Do you or a loved one take Singulair (generic name is Montelukast) for asthma or allergies? Earlier this year, the U.S. Food and Drug Administration (FDA) acknowledged serious mental health side effects related to this popular medicine, prescribed to over 35 million people. The side effects include suicidal thoughts or actions, agitation, hallucinations, and depression. Since March 2020, the medication now requires a Black Box warning, due to the overwhelming evidence of serious mental health side effects.
According to A Guide to Drug Safety Terms at FDA, a black box warning “appears on a prescription drug’s label and is designed to call attention to serious or life-threatening risks.” Medline Plus, a website operated by the U.S. National Library of Medicine, has the following information about Singulair/Montelukast:
Montelukast may cause serious or life-threatening mental health changes while you are taking this medication or after treatment has stopped. You should call your doctor right away and stop taking montelukast if you experience any of the following symptoms: agitation, aggressive behavior, anxiety, irritability, difficulty paying attention, memory loss or forgetfulness, confusion, unusual dreams, hallucinations (seeing things or hearing voices that do not exist), repeating thoughts that you cannot control, depression, difficulty falling asleep or staying asleep, restlessness, sleep walking, suicidal thoughts or actions (thinking about harming or killing yourself or planning or trying to do so), or tremor (uncontrollable shaking of a part of the body). Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor if you are unable to seek treatment on your own.~ National Institutes of Health
If someone you know takes Singulair/Montelukast, encourage them to contact their doctor to discuss whether they should continue taking the medication.
Benefits vs. Risks
Medicine, whether over-the-counter (OTC) or prescription, has side effects. In the best case scenario, the benefits of any drug should outweigh the side effects. However, the FDA found that the benefits of Singulair/Montelukast often did not outweigh the risks.
To educate yourself about the side effects/adverse reactions of any FDA-approved medication, visit DailyMed, a website maintained by the National Institutes of Health (NIH). To help you make the best decisions related to your health, read Think It Through: Managing the Benefits and Risks of Medicines, a guide written by the FDA.
Report Adverse Reactions
If you or a loved one have taken Singulair/Montelukast and have experienced any adverse reactions, you are encouraged to make a report to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program. To do this, visit MedWatch to submit a report online or to download a reporting form.
Written by: Laura Stanton, MA, MS, Family and Consumer Sciences Educator, Ohio State University Extension, Warren County, firstname.lastname@example.org.
Reviewed by: Shari Gallup, MS, CHWC, Family and Consumer Sciences Educator, Ohio State University Extension, Licking County, email@example.com.
DailyMed- Singular/Montelukast: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8c166755-7711-4df9-d689-8836a1a70885#S5.1
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: https://www.fda.gov/drugs/drug-safety-and-availability/fda-requires-boxed-warning-about-serious-mental-health-side-effects-asthma-and-allergy-drug
Finding and Learning about Side Effects (adverse reactions): https://www.fda.gov/drugs/drug-information-consumers/finding-and-learning-about-side-effects-adverse-reactions
A Guide to Drug Safety Terms at FDA: https://www.fda.gov/media/74382/download
MedlinePlus- Singulair/Montelukast: https://medlineplus.gov/druginfo/meds/a600014.html
National Institutes of Health: https://www.nih.gov
Singulair (montelukast) and All Montelukast Generics: Strengthened Boxed Warning – Due to Restricting Use for Allergic Rhinitis: https://www.fda.gov/safety/medical-product-safety-information/singulair-montelukast-and-all-montelukast-generics-strengthened-boxed-warning-due-restricting-use
Think It Through: Managing the Benefits and Risks of Medicines: https://www.fda.gov/drugs/drug-information-consumers/think-it-through-managing-benefits-and-risks-medicines