Provider Alert! New “Black Box” warning for Singulair (montelukast) and generic formulations

Provider Alert!

Provider Alert! New “Black Box” warning for Singulair (montelukast) and generic formulations

Attention: PCPs, Pulmonologists, and Pharmacists
Effective Date: March 20, 2020

After careful analysis of the benefits and risks, the Food and Drug Administration (FDA) has strengthened the existing warnings on potential side effects on all Singulair and generic montelukast formulations. A “Black Box” warning has been included to stress the potential for serious side effects, including but not limited to serious behavior and mood-related changes. The FDA has also advised restricting the use for allergic rhinitis (hay fever) to those not treated effectively with, or cannot tolerate other allergy medications.


How this impacts providers: Health Professionals should take the following steps of precaution.

  • Ask patients about any history of psychiatric illness prior to initiating treatment.
  • Ensure warnings about these side effects are included in the existing prescribing information.
  • Look for “Black Box warnings” that may arise after initiating montelukast. Symptoms can include, but are not limited to: mood changes, attention problems, irritability, agitation, aggressive behavior, confusion, hallucinations, insomnia, nightmares, depression, suicidal thoughts, uncontrolled muscle movements, obsessive-compulsive symptoms, and anxiety.
  • Consider if reported neuropsychiatric symptoms could be due to the montelukast, especially if the symptoms start or get worse after starting montelukast.


Health professionals are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report online.
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the form, or submit by fax to 1-800-FDA-0178.


If you have any questions, please email Provider Network Management at:

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