Abstract:Objective The Adverse Drug Events (ADE) signals of fluorouracil and capecitabine were mined to provide reference for safe medication. Methods The reports of the above-mentioned drugs in the 19 quarters from the first quarter of 2017 to the third quarter of 2021 were extracted from the FAERS database, and the reported ratio method (ROR method) and the comprehensive standard method (MHRA method) were used to jointly test, and then use the MedDRA terminology set Chinese and System organ classification standardized the results.Results After deduplication, 654 ADE signals were detected, involving 27 system organs. Among them, fluorouracil was mainly concentrated in blood and lymphatic system diseases, systemic diseases and various reactions at the administration site, gastrointestinal system diseases and various nervous system diseases. Capecitabine mainly focuses on gastrointestinal system diseases, skin and subcutaneous tissue diseases, systemic diseases and various reactions at the administration site, and blood and lymphatic system diseases. In terms of digestive system toxicity, both drugs showed strong correlations. The difference is that fluorouracil is more strongly associated with cardiac-related toxicity and hematological toxicity, while capecitabine is more strongly associated with skin-related toxicity.Conclusion Most of the detected signals have good coincidence with the drug instructions, which proves the reliability of the research method. At the same time, adverse events that do not appear in the instructions are also found for clinical reference.