Drug-Induced Liver Injury Associated With Moxifloxacin: A Pharmacovigilance Analysis of the FDA Adverse Event Reporting System and a Real-World Retrospective Study.

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 and concomitant medications into prescribing practices. Elucidating DILI mechanisms and high-risk populations may optimize therapeutic decision-making and patient safety.