What the label lists and what reports show
Fluticasone and salmeterol side effects
Fluticasone and salmeterol's FDA label: “Most common adverse reactions (incidence ≥3%) include: • Asthma: Upper respiratory tract infection or inflammation, pharyngitis, dysphonia, oral candidiasis, bronchitis, cough, headaches, nausea and vomiting.” FAERS holds 100,237 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 (16,161 reports).
- Generic listed
- A presentation discontinued
Check it at the source: the fluticasone and salmeterol FDA label on DailyMed (effective March 26, 2026, 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 ADVAIR DISKUS?ADVAIR DISKUS can cause serious side effects, including: • fungal infection in your mouth or throat (thrush). Rinse your mouth with water without swallowing after using ADVAIR DISKUS to help reduce your chance of getting thrush. • pneumonia. People with COPD have a higher chance of getting pneumonia. ADVAIR DISKUS may increase the chance of you getting pneumonia. Call your healthcare provider right away if you have 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 March 26, 2026 (SPL set 4eeb5f6a-593f-4a9e-9692-adefa2caf8fc), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (incidence ≥3%) include: • Asthma: Upper respiratory tract infection or inflammation, pharyngitis, dysphonia, oral candidiasis, bronchitis, cough, headaches, nausea and vomiting.
Table 2. Adverse Reactions with ADVAIR DISKUS with ≥3% Incidence and More Common than Placebo in Adult and Adolescent Subjects with Asthma
| Adverse Event | ADVAIR DISKUS 100/50 (n = 92) % | ADVAIR DISKUS 250/50 (n = 84) % | Fluticasone Propionate 100 mcg (n = 90) % | Fluticasone Propionate 250 mcg (n = 84) % | Salmeterol 50 mcg (n = 180) % | Placebo (n = 175) % |
|---|---|---|---|---|---|---|
| Upper respiratory tract infection | 27 | 21 | 29 | 25 | 19 | 14 |
| Pharyngitis | 13 | 10 | 7 | 12 | 8 | 6 |
| Upper respiratory inflammation | 7 | 6 | 7 | 8 | 8 | 5 |
| Sinusitis | 4 | 5 | 6 | 1 | 3 | 4 |
| Hoarseness/dysphonia | 5 | 2 | 2 | 4 | <1 | <1 |
| Oral candidiasis | 1 | 4 | 2 | 2 | 0 | 0 |
| Viral respiratory infections | 4 | 4 | 4 | 10 | 6 | 3 |
| Bronchitis | 2 | 8 | 1 | 2 | 2 | 2 |
| Cough | 3 | 6 | 0 | 0 | 3 | 2 |
| Headaches | 12 | 13 | 14 | 8 | 10 | 7 |
| Nausea and vomiting | 4 | 6 | 3 | 4 | 1 | 1 |
| Gastrointestinal discomfort and pain | 4 | 1 | 0 | 2 | 1 | 1 |
| Diarrhea | 4 | 2 | 2 | 2 | 1 | 1 |
| Viral gastrointestinal infections | 3 | 0 | 3 | 1 | 2 | 2 |
| Candidiasis unspecified site | 3 | 0 | 1 | 4 | 0 | 1 |
| Musculoskeletal pain | 4 | 2 | 1 | 5 | 3 | 3 |
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, continuedUse of LABA may result in the following: • Serious asthma-related events – hospitalizations, intubations, death [see Warnings and Precautions ( 5.1 )] • Cardiovascular and central nervous system effects [see Warnings and Precautions ( 5.12 )] Systemic and local corticosteroid use may result in the following: • Candida albicans infection [see Warnings and Precautions ( 5.4 )] • Pneumonia in patients with COPD [see Warnings and Precautions ( 5.5 )] • Immunosuppression [see Warnings and Precautions ( 5.6 )] • Hypercorticism and adrenal suppression [see Warnings and Precautions ( 5.8 )] • 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. Most common adverse reactions (incidence ≥3%) include: • Asthma: Upper respiratory tract infection or inflammation, pharyngitis, dysphonia, oral candidiasis, bronchitis, cough, headaches, nausea and vomiting. ( 6.1 ) • COPD: Pneumonia, oral candidiasis, throat irritation, dysphonia, viral respiratory infections, headaches, musculoskeletal pain.
Source: FDA drug label, GlaxoSmithKline LLC, effective March 26, 2026 (SPL set 4eeb5f6a-593f-4a9e-9692-adefa2caf8fc), via openFDA; the full label on DailyMed
What do FAERS reports show?
100,237 reports list fluticasone and salmeterol among the medicines taken, each a report of something that happened, not proof the medicine caused it; 5,575 are coded as a death and 26,464 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 17 reactions below, 12 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 salmeterol: 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