Cutaneous Adverse Reactions Associated With Enfortumab Vedotin: A Pharmacovigilance Study Based on the FDA Adverse Event Reporting System

A pharmacovigilance study using the FDA Adverse Event Reporting System identified 1,389 cases of cutaneous adverse events (AEs) associated with enfortumab vedotin (EV), a treatment for urothelial carcinoma. Common AEs included rash, pruritus, and alopecia, with severe reactions like Stevens–Johnson syndrome. The study found 44 positive safety signals, 10 of which were previously unlabeled. Most AEs occurred within the first 2 weeks of treatment, primarily in elderly males. Concomitant prednisolone use increased AE reporting and mortality, while amlodipine use decreased AE reporting. These findings underscore the need for early dermatologic surveillance and personalized safety management during EV therapy.