FDA label
What is Pradaxa used for?
Pradaxa contains dabigatran etexilate. The FDA-approved uses below are quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label for Pradaxa lists 2 uses: Treatment of Venous Thromboembolic Events in Pediatric Patients; Reduction in the Risk of Recurrence of Venous Thromboembolic Events in Pediatric Patients.
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Pradaxa, pellet
Indications and Usage, quoted from the label by Boehringer Ingelheim Pharmaceuticals, Inc. (NDA214358). Cross-references to other label sections are left out.
Treatment of Venous Thromboembolic Events in Pediatric Patients
PRADAXA Oral Pellets are indicated for the treatment of venous thromboembolic events (VTE) in pediatric patients aged 3 months to less than 12 years of age who have been treated with a parenteral anticoagulant for at least 5 days.
Reduction in the Risk of Recurrence of Venous Thromboembolic Events in Pediatric Patients
PRADAXA Oral Pellets are indicated to reduce the risk of recurrence of VTE in pediatric patients aged 3 months to less than 12 years of age who have been previously treated.
Source: DailyMed label, set id 9ac0a64a-8666-45f7-9d4f-40fd894f7e6d, version 7, effective June 27, 2025. NDC 0597-0425, one of 6 listings for this product.
Pradaxa, capsule
Indications and Usage, quoted from the label by Boehringer Ingelheim Pharmaceuticals Inc. (NDA022512). Cross-references to other label sections are left out.
Reduction of Risk of Stroke and Systemic Embolism in Non-valvular Atrial Fibrillation in Adult Patients
PRADAXA Capsules is indicated to reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation.
Treatment of Deep Venous Thrombosis and Pulmonary Embolism in Adult Patients
PRADAXA Capsules is indicated for the treatment of deep venous thrombosis and pulmonary embolism in adult patients who have been treated with a parenteral anticoagulant for 5-10 days.
Reduction in the Risk of Recurrence of Deep Venous Thrombosis and Pulmonary Embolism in Adult Patients
PRADAXA Capsules is indicated to reduce the risk of recurrence of deep venous thrombosis and pulmonary embolism in adult patients who have been previously treated.
Prophylaxis of Deep Vein Thrombosis and Pulmonary Embolism in Adult Patients Following Hip Replacement Surgery
PRADAXA Capsules is indicated for the prophylaxis of deep vein thrombosis and pulmonary embolism in adult patients who have undergone hip replacement surgery.
Treatment of Venous Thromboembolic Events in Pediatric Patients
PRADAXA Capsules is indicated for the treatment of venous thromboembolic events (VTE) in pediatric patients 8 to less than 18 years of age who have been treated with a parenteral anticoagulant for at least 5 days.
Reduction in the Risk of Recurrence of Venous Thromboembolic Events in Pediatric Patients
PRADAXA Capsules is indicated to reduce the risk of recurrence of VTE in pediatric patients 8 to less than 18 years of age who have been previously treated.
Source: DailyMed label, set id ba74e3cd-b06f-4145-b284-5fd6b84ff3c9, version 48, effective June 25, 2025. NDC 0597-0108, one of 3 listings for this product.
Questions
What is Pradaxa used for?
The FDA label for Pradaxa lists 2 uses: Treatment of Venous Thromboembolic Events in Pediatric Patients; Reduction in the Risk of Recurrence of Venous Thromboembolic Events in Pediatric Patients.
What drug class is Pradaxa?
FDA lists dabigatran etexilate in the Direct Thrombin Inhibitor established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.
More on Pradaxa
- Is Pradaxa a controlled substance?Federal schedule
- Generic for PradaxaFDA Orange Book
- What is Dabigatran Etexilate used for?FDA label uses
- Is Dabigatran Etexilate a controlled substance?Federal schedule
- Direct Thrombin Inhibitors listFDA drug class
- NDC 0597-0108Pradaxa NDC record
- NDC 0597-0355Pradaxa NDC record
- NDC 0597-0360Pradaxa NDC record