Characterization of adverse event reports of antibiotic therapy in pediatrics in Brazil between 2018 and 2025

Abstract

Objective: To describe the characteristics of adverse events related to the main antibiotics used in pediatrics reported to VigiMed in Brazil, from 2018 to 2025. Methods: This is a retrospective ecological quantitative study, in which data collected from VigiMed referring to the pediatric population (0 to 17 years) were evaluated. The chi-square test was applied to assess statistical relevance, with a significance level of 0.05. Results: Adverse events related to antibiotics in pediatrics revealed a significant influence of age group on the frequency and type of reactions, particularly with vancomycin, ceftriaxone, and meropenem. Pruritus and skin rashes were common in children and adolescents. Meropenem and ceftriaxone showed greater variation between age groups and were associated with more severe reactions, including hospitalizations and deaths. Oxacillin, although frequently reported, did not demonstrate a statistically significant difference between ages and was linked to less severe events. Vancomycin accounted for the highest number of reports, but with incomplete data. The results highlight the importance of age in antibiotic response and the need for greater accuracy in severity records. Conclusion: The study reinforces the relevance of pharmacovigilance in pediatric clinical practice, emphasizing the need to improve reporting quality and promote the rational use of antibiotics to ensure greater therapeutic safety.