MID-VOLUME · HOSP-MID
umeclidinium Side Effects
umeclidinium (also sold as Incruse Ellipta) sits MID-VOLUME #335 of 524 by FAERS report count. Lead signal: HOSP-MID - 26.6% mention hospitalization (2,270 reports). Demographics and serious-outcome tables follow.
Data updated 2026-05-15
- 8,530
- FAERS reports
FDA Adverse Event Reporting System extract for umeclidinium. Stamp set WATCHLIST · DEATH-HEAVY · HOSP-MID. How figures are compiled.
umeclidinium: 26.6% mention hospitalization (2,270 reports). Death stamp DEATH-HEAVY; volume band MID-VOLUME #335 of 524 by FAERS report count.
Mid-book FAERS page for umeclidinium (Incruse Ellipta) (8,530 reports). Signature HOSP-MID. Dominant age band on file: 65-74. Educational reference only.
Counts from the openFDA FAERS extract (2010–2025). Stamps WATCHLIST · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
DYSPNOEA leads 1,352 of 8,530 reports
Who reports · age peak 65-74 (SEX-BALANCED)
Sex coding · SEX-BALANCED
Age peak 65-74 (1,393 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death-mentioned subset is HEAVY here (605 reports, 7.1%). Top co-reported reactions in that subset - voluntary, not causal.
| Reaction | Reports |
|---|---|
| DEATH | 319 |
| PNEUMONIA | 60 |
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | 57 |
| DYSPNOEA | 44 |
| MALAISE | 35 |
| ACUTE KIDNEY INJURY | 30 |
| SEPSIS | 29 |
| DIARRHOEA | 27 |
| NAUSEA | 27 |
| VOMITING | 27 |
| MULTIPLE ORGAN DYSFUNCTION SYNDROME | 26 |
| CARDIAC ARREST | 25 |
| CONSTIPATION | 24 |
| CONDITION AGGRAVATED | 23 |
| GENERAL PHYSICAL HEALTH DETERIORATION | 23 |
| FALL | 22 |
| PULMONARY EMBOLISM | 22 |
| ASCITES | 21 |
| FATIGUE | 21 |
Reactions in Hospitalization Reports
Hospitalization mid-share (2,270, 26.6%). Co-reported reactions:
| Reaction | Reports |
|---|---|
| DYSPNOEA | 488 |
| PNEUMONIA | 374 |
| ASTHMA | 294 |
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | 249 |
| COUGH | 202 |
| HOSPITALISATION | 168 |
| FALL | 151 |
| FATIGUE | 140 |
| WHEEZING | 136 |
| MALAISE | 120 |
| DIARRHOEA | 116 |
| NAUSEA | 104 |
| CONDITION AGGRAVATED | 101 |
| PAIN | 97 |
| HEADACHE | 95 |
| LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES | 92 |
| VOMITING | 90 |
| ASTHENIA | 89 |
How to read umeclidinium FAERS figures (WATCHLIST · DEATH-HEAVY · HOSP-MID)
FAERS holds 8,530 voluntary reports linked to umeclidinium (Incruse Ellipta), 2010-2025. Death is listed on 605 (7.1%). Hospitalization appears on 2,270 (26.6%). Top co-reported indication: Product Used For Unknown Indication.
Mid-volume extract - treat DEATH-HEAVY · HOSP-MID as signal-detection rates next to 26.6% mention hospitalization (2,270 reports).
Read with umeclidinium
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 8,521 FAERS cases (Δ 9 lighter vs umeclidinium); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
ABS(total_reports) peer at 8,574 FAERS cases (Δ 44 heavier vs umeclidinium); DEATH-MARKED · HOSP-MID · SEX-BALANCED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
ABS(total_reports) peer at 8,461 FAERS cases (Δ 69 lighter vs umeclidinium); DEATH-HEAVY · HOSP-MID · SEX-BALANCED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
ABS(total_reports) peer at 8,426 FAERS cases (Δ 104 lighter vs umeclidinium); 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 55.0 pp vs umeclidinium's DEATH-HEAVY): CASELOAD · HOSP-MID.
umeclidinium stamps DEATH-HEAVY · HOSP-MID; FAERS outcome shares are signal-detection rates, not incidence. Read them next to caseload WATCHLIST and the label guide.