umeclidinium Side Effects
Also known as: Incruse Ellipta
Analysis of 8,530 adverse event reports submitted to the FDA from 2010 to 2025.
Total Reports
8,530
Death-Related
605
7.1% of reports
Hospitalizations
2,270
26.6% of reports
Top Indication
Product Used For Unknown Indication
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 605 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DEATH | 319 |
| PNEUMONIA | 60 |
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | 57 |
| DYSPNOEA | 44 |
| MALAISE | 35 |
| OFF LABEL USE | 34 |
| 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
Top reactions in 2,270 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| DYSPNOEA | 488 |
| PNEUMONIA | 374 |
| ASTHMA | 294 |
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | 249 |
| COUGH | 202 |
| HOSPITALISATION | 168 |
| FALL | 151 |
| FATIGUE | 140 |
| WHEEZING | 136 |
| DRUG INEFFECTIVE | 134 |
| MALAISE | 120 |
| DIARRHOEA | 116 |
| NAUSEA | 104 |
| CONDITION AGGRAVATED | 101 |
| PAIN | 97 |
| HEADACHE | 95 |
| OFF LABEL USE | 95 |
| LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES | 92 |
| VOMITING | 90 |
| ASTHENIA | 89 |
Nearby — Related Medications
What the FAERS Data Reveals About umeclidinium Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 8,530 voluntary reports linked to umeclidinium and its brand equivalents (Incruse Ellipta), spanning 2010 through 2025. Of those, 605 (7.1%) listed death as an outcome and 2,270 (26.6%) involved hospitalization. The most common indication reported alongside adverse events was Product Used For Unknown Indication.
Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 62% were female and 38% male; age distribution skews toward 65-74, with 1,393 reports in that bracket. The single most reported reaction is dyspnoea with 1,352 submissions, followed by drug ineffective and cough.
FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice — speak with a licensed clinician about any side-effect concerns.
Read our methodology — how this data is sourced, computed, and verified.