Adverse Drug Reactions To Antiinfectives In Hospitalized Children: A Multicenter Study In Brazil.

INTRODUCTION
Adverse drug reactions (ADRs) to antiinfectives affect especially hospitalized children and contribute to increased morbidity, mortality, length of stay, and costs in healthcare systems.


OBJECTIVE
To assess ADRs associated with antiinfectives use in Brazilian hospitalized children.


METHODS
A prospective cohort study was conducted in five public hospitals over six months. Children aged 0 to 11 years and 11 months who were hospitalized for more than 48 hours and prescribed antiinfectives for over 24 hours were included.


RESULTS
A total of 1.020 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 < 0.001), increased length of therapy (p <0.015), increased days of therapy (p = 0.038), and increased number of antiinfectives prescribed per patient (p < 0.001).


CONCLUSION
Almost 15% of hospitalized children exposed to antiinfectives 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 antiinfectives prescribed per patient.