Section 13 · Monograph

Rivaroxaban

Reviewed Nov 2026FDA label
XareltoFactor Xa inhibitor (DOAC)
Forms
Tab: 2.5, 10, 15, 20mg
Dose
AF stroke prevention: 20mg once daily with evening meal (15mg if CrCl 15-50)
MOA
Direct factor Xa inhibition

Black Box Warning

  • Premature discontinuation increases the risk of thrombotic events including stroke
  • Spinal/epidural hematoma risk with neuraxial anesthesia or puncture

Indications

  • Reduce risk of stroke and systemic embolism in nonvalvular atrial fibrillationFDA-labeled
  • Treatment and prevention of DVT/PEFDA-labeled
  • Reduce major cardiovascular events in CAD/PAD (2.5mg twice daily with aspirin)FDA-labeled

Mechanism of Action

  • Direct factor Xa inhibitor

Full Dosing

Adult / usual

  • VTE treatment: 15mg twice daily for 21 days, then 20mg once daily with food

Renal

  • AF: 20mg once daily with the evening meal; 15mg once daily if CrCl 15-50mL/min
  • Avoid in AF if CrCl below 15mL/min

Contraindications

  • Active pathological bleeding
  • Severe hypersensitivity to rivaroxaban

Drug Interactions

  • Combined strong CYP3A4/P-gp inhibitors or inducers: avoid (includes carbamazepine, phenytoin, rifampin which lower levels)
  • NSAIDs, antiplatelets and SSRIs increase bleeding risk

Adverse Effects

  • Bleeding (GI, intracranial)
  • Anemia
  • Pruritus, back pain

Monitoring Parameters

  • Renal function and CBC
  • Take 15mg and 20mg doses with food for absorption
  • Bleeding signs

Pregnancy & Lactation

  • Limited data; avoid in pregnancy
  • Avoid during breastfeeding

References

  1. XARELTO (rivaroxaban) Prescribing Information — DailyMed (NIH) search

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