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What the FDA labels say about taking them together

Fluconazole and macitentan

Macitentan's FDA label of April 11, 2025 names fluconazole in its drug interactions section; the fluconazole labels PlainMeds reads (2) do not name macitentan. The macitentan label: “Moderate dual CYP3A4 and CYP2C9 inhibitors (fluconazole, amiodarone) or use of combined CYP3A4 and CYP2C9 inhibitors may increase exposure to macitentan: avoid co-administration with OPSUMIT.”

Check it at the source: the fluconazole FDA label on DailyMed (effective April 7, 2026, Zydus Pharmaceuticals (USA) Inc.); the macitentan FDA label on DailyMed (effective April 11, 2025, Actelion Pharmaceuticals US, Inc.).

What does the fluconazole label say about macitentan?

Fluconazole's label (effective April 7, 2026) and its 1 other brand-application label do 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 (fluconazole), Zydus Pharmaceuticals (USA) Inc., effective April 7, 2026 (SPL set d1364455-1537-46d4-b093-38cca3be778f), via openFDA; the full label on DailyMed

What does the macitentan label say about fluconazole?

Macitentan label, drug interactions

Moderate dual CYP3A4 and CYP2C9 inhibitors (fluconazole, amiodarone) or use of combined CYP3A4 and CYP2C9 inhibitors may increase exposure to macitentan: avoid co-administration with OPSUMIT ( 7.3 , 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

41Fluconazole generic labelers
13Macitentan generic labelers
FluconazoleMacitentan
Labeled forFungal infections, Urinary tract infectionsPulmonary arterial hypertension
Boxed warningNoYes
Pharmacy cost (NADAC)$0.380 per tablet 200 mg tabletn/a
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?