Prescription medicine
Andexanet alfa Brand names: Andexxa
Andexanet alfa (Andexxa) is a prescription medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the andexanet alfa FDA label on DailyMed (effective May 23, 2025); every andexanet alfa label on DailyMed.
Highlights of the record
FDA label of May 23, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
THROMBOEMBOLIC RISKS, ISCHEMIC RISKS, CARDIAC ARREST, AND SUDDEN DEATHS.
Treatment with ANDEXXA has been associated with serious and life-threatening adverse events, including: ( 5.1 )
Arterial and venous thromboembolic events
Ischemic events, including myocardial infarction and ischemic stroke
Cardiac arrest
Sudden deaths Monitor for thromboembolic events and initiate anticoagulation when medically appropriate. Monitor for symptoms and signs that precede cardiac arrest and provide treatment as needed. WARNING: THROMBOEMBOLIC RISKS, ISCHEMIC RISKS, CARDIAC ARREST, and SUDDEN DEATHS See full prescribing information for complete boxed warning Treatment with ANDEXXA has been associated with serious and life-threatening adverse events, including: ( 5.1 )
Arterial and venous thromboembolic events
Ischemic events, including myocardial infarction and ischemic stroke
Cardiac arrest
Sudden deaths Monitor for thromboembolic events and initiate anticoagulation when medically appropriate. Monitor for symptoms and signs that precede cardiac arrest and provide treatment as needed.
Used for
From the label: indications and usageANDEXXA is indicated for patients treated with rivaroxaban or apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.
Forms and strengths
- 200 mg/20ml
Injection (powder) (lyophilized) for solution.
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 708 through July 30, 2026
What is andexanet alfa used for?
From the label: indications and usageANDEXXA 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. […]
Source: FDA drug label (ANDEXXA), AstraZeneca Pharmaceuticals LP, effective May 23, 2025 (SPL set 2d9d90a6-63e6-46ef-96ff-dd6519ae7b6c), via openFDA; the full label on DailyMed
Is there a generic for andexanet alfa (Andexxa)?
No generic andexanet alfa is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the andexanet alfa label say about other medicines?
The andexanet alfa label names 3 other medicines in its interaction, contraindication or warning sections. The labels of 2 other medicines name andexanet alfa. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Apixaban | warnings and precautions | The thromboembolic and ischemic risks were assessed in 419 bleeding -patients in the ANNEXA-4 study who received ANDEXXA and were treated with apixaban or rivaroxaban. |
| Heparin | drug interactions | DRUG INTERACTIONS Do not use unfractionated heparin following ANDEXXA administration due to unresponsiveness characterized by non-prolongation of activated clotting times ( 7.1 ). |
| Rivaroxaban | warnings and precautions | The thromboembolic and ischemic risks were assessed in 419 bleeding -patients in the ANNEXA-4 study who received ANDEXXA and were treated with apixaban or rivaroxaban. |
Source: FDA drug label (ANDEXXA), AstraZeneca Pharmaceuticals LP, effective May 23, 2025 (SPL set 2d9d90a6-63e6-46ef-96ff-dd6519ae7b6c), via openFDA; the full label on DailyMed
What do FAERS reports show for andexanet alfa?
The FDA Adverse Event Reporting System holds 708 reports that list andexanet alfa among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 321 are coded as a death and 174 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Andexanet alfa side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other