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These highlights do not include all the information needed to use RIVAROXABAN TABLETS safely and effectively. See full prescribing information for RIVAROXABAN TABLETS. RIVAROXABAN tablets, for oral use Initial U.S. Approval: 2011
Medication labelWhy this: Advisory · dailymed-prescription
Rivaroxaban tablets are indicated to reduce the risk of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation. There are limited data on the relative effectiveness of rivaroxaban tablets and warfarin in reducing the risk of stroke and systemic embolism when warfarin therapy is well-controlled [see Clinical Studies (14.1)]. Rivaroxaban tablets are indicated for the treatment of deep vein thrombosis (DVT). Rivaroxaban tablets are indicated for the treatment of pulmonary embolism (PE). Rivaroxaban tablets are indicated for the reduction in the risk of recurrence of DVT and/or PE in adult patients at continued risk for recurrent DVT and/or PE after completion of initial treatment lasting at least 6 months. Rivaroxaban tablets are indicated for the prophylaxis of DVT, which may lead to PE in adult patients undergoing knee or hip replacement surgery. Rivaroxaban tablets are indicated for the prophylaxis of venous thromboembolism (VTE) and VTE related death during hospitalization and post hospital discharge in adult patients admitted for an acute medical illness who are at risk for thromboembolic complications due to moderate or severe restricted mobility and other risk factors for VTE and not at high risk of bleeding [see Warnings and Precautions (5.2) and Clinical Studies (14.5)]. Rivaroxaban tablets, in combination with aspirin, is indicated to reduce the risk of major cardiovascular events (cardiovascular death, myocardial infarction and stroke) in adult patients with coronary artery disease. Rivaroxaban tablets, in combination with aspirin, is indicated to reduce the risk of major thrombotic vascular events (myocardial infarction, ischemic stroke, acute limb ischemia, and major amputation of a vascular etiology) in adult patients with PAD, including patients who have recently undergone a lower extremity revascularization procedure due to symptomatic PAD. Rivaroxaban tablets are indicated for the treatment of venous thromboembolism (VTE) and the reduction in the risk of recurrent VTE in pediatric patients from birth to less than 18 years after at least 5 days of initial parenteral anticoagulant treatment. Rivaroxaban tablets are indicated for thromboprophylaxis in pediatric patients aged 2 years and older with congenital heart disease who have undergone the Fontan procedure.
- generic_name
- rivaroxaban
- product_names
- RIVAROXABAN
- ndc
- 46708-240, 46708-346, 46708-347, 46708-348, 46708-683, 46708-346-30, 46708-346-91, 46708-346-10, 46708-346-90, 46708-347-30, 46708-347-91, 46708-347-10, 46708-347-90, 46708-348-30, 46708-348-91, 46708-348-10, 46708-348-90, 46708-683-60, 46708-683-45, 46708-683-91, 46708-683-10, 46708-240-51, 46708-230, 46708-231
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en