Prescription medicine
Idarucizumab Brand names: Praxbind
Idarucizumab (Praxbind) is a prescription medicine with an FDA approval on record since 2015. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the idarucizumab FDA label on DailyMed (effective January 23, 2024, Boehringer Ingelheim Pharmaceuticals, Inc.); the BLA 761025 record on Drugs@FDA; every idarucizumab label on DailyMed.
Highlights of the record
FDA label of January 23, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usagePRAXBIND is indicated in patients treated with Pradaxa when reversal of the anticoagulant effects of dabigatran is needed: For emergency surgery/urgent procedures In life-threatening or uncontrolled bleeding PRAXBIND is a humanized monoclonal antibody fragment (Fab) indicated in patients treated with Pradaxa ® when reversal of the anticoagulant effects of dabigatran is needed: For emergency surgery/urgent procedures
Forms and strengths
- 50 mg/ml
Injection.
On the market
- Earliest approval on file
- October 16, 2015 Praxbind, Boehringer Ingelheim; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 1,428 through July 30, 2026
What is idarucizumab used for?
From the label: indications and usagePRAXBIND is indicated in patients treated with Pradaxa when reversal of the anticoagulant effects of dabigatran is needed: For emergency surgery/urgent procedures In life-threatening or uncontrolled bleeding PRAXBIND is a humanized monoclonal antibody fragment (Fab) indicated in patients treated with Pradaxa ® when reversal of the anticoagulant effects of dabigatran is needed: For emergency surgery/urgent procedures In life-threatening or uncontrolled bleeding
FDA pharmacologic class: Humanized Monoclonal Antibody Fragment.
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
Is there a generic for idarucizumab (Praxbind)?
No generic idarucizumab is approved (Drugs@FDA, October 8, 2026).
- 2015 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the idarucizumab label say about other medicines?
The idarucizumab label names 1 other medicine in its interaction, contraindication or warning sections. The labels of 1 other medicine name idarucizumab. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Dabigatran | warnings and precautions | WARNINGS 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
What do FAERS reports show for idarucizumab?
The FDA Adverse Event Reporting System holds 1,428 reports that list idarucizumab among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 894 are coded as a death and 515 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Idarucizumab side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other