Abstract: Objective To search and evaluate the adverse drug events (AE) of monoclonal antibody drugs rituximab and adalimumab in the database of the US Food and drug administration public data open project (OpenFDA), and to compare and analyze their AE. Methods The reporting odds ratio (ROR) method was used for quantitative detection of signals from the API module in the interactive chart section in OpenFDA database, the AE report data of rituximab and adalimumab from January 1, 2004 to October 15, 2021 were detailed retrieval. The profile of AE of both drugs was also analyzed from multiple perspectives simultaneously. Results A total of 131 408 adverse event reports referring to rituximab (including 376 203 adverse reaction signals) and 515 782 adverse event reports of adalimumab (including 1 238 760 adverse reaction signals) were obtained. Most of the reported persons of rituximab were personnel of other health systems, and most of adalimumab were consumers or non health system personnel. Due to the large number of adverse reaction signals, this study only screened the top 9 adverse reaction signals of rituximab and adalimumab for analysis. There were 9 379 cases of rituximab and 6 441 cases of adalimumab. The strongest signal of adverse events of rituximab was infectious and infectious diseases, and the strongest signal of adverse events of adalimumab was skin and subcutaneous tissue diseases. Conclusion In-depth analysis of the adverse drug event data of rituximab and adalimumab in the OpenFDA database would provide reference for clinical safe drug use. Paying attention to the adverse events of the above two drugs would help to take corresponding preventive measures and promote clinical rational drug use.

Key words: rituximab, adalimumab, OpenFDA, adverse event, safety