Disproportionality analysis comparing safety profiles of sonidegib and vismodegib based on the FAERS database.

ABSTRACT: This study aims to comprehensively evaluate the long-term safety profiles of hedgehog pathway inhibitors (HPIs), sonidegib and vismodegib, which have been approved for basal cell carcinoma but lack extensive real-world safety data. Using the FDA Adverse Event Reporting System (FAERS) data from 2012 to 2024, we analyzed adverse events (AEs) associated with these drugs. Notably, most reports were from North America and Europe, which may result in limited generalizability to other populations. Four disproportionality analysis algorithms (ROR, PRR, BCPNN, MGPS) were employed to identify significant AEs across 25 System Organ Classes (SOCs). Common AEs included muscle spasms, alopecia, and ageusia. Unexpected AEs, such as triple negative breast cancer (TNBC), squamous cell carcinoma, and comple

SUBMITTER: Zheng Z 

PROVIDER: S-EPMC12578889 | biostudies-literature | 2025 Oct

REPOSITORIES: biostudies-literature