Montelukast combined with inhaled corticosteroids may increase the risk of neuropsychiatric adverse events in pediatric asthma patients compared to ICS monotherapy
A systematic review and meta-analysis of 6 studies (3 RCTs, 3 cohort studies) involving 559 pediatric patients found that the combination of montelukast with ICS was associated with a 12.1% incidence of neuropsychiatric adverse events versus 8.6% with ICS alone. The pooled risk ratio was 1.41 (95% CI: 0.89-2.22, P=0.14), with an absolute risk difference of 3.5%, translating to approximately 35 additional events per 1,000 children, though this result was not statistically significant.
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Montelukast combined with inhaled corticosteroids may increase the risk of neuropsychiatric adverse events in pediatric asthma patients compared to ICS monotherapy The current body of evidence comprises 1 study and 1 meta-analysis. EvidenceHub rates the overall confidence at 49/100 (low).
The Claim
Montelukast combined with inhaled corticosteroids may increase the risk of neuropsychiatric adverse events in pediatric asthma patients compared to ICS monotherapy
This conclusion is most relevant to: Children and adolescents with asthma (pediatric patients, age not further specified in abstract).
What the Research Shows
The conclusion draws on 1 linked study. Highlights from the cited literature:
- ▸Risk of Neuropsychiatric Adverse Events with Montelukast Combined with Inhaled Corticosteroids (ICS) in the Treatment of Asthma in Children and Adolescents: A Systematic Review and Meta-Analysis. (The Journal of asthma : official journal of the Association for the Care of Asthma, 2026) —
How It Works
The proposed biological pathway:
- ▸Montelukast is a leukotriene receptor antagonist that modulates inflammatory pathways in asthma
- ▸Combination with ICS may alter drug metabolism or central nervous system exposure
- ▸Potential neuropsychiatric effects may involve leukotriene receptor activity in the brain
- ▸Result: Increased risk of neuropsychiatric adverse events (not statistically significant)
Who Might Benefit
Evidence fit by population:
- ▸Children and adolescents with asthma (pediatric patients, age not further specified in abstract)
Recommended Dose
N/A
Limitations & Caveats
Important context when interpreting this evidence:
- ▸The finding was not statistically significant (P=0.14), indicating considerable statistical uncertainty
- ▸Only 6 studies were included with a total sample size of 559 patients, limiting power to detect small effects
- ▸The abstract does not specify the age range, duration of treatment, or control for confounding variables in cohort studies
Frequently Asked Questions
Does montelukast combined with ICS significantly increase neuropsychiatric adverse events in children?▼
The meta-analysis found a 41% relative risk increase (RR=1.41) but this was not statistically significant (P=0.14), so the evidence is inconclusive and suggests a potential trend rather than a confirmed risk.
What are the most common neuropsychiatric adverse events reported?▼
Subgroup analyses identified headaches and sleep disturbances as the most common events, with risk increases of 62% and 53% respectively, though these also did not reach statistical significance.
How many children would need to be treated to see one additional adverse event?▼
The number needed to harm (NNH) was 29, meaning that for every 29 children receiving combination therapy, one additional neuropsychiatric adverse event would occur compared to ICS alone.
Should clinicians avoid prescribing montelukast with ICS in children?▼
The authors recommend caution in high-risk populations but do not advise against use, as the results were not statistically significant. They call for prospective validation studies to clarify the risk.
References
- 1.Yang Q, Guo C, Yu X, Liu X, Xie J, Liu K. “Risk of Neuropsychiatric Adverse Events with Montelukast Combined with Inhaled Corticosteroids (ICS) in the Treatment of Asthma in Children and Adolescents: A Systematic Review and Meta-Analysis..” The Journal of asthma : official journal of the Association for the Care of Asthma, 2026. PMID: 42501004 DOI: 10.1080/02770903.2026.2706354