U.S. flag An official website of the United States government
  1. Home
  2. Drugs
  3. Drug Safety and Availability
  4. FDA requires Boxed Warning about serious mental health side effects for asthma and allergy drug montelukast (Singulair); advises restricting use for allergic rhinitis
  1. Drug Safety and Availability

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

3-4-2020 FDA Drug Safety Communication

en Español

Drug Safety Communication (PDF - 68 KB)

Related Information

Contact FDA

For More Info
855-543-DRUG (3784) and press 4
druginfo@fda.hhs.gov

Report a Serious Problem to MedWatch
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 pre-addressed form, or submit by fax to 1-800-FDA-0178.