A Disproportionality Analysis of Adverse Events Caused by Pexidartinib from the FDA Adverse Event Reporting System

This study analyzed 844 reports of adverse events (AEs) associated with pexidartinib, a CSF1R inhibitor used for treating tenosynovial giant cell tumor (TGCT), using data from the FDA Adverse Event Reporting System. The analysis revealed that hepatic events and systemic reactions, such as fatigue and hair discoloration, were the most common AEs, with a median onset of 35 days. Females, who made up 71.3% of cases, showed higher susceptibility to constipation and alopecia. The study identified 84 significant adverse event terms and highlighted the importance of long-term monitoring due to hepatotoxicity and delayed-onset AEs. These findings emphasize the need for risk mitigation protocols and validate the use of FAERS for post-marketing surveillance in TGCT management.