ArticleThe European respiratory journal2017
Neuropsychiatric adverse drug reactions in children initiated on montelukast in real-life practice.
Article in The European respiratory journal, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06887673 (Exploring the Impact of Montelukast, SPM, and/or Almond/Almond Oil Supplementation on Lipid Mediator Biosynthesis in Colorectal, Sarcomas, Brain Tumors, Endometrial, and Ovarian Cancer), which is not on this map. Cited by 32 papers, 4 of them syntheses that pooled it.
What it found
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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.
Exploring the Impact of Montelukast, SPM, and/or Almond/Almond Oil Supplementation on Lipid Mediator Biosynthesis in Colorectal, Sarcomas, Brain Tumors, Endometrial, and Ovarian Cancer: A Pilot Study
Who cites it
32 citing papers in PubMed, 4 syntheses or guidelines pooled it, 96 citations in OpenAlex.
- Association between leukotriene receptor antagonists and neuropsychiatric disorders: a systematic review and meta-analysis.Frontiers in pharmacology · 2026Pooled it
- Neuropsychiatric events associated with montelukast in patients with asthma: a systematic review.European respiratory review : an official journal of the European Respiratory Society · 2023Pooled it
- Adverse drug reactions of leukotriene receptor antagonists in children with asthma: a systematic review.BMJ paediatrics open · 2021Pooled it
- 2020 Brazilian Thoracic Association recommendations for the management of asthma.Jornal brasileiro de pneumologia : publicacao oficial da Sociedade Brasileira de Pneumologia e TisilogiaGuideline
- [Sleep disorders associated with montelukast in children with respiratory allergy].Revista medica del Instituto Mexicano del Seguro Social · 2026Article
- Changes in the Use of Montelukast for Asthma After a US Food and Drug Administration Boxed Warning.JAMA network open · 2026Article
- Use of Clinical Notes to Assess Neuropsychiatric Events After Montelukast Initiation.JAMA network open · 2026Article
- Risk of drug-related aggression in pediatric populations: a pharmacovigilance analysis using the FAERS database.Frontiers in pediatrics · 2026Article
- Comparative Risk for Neuropsychiatric Events in Leukotriene Receptor Antagonist vs. Inhaled Corticosteroid in Children With Asthma: A Nationwide Observational Study With a Complementary Analysis Using Natural Language Processing.Pharmacoepidemiology and drug safety · 2025Observational
- Pediatric Pharmacy Association 2025 KIDs List of Key Potentially Inappropriate Drugs in Pediatrics.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2025Article
- Potentially Overlooked Risk for Neuropsychiatric Symptoms in Children: Montelukast Treatment.Journal of paediatrics and child health · 2025Observational
- The ADCY1-mediated cAMP signaling pathway mediates functional effects of montelukast treatment in brain organoids.Cellular and molecular life sciences : CMLS · 2025Article
- Montelukast Use and the Risk of Neuropsychiatric Adverse Events in Children.JAMA pediatrics · 2025Article
- Evaluating the Association of Montelukast Use on Neuropsychiatry-Related Healthcare Utilization and Depression in COVID-19-Hospitalized Veterans: A Nationwide VA Observational Cohort Study.Clinical drug investigation · 2023Observational
- Evaluation of Neuropsychiatric Effects of Montelukast-Levocetirizine Combination Therapy in Children with Asthma and Allergic Rhinitis.Children (Basel, Switzerland) · 2023Article
- Adverse Drug Reactions (ADRs) of Montelukast in Children.Children (Basel, Switzerland) · 2022Article
- Leukotriene receptor antagonists and risk of neuropsychiatric events in children, adolescents and young adults: a self-controlled case series.The European respiratory journal · 2022Article
- Increased Risk of Tourette Syndrome with Leukotriene Modifier Use in Children with Allergic Diseases and Asthma: A Nationwide Population-Based Study.Children (Basel, Switzerland) · 2022Article
- Leukotrienes vs. Montelukast-Activity, Metabolism, and Toxicity Hints for Repurposing.Pharmaceuticals (Basel, Switzerland) · 2022Review
- Article
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Authors and funding
6 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Although montelukast is generally well tolerated, postmarketing studies have reported serious neuropsychiatric adverse drug reactions (ADRs) leading to a United States Food and Drug Administration black box warning. The objective of this study was to determine the incidence of neuropsychiatric ADRs leading to discontinuation of montelukast in asthmatic children.We conducted a retrospective cohort study in children aged 1-17 years initiated on montelukast. In a nested cohort study, children initiated on montelukast as monotherapy or adjunct therapy to inhaled corticosteroids (ICS) were matched to those initiated on ICS monotherapy. A non-leading parental interview served to ascertain the occurrence of any ADRs with any asthma medication, and circumstances related to, and evolution of, the event.Out of the 106 participants who initiated montelukast, most were male (58%), Caucasian (62%) with a median (interquartile range) age of 5 (3-8) years. The incidence (95% CI) of drug cessation due to neuropsychiatric ADRs was 16 (10-26)%, mostly occurring within 2 weeks. Most frequent ADRs were irritability, aggressiveness and sleep disturbances. The relative risk of neuropsychiatric ADRs associated with montelukast
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.