Comparative safety profile of levofloxacin versus moxifloxacin in first-line tuberculosis therapy: a pharmacovigilance study of the FAERS database
Abstract
Objective This study aimed to compare the safety profiles of two fluoroquinolone-containing regimens, HREL (isoniazid, rifampicin, ethambutol, levofloxacin) and HREM (isoniazid, rifampicin, ethambutol, moxifloxacin), in the treatment of drug-susceptible tuberculosis (DS-TB), focusing on adverse events (AEs) across age and gender subgroups. Methods Data were extracted from the FDA Adverse Event Reporting System (FAERS) database (2004–2024). Disproportionality analyses were conducted to assess AE signals for HREL and HREM. Pharmacovigilance metrics, including reporting odds ratios (RORs), proportional reporting ratios (PRRs), Bayesian confidence propagation neural networks (BCPNN), and empirical Bayesian geometric means (EBGMs), were calculated. Subgroup analyses were stratified by age (≥60 vs. <60 years) and gender. Results The analysis included 451 HREL-related and 338 HREM-related AEs. HREL was associated with a significantly higher risk of immune reconstitution inflammatory syndrome (IRIS-TB) and drug-induced liver injury, particularly in females and patients under 60 years of age. In contrast, HREM demonstrated a higher risk of drug reaction with eosinophilia and systemic symptoms (DRESS), peripheral neuropathy, and severe hepatobiliary events such as acute liver failure. Subgroup analyses revealed that these risk profiles were influenced by age and gender. Specifically, elderly patients (≥60 years) receiving HREM had a lower risk of IRIS-TB but a higher propensity for…
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