Real-World Safety Profile of Levofloxacin: Pharmacovigilance Signals, Co-Medication Patterns, and Signal Validation

To characterize epidemiological features and co-medication patterns of Levofloxacin-associated adverse events (AEs) using spontaneous reports and cross-validate pharmacovigilance signals against the FDA Adverse Event Reporting System (FAERS). We retrospectively analyzed spontaneous reports for Levofloxacin from the Adverse Drug Reaction Monitoring Center (2020-2024). Patient demographics, regimens, and clinical outcomes were evaluated. Co-medication patterns were identified using association rule mining. Disproportionality analyses were employed for signal detection, with findings cross-validated in FAERS. Among 4,353 reports, 7.14% were severe. The median age was 57 years (male-to-female ratio 1.29:1). Parenteral administration for respiratory, urogenital, and skin infections was predominant. Analysis of 575 co-medication cases yielded 11 significant association rules. The reported AEs manifested primarily as Skin and appendages disorders, Gastrointestinal disorders, and Vascular/coagulation disorders, with 96.76% of patients showing favorable outcomes. At the System Organ Class level, 5 significant signals were detected, with general disorders and administration site conditions showing the strongest signal intensity (ROR=4.98). At the Preferred Term level, 40 signals were identified, 27 of which were cross-validated in FAERS, including Infusion site pruritus (highest intensity, ROR=39.77). Cross-validation with FAERS confirmed Levofloxacin's established safety profile, characterized by frequent Skin and Appendages Disorders and strong signals for injection site reactions. Notably, co-medication patterns suggest caution when combining Levofloxacin with cephalosporins. Individualized risk assessment and vigilant monitoring are essential to mitigate potential risks.