Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                Drugs

Drugs

                        


                        Regulatory Science Research and Education
          Development & Approval Process | Drugs
          Drug Safety and Availability
          Emergency Preparedness | Drugs
          Guidance, Compliance, & Regulatory Information
          News & Events for Human Drugs
          Resources | Drugs
          Science and Research | Drugs Home
          Drugs
          FDA requires Boxed Warning about serious mental health side effects for asthma and allergy drug montelukast (Singulair); advises restricting use for allergic rhinitisDrugs FDA requires Boxed Warning about serious mental health side effects for asthma and allergy drug montelukast (Singulair); advises restricting use for allergic rhinitis
  
  					FDA Drug Safety Podcast
	
    Share
    Post
    Linkedin

    Email
    PrintListen

Welcome to the FDA Drug Safety Podcast for health care professionals from the Division of Drug Information.

On March 4, 2020 FDA strengthened existing warnings about serious behavior and mood-related changes with montelukast (brand name Singulair), a prescription medicine for asthma and allergy.

We are taking this action after a review of available information that led us to reevaluate the benefits and risks of montelukast use. Prescribing information already includes warnings about mental health side effects, including suicidal thoughts or actions; however, many health care professionals, patients and caregivers are not aware of the risk. We decided a stronger warning is needed after conducting an extensive review of available information and convening a panel of outside experts. We are requiring a *Boxed Warning*, our most prominent warning, be added to the prescribing information to describe these serious mental health side effects. We are also requiring a new patient Medication Guide to educate patients about the medicine.

We reviewed case reports submitted to FDA, conducted an observational study using data from the FDA’s Sentinel System, and reviewed observational and animal studies in the published literature. Given the available information, we also reevaluated the benefits and risks of use of montelukast and determined it should not be the first-choice treatment for mild allergic rhinitis.

Health care professionals should consider the risks and benefits of montelukast when deciding to prescribe or continue patients on the medicine. Counsel all patients about mental health side effects and advise them to stop the medicine and contact a health care professional immediately if they develop any symptoms. Only prescribe montelukast for allergic rhinitis in patients who have an inadequate response or intolerance to alternative therapies and for patients with asthma, we recommend that health care professionals consider the benefits, and risks of mental health side effects, before prescribing montelukast.

We continue to receive reports of mental health side effects with montelukast use. 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.

Side effects involving montelukast should be reported to FDA’s MedWatch program at www.fda.gov/medwatch.

A link to the full communication detailing specific information for health care professionals and the complete Data Summary can be found at www.fda.gov/DrugSafetyCommunications. If you have drug questions, you can reach us at druginfo@fda.hhs.gov.

And follow us on Twitter @FDA_Drug_Info for up to the minute important drug information.

Related Information

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

                                                                                  Content current as of:
      01/14/2022
              
              
Regulated Product(s)
		 DrugsDrugs

          
                        


                        Regulatory Science Research and Education
          Development & Approval Process | Drugs
          Drug Safety and Availability
          Emergency Preparedness | Drugs
          Guidance, Compliance, & Regulatory Information
          News & Events for Human Drugs
          Resources | Drugs
          Science and Research | Drugs
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop