Abstract: Objective To study the characteristics and number of reports of oral adverse drug reaction (ADR), and to explore suspicious ADR signals, so as to provide references for clinical safe drug use. Methods Due to the research needs of the project, statistical analysis was conducted on 141 ADR reports caused by oral targeted anti-tumor drugs received by a drug adverse reaction monitoring center in a certain city from January 1, 2018 to December 31, 2022, including patient age, gender, underlying disease, ADR occurrence time, Severity and outcome of ADR, ADR involvement of system organs, ADR clinical manifestations, and occurrence cases. The reporting odds ratio (ROR) method was used to mine ADR signals. Results The 141 cases of ADR involved a total of 23 drugs, with a total of 164 ADR symptoms affecting 13 systemic organs. The top three ADR occurrences were rash (28 cases, 17.07%), hypertension (16 cases, 9.76%), and diarrhea (14 cases, 8.54%). A total of 8 suspected ADR signals related to drugs were identified. Three signals of hypertension, oral ulcers, and hand foot syndrome were identified from anlotinib. Three signals of hypertension, hand foot syndrome, and proteinuria were identified from Apatinib. Two signals of rash and diarrhea were identified from osimertinib. One signal of rash was detected from afatinib, one signal of rash was detected from dacotinib, and one signal of rash was detected from gefitinib. One signal of rash was identified from imatinib. Dig out one signal of diarrhea from Regorafenib. Conclusion During the use of oral targeted anti-tumor drugs by patients, special groups such as the elderly should be closely monitored. Focus on patients within the first month of taking medication. Focus on monitoring ADR such as rash, hypertension, diarrhea, hand foot syndrome, oral ulcers, proteinuria, and take preventive and treatment measures.

Key words: oral medication, antitumor therapy, targeted drugs, adverse drug reaction(ADR), report analysis, signal mining, ROR