MID-VOLUME · HOSP-MID
icosapent ethyl Side Effects
icosapent ethyl (also sold as Vascepa) sits MID-VOLUME #346 of 524 by FAERS report count. Lead signal: HOSP-MID - 18.1% mention hospitalization (1,413 reports). Demographics and serious-outcome tables follow.
Data updated 2026-05-15
- 7,801
- FAERS reports
FDA Adverse Event Reporting System extract for icosapent ethyl. Stamp set WATCHLIST · DEATH-HEAVY · HOSP-MID. How figures are compiled.
icosapent ethyl: 18.1% mention hospitalization (1,413 reports). Death stamp DEATH-HEAVY; volume band MID-VOLUME #346 of 524 by FAERS report count.
Mid-book FAERS page for icosapent ethyl (Vascepa) (7,801 reports). Signature HOSP-MID. Dominant age band on file: 45-64. Educational reference only.
Counts from the openFDA FAERS extract (2011–2025). Stamps WATCHLIST · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
PRODUCT ODOUR ABNORMAL leads 963 of 7,801 reports
Who reports · age peak 45-64 (SEX-BALANCED)
Sex coding · SEX-BALANCED
Age peak 45-64 (1,701 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death-mentioned subset is HEAVY here (497 reports, 6.4%). Top co-reported reactions in that subset - voluntary, not causal.
| Reaction | Reports |
|---|---|
| DEATH | 224 |
| CONDITION AGGRAVATED | 129 |
| MATERNAL EXPOSURE DURING PREGNANCY | 101 |
| TYPE 2 DIABETES MELLITUS | 68 |
| FIBROMYALGIA | 67 |
| OVERLAP SYNDROME | 67 |
| STOMATITIS | 67 |
| HYPOAESTHESIA | 65 |
| URTICARIA | 65 |
| SWELLING | 64 |
| FATIGUE | 63 |
| ALOPECIA | 61 |
| HELICOBACTER INFECTION | 61 |
| HYPERTENSION | 61 |
| OSTEOARTHRITIS | 61 |
| MOBILITY DECREASED | 59 |
| NASOPHARYNGITIS | 59 |
| PYREXIA | 52 |
| VOMITING | 52 |
Reactions in Hospitalization Reports
Hospitalization mid-share (1,413, 18.1%). Co-reported reactions:
| Reaction | Reports |
|---|---|
| FATIGUE | 120 |
| PNEUMONIA | 95 |
| CONDITION AGGRAVATED | 93 |
| HEADACHE | 92 |
| HYPERTENSION | 92 |
| PYREXIA | 92 |
| DYSPNOEA | 89 |
| VOMITING | 89 |
| HYPOAESTHESIA | 84 |
| SWELLING | 81 |
| TYPE 2 DIABETES MELLITUS | 81 |
| DIZZINESS | 80 |
| NASOPHARYNGITIS | 80 |
| HOSPITALISATION | 78 |
| STOMATITIS | 78 |
| ASTHENIA | 77 |
| FIBROMYALGIA | 77 |
| DIARRHOEA | 76 |
How to read icosapent ethyl FAERS figures (WATCHLIST · DEATH-HEAVY · HOSP-MID)
FAERS holds 7,801 voluntary reports linked to icosapent ethyl (Vascepa), 2011-2025. Death is listed on 497 (6.4%). Hospitalization appears on 1,413 (18.1%). Top co-reported indication: Product Used For Unknown Indication.
Mid-volume extract - treat DEATH-HEAVY · HOSP-MID as signal-detection rates next to 18.1% mention hospitalization (1,413 reports).
Read with icosapent ethyl
Peers ranked by ABS(total_reports), then an ABS(death_share) pole; guide hop follows DEATH-HEAVY · HOSP-MID stamps.
ABS(total_reports) peer at 7,819 FAERS cases (Δ 18 heavier vs icosapent ethyl); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
ABS(total_reports) peer at 7,881 FAERS cases (Δ 80 heavier vs icosapent ethyl); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
ABS(total_reports) peer at 7,629 FAERS cases (Δ 172 lighter vs icosapent ethyl); DEATH-HEAVY · HOSP-MID · FEMALE-LED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
ABS(total_reports) peer at 7,980 FAERS cases (Δ 179 heavier vs icosapent ethyl); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
ABS(death_share) pole at 62.1% death-mentioned reports (Δ 55.7 pp vs icosapent ethyl's DEATH-HEAVY): CASELOAD · HOSP-MID.
icosapent ethyl stamps DEATH-HEAVY · HOSP-MID; FAERS outcome shares are signal-detection rates, not incidence. Read them next to caseload WATCHLIST and the label guide.