Postmarketing Safety Concerns With Caplacizumab: A Real-World Pharmacovigilance Study Based on the FDA Adverse Event Reporting System Database

CONCLUSIONS: These findings underscore the importance of pharmacovigilance and postmarketing surveillance for caplacizumab. Clinicians should closely monitor bleeding events and injection site reactions during treatment. To ensure the safe use of caplacizumab, the mechanisms underlying these potential signals should be elucidated, and targeted monitoring strategies should be developed.