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These highlights do not include all the information needed to use PRADAXA Capsules safely and effectively. See full prescribing information for PRADAXA Capsules. PRADAXA® (dabigatran etexilate) capsules, for oral use Initial U.S. Approval: 2010
Medication labelWhy this: Advisory · dailymed-prescription
PRADAXA Capsules is indicated to reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation. 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. 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. PRADAXA Capsules is indicated for the prophylaxis of deep vein thrombosis and pulmonary embolism in adult patients who have undergone hip replacement surgery. 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 [see Dosage and Administration (2.3)]. 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 [see Dosage and Administration (2.3)].
- generic_name
- dabigatran etexilate mesylate
- product_names
- dabigatran etexilate mesylate
- ndc
- 0597-0108, 0597-0355, 0597-0360, 0597-0108-54, 0597-0108-60, 0597-0355-09, 0597-0355-56, 0597-0355-53, 0597-0360-55, 0597-0360-42, 0597-0360-82
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en