What the FDA labels say about taking them together
Ketoconazole and roflumilast
Roflumilast's FDA label of March 12, 2020 names ketoconazole in its drug interactions section; the ketoconazole label PlainMeds reads does not name roflumilast. The roflumilast label: “Use with inhibitors of CYP3A4 or dual inhibitors of CYP3A4 and CYP1A2 will increase roflumilast systemic exposure and may result in increased adverse reactions.”
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 roflumilast FDA label on DailyMed (effective March 12, 2020, AstraZeneca Pharmaceuticals LP).
What does the ketoconazole label say about roflumilast?
Ketoconazole's label (effective January 28, 2026) does not name roflumilast 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 roflumilast label say about ketoconazole?
Roflumilast label, drug interactionsUse with inhibitors of CYP3A4 or dual inhibitors of CYP3A4 and CYP1A2 (e.g., erythromycin, ketoconazole, fluvoxamine, enoxacin, cimetidine) will increase roflumilast systemic exposure and may result in increased adverse reactions.
Source: FDA drug label (Daliresp), AstraZeneca Pharmaceuticals LP, effective March 12, 2020 (SPL set c9a1d0a8-581f-4f91-a2b8-f419192d0ebf), 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
| Ketoconazole | Roflumilast | |
|---|---|---|
| Labeled for | Fungal infections | COPD, Psoriasis, Eczema (atopic dermatitis) |
| Boxed warning | No | No |
| Pharmacy cost (NADAC) | $0.249 per gram 2% cream | $0.311 per tablet 500 mcg tablet |
| 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