Background: Clarithromycin is a widely used antibiotic, but its safety profile, particularly in different age groups, remains inadequately explored.
Objectives: This study aims to characterize and illustrate the features of clarithromycin-related adverse events (AEs) across different age groups using the FDA Adverse Event Reporting System (FAERS) database, providing a reference for the clinical detection, prevention, and management of AEs in various age groups.
Design: A disproportionality analysis was performed using data from the FAERS database. The study included all AE reports related to clarithromycin, stratified by age groups.
Methods: Disproportionality analysis was conducted using reporting odds ratio, proportional reporting ratio, Bayesian confidence propagation neural network, and multiple gamma Poisson shrinkers. Statistical analyses included descriptive statistics and Chi-square tests.
Results: A total of 7319 reports of clarithromycin AEs were retrieved from the FAERS database. Vomiting, diarrhea, drug interactions, and drug interactions were reported most frequently in the age groups 0-17, 18-44, 45-64, and ⩾65 years, respectively. Abnormal product taste, taste disorder, and medication errors related to drug interactions specified in the package insert were the strongest signals in the age groups 0-17, 18-44, 45-64, and ⩾65 years, respectively. A total of 41 Preferred Terms signals were not explicitly included in the clarithromycin package insert and were mainly associated with psychiatric disorders, skin and subcutaneous tissue disorders, and gastrointestinal disorders, among others. Specific signals for age differences were identified, with 18 signals being age-specific, including 3 in children and 15 in elderly individuals.
Conclusion: The safety profile of clarithromycin varies across age groups. In children, it is mainly associated with vomiting, hypersensitivity, and dyspnea, while in adults, psychiatric AEs are more common. In the elderly, clarithromycin should be used cautiously, with attention to drug interactions.
Keywords: FAERS; adverse event; children; clarithromycin; elderly.
A study on the adverse effects of clarithromycin.
Introduction: Clarithromycin is a relatively newer macrolide antibiotic derived from erythromycin, that is included in the WHO Model List of Essential Medicines, and is one of the important drugs needed in basic healthcare systems. Currently, there are no studies mining adverse events and outcomes related to the clinical use of clarithromycin in the FDA Adverse Event Reporting System (FAERS) database. This study investigated the safety signals related to clarithromycin.
Methods: Disproportionality analysis, including reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and multiple gamma Poisson shrinker (MGPS) algorithms, were used to quantify signals of clarithromycin-related adverse events (AEs) across different age groups.
Results: 7,319 AE reports were identified, 41 PT signals were not explicitly included in the clarithromycin package insert. Specific signals for age differences were identified, with 18 signals being age specific.
Conclusion: We discovered important safety concerns related to clarithromycin. The safety of clarithromycin is different in different age groups. Children are more closely associated with adverse events related to vomiting, drug-induced hypersensitivity, and dyspnea. In adults, it is more associated with psychiatric adverse events. In addition, the use of clarithromycin in the elderly should be strictly in accordance with the instructions and be alert to drug interactions.
© The Author(s), 2025.