EPIDEMIOLOGICAL AND CLINICAL PROFILE OF NOTIFICATIONS RELATED TO ADVERSE EVENTS TO BOTULINUM TOXIN IN BRAZIL: AN ANALYSIS OF DATA FROM VIGIMED (2018–2025)

Abstract

This article sought to report adverse events related to the use of botulinum toxin in Brazil from 2018 to 2025. This study is a cross-sectional, descriptive, retrospective analysis with a quantitative approach. To this end, data was collected from the vigiMed platform, including: patient gender, period from 2018 to 2025, adverse event classification, notification status, and the reporting professional in Brazil. The data were tabulated using Microsoft Excel software and evaluated using descriptive statistics. As a result, 401 reports of adverse events related to the use of botulinum toxin were observed, with the highest number of reports in 2024, involving female patients, with no age reported, in the state of São Paulo, reported by health professionals. The toxin presented life-threatening events, mainly neurological disorders, and presents as a problem the high number of cases of therapeutic ineffectiveness. Therefore, there is evidence of low reporting of this medicine, which reinforces the importance of strengthening pharmacovigilance actions and the rational use of this substance.