What the FDA labels say about taking them together
Dabigatran and idarucizumab
Dabigatran's FDA label of June 25, 2025 names idarucizumab in its warnings and precautions section, and idarucizumab's label names dabigatran too. The idarucizumab label: “WARNINGS AND PRECAUTIONS Thromboembolic Risk: Reversing dabigatran therapy exposes patients to the thrombotic risk of their underlying disease.”
Check it at the source: the dabigatran FDA label on DailyMed (effective June 25, 2025, Boehringer Ingelheim Pharmaceuticals Inc.); the idarucizumab FDA label on DailyMed (effective January 23, 2024, Boehringer Ingelheim Pharmaceuticals, Inc.).
What does the dabigatran label say about idarucizumab?
Dabigatran label, warnings and precautionsFor emergency surgery/urgent procedures In life-threatening or uncontrolled bleeding In pediatric patients, the efficacy and safety of idarucizumab have not been established.
Pradaxa label (Boehringer Ingelheim Pharmaceuticals, Inc., June 27, 2025), warnings and precautionsIn adults, a specific reversal agent (idarucizumab) for PRADAXA is available when reversal of the anticoagulant effect of dabigatran is needed.
Source: FDA drug label (Pradaxa, NDA214358), Boehringer Ingelheim Pharmaceuticals, Inc., effective June 27, 2025 (SPL set 9ac0a64a-8666-45f7-9d4f-40fd894f7e6d), via openFDA
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 idarucizumab label say about dabigatran?
Idarucizumab label, warnings and precautionsWARNINGS AND PRECAUTIONS Thromboembolic Risk: Reversing dabigatran therapy exposes patients to the thrombotic risk of their underlying disease.
Source: FDA drug label (Praxbind), Boehringer Ingelheim Pharmaceuticals, Inc., effective January 23, 2024 (SPL set c7400f8a-dcf4-a6df-6d07-983081b1bf34), 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 | Idarucizumab | |
|---|---|---|
| Labeled for | Atrial fibrillation, Blood clots (DVT and PE), Stroke prevention | n/a |
| Boxed warning | Yes | No |
| Pharmacy cost (NADAC) | $0.795 per capsule 150 mg capsule | 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