Toward the future management of patients with CML and Ph + ALL: real-world safety insights from dasatinib pharmacovigilance

This large FAERS analysis characterized known respiratory complications of dasatinib, particularly pleural effusion, and identified several rare but potentially relevant safety signals hepatotoxicity, cardiovascular events, and novel AEs such as alveolar proteinosis and cytomegalovirus-related complications. The early failure pattern underscores the need for intensive monitoring during initiation and continued vigilance during long-term therapy. These findings provide real-world, hypothesis-generating evidence to optimize safety management and inform future clinical investigations, and should be interpreted with caution in view of the inherent limitations of spontaneous reporting data.