Drug · FAERS side-effect profile with label screen
Icosapent Ethyl side effects: what 8,453 FDA adverse event reports show
Drug class
Not stated in label
Who reports
8,453 reports · 39% serious · 542 with death outcome · 47% female
openFDA FAERS counts, all years, deduplication not applied
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.
FDA label, Indications and Usage
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).
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 40 strongest signals
Labeled adverse reaction 1Reporting / coding artifact 9Lab value / disease marker 8Not in label — unassessed 22
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.
- 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. 968 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Overlap syndrome | 74 | 297.9 234.3–378.9ROR 300.5 · χ² 19,256 / p <1e-300 | 248.6 EB05 204.6 · IC025 +6.2 3/3 methods agree | Not in label — unassessed | serious n=74 · ♀ 100% (drug 47%) · 96% clinician | no trial data cached |
| Product odour abnormal | 1,031 | 273.4 257.3–290.5ROR 311.2 · χ² 251,557 / p <1e-300 | 244.9 EB05 232.6 · IC025 +7.7 3/3 methods agree | Reporting / coding artifact | serious n=91 · 86% consumer | no trial data cached |
| Poor quality product administered | 633 | 163.6 151.4–176.8ROR 176.7 · χ² 95,767 / p <1e-300 | 152.7 EB05 143.0 · IC025 +7.0 3/3 methods agree | Not in label — unassessed | serious n=48 · 88% consumer | no trial data cached |
| Blood immunoglobulin m increased | 32 | 136.7 95.8–195.1ROR 137.2 · χ² 3,955 / p <1e-300 | 120.4 EB05 89.3 · IC025 +4.9 3/3 methods agree | Lab value / disease marker | serious n=32 · ♀ 100% (drug 47%) | no trial data cached |
| Blood immunoglobulin a decreased | 32 | 128.0 89.8–182.5ROR 128.5 · χ² 3,712 / p <1e-300 | 113.6 EB05 84.2 · IC025 +4.8 3/3 methods agree | Lab value / disease marker | serious n=32 · ♀ 100% (drug 47%) | no trial data cached |
| Product coating issue | 49 | 125.3 94.1–166.8ROR 126.0 · χ² 5,628 / p <1e-300 | 114.0 EB05 89.6 · IC025 +5.3 3/3 methods agree | Reporting / coding artifact | serious n=3 · 90% consumer | no trial data cached |
| Product physical issue | 873 | 113.5 106.4–121.1ROR 126.4 · χ² 93,006 / p <1e-300 | 108.3 EB05 102.4 · IC025 +6.6 3/3 methods agree | Reporting / coding artifact | serious n=84 · 86% consumer | no trial data cached |
| Milk-alkali syndrome | 23 | 112.9 74.3–171.3ROR 113.2 · χ² 2,332 / p <1e-300 | 99.3 EB05 69.7 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=23 · ♀ 100% (drug 47%) · 100% clinician | no trial data cached |
| Product colour issue | 220 | 112.5 98.4–128.5ROR 115.4 · χ² 23,131 / p <1e-300 | 106.6 EB05 95.3 · IC025 +6.2 3/3 methods agree | Reporting / coding artifact | serious n=25 · 88% consumer | no trial data cached |
| C-reactive protein | 37 | 105.3 75.8–146.2ROR 105.7 · χ² 3,564 / p <1e-300 | 96.1 EB05 72.8 · IC025 +4.9 3/3 methods agree | Lab value / disease marker | serious n=37 · ♀ 100% (drug 47%) · 100% clinician | no trial data cached |
| Hypocholesterolaemia | 11 | 91.7 50.3–167.4ROR 91.9 · χ² 866 / p 1e-190 | 77.1 EB05 45.9 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Product after taste | 32 | 87.6 61.6–124.5ROR 87.9 · χ² 2,561 / p <1e-300 | 80.6 EB05 59.8 · IC025 +4.6 3/3 methods agree | Reporting / coding artifact | 100% consumer | no trial data cached |
| Product taste abnormal | 445 | 84.8 77.3–93.0ROR 89.4 · χ² 35,547 / p <1e-300 | 81.7 EB05 75.5 · IC025 +6.1 3/3 methods agree | Reporting / coding artifact | serious n=33 · 89% consumer | no trial data cached |
| Blood triglycerides abnormal | 29 | 84.7 58.5–122.5ROR 85.0 · χ² 2,237 / p <1e-300 | 77.8 EB05 56.8 · IC025 +4.5 3/3 methods agree | Lab value / disease marker | serious n=4 | no trial data cached |
| Blood immunoglobulin g increased | 32 | 66.7 47.0–94.7ROR 66.9 · χ² 1,952 / p <1e-300 | 62.6 EB05 46.4 · IC025 +4.4 3/3 methods agree | Lab value / disease marker | serious n=32 · ♀ 100% (drug 47%) | no trial data cached |
| Rheumatic disorder | 42 | 54.7 40.3–74.2ROR 55.0 · χ² 2,114 / p <1e-300 | 52.3 EB05 40.4 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=42 · ♀ 100% (drug 47%) | no trial data cached |
| Intentional underdose | 156 | 54.2 46.3–63.4ROR 55.2 · χ² 7,918 / p <1e-300 | 52.7 EB05 46.1 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious n=20 · 91% consumer | no trial data cached |
| Anti-cyclic citrullinated peptide antibody | 13 | 49.2 28.4–85.1ROR 49.3 · χ² 555 / p 5e-123 | 45.3 EB05 28.1 · IC025 +3.2 3/3 methods agree | Lab value / disease marker | serious n=13 | no trial data cached |
| Lupus vulgaris | 23 | 48.8 32.3–73.7ROR 48.9 · χ² 1,009 / p 9e-222 | 46.1 EB05 32.4 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=23 | no trial data cached |
| Product size issue | 97 | 46.0 37.7–56.2ROR 46.6 · χ² 4,151 / p <1e-300 | 44.8 EB05 37.8 · IC025 +4.9 3/3 methods agree | Reporting / coding artifact | serious n=16 · 90% consumer | no trial data cached |
| Product leakage | 96 | 45.4 37.1–55.5ROR 45.9 · χ² 4,050 / p <1e-300 | 44.2 EB05 37.3 · IC025 +4.8 3/3 methods agree | Reporting / coding artifact | serious n=11 · 85% consumer | no trial data cached |
| Facet joint syndrome | 54 | 43.2 33.0–56.4ROR 43.4 · χ² 2,144 / p <1e-300 | 41.8 EB05 33.3 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=54 · ♀ 100% (drug 47%) · 94% clinician | no trial data cached |
| Blood triglycerides increased | 301 | 42.8 38.3–47.8ROR 44.3 · χ² 12,040 / p <1e-300 | 42.0 EB05 38.1 · IC025 +5.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 17.8 | no trial data cached |
| Prescribed underdose | 309 | 39.0 34.9–43.5ROR 40.4 · χ² 11,226 / p <1e-300 | 38.3 EB05 34.8 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 31.5 | no trial data cached |
| Eructation (belching) | 279 | 36.9 32.8–41.4ROR 38.1 · χ² 9,566 / p <1e-300 | 36.3 EB05 32.8 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=11 · 87% consumer | no trial data cached |
| Retinitis | 23 | 34.6 22.9–52.2ROR 34.7 · χ² 707 / p 4e-156 | 33.3 EB05 23.4 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=23 · ♀ 100% (drug 47%) · 100% clinician | no trial data cached |
| Deep vein thrombosis postoperative | 26 | 33.3 22.6–49.0ROR 33.4 · χ² 771 / p 5e-170 | 32.1 EB05 23.0 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=26 · ♀ 100% (drug 47%) | no trial data cached |
| Porphyria acute | 18 | 32.7 20.6–52.0ROR 32.8 · χ² 515 / p 2e-114 | 31.3 EB05 21.0 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=17 | no trial data cached |
| X-ray abnormal | 20 | 28.1 18.1–43.6ROR 28.1 · χ² 490 / p 9e-109 | 27.1 EB05 18.5 · IC025 +3.3 3/3 methods agree | Lab value / disease marker | serious n=20 | no trial data cached |
| Hepatic necrosis | 39 | 25.8 18.8–35.3ROR 25.9 · χ² 896 / p 5e-197 | 25.3 EB05 19.3 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=39 · ♀ 100% (drug 47%) | no trial data cached |
| Seronegative arthritis | 11 | 24.5 13.5–44.4ROR 24.5 · χ² 223 / p 1e-50 | 23.2 EB05 13.5 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Muscle injury | 79 | 24.1 19.3–30.0ROR 24.3 · χ² 1,707 / p <1e-300 | 23.7 EB05 19.6 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 37.0 · ♀ 100% (drug 47%) · 96% clinician | no trial data cached |
| Colitis microscopic | 44 | 23.4 17.4–31.5ROR 23.6 · χ² 914 / p 4e-201 | 23.0 EB05 17.9 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=43 · ♀ 100% (drug 47%) | no trial data cached |
| Helicobacter infection | 95 | 23.3 19.1–28.5ROR 23.5 · χ² 1,987 / p <1e-300 | 23.0 EB05 19.4 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 35.9 · ♀ 100% (drug 47%) · 96% clinician | no trial data cached |
| C-reactive protein abnormal | 58 | 22.6 17.5–29.3ROR 22.8 · χ² 1,167 / p 6e-256 | 22.3 EB05 17.9 · IC025 +3.8 3/3 methods agree | Lab value / disease marker | serious n=58 · ♀ 100% (drug 47%) | no trial data cached |
| Product residue present | 47 | 22.1 16.6–29.5ROR 22.3 · χ² 920 / p 2e-202 | 21.8 EB05 17.0 · IC025 +3.7 3/3 methods agree | Reporting / coding artifact | serious n=6 | no trial data cached |
| Duodenal ulcer perforation | 65 | 22.1 17.3–28.2ROR 22.3 · χ² 1,279 / p 3e-280 | 21.8 EB05 17.7 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 32.2 · ♀ 100% (drug 47%) · 95% clinician | no trial data cached |
| Drug tolerance decreased | 24 | 21.4 14.3–32.0ROR 21.5 · χ² 443 / p 1e-98 | 20.9 EB05 14.7 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=24 · 92% clinician | no trial data cached |
| Dislocation of vertebra | 19 | 21.3 13.6–33.5ROR 21.4 · χ² 345 / p 2e-77 | 20.7 EB05 13.9 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=19 | no trial data cached |
| Adjustment disorder with depressed mood | 17 | 21.1 13.1–33.9ROR 21.1 · χ² 302 / p 5e-68 | 20.4 EB05 13.3 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=17 | 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 | 1,031 | 273.4 257.3–290.5ROR 311.2 · χ² 251,557 / p <1e-300 | 244.9 EB05 232.6 · IC025 +7.7 3/3 methods agree | Reporting / coding artifact | serious n=91 · 86% consumer | no trial data cached |
| Product physical issue | 873 | 113.5 106.4–121.1ROR 126.4 · χ² 93,006 / p <1e-300 | 108.3 EB05 102.4 · IC025 +6.6 3/3 methods agree | Reporting / coding artifact | serious n=84 · 86% consumer | no trial data cached |
| Off label use (used outside approved label) | 781 | 2.2 2.1–2.4ROR 2.4 · χ² 551 / p 3e-122 | 2.2 EB05 2.1 · IC025 +1.0 3/3 methods agree | Reporting / coding artifact | serious PRR 2.6 | no trial data cached |
| Poor quality product administered | 633 | 163.6 151.4–176.8ROR 176.7 · χ² 95,767 / p <1e-300 | 152.7 EB05 143.0 · IC025 +7.0 3/3 methods agree | Not in label — unassessed | serious n=48 · 88% consumer | no trial data cached |
| Diarrhoea (diarrhea) | 597 | 2.3 2.1–2.5ROR 2.4 · χ² 451 / p 2e-100 | 2.3 EB05 2.1 · IC025 +1.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.4 | no trial data cached |
| Drug ineffective (drug did not work) | 563 | 1.1 1.0–1.1ROR 1.1 · χ² 2 / p 0.082 | 1.1 EB05 1.0 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 2.1 | no trial data cached |
| Nausea | 533 | 1.7 1.5–1.8ROR 1.7 · χ² 150 / p 1e-34 | 1.7 EB05 1.6 · IC025 +0.6 | Not in label — unassessed | serious PRR 1.8 | no trial data cached |
| Arthralgia (joint pain) | 492 | 2.9 2.7–3.2ROR 3.1 · χ² 642 / p 8e-142 | 2.9 EB05 2.7 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.0 | no trial data cached |
| Product taste abnormal | 445 | 84.8 77.3–93.0ROR 89.4 · χ² 35,547 / p <1e-300 | 81.7 EB05 75.5 · IC025 +6.1 3/3 methods agree | Reporting / coding artifact | serious n=33 · 89% consumer | no trial data cached |
| Fatigue (tiredness) | 434 | 1.4 1.3–1.5ROR 1.4 · χ² 48 / p 3e-12 | 1.4 EB05 1.3 · IC025 +0.3 | Not in label — unassessed | serious PRR 2.3 | no trial data cached |
| Prescribed underdose | 309 | 39.0 34.9–43.5ROR 40.4 · χ² 11,226 / p <1e-300 | 38.3 EB05 34.8 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 31.5 | no trial data cached |
| Blood triglycerides increased | 301 | 42.8 38.3–47.8ROR 44.3 · χ² 12,040 / p <1e-300 | 42.0 EB05 38.1 · IC025 +5.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 17.8 | no trial data cached |
| Headache | 300 | 1.2 1.1–1.3ROR 1.2 · χ² 9 / p 0.001 | 1.2 EB05 1.1 · IC025 +0.1 | Not in label — unassessed | serious PRR 1.9 · ♀ 68% (drug 47%) | no trial data cached |
| Dizziness | 300 | 1.5 1.3–1.7ROR 1.5 · χ² 50 / p 1e-12 | 1.5 EB05 1.4 · IC025 +0.4 | Not in label — unassessed | serious PRR 2.1 | no trial data cached |
| Eructation (belching) | 279 | 36.9 32.8–41.4ROR 38.1 · χ² 9,566 / p <1e-300 | 36.3 EB05 32.8 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=11 · 87% consumer | 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.
- Overlap syndrome — n=74, PRR 297.9
- Poor quality product administered — n=633, PRR 163.6
- Milk-alkali syndrome — n=23, PRR 112.9
- Rheumatic disorder — n=42, PRR 54.7
- Intentional underdose — n=156, PRR 54.2
- Lupus vulgaris — n=23, PRR 48.8
- Facet joint syndrome — n=54, PRR 43.2
- Prescribed underdose — n=309, PRR 39.0
- Eructation — n=279, PRR 36.9
- Retinitis — n=23, PRR 34.6
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 poor quality product administered, diarrhoea, nausea, arthralgia, fatigue, prescribed underdose. 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, 1,008 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.