Gastrointestinal safety of oral erythromycin, clarithromycin, and azithromycin in pediatric patients: a FAERS pharmacovigilance study.

Abstract

This study investigates the gastrointestinal adverse events (AEs) associated with oral erythromycin, clarithromycin, and azithromycin in pediatric patients using the FAERS database. A retrospective pharmacovigilance analysis was conducted on FAERS reports from January 2004 to June 2024. Reports involving pediatric patients (<18 years) with gastrointestinal AEs linked to oral macrolides were analyzed. Disproportionality analysis using the reporting odds ratio (ROR) was performed to assess AE signals. A total of 2179 AE reports were identified from the FAERS database in which oral erythromycin, clarithromycin, or azithromycin served as the primary suspect drugs, and among these, 705 (32.35%) reports involved gastrointestinal AEs. Azithromycin accounted for 57.45% of cases (ROR = 2.07), clarithromycin 36.17% (ROR = 2.10), and erythromycin 6.38% (ROR = 3.17). Vomiting, diarrhea, and nausea were the most frequently reported AEs. Several novel AE signals not listed in drug labels were detected, including lip swelling and gastric hemorrhage. The median onset time for AEs was 0 days for azithromycin and clarithromycin, and 3 days for erythromycin. While most gastrointestinal AEs align with known drug profiles, newly identified signals warrant further investigation. Due to limitations of spontaneous reporting systems, future cohort studies are needed to validate these findings and enhance pediatric antibiotic safety. This study examined gastrointestinal side effects in children taking three oral macrolide antibiotics (erythromycin, clarithromycin, and azithromycin) using data from the FAERS database. Out of 2179 adverse event reports, nearly one-third involved gastrointestinal issues, with vomiting, diarrhea, and nausea being the most common. Unexpected signals-such as lip swelling and gastric hemorrhage-were also identified, highlighting the need for further research to enhance the safety of these antibiotics in pediatric patients.