What the FDA labels say about taking them together
Amiodarone and macitentan
Macitentan's FDA label of April 11, 2025 names amiodarone in its drug interactions section; the amiodarone 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 amiodarone FDA label on DailyMed (effective December 9, 2025, Chartwell RX, LLC); the macitentan FDA label on DailyMed (effective April 11, 2025, Actelion Pharmaceuticals US, Inc.).
What does the amiodarone label say about macitentan?
Amiodarone's label (effective December 9, 2025) 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 (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 macitentan label say about amiodarone?
Macitentan label, drug interactionsModerate 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
| Amiodarone | Macitentan | |
|---|---|---|
| Labeled for | n/a | Pulmonary arterial hypertension |
| Boxed warning | Yes | Yes |
| Pharmacy cost (NADAC) | $0.122 per tablet 200 mg tablet | 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