What the FDA labels say about taking them together
Ketoconazole and macitentan
Macitentan's FDA label of April 11, 2025 names ketoconazole in its drug interactions section; the ketoconazole label PlainMeds reads does not name macitentan. The macitentan label: “Strong CYP3A4 inhibitors (ketoconazole, ritonavir) increase exposure to macitentan: avoid co-administration with OPSUMIT.”
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 macitentan FDA label on DailyMed (effective April 11, 2025, Actelion Pharmaceuticals US, Inc.).
What does the ketoconazole label say about macitentan?
Ketoconazole's label (effective January 28, 2026) does not name macitentan 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 macitentan label say about ketoconazole?
Macitentan label, drug interactionsStrong CYP3A4 inhibitors (ketoconazole, ritonavir) increase exposure to macitentan: avoid co-administration with OPSUMIT ( 7.2 , 12.3 ).
Source: FDA drug label (OPSUMIT), Actelion Pharmaceuticals US, Inc., effective April 11, 2025 (SPL set 1e484a50-55db-4b85-8c57-6cd1b0353abd), 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 | Macitentan | |
|---|---|---|
| Labeled for | Fungal infections | Pulmonary arterial hypertension |
| Boxed warning | No | Yes |
| Pharmacy cost (NADAC) | $0.249 per gram 2% cream | n/a |
| 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