Rivaroxaban

(Xarelto®)

Xarelto®

Latest News

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Drug updated on 6/11/2024

Dosage FormTablet (oral; 2.5 mg, 10 mg, 15 mg, 20 mg); suspension (oral; 1 mg/mL)
Drug ClassFactor Xa inhibitors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated to reduce risk of stroke and systemic embolism in nonvalvular atrial fibrillation.
  • Indicated for treatment of deep vein thrombosis (DVT).
  • Indicated for treatment of pulmonary embolism (PE).
  • Indicated to reduce the risk of recurrence of DVT or PE.
  • Indicated as prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery.
  • Indicated as prophylaxis of venous thromboembolism (VTE) in acutely ill medical patients.
  • Indicated to reduce the risk of major cardiovascular events in patients with coronary artery disease (CAD).
  • Indicated 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.
  • Indicated for the treatment of VTE and reduction in the risk of recurrent VTE in pediatric patients from birth to less than 18 years.
  • Indicated as thromboprophylaxis in pediatric patients 2 years and older with congenital heart disease after the Fontan procedure.

Summary
This AI-generated content is provided without warranty and may be inaccurate or outdated; it should be used only as a research starting point, with no liability accepted for reliance on it. Learn more.

  • Rivaroxaban (Xarelto) is effective in reducing the risk of stroke and systemic embolism in nonvalvular atrial fibrillation, deep vein thrombosis, pulmonary embolism, and preventing venous thromboembolism after knee or hip replacement surgery.
  • A total of 101 studies were reviewed to gather information about this drug's effectiveness and safety.
  • Compared to warfarin, rivaroxaban resulted in significantly lower risks of ischemic and hemorrhagic stroke in obese patients with non-valvular atrial fibrillation.
  • In a subgroup analysis focusing on elderly patients, rivaroxaban demonstrated generally neutral or positive effects on thrombosis with mixed results regarding bleeding outcomes.
  • For treatment of Venous Thromboembolism (VTE), rivaroxaban was associated with a significantly lower risk of recurrent VTE compared to apixaban indicating its potential advantage for VTE treatment.
  • When compared with other direct oral anticoagulants like dabigatran and edoxaban under real-world settings, it showed less bleeding risk, while apixaban had the lowest major bleeding risk among these drugs for treating VTE.
  • The occurrence rate for both thrombotic events and bleedings did not differ significantly between severe renal insufficiency NVAF patients treated by rivaroxaban versus the control group, which suggests that its safety profile remains consistent even within high-risk groups.
  • The use of Xarelto has been linked consistently across multiple studies where cancer patients suffering from catheter-related blood clots appeared at greater risks when using Xarelto than Warfarin due to increased chances for major bleeds.
  • In comparison against aspirin alone or combined with other low-dose anticoagulants for chronic maintenance of coronary artery disease patients, rivaroxaban had a higher total bleeding rate.
  • The use of Xarelto in elderly populations and those with renal impairments requires careful consideration due to mixed outcomes on thrombosis and bleeding.

Product Monograph / Prescribing Information

Document TitleYearSource
Xarelto (rivaroxaban) Prescribing Information. 2023Janssen Ortho LLC Gurabo, PR

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Efficacy and Safety of Different Dosing Regimens of Rivaroxaban in Patients With Atrial Fibrillation for Stroke Prevention: A Systematic Review and Meta-Analysis.2024Cureus
Comparing the Clinical Outcomes Observed with Rivaroxaban Versus Warfarin for the Management of Obese Patients with Non valvular Atrial Fibrillation: A Systematic Review and Meta analysis.2024Cardiovascular Drugs and Therapy
Outcome of antithrombotic therapy in cancer patients with catheter-related thrombosis: A systematic review.2023Frontiers in Cardiovascular Medicine
Comparison of Different Chronic Maintenance Antithrombotic Strategies in Patients with Coronary Artery Disease: A Systematic Review and Network Meta-Analysis.2023Cardiovascular therapeutics
Comparative outcomes associated with rivaroxaban versus warfarin use in elderly patients with atrial fibrillation or acute venous thromboembolism managed in the United States: A systematic review of observational studies.2023Current Medical Research and Opinion
Efficacy and safety of rivaroxaban versus apixaban for venous thromboembolism: A systematic review and meta-analysis of observational studies.2023Journal of Thrombosis and Thrombolysis
Novel oral anticoagulants in patients with atrial fibrillation and moderate to severe mitral stenosis: A systematic review.2023Cureus
Application of rivaroxaban in patients with non-valvular atrial fibrillation and end-stage kidney disease: A systematic review and meta-analysis.2023Frontiers in Cardiovascular Medicine
Is a lower dose of rivaroxaban required for Asians? A systematic review of a population pharmacokinetics and pharmacodynamics analysis of rivaroxaban.2023Pharmaceutics
The association of nnon-vitamin K antagonist oral anticoagulants vs. warfarin and the risk of fractures for patients with atrial fibrillation: A systematic review and meta-analysis.2023Acta Cardiology
Efficacy and safety outcomes of long-term anti-thrombotic treatment of chronic coronary artery disease: A systematic review and network meta-analysis.2023Frontiers in Cardiovascular Medicine
Comparisons of effectiveness and safety between on-label dosing, off-label underdosing, and off-label overdosing in Asian and non-Asian atrial fibrillation patients treated with rivaroxaban: A systematic review and meta-analysis of observational studies.2023Europace
Oral direct thrombin inhibitors or oral factor Xa inhibitors versus conventional anticoagulants for the treatment of deep vein thrombosis.2023The Cochrane Database of Systematic Reviews
Safety of Direct Oral Anticoagulants for Gastrointestinal Hemorrhage in Patients With Nonvalvular Atrial Fibrillation: A Systematic Review and Meta-analysis of Real-world Studies.2023Journal of Clinical Gastroentorology
Efficacy of 11 anticoagulants for the prevention of venous thromboembolism after total hip or knee arthroplasty: A systematic review and network meta-analysis.2023Medicine
Oral Anticoagulants for Stroke Prevention in Atrial Fibrillation: A Systematic Review of Economic Evaluations.2023Value in Health Regional Issues
Severe Bleeding Risk of Direct Oral Anticoagulants Versus Vitamin K Antagonists for Stroke Prevention and Treatment in Patients with Atrial Fibrillation: A Systematic Review and Network Meta-Analysis.2023Cardiovascular Drugs and Therapy
Comparison of Aspirin and Rivaroxaban Plus Aspirin in the Management of Stable Coronary Artery Disease or Peripheral Artery Disease: A Systematic Review of Randomized Controlled Trials.2022International Journal of General Medicine
Comparison of the Efficacy and Safety of Rivaroxaban and Enoxaparin as Thromboprophylaxis Agents for Orthopedic Surgery - Systematic Review and Meta-Analysis.2022Journal of Clinical Medicine
Oral anticoagulants and relative risk of acute kidney injury in patients with atrial fibrillation: A systematic review and network meta-analysis.2022American Heart Journal Plus: Cardiology Research and Practice
Outpatient versus inpatient treatment for acute pulmonary embolism.2022Cochrane Database of Systematic Reviews
Efficacy and safety of direct oral anticoagulants (DOACs) versus warfarin in atrial fibrillation patients with prior stroke: A systematic review and meta analysis.2022Cardiovascular Drugs and Therapy
Efficacy and safety of direct oral anticoagulants with and without aspirin: A systematic review and meta-analysis.2022IJC Heart & Vasculature
Latest outcomes of transcatheter left atrial appendage closure devices and direct oral anticoagulant therapy in patients with atrial fibrillation over the past 5 years: A systematic review and meta analysis.2022Cardiovascular Intervention and Therapeutics
Extended venous thromboprophylaxis in patients hospitalized for acute ischemic stroke: A systematic review and meta-analysis.2022European Journal of Internal Medicine
Wound complications and bleeding with new oral anticoagulants in patients undergoing total joint arthroplasty: A systematic review and meta-analysis of randomized controlled trials. 2022British Journal of Pharmacology
Risk of intracranial hemorrhage with direct oral anticoagulants: A systematic review and meta-analysis of randomized controlled trials.2022Journal of Neurology
New oral anticoagulants for venous thromboembolism prophylaxis in total hip and knee arthroplasty: A systematic review and network meta-analysis.2022Frontiers in Pharmacology
Antithrombotic therapy for secondary prevention of unprovoked venous thromboembolism: A systematic review and network meta-analysis of randomized controlled trials.2022Annals of Medicine
Risk of Intracranial hemorrhage caused by direct oral anticoagulants for stroke prevention in patients with atrial fibrillation (from a network meta-analysis of randomized controlled trials). 2022The American Journal of Cardiology
Meta-analysis comparing apixaban versus rivaroxaban for management of patients with nonvalvular atrial fibrillation.2022The American Journal of Cardiology
Standard vs. low dose rivaroxaban in patients with atrial fibrillation: A systematic review and meta analysis.2022European Journal of Clinical Pharmacology
Comparative efficacy and safety of oral anticoagulants for the treatment of venous thromboembolism in the patients with different renal functions: A systematic review, pairwise and network meta-analysis.2022BMJ Open
Direct oral anticoagulants for cancer-associated venous thromboembolisms: A systematic review and network meta-analysis.2022Internal Medicine Journal
Risk of stroke and bleeding in relation to hypertension in anticoagulated patients with atrial fibrillation: A meta-analysis of randomised controlled trials. 2022Acta Cardiologica
Severe bleeding risks of direct oral anticoagulants in the prevention and treatment of venous thromboembolism: A network meta-analysis of randomised controlled trials. 2022European Journal of Vascular and Endovascular Surgery
Combination anticoagulant or P2Y12 inhibitor with low-dose aspirin versus low-dose aspirin alone in patients at risk or with documented coronary and/or peripheral artery disease. 2022Current Medical Research and Opinion
Real-world evidence comparing oral anticoagulants in non-valvular atrial fibrillation: A systematic review and network meta-analysis.2022Future Cardiology
Prevention of nnon-vitamin K oral anticoagulants-related gastrointestinal bleeding with acid suppressants: A systematic review and meta-analysis.2022Clinical and Applied Thrombosis/Hemostasis
Risk of stroke and bleeding in relation to hypertension in anticoagulated patients with atrial fibrillation: A meta-analysis of randomised controlled trials. 2022Acta Cardiologica
Thromboprophylaxis after knee arthroscopy does not decrease the risk of deep vein thrombosis: A network meta-analysis. 2022Knee Surgery, Sports Traumatology, Arthroscopy
Safety of direct oral anticoagulants in patients with liver disease: A systematic review and meta-analysis.2022International Journal of Clinical and Laboratory Medicine
Efficacy and safety of vitamin-k antagonists and direct oral anticoagulants for stroke prevention in patients with heart failure and sinus rhythm: An updated systematic review and meta-analysis of randomized clinical trials.2022International Journal of Stroke
Effectiveness and Safety of Nonvitamin K Oral Anticoagulants Rivaroxaban and Apixaban in Patients with Venous Thromboembolism: A Meta-Analysis of Real-World Studies.2022Cardiovascular Therapeutics
Comparing the Clinical Outcomes Observed with Rivaroxaban Versus Warfarin for the Management of Obese Patients with Non-valvular Atrial Fibrillation: A Systematic Review and Meta-analysis.2022Cardiovascular Drugs and Therapy
Direct oral anticoagulants for venous thromboembolism in cancer patients: A systematic review and network meta-analysis.2022Supportive Care in Cancer
Comparative efficacy and safety of antiplatelet or anticoagulant therapy in patients with chronic coronary syndromes after percutaneous coronary intervention: A network meta-analysis of randomized controlled trials.2022Frontiers in pharmacology
Efficacy and Safety of Direct Oral Anticoagulants in Stable Coronary Artery Disease and Atrial Fibrillation: A Systematic Review and Network Meta-Analysis.2022Clinical and Applied Thrombosis/Hemostasis
Risk of nonmajor bleeding upon use of direct oral anticoagulants for preventing and treating venous thromboembolism: A network meta-analysis.2022Vascular Medicine
Antithrombotic Therapy for Symptomatic Peripheral Arterial Disease: A Systematic Review and Network Meta-Analysis.2022Drugs
Efficacy and Safety of Rivaroxaban Compared with Other Therapies Used in Patients with Peripheral Artery Disease Undergoing Peripheral Revascularization: A Systematic Literature Review and Network Meta-Analysis.2021Cardiovascular Therapeutics
Efficacy of rivaroxaban in prevention of post-thrombotic syndrome: A systematic review and meta-analysis.2021Journal of Vascular Surgery: Venous and Lymphatic Disorders
Drug-drug interactions leading to adverse drug reactions with rivaroxaban: A systematic review of the literature and analysis of VigiBase. 2021Journal of Personalized Medicine
Severe bleeding risk of direct oral anticoagulants versus vitamin K antagonists for stroke prevention and treatment in patients with atrial fibrillation: A systematic review and network meta-analysis. 2021Cardiovascular Drugs and Therapy
Antiplatelet therapy with or without anticoagulant therapy for lower extremity peripheral artery disease: A systematic review.2021American Journal of Health-System Pharmacy
Comparison of non-vitamin K antagonist oral anticoagulants on bleeding and thrombosis.2021Journal of Clinical Pharmacy and Therapeutics
Twice- or once-daily dosing of direct oral anticoagulants, a systematic review and meta-analysis.2021Thrombosis Research
Association of risk of dementia with direct oral anticoagulants versus warfarin use in patients with non-valvular atrial fibrillation: A systematic review and meta-analysis.2021Journal of Cardiovascular Pharmacology
Non-vitamin K oral anticoagulants and risk of fractures: A systematic review and meta-analysis. 2021EP Europace
A network meta-analysis of non-vitamin K antagonist oral anticoagulants versus warfarin in patients with atrial fibrillation and diabetes mellitus.2021Acta Cardiologica
Fracture risks in patients treated with different oral anticoagulants: A systematic review and meta-analysis. 2021Journal of the American Heart Association
Efficacy and safety of anticoagulants for postoperative thrombophylaxis in total hip and knee arthroplasty: A PRISMA-compliant Bayesian network meta-analysis.2021PLoS One
Efficacy and safety of dual-pathway inhibition in patients with cardiovascular disease: a meta-analysis of 49 802 patients from 7 randomized trials. 2021European Heart Journal
Ranking the efficacy of anticoagulants for the prevention of venous thromboembolism after total hip or knee arthroplasty: A systematic review and a network meta-analysis. 2021Pharmacological Research
Benefits and harms of low-dose rivaroxaban in Asian patients with atrial fibrillation: A systematic review and meta-analysis of real-world studies.2021Frontiers in Pharmacology
Real-world persistence to direct oral anticoagulants in patients with atrial fibrillation: A systematic review and network meta-analysis.2021Current Medical Research and Opinion
The efficacy and safety of direct oral anticoagulants plus aspirin in symptomatic lower extremity peripheral arterial disease: A systematic review and meta‑analysis of randomized controlled trials.2021Journal of Thrombosis and Thrombolysis
Low dose rivaroxaban for atherosclerotic cardiovascular diseases: A systematic review and meta-analysis.2021Frontiers in Pharmacology
Bleeding risks with novel oral anticoagulants especially rivaroxaban versus aspirin: A meta-analysis.2021Thrombosis Journal
Efficacy and safety of Xa inhibitors in patients with heart failure and coronary or peripheral artery disease: A systematic review and meta-analysis of randomized controlled trials. 2021Annals of Palliative Medicine
The association of fracture risk in atrial fibrillation patients and long-term anticoagulant therapy category: A systematic review and meta-analysis.2021PeerJ
Reasons for discontinuing oral anticoagulation therapy for atrial fibrillation: A systematic review. 2021Age and Ageing
Efficacy and safety of non-vitamin K antagonist oral anticoagulants in pediatric venous thromboembolism treatment and thromboprophylaxis: A systematic review of the literature.2021Seminars in Thrombosis and Hemostasis
Use of direct-acting oral anticoagulants in solid organ transplantation: A systematic review.2021Pharmacotherapy
Direct-acting oral anticoagulants versus warfarin in relation to risk of gastrointestinal bleeding: A systematic review and meta-analysis of randomized controlled trials.2021Annals of Gastroenterology
A systematic review of the efficacy and safety of direct oral anticoagulants in atrial fibrillation patients with diabetes using a risk index. 2021Journal of Clinical Medicine
Bleeding outcomes after dental extraction in patients under direct-acting oral anticoagulants vs. vitamin K antagonists: A systematic review and meta-analysis. 2021Frontiers in Pharmacology
Current trends in the duration of anticoagulant therapy for venous thromboembolism: A systematic review. 2021Cureus
The efficacy and safety of rivaroxaban in coronary artery disease patients with heart failure and sinus rhythm: A systematic review and meta-analysis.2021European Journal of Clinical Pharmacology
Benefit and risk of adding rivaroxaban in patients with coronary artery disease: A systematic review and meta-analysis.2021Clinical Cardiology
Extended Thromboprophylaxis With Betrixaban or Rivaroxaban for Acutely Ill Hospitalized Medical Patients: Meta-Analysis of Prespecified Subgroups.2021Critical Pathways in Cardiology
Rivaroxaban for cancer-associated venous thromboembolism.2021Science Progress
A comparison of aspirin against rivaroxaban for venous thromboembolism prophylaxis after hip or knee arthroplasty: A meta-analysis. 2020Journal of Orthopaedic Surgery
A systematic review of network meta-analyses and real-world evidence comparing apixaban and rivaroxaban in nonvalvular atrial fibrillation. 2020Clinical and Applied Thrombosis/Hemostasis
The safety and efficacy of rivaroxaban compared with warfarin in patients with atrial fibrillation and diabetes: A systematic review and meta-analysis.2020American Journal of Cardiovascular Drugs
Risk of post-thrombotic syndrome after deep vein thrombosis treated with rivaroxaban versus vitamin-K antagonists: A systematic review and meta-analysis.2020Thrombosis Research
Clinical effectiveness and safety of aspirin for venous thromboembolism prophylaxis after total hip and knee replacement. 2020JAMA
Efficacy and safety of low dose rivaroxaban in patients with coronary heart disease: A systematic review and meta-analysis. 2020Journal of Thrombosis and Thrombolysis
Efficacy and safety of non-vitamin K anticoagulants for atrial fibrillation in relation to different renal function levels: A network meta-analysis. 2020Cardiovascular Therapeutics
Risk of major gastrointestinal bleeding with new vs conventional oral anticoagulants: A systematic review and meta-analysis.2020Clinical Gastroenterology and Hepatology
Real-world adherence and persistence to direct oral anticoagulants in patients with atrial fibrillation. 2020Circulation: Cardiovascular Quality and Outcomes
Efficacy and safety of direct oral anticoagulants in elderly patients with atrial fibrillation: A network meta-analysis. 2020Frontiers in Medicine
Interventions for preventing venous thromboembolism in adults undergoing knee arthroscopy.2020Cochrane Database of Systematic Reviews
Efficacy of rivaroxaban for pulmonary embolism2019Medicine
Effectiveness and safety of rivaroxaban for the prevention of thrombosis following total hip or knee replacement: A systematic review and meta-analysis. 2019Medicine
Systematic review and meta-analysis of the efficacy and safety of apixaban compared to rivaroxaban in acute VTE in the real world. 2019Blood Advances
Rivaroxaban versus aspirin in prevention of venous thromboembolism: A meta-analysis of 9 randomized controlled trials comprising 7,656 patients. 2019Stroke, Systemic or Venous Thromboembolism
A systematic review of direct oral anticoagulant use in chronic kidney disease and dialysis patients with atrial fibrillation. 2019Nephrology Dialysis Transplantation
Medication adherence to rivaroxaban and dabigatran in patients with non-valvular atrial fibrillation: A meta-analysis. 2019Journal of Thrombosis and Thrombolysis
Venous thromboembolism prophylaxis strategies for people undergoing elective total knee replacement: A systematic review and network meta-analysis. 2019The Lancet Haematology
Venous thromboembolism prophylaxis strategies for people undergoing elective total hip replacement: A systematic review and network meta-analysis. 2019Value in Health
Safety and efficacy of direct acting oral anticoagulants and vitamin K antagonists in nonvalvular atrial fibrillation – A network meta-analysis of real-world data.2019VASA

Clinical Practice Guidelines

Document TitleYearSource
Venous Thromboembolism Prophylaxis and Treatment in Patients With Cancer: ASCO Guideline Update.2023Journal of Clinical Oncology
Direct Oral Anticoagulant (DOAC) Guidelines.2023New South Wales Government – Clinical Excellence Commission
2023 ACC/AHA/ACCP/HRS Guideline for the Diagnosis and Management of Atrial Fibrillation: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines.2023Journal of the American College of Cardiology
American College of Gastroenterology-Canadian Association of Gastroenterology clinical practice guideline: Management of anticoagulants and antiplatelets during acute gastrointestinal bleeding and the periendoscopic period.2022Journal of the Canadian Association of Gastroenterology
2022 international clinical practice guidelines for the treatment and prophylaxis of venous thromboembolism in patients with cancer, including patients with COVID-19.2022The Lancet: Oncology
Canadian cardiovascular society 2022 guidelines for peripheral arterial disease.2022Canadian Journal of Cardiology
Perioperative Management of Antithrombotic Therapy: An American College of Chest Physicians Clinical Practice Guideline.2022Chest
2021 ESC guidelines on cardiovascular disease prevention in clinical practice.2021European Heart Journal
2019 ESC guidelines for the diagnosis and management of chronic coronary syndromes.2020European Heart Journal
Venous thromboembolic diseases: diagnosis, management and thrombophilia testing.2020NICE
Venous thromboembolism prophylaxis and treatment in patients with cancer: ASCO clinical practice guideline update. 2020Journal of Clinical Oncology
2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS). 2020European Heart Journal
The 2020 Canadian cardiovascular society/Canadian heart rhythm society comprehensive guidelines for the management of atrial fibrillation. 2020Canadian Journal of Cardiology
American Society of Hematology 2020 guidelines for management of venous thromboembolism: Treatment of deep vein thrombosis and pulmonary embolism. 2020Blood Advances
2019 ESC guidelines for the diagnosis and management of acute pulmonary embolism developed in collaboration with the European Respiratory Society (ERS).2020European Heart Journal
Reversal of direct oral anticoagulants: Guidance from the Anticoagulation Forum2019American Journal of Hematology
2019 AHA/ACC/HRS focused update of the 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation. 2019Circulation