FDA Approves Xarelto (rivaroxaban) for multiple indications including stroke prevention in nonvalvular atrial fibrillation and treatment of VTE.

FDA Published March 31, 2026 DOI ↗

Key Takeaway

Consider rivaroxaban for multiple thromboembolic indications with dosing varying by specific use and renal function.

The FDA has approved rivaroxaban (Xarelto), a factor Xa inhibitor, for a broad range of thromboembolic indications. Key approved uses include reducing the risk of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation, treating deep vein thrombosis (DVT) and pulmonary embolism (PE), and reducing the risk of recurrence of DVT and/or PE after initial treatment. For clinicians, this approval provides an oral anticoagulant option across several patient populations, including for prophylaxis in orthopedic surgery and acutely ill medical patients, as well as for reducing major cardiovascular events in coronary artery disease and peripheral artery disease when combined with aspirin. The label specifies dosing varies by indication and includes renal considerations, particularly for atrial fibrillation.

＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)

Mechanism of Action

XARELTO is a factor Xa inhibitor.

Indication & Patient Population

XARELTO is indicated: to reduce risk of stroke and systemic embolism in nonvalvular atrial fibrillation; for treatment of DVT; for treatment of PE; for reduction in the risk of recurrence of DVT or PE; for the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery; for prophylaxis of VTE in acutely ill medical patients at risk for thromboembolic complications not at high risk of bleeding; to reduce the risk of major cardiovascular events in patients with CAD, in combination with aspirin; to reduce the risk of major thrombotic vascular events in patients with PAD, including patients after recent lower extremity revascularization due to symptomatic PAD, in combination with aspirin; for treatment of VTE and reduction in the risk of recurrent VTE in pediatric patients from birth to less than 18 years; for thromboprophylaxis in pediatric patients 2 years and older with congenital heart disease after the Fontan procedure.

Dosing & Administration

For nonvalvular atrial fibrillation: 15 or 20 mg once daily with food (use 20 mg once daily with evening meal if CrCl >50 mL/min; CrCl ≤50 mL/min requires consideration as patients with CrCl <30 mL/min were not studied). For treatment of DVT and/or PE: 15 mg orally twice daily with food for the first 21 days followed by 20 mg orally once daily with food. For reduction in the risk of recurrence of DVT and/or PE: 10 mg once daily with or without food, after at least 6 months of standard anticoagulant treatment. For prophylaxis of DVT following hip or knee replacement surgery: 10 mg orally once daily with or without food. For prophylaxis of VTE in acutely ill medical patients: 10 mg once daily, with or without food, in hospital and after discharge for a total recommended duration of 31 to 39 days. For CAD or PAD: 2.5 mg orally twice daily with or without food, in combination with aspirin (75–100 mg) once daily. Pediatric dosing: See Full Prescribing Information.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

Not reported in label.

Place in Therapy

Not reported in label.

The U.S. Food and Drug Administration (FDA) has given its approval to a medication called rivaroxaban, which will be sold under the brand name Xarelto. This drug is a type of blood thinner, which means it helps prevent dangerous blood clots from forming. It is approved to treat several conditions, including a common type of irregular heartbeat that can lead to stroke, deep vein clots in the legs, and serious clots that travel to the lungs. It is also used to prevent these clots from coming back after initial treatment and to protect some patients after major surgeries.

This approval is for adult patients with these specific health issues. For doctors, it provides another oral medication option that can be used across a range of situations where preventing clots is critical for patient safety. The dose of the medicine is not the same for every condition, and doctors will consider a patient's kidney function, especially for those with the irregular heartbeat condition, when deciding on the right amount.

This regulatory step means that Xarelto has been reviewed for safety and effectiveness for these uses and is now officially available as a treatment choice. It's important to remember that every medication has benefits and risks, and what works for one person may not be right for another. The most important thing for any patient to know is that this news does not change their current care plan unless their doctor says so.

If you or someone you know has one of the conditions this drug treats, this FDA approval is simply news about a new option in the doctor's toolkit. The best and only step to take is to have a calm conversation with your healthcare provider. They can explain if this medication is a suitable consideration based on your complete personal health history and current treatments.

What this means for you: This is a new FDA-approved treatment option. Talk to your doctor to see if it's right for you.

View Original Abstract ↓

1 INDICATIONS AND USAGE XARELTO is a factor Xa inhibitor indicated: to reduce risk of stroke and systemic embolism in nonvalvular atrial fibrillation ( 1.1 ) for treatment of deep vein thrombosis (DVT) ( 1.2 ) for treatment of pulmonary embolism (PE) ( 1.3 ) for reduction in the risk of recurrence of DVT or PE ( 1.4 ) for the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery ( 1.5 ) for prophylaxis of venous thromboembolism (VTE) in acutely ill medical patients ( 1.6 ) to reduce the risk of major cardiovascular events in patients with coronary artery disease (CAD) ( 1.7 ) to reduce the risk of major thrombotic vascular events in patients with peripheral artery disease (PAD), including patients after recent lower extremity revascularization due to symptomatic PAD ( 1.8 ) for treatment of VTE and reduction in the risk of recurrent VTE in pediatric patients from birth to less than 18 years ( 1.9 ) for thromboprophylaxis in pediatric patients 2 years and older with congenital heart disease after the Fontan procedure ( 1.10 ) 1.1 Reduction of Risk of Stroke and Systemic Embolism in Nonvalvular Atrial Fibrillation XARELTO is 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 XARELTO and warfarin in reducing the risk of stroke and systemic embolism when warfarin therapy is well-controlled [see Clinical Studies (14.1) ]. 1.2 Treatment of Deep Vein Thrombosis XARELTO is indicated for the treatment of deep vein thrombosis (DVT). 1.3 Treatment of Pulmonary Embolism XARELTO is indicated for the treatment of pulmonary embolism (PE). 1.4 Reduction in the Risk of Recurrence of Deep Vein Thrombosis and/or Pulmonary Embolism XARELTO is 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. 1.5 Prophylaxis of Deep Vein Thrombosis Following Hip or Knee Replacement Surgery XARELTO is indicated for the prophylaxis of DVT, which may lead to PE in adult patients undergoing knee or hip replacement surgery. 1.6 Prophylaxis of Venous Thromboembolism in Acutely Ill Medical Patients at Risk for Thromboembolic Complications Not at High Risk of Bleeding XARELTO is 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) ] . 1.7 Reduction of Risk of Major Cardiovascular Events in Patients with Coronary Artery Disease (CAD) XARELTO, 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. 1.8 Reduction of Risk of Major Thrombotic Vascular Events in Patients with Peripheral Artery Disease (PAD), Including Patients after Lower Extremity Revascularization due to Symptomatic PAD XARELTO, 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. 1.9 Treatment of Venous Thromboembolism and Reduction in Risk of Recurrent Venous Thromboembolism in Pediatric Patients XARELTO is 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. 1.10 Thromboprophylaxis in Pediatric Patients with Congenital Heart Disease after the Fontan Procedure XARELTO is indicated for thromboprophylaxis in pediatric patients aged 2 years and older with congenital heart disease who have undergone the Fontan procedure.