What the label lists and what reports show
Fluticasone and vilanterol side effects
Fluticasone and vilanterol's FDA label: “Most common adverse reactions (incidence ≥3%) are nasopharyngitis, upper respiratory tract infection, headache, oral candidiasis, back pain, pneumonia, bronchitis, sinusitis, cough, oropharyngeal pain, arthralgia, hypertension, influenza, pharyngitis, and …” FAERS holds 35,760 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 (6,164 reports).
- No generic listed
Check it at the source: the fluticasone and vilanterol FDA label on DailyMed (effective November 7, 2024, 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 BREO ELLIPTA?BREO ELLIPTA can cause serious side effects, including: • fungal infection in your mouth or throat (thrush). Rinse your mouth with water without swallowing after using BREO ELLIPTA to help reduce your chance of getting thrush. • pneumonia. People with COPD have a higher chance of getting pneumonia. BREO 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 o chills o increased cough o 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 November 7, 2024 (SPL set 96428df1-ea05-431a-98d3-1ec2c4b63878), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (incidence ≥3%) are nasopharyngitis, upper respiratory tract infection, headache, oral candidiasis, back pain, pneumonia, bronchitis, sinusitis, cough, oropharyngeal pain, arthralgia, hypertension, influenza, pharyngitis, and pyrexia.
Table 4. Adverse Reactions with BREO ELLIPTA 100/25 mcg and BREO ELLIPTA 200/25 mcg with ≥2% Incidence in Patients with Asthma (Trial 9)
| Adverse Reaction | BREO ELLIPTA 200/25 mcg (n = 346) % | BREO ELLIPTA 100/25 mcg (n = 346) % | Fluticasone Furoate 100 mcg (n = 347) % |
|---|---|---|---|
| Headache | 8 | 8 | 9 |
| Nasopharyngitis | 7 | 6 | 7 |
| Influenza | 3 | 3 | 1 |
| Upper respiratory tract infection | 2 | 2 | 3 |
| Sinusitis | 2 | 1 | <1 |
| Bronchitis | 2 | <1 | 2 |
| Oropharyngeal pain | 2 | 2 | 1 |
| Cough | 1 | 2 | 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 )] • Pneumonia [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 )] • Growth Effects [see Warnings and Precautions ( 5.14 )] • Glaucoma and Cataracts [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. • COPD: Most common adverse reactions (incidence ≥3%) are nasopharyngitis, upper respiratory tract infection, headache, oral candidiasis, back pain, pneumonia, bronchitis, sinusitis, cough, oropharyngeal pain, arthralgia, hypertension, influenza, pharyngitis, and pyrexia. …
Source: FDA drug label, GlaxoSmithKline LLC, effective November 7, 2024 (SPL set 96428df1-ea05-431a-98d3-1ec2c4b63878), via openFDA; the full label on DailyMed
What do FAERS reports show?
35,760 reports list fluticasone and vilanterol among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1,466 are coded as a death and 7,371 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?
- Fluticasone 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