Andexanet Alfa: Side Effects, Uses & Monitoring
ANDEXXA is indicated for patients treated with rivaroxaban or apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.
- Data source
- FDA labeling via NIH DailyMed (label 2d9d90a6…)
- Label version
- current
- Last reviewed
- 2026
Reported adverse reactions
Reactions listed in current FDA labeling, with the highest frequency reported across summarized placebo-controlled trials.
No structured frequency data available in current labeling. Consult the official label.
Labeled uses (from FDA prescribing information)
ANDEXXA is indicated for patients treated with rivaroxaban or apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding. This indication is approved under accelerated approval based on the change from baseline in anti-FXa activity in healthy volunteers [see Clinical Studies (14) ] . An improvement in hemostasis has not been established. Continued approval for this indication may be contingent upon the results of studies that demonstrate an improvement in hemostasis in patients.
Frequently Asked Questions
What is Andexanet Alfa used for?
FDA labeling lists the approved uses shown above under "Labeled uses." This summary is informational; only a qualified prescriber can determine whether a medication is appropriate for you.
What are the most commonly reported side effects of Andexanet Alfa?
Current labeling for this ingredient does not include a structured frequency table that we can reproduce. Review the official label linked below.
Does Andexanet Alfa require lab monitoring?
Monitoring needs vary. Ask your healthcare provider whether any lab tests apply while taking Andexanet Alfa.
Where does this information come from?
All clinical facts on this page were extracted from the current FDA-registered product labeling for this ingredient, published by manufacturers through NIH DailyMed. See the source link below.
Medical disclaimer: Educational content extracted from public FDA labeling. Not medical advice. Always consult a qualified healthcare professional before starting, stopping, or changing any medication.