Adverse events associated with vismodegib: insights from a real-world pharmacovigilance study using the FAERS database

This study analyzed 7,733 adverse event reports for vismodegib from the FDA Adverse Event Reporting System to assess its safety profile in treating advanced basal cell carcinoma. Known adverse events such as muscle spasms, taste alterations, alopecia, fatigue, and weight loss were confirmed, while potential new adverse events like squamous cell carcinoma, dehydration, and dysphagia were identified. The median onset for these events was 69 days after starting treatment, emphasizing the need for close monitoring, especially in the first 2 months. The findings enhance understanding of vismodegib's safety in real-world settings, aiding in its informed use in clinical practice.