Data mining and analysis of adverse events signals for Montelukast Sodium in children based on FAERS database

LIAO Wen; HOU Wenjing; WEN Aiping

doi:10.13506/j.cnki.jpr.2025.03.016

Abstract：Objective To analyze post-marketing adverse event reported for Montelukast Sodium in children based on the U.S.Food and Drug Administration Adverse Event Reporting System(FAERS),and provide references for the safe clini-cal using of the drug.Methods Disproportion analysis techniques,including the reporting odds ratio and proportional repor-ting ratio,were used to screen and analyze the signals of adverse events in children involving Montelukast Sodium from the FAERS database between the first quarter of 2004 and the first quarter of 2023.Results A total of 12 148 case reports re-lated to Montelukast Sodium were collected,of which 226 were found to be positive.These positive reactions were distributed in 18 different system and organ categories.According to the frequency of occurrence,the most frequent adverse signals of Montelukast Sodium were aggression,anxiety,abnormal behavior,depression,and suicidal thoughts,which can be seen in the drug label.In order of signal intensity,Montelukast induced visual deformations and the resulting Miller-Fisher syndrome were not mentioned in the drug label.Conclusion Health care professionals should be extremely concerned about the possi-ble neurological and psychiatric adverse events of Montelukast Sodium,especially when treating children and patients with related medical histories.And they should pay attention to adverse reactions not mentioned in the instructions.