Icosapent Ethyl has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Icosapent Ethyl 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 20686acb-66c5-4d75-9684-7474436e8bef, effective 20251030; matched on
openfda.generic_name.exact:"ICOSAPENT ETHYL") - 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, fieldpatient.drug.openfda.generic_name.exact, 37 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.