Pharmacovigilance in the treatment of cutaneous leishmaniasis: adverse event profile at a reference center.

BACKGROUND: Cutaneous leishmaniasis treatment is frequently associated with adverse events (AEs). We investigated the profile of AEs and examined their associations. METHODS: This prospective observational study was conducted at a Brazilian reference center to describe AEs according to their occurrence rate, severity, and seriousness. RESULTS: Among 318 AEs recorded in 92 patients, the highest AE occurrence rate was among those treated with miltefosine. The highest rate of serious AEs was among patients treated with liposomal amphotericin B. Local therapy using meglumine antimoniate showed a more favorable safety profile. CONCLUSION: The different profiles highlight the importance of pharmacovigilance in real-world settings.