Drug · FAERS side-effect profile with label screen
Umeclidinium side effects: what 8,899 FDA adverse event reports show
Drug class
Anticholinergic
FDA label, Indications wording
Brand names
Umeclidinium Ellipta
openFDA label
Who reports
8,899 reports · 53% serious · 649 with death outcome · 63% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Umeclidinium ELLIPTA is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Umeclidinium ELLIPTA is an anticholinergic indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). ( 1 )
FDA label, Indications and Usage
What it is
Umeclidinium ELLIPTA is an inhalation powder drug product for delivery of umeclidinium (an anticholinergic) to patients by oral inhalation. Umeclidinium bromide has the chemical name 1-[2-(ben.
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 (related wording) 3Likely indication confounding 2Reporting / coding artifact 8Lab value / disease marker 5Not in label — unassessed 22
What the badges mean
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- 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. 971 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 |
|---|---|---|---|---|---|---|
| Testicular infarction | 13 | 642.6 347.8–1,187.2ROR 643.5 · χ² 6,030 / p <1e-300 | 289.3 EB05 179.9 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Coagulation factor v level abnormal | 18 | 398.3 241.7–656.4ROR 399.1 · χ² 5,755 / p <1e-300 | 250.0 EB05 167.3 · IC025 +4.3 3/3 methods agree | Lab value / disease marker | serious n=18 | no trial data cached |
| Acquired factor v deficiency | 16 | 395.4 232.8–671.6ROR 396.2 · χ² 5,048 / p <1e-300 | 241.0 EB05 157.3 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Coagulation factor deficiency | 17 | 276.2 167.1–456.5ROR 276.7 · χ² 3,924 / p <1e-300 | 193.6 EB05 128.0 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=17 | no trial data cached |
| Nsaid exacerbated respiratory disease | 16 | 111.3 67.4–183.7ROR 111.5 · χ² 1,565 / p <1e-300 | 94.6 EB05 61.7 · IC025 +3.8 3/3 methods agree | Labeled (related wording) related wording | serious n=16 | no trial data cached |
| Bacteroides infection | 11 | 104.3 57.0–190.8ROR 104.4 · χ² 981 / p 2e-215 | 85.5 EB05 51.0 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Appendicolith | 16 | 103.5 62.8–170.8ROR 103.7 · χ² 1,459 / p <1e-300 | 89.0 EB05 58.1 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Factor v leiden mutation | 15 | 92.2 55.1–154.4ROR 92.3 · χ² 1,215 / p 2e-266 | 80.0 EB05 51.5 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Bronchopulmonary aspergillosis allergic | 29 | 76.9 53.2–111.3ROR 77.2 · χ² 2,030 / p <1e-300 | 71.1 EB05 51.9 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=29 · ♀ 0% (drug 63%) | no trial data cached |
| Product confusion | 19 | 59.0 37.4–93.0ROR 59.1 · χ² 1,001 / p 6e-220 | 54.6 EB05 36.9 · IC025 +3.8 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Bronchial wall thickening | 12 | 39.6 22.4–70.0ROR 39.7 · χ² 407 / p 9e-91 | 36.9 EB05 22.5 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Progressive multiple sclerosis | 19 | 38.8 24.7–61.1ROR 38.9 · χ² 652 / p 4e-144 | 36.9 EB05 25.0 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=19 | no trial data cached |
| Total lung capacity decreased | 22 | 32.8 21.5–49.9ROR 32.9 · χ² 638 / p 6e-141 | 31.6 EB05 22.0 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=17 · ♀ 30% (drug 63%) | no trial data cached |
| Parotitis | 15 | 30.7 18.5–51.1ROR 30.8 · χ² 397 / p 1e-88 | 29.3 EB05 18.8 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Dust allergy | 12 | 29.7 16.8–52.4ROR 29.7 · χ² 300 / p 1e-67 | 28.1 EB05 17.0 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Wrong technique in device usage process | 540 | 28.1 25.9–30.6ROR 29.9 · χ² 13,969 / p <1e-300 | 27.8 EB05 25.9 · IC025 +4.6 3/3 methods agree | Reporting / coding artifact | serious n=26 · 98% consumer | no trial data cached |
| Testicular disorder | 12 | 28.1 15.9–49.7ROR 28.2 · χ² 284 / p 5e-64 | 26.7 EB05 16.2 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Product complaint | 278 | 26.5 23.6–29.8ROR 27.3 · χ² 6,733 / p <1e-300 | 26.2 EB05 23.7 · IC025 +4.5 3/3 methods agree | Reporting / coding artifact | serious n=21 · 94% consumer | no trial data cached |
| Sputum discoloured | 94 | 23.6 19.3–28.9ROR 23.9 · χ² 1,997 / p <1e-300 | 23.3 EB05 19.6 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 30.4 | no trial data cached |
| Halo vision | 11 | 23.1 12.8–41.8ROR 23.1 · χ² 209 / p 1e-47 | 21.9 EB05 12.6 · IC025 +2.5 3/3 methods agree | Labeled (related wording) related wording | serious n=5 | no trial data cached |
| Allergy to animal | 10 | 22.6 12.2–42.2ROR 22.7 · χ² 184 / p 3e-42 | 21.3 EB05 11.7 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious n=8 | no trial data cached |
| Testicular swelling | 12 | 22.4 12.7–39.6ROR 22.4 · χ² 222 / p 1e-50 | 21.3 EB05 12.6 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Lower respiratory tract congestion | 14 | 19.5 11.5–33.0ROR 19.5 · χ² 226 / p 2e-51 | 18.7 EB05 11.4 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | serious n=5 | no trial data cached |
| Labelled drug-drug interaction medication error | 73 | 19.4 15.4–24.4ROR 19.6 · χ² 1,247 / p 2e-273 | 19.2 EB05 15.7 · IC025 +3.7 3/3 methods agree | Reporting / coding artifact | serious PRR 5.8 · 97% consumer | no trial data cached |
| Chronic obstructive pulmonary disease | 416 | 18.9 17.2–20.8ROR 19.8 · χ² 7,010 / p <1e-300 | 18.8 EB05 17.3 · IC025 +4.0 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 20.5 | no trial data cached |
| Increased bronchial secretion | 20 | 18.5 11.9–28.7ROR 18.5 · χ² 311 / p 6e-70 | 17.9 EB05 12.0 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=20 | no trial data cached |
| Multiple allergies | 61 | 18.4 14.3–23.7ROR 18.6 · χ² 982 / p 9e-216 | 18.2 EB05 14.7 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=55 · 72% consumer | no trial data cached |
| Obstructive airways disorder | 86 | 18.3 14.8–22.6ROR 18.4 · χ² 1,377 / p <1e-300 | 18.1 EB05 15.1 · IC025 +3.7 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 20.0 · ♀ 42% (drug 63%) | no trial data cached |
| Pulmonary function test abnormal | 12 | 18.2 10.3–32.1ROR 18.2 · χ² 177 / p 1e-40 | 17.1 EB05 9.7 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious n=12 | no trial data cached |
| Full blood count abnormal | 78 | 17.5 14.1–21.9ROR 17.7 · χ² 1,192 / p 2e-261 | 17.3 EB05 14.3 · IC025 +3.6 3/3 methods agree | Lab value / disease marker | serious PRR 24.8 | no trial data cached |
| Blood immunoglobulin e increased | 18 | 17.5 11.0–27.8ROR 17.6 · χ² 262 / p 3e-59 | 16.9 EB05 10.9 · IC025 +2.8 3/3 methods agree | Lab value / disease marker | serious n=15 | no trial data cached |
| Oxygen therapy | 12 | 17.5 9.9–30.8ROR 17.5 · χ² 169 / p 6e-39 | 16.3 EB05 9.1 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious n=12 | no trial data cached |
| Forced expiratory volume decreased | 19 | 15.9 10.1–24.9ROR 15.9 · χ² 248 / p 3e-56 | 15.2 EB05 9.9 · IC025 +2.7 3/3 methods agree | Lab value / disease marker | serious n=18 | no trial data cached |
| Product packaging confusion | 16 | 15.6 9.5–25.5ROR 15.6 · χ² 203 / p 3e-46 | 14.7 EB05 9.0 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Infusion site discharge | 11 | 15.2 8.4–27.6ROR 15.3 · χ² 132 / p 9e-31 | 13.7 EB05 7.1 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious n=8 | no trial data cached |
| Chorea | 11 | 15.1 8.3–27.2ROR 15.1 · χ² 130 / p 2e-30 | 13.5 EB05 7.0 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| High density lipoprotein decreased | 21 | 14.9 9.7–22.9ROR 14.9 · χ² 257 / p 4e-58 | 14.3 EB05 9.4 · IC025 +2.8 3/3 methods agree | Lab value / disease marker | serious n=21 | no trial data cached |
| Sleep disorder due to a general medical condition | 101 | 14.8 12.2–18.0ROR 15.0 · χ² 1,278 / p 3e-280 | 14.6 EB05 12.4 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 30.3 | no trial data cached |
| Product label confusion | 36 | 14.7 10.6–20.3ROR 14.7 · χ² 442 / p 2e-98 | 14.3 EB05 10.6 · IC025 +3.1 3/3 methods agree | Reporting / coding artifact | 100% consumer | no trial data cached |
| Sputum increased | 13 | 14.6 8.4–25.1ROR 14.6 · χ² 150 / p 9e-35 | 13.3 EB05 7.4 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious n=10 | 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 |
|---|---|---|---|---|---|---|
| Dyspnoea (shortness of breath) | 1,407 | 5.9 5.6–6.2ROR 6.8 · χ² 5,825 / p <1e-300 | 5.8 EB05 5.6 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 | no trial data cached |
| Drug ineffective (drug did not work) | 771 | 1.4 1.3–1.5ROR 1.4 · χ² 85 / p 1e-20 | 1.4 EB05 1.3 · IC025 +0.3 | Reporting / coding artifact | serious PRR 1.5 · 77% consumer | no trial data cached |
| Cough | 718 | 6.1 5.6–6.5ROR 6.5 · χ² 3,060 / p <1e-300 | 6.0 EB05 5.7 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.5 | no trial data cached |
| Asthma | 627 | 13.2 12.3–14.3ROR 14.2 · χ² 7,082 / p <1e-300 | 13.2 EB05 12.3 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 17.0 | no trial data cached |
| Pneumonia (lung infection) | 559 | 4.1 3.8–4.4ROR 4.3 · χ² 1,314 / p 5e-288 | 4.1 EB05 3.8 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.5 | no trial data cached |
| Wrong technique in device usage process | 540 | 28.1 25.9–30.6ROR 29.9 · χ² 13,969 / p <1e-300 | 27.8 EB05 25.9 · IC025 +4.6 3/3 methods agree | Reporting / coding artifact | serious n=26 · 98% consumer | no trial data cached |
| Chronic obstructive pulmonary disease | 416 | 18.9 17.2–20.8ROR 19.8 · χ² 7,010 / p <1e-300 | 18.8 EB05 17.3 · IC025 +4.0 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 20.5 | no trial data cached |
| Fatigue (tiredness) | 382 | 1.2 1.1–1.3ROR 1.2 · χ² 8 / p 0.002 | 1.2 EB05 1.1 · IC025 +0.0 | Not in label — unassessed | serious PRR 1.6 | no trial data cached |
| Product dose omission issue | 346 | 2.9 2.6–3.2ROR 2.9 · χ² 423 / p 2e-94 | 2.9 EB05 2.6 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 3.7 · 83% consumer | no trial data cached |
| Death | 338 | 0.9 0.8–1.0ROR 0.9 · χ² 2 / p 0.073 | 0.9 EB05 0.8 · IC025 -0.3 PRR-only: not supported by EBGM or IC | Outcome field, not a reaction | serious PRR 1.0 | no trial data cached |
| Wheezing | 336 | 13.4 12.1–14.9ROR 13.9 · χ² 3,848 / p <1e-300 | 13.4 EB05 12.2 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 16.4 | no trial data cached |
| Headache | 327 | 1.2 1.1–1.4ROR 1.2 · χ² 14 / p 8e-5 | 1.2 EB05 1.1 · IC025 +0.1 | Labeled adverse reaction exact term | serious PRR 1.6 | no trial data cached |
| Off label use (used outside approved label) | 325 | 0.9 0.8–1.0ROR 0.9 · χ² 5 / p 0.011 | 0.9 EB05 0.8 · IC025 -0.4 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 1.0 · 70% consumer | no trial data cached |
| Malaise (feeling unwell) | 322 | 1.7 1.6–1.9ROR 1.8 · χ² 100 / p 9e-24 | 1.7 EB05 1.6 · IC025 +0.6 | Not in label — unassessed | serious PRR 2.3 | no trial data cached |
| Nausea | 298 | 0.9 0.8–1.0ROR 0.9 · χ² 4 / p 0.021 | 0.9 EB05 0.8 · IC025 -0.4 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 1.2 | 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.
- Bronchopulmonary aspergillosis allergic — n=29, PRR 76.9
- Total lung capacity decreased — n=22, PRR 32.8
- Sputum discoloured — n=94, PRR 23.6
- Increased bronchial secretion — n=20, PRR 18.5
- Multiple allergies — n=61, PRR 18.4
- Sleep disorder due to a general medical condition — n=101, PRR 14.8
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 Umeclidinium?
In FDA FAERS, the most frequently co-reported reaction terms for Umeclidinium are dyspnoea, cough, asthma, pneumonia, chronic obstructive pulmonary disease, fatigue. 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 Umeclidinium have an FDA boxed warning?
No. The FDA label retrieved for Umeclidinium has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Umeclidinium 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 763388a5-cc89-4c25-8562-521df679b7e8, effective 20251106; matched on
openfda.generic_name.exact:"UMECLIDINIUM") - 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, 1,011 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.