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What the label lists and what reports show

Andexanet alfa side effects

Andexanet alfa's FDA label: “The most common adverse reactions (≥ 5%) in bleeding patients receiving ANDEXXA were urinary tract infections and pneumonia.” FAERS holds 708 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is cerebral infarction (54 reports).

  • No generic listed
  • Boxed warning

Check it at the source: the andexanet alfa FDA label on DailyMed (effective May 23, 2025); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

The most common adverse reactions (≥ 5%) in bleeding patients receiving ANDEXXA were urinary tract infections and pneumonia.

From the label: adverse reactions, continued

The most common adverse reactions (≥ 5%) in bleeding patients receiving ANDEXXA were urinary tract infections and pneumonia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AstraZeneca at 1-800-236-9933 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The most common adverse reactions (≥ 5%) in bleeding patients receiving ANDEXXA were urinary tract infections and pneumonia. In Study 3 (ANNEXA-4), four hundred and seventy-seven patients with acute major bleeding were enrolled and received ANDEXXA. Of these 477 patients, 419 patients were treated with apixaban (245/419; 58.5%) or rivaroxaban (174/419; 41.5%). Most patients had received apixaban or rivaroxaban as anticoagulation treatment for atrial fibrillation (348/419; 83%) or venous thromboembolism (65/419; 16%). In the majority of patients, ANDEXXA was used to reverse anticoagulant therapy following either an intracranial hemorrhage (289/419; 69%) or a gastrointestinal bleed (95/419; 23%), with the remaining patients (35/419; 8.4%) experiencing bleeding at other sites. …

Source: FDA drug label, 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?

708 reports list andexanet alfa among the medicines taken, 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. Of the 21 reactions below, 11 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

Reports received each year

The 25 most reported reactions

  • Death (an outcome recorded in the report)124
  • Off Label Use (a use or a product term, not a reaction)55
  • Cerebral Infarction54
  • Acute Myocardial Infarction37
  • Cerebral Haemorrhage36
  • Ischaemic Stroke (named in the label)36
  • Heparin Resistance (named in the label)34
  • Pulmonary Embolism (named in the label)34
  • Cerebrovascular Accident (named in the label)30
  • Myocardial Infarction (named in the label)30
  • Thrombosis (named in the label)27
  • Haemorrhage (named in the label)24
  • Deep Vein Thrombosis21
  • Subdural Haematoma19
  • Drug Interaction (a use or a product term, not a reaction)17
  • Intraventricular Haemorrhage17
  • Cardiac Arrest (named in the label)15
  • Embolism (named in the label)15
  • Drug Ineffective (a use or a product term, not a reaction)14
  • Pneumonia (named in the label)14
  • Haematoma13
  • Brain Oedema12
  • Haemorrhage Intracranial12
  • Cerebral Mass Effect11
  • Hypertension (named in the label)11

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Andexanet alfa: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions