In March 2020, the U.S. Food and Drug Administration (FDA) acknowledged serious mental health side effects related to a popular asthma medicine, Singulair (the generic name is Montelukast). The drug is currently prescribed to over 35 million people in the United States. Since last March, the medication now requires a Black Box warning, due to the overwhelming evidence of severe mental health side effects, including suicidal thoughts or actions, agitation, hallucinations, and depression. In an effort to increase awareness about these side effects, we have compiled information and resources to help educate more people about the potential side effects in children, youth, and adults.

Educational Resources:

Serious Mental Health Side Effects Related to Singulair by Laura M. Stanton for Ohio State University Extension's Live Healthy Live Well Blog

Healthy Living Resources Telecast: Popular Asthma Medication Has Significant Mental Health Side Effects (25-minute YouTube video)

Suzanne Migrin: Montelukast and How it Impacted my Life

Think It Through: Managing the Benefits and Risks of Medicines (PDF)

FDA Announcements:

FDA NEWS RELEASE: FDA Requires Stronger Warning About Risk of Neuropsychiatric Events Associated with Asthma and Allergy Medication Singulair and Generic Montelukast

FDA DRUG SAFETY COMMUNICATIONS: FDA requires Boxed Warning about serious mental health side effects for asthma and allergy drug montelukast (Singulair); advises restricting use for allergic rhinitis; Risks may include suicidal thoughts or actions

FDA MEDICAL PRODUCT SAFETY INFORMATION: Singulair (Montelukast) and All Montelukast Generics: Strengthened Boxed Warning - Due to Restricting Use for Allergic Rhinitis

Websites:

FDA Adverse Events Reporting System (FAERS) Public Dashboard

DailyMed Information for Singulair and Montelukast

MedWatch Forms for FDA Safety Reporting: Voluntary Reporting For Use by Health Professionals, Consumers, and Patients