Drug · FAERS side-effect profile with label screen
Umeclidinium and Vilanterol Trifenatate side effects: what 16,579 FDA adverse event reports show
Drug class
Anticholinergic
FDA label, Indications wording of the closest related product
Label matched
Umeclidinium (Umeclidinium Ellipta)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
16,579 reports · 35% serious · 843 with death outcome · 58% 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) 4Reporting / coding artifact 12Lab value / disease marker 3Not in label — unassessed 21
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.
- 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. 984 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 |
|---|---|---|---|---|---|---|
| Total lung capacity increased | 57 | 333.2 248.8–446.1ROR 334.3 · χ² 14,630 / p <1e-300 | 241.8 EB05 193.5 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious n=57 · ♀ 100% (drug 58%) · 93% clinician | no trial arm names this drug |
| Capillaritis | 43 | 241.1 174.0–334.1ROR 241.8 · χ² 8,414 / p <1e-300 | 185.6 EB05 143.5 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=43 · ♀ 0% (drug 58%) | no trial arm names this drug |
| Total lung capacity abnormal | 51 | 195.4 145.5–262.3ROR 196.0 · χ² 8,357 / p <1e-300 | 159.0 EB05 125.7 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious n=51 · ♀ 0% (drug 58%) | no trial arm names this drug |
| Pulmonary vasculitis | 65 | 177.1 136.6–229.5ROR 177.8 · χ² 9,810 / p <1e-300 | 148.5 EB05 120.6 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious n=65 · ♀ 0% (drug 58%) | no trial arm names this drug |
| Asthma-chronic obstructive pulmonary disease overlap syndrome | 61 | 167.6 128.4–218.9ROR 168.3 · χ² 8,759 / p <1e-300 | 141.4 EB05 114.0 · IC025 +5.6 3/3 methods agree | Labeled (related wording) related wording | serious n=60 · ♀ 92% (drug 58%) · 90% clinician | no trial arm names this drug |
| Failure to anastomose | 12 | 152.4 83.7–277.6ROR 152.6 · χ² 1,476 / p <1e-300 | 112.2 EB05 68.4 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial arm names this drug |
| Spirometry abnormal | 61 | 146.3 112.3–190.7ROR 146.9 · χ² 7,749 / p <1e-300 | 126.0 EB05 101.6 · IC025 +5.6 3/3 methods agree | Lab value / disease marker | serious n=61 · ♀ 0% (drug 58%) | no trial arm names this drug |
| Mite allergy | 65 | 143.2 110.8–185.1ROR 143.8 · χ² 8,106 / p <1e-300 | 123.9 EB05 100.7 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious n=65 · ♀ 0% (drug 58%) | no trial arm names this drug |
| Product packaging confusion | 215 | 122.4 106.5–140.7ROR 124.0 · χ² 23,461 / p <1e-300 | 110.5 EB05 98.6 · IC025 +6.2 3/3 methods agree | Reporting / coding artifact | serious n=5 · 99% consumer | no trial arm names this drug |
| Mycotic allergy | 65 | 105.5 81.9–135.8ROR 105.9 · χ² 6,107 / p <1e-300 | 94.7 EB05 76.9 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=65 · ♀ 0% (drug 58%) | no trial arm names this drug |
| Antineutrophil cytoplasmic antibody positive | 52 | 97.1 73.2–128.6ROR 97.4 · χ² 4,497 / p <1e-300 | 87.3 EB05 69.1 · IC025 +5.1 3/3 methods agree | Lab value / disease marker | serious n=52 · ♀ 0% (drug 58%) | no trial arm names this drug |
| Dust allergy | 65 | 91.2 71.0–117.3ROR 91.6 · χ² 5,321 / p <1e-300 | 83.1 EB05 67.5 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=65 · ♀ 0% (drug 58%) | no trial arm names this drug |
| Product confusion | 47 | 81.3 60.5–109.1ROR 81.5 · χ² 3,423 / p <1e-300 | 74.1 EB05 58.0 · IC025 +4.9 3/3 methods agree | Reporting / coding artifact | 100% consumer | no trial arm names this drug |
| Bronchospasm paradoxical | 15 | 66.2 39.4–111.3ROR 66.3 · χ² 854 / p 5e-188 | 58.5 EB05 37.6 · IC025 +3.5 3/3 methods agree | Labeled (related wording) related wording | serious n=8 | no trial arm names this drug |
| Product complaint | 1,185 | 62.9 59.5–66.6ROR 67.7 · χ² 68,763 / p <1e-300 | 59.9 EB05 57.1 · IC025 +5.8 3/3 methods agree | Reporting / coding artifact | serious n=88 · 92% consumer | no trial arm names this drug |
| Conjunctivitis allergic | 66 | 59.6 46.6–76.3ROR 59.9 · χ² 3,575 / p <1e-300 | 56.1 EB05 45.6 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=66 · ♀ 0% (drug 58%) | no trial arm names this drug |
| Neuritis | 66 | 56.5 44.2–72.3ROR 56.8 · χ² 3,392 / p <1e-300 | 53.3 EB05 43.4 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=66 · ♀ 0% (drug 58%) | no trial arm names this drug |
| Labelled drug-disease interaction medication error | 25 | 55.8 37.4–83.2ROR 55.9 · χ² 1,235 / p 6e-271 | 51.5 EB05 36.7 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=4 · 100% consumer | no trial arm names this drug |
| Pulmonary resection | 10 | 54.1 28.7–101.9ROR 54.2 · χ² 450 / p 3e-100 | 47.5 EB05 27.6 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial arm names this drug |
| Appendicolith | 15 | 51.9 31.0–86.9ROR 51.9 · χ² 670 / p 4e-148 | 47.1 EB05 30.3 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial arm names this drug |
| Analgesic therapy | 12 | 51.3 28.8–91.4ROR 51.4 · χ² 521 / p 1e-115 | 46.0 EB05 28.0 · IC025 +3.1 3/3 methods agree | Reporting / coding artifact | serious n=12 | no trial arm names this drug |
| Drug therapy | 12 | 49.1 27.6–87.5ROR 49.2 · χ² 499 / p 7e-111 | 44.2 EB05 27.0 · IC025 +3.1 3/3 methods agree | Reporting / coding artifact | serious n=12 | no trial arm names this drug |
| Wrong technique in device usage process | 1,630 | 46.7 44.5–48.9ROR 51.6 · χ² 70,305 / p <1e-300 | 45.0 EB05 43.2 · IC025 +5.4 3/3 methods agree | Reporting / coding artifact | serious n=77 · 96% consumer | no trial arm names this drug |
| Product label confusion | 207 | 46.6 40.6–53.4ROR 47.1 · χ² 8,854 / p <1e-300 | 44.7 EB05 39.9 · IC025 +5.1 3/3 methods agree | Reporting / coding artifact | serious n=6 · 98% consumer | no trial arm names this drug |
| Intercepted drug prescribing error | 17 | 44.4 27.4–72.0ROR 44.4 · χ² 655 / p 1e-144 | 41.1 EB05 27.1 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | – | no trial arm names this drug |
| Eosinophilic granulomatosis with polyangiitis | 66 | 42.6 33.4–54.5ROR 42.8 · χ² 2,555 / p <1e-300 | 40.8 EB05 33.2 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=66 · ♀ 0% (drug 58%) | no trial arm names this drug |
| Drug dispensing error | 496 | 41.7 38.2–45.6ROR 43.0 · χ² 19,054 / p <1e-300 | 40.4 EB05 37.5 · IC025 +5.1 3/3 methods agree | Reporting / coding artifact | serious n=10 · 99% consumer | no trial arm names this drug |
| Breast conserving surgery | 14 | 35.5 20.9–60.4ROR 35.5 · χ² 423 / p 2e-94 | 33.1 EB05 21.0 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial arm names this drug |
| Respiratory symptom | 68 | 31.4 24.7–39.9ROR 31.5 · χ² 1,922 / p <1e-300 | 30.4 EB05 24.8 · IC025 +4.3 3/3 methods agree | Labeled (related wording) related wording | serious n=67 · ♀ 5% (drug 58%) | no trial arm names this drug |
| Intercepted drug administration error | 10 | 29.0 15.5–54.3ROR 29.0 · χ² 238 / p 6e-54 | 27.0 EB05 15.4 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | – | no trial arm names this drug |
| Labelled drug-drug interaction medication error | 198 | 28.6 24.9–32.9ROR 29.0 · χ² 5,136 / p <1e-300 | 27.9 EB05 24.8 · IC025 +4.5 3/3 methods agree | Reporting / coding artifact | serious PRR 12.5 · 100% consumer | no trial arm names this drug |
| Normochromic normocytic anaemia | 64 | 27.5 21.5–35.2ROR 27.6 · χ² 1,572 / p <1e-300 | 26.7 EB05 21.7 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=64 · ♀ 0% (drug 58%) | no trial arm names this drug |
| Lung operation | 17 | 26.2 16.2–42.3ROR 26.2 · χ² 379 / p 1e-84 | 25.0 EB05 16.5 · IC025 +3.1 3/3 methods agree | Reporting / coding artifact | serious n=17 | no trial arm names this drug |
| Forced expiratory volume decreased | 55 | 24.9 19.1–32.6ROR 25.0 · χ² 1,216 / p 1e-266 | 24.3 EB05 19.4 · IC025 +3.9 3/3 methods agree | Lab value / disease marker | serious n=54 · ♀ 7% (drug 58%) | no trial arm names this drug |
| Oxygen therapy | 30 | 23.7 16.5–34.0ROR 23.7 · χ² 617 / p 2e-136 | 22.9 EB05 16.8 · IC025 +3.5 3/3 methods agree | Reporting / coding artifact | serious n=22 · 100% consumer | no trial arm names this drug |
| Inhalation therapy | 10 | 20.1 10.8–37.5ROR 20.1 · χ² 160 / p 5e-37 | 18.5 EB05 9.8 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | – | no trial arm names this drug |
| Intentional underdose | 101 | 17.7 14.6–21.6ROR 17.8 · χ² 1,556 / p <1e-300 | 17.4 EB05 14.8 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=11 · 98% consumer | no trial arm names this drug |
| Jaundice cholestatic | 49 | 17.7 13.4–23.5ROR 17.8 · χ² 745 / p 2e-164 | 17.3 EB05 13.6 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=49 · ♀ 90% (drug 58%) · 100% clinician | no trial arm names this drug |
| Rhinitis allergic | 60 | 17.3 13.4–22.3ROR 17.3 · χ² 892 / p 3e-196 | 16.9 EB05 13.6 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=59 · ♀ 100% (drug 58%) · 90% clinician | no trial arm names this drug |
| Lower respiratory tract congestion | 23 | 17.3 11.4–26.1ROR 17.3 · χ² 332 / p 2e-74 | 16.7 EB05 11.5 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious n=9 · 91% consumer | no trial arm names this drug |
Trial evidence (ClinicalTrials.gov)
ClinicalTrials.gov returned results-bearing trials mentioning Umeclidinium and Vilanterol Trifenatate only as a background or rescue medication (NCT02164513); no trial listing it as the tested intervention was cached, so no trial cross-check is shown.
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) | 2,358 | 5.3 5.1–5.5ROR 6.0 · χ² 8,372 / p <1e-300 | 5.3 EB05 5.1 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 · 84% consumer | no trial arm names this drug |
| Wrong technique in device usage process | 1,630 | 46.7 44.5–48.9ROR 51.6 · χ² 70,305 / p <1e-300 | 45.0 EB05 43.2 · IC025 +5.4 3/3 methods agree | Reporting / coding artifact | serious n=77 · 96% consumer | no trial arm names this drug |
| Drug ineffective (drug did not work) | 1,619 | 1.6 1.5–1.6ROR 1.6 · χ² 339 / p 4e-76 | 1.6 EB05 1.5 · IC025 +0.6 | Reporting / coding artifact | serious PRR 1.5 · 91% consumer | no trial arm names this drug |
| Product complaint | 1,185 | 62.9 59.5–66.6ROR 67.7 · χ² 68,763 / p <1e-300 | 59.9 EB05 57.1 · IC025 +5.8 3/3 methods agree | Reporting / coding artifact | serious n=88 · 92% consumer | no trial arm names this drug |
| Cough | 1,102 | 5.0 4.7–5.3ROR 5.3 · χ² 3,544 / p <1e-300 | 5.0 EB05 4.7 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.7 · 89% consumer | no trial arm names this drug |
| Product dose omission issue | 889 | 4.0 3.7–4.2ROR 4.1 · χ² 1,978 / p <1e-300 | 3.9 EB05 3.7 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious PRR 4.2 · 89% consumer | no trial arm names this drug |
| Pneumonia (lung infection) | 674 | 2.6 2.4–2.8ROR 2.7 · χ² 692 / p 8e-153 | 2.6 EB05 2.5 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.5 | no trial arm names this drug |
| Chronic obstructive pulmonary disease | 624 | 15.3 14.1–16.5ROR 15.8 · χ² 8,235 / p <1e-300 | 15.1 EB05 14.1 · IC025 +3.8 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 23.6 | no trial arm names this drug |
| Condition aggravated | 513 | 2.1 2.0–2.3ROR 2.2 · χ² 317 / p 3e-71 | 2.1 EB05 2.0 · IC025 +1.0 | Reporting / coding artifact | serious PRR 3.1 | no trial arm names this drug |
| Drug dispensing error | 496 | 41.7 38.2–45.6ROR 43.0 · χ² 19,054 / p <1e-300 | 40.4 EB05 37.5 · IC025 +5.1 3/3 methods agree | Reporting / coding artifact | serious n=10 · 99% consumer | no trial arm names this drug |
| Off label use (used outside approved label) | 480 | 0.7 0.6–0.8ROR 0.7 · χ² 65 / p 4e-16 | 0.7 EB05 0.6 · IC025 -0.7 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 1.0 | no trial arm names this drug |
| Drug dose omission | 472 | 3.6 3.3–3.9ROR 3.6 · χ² 871 / p 8e-192 | 3.5 EB05 3.3 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious PRR 3.2 · 97% consumer | no trial arm names this drug |
| Death | 471 | 0.7 0.6–0.8ROR 0.7 · χ² 68 / p 9e-17 | 0.7 EB05 0.6 · IC025 -0.7 PRR-only: not supported by EBGM or IC | Outcome field, not a reaction | serious PRR 1.1 · ♀ 36% (drug 58%) | no trial arm names this drug |
| Fatigue (tiredness) | 448 | 0.7 0.7–0.8ROR 0.7 · χ² 47 / p 4e-12 | 0.7 EB05 0.7 · IC025 -0.6 PRR-only: not supported by EBGM or IC | Not in label — unassessed | serious PRR 1.1 · 72% consumer | no trial arm names this drug |
| Product use in unapproved indication | 448 | 2.3 2.1–2.5ROR 2.4 · χ² 338 / p 1e-75 | 2.3 EB05 2.1 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious PRR 3.2 · 83% consumer | no trial arm names this drug |
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.
- Total lung capacity increased — n=57, PRR 333.2
- Capillaritis — n=43, PRR 241.1
- Total lung capacity abnormal — n=51, PRR 195.4
- Pulmonary vasculitis — n=65, PRR 177.1
- Mite allergy — n=65, PRR 143.2
- Mycotic allergy — n=65, PRR 105.5
- Dust allergy — n=65, PRR 91.2
- Conjunctivitis allergic — n=66, PRR 59.6
- Neuritis — n=66, PRR 56.5
- Labelled drug-disease interaction medication error — n=25, PRR 55.8
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 and Vilanterol Trifenatate?
In FDA FAERS, the most frequently co-reported reaction terms for Umeclidinium and Vilanterol Trifenatate are dyspnoea, cough, 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 and Vilanterol Trifenatate have an FDA boxed warning?
No. The FDA label retrieved for Umeclidinium and Vilanterol Trifenatate has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Umeclidinium and Vilanterol Trifenatate 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, 1,024 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 - ClinicalTrials.gov API v2 (query
UMECLIDINIUM, results-bearing studies sorted by enrollment)
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.