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Mohd Shadab
Jyotsna Sharma
Rajni Kumari Rai
Shaktibala Dutta


Adverse Drug Reactions, Antibiotics, Pediatrics, Gender Disparities, Age Differences, Drug Safety


Background: Adverse Drug Reactions (ADRs) are a significant concern in pediatric healthcare, potentially leading to increased morbidity and healthcare costs. This study aimed to characterize ADRs to antibiotics among pediatric patients, focusing on age and gender disparities.

Methods: A prospective observational study was conducted over 11 months at a tertiary care hospital involving 300 pediatric patients aged 28 days to 18 years. Antibiotics were prescribed according to standard treatment guidelines, and ADRs were assessed using the WHO causality assessment scale. Data were analyzed using IBM SPSS Statistics 25.

Results: A total of 34 ADRs were observed, with a higher prevalence in males (61.76%) compared to females (38.23%). The age group of 17-18 years exhibited the most ADRs (44.11%). Penicillins were the leading cause of ADRs (67.64%), followed by cephalosporins, macrolides, fluoroquinolones, and lincosamides. The most common ADRs were thrombophlebitis, eosinophilia, vomiting, and abdominal pain. Recovery from ADRs during the hospital stay was 100%.

Conclusion: The study highlights significant age and gender disparities in ADRs to antibiotics in pediatric patients, with adolescent males being the most affected group. These findings suggest the need for age and gender-specific considerations in antibiotic prescribing practices to enhance patient safety.

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