What are the side effects of Eliquis (apixaban)?

Side Effects of Eliquis (Apixaban)

The most significant side effect of Eliquis (apixaban) is bleeding, which can range from minor bruising to potentially life-threatening hemorrhage, though it has a lower risk of major bleeding compared to warfarin. 1

Common Side Effects

Eliquis (apixaban) can cause several side effects, including:

• Bleeding-related complications:

  • Major bleeding (including intracranial hemorrhage)
  • Clinically relevant non-major bleeding
  • Minor bleeding (bruising, nosebleeds, gum bleeding)
  • Gastrointestinal bleeding

• Other reported side effects:

  • Skin rash
  • Allergic reactions (which can be severe)
  • Nausea
  • Anemia
  • Bruising

Bleeding Risk Factors

Several factors can increase the risk of bleeding with apixaban:

• Patient-related factors:

  • Advanced age (≥80 years) 2
  • Low body weight (≤60 kg) 2
  • Renal impairment (elevated serum creatinine ≥1.5 mg/dL) 2, 3
  • History of bleeding 2
  • Concurrent use of antiplatelet medications 2
  • Fall risk 2

• Medication interactions:

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir) 2
  • P-glycoprotein (P-gp) inhibitors 2
  • Concurrent use of other anticoagulants or antiplatelets 2
  • SSRIs (like sertraline) may potentially increase bleeding risk 3

Dosing Considerations

Inappropriate dosing can affect both safety and efficacy:

• Underdosing risks:

  • Potential increased risk of thromboembolic events 2

• Overdosing risks:

  • Significantly increased risk of bleeding events 2

The FDA-approved dosing criteria for apixaban require dose reduction to 2.5 mg twice daily when at least two of the following criteria are met 3:

• Age ≥80 years
• Body weight ≤60 kg
• Serum creatinine ≥1.5 mg/dL

Special Populations

• Severe renal impairment:

  • Higher doses (5 mg twice daily) are associated with increased bleeding risk compared to reduced doses (2.5 mg twice daily) in patients with severe chronic kidney disease, without differences in stroke prevention or mortality 4
  • Apixaban should be avoided in patients with severe renal impairment (CrCl <15 mL/min) 2

• Hepatic impairment:

  • Apixaban should be avoided in patients with significant hepatic impairment (transaminases >2 times upper limit of normal or total bilirubin >1.5 times upper limit of normal) 2

Monitoring and Management

• Monitor for signs of bleeding:

  • Unexplained bruising
  • Prolonged bleeding after minor cuts
  • Blood in urine or stool
  • Unusual headaches or dizziness 3

• Seek immediate medical attention for:

  • Chest pain or tightness
  • Swelling of face or tongue
  • Trouble breathing or wheezing
  • Feeling dizzy or faint 1

• If a fall or injury occurs, especially to the head, contact healthcare provider immediately for evaluation 1

Pharmacokinetic Considerations

Apixaban has several characteristics that affect its safety profile:

• Half-life of approximately 12 hours 2, 5
• Primarily metabolized via the liver (CYP3A4-dependent) 2
• Approximately 27% renal elimination 2, 5
• Multiple elimination pathways (metabolism, biliary excretion, direct intestinal excretion) 5

Understanding these side effects and risk factors is crucial for safe use of apixaban. Regular monitoring and appropriate dose selection based on patient characteristics can help minimize adverse events while maintaining therapeutic efficacy.