What the FDA labels say about taking them together
Dabigatran and dronedarone
Dabigatran's FDA label of June 25, 2025 names dronedarone in its drug interactions section, and dronedarone's label names dabigatran too. The dronedarone label: “Dabigatran Dronedarone increases dabigatran plasma exposures by inhibiting the P-gp transporter.”
Check it at the source: the dabigatran FDA label on DailyMed (effective June 25, 2025, Boehringer Ingelheim Pharmaceuticals Inc.); the dronedarone FDA label on DailyMed (effective May 29, 2025, Sanofi-Aventis U.S. LLC).
What does the dabigatran label say about dronedarone?
Dabigatran label, drug interactionsIn patients with moderate renal impairment (CrCl 30-50 mL/min), reduce the dosage of PRADAXA to 75 mg twice daily when administered concomitantly with the P-gp inhibitors dronedarone or systemic ketoconazole.
Dabigatran label, warnings and precautionsReduction of Risk of Stroke and Systemic Embolism in Non-valvular Atrial Fibrillation in Adult Patients Reduce the dosage of PRADAXA Capsules to 75 mg twice daily when dronedarone or systemic ketoconazole is co-administered with PRADAXA Capsules in patients with moderate renal impairment (CrCl 30-50 mL/min).
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
What does the dronedarone label say about dabigatran?
Dronedarone label, drug interactionsDabigatran Dronedarone increases dabigatran plasma exposures by inhibiting the P-gp transporter [see Clinical Pharmacology (12.3) ].
Source: FDA drug label (Multaq), Sanofi-Aventis U.S. LLC, effective May 29, 2025 (SPL set 7fa41601-7fb5-4155-8e50-2ae903f0d2d6), 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
| Dabigatran | Dronedarone | |
|---|---|---|
| Labeled for | Atrial fibrillation, Blood clots (DVT and PE), Stroke prevention | n/a |
| Boxed warning | Yes | Yes |
| Pharmacy cost (NADAC) | $0.795 per capsule 150 mg capsule | $13.19 per tablet 400 mg tablet |
| 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