Quick answers
- What is Andexanet alfa used for?
- The FDA-approved label (Andexxa, AstraZeneca Pharmaceuticals LP, May 23, 2025) says: “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 […]. An improvement in hemostasis has not been established. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Andexanet alfa have a boxed warning?
- Yes. The FDA label for Andexxa has a boxed warning (“WARNING: THROMBOEMBOLIC RISKS, ISCHEMIC RISKS, CARDIAC ARREST, AND SUDDEN DEATHS”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Andexanet alfa?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Andexanet alfa been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Andexanet alfa?
- 1 company lists prescription products of Andexanet alfa in the FDA NDC Directory, including AstraZeneca Pharmaceuticals LP.
What Andexanet alfa is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
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 […]. An improvement in hemostasis has not been established. …
— FDA label: Andexxa, AstraZeneca Pharmaceuticals LP, effective May 23, 2025. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Its heading: WARNING: THROMBOEMBOLIC RISKS, ISCHEMIC RISKS, CARDIAC ARREST, AND SUDDEN DEATHS
. Read it on the full label →
Forms and how it is given
| Dosage forms | Injection, powder, lyophilized, for solution |
|---|---|
| Route | Intravenous |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Andexxa |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- AstraZeneca Pharmaceuticals LP1 product
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA125586 | — | Date not on file | — |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 2108128, 2108130 |
|---|---|
| SPL set ID of the quoted label | 2d9d90a6-63e6-46ef-96ff-dd6519ae7b6c |
| FDA labels (SPL) | 1 |
| FDA applications | BLA125586 |
| Active ingredients (FDA) | ANDEXANET ALFA |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Andexxa, AstraZeneca Pharmaceuticals LP, effective May 23, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →