Analysis of 193 Cases of Betahistine-Related Adverse Reaction Reports in Rizhao
Objective To provide a reference for the safe use of betahistine in clinical practice.Methods The adverse drug reaction(ADR)reports with betahistine as the suspicious drug reported to the National Adverse Drug Reaction Monitoring System from January 1,2014 to January 1,2023 that had been evaluated were collected by the Drug Adverse Reaction Monitoring Center of Rizhao.The ADR types,patients' basic information,route of administration,involved systems/organs,clinical manifestations,outcomes and serious ADRs were analyzed.Results A total of 193 cases of ADR reports(268 case times)were collected,there were 183 cases of general ADRs(94.82%),26 cases of new general ADRs(13.47%)and 10 cases of serious ADRs(5.18%).The ADRs were probably and possibly associated with betahistine,with 71 cases(36.79%)and 122 cases(63.21%)respectively.A total of 193 patients were involved,including 71 males and 122 females,aged from 20 to 95 years,with the majority being over 60 years(113 cases,58.55%).The most common route of administration was intravenous drip(174 cases,90.16%).The main involved systems/organs were the nervous system,gastrointestinal system,skin and subcutaneous tissue.The main clinical manifestations included headache,dizziness,palpitations and so on,while those in patients with serious ADRs included chest tightness,dyspnea and so on.A total of 123 cases(63.73%)recovered,66 cases(34.20%)improved,one case(0.52%)did not improve,and three cases(1.55%)had unclear outcomes.Conclusion When using betahistine in clinical practice,we should pay attention to pharmaceutical care,evaluate medication risks based on existing ADRs to ensure the patients' medication safety.
betahistineadverse drug reactionRizhaoNational Adverse Drug Reaction Monitoring Systempharmaceutical care