Rivaroxaban

XARELTO is a selective inhibitor of FXa. It does not require a cofactor (such as Anti-thrombin III) for activity.

• 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 an…ICD-10: I26.99, I48.91, I63.9, I82.409, I82.90

• XARELTO is contraindicated in patients with: active pathological bleeding [see Warnings and Precautions (5.2) ] severe hypersensitivity reaction to XARELTO (e.g., anaphylactic reactions) [see Adverse Reactions (6.2) ] Active pathological bleeding ( 4 ) Severe hypersensitivity reaction to XARELTO ( 4 )contraindicated

Nonvalvular Atrial Fibrillation : 15 or 20 mg, once daily with food ( 2.1 ) 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 the remaining treatment ( 2.1 ) Reduction in the Risk of Recurrence of DVT and/or PE in patients at continued risk for DVT and/or PE : 10 mg once daily with or without food, after at least 6 months of standard anticoagulant treatment ( 2.1 ) Prophylaxis of DVT Following Hip or Knee Replacement Surgery : 10 mg orally once daily with or without food ( 2.1 ) Prophylaxis of VTE in Acutely Ill Medical Patients at Risk for Thromboembolic Complications Not at High Risk of Bleeding : 10 mg once daily, with or without food, in hospital and after hospital discharge for a total recommended duration of 31 to 39 days ( 2.1 ) CAD or PAD : 2.5 mg orally twice daily with or without food, in combination with aspirin (75–100 mg) once daily ( 2.1 ) Pediatric Patients: See dosing recommendations in the Full Prescribing Information ( 2.2 ) 2.1 Recommended Dosage in Adults Table 1: Recommended Dosage in Adults Indication Renal Considerations Calculate CrCl based on actual weight [see Warnings and Precautions (5.4) and Use in Specific Populations (8.6) ] . Dosage Food/Timing [See Clinical Pharmacology (12.3) ] .

Risk of bleeding: XARELTO can cause serious and fatal bleeding ( 5.2 ) Pregnancy-related hemorrhage: Use XARELTO with caution in pregnant women due to the potential for obstetric hemorrhage and/or emergent delivery ( 5.7 , 8.1 ) Prosthetic heart valves: XARELTO use not recommended ( 5.8 ) Increased Risk of Thrombosis in Patients with Triple Positive Antiphospholipid Syndrome: XARELTO use not recommended ( 5.10 ) 5.1 Increased Risk of Thrombotic Events after Premature Discontinuation Premature discontinuation of any oral anticoagulant, including XARELTO, in the absence of adequate alternative anticoagulation increases the risk of thrombotic events. An increased rate of stroke was observed during the transition from XARELTO to warfarin in clinical trials in atrial fibrillation patients. If 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) and Clinical Studies (14.1) ] . 5.2 Risk of Bleeding XARELTO increases the risk of bleeding, including in any organ, and can cause serious or fatal bleeding. In deciding whether to prescribe XARELTO to patients at increased risk of bleeding, the risk of thrombotic events should be weighed against the risk of bleeding. Promptly evaluate any signs or symptoms of blood loss and consider the need for blood replacement. Discontinue XARELTO in patients with active pathological hemorrhage. The terminal elimination half-life of rivaroxaban is 5 to 9 hours in healthy subjects aged 20 to 45 years.

The following clinically significant adverse reactions are also discussed in other sections of the labeling: Increased Risk of Stroke After Discontinuation in Nonvalvular Atrial Fibrillation [see Boxed Warning and Warnings and Precautions (5.1) ] Bleeding Risk [see Warnings and Precautions (5.2 , 5.4 , 5.5 , 5.6 , 5.7) ] Spinal/Epidural Hematoma [see Boxed Warning and Warnings and Precautions (5.3) ] The most common adverse reaction (>5%) in adult patients was bleeding ( 6.1 ) The most common adverse reactions (>10%) in pediatric patients were bleeding, cough, vomiting, and gastroenteritis ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Janssen Pharmaceuticals, Inc. at 1-800-526-7736 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. During clinical development for the approved indications, 34,947 adult patients were exposed to XARELTO. Hemorrhage The most common adverse reactions with XARELTO were bleeding complications [see Warnings and Precautions (5.2) ] . Nonvalvular Atrial Fibrillation In the ROCKET AF trial, the most frequent adverse reactions associated with permanent drug discontinuation were bleeding events, with incidence rates of 4.3% for XARELTO vs. 3.1% for warfarin.

Renal impairment: Avoid or adjust dose ( 8.6 ) Hepatic impairment: Avoid use in Child-Pugh B and C hepatic impairment or hepatic disease associated with coagulopathy ( 8.7 ) 8.1 Pregnancy Risk Summary The limited available data on XARELTO in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes. Use XARELTO with caution in pregnant patients because of the potential for pregnancy related hemorrhage and/or emergent delivery. The anticoagulant effect of XARELTO cannot be reliably monitored with standard laboratory testing. Consider the benefits and risks of XARELTO for the mother and possible risks to the fetus when prescribing XARELTO to a pregnant woman [see Warnings and Precautions (5.2 , 5.7) ] . Adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications. The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Pregnancy is a risk factor for venous thromboembolism and that risk is increased in women with inherited or acquired thrombophilias.

Metabolism

Absorption The absolute bioavailability of rivaroxaban is dose-dependent. For the 2.5 mg and 10 mg dose, it is estimated to be 80% to 100% and is not affected by food.

Overdose of XARELTO may lead to hemorrhage. Discontinue XARELTO and initiate appropriate therapy if bleeding complications associated with overdosage occur. Rivaroxaban systemic exposure is not further increased at single doses >50 mg due to limited absorption. The use of activated charcoal to reduce absorption in case of XARELTO overdose may be considered. Due to the high plasma protein binding, rivaroxaban is not dialyzable [see Warnings and Precautions (5.2) and Clinical Pharmacology (12.3) ] . Partial reversal of laboratory anticoagulation parameters may be achieved with use of plasma products. A specific agent to reverse the anti-factor Xa activity of rivaroxaban is not available.

• Jul 1, 2011NDANDA022406Janssen Pharms
• Dec 20, 2021NDANDA215859Janssen Pharms
• Mar 3, 2025ANDAANDA208557Taro
• Mar 3, 2025ANDAANDA208555Lupin
• Apr 10, 2025ANDAANDA208544Aurobindo Pharma Ltd
• May 2, 2025ANDAANDA217810Apotex
• May 14, 2025ANDAANDA208534Dr Reddys
• May 14, 2025ANDAANDA210301Alembic

1. 1Gastrointestinal Haemorrhage21,61111%
2. 2Off Label Use7,8693.8%
3. 3Haemorrhage7,7523.8%
4. 4Dyspnoea7,2473.5%
5. 5Epistaxis6,7373.3%
6. 6Fatigue6,6373.2%
7. 7Death6,0973.0%
8. 8Fall6,0623.0%
9. 9Pulmonary Embolism5,9882.9%
10. 10Drug Ineffective5,8582.9%
11. 11Anaemia5,6422.8%
12. 12Diarrhoea5,5812.7%
13. 13Cerebrovascular Accident5,5672.7%
14. 14Dizziness5,4482.7%
15. 15Nausea5,3272.6%

Recent PubMed references pinned to Rivaroxaban as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• Population pharmacokinetic and pharmacodynamic analysis of rivaroxaban in real-world patients with pulmonary embolism in China.
  Research and practice in thrombosis and haemostasis · 2026 · Ren J, Li Y, Zheng X, et al.
  PMID 42232251DOI 10.1016/j.rpth.2026.106618
• Comparison of aspirin and rivaroxaban for the prevention of pulmonary embolism and deep vein thrombosis in high thrombotic risk patients with systemic lupus erythematosus: study protocol for a multicentre, prospective, randomised controlled trial.
  Lupus science & medicine · 2026 · Zhang Z, Li F, Li Y, et al.
  PMID 42161432DOI 10.1136/lupus-2026-001981
• Comparative efficacy and safety of apixaban and rivaroxaban versus warfarin in atrial fibrillation patients with end-stage renal disease: a systematic review and meta-analysis.
  Renal failure · 2026 · Wu X, Meng J, Yang Y, et al.
  PMID 42128628DOI 10.1080/0886022X.2026.2666454
• [The role and place of rivaroxaban in modern anticoagulant therapy of patients with atrial fibrillation. A review].
  Terapevticheskii arkhiv · 2026 · Zyryanov SK, Baybulatova EA, Ogurlieva BB, et al.
  PMID 42107127DOI 10.26442/00403660.2026.04.203513
• Andexanet alfa for the reversal of anticoagulation: Dutch practice data.
  Research and practice in thrombosis and haemostasis · 2026 · Krommenhoek JF, Beekman W, Kor F, et al.
  PMID 42088901DOI 10.1016/j.rpth.2026.103438
• Predicting plasma concentration-time profiles of orally disintegrating tablets with delayed absorption under fed conditions without water.
  International journal of pharmaceutics · 2026 · Oyabu Y, Takagi T, Yamashita S, et al.
  PMID 42082063DOI 10.1016/j.ijpharm.2026.126931
• Emergency reversal of Rivaroxaban with Andexanet alfa in a child with hemorrhagic brain metastasis from Wilms tumor.
  Child's nervous system : ChNS : official journal of the International Society for Pediatric Neurosurgery · 2026 · Rafaelian A, Won SY, Mueller L, et al.
  PMID 42069956DOI 10.1007/s00381-026-07286-w
• Eligibility for dual pathway inhibition in patients with peripheral artery disease undergoing revascularization.
  Journal of cardiovascular medicine (Hagerstown, Md.) · 2026 · Greco A, Laudani C, Spagnolo M, et al.
  PMID 42065945DOI 10.2459/JCM.0000000000001862

The 10 most recently updated of 681 ClinicalTrials.gov registrations naming Rivaroxaban as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• LA-HCM Study : Rivaroxaban for Antithrombotic Prevention in Hypertrophic Cardiomyopathy Patients With Abnormal Left Atrial Strain.
  Recruiting · Phase 3 · Interventional · 532 enrolled · Rennes University Hospital
  NCT07202897updated 2026-06-12
• Emulation of the RECORD3 Trial Using Healthcare Claims Data
  Active not recruiting · Observational · 149,248 enrolled · Brigham and Women's Hospital
  NCT07599384updated 2026-06-11
• Replication of the RECORD1 Anticoagulant Trial in Healthcare Claims Data
  Active not recruiting · Observational · 89,215 enrolled · Brigham and Women's Hospital
  NCT05083455updated 2026-06-11
• Comparison of Anti-coagulation and Anti-Platelet Therapies for Intracranial Vascular Atherostenosis
  Active not recruiting · Phase 3 · Interventional · 1,683 enrolled · University of Florida
  NCT05047172updated 2026-06-11
• Replication of the EINSTEIN-DVT Anticoagulant Trial in Healthcare Claims Data
  Active not recruiting · Observational · 78,605 enrolled · Brigham and Women's Hospital
  NCT04736420updated 2026-06-11
• Antithrombotic Treatment Strategies in Cervical Artery Dissection
  Not yet recruiting · Interventional · 1,100 enrolled · University Department of Geriatric Medicine FELIX PLATTER
  NCT07639892updated 2026-06-10
• The PEERLESS II Study
  Recruiting · Interventional · 1,200 enrolled · Inari Medical
  NCT06055920updated 2026-06-10
• AntiCoagulation Versus AcetylSalicylic Acid After Transcatheter Aortic Valve Implantation
  Completed · Phase 3 · Interventional · 360 enrolled · Oslo University Hospital
  NCT05035277updated 2026-06-09
• Stroke Prevention In Ischemic Stroke With Covert Atrial Fibrillation
  Recruiting · Phase 4 · Interventional · 1,148 enrolled · Assistance Publique - Hôpitaux de Paris
  NCT06486792updated 2026-06-05
• THRomboprophylaxis in Individuals Undergoing Superficial endoVEnous Treatment (THRIVE)
  Recruiting · Phase 4 · Interventional · 3,175 enrolled · Imperial College London
  NCT05735639updated 2026-06-04

Ranked by 2D fingerprint (Tanimoto) similarity over PubChem structures. Structural proximity only — not a claim of therapeutic equivalence.

• LinezolidOxazolidinone Antibacterial79%

Frequently asked questions

How does Rivaroxaban work?

XARELTO is a selective inhibitor of FXa. It does not require a cofactor (such as Anti-thrombin III) for activity.

What is Rivaroxaban used for?

According to FDA labeling, Rivaroxaban carries indications including: 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 an…. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Rivaroxaban?

Rivaroxaban is classified as Direct factor Xa inhibitors, Factor Xa Inhibitor, Factor Xa Inhibitors, Decreased Coagulation Factor Activity.

What are the brand names for Rivaroxaban?

Rivaroxaban is marketed under brand names including Xarelto.

What are the contraindications for Rivaroxaban?

Rivaroxaban labeling lists contraindications including: XARELTO is contraindicated in patients with: active pathological bleeding [see Warnings and Precautions (5.2) ] severe hypersensitivity reaction to XARELTO (e.g., anaphylactic reactions) [see Adverse Reactions (6.2) ] Active pathological bleeding ( 4 ) Severe hypersensitivity reaction to XARELTO ( 4 ). Always consult the full prescribing information and a clinician.