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What the FDA labels say about taking them together

Bosentan and fluconazole

Bosentan's FDA label of November 17, 2025 names fluconazole in its drug interactions section; the fluconazole labels PlainMeds reads (2) do not name bosentan. The bosentan label: “Concomitant administration of both a CYP2C9 inhibitor and a strong CYP3A inhibitor or a moderate CYP3A inhibitor with TRACLEER will likely lead to large increases in plasma concentrations of bosentan.”

Check it at the source: the bosentan FDA label on DailyMed (effective November 17, 2025, Actelion Pharmaceuticals US, Inc.); the fluconazole FDA label on DailyMed (effective April 7, 2026, Zydus Pharmaceuticals (USA) Inc.).

What does the bosentan label say about fluconazole?

Bosentan label, drug interactions

Concomitant administration of both a CYP2C9 inhibitor (such as fluconazole or amiodarone) and a strong CYP3A inhibitor (e.g., ketoconazole, itraconazole) or a moderate CYP3A inhibitor (e.g., amprenavir, erythromycin, fluconazole, diltiazem) with TRACLEER will likely lead to large increases in plasma concentrations of bosentan.

Source: FDA drug label (Tracleer), Actelion Pharmaceuticals US, Inc., effective November 17, 2025 (SPL set 749e42fb-2fe0-45dd-9268-b43bb3f4081c), via openFDA; the full label on DailyMed

What does the fluconazole label say about bosentan?

Fluconazole's label (effective April 7, 2026) and its 1 other brand-application label do not name bosentan 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

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

5Bosentan generic labelers
41Fluconazole generic labelers
BosentanFluconazole
Labeled forPulmonary arterial hypertensionFungal infections, Urinary tract infections
Boxed warningYesNo
Pharmacy cost (NADAC)n/a$0.380 per tablet 200 mg tablet
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?