Drug‐Induced Vitiligo: FDA Adverse Events Reporting System ( FAERS ) and Canada Vigilance Adverse Reaction ( CAVR ) Database Analysis and Literature Review

Background Vitiligo is a common chronic acquired pigmentation disease, that usually occurs with an asymptomatic whitish patch or macule. Although previous studies have reported several cases of drug‐induced vitiligo, there are few comprehensive studies determining the drugs that induce vitiligo. Aims This study investigated the risk factors for drug‐induced vitiligo by analyzing a large dataset from the FDA Adverse Event Reporting System (FAERS) and the Canada Vigilance Adverse Reaction (CVAR) database. Methods Disproportionality analysis using the reporting odds ratio (ROR) method, with p ‐values adjusted via Bonferroni correction, identified significant signals. Drugs with positive signals were analyzed for annual reporting trends using linear regression. Time‐to‐onset analysis was also performed. Results We identified 1910 reports in FAERS and 316 reports in the CAVR database related to vitiligo. Disproportionality analysis revealed significant signals for 57 drugs in FAERS and 7 drugs in the CAVR database. Most were antineoplastic drugs and immune inhibitors with significant annual increases in vitiligo reports. Through reviewing reports of immune inhibitors induced vitiligo, we found that the severity of the disease may be related to the occurrence of vitiligo AE. The median time to onset of vitiligo was 86 days, with over half of the cases occurring within 90 days of initiating medication. Conclusions This study confirmed safety signals associated with various antineoplastic agents and immune inhibitors, highlighting the importance of ongoing pharmacovigilance. Further mechanistic investigations are needed to clarify the pathological pathways underlying drug‐induced vitiligo.