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AAAAI Urges Patients on Montelukast to Contact Their Healthcare Provider

AAAAI News Release

March 4, 2020

Megan Brown, CAE
(414) 272-6071

In light of the FDA’s announcement that it is requiring a boxed warned for montelukast due to the risk of neuropsychiatric events, AAAAI is urging patients on the drug to contact their healthcare provider.

Milwaukee, WI – With the U.S. Food and Drug Administration (FDA) today announcing it is requiring a boxed warning for montelukast due to the risk of neuropsychiatric events, such as agitation, depression, sleeping problems, and suicidal thoughts and actions, the American Academy of Allergy, Asthma & Immunology (AAAAI) is stressing the importance of contacting your healthcare provider if you are on this drug.

“If you are taking montelukast and this is helpful for your symptoms, you should speak with your healthcare provider first prior to making a decision to suspend this medication,” said AAAAI President David M. Lang, MD, FAAAAI, who is also Chair of the Allergy/Immunology Department in the Respiratory Institute at Cleveland Clinic.

“Alternatively, if you begin taking montelukast, or if you have been taking montelukast, and you feel sad, experience mood changes, or vivid dreams, you should suspend montelukast and contact your healthcare provider,” added Dr. Lang.

Montelukast, which is sold under the brand name Singulair and in generic form, is frequently prescribed. For asthma, montelukast can be used as the sole medication taken regularly for treatment of mild persistent asthma, or in combination with other medications (e.g., inhaled corticosteroids) for management of moderate or severe persistent asthma. Patients with asthma frequently also have allergic rhinitis.  

Montelukast was initially FDA approved for management of asthma, and then was also approved for seasonal and perennial allergic rhinitis and for prevention of exercise-induced bronchospasm. FDA approval is as young as 12 months in asthma, two years in seasonal allergic rhinitis, six months in perennial allergic rhinitis, and six years in exercise induced bronchoconstriction.   

The boxed warning that the FDA is now requiring strengthens an existing warning about the risk of neuropsychiatric events associated with the drug, and it advises healthcare providers to avoid prescribing montelukast for patients with mild symptoms, particularly those with allergic rhinitis.

You can learn more about asthma and allergic rhinitis on the AAAAI’s website,

The American Academy of Allergy, Asthma & Immunology (AAAAI) represents allergists, asthma specialists, clinical immunologists, allied health professionals and others with a special interest in the research and treatment of allergic and immunologic diseases. Established in 1943, the AAAAI has nearly 7,000 members in the United States, Canada and 72 other countries. The AAAAI’s Find an Allergist/Immunologist service is a trusted resource to help you find a specialist close to home.