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.

A 63-year-old female patient underwent coronary CT angiography and received an intravenous iohexol injection(350 mg/ ml )80 ml as the contrast agent. At the sixth minutes of observation after CT test completion,the patient developed palm itching,bilateral conjunctival congestion and edema, sweating,vertigo,nausea,and vomiting a small amount of gastric contents and then followed by lip cyanosis, facial edema,cold limbs,skin ecchymosis,and bleeding the injection site. Blood gas analysis showed an oxygen saturation of 0. 83 and an oxygen partial pressure of 47 mmHg. About an hour after CT scan,the laboratory test revealed the following levels:blood platelet count 19 × 109 / L,prothrombin time(PT)18 s, and thrombin time( TT)6 s. Treatments with anti-anaphylaxis,coagulation factor supplementation,and correction of acidosis and electrolyte disorder were given. After 7. 5 hours after CT scan,her blood platelet count was 8 ×109 / L. The next day,large pieces of skin ecchymosis appeared in many parts of her body,a body temperature reached 38. 1 ℃ and a blood platelet count was 6 × 109 / L. Symptomatic and supportive therapy was continued and her condition gradually improved. On day 4,she presented with normal temperature,disappeared facial edema,and relief of skin ecchymosis. On day 6,her level of blood platelet and all the values of coagulation functions returned to normal.

A 63-year-old female patient underwent coronary CT angiography and received an intravenous iohexol injection(350 mg/ ml )80 ml as the contrast agent. At the sixth minutes of observation after CT test completion,the patient developed palm itching,bilateral conjunctival congestion and edema, sweating,vertigo,nausea,and vomiting a small amount of gastric contents and then followed by lip cyanosis, facial edema,cold limbs,skin ecchymosis,and bleeding the injection site. Blood gas analysis showed an oxygen saturation of 0. 83 and an oxygen partial pressure of 47 mmHg. About an hour after CT scan,the laboratory test revealed the following levels:blood platelet count 19 × 109 / L,prothrombin time(PT)18 s, and thrombin time( TT)6 s. Treatments with anti-anaphylaxis,coagulation factor supplementation,and correction of acidosis and electrolyte disorder were given. After 7. 5 hours after CT scan,her blood platelet count was 8 ×109 / L. The next day,large pieces of skin ecchymosis appeared in many parts of her body,a body temperature reached 38. 1 ℃ and a blood platelet count was 6 × 109 / L. Symptomatic and supportive therapy was continued and her condition gradually improved. On day 4,she presented with normal temperature,disappeared facial edema,and relief of skin ecchymosis. On day 6,her level of blood platelet and all the values of coagulation functions returned to normal.