ABSTRACT
OBJECTIVE To mine adverse drug event （ADE） signals related to baloxavir marboxil， and to provide reference for clinically safe drug use. METHODS The ADE signals related to baloxavir marboxil from January 1， 2018 to May 31， 2022 in the US FDA adverse event reporting system （FAERS） were mined using the proportional reporting odds ratio （PRR） method. ADE with report number≥3， PRR≥2 and χ2≥4 was defined as a positive signal， and PRR method was used to analyze the ADE signal. RESULTS A total of 1 424 ADE reports with baloxavir marboxil as the main suspected drug were collected， involving 460 ADE signals. The femininity and patient under 18 years old were reported more， the country with the highest number of reports was the United States， and the main indication of drug reported was influenza. A total of 37 ADE positive signals were obtained after PRR calculation and screening exclusion， the first three ADE signals in the list of the reported number were diarrhea， vomiting and immediate hypersensitivity， and the first three ADE signals in the list of PRR value were febrile delirium， ischaemic colitis and hemorrhagic cystitis. Compared with the instructions of baloxavir marboxil， 18 ADE signals had not yet been included， such as abnormal liver function， hematuria， hemorrhagic cystitis， etc. Five new SOCs were involved， such as kidney and urinary system diseases， hepatobiliary system diseases， investigations， nervous system disorders and musculoskeletal and connective tissue disorders. CONCLUSIONS When clinical application of baloxavir marboxil， in addition to the adverse drug reactions mentioned in the drug instructions， attention should be paid to abnormal liver function， hematuria， hemorrhagic cystitis， etc， so as to guarantee the safety of drug use.