Drug-Induced Liver Injury Associated With Moxifloxacin: A Pharmacovigilance Analysis of the FDA Adverse Event Reporting System and a Real-World Retrospective Study
Abstract
OBJECTIVE: While current studies have focused on the incidence of moxifloxacin-associated liver injury, risk factors and clinical characteristics for moxifloxacin-induced liver injury in hospitalized patients remain unexplored.
METHODS: We analysed antibiotic-induced liver injury using the US Food and Drug Administration Adverse Event Reporting System (FAERS) database. A retrospective observational study was further conducted on 1265 hospitalized patients treated with moxifloxacin for infections. Independent risk factors for moxifloxacin-induced DILI were identified via multivariable logistic regression.
RESULTS: FAERS data indicated that moxifloxacin-induced liver injury exacerbates clinical outcomes, prolongs hospitalization, and may be life-threatening. Infections were the primary indication for fluoroquinolone use, with gender-specific differences observed in liver injury profiles across quinolones. Retrospective analyses revealed gender as an independent protective factor (p = 0.003). Risk factors included hypoalbuminemia (p = 0.003), hepatic comorbidities (fatty liver, p = 0.013; pre-existing liver injury, p < 0.013), elevated baseline alkaline phosphatase (ALP, p < 0.001) and concomitant use of traditional Chinese medicine or respiratory drugs (p < 0.001).
CONCLUSION: Despite widespread clinical use, moxifloxacin's safety profile requires systematic evaluation. Clinicians should monitor liver function and integrate risk stratification, including albumin levels, gender…
How strong is the evidence?
Evidence Hub reads this as a cohort study, done in people. 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. Reported size: 1,265 participants or records.
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