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  • Clinical Research Article
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Gastrointestinal safety of oral erythromycin, clarithromycin, and azithromycin in pediatric patients: a FAERS pharmacovigilance study

Pediatric Research (2025)Cite this article

Abstract

Background

This study investigates the gastrointestinal adverse events (AEs) associated with oral erythromycin, clarithromycin, and azithromycin in pediatric patients using the FAERS database.

Methods

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.

Results

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.

Conclusion

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.

Impact

  • 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.

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Fig. 1: Flow diagram of gastrointestinal AE reports related to oral erythromycin, clarithromycin, and azithromycin from the FAERS database.
Fig. 2: Onset time distributions of gastrointestinal AEs associated with oral erythromycin, clarithromycin, and azithromycin.

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Data availability

The data supporting the findings of this study are not publicly available due to data privacy regulations but may be requested from the corresponding author upon reasonable request.

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Funding

This work was supported by the Natural Science Foundation of Hubei Province, China (Grant No. 2024AFB411); the Yichang Medical and Health Research Project (Grant No. A25-2-007); the Teaching Research Project of China Three Gorges University (Grant No. J2022075); and the Higher Education Research Project of China Three Gorges University (Grant No. GJ2342).

Author information

Authors and Affiliations

  1. Department of Pediatrics, The First College of Clinical Medical Science, China Three Gorges University & Yichang Central People’s Hospital, Yichang, Hubei, PR China

    Zhu Wang

  2. College of Pharmacy, Hubei University of Chinese Medicine, Wuhan, Hubei, PR China

    Guoping Gan & Haiping Yao

  3. Department of Pharmacy, The First College of Clinical Medical Science, China Three Gorges University & Yichang Central People’s Hospital, Yichang, Hubei, PR China

    Haiping Yao

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  1. Zhu Wang
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  2. Guoping Gan
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Contributions

Haiping Yao, Guoping Gan, and Zhu Wang were responsible for data collection and verification, as well as study conceptualization and design. All authors participated in data analysis and interpretation, contributed to writing the initial draft, and approved the final version of the manuscript.

Corresponding author

Correspondence to Haiping Yao.

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Wang, Z., Gan, G. & Yao, H. Gastrointestinal safety of oral erythromycin, clarithromycin, and azithromycin in pediatric patients: a FAERS pharmacovigilance study. Pediatr Res (2025). https://doi.org/10.1038/s41390-025-04312-6

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