Rivaroxaban
Direct Factor Xa Inhibitors
Sold as XARELTO
- Drug class
- Direct Factor Xa Inhibitors
- Availability
- Prescription only
- Routes
- Oral
- Markets covered
- 4
- Products on record
- 393
- FDA reports (12 mo)
- 5,706
Overview
Plain-language summary, compiled from the cited regulatory records
Rivaroxaban is a medication classified as a direct Factor Xa inhibitor [1]. It is approved for several uses related to blood clot prevention and treatment. These include reducing the risk of stroke and systemic embolism in individuals with nonvalvular atrial fibrillation [1]. Rivaroxaban is also indicated for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) [1]. Furthermore, it is used to lower the chance of DVT or PE recurring and for preventing venous thromboembolism (VTE) in certain hospitalized patients who are acutely ill [1]. It is also used to prevent DVT, which can lead to PE, in patients recovering from knee or hip replacement surgery [1].
This medication is available under various brand names, including Xarelto [1]. In the past 12 months, there have been 5,706 adverse event reports associated with this active ingredient [2].
This is not medical advice. Consult a qualified healthcare professional.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 299 | May 29, 2026 |
| CA Canada | Health Canada | 88 | May 20, 2026 |
| EU European Union | EMA | 4 | May 8, 2026 |
| US United States | FDA | 2 | April 29, 2026 |
GBUnited Kingdom· MHRA
299 products
Uses
1). Rivaroxaban co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk of ischaemic events.
How to take
CACanada· Health Canada
88 products
Uses
NRA-Rivaroxaban Tablets (rivaroxaban) film-coated tablet (10 mg, 15 mg, 20 mg) is indicated for the: • prevention of venous thromboembolic events (VTE) in patients who have undergone elective total hip replacement (THR) or total knee replacement (TKR) surgery.
• treatment of venous thromboembolic events (deep vein thrombosis [DVT], pulmonary embolism [PE]) and prevention of recurrent DVT and PE. • prevention of stroke and systemic embolism in patients with atrial fibrillation, in whom anticoagulation is appropriate.
5 mg), in combination with 75 mg – 100 mg acetylsalicylic acid (ASA), is indicated for the: • prevention of stroke, myocardial infarction and cardiovascular death, and for the prevention of acute limb ischemia and mortality in patients with coronary artery disease (CAD) with or without peripheral artery disease (PAD).
• prevention of atherothrombotic events in patients with symptomatic PAD at demonstrated high risk of major adverse limb events (MALE) or major adverse cardiovascular and cerebrovascular events (MACCE). NRA-Rivaroxaban Tablets (rivaroxaban) film-coated tablet (15 mg) is indicated for the: • treatment of venous thromboembolic events (VTE) and prevention of VTE recurrence in children and adolescents aged less than 18 years and weighing from 30 kg to 50 kg after at least 5 days of initial parenteral anticoagulation treatment (see 4 DOSAGE AND ADMINISTRATION).
EUEuropean Union· EMA
4 products
Uses
1). Rivaroxaban Viatris co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk of ischaemic events.
How to take
USUnited States· FDA
2 products
Uses
7 Reduction of Risk of Major Cardiovascular Events in Patients with Coronary Artery Disease (CAD) Rivaroxaban tablets, in combination with aspirin, are indicated to reduce the risk of major cardiovascular events (cardiovascular death, myocardial infarction, and stroke) in adult patients with coronary artery disease.
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 Rivaroxaban tablets, in combination with aspirin, are 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.
Drug interactions
Known interactions involving Rivaroxaban. Select one for details. This list is informational and not a complete interaction checker.
Showing 240 of 284. Type above to find a specific drug.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]MHRA (UK) · PL177800838 · revised May 29, 2026
- [2]Health Canada (DPD) · 02566397 · revised March 10, 2026
- [3]European Medicines Agency · EMEA/H/C/005600 · revised May 8, 2026
- [4]FDA DailyMed · 122e6f78-067b-90… · revised April 29, 2026 [PDF]
- [5]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.