Antibiotic-associated adverse events in bone and joint infections: a FAERS pharmacovigilance study
Abstract
Background: Bone and joint infections (BJI) require prolonged antibiotic therapy that may amplify cumulative toxicity risk, yet indication-contextualized safety data remain sparse.
Methods: Using the FDA Adverse Event Reporting System (FAERS, 2004Q1-2025Q4; 20,006,981 deduplicated cases), we identified 9,072 cases involving 17 BJI-target antibiotics. Four disproportionality measures, namely reporting odds ratio (ROR), proportional reporting ratio (PRR), information component (IC), and empirical Bayes geometric mean (EBGM), were applied against the full FAERS database. We then performed BJI within-cohort contextualization, primary-suspect-only (PS-only) sensitivity analysis, exploratory XGBoost machine learning, and Weibull time-to-onset (TTO) modeling, in accordance with the READUS-PV reporting framework.
Results: Of 153 drug-adverse drug event (ADE) pairs, 103 met the prespecified four-method robust full-FAERS signal criterion; 28 were retained after BJI within-cohort contextualization. Indication-supported signals included vancomycin-nephrotoxicity (within-cohort ROR 3.30, 95% CI 2.95-3.70), linezolid-hematologic toxicity (3.65, 3.21-4.16), ceftaroline-hematologic toxicity (4.81, 3.42-6.77), and ertapenem-neurotoxicity (4.76, 3.50-6.47). Several strong full-FAERS signals (e.g., fluoroquinolone-tendon and broad-spectrum-C. difficile infection) were attenuated within the BJI cohort or under PS-only restriction, highlighting the role of prescribing pattern and reporting-role…
How strong is the evidence?
Evidence Hub reads this as a cohort study. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence.
Read the paper
Related studies
- Severe clinical outcomes of COVID-19 associated with proton pump inhibitors: a nationwide cohort study with propensity score matching
- Penicillins for Treatment of Pneumococcal Pneumonia: Does In Vitro Resistance Really Matter?
- Thiophenes—Naturally Occurring Plant Metabolites: Biological Activities and In Silico Evaluation of Their Potential as Cathepsin D Inhibitors
- Inhalable Mannosylated Rifampicin–Curcumin Co-Loaded Nanomicelles with Enhanced In Vitro Antimicrobial Efficacy for an Optimized Pulmonary Tuberculosis Therapy
- Development and validation of microbial bioassay for quantification of Levofloxacin in pharmaceutical preparations
- Association between cord blood 25-hydroxyvitamin D concentrations and respiratory tract infections in the first 6 months of age in a Korean population: a birth cohort study (COCOA)
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.