ArticleDrug safety2016
Psychiatric Disorders and Montelukast in Children: A Disproportionality Analysis of the VigiBase(®).
Article in Drug safety, 2016. 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 35 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
35 citing papers in PubMed, 4 syntheses or guidelines pooled it, 93 citations in OpenAlex.
- 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
- Antileukotrienes for the prevention and treatment of chronic lung disease in very preterm newborns: a systematic review.Respiratory research · 2021Pooled it
- A systematic review of adverse drug events associated with administration of common asthma medications in children.PloS one · 2017Pooled it
- Contemporary management of chronic rhinosinusitis with nasal polyposis in aspirin-exacerbated respiratory disease: an evidence-based review with recommendations.International forum of allergy & rhinology · 2016Pooled it
- 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
- Prescribed Drugs and Interpersonal Violence: A Case-Non-Case Study in the Spanish Pharmacovigilance Database.Pharmaceuticals (Basel, Switzerland) · 2025Article
- 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
- A real-world data analysis of montelukast in FDA Adverse Event Reporting System (FAERS) database.BMC pharmacology & toxicology · 2025Article
- Risk of neuropsychiatric adverse events associated with montelukast use in children and adolescents: a population-based case-crossover study.BMJ paediatrics open · 2024Article
- Maximal medical treatment of adenoid hypertrophy: a prospective study of preschool children.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2024Article
- Article
- 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
- Prescribed Drugs and Self-Directed Violence: A Descriptive Study in the Spanish Pharmacovigilance Database.Pharmaceuticals (Basel, Switzerland) · 2023Article
- 150th Anniversary of global adenoid investigations: unanswered questions and unsolved problems.Frontiers in pediatrics · 2023Review
- 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
- Leukotrienes vs. Montelukast-Activity, Metabolism, and Toxicity Hints for Repurposing.Pharmaceuticals (Basel, Switzerland) · 2022Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionIn 2008, the US FDA issued an alert about an increased risk of psychiatric events associated with montelukast. Recent national pharmacovigilance analyses in Sweden, France and Spain detected a potential increase in reporting risk of the association.
aimOur objective was to analyse spontaneous reports of psychiatric events in children and adolescents worldwide treated with montelukast.
methodsWe conducted a retrospective analysis of Individual Case Safety Reports (ICSRs) recorded up to 1 January 2015 in the World Health Organization (WHO) database (VigiBase(®)), in which montelukast was associated with 'psychiatric disorders'. We used the Bayesian Confidence Propagation Neural Network (BCPNN) approach for signal generation.
resultsA total of 14,670 ICSRs for montelukast were recorded, of which 2630 corresponded to psychiatric disorders in people aged <18 years. The main symptoms reported for infants (aged <2 years) were sleep disorders, for children (aged 2-11 years) the main symptoms were depression/anxiety, and for adolescents (aged 12-17 years) they were suicidal behaviour and depression/anxiety. Suicidal behaviour was over-represented in all age groups with information component (IC) values that reached 5.01 in children and 3.85 in adolescents. Unexpectedly, completed suicides were reported more frequently for children (IC: 3.15; IC025: 1.98) than for adolescents (IC: 3.11; IC025: 2.61) or the total population (IC 1.95; IC025: 1.73).
conclusionsNeuropsychiatric disorders as side effects of montelukast were more frequently reported for children than for adults. Infants and children seem to be more prone to sleep disturbances, whereas adolescents present symptoms of depression/anxiety and psychotic reactions more often. Suicidal behaviour and completed suicide appear to be more frequently reported than previously thought in practice. Risk management plans and epidemiological studies are needed to quantify the risk. Practitioners should be aware of the risk of neuropsychiatric events associated with montelukast use, and should advise the patient and report new cases.
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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.