Disproportionality Analysis Comparing Safety Profiles of Sonidegib and Vismodegib Based on the FAERS Database

This study analyzed the long-term safety profiles of hedgehog pathway inhibitors, sonidegib and vismodegib, using FAERS data from 2012 to 2024. It identified common adverse events (AEs) like muscle spasms, alopecia, and ageusia, and unexpected AEs such as triple negative breast cancer and squamous cell carcinoma for sonidegib, and atrophic glossitis and deafness for vismodegib. Gender differences in AE signals and median time to onset were noted. The study highlights differences in reporting patterns between the drugs, suggesting areas for further research, but emphasizes that FAERS data cannot establish causality, serving instead as a basis for generating clinical hypotheses.