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Antiplatelet therapy and central nervous system hematomas: a cohort study using real-world data from the FAERS and

Lei Wang1, Haixia Cai, Shujuan Zhao

  • 1Department of Pharmacy, Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, School of Clinical Medicine, Henan University, Zhengzhou, Henan, China.

International Journal of Surgery (London, England)
|September 10, 2025
PubMed

Insights

Antiplatelet therapy is linked to central nervous system (CNS) hematomas, with aspirin and clopidogrel showing the strongest associations. Findings aid in managing risks for patients on these crucial cardiovascular medications.

Area of Science:

  • Cardiovascular Medicine
  • Neurology
  • Pharmacovigilance

Background:

  • Antiplatelet therapy is essential for managing atherosclerotic cardiovascular disease.
  • The risk of central nervous system (CNS) hematomas with antiplatelet agents requires further characterization.

Purpose of the Study:

  • To analyze the association between antiplatelet drugs and CNS hematomas.
  • To characterize risk differentials by demographics and temporal patterns.

Main Methods:

  • Analysis of CNS hematoma adverse event reports from FAERS and VigiAccess databases.
  • Disproportionality analysis (ROR) to identify safety signals.
  • Stratified analysis by age, gender, and time-to-onset.

Main Results:

  • Significant disproportionality signals for all four antiplatelet drugs (aspirin, clopidogrel, prasugrel, ticagrelor).
  • Aspirin and clopidogrel showed the strongest associations (RORs up to 40.13).
  • Subdural hematomas were most common; females showed stronger signals; early onset patterns observed.

Conclusions:

  • A significant association exists between antiplatelet therapy and CNS hematomas.
  • Distinct patterns vary by drug, patient demographics, and onset time.
  • Findings support improved risk stratification and safety monitoring for antiplatelet use.
Abstract

Keywords:
FAERSVigiAccessantiplatelet drugscentral nervous systemhematomaspharmacovigilance

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