Last reviewed: August 2020
Last updated: September  2018
21 Apr 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 about the risk of serious behavior and mood-related changes. 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.

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.

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

Montelukast (a leukotriene receptor antagonist) 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

  • cough
  • unpleasant sensation in throat
  • postnasal drip
  • cobblestone mucosa

Other diagnostic factors

  • nasal abnormalities
  • symptoms of rhinitis
  • posterior pharyngeal mucus
  • wheeze
  • voice disturbance
  • heartburn/indigestion

Risk factors

  • seasonal triggers
  • occupational triggers
  • female gender

Diagnostic investigations

1st investigations to order

  • empiric treatment trial
  • CXR
  • CBC
  • ESR
  • CRP
  • spirometry
More 1st investigations to order

Investigations to consider

  • direct nasolaryngoscopy
  • serum IgE level
  • specific aeroallergen radioallergosorbent test (RAST)
  • peak expiratory flow rate (PEFR)
  • CT sinus
More investigations to consider

Treatment algorithm


Professor of Respiratory Medicine

Head of Experimental Studies Medicine

National Heart and Lung Institute

Imperial College London

Royal Brompton Hospital




KFC has received remuneration for taking part in advisory board meetings on asthma, COPD, and cough, organised by GSK, AstraZeneca, Novartis, Merck, Boehringer Ingelheim, TEVA, Menlo Therapeutics, and 4D pharma. KFC has also been on a speaker's bureau for AstraZeneca and Novartis, and has received educational grants from AstraZeneca, GSK, Bionorica, PGT Healthcare, and Vernalis Therapeutics, for supporting the Ninth London International Cough Symposium held in London in 2016.

Consultant Respiratory Physician

Respiratory Medicine

Royal Brompton Hospital




JHH has received advisory board fees from Menlo Pharmaceuticals, and speaking and travel fees from TEVA and Boehringer Ingelheim.

Peer reviewersVIEW ALL

Professor of Medicine


Pulmonary, Allergy and Critical Care Medicine

University of Massachusetts Medical School




JMM declares that he has no competing interests.

NIHR Career Development Fellow

Clinical Senior Lecturer

Imperial College London

Consultant Physician in Respiratory & Internal Medicine

Royal Brompton Hospital




OSU declares that he has no competing interests.

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