ArticleThe World Allergy Organization journal2021
Neuropsychiatric side reactions of leukotriene receptor antagonist, antihistamine, and inhaled corticosteroid: A real-world analysis of the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS).
Article in The World Allergy Organization journal, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 1 of them a synthesis that pooled it.
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Who cites it
15 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Psychiatric Symptoms Associated with Corticosteroid Use: A Systematic Review and Meta-analysis.CNS drugs · 2026Pooled it
- [Sleep disorders associated with montelukast in children with respiratory allergy].Revista medica del Instituto Mexicano del Seguro Social · 2026Article
- Respiratory drugs and psychiatric adverse events in children and adolescents: a pharmacovigilance study based on the FAERS database.Naunyn-Schmiedeberg's archives of pharmacology · 2026Article
- Risk of drug-related aggression in pediatric populations: a pharmacovigilance analysis using the FAERS database.Frontiers in pediatrics · 2026Article
- 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
- 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
- Drug-induced pancreatitis: a real-world analysis of the FDA Adverse Event Reporting System and network pharmacology.Frontiers in pharmacology · 2025Article
- Gender and age variations in neuropsychiatric adverse events of cetirizine and levocetirizine: a disproportionality analysis of ICSRs from FAERS and EudraVigilance data.Frontiers in pharmacology · 2025Article
- Article
- Risk of neuropsychiatric adverse events associated with montelukast use in children and adolescents: a population-based case-crossover study.BMJ paediatrics open · 2024Article
- Focused allergic rhinitis practice parameter for Canada.Allergy, asthma, and clinical immunology : official journal of the Canadian Society of Allergy and Clinical Immunology · 2024Article
- Article
- Article
- Evaluation of Neuropsychiatric Effects of Montelukast-Levocetirizine Combination Therapy in Children with Asthma and Allergic Rhinitis.Children (Basel, Switzerland) · 2023Article
- Use of Leukotriene-Receptor Antagonists During Pregnancy and Risk of Neuropsychiatric Events in Offspring.JAMA network open · 2023Article
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9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThere are limited real-world studies on the differences in leukotriene receptor antagonists (LTRA), H1-antihistamines (H1-AH), and inhaled corticosteroids (ICS) associated neuropsychiatric events. In this study, we aimed to analyze the characteristics of drug associated neuropsychiatric events, and compare the differences among different drug categories.
methodsDisproportionality analysis and Bayesian analysis were used in data mining to identify suspected neuropsychiatric events associated with LTRA, H1-AH, and ICS based on the United States Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) from January 2004 to September 2020. Demographic information, time interval to onset, and death rates of LTRA, H1-AH, and ICS-associated neuropsychiatric events were also analyzed.
resultsA total of 9475 neuropsychiatric events were identified. The number of neuropsychiatric events related to LTRA, H1-AH, and ICS were 5201 (54.89%), 3226 (34.05%), and 1048 (11.06%), respectively. LTRA related neuropsychiatric events were more common in patients aged 4-6 years (18.66%). H1-AH and ICS related neuropsychiatric events were more common in patients aged 18-44 years (29.92%) and older than 65 years (30.60%), respectively. Montelukast was highly associated with neuropsychiatric events, with a high reporting odds ratio (ROR). Most neuropsychiatric symptoms occurred within the first 10 days after drug initiation (78.63% for LTRA, 91.39% for H1-AH, and 84.07% for ICS). The death rate due to neuropsychiatric events of first generation H1-AH was significantly higher than that of LTRA and ICS (p < 0.001).
conclusionsLTRA associated neuropsychiatric events reported in FAERS were most frequent in 4 to 6-year-old children. Most reported cases occurred within the first 10 days after drug initiation. The second generation H1-AH was relatively safe for neuropsychiatric events compared with the first generation. The fatality rate due to first generation H1-AH associated neuropsychiatric events was higher than that of LTRA and ICS. More attention should be paid to specific patients treated with LTRA and H1-AH.
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