Praxis Medical Insights

Est. 2024 • Clinical Guidelines Distilled

Made possible by volunteer editors from the University of Calgary & University of Alberta

Last Updated: 9/14/2025

Acalabrutinib Side Effects and Management

Introduction to Acalabrutinib Side Effects

  • Acalabrutinib has a more favorable cardiovascular safety profile compared to ibrutinib, with lower rates of atrial fibrillation and hypertension, and commonly causes headache, diarrhea, and bleeding events 1, 2

Common Side Effects

  • Diarrhea occurs in 58% of patients 2
  • Headache occurs in 39% of patients, typically resolves after 1-2 months, and can be managed with acetaminophen and caffeine supplements 1, 2
  • Fatigue occurs in 10-18% of patients 2
  • Pyrexia occurs in 12-21% of patients 2

Cardiovascular Side Effects

  • Atrial fibrillation has an overall incidence of 4-5% and 1% grade ≥3 1
  • Hypertension has an overall incidence of 3-5% and 2-3% grade ≥3 1

Bleeding Events

  • Overall bleeding risk is 26-39% for any grade bleeding and 2% for grade ≥3 bleeding 1
  • Monitor patients requiring antiplatelet or anticoagulant therapies and avoid concomitant warfarin use 1, 3

Infections

  • Overall infection rate is 65% and grade ≥3 infections occur in 14% of patients 1
  • Pneumonia and upper respiratory tract infections are most common 1, 2

Management Considerations

  • For headaches, manage with analgesics (acetaminophen) and caffeine supplements 1
  • For cardiovascular events, monitor for atrial fibrillation and hypertension and consider switching therapy if not medically controllable 1
  • For patients on anticoagulants, evaluate benefit and risk carefully, avoid concomitant warfarin use, and monitor for signs of bleeding 1, 3

REFERENCES

3

Safety of Aripiprazole with Warfarin [LINK]

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