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.