Safety Risk of Azithromycin in Minors

doi:10.19803/j.1672-8629.20250550

Abstract

Abstract: Objective To investigate the incidence and characteristics of adverse drug reactions (ADR) of azithromycin (AZM) in minors in order to provide data on safety of medications. Methods Reports of ADR caused by AZM in Sichuan Province that were published between January 2010 and March 2024 were retrieved. Key information, including patient demographics, medication-specific details (such as dosage, administration routes, and courses of treatment), manifestations of ADR, clinical outcomes, and other related parameters, was analyzed to delineate the patterns of AZM-associated ADR. Results A total of 5,143 ADR cases were collected, with no significant gender difference observed. Inappropriate dosage was found in 981 cases (19.07%), with 126 serious reports (38 new serious reports). Most of the ADR occurred within 3 days of administration (4,875, 94.79%). These ADR involved multiple systems-organs, the top three of which were gastrointestinal system disorders, skin/subcutaneous tissue reactions, and general disorders/reactions at the sites of administration. Severe ADR mostly manifested themselves as gast-rointestinal symptoms. Favorable clinical outcomes were observed in 98.83% of these cases, with complete recovery or significant improvement. Conclusion ADR caused by azithromycin among minors often involve multiple systems, but are mostly tolerable. Rational dosing, individualized medications, and close monitoring for early detection/intervention are recommended.

Key words: Azithromycin, Gastrointestinal System, Skin/Subcutaneous Tissue, Adverse Drug Reaction (ADR), Rational Drug Use, Safety, Minor Population

CLC Number:

R978
R994.11

QIN Bo, LI Gen, DU Yu, GAO Shan, LAN Shan, PENG Dan, JIANG Yongxian. Safety Risk of Azithromycin in Minors[J]. Chinese Journal of Pharmacovigilance, 2026, 23(3): 302-306.

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https://zgywjj.magtechjournal.com/EN/Y2026/V23/I3/302

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