Neuropsychiatric Events following Montelukast Use

Basic Details
Date Posted
Monday, April 22, 2019
Medical Product
inhaled corticosteroid
nasal corticosteroid
Health Outcome(s)
neuropsychiatric event
psychotropic medication use

The goal of this request was to estimate the number of neuropsychiatric events, including suicide, and psychotropic medication use among patients using montelukast in the Sentinel Distributed Database (SDD). This request has two reports:

  • Report 1 contains estimates of the number of new users of montelukast, zafirlukast, inhaled corticosteroids, and nasal corticosteroids in the SDD.¬†
  • Report 2 contains estimates of neuropsychiatric events and psychotropic medication use among patients using montelukast, zafirlukast, inhaled corticosteroids, or nasal corticosteroids in the SDD.

Data from January 1, 2000 to September 30, 2015 from 16 Data Partners contributing to the SDD were included in this request. This request was distributed to Data Partners on March 22, 2018.

Additional Details
FDA Center
Time Period
January 1, 2000 - September 30, 2015
Study Type
Modular Program
Assessment Type
Exploratory Analyses
Data Sources
Sentinel Distributed Database (SDD)