FDA requires Boxed Warning about serious mental health side effects for asthma and allergy drug montelukast (Singulair); advises restricting use for allergic rhinitis | FDA

May 28, 2026

https://www.fda.gov/drugs/drug-safety-communications/fda-requires-boxed-warning-about-serious-mental-health-side-effects-asthma-and-allergy-drug QT:{{” We continue to receive reports of mental health side effects reported with montelukast use. Consistent with our prior evaluations, a wide variety of mental health side effects have been reported, including completed suicides. Some occurred during montelukast treatment and resolved after stopping the medicine. Other reports indicated that mental health side effects developed or continued after stopping montelukast. The Sentinel study, which studied asthma patients 6 years and older, and other observational studies did not find an increased risk of mental health side effects with montelukast compared to inhaled corticosteroids (ICS). However, the Sentinel study and the observational studies had some limitations which may affect how we interpret the results. We also reviewed animal studies, which showed that montelukast given orally reaches the brain in rats.1 (See Data Summary for more information) “}}

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