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What the FDA labels say about taking them together

Amiodarone and dabigatran

Dabigatran's FDA label of June 25, 2025 names amiodarone in its drug interactions section; the amiodarone labels PlainMeds reads (2) do not name dabigatran. The dabigatran label: “The use of the P-gp inhibitors verapamil, amiodarone, quinidine, clarithromycin, and ticagrelor does not require a dosage adjustment of PRADAXA.”

Check it at the source: the amiodarone FDA label on DailyMed (effective December 9, 2025, Chartwell RX, LLC); the dabigatran FDA label on DailyMed (effective June 25, 2025, Boehringer Ingelheim Pharmaceuticals Inc.).

What does the amiodarone label say about dabigatran?

Amiodarone's label (effective December 9, 2025) and its 1 other brand-application label do not name dabigatran 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 dabigatran label say about amiodarone?

Dabigatran label, drug interactions

The use of the P-gp inhibitors verapamil, amiodarone, quinidine, clarithromycin, and ticagrelor does not require a dosage adjustment of PRADAXA.

Source: FDA drug label (Pradaxa), Boehringer Ingelheim Pharmaceuticals Inc., effective June 25, 2025 (SPL set ba74e3cd-b06f-4145-b284-5fd6b84ff3c9), 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
16Dabigatran generic labelers
AmiodaroneDabigatran
Labeled forn/aAtrial fibrillation, Blood clots (DVT and PE), Stroke prevention
Boxed warningYesYes
Pharmacy cost (NADAC)$0.122 per tablet 200 mg tablet$0.795 per capsule 150 mg capsule
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?