Adverse drug reactions of commonly used antibiotics in pediatric populations: A clinical perspective

Abstract

How frequently do children prescribed routine antibiotics experience clinically meaningful adverse drug reactions, and what factors shape the severity of these events? This research addressed that question through a prospective, multicenter evaluation conducted across two Irish academic pediatric centers between February 2022 and October 2024. A total of 738 pediatric patients aged 0 to 17 years who received at least one systemic antibiotic course were included in the final analysis following rigorous screening of 1,847 potential candidates. Adverse drug reactions were identified using the Naranjo causality assessment scale and classified by organ system involvement, severity grade, and temporal onset relative to antibiotic initiation. Among all participants, 17.6% experienced at least one adverse drug reaction during the observation window. Gastrointestinal manifestations accounted for the largest proportion at 43.1%, followed by dermatological reactions at 29.8% and hepatic disturbances at 11.4%. Co-amoxiclav was associated with the highest overall reaction rate of 24.7%, whereas clarithromycin demonstrated the lowest at 9.8%. Younger children, particularly those below two years of age, exhibited significantly elevated rates of mild and moderate reactions compared with adolescents in the 14 to 17 year bracket (p