Skip to main content

What the FDA labels say about taking them together

Ketoconazole and umeclidinium/vilanterol

Umeclidinium/vilanterol's FDA label of June 2, 2023 names ketoconazole in its drug interactions section; the ketoconazole label PlainMeds reads does not name umeclidinium/vilanterol. The umeclidinium/vilanterol label: “Interactions with Strong Cytochrome P450 3A4 Inhibitors Caution should be exercised when considering the coadministration of ANORO ELLIPTA with ketoconazole and other known strong cytochrome P450 3A4 (CYP3A4) inhibitors …”

Check it at the source: the ketoconazole FDA label on DailyMed (effective January 28, 2026, E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC); the umeclidinium/vilanterol FDA label on DailyMed (effective June 2, 2023, GlaxoSmithKline LLC).

What does the ketoconazole label say about umeclidinium/vilanterol?

Ketoconazole's label (effective January 28, 2026) does 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 (ketoconazole), E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC, effective January 28, 2026 (SPL set cad7c647-34a9-4e4e-83b3-8d78e58f588f), via openFDA; the full label on DailyMed

What does the umeclidinium/vilanterol label say about ketoconazole?

Umeclidinium/vilanterol label, drug interactions

Strong cytochrome P450 3A4 inhibitors (e.g., ketoconazole): Use with caution.

Umeclidinium/vilanterol label, warnings and precautions

Interactions with Strong Cytochrome P450 3A4 Inhibitors Caution should be exercised when considering the coadministration of ANORO ELLIPTA with ketoconazole and other known strong cytochrome P450 3A4 (CYP3A4) inhibitors (including, but not limited to, ritonavir, clarithromycin, conivaptan, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, saquinavir, telithromycin, troleandomycin, voriconazole) because increased cardiovascular adverse effects may occur [see Drug Interactions ( 7.1 ), Clinical Pharmacology ( 12.3 )].

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

30Ketoconazole generic labelers
0Umeclidinium/vilanterol generic labelers
KetoconazoleUmeclidinium/vilanterol
Labeled forFungal infectionsCOPD
Boxed warningNoNo
Pharmacy cost (NADAC)$0.249 per gram 2% cream$4.95 per inhaler 62.5-25 mcg inhaler
Shortage nowNo current entryNo 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?