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# FDA Requires Singulair Boxed Warning
- URL: https://www.fdaweb.com/fda-requires-singulair-boxed-warning/
- Published: 2020-03-04T12:00:00.000Z
- Updated: 2026-09-14T16:05:39.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146244

FDA says it is requiring a Boxed Warning for Merck’s Singulair (montelukast sodium) and its generic forms to strengthen an existing warning about the risk of neuropsychiatric events associated with the drug that is indicated to treat asthma and allergic rhinitis. The [Boxed Warning](https://www.fda.gov/news-events/press-announcements/fda-requires-stronger-warning-about-risk-neuropsychiatric-events-associated-asthma-and-allergy?ref=fdaweb.com) will advise healthcare providers to avoid prescribing montelukast for patients with mild symptoms, particularly those with allergic rhinitis.

The agency says the warning follows its review of available data on continued reports of neuropsychiatric events with montelukast such as agitation, depression, sleeping problems, and suicidal ideation.

FDA also is requiring a new Medication Guide to be given to patients with each montelukast prescription.