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What the FDA labels say about taking them together

Amiodarone and bosentan

Bosentan's FDA label of November 17, 2025 names amiodarone in its drug interactions section; the amiodarone 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 amiodarone FDA label on DailyMed (effective December 9, 2025, Chartwell RX, LLC); the bosentan FDA label on DailyMed (effective November 17, 2025, Actelion Pharmaceuticals US, Inc.).

What does the amiodarone label say about bosentan?

Amiodarone's label (effective December 9, 2025) 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 (Amiodarone Hydrochloride), Chartwell RX, LLC, effective December 9, 2025 (SPL set 5520f11d-968d-4f4f-bf57-d14369c0d746), via openFDA; the full label on DailyMed

What does the bosentan label say about amiodarone?

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

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

32Amiodarone generic labelers
5Bosentan generic labelers
AmiodaroneBosentan
Labeled forn/aPulmonary arterial hypertension
Boxed warningYesYes
Pharmacy cost (NADAC)$0.122 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?