ArticleJournal of pharmaceutical policy and practice2025
Age-stratified pharmacovigilance of azithromycin: a multimethod signal detection analysis in the FAERS database.
Article in Journal of pharmaceutical policy and practice, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
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.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.