Skip to main content

Coagulation factor Xa Side Effects

Medically reviewed by Drugs.com. Last updated on Feb 2, 2024.

Applies to coagulation factor Xa: intravenous powder for solution.

Warning

Intravenous route (Powder for Solution)

Thromboembolic Risks, Ischemic Risks, Cardiac Arrest, and Sudden DeathsTreatment with coagulation factor Xa (recombinant) IV injection has been associated with serious and life-threatening adverse events, including:Arterial and venous thrombolic eventsIschemic events, including myocardial infarction and ischemic strokeCardiac arrestSudden deathsMonitor for thromboembolic events and initiate anticoagulation when medically appropriate. Monitor for symptoms and signs that precede cardiac arrest and provide treatment as needed.

Serious side effects

Along with its needed effects, coagulation factor Xa may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking coagulation factor Xa:

More common

Less common

Other side effects

Some side effects of coagulation factor Xa may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

For Healthcare Professionals

Applies to coagulation factor Xa: intravenous powder for injection.

General

The most frequently reported side effects included urinary tract infections, infusion-related reactions, flushing, feeling hot, cough, dysgeusia, dyspnea, and pneumonia.[Ref]

Cardiovascular

Very common (10% or more): Acute myocardial infarction (up to 16%), deep vein thrombosis (up to 25%)

Common (1% to 10%): Cardiogenic shock, congestive heart failure, hypertension, hypotension, myocardial infarction

Uncommon (0.1% to 1%): Cardiac arrest, cardiac thrombus, iliac artery occlusion, non-sustained ventricular tachycardia

Frequency not reported: Flushing[Ref]

Dermatologic

Frequency not reported: Mild hives[Ref]

Gastrointestinal

Common (1% to 10%): Constipation, nausea

Genitourinary

Very common (10% or more): Urinary tract infection (10%)[Ref]

Hematologic

Very common (10% or more): Thromboembolic events (up to 18%)

Immunologic

Very common (10% or more): Anti-drug antibodies (up to 17%)[Ref]

Other

Very common (10% or more): Death (up to 15%), infusion-related reactions (up to 18%)

Common (1% to 10%): Pyrexia, sudden death

Frequency not reported: Chills, feeling hot, rigors[Ref]

Nervous system

Very common (10% or more): Cerebrovascular accident (up to 25%)

Common (1% to 10%): Headache, ischemic stroke

Uncommon (0.1% to 1%): Cerebral infarction, embolic stroke, transient ischemic attack

Frequency not reported: Dysgeusia[Ref]

Other

Infusion-related reactions were characterized by a range of symptoms, which included flushing, feeling hot, cough, dysgeusia, dyspnea, rigors, chills, hypertension, oxygen desaturation, agitation, and confusion.

In clinical studies, death was reported in 15% of patients prior to the day 30 follow-up visit. The percentage of patients, by bleeding type, who died prior to the day 30 follow-up was: 14% for intracranial bleeding, 10% for gastrointestinal bleeding, and 19% for other bleeding types.[Ref]

Respiratory

Very common (10% or more): Pulmonary embolism (up to 8%)

Common (1% to 10%): Acute respiratory failure, pneumonia, pneumonia aspiration

Frequency not reported: Cough, dyspnea, oxygen desaturation[Ref]

Psychiatric

Common (1% to 10%): Delirium

Frequency not reported: Agitation, confusion

References

1. Product Information. Andexxa (coagulation factor Xa). Portola Pharmaceuticals. 2022.

2. Product Information. Andexxa (coagulation factor Xa). AstraZeneca Pty Ltd. 2023.

3. Product Information. Ondexxya (coagulation factor Xa). AstraZeneca UK Ltd. 2023.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.