Objective To analyze the reporting characteristics of intracranial hemorrhage associated with anti-amyloid beta (Aβ) monoclonal antibodies and investigate the association between concomitant antithrombotic therapy and reporting of intracranial hemorrhage and serious adverse events (SAEs), utilizing data from the FDA Adverse Event Reporting System (FAERS).

Methods Adverse event reports from the FAERS database spanning the first quarter of 2021 to the first quarter of 2026 were extracted. Cases were selected where aducanumab, donanemab, or lecanemab were listed as the primary suspected drugs. Data on amyloid-related imaging abnormalities-hemorrhage (ARIA-H), amyloid-related imaging abnormalities-edema/effusion (ARIA-E), intracranial hemorrhage, severe neurological adverse events, and concomitant use of antithrombotic agents were recorded. Multivariable logistic regression was employed to identify factors associated with intracranial hemorrhage and SAEs.

Results A total of 5,908 reports were analyzed, comprising 110 cases of ARIA-H, 112 of ARIA-E, 321 of intracranial hemorrhage, and 529 of severe neurological adverse events. Concomitant antithrombotic therapy was documented in 430 reports. The group receiving antithrombotic agents exhibited a significantly higher proportion of intracranial hemorrhage (9.30% vs. 5.13%) and SAEs (62.33% vs. 42.75%) compared to the group without concomitant therapy (P<0.001). Multivariable regression analysis revealed that antiplatelet drugs were significantly associated with an elevated risk of intracranial hemorrhage [OR=1.73, 95%CI(1.13, 2.65), P=0.012]. Furthermore, ARIA-E, antiplatelet agents, anticoagulants, advanced age, and donanemab use were all associated with an increasing reporting rate of SAEs, with age demonstrating a non-linear dose-response relationship with SAE risk.

Conclusion Concomitant antithrombotic therapy is significantly associated with a higher reporting rate of intracranial hemorrhage and SAEs related to anti-Aβ monoclonal antibodies. Advanced age constitutes a significant risk factor for SAEs. These findings warrant validation through prospective studies. Proactive risk assessment before treatment initiation and enhanced therapeutic monitoring in clinical practice are recommended.

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