Objective  To search for the reports of adverse events of levofloxacin use in children using the FAERS database, and to mine and analyze the data to provide reference for safe clinical use.

Methods  The data reported of adverse events of levofloxacin use in children from January 1, 2004 to June 30, 2023 were retrieved through the OpenVigil 2.1 platform, and the relevant data were analyzed based on the reporting odds ratio (ROR) method.

Results  A total of 484 cases of adverse events of levofloxacin in children were retrieved, and 94 positive risk signals were found. The main systemic organs involved were various musculoskeletal and connective tissues, gastrointestinal system, systemic and administration sites, and the top five positive signals were Dimycodes infection (ROR=822.87), tendon pain (ROR=563.71), Mycobacterium ulcers infection (ROR=352.65), tendon rupture (ROR=341.91), and immune reconstitution inflammatory syndrome-related tuberculosis (ROR=310.84). The top five positive signals not mentioned in the label were Mycobacterium ulcerans infection (ROR=352.65), immune reconstitution inflammatory syndrome-associated tuberculosis (ROR=310.84), central nervous system tuberculoma (ROR=102.85), linear IgA disease (ROR=82.68), and increased intracranial pressure (ROR=32.46).

Conclusion  In addition to the known adverse events, levofloxacin is used in children, and the risk signal intensity of adverse reactions such as increased intracranial pressure and tuberculosis-related diseases is high, so it is recommended to carefully select and strengthen relevant safety monitoring.

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