ObjectiveTo conduct a comprehensive analysis of hematologic and lymphatic adverse events associated with Axicabtagene ciloleucel using the FDA adverse event reporting system (FAERS) database, providing valuable references for clinical safety in medication. MethodsWe retrieved reports of adverse reactions related to Axicabtagene ciloleucel from the FAERS database covering the period from October 2017 to December 2023. A disproportionality analysis was performed using the reporting odds ratio (ROR) and information component (IC) to identify hematologic and lymphatic adverse events associated with Axicabtagene ciloleucel. ResultsA total of 790 reports of hematologic and lymphatic adverse events related to Axicabtagene ciloleucel were identified, leading to the detection of 16 signals. Six of these adverse events were not included in the product labeling. Neutropenia was the most frequently reported hematologic adverse event associated with Axicabtagene ciloleucel. The strongest signal identified was cytopenia. Notably, 13.9% of cases resulted in death, with pancytopenia being the most common adverse event among the fatal outcomes. ConclusionAdverse events such as disseminated intravascular coagulation, coagulopathy, and bone marrow dysfunction are rarely reported in clinical practice and are not included in the product labeling, yet they are highly associated with mortality.
