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What the FDA labels say about taking them together

Dabigatran and warfarin

Dabigatran's FDA label of June 25, 2025 names warfarin in its warnings and precautions section, and warfarin's label names dabigatran too. The dabigatran label: “… bileaflet mechanical prosthetic heart valves were randomized to dose-adjusted warfarin or 150 mg, 220 mg, or 300 mg of PRADAXA Capsules twice a day.”

Check it at the source: the dabigatran FDA label on DailyMed (effective June 25, 2025, Boehringer Ingelheim Pharmaceuticals Inc.); the warfarin FDA label on DailyMed (effective May 29, 2026, Amneal Pharmaceuticals LLC).

What does the dabigatran label say about warfarin?

Dabigatran label, warnings and precautions

Events in Patients with Prosthetic Heart Valves The safety and efficacy of PRADAXA Capsules in adult patients with bileaflet mechanical prosthetic heart valves was evaluated in the RE-ALIGN trial, in which patients with bileaflet mechanical prosthetic heart valves (recently implanted or implanted more than three months prior to enrollment) were randomized to dose-adjusted warfarin or 150 mg, 220 mg, or 300 mg of PRADAXA Capsules twice a day.

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 warfarin label say about dabigatran?

Warfarin label, drug interactions

Drug Class: Anticoagulants; Specific Drugs: argatroban, dabigatran, bivalirudin, desirudin, heparin, lepirudin

Source: FDA drug label (Warfarin Sodium), Amneal Pharmaceuticals LLC, effective May 29, 2026 (SPL set 558b7a0d-5490-4c1b-802e-3ab3f1efe760), 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

16Dabigatran generic labelers
19Warfarin generic labelers
DabigatranWarfarin
Labeled forAtrial fibrillation, Blood clots (DVT and PE), Stroke preventionBlood clots (DVT and PE), Atrial fibrillation
Boxed warningYesYes
Pharmacy cost (NADAC)$0.795 per capsule 150 mg capsule$0.093 per tablet 2 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)

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