Adverse events associated with ustekinumab in Crohn's disease treatment: an analysis based on the FAERS database

CONCLUSION: In the treatment of CD with ustekinumab, it is critical to monitor not only common AEs like infections and tumors, but also less frequent yet severe AEs, including cardiac disorders, hepatobiliary disorders, and possible congenital anomalies. The latter, however, requires further validation through additional clinical evidence.