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What the FDA labels say about taking them together

Andexanet alfa and rivaroxaban

Andexanet alfa's FDA label of May 23, 2025 names rivaroxaban in its warnings and precautions section; the rivaroxaban labels PlainMeds reads (2) do not name andexanet alfa. The andexanet alfa label: “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.”

Check it at the source: the andexanet alfa FDA label on DailyMed (effective May 23, 2025); the rivaroxaban FDA label on DailyMed (effective September 10, 2026, Janssen Pharmaceuticals, Inc.).

What does the andexanet alfa label say about rivaroxaban?

Andexanet alfa label, 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 does the rivaroxaban label say about andexanet alfa?

Rivaroxaban's label (effective September 10, 2026) and its 1 other brand-application label do not name andexanet alfa in these sections. A label lists what its studies and reports found; it is not a complete list.

Source: FDA drug label (Xarelto), Janssen Pharmaceuticals, Inc., effective September 10, 2026 (SPL set 10db92f9-2300-4a80-836b-673e1ae91610), via openFDA; the full label on DailyMed

These are the labels' own sentences. PlainMeds does not grade interactions; a pharmacist or prescriber can say what they mean for one person's medicines.

Both medicines on the record

0Andexanet alfa generic labelers
20Rivaroxaban generic labelers
Andexanet alfaRivaroxaban
Labeled forn/aAtrial fibrillation, Heart attack and coronary artery disease, Blood clots (DVT and PE), Stroke prevention
Boxed warningYesYes
Pharmacy cost (NADAC)n/a$0.650 per tablet 2.5 mg tablet
Shortage nowNo current entryA presentation being discontinued

Source: FDA NDC Directory, CMS NADAC of October 7, 2026 and the FDA Drug Shortage Database (FDA files October 8, 2026)

What next?