What the label lists and what reports show
Umeclidinium side effects
Umeclidinium's FDA label: “Most common adverse reactions (incidence ≥2% and more common than placebo) include nasopharyngitis, upper respiratory tract infection, cough, arthralgia.” FAERS holds 8,903 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is dyspnoea (1,407 reports).
- No generic listed
Check it at the source: the umeclidinium FDA label on DailyMed (effective December 13, 2023, GlaxoSmithKline LLC); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of INCRUSE ELLIPTA?INCRUSE ELLIPTA can cause serious side effects, including: • sudden breathing problems immediately after inhaling your medicine. If you have sudden breathing problems immediately after inhaling your medicine, stop using INCRUSE ELLIPTA and call your healthcare provider right away. • serious allergic reactions (anaphylaxis). Stop using INCRUSE ELLIPTA and call your healthcare provider or go to the nearest emergency room right away if you get any of the following symptoms of a serious allergic reaction: o rash o hives o severe itching o swelling of your face, mouth, and tongue o breathing problems • new or worsening eye problems including acute narrow-angle glaucoma. You should have regular eye exams while using INCRUSE ELLIPTA. Acute narrow-angle glaucoma can cause permanent loss of vision if not treated. […]
Source: FDA drug label, GlaxoSmithKline LLC, effective December 13, 2023 (SPL set dbb64747-1505-49d7-9a33-99dd402e96d3), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (incidence ≥2% and more common than placebo) include nasopharyngitis, upper respiratory tract infection, cough, arthralgia.
Table 1. Adverse Reactions with INCRUSE ELLIPTA with ≥1% Incidence and More Common than Placebo in Subjects with Chronic Obstructive Pulmonary Disease
| Adverse Reaction | INCRUSE ELLIPTA (n = 487) % | Placebo (n = 348) % |
|---|---|---|
| Nasopharyngitis | 8% | 7% |
| Upper respiratory tract infection | 5% | 4% |
| Pharyngitis | 1% | <1% |
| Viral upper respiratory tract infection | 1% | <1% |
| Cough | 3% | 2% |
| Arthralgia | 2% | 1% |
| Myalgia | 1% | <1% |
| Abdominal pain upper | 1% | <1% |
| Toothache | 1% | <1% |
| Contusion | 1% | <1% |
| Tachycardia | 1% | <1% |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following adverse reactions are described in greater detail in other sections: • Paradoxical bronchospasm [see Warnings and Precautions ( 5.2 )] • Worsening of narrow-angle glaucoma [see Warnings and Precautions ( 5.4 )] • Worsening of urinary retention [see Warnings and Precautions ( 5.5 )] Most common adverse reactions (incidence ≥2% and more common than placebo) include nasopharyngitis, upper respiratory tract infection, cough, arthralgia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. In the 8 clinical trials conducted to support initial approval of INCRUSE ELLIPTA, a total of 1,663 subjects with COPD (mean age: 62.7 years; 89% white; 65% male across all treatments, including placebo) received at least 1 inhalation dose of umeclidinium at doses of 62.5 or 125 mcg. In the 4 randomized, double-blind, placebo- or active-controlled, efficacy clinical trials, 1,185 subjects received umeclidinium for up to 24 weeks, of which 487 subjects received the recommended dose of umeclidinium 62.5 mcg. …
Source: FDA drug label, GlaxoSmithKline LLC, effective December 13, 2023 (SPL set dbb64747-1505-49d7-9a33-99dd402e96d3), via openFDA; the full label on DailyMed
What do FAERS reports show?
8,903 reports list umeclidinium among the medicines taken, each a report of something that happened, not proof the medicine caused it; 649 are coded as a death and 2,402 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 16 reactions below, 7 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Umeclidinium: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions