Signals mining and analysis of adverse drug reaction for ritlecitinib based on FAERS
Objective Mining the adverse drug event signals of ritlecitinib based on the FAERS,to provide a basis for clinical medication.Methods The open OpenVigil 2.1 data platform was used to collect adverse drug event reports of ritlecitinib in FAERS database from June 7,2023 to June 30,2024.The ROR and PRR in the proportional imbalance method were used for signal mining.Results A total of 546 reports of adverse events related to ritlecitinib were retrieved,and 17 adverse drug event signals were obtained after secondary screening.Among them,37 adverse drug event signals such as anxiety,diabetes,food allergy,vomiting,pain,asthma,and abnormal blood pressure were not mentioned in the drug package insert.The system organ categories with high signal number or cumulative number of cases included skin and subcutaneous tissue diseases(38 signals,208 cases),systemic diseases and various reactions at the drug administration site(30 signals,258 cases),various examinations(28 signals,210 cases),gastrointestinal diseases(22 signals,94 cases),psychiatric diseases(17 signals,64 cases),and gastrointestinal diseases(22 signals,94 cases).Infection and infectious diseases(16 signals,58 cases),various types of injury,poisoning and operational complications(11 signals,62 cases),etc.Conclusions In addition to the common adverse drug event indicated by the package insert,this study identified new risk signals for adverse events with ritlecitinib.It is recommended to pay more attention to the known common adverse drug event such as headache,diarrhea,severe infection,herpes zoster,malignant tumor,urticaria,and thromboembolism events,and to the new risk signals such as anxiety,depression,dyspnea,diabetes,and arthralgia.
ritlecitinibalopecia areataadverse drug eventssignal mininganxietydiabetesfood allergyvomiting
NETL
NSTL
万方数据
