Last reviewed: 5 Nov 2020
Last updated: 04 Aug 2020
04 Aug 2020

FDA strengthens warning of risk of serious neuropsychiatric events associated with montelukast, and advises restricting use for allergic rhinitis

The Food and Drug Administration (FDA) has strengthened its warnings for montelukast (a leukotriene receptor antagonist) with regard to the risk of serious behavior- and mood-related changes. The FDA has taken this action after re-evaluating the risks and benefits of montelukast following a review of submitted case reports and published observational and animal studies, and carrying out an observational study of FDA safety data. For allergic rhinitis, the FDA have determined that montelukast should be reserved for those who are not treated effectively with, or cannot tolerate, other allergy medicines. 

Warnings about the risk of neuropsychiatric events (including suicidal thoughts or actions) are already included in the prescribing information for montelukast, but many healthcare professionals and patients/caregivers are not aware of the risk.

Montelukast is indicated for the relief of symptoms of allergic rhinitis; the prevention and chronic treatment of asthma; and the acute prevention of exercise-induced bronchoconstriction. 

See Management: approach

See Management: treatment algorithm

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History and exam

Key diagnostic factors

  • facial pain/pressure
  • nasal obstruction
  • nasal discharge/postnasal drip
  • purulence
  • headache

Other diagnostic factors

  • fatigue
  • cough
  • hyposmia/anosmia
  • fever
  • halitosis
  • dental pain
  • ear pain/pressure

Risk factors

  • ciliary dysfunction
  • aspirin sensitivity
  • allergic rhinitis
  • airway hyperreactivity/asthma
  • previous sinus surgery
  • immunodeficiency
  • severe mid-septal deviations
  • concha bullosa deformity
  • paradoxically bent middle turbinates
  • foreign bodies
  • craniofacial anomalies
  • smoking
  • sarcoidosis
  • granulomatosis with polyangiitis
  • history of asthma

Diagnostic investigations

Investigations to consider

  • sinus CT
  • sinus MRI
  • nasal/sinus cultures
  • allergy testing
More investigations to consider

Treatment algorithm


Section Head of Rhinology, Sinus, and Skull Base Surgery

Head and Neck Institute

Cleveland Clinic Foundation




RS is an author of a number of references cited in this topic.

Assistant Professor

Rhinology and Endoscopic Skull Base Surgery 

Section of Otolaryngology - Head and Neck Surgery

Department of Surgery

University of Chicago Medicine & Biological Sciences




CR declares that he has no competing interests.

Dr R Sindwani and Dr C Roxbury would like to acknowledge Dr J Antisdel, a previous contributor to this topic.

Peer reviewersVIEW ALL


James H. Quillen College of Medicine

East Tennessee State University

Johnson City



RPB declares that he has no competing interests.

Assistant Professor of Otolaryngology - Head and Neck Surgery

St Louis University School of Medicine

St Louis



TS declares that he has no competing interests.


ENT Department

Istanbul Training and Research Hospital




OY declares that he has no competing interests.

Assistant Professor/Consultant

Academic Medical Center


The Netherlands


CG declares that he has no competing interests.

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