Adverse Drug Reactions to Anti-infectives in Hospitalized Children: A Multicenter Study in Brazil.

Introduction Adverse drug reactions (ADRs) to anti-infectives affect especially hospitalized children and contribute to increased morbidity, mortality, length of stay, and costs in healthcare systems. Objective To assess ADRs associated with anti-infective use in Brazilian hospitalized children. Methods A prospective cohort study was conducted in 5 public hospitals over 6 months. Children aged 0–11 years and 11 months who were hospitalized for more than 48 h and prescribed anti-infectives for over 24 h were included. Results A total of 1020 patients met the inclusion criteria. Of these, 152 patients experienced 183 suspected ADRs. Most reactions were related to the gastrointestinal system (65.6%), followed by skin reactions (18.6%). Most reactions were classified as probable causality (58.5%), moderate severity (61.1%), and unavoidable (56.2%). Our findings showed that ADRs were associated with increased length of stay (P <.001), increased length of therapy (P <.015), increased days of therapy (P =.038), and increased number of anti-infectives prescribed per patient (P <.001). Conclusion Almost 15% of hospitalized children exposed to anti-infectives presented suspected ADRs. Their occurrence was classified as probable, of moderate severity, and unavoidable. ADRs were significantly influenced by the length of hospital stay and the number of anti-infectives prescribed per patient. [ABSTRACT FROM AUTHOR]