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. 2025 Jul 8;18(1):2525356.
doi: 10.1080/20523211.2025.2525356. eCollection 2025.

Age-stratified pharmacovigilance of azithromycin: a multimethod signal detection analysis in the FAERS database

Zhenpo Zhang  1 , Jiangxiong Li  2 , Jingping Zheng  1 , Yankun Liang  1 , Lin Ma  3   4 , Ling Su  1
Affiliations

Age-stratified pharmacovigilance of azithromycin: a multimethod signal detection analysis in the FAERS database

Zhenpo Zhang et al. J Pharm Policy Pract. .

Abstract

Background: Azithromycin, a widely prescribed macrolide antibiotic, faces emerging safety concerns due to inappropriate use and age-specific adverse drug reactions (ADRs). This study characterises age-stratified safety profiles of azithromycin using pharmacovigilance data.

Methods: Adverse event (AE) reports for azithromycin prescribed in Mycoplasma pneumoniae pneumonia treatment (2004-2024) were extracted from the FDA Adverse Event Reporting System (FAERS). Disproportionality analyses (Reporting Odds Ratio, Proportional Reporting Ratio, Bayesian Confidence Propagation Neural Network, Multi-item Gamma Poisson Shrinker) identified safety signals across four age groups: 0-17, 18-44, 45-64, and ≥65 years.

Results: Among 7,496 AE reports, age-specific risks varied significantly. Paediatric populations (0-17 years) exhibited predominant cutaneous/hypersensitivity reactions (rash, pruritus, Stevens-Johnson syndrome) and unlabelled psychiatric signals (hallucinations). Adults (18-44 years) showed pregnancy-related risks (preterm delivery). Geriatric patients (≥65 years) had heightened cardiac risks (QT prolongation, torsades de pointes), often exacerbated by off-label COVID-19 use. The 45-64-year cohort displayed the highest signal frequency, primarily involving drug hypersensitivity. Off-label prescribing accounted for 65% of geriatric AEs.

Conclusion: Azithromycin safety profiles differ markedly across age groups. Children face dermatologic and neuropsychiatric risks, while elderly patients are vulnerable to cardiac complications. Strict adherence to labelled indications, age-specific monitoring, and avoidance of off-label use - particularly during public health crises - are critical to mitigating ADRs. These findings underscore the need for stratified clinical decision-making and targeted pharmacovigilance.

Keywords: Azithromycin; FAERS; adverse events; data mining; pharmacovigilance.

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Conflict of interest statement

No potential conflict of interest was reported by the author(s).

Figures

Figure 1.
Figure 1.
AE reports of azithromycin across different age groups.
Figure 2.
Figure 2.
Azithromycin AE signals detected using four algorithms.
See this image and copyright information in PMC

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