Last reviewed 2026-04-20 · How we verify

Xarelto (rivaroxaban)

Selective FXa inhibitor that decreases thrombin generation without requiring cofactors.

XARELTO is a selective Factor Xa inhibitor indicated for multiple thromboembolic conditions including stroke prevention in atrial fibrillation, DVT/PE treatment and prophylaxis, and cardiovascular event reduction in CAD and PAD. The drug demonstrates dose-dependent bioavailability (66-100%) with food-dependent absorption for higher doses and is metabolized primarily by CYP3A4/5 with renal excretion of unchanged drug. Major contraindications include active bleeding and severe hypersensitivity, with significant drug interactions involving CYP3A inhibitors/inducers and P-gp transporters requiring careful management. XARELTO represents an important anticoagulant option with broad clinical applications, though careful patient selection and monitoring for bleeding risk are essential.

At a glance

Mechanism of action

XARELTO is a selective inhibitor of Factor Xa (FXa) that does not require a cofactor such as antithrombin III for activity. It inhibits both free FXa and prothrombinase activity, thereby decreasing thrombin generation. While rivaroxaban has no direct effect on platelet aggregation, it indirectly inhibits platelet aggregation induced by thrombin through its mechanism of reducing thrombin generation.

Approved indications

• Deep venous thrombosis
• Nonvalvular atrial fibrillation
• Peripheral arterial disease
• Prevention of atherothrombotic events after an acute coronary syndrome
• Prevention of atherothrombotic events at high risk of ischaemic events
• Prevention of atherothrombotic events in symptomatic peripheral artery disease
• Prevention of deep vein thrombosis
• Prevention of pulmonary embolism
• Prevention of stroke caused by a clot in a blood vessel in the brain
• Prevention of systemic embolism caused by a clot in a blood vessel
• Prevention of venous thromboembolism from re-occuring
• Prevention of venous thromboembolism in undergoing surgery
• Pulmonary embolism
• Stroke prevention
• Venous thromboembolic disease

Boxed warnings

• WARNING: (A) PREMATURE DISCONTINUATION OF XARELTO INCREASES THE RISK OF THROMBOTIC EVENTS, (B) SPINAL/EPIDURAL HEMATOMA A. Premature discontinuation of XARELTO increases the risk of thrombotic events Premature discontinuation of any oral anticoagulant, including XARELTO, increases the risk of thrombotic events. If anticoagulation with XARELTO is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant [see Dosage and Administration (2.3 , 2.4) , Warnings and Precautions (5.1) , and Clinical Studies (14.1) ] . B. Spinal/epidural hematoma Epidural or spinal hematomas have occurred in patients treated with XARELTO who are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include: use of indwelling epidural catheters concomitant use of other drugs that affect hemostasis, such as non-steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, other anticoagulants a history of traumatic or repeated epidural or spinal punctures a history of spinal deformity or spinal surgery optimal timing between the administration of XARELTO and neuraxial procedures is not known [see Warnings and Precautions (5.2 , 5.3) and Adverse Reactions (6.2) ]. Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary [see Warnings and Precautions (5.3) ] . Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis [see Warnings and Precautions (5.3) ] . WARNING: (A) PREMATURE DISCONTINUATION OF XARELTO INCREASES THE RISK OF THROMBOTIC EVENTS, (B) SPINAL/EPIDURAL HEMATOMA See full prescribing information for complete boxed warning. (A) Premature discontinuation of XARELTO increases the risk of thrombotic events Premature discontinuation of any oral anticoagulant, including XARELTO, increases the risk of thrombotic events. To reduce this risk, consider coverage with another anticoagulant if XARELTO is discontinued for a reason other than pathological bleeding or completion of a course of therapy. ( 2.2 , 2.3 , 5.1 , 14.1 ) (B) Spinal/epidural hematoma Epidural or spinal hematomas have occurred in patients treated with XARELTO who are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. ( 5.2 , 5.3 , 6.2 ) Monitor patients frequently for signs and symptoms of neurological impairment and if observed, treat urgently. Consider the benefits and risks before neuraxial intervention in patients who are or who need to be anticoagulated. ( 5.3 )

Common side effects

• Hypertension
• Pain in extremity
• Intermittent claudication
• Atrial fibrillation
• Peripheral arterial occlusive disease
• Anaemia
• Diarrhoea
• Dizziness
• Back pain
• Nasopharyngitis
• Urinary tract infection
• Abdominal pain upper

Drug interactions

• Combined P-gp and strong CYP3A inhibitors (e.g., ketoconazole, ritonavir)
• Clarithromycin
• Combined P-gp and moderate CYP3A inhibitors (e.g., erythromycin) in patients with renal impairment
• Combined P-gp and strong CYP3A inducers (e.g., carbamazepine, phenytoin, rifampin, St. John's wort)
• Anticoagulants and NSAIDs/Aspirin

Key clinical trials

• Rivaroxaban (10mg) Given Once Daily in Patients Undergoing Total Hip Replacement Compared to Enoxaparin (PHASE3)
• Reduced-dosed Rivaroxaban in the Long-term Prevention of Recurrent Symptomatic VTE(Venous Thromboembolism) (PHASE3)
• An Efficacy and Safety Study of Rivaroxaban With Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Patients With Non-Valvular Atrial Fibrillation (PHASE3)
• Regulation of Coagulation in Orthopedic Surgery to Prevent DVT and PE, a Controlled, Double-blind, Randomized Study of BAY 59-7939 in the Extended Prevention of VTE in Patients Undergoing Elective Total Hip Replacement (PHASE3)
• Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients With Acute Symptomatic Deep Vein Thrombosis - The EINSTEIN DVT Study (PHASE3)
• Regulation of Coagulation in Orthopedic Surgery to Prevent Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE). A Study of BAY 59-7939 in the Prevention of VTE in Subjects Undergoing Elective Total Knee Replacement. (PHASE3)
• Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients With Acute Symptomatic Pulmonary Embolism - The EINSTEIN PE Study (PHASE3)
• Venous Thromboembolic Event (VTE) Prophylaxis in Medically Ill Patients (PHASE3)

Patents

Primary sources

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Competitive intelligence

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