Official websites use. Share sensitive information only on official, secure websites. Antibiotics are among the most prescribed drugs in pediatric inpatients and are frequently associated with adverse drug reactions ADRs in children.
This study aimed to assess the frequency and type of ADRs related to the use of antibiotics in pediatric inpatients through a prospective observational study, conducted over 6 months, covering the winter and spring seasons when the incidence of infections peaks in Romania. ADRs were evaluated for causality, avoidability and severity. Among the included children, 25 9. Gastrointestinal and hematological ADRs were most frequently observed.
Diarrhea was the most common ADR associated with antibiotics 8 of 30, Ceftriaxone 16 of 30, After causality assessment, 2 6. One ADR was classified as definitely avoidable and one as possibly avoidable. Seven children required treatment for ADRs. Antibiotic treatment was discontinued in 4 children. Close monitoring of antibiotic-associated ADRs remains important in the pediatric population.
Keywords: adverse drug reaction, antibiotics, hospitalized children, causality, avoidability. Antibiotics are widely prescribed to children in primary care and hospital settings [ 1 , 2 ]. Patterns of antibiotic prescription vary across different age groups [ 1 ] and in different countries according to national guidelines [ 3 , 4 ]. Antibiotics are responsible for almost a quarter of the adverse drug reactions ADRs occurring in hospitalized children; a higher incidence of ADRs was observed in hospitalized versus non-hospitalized children [ 5 , 6 ].
The low number of clinical trials conducted on children limits the amount of available data on drug safety for this category of patients [ 7 ]. In addition, not all ADRs experienced by adults can be extrapolated to children due to the state of developing organs and systems in the pediatric population, resulting in age-specific physiology [ 8 , 9 ].
