What the label lists and what reports show
Umeclidinium and vilanterol side effects
Umeclidinium and vilanterol's FDA label: “Most common adverse reactions (incidence ≥1% and more common than placebo) are pharyngitis, sinusitis, lower respiratory tract infection, constipation, diarrhea, pain in extremity, muscle spasms, neck pain, and chest pain.” FAERS holds 16,608 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 (2,358 reports).
- No generic listed
Check it at the source: the umeclidinium and vilanterol FDA label on DailyMed (effective June 2, 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 ANORO ELLIPTA?ANORO ELLIPTA can cause serious side effects, including: • serious problems in people with asthma. People with asthma who take LABA medicines, such as vilanterol (one of the medicines in ANORO ELLIPTA), without also using a medicine called an inhaled corticosteroid, have an increased risk of serious problems from asthma, including death. o Call your healthcare provider if breathing problems worsen over time while using ANORO ELLIPTA. You may need a different treatment. o Get emergency medical care if: ▪ your breathing problems worsen quickly. ▪ you use your rescue inhaler medicine, but it does not relieve your breathing problems. • COPD symptoms that get worse over time. If your COPD symptoms worsen over time, do not increase your dose of ANORO ELLIPTA; instead call your healthcare provider. […]
Source: FDA drug label, GlaxoSmithKline LLC, effective June 2, 2023 (SPL set 2dbd0671-c565-40c5-bf0f-e324db26799c), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (incidence ≥1% and more common than placebo) are pharyngitis, sinusitis, lower respiratory tract infection, constipation, diarrhea, pain in extremity, muscle spasms, neck pain, and chest pain.
Table 1. Adverse Reactions with ANORO ELLIPTA with ≥1% Incidence and More Common than Placebo in Subjects with Chronic Obstructive Pulmonary Disease
| Adverse Reaction | ANORO ELLIPTA (n = 842) % | Umeclidinium 62.5 mcg (n = 418) % | Vilanterol 25 mcg (n = 1,034) % | Placebo (n = 555) % |
|---|---|---|---|---|
| Pharyngitis | 2 | 1 | 2 | <1 |
| Sinusitis | 1 | <1 | 1 | <1 |
| Lower respiratory tract infection | 1 | <1 | <1 | <1 |
| Constipation | 1 | <1 | <1 | <1 |
| Diarrhea | 2 | <1 | 2 | 1 |
| Pain in extremity | 2 | <1 | 2 | 1 |
| Muscle spasms | 1 | <1 | <1 | <1 |
| Neck pain | 1 | <1 | <1 | <1 |
| Chest pain | 1 | <1 | <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 clinically significant adverse reactions are described elsewhere in labeling: • Serious asthma-related events–hospitalizations, intubations, death [see Warnings and Precautions ( 5.1 )] • Paradoxical bronchospasm [see Warnings and Precautions ( 5.5 )] • Cardiovascular effects [see Warnings and Precautions ( 5.7 )] • Worsening of narrow-angle glaucoma [see Warnings and Precautions ( 5.9 )] • Worsening of urinary retention [see Warnings and Precautions ( 5.10 )] Most common adverse reactions (incidence ≥1% and more common than placebo) are pharyngitis, sinusitis, lower respiratory tract infection, constipation, diarrhea, pain in extremity, muscle spasms, neck pain, and chest pain. ( 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. The clinical program for ANORO ELLIPTA included 8,138 subjects with COPD in four 6‑month lung function trials, one 12-month long-term safety study, and 9 other trials of shorter duration. …
Source: FDA drug label, GlaxoSmithKline LLC, effective June 2, 2023 (SPL set 2dbd0671-c565-40c5-bf0f-e324db26799c), via openFDA; the full label on DailyMed
What do FAERS reports show?
16,608 reports list umeclidinium and vilanterol among the medicines taken, each a report of something that happened, not proof the medicine caused it; 843 are coded as a death and 2,998 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 14 reactions below, 6 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 and vilanterol: 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