Research on the signal mining of adverse events of montelukast sodium based on FAERS

Objective To conduct data-mining of montelukast-related adverse events after marketing to provide a reference for safe clinical medication. Methods We use reporting odds ratio (ROR) and proportional reporting ratio (PRR) methods to mine the adverse reaction signals of montelukast on the adverse reaction report data of 22 quarters from 2015Q1 to 2020Q2, extracted from the FAERS database. Results Totally 467 signals were detected with ROR and PRR, and the most relevant 50 preferred terms are conducted based on the signal strength and signal frequency, 55.32% of signals were not reported in the proved label. Adverse reaction signals of montelukast involve 27 systems and organs, in addition to psychiatric diseases, majority of adverse events included respiratory, thoracic, and mediastinal disorders and examination. Conclusion Clinical use of montelukast should pay attention to the patient's neuropsychiatric symptoms, especially those not reported in the proved label, such as Separation anxiety disorder, Sleep terror and PANDAS. For patients with mental history, phenylketonuria and autoimmune diseases who use the montelukast，relevant workers should pay attention to monitoring to ensure safe and rational drug use.