Andexxa Side Effects
Generic name: coagulation factor Xa
Medically reviewed by Drugs.com. Last updated on Jul 29, 2023.
Note: This document contains side effect information about coagulation factor Xa. Some dosage forms listed on this page may not apply to the brand name Andexxa.
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 of Andexxa
Along with its needed effects, coagulation factor Xa (the active ingredient contained in Andexxa) 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
- Anxiety
- blue lips, fingernails, or skin
- chest pain or discomfort
- confusion
- cool, sweaty skin
- cough
- decreased urine output
- difficulty in speaking
- dilated neck veins
- dizziness
- double vision
- extreme tiredness or weakness
- fainting
- fast heartbeat
- headache
- inability to move the arms, legs, or facial muscles
- inability to speak
- irregular heartbeat
- irregular, fast or slow, or shallow breathing
- lightheadedness
- nausea
- pain or discomfort in the arms, jaw, back, or neck pain
- redness, or swelling in the arm or leg
- slow speech
- sweating
- swelling of the face, fingers, feet, or lower legs
- tightness in the chest
- troubled breathing
- vomiting
- weakness
- weight gain
Less common
- Fast, pounding, or irregular heartbeat or pulse
- palpitations
Other side effects of Andexxa
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
- Bladder pain
- bloody or cloudy urine
- change in taste
- chills
- cough
- difficult, burning, or painful urination
- feeling of warmth
- fever
- frequent urge to urinate
- loss of taste
- lower back or side pain
- redness of the face, neck, arms, and occasionally, upper chest
- sneezing
- sore throat
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
Frequently asked questions
More about Andexxa (coagulation factor Xa)
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- FDA approval history
- Drug class: anticoagulant reversal agents
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Patient resources
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Related treatment guides
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.
