Rivaroxaban

Pronunciation: riv-a-ROX-a-ban.

Generic name
rivaroxaban
Drug class
Anticoagulant (direct oral factor Xa inhibitor)
Form
Film-coated tablet (2.5 mg, 10 mg, 15 mg, 20 mg) and, for certain pediatric and swallowing-difficulty uses, granules for oral suspension (1 mg/mL)
Route
Oral
Legal status
Prescription-only

Availability and supply rules vary by country

Trade names by country: United States · United Kingdom · Canada · Australia · New Zealand

Australia: Xarelto (5) · Full directory

What rivaroxaban is and how it works

Rivaroxaban is an oral anticoagulant (blood thinner) that works by directly blocking a clotting factor called factor Xa. It is used to prevent and treat blood clots in the veins and to help prevent stroke in people with a certain type of irregular heartbeat (non-valvular atrial fibrillation), and, combined with low-dose aspirin, to reduce the risk of heart attack, stroke, and other serious blood-vessel events in people with coronary or peripheral artery disease. (1)

Rivaroxaban carries two genuine, serious boxed-warning risks: stopping it early (without your prescriber's guidance) can increase your risk of a stroke or blood clot, and taking it around the time of spinal or epidural anesthesia or a spinal puncture carries a risk of a spinal blood clot that can cause long-term or permanent paralysis. It also increases your overall bleeding risk. Never stop, start, or change the timing of this medicine around a procedure without your prescriber's specific instructions.

Mechanism of action: how rivaroxaban works

Rivaroxaban is a direct, selective inhibitor of activated factor X (factor Xa), a key enzyme in the coagulation cascade. By inhibiting factor Xa, rivaroxaban interrupts both the intrinsic and extrinsic pathways of the coagulation cascade, reducing thrombin generation and thrombus formation, without requiring antithrombin as a cofactor. (1) (4)

What rivaroxaban is used for

Stroke and systemic embolism prevention in non-valvular atrial fibrillation

Used to reduce the risk of stroke and blood clots travelling to other parts of the body in adults with non-valvular atrial fibrillation (an irregular heart rhythm not caused by a heart valve problem). (1) (2)

Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrence

Used to treat a blood clot in a deep vein (DVT) or in the lungs (PE), and, after an initial treatment course, to reduce the risk of these clots happening again -- in adults and, for VTE specifically, in children and adolescents after at least 5 days of initial injectable anticoagulant treatment. (1) (2) (4)

Prevention of blood clots after hip or knee replacement surgery

Used to prevent venous thromboembolism (blood clots in the veins) in adults who have had elective total hip or total knee replacement surgery. (1) (5)

Prevention of blood clots in acutely ill hospitalised patients

Used in some countries to prevent venous thromboembolism in adults hospitalised for an acute medical illness who are at risk of blood clots but not at high bleeding risk. (1)

Reducing cardiovascular risk in coronary or peripheral artery disease (combined with low-dose aspirin)

Used together with low-dose aspirin (75-100 mg) to reduce the risk of stroke, heart attack, and cardiovascular death in adults with coronary artery disease, and to reduce the risk of major limb events in adults with peripheral artery disease. (1) (4)

Before taking rivaroxaban

Do not take / not appropriate for

  • Do not take rivaroxaban if you have active, clinically significant bleeding. (all countries) (1) (2)
  • Do not take rivaroxaban together with any other anticoagulant (such as warfarin, another direct oral anticoagulant, or a low molecular weight heparin), except under specific medically supervised switching circumstances. (all countries) (2) (4)
  • Do not take rivaroxaban if you have liver disease associated with a bleeding tendency (coagulopathy), including certain types of cirrhosis. (all countries) (2) (4)
  • Do not take rivaroxaban together with strong combined CYP3A4 and P-glycoprotein inhibitors, such as ketoconazole, itraconazole, or certain HIV protease inhibitors, because blood levels can rise significantly. (all countries) (1) (4)
  • Do not take rivaroxaban if you are pregnant or breastfeeding. (United Kingdom, and consistent with regulator sources reviewed for other markets) (2)

Tell your clinician about

  • Any history of bleeding problems, stomach ulcers, or recent stroke.
  • Your kidney and liver function, since dosing and eligibility depend on both.
  • Any planned surgery, dental work, spinal or epidural anesthesia, or spinal puncture, so timing around your rivaroxaban dose can be planned safely.
  • All other medicines you take, especially other anticoagulants, antiplatelet medicines, NSAIDs, and antifungal or HIV medicines.
  • Whether you have a mechanical heart valve or antiphospholipid syndrome, since rivaroxaban is not recommended in these situations.
  • Whether you are pregnant, planning pregnancy, or breastfeeding.
(1) (2) (4)

How to take rivaroxaban

  • Take rivaroxaban exactly as prescribed, at the dose and frequency for your specific condition -- doses differ significantly between indications and are not interchangeable.
  • Doses of 15 mg and 20 mg should be taken with food to help absorption; lower doses can be taken with or without food, depending on the indication -- follow your prescriber's or pharmacist's specific instructions.
  • Never stop taking rivaroxaban on your own, even briefly, without talking to your prescriber first -- stopping early increases your risk of a stroke or blood clot.
  • If you have surgery, a dental procedure, or a spinal/epidural procedure planned, your care team will tell you exactly when to stop and restart rivaroxaban around it.
(1) (2)

Procedures and treatment changes

Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (2) (3) (4) (5) (6)

Missed dose

If you miss a dose, take it as soon as you remember on the same day, then continue your normal dosing schedule the next day -- do not take a double dose to make up for a missed one. If you are unsure, or if you take a twice-daily dose and are close to your next scheduled dose, contact your prescriber or pharmacist for guidance rather than guessing.

Overdose

Seek urgent medical attention for a suspected overdose. Signs of too much anticoagulant effect include unusual bruising, nosebleeds, blood in urine or stool, or unusually heavy bleeding. A reversal agent is available in some healthcare settings for serious bleeding. (1)

Side effects

Side effects and their urgency vary; report severe, persistent, or concerning symptoms.

Nosebleeds (epistaxis).

What to notice: Nosebleeds (epistaxis).

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (2)

Bleeding from the gums, bruising, or gastrointestinal bleeding.

What to notice: Bleeding from the gums, bruising, or gastrointestinal bleeding.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (2)

Anaemia, dizziness, and headache.

What to notice: Anaemia, dizziness, and headache.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (2)

Serious warnings

Signs of a spinal or epidural blood clot (hematoma) — boxed_warning

Symptoms: New or worsening back pain, numbness, tingling, weakness in the legs, or loss of control of bowel or bladder function, especially after spinal or epidural anesthesia or a spinal puncture.

Action: Seek emergency medical help immediately -- this can indicate a spinal or epidural blood clot pressing on the spinal cord, which can cause long-term or permanent paralysis if not treated urgently. (1) (2)

Risk of stroke or blood clot from stopping this medicine early — boxed_warning

Symptoms: Not applicable -- this is a warning about the danger of unsupervised discontinuation, not a symptom to watch for.

Action: Never stop taking rivaroxaban on your own. If you need to stop for any reason, including before a procedure or because of bleeding, this must be planned with your prescriber, who may cover you with a different anticoagulant during the switch. (1)

Signs of serious bleeding — boxed_warning_adjacent_serious

Symptoms: Unusual bruising, nosebleeds that won't stop, blood in urine or stool, coughing up blood, severe headache, vomiting blood, or bleeding from the gums.

Action: Contact your clinician or seek emergency care immediately -- rivaroxaban increases bleeding risk, and this risk is higher with kidney or liver impairment, other blood-thinning medicines, or older age. (1) (2)

Signs of a serious allergic reaction — emergency

Symptoms: Swelling of the face, lips, tongue, or throat; difficulty breathing; widespread rash or hives; signs of a severe skin reaction (peeling or blistering skin).

Action: Seek emergency medical help immediately. (1)

Signs of liver problems — high caution

Symptoms: Yellowing of the skin or eyes, dark urine, unusual tiredness, or pain in the upper right abdomen.

Action: Contact your clinician promptly -- rare cases of liver injury have been reported. (1)

Interactions

  • Other medicines that affect bleeding or clotting -- including NSAIDs, aspirin and other antiplatelet medicines, and other anticoagulants -- increase bleeding risk and increase the spinal/epidural hematoma risk if combined around the time of a spinal procedure. (1) (2)
  • Strong combined CYP3A4 and P-glycoprotein inhibitors (such as ketoconazole, itraconazole, and certain HIV protease inhibitors) significantly increase rivaroxaban blood levels and must not be combined with it. (1) (2)
  • Strong CYP3A4/P-glycoprotein inducers can reduce rivaroxaban's effectiveness, increasing clot risk. (1)
  • SSRIs and SNRIs (certain antidepressants) may increase bleeding risk when combined with rivaroxaban. (2)

Pregnancy, breastfeeding, kidney/liver function, age

Pregnancy

Not recommended in pregnancy; rivaroxaban's safety has not been established for use during pregnancy, and animal data have shown reproductive toxicity. (1) (2) (3) (4) (5) (6)

Breastfeeding

Not recommended while breastfeeding; discontinue either breastfeeding or the medicine, based on clinician guidance. (1) (2) (3) (4) (5) (6)

Children

Used for VTE treatment and recurrence prevention in neonates, infants, children, and adolescents after at least 5 days of initial injectable anticoagulant treatment, using weight-banded formulations and doses; not established for other indications in children. (1) (2) (3) (4) (5) (6)

Elderly

No specific dose reduction is required based on age alone, but epidural-catheter-timing guidance differs by age (18 hours for younger adults vs. 26 hours for elderly patients before catheter removal), and bleeding risk generally increases with age. (1) (2) (3) (4) (5) (6)

Hepatic_impairment

Avoid in moderate-to-severe hepatic impairment or any liver disease associated with a bleeding tendency (coagulopathy), including Child-Pugh B/C cirrhosis. (1) (2) (3) (4) (5) (6)

Renal_impairment

Dose adjustment required for several indications with moderate renal impairment; avoid in severe renal impairment (creatinine clearance below 15 mL/min) for most indications; kidney function should be checked before starting and monitored periodically during treatment. (1) (2) (3) (4) (5) (6)

Source_ids

US-DAILYMED-XARELTO-2026,UK-EMC-XARELTO-SMPC-2026,CA-HEALTHCANADA-XARELTO-PM-2026 (1) (2) (3) (4) (5) (6)

Monitoring

Before starting

  • Kidney function (estimated creatinine clearance)
  • Liver function
  • Baseline bleeding risk assessment
  • Review of other medicines affecting bleeding/clotting or CYP3A4/P-glycoprotein
  • Review of any planned spinal/epidural procedure or surgery

During treatment

  • Kidney function reassessed at least annually, and more often if it may be compromised (such as during acute illness).
  • Ongoing monitoring for signs of bleeding at every visit.
  • Close monitoring for neurological signs (back pain, numbness, weakness, bowel/bladder changes) around the time of any spinal or epidural procedure.
(4) (1)

Storage

Store at room temperature as directed on the product label, protected from moisture, out of reach of children.

Study the drug class: Direct oral anticoagulants

Professional information

Clinician-facing context only, sourced from the current US FDA and Health Canada labels reviewed for this dossier; verify against the current full label before prescribing.

United States

Indication: Non-valvular atrial fibrillation

Dose summary: 20 mg once daily with evening meal; 15 mg once daily if CrCl 15-50 mL/min; avoid if CrCl <15 mL/min.

Renal context: Dose-reduced at CrCl 15-50 mL/min; avoid below 15 mL/min. (1)

United States, United Kingdom

Indication: DVT/PE treatment and prevention of recurrence

Dose summary: 15 mg twice daily x21 days with food, then 20 mg once daily with food; extended prevention 10 mg once daily (20 mg if higher recurrence risk, UK).

Renal context: Use with caution in renal impairment; avoid in severe impairment per US label (CrCl <15 mL/min for VTE treatment/prevention dosing not established). (1) (2)

Mechanism of action

Hepatic guidance

Avoid in moderate-to-severe hepatic impairment (Child-Pugh B/C) or any hepatic disease associated with coagulopathy and clinically relevant bleeding risk.

Overdose note

No specific antidote is universally available for every clinical situation; a targeted reversal agent exists for life-threatening bleeding in some healthcare settings. Management is otherwise supportive, with attention to bleeding source control and hemodynamic status. (1) (4)

Frequently asked questions

Why does rivaroxaban have two boxed warnings?

Because two separate, serious risks were identified as important enough for the US FDA's strongest warning category. The first is that stopping rivaroxaban early or without medical guidance increases your risk of a stroke or blood clot. The second is that, like other anticoagulants, rivaroxaban carries a risk of a spinal or epidural blood clot if it is given around the time of spinal or epidural anesthesia or a spinal puncture, which can cause long-term or permanent paralysis. (1)

Can I just stop taking rivaroxaban if I have a procedure coming up?

No -- never stop rivaroxaban on your own. Your prescriber will give you specific instructions for when to stop and restart it around any surgery, dental work, or spinal/epidural procedure, because both stopping too early (clot/stroke risk) and continuing too close to certain procedures (spinal bleeding risk) carry genuine dangers. (1) (2)

Does the dose of rivaroxaban stay the same for every condition it treats?

No -- the dose varies significantly depending on what it's being used for, and sometimes changes partway through treatment (for example, a higher twice-daily dose for the first three weeks of DVT/PE treatment, then a lower once-daily dose afterward). Always take the exact dose prescribed for your specific condition. (1) (2)

What is the mechanism of action of rivaroxaban?

Rivaroxaban is a direct, selective inhibitor of activated factor X (factor Xa), a key enzyme in the coagulation cascade. By inhibiting factor Xa, rivaroxaban interrupts both the intrinsic and extrinsic pathways of the coagulation cascade, reducing thrombin generation and thrombus formation, without requiring antithrombin as a cofactor. (1) (4)

What is the generic name of Rivaroxaban?

The generic name is rivaroxaban. (1) (3)

What class of drug is rivaroxaban?

Rivaroxaban is classed as: Anticoagulant (direct oral factor Xa inhibitor). (1) (3)

References

  1. XARELTO (rivaroxaban) tablets / for oral suspension -- full prescribing informationU.S. Food and Drug Administration / DailyMed (NIH), full prescribing information, Janssen Pharmaceuticals, Inc. · United States · accessed 2026-07-30 · source 1
  2. Xarelto 20mg film-coated tablets -- Summary of Product Characteristicselectronic medicines compendium (emc), United Kingdom -- Bayer plc · United Kingdom · accessed 2026-07-30 · source 2
  3. Xarelto, INN-rivaroxaban -- EPAREuropean Medicines Agency (EMA) -- centralised EU marketing authorisation, EPAR · European Union · accessed 2026-07-30 · source 3
  4. XARELTO (rivaroxaban tablets; rivaroxaban granules for oral suspension) -- Product Monograph including Patient Medication InformationHealth Canada product monograph, Bayer Inc. · Canada · accessed 2026-07-30 · source 4
  5. XARELTO rivaroxaban tablets -- ARTG entries 147400 (10 mg), 181185 (15 mg), 181186 (20 mg)Therapeutic Goods Administration (TGA), Australia · Australia · accessed 2026-07-30 · source 5
  6. XARELTO (rivaroxaban) tablets -- New Zealand Data Sheet (XARELTO DS VX8.0; CCDS 17, 19)Medsafe (New Zealand Medicines and Medical Devices Safety Authority) · New Zealand · accessed 2026-07-30 · source 6

Brand names by country

Single-ingredient rivaroxaban names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.

Priority countries

United States

  • Xarelto10 mg, 20 mg, 155 mg, 2.5 mg, 15 mg · janssen pharmaceuticals, inc.
  • rivaroxaban granule155 mg · lupin pharmaceuticals, inc.

United Kingdom

  • Xarelto (2)MHRA licensed emc smpc confirmed · 2.5 mg, 10 mg, 15 mg, 20 mg · Bayer plc

Canada

  • XARELTO

Australia

  • Xarelto (5)TGA ARTG registered PBS listed confirmed · 2.5 mg, 10 mg, 15 mg, 20 mg, 1 mg/mL granules · Bayer Australia Ltd

New Zealand

  • Xarelto (plus generic rivaroxaban brands, e.g. Pharmacor Rivaroxaban) (6)Medsafe data sheet confirmed current version 8.0 · not fully specified in source · not specified in source
View brands in additional countries.

European Union

Xarelto (3), Rivaroxaban Accord / Rivaroxaban Koanaa (generics) (3)

This page provides general reference information about rivaroxaban (Xarelto) and is not a substitute for advice from the clinician managing your treatment. All dosing, timing around procedures, and treatment-continuation decisions should be made with your prescriber or care team -- never stop, start, or change this medicine on your own.

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