How Singulair Side Effects Could Possibly Affect Your Mental Health

By
Pat Bass, MD
Pat Bass, MD
Pat Bass, MD
Dr. Bass is a board-certified internist, pediatrician, and a Fellow of the American Academy of Pediatrics and the American College of Physicians.
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Updated on March 13, 2021
Medically reviewed
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 by
Sanja Jelic, MD
Medically reviewed by Sanja Jelic, MD

Sanja Jelic, MD is board-certified in pulmonary disease, sleep medicine, critical care medicine, and internal medicine. She is an assistant professor and attending physician at Columbia University College of Physicians and Surgeons in New York, NY.

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Singulair blister pack
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Singulair, Accolate, Zyflo, and Zyflo CR have modified their product labeling to include information about certain potential mental health side effects that have been noted in patients using these products. Events that patients and healthcare providers need to be aware of include:

  • Agitation
  • Aggression
  • Anxiousness
  • Dream abnormalities
  • Hallucinations
  • Depression
  • Insomnia
  • Irritability
  • Restlessness
  • Suicidal thinking and behavior
  • Suicide
  • Tremor

If you notice any of these side effects you need to make sure that you immediately talk with your prescribing doctor. The FDA has the following recommendations to patients and providers regarding Singulair side effects and side effects of other leukotriene modifiers:

  • Patients and healthcare professionals should be aware of the potential for neuropsychiatric events with these medications.
  • Patients should talk with their healthcare providers if these events occur.
  • Healthcare professionals should consider discontinuing these medications if patients develop neuropsychiatric symptoms.

The latest prescribing information for these products can be found on the FDA website.

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5 Sources
Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read our editorial process to learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.

  1. FDA Pediatric Advisory Committee. FDA Briefing Document for the September 27, 2019 Joint Meeting of the Pediatric and Drug Safety and Risk Management Committees. FDA.

  2. Badri T. Montelukast. StatPearls [Internet].

  3. Philip G, Hustad C, Noonan G, et al. Reports of suicidality in clinical trials of montelukast. J Allergy Clin Immunol. 2009;124(4):691-6.e6. doi:10.1016/j.jaci.2009.08.010

  4. Erdem SB, Nacaroglu HT, Unsal Karkiner CS, Gunay I, Can D. Side Effects of Leukotriene Receptor Antagonists in Asthmatic Children. Iran J Pediatr. 2015;25(5):e3313. doi:10.5812/ijp.3313

  5. Haarman MG, van Hunsel F, de Vries TW. Adverse drug reactions of montelukast in children and adults. Pharmacol Res Perspect. 2017;5(5):e00341. doi:10.1002/prp2.341

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