Mining and analysis of adverse event signals of rasagiline mesylate based on the FAERS and JADER databases

ZHAO Guo-zhen; XU Jin; WANG Xuan

doi:10.20251/j.cnki.1003-3734.2026.10.011

Abstract：Objective:To explore and analyze the adverse drug events(ADEs)of rasagiline mesylate after its launch,in order to improve the safety and rationality of clinical medication.Methods:Adverse event reports of rasagiline mesylate from May 2006 to September 2024 were searched and extracted from the FDA Adverse Event Reporting System(FAERS)in the United States and the Japanese Adverse Drug Event Report Database(JADER).The reporting odds ratio(ROR)and proportional reporting ratio(PRR)methods were used to process and analyze the data.Positive signals were screened and compared with the instructions to identify potential new drug adverse reactions.Results:A total of 7 303 and 1 263 ADE reports with rasagiline mesylate as the primary suspected drug were screened from the two databases,respectively,and 122 and 45 positive signals were obtained,involving 16 and 10 SOCs.There were slightly more female patients than male patients who experience adverse events,with the highest proportion being elderly patients(aged ≥ 65 years).Most cases experienced adverse reactions within one month after medication.The top three reported ADE signals in the FAERS database were falls,tremors,and dizziness,while the top three correlated ADE signals were sexual abnormalities(ROR=266.23,PRR=266.08),sudden sleep(ROR=167.63,PRR=166.97),and cerebral hypoperfusion(ROR=129.75,PRR=129.62).The top three ADE signals reported in the JADER database were hallucinations,visual hallucinations,and falls.The top three ADE signals with high correlation were orthostatic hypotension(ROR=226.93,PRR=216.91),blood pressure fluctuations(ROR=212.31,PRR=208.63),and sudden sleep(ROR=181.89,PRR=179.6).It mainly involved various neurological diseases,mental illnesses,various injuries,poisoning and operational complications,vascular and lymphatic diseases,etc.Forty-seven ADEs not included in the instruction manual were identified,including safety warning signals such as infectious aspiration pneumonia,cerebral infarction,rapid eye movement sleep behavior disorder,aortic dissection,etc.Conclusion:When using rasagiline mesylate in clinical practice,in addition to paying attention to the ADEs already mentioned in the instructions,it is also necessary to pay attention to new suspected ADEs,and take intervention measures when necessary to ensure the safe and effective use of the drug for patients.