ArticleBMJ paediatrics open2024
Risk of neuropsychiatric adverse events associated with montelukast use in children and adolescents: a population-based case-crossover study.
Article in BMJ paediatrics open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
6 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Association between leukotriene receptor antagonists and neuropsychiatric disorders: a systematic review and meta-analysis.Frontiers in pharmacology · 2026Pooled it
- Montelukast alleviates levels of inflammatory factors and chemokines in patients with allergic rhinitis.Inflammopharmacology · 2026Trial
- Montelukast Prescription Prevalence and Impact on Clinical Outcomes Among Patients with Asthma: A Cross-Sectional Study in Saudi Arabia.Journal of asthma and allergy · 2026Article
- New insights on pharmacological potential of montelukast: a comprehensive review.Inflammopharmacology · 2025Review
- Efficacy and Safety of Combined Treatment with Traditional Herbal Medicine and Western Medicine for Children with Pertussis-like Syndrome: Systematic Review and Meta-Analysis.Healthcare (Basel, Switzerland) · 2025Review
- Computational Investigation of Montelukast and Its Structural Derivatives for Binding Affinity to Dopaminergic and Serotonergic Receptors: Insights from a Comprehensive Molecular Simulation.Pharmaceuticals (Basel, Switzerland) · 2025Article
Corrections and comments
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeMontelukast is used extensively in children and adolescents for allergic rhinitis and asthma. However, concerns have been raised regarding the increased risk of neuropsychiatric adverse events (NPAEs) associated with montelukast use. Therefore, our case-crossover study was conducted to observe whether there is an increased risk of NPAEs associated with montelukast use in children and adolescents. MATERIALS AND
methodsA population-based case-crossover study using the customised Health Insurance Review and Assessment (HIRA) dataset was conducted. Paediatric patients aged between 0 and 19 years diagnosed with allergic rhinitis and/or asthma with a history of at least one montelukast prescription between 1 January 2018 and 31 December 2021 were included. Exposure to montelukast was assessed during 3-, 7-, 14-, 28- and 56-day hazard periods prior to each patient's NPAE. Stratified analyses according to age group, gender and season for the risk of NPAEs associated with montelukast use in the previous 7 days and 14 days were performed, respectively. Conditional logistic regression analysis was used to calculate adjusted ORs (aORs) with their corresponding 95% CIs, adjusting for concomitant medications.
resultsA total of 161 386 paediatric patients was identified. An increased risk of NPAEs associated with montelukast was found in all time window periods, including 3-day (aOR 1.28, 95% CI 1.24 to 1.32), 7-day (aOR 1.29, 95% CI 1.26 to 1.33), 14-day (aOR 1.34, 95% CI 1.31 to 1.37), 28-day (aOR 1.38, 95% CI 1.36 to 1.41) and 56-day (aOR 1.21, 95% CI 1.19 to 1.22) preceding hazard periods compared with use in the four control periods.
conclusionChildren and adolescents with allergic rhinitis and/or asthma should be prescribed montelukast with caution considering clinical benefits.
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