Can montelukast use lead to depression and suicide?

Montelukast, a drug often prescribed for asthma and allergic rhinitis, can lead to depression and suicidal thoughts, a significant side effect that is being taken seriously by health authorities.

The U.S. Food and Drug Administration (FDA) has issued a “Black Box Warning” for montelukast, which is the most severe warning that can be issued. This warning highlights the risk of neuropsychiatric side effects, including depression, agitation, aggression, and suicidal thoughts and behavior.

Several studies and case reports have found a link between the use of montelukast and the occurrence of neuropsychiatric side effects. These side effects can range from mild symptoms such as sleep problems and nightmares to more serious symptoms such as depression and suicidal thoughts.

Both the FDA and the European Medicines Agency (EMA) have informed health professionals and patients about these risks. They advise that patients taking montelukast, especially if they notice any changes in their mood or behavior, should consult their doctor immediately.

Montelukast use can indeed lead to serious neuropsychiatric side effects such as depression and suicidal thoughts. Patients taking this medication should be monitored carefully and any symptoms should be reported promptly to their doctor.

Source: https://www.fda.gov/drugs/drug-safety-and-availability/fda-requires-boxed-warning-about-serious-mental-health-side-effects-asthma-and-allergy-drug

Author: Prof. Dr. Dirk Devroey - Latest update: 2024-08-02 - Copyright: Clinifacts 2025