Black Box Warning

BOXED WARNING — Premature Discontinuation Risk: Premature discontinuation of Xarelto in AFib increases stroke risk. If Xarelto is discontinued for reasons other than completed treatment or pathological bleeding, consider transitioning to another anticoagulant immediately.

What this means:A black box warning is the FDA's strongest required safety notice. It signals a serious or life-threatening risk. Patients should review this with their prescriber before starting, continuing, or switching Xarelto.

Other warnings & precautions

BOXED WARNING — Spinal/Epidural Hematoma: Neuraxial anesthesia or spinal puncture in patients on Xarelto risks spinal hematoma causing permanent paralysis. Consider timing of last dose before and after neuraxial procedure.
BOXED WARNING — Bleeding Risk: Xarelto has no approved reversal agent that is universally available. Andexanet alfa (Andexxa) can reverse anti-Xa activity but is not available everywhere. For life-threatening bleeding: andexanet alfa or 4-factor PCC (Kcentra).
No routine INR monitoring required. However, patients must adhere to dosing schedule — missed doses increase thromboembolic risk.
Pregnancy: Xarelto crosses the placenta; increased risk of fetal harm and obstetric hemorrhage. Use only if benefits outweigh risks.
Renal monitoring: Check renal function at least annually. More frequent monitoring with borderline CrCl.
Crushed tablets: Xarelto can be crushed and mixed with applesauce for patients unable to swallow. Must be taken with food for 15 mg and 20 mg doses.

Black Box Warning

Other warnings & precautions

BOXED WARNING — Spinal/Epidural Hematoma: Neuraxial anesthesia or spinal puncture in patients on Xarelto risks spinal hematoma causing permanent paralysis. Consider timing of last dose before and after neuraxial procedure.
BOXED WARNING — Bleeding Risk: Xarelto has no approved reversal agent that is universally available. Andexanet alfa (Andexxa) can reverse anti-Xa activity but is not available everywhere. For life-threatening bleeding: andexanet alfa or 4-factor PCC (Kcentra).
No routine INR monitoring required. However, patients must adhere to dosing schedule — missed doses increase thromboembolic risk.
Pregnancy: Xarelto crosses the placenta; increased risk of fetal harm and obstetric hemorrhage. Use only if benefits outweigh risks.
Renal monitoring: Check renal function at least annually. More frequent monitoring with borderline CrCl.
Crushed tablets: Xarelto can be crushed and mixed with applesauce for patients unable to swallow. Must be taken with food for 15 mg and 20 mg doses.

Xarelto Black Box Warning

Black Box Warning

Other warnings & precautions

Xarelto Black Box Warning

Black Box Warning

Other warnings & precautions