| アブストラクト | 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. |
|---|
| ジャーナル名 | Journal of pharmaceutical policy and practice |
|---|
| Pubmed追加日 | 2025/7/10 |
|---|
| 投稿者 | Zhang, Zhenpo; Li, Jiangxiong; Zheng, Jingping; Liang, Yankun; Ma, Lin; Su, Ling |
|---|
| 組織名 | College of Pharmacy, Jinan University, Guangzhou, People's Republic of China.;Zhuhai Jiuhuatong Biomedical Technology., Ltd, Zhuhai, People's Republic of;China.;School of Food Science and Engineering, South China University of Technology,;Guangzhou, People's Republic of China.;Medical Affairs Department, Guangdong Provincial Hospital of Traditional Chinese;Medicine, Guangzhou, People's Republic of China. |
|---|
| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/40636562/ |
|---|
