The safety profile of azithromycin in pediatrics: a pharmacovigilance disproportionality analysis

To mine and analyze adverse drug events (ADEs) signals of azithromycin use in children in the real world to inform the safety assessment of azithromycin use in children.

ADE reports from the FDA Adverse Event Reporting System (FAERS) involving children (0-17 years) with azithromycin as the primary suspected drug from 2004 to early 2024 were extracted. ADEs were categorized using MedDRA, and signal detection was conducted using Reporting Odds Ratio (ROR) and Proportional Reporting Ratio (PRR). Arrhythmias and infantile hypertrophic pyloric stenosis (IHPS) were of special interest.

A total of 2203 ADE reports associated with azithromycin in children were collected, covering 271 cases across 24 organ systems. Skin and subcutaneous tissue disorders were most common, with children more susceptible than adults. Arrhythmia reports increased from 2.8% to 3.2% after the FDA's 2013 black box warning. Ten IHPS cases were identified, mainly occurring in early infancy.

These findings provide crucial insights into the ADE profile of azithromycin in pediatric patients, supporting enhanced clinical vigilance and risk identification efforts. This study underscores the importance of monitoring both common and rare ADEs to ensure safer azithromycin use in children.