Rivaroxaban

DRUG INFORMATION

  ADULT
    - If oral medication cannot be taken during or after surgical intervention, consider
      administering a parenteral anticoagulant. 2.5 Missed Dose Adults For patients
      receiving 2.5 mg twice daily: if a dose is missed, the patient should take a
      single 2.5 mg rivaroxaban tablet dose as recommended at the next scheduled time.
      Source: US FDA label for rivaroxaban (Rivaroxaban), section 'dosage and
      administration', retrieved 2026-08-29

  CHILD
    - For the rivaroxaban 2.5 mg tablets, there are no safety, efficacy, pharmacokinetic
      and pharmacodynamics data to support the use in pediatric patients. Therefore,
      rivaroxaban 2.5 mg tablets are not recommended for use in pediatric patients.
      Source: US FDA label for rivaroxaban (Rivaroxaban), section 'pediatric use',
      retrieved 2026-08-29

  RENAL IMPAIRMENT
    - Take with or without food * Calculate CrCl based on actual weight. [See Warnings
      and Precautions ( 5.4 ) and Use in Specific Populations ( 8.6 )] . † [See Clinical
      Pharmacology ( [12.3 )] 2.2 Recommended Dosage in Pediatric Patients Rivaroxaban
      2.5 mg tablets are not recommended for use in pediatric patients [see Use in
      Specific Populations ( 8.4 )] .
      Source: US FDA label for rivaroxaban (Rivaroxaban), section 'dosage and
      administration', retrieved 2026-08-29
    - 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
      rivaroxaban in pregnant women are insufficient to inform a drug-associated risk of
      adverse developmental outcomes.
      Source: US FDA label for rivaroxaban (Rivaroxaban), section 'use in specific
      populations', retrieved 2026-08-29
    - Both thrombotic and bleeding event rates were higher in these older patients [see
      Clinical Pharmacology ( 12.3 ) and Clinical Studies ( 14) ]. 8.6 Renal Impairment
      In pharmacokinetic studies, compared to healthy adult subjects with normal
      creatinine clearance, rivaroxaban exposure increased by approximately 44% to 64%
      in adult subjects with renal impairment.
      Source: US FDA label for rivaroxaban (Rivaroxaban), section 'use in specific
      populations', retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - 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
      rivaroxaban in pregnant women are insufficient to inform a drug-associated risk of
      adverse developmental outcomes.
      Source: US FDA label for rivaroxaban (Rivaroxaban), section 'use in specific
      populations', retrieved 2026-08-29
    - It is not known whether these concentrations will lead to similar CV risk
      reduction and bleeding risk in patients with ESRD on dialysis as was seen in
      COMPASS. 8.7 Hepatic Impairment In a pharmacokinetic study, compared to healthy
      adult subjects with normal liver function, AUC increases of 127% were observed in
      adult subjects with moderate hepatic impairment (Child-Pugh B).
      Source: US FDA label for rivaroxaban (Rivaroxaban), section 'use in specific
      populations', retrieved 2026-08-29
    - The safety or PK of rivaroxaban in patients with severe hepatic impairment (Child-
      Pugh C) has not been evaluated [see Clinical Pharmacology ( 12.3 )].
      Source: US FDA label for rivaroxaban (Rivaroxaban), section 'use in specific
      populations', retrieved 2026-08-29

  PREGNANCY
    - Risk Summary The limited available data on rivaroxaban in pregnant women are
      insufficient to inform a drug-associated risk of adverse developmental outcomes.
      Source: US FDA label for rivaroxaban (Rivaroxaban), section 'pregnancy', retrieved
      2026-08-29
    - Use rivaroxaban with caution in pregnant patients because of the potential for
      pregnancy related hemorrhage and/or emergent delivery.
      Source: US FDA label for rivaroxaban (Rivaroxaban), section 'pregnancy', retrieved
      2026-08-29
    - The anticoagulant effect of rivaroxaban cannot be reliably monitored with standard
      laboratory testing.
      Source: US FDA label for rivaroxaban (Rivaroxaban), section 'pregnancy', retrieved
      2026-08-29

  BREASTFEEDING
    - Females of reproductive potential requiring anticoagulation should discuss
      pregnancy planning with their physician.
      Source: US FDA label for rivaroxaban (Rivaroxaban), section 'nursing mothers',
      retrieved 2026-08-29
    - The risk of clinically significant uterine bleeding, potentially requiring
      gynecological surgical interventions, identified with oral anticoagulants
      including rivaroxaban should be assessed in females of reproductive potential and
      those with abnormal uterine bleeding.
      Source: US FDA label for rivaroxaban (Rivaroxaban), section 'nursing mothers',
      retrieved 2026-08-29
    - In rats, peripartal maternal bleeding and maternal and fetal death occurred at the
      rivaroxaban dose of 40 mg/kg (about 6 times maximum human exposure of the unbound
      drug at the human dose of 20 mg/day). 8.2 Lactation Risk Summary Rivaroxaban has
      been detected in human milk.
      Source: US FDA label for rivaroxaban (Rivaroxaban), section 'use in specific
      populations', retrieved 2026-08-29