What the label lists and what reports show
Fluticasone and umeclidinium and vilanterol side effects
Fluticasone and umeclidinium and vilanterol's FDA label: “Most common adverse reactions (incidence ≥1%) are upper respiratory tract infection, pneumonia, bronchitis, oral candidiasis, headache, back pain, arthralgia, influenza, sinusitis, pharyngitis, rhinitis, dysgeusia, constipation, urinary tract infection …” FAERS holds 41,185 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 (5,784 reports).
- No generic listed
Check it at the source: the fluticasone and 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 TRELEGY ELLIPTA?TRELEGY ELLIPTA can cause serious side effects, including: • fungal infection in your mouth or throat (thrush). Rinse your mouth with water without swallowing after using TRELEGY ELLIPTA to help reduce your chance of getting thrush. • pneumonia. People with COPD have a higher chance of getting pneumonia. TRELEGY ELLIPTA may increase the chance of getting pneumonia. Call your healthcare provider if you notice any of the following symptoms: o increase in mucus (sputum) production o change in mucus color o fever ο chills ο increased cough ο increased breathing problems • weakened immune system and increased chance of getting infections (immunosuppression). • reduced adrenal function (adrenal insufficiency). Adrenal insufficiency is a condition where the adrenal glands do not make enough steroid hormones. […]
Source: FDA drug label, GlaxoSmithKline LLC, effective June 2, 2023 (SPL set b5a81d5a-4648-4c7a-951d-33c014a63c7e), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (incidence ≥1%) are upper respiratory tract infection, pneumonia, bronchitis, oral candidiasis, headache, back pain, arthralgia, influenza, sinusitis, pharyngitis, rhinitis, dysgeusia, constipation, urinary tract infection, diarrhea, gastroenteritis, oropharyngeal pain, cough, and dysphonia.
Table 3. Adverse Reactions with TRELEGY ELLIPTA with ≥1% Incidence in Subjects with Asthma (Trial 4)
| Adverse Reaction | TRELEGY ELLIPTA 200/62.5/25 mcg (n = 408) % | TRELEGY ELLIPTA 100/62.5/25 mcg (n =406) % | FF/VI 200/25 mcg (n = 406) % | FF/VI 100/25 mcg (n = 407) % |
|---|---|---|---|---|
| Pharyngitis/nasopharyngitis | 15 | 17 | 16 | 16 |
| Upper respiratory tract infection/viral upper respiratory tract infection | 7 | 5 | 6 | 7 |
| Bronchitis | 5 | 4 | 5 | 3 |
| Respiratory tract infection/viral respiratory tract infection | 3 | 4 | 2 | 4 |
| Sinusitis/acute sinusitis | 3 | 2 | 2 | 3 |
| Urinary tract infection | 2 | <1 | <1 | 1 |
| Rhinitis | 1 | 2 | 2 | 3 |
| Influenza | 1 | 4 | 2 | 3 |
| Pneumonia | <1 | 1 | 2 | 2 |
| Headache | 5 | 9 | 6 | 7 |
| Back pain | 2 | 3 | 1 | 4 |
| Dysphonia | 1 | 1 | 2 | 1 |
| Oropharyngeal pain | 1 | 1 | <1 | <1 |
| Cough | 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 )] • Oropharyngeal Candidiasis [see Warnings and Precautions ( 5.4 )] • Increased Risk of Pneumonia in COPD [see Warnings and Precautions ( 5.5 )] • Immunosuppression and Risk of Infections [see Warnings and Precautions ( 5.6 )] • Hypercorticism and Adrenal Suppression [see Warnings and Precautions ( 5.8 )] • Paradoxical Bronchospasm [see Warnings and Precautions ( 5.10 )] • Cardiovascular Effects [see Warnings and Precautions ( 5.12 )] • Reduction in Bone Mineral Density [see Warnings and Precautions ( 5.13 )] • Worsening of Narrow-Angle Glaucoma [see Warnings and Precautions ( 5.14 )] • Worsening of Urinary Retention [see Warnings and Precautions ( 5.15 )] 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. …
Source: FDA drug label, GlaxoSmithKline LLC, effective June 2, 2023 (SPL set b5a81d5a-4648-4c7a-951d-33c014a63c7e), via openFDA; the full label on DailyMed
What do FAERS reports show?
41,185 reports list fluticasone and umeclidinium and vilanterol among the medicines taken, each a report of something that happened, not proof the medicine caused it; 3,276 are coded as a death and 8,325 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 13 reactions below, 8 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?
- Fluticasone and 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