What the FDA labels say about taking them together
Fluticasone and umeclidinium/vilanterol
Umeclidinium/vilanterol's FDA label of June 2, 2023 names fluticasone in its warnings and precautions section; the fluticasone labels PlainMeds reads (4) do not name umeclidinium/vilanterol. The umeclidinium/vilanterol label: “… on-treatment death due to cardiovascular events, was 2.2 per 100 patient-years for fluticasone furoate/umeclidinium/vilanterol 100/62.5/25 mcg (n = 4,151), 1.9 per 100 patient-years for fluticasone furoate/vilanterol …”
Check it at the source: the fluticasone FDA label on DailyMed (effective December 19, 2024, Haleon US Holdings LLC); the umeclidinium/vilanterol FDA label on DailyMed (effective June 2, 2023, GlaxoSmithKline LLC).
What does the fluticasone label say about umeclidinium/vilanterol?
Fluticasone's label (effective December 19, 2024) and its 3 other brand-application labels do not name umeclidinium/vilanterol in these sections. A label lists what its studies and reports found; it is not a complete list.
Source: FDA drug label (FLONASE ALLERGY RELIEF), Haleon US Holdings LLC, effective December 19, 2024 (SPL set b6134ba0-b70a-4eac-9a82-cef64b242c1d), via openFDA; the full label on DailyMed
What does the umeclidinium/vilanterol label say about fluticasone?
Umeclidinium/vilanterol label, warnings and precautionsIn a 52-week trial of subjects with COPD, the exposure-adjusted rates for any on-treatment major adverse cardiac event, including non-fatal central nervous system hemorrhages and cerebrovascular conditions, non-fatal myocardial infarction, non-fatal acute myocardial infarction, and adjudicated on-treatment death due to cardiovascular events, was 2.2 per 100 patient-years for fluticasone furoate/umeclidinium/vilanterol 100/62.5/25 mcg (n = 4,151), 1.9 per 100 patient-years for fluticasone furoate/vilanterol 100/25 mcg (n = 4,134), and 2.2 per 100 patient-years for ANORO ELLIPTA (n = 2,070).
Source: FDA drug label (Anoro Ellipta), GlaxoSmithKline LLC, effective June 2, 2023 (SPL set 2dbd0671-c565-40c5-bf0f-e324db26799c), via openFDA; the full label on DailyMed
These are the labels' own sentences. PlainMeds does not grade interactions; a pharmacist or prescriber can say what they mean for one person's medicines.
Both medicines on the record
| Fluticasone | Umeclidinium/vilanterol | |
|---|---|---|
| Labeled for | Allergies, Asthma, Eczema (atopic dermatitis) | COPD |
| Boxed warning | No | No |
| Pharmacy cost (NADAC) | $0.243 per gram 0.05% cream | $4.95 per inhaler 62.5-25 mcg inhaler |
| Shortage now | No current entry | No current entry |
Source: FDA NDC Directory, CMS NADAC of October 7, 2026 and the FDA Drug Shortage Database (FDA files October 8, 2026)
What next?
- Check more medicines together
- up to five at once