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Last reviewed: 19 Sep 2025
Last updated: 18 Sep 2025
01 Aug 2024

GINA reiterates montelukast safety warning

​The 2024 GINA guideline update reminds prescribers of the potential risk of neuropsychiatric adverse events in patients receiving montelukast, including:[3]

  • new-onset nightmares,

  • behavioral and mood problems (e.g., agitation, hyperactivity, irritability, nervousness, aggression), and

  • suicidal ideation.

Healthcare professionals should consider the benefits and risks before prescribing montelukast and have an open discussion with patients about potential adverse effects.

Healthcare professionals and patients should be alert to, and monitor for, serious behavior and mood-related changes during treatment.

Original source of update

Summary

Your Organizational Guidance

ebpracticenet urges you to prioritize the following organizational guidance:

Astma bij volwassenen: diagnose en monitoring in de eerste lijnPublished by: Werkgroep Ontwikkeling Richtlijnen Eerste Lijn (Worel)Last published: 2020Asthme chez l’adulte : diagnostic et surveillance en soins de santé primairesPublished by: Groupe de Travail Développement de recommmandations de première ligneLast published: 2020

Definition

History and exam

Key diagnostic factors

  • recent upper respiratory tract infection
  • dyspnea
  • cough
  • expiratory wheezes
  • nasal polyposis

Risk factors

  • family history
  • gene polymorphisms and epigenetics
  • allergen/irritant exposure
  • occupational exposure
  • air pollution
  • atopic disease history
  • obesity
  • cigarette smoking
  • vaping
  • early life respiratory viral infection and viral wheeze
  • nasal polyposis
  • aspirin and nonsteroidal anti-inflammatory drug (NSAID) use
  • low socioeconomic status
  • gastroesophageal reflux
  • obstructive sleep apnea
  • sex
  • preterm birth
  • polycystic ovary syndrome
  • vitamin D deficiency

Diagnostic tests

1st tests to order

  • FEV₁/FVC ratio
  • peak expiratory flow (PEF)

Tests to consider

  • chest x-ray
  • CBC with differential
  • fractional exhaled nitric oxide (FeNO)
  • bronchial challenge test
  • serum radioallergosorbent test (RAST) immunoassay for allergen-specific IgE
  • skin-prick allergy testing
  • high-resolution CT (HRCT) chest
  • CT sinus

Emerging tests

  • sputum eosinophil count

Treatment algorithm

Contributors

Authors

Lauren E. Eggert, MD

Clinical Assistant Professor

Division of Pulmonary, Allergy, and Critical Care Medicine

Department of Medicine

Stanford University School of Medicine

Stanford

CA

Disclosures

LEE has participated on advisory boards for Regeneron and AstraZeneca.

Sourav Majumdar, MD

Clinical Assistant Professor (Affiliated)

Division of Pulmonary and Critical Care Medicine

Department of Medicine

Stanford University School of Medicine

Stanford

CA

Disclosures

SM declares that he has no competing interests.

Acknowledgements

Dr Lauren E. Eggert and Dr Sourav Majumdar would like to gratefully acknowledge Dr Irwani Ibrahim, Dr Kay Choong See, Dr Francis Thien, and Dr Catherine Weiler, previous contributors to this topic.

Disclosures

II, KCS, FT, and CW declare that they have no competing interests.

Peer reviewers

Javed Sheikh, MD

Clinical Director

Division of Allergy and Inflammation

Beth Israel Deaconess Medical Center/Harvard Medical School

Boston

MA

Disclosures

JS is a consultant for Aventis, GSK, and Novartis/Genentech; is on the Speakers Bureau for Merck, Aventis, GSK, AstraZeneca, Pfizer, Novartis/Genentech, Inspire, and UCB; has had research sponsored by GSK; is an expert witness at Haemonetics; and has received publication honorarium at Emedicine.

Sheree M.S. Smith, PhD

Research Manager

Imperial College Healthcare Trust

NHLI Airways Division

Imperial College London (Honorary) Respiratory Research

Chest & Allergy

St Mary's Hospital

London

UK

Disclosures

SMSS declares that she has no competing interests.

Neil Thomson, MBChB, MD, FRCP

Professor of Respiratory Medicine

Respiratory Medicine Section

Division of Immunology, Infection & Inflammation

University of Glasgow

Glasgow

UK

Disclosures

NT declares that he has no competing interests.

Peer reviewer acknowledgements

BMJ Best Practice topics are updated on a rolling basis in line with developments in evidence and guidance. The peer reviewers listed here have reviewed the content at least once during the history of the topic.

Disclosures

Peer reviewer affiliations and disclosures pertain to the time of the review.

References

Our in-house evidence and editorial teams collaborate with international expert contributors and peer reviewers to ensure that we provide access to the most clinically relevant information possible.

Key articles

National Institutes of Health; National Heart, Lung, and Blood Institute, National Asthma Education and Prevention Program. Expert panel report 3: guidelines for the diagnosis and management of asthma. Aug 2007 [internet publication].Full text

Global Initiative for Asthma. 2024 global strategy for asthma management and prevention. May 2024 [internet publication].Full text

Parsons JP, Hallstrand TS, Mastronarde JG, et al. An official American Thoracic Society clinical practice guideline: exercise-induced bronchoconstriction. Am J Respir Crit Care Med. 2013 May 1;187(9):1016-27.Full text  Abstract

Expert Panel Working Group of the National Heart, Lung, and Blood Institute (NHLBI) administered and coordinated National Asthma Education and Prevention Program Coordinating Committee (NAEPPCC); Cloutier MM, Baptist AP, Blake KV, et al. 2020 focused updates to the asthma management guidelines: a report from the National Asthma Education and Prevention Program Coordinating Committee Expert Panel Working Group. J Allergy Clin Immunol. 2020 Dec;146(6):1217-70.Full text  Abstract

Reference articles

A full list of sources referenced in this topic is available here.

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