Substance / Medication

Montelukast

Overview

Active Ingredient
montelukast
RxNorm CUI
88249
Labeler: Preferred Pharmaceuticals, Inc.Updated: 2026-01-13T00:00:00.000ZFull label on DailyMed

Boxed Warning

FDA Black Box Warning

[see Warnings and Precautions ( Serious neuropsychiatric (NP) events have been reported with the use of montelukast sodium. The types of events reported were highly variable, and included, but were not limited to, agitation, aggression, depression, sleep disturbances, suicidal thoughts and behavior

Contraindications

When this intervention should not be used

• Hypersensitivity to any component of this product.

Indications & Related Conditions

Conditions associated via SNOMED clinical relationships

Administration & Protocol

Dosing, route, and treatment protocol

Detailed dosage and administration information is available in the full FDA drug label.

View full prescribing information on DailyMed

Monitoring & Follow-Up

Biomarkers relevant to this intervention via related conditions

Clinical Trials

69 trials linked to this intervention

69
Total Trials
3
Recruiting
18
With Results

Research Evidence

Published studies and systematic reviews

Sort:
Montelukast use in pregnancy: A systematic review and meta-analysis of maternal and fetal outcomes in asthma treatment.
Fareed Areeba, Siblini Dima, Vaid Rayyan et al. · Congenit Anom (Kyoto) · 2024
PMID: 39129058Meta-Analysis
Clinical efficacy of montelukast sodium combination therapy for cough variant asthma in children: A meta-analysis.
Yang Shihai, He Xia, Zhang Rixia · Pediatr Pulmonol · 2024
PMID: 38501316Meta-Analysis
Efficacy of montelukast for adenoid hypertrophy in paediatrics: A systematic review and meta-analysis.
Alanazi Farhan, Alruwaili Moteb, Alanazy Sultan et al. · Clin Otolaryngol · 2024
PMID: 38700144Meta-Analysis
Montelukast in paediatric asthma and allergic rhinitis: a systematic review and meta-analysis.
Mayoral Karina, Lizano-Barrantes Catalina, Zamora Víctor et al. · Eur Respir Rev · 2023
PMID: 37852659Meta-AnalysisFull text (PMC)
Effect of Montelukast Combined with Budesonide on Inflammatory Response and Pulmonary Function in Children with Cough Variant Asthma: A Meta-analysis.
Wu Qingxia, Wang Lianou, Wu Meixia et al. · J Coll Physicians Surg Pak · 2023
PMID: 37691368Meta-Analysis
Efficacy and safety of montelukast adjuvant therapy in adults with cough variant asthma: A systematic review and meta-analysis.
Xu Qian, Lu Tingting, Song Zhongyang et al. · Clin Respir J · 2023
PMID: 37218346Meta-AnalysisFull text (PMC)
A systematic review and meta-analysis of loratadine combined with montelukast for the treatment of allergic rhinitis.
Wang Huan, Ji Qing, Liao Chao et al. · Front Pharmacol · 2023
PMID: 37915414Meta-AnalysisFull text (PMC)

Research data from MEDLINE/PubMed

Benefits & Expected Outcomes

Benefits, expected outcomes, efficacy data, and NNT (Number Needed to Treat) are pending physician authorship and evidence review.

Risks & Side Effects

Adverse reaction and safety data for this drug is sourced from the FDA-approved label.

View adverse reactions & drug interactions on DailyMed

Related Symptoms

Symptoms associated with conditions this intervention addresses

No related symptoms have been mapped yet. Symptom linkages are derived through associated conditions.

Alternatives & Comparisons

Alternative treatments, comparison data, and clinical decision support are pending physician authorship.

Medical Disclaimer

This information is for educational purposes only and does not constitute medical advice, diagnosis, or treatment. Always consult with a qualified healthcare provider regarding any medical condition or treatment plan.

Do not start, stop, or change any treatment without consulting your healthcare provider.

Health Goals

Goals connected through associated conditions

Quick Facts

Type
Substance / Medication
Fully Specified Name
Montelukast (substance)
SNOMED CT
373728005
UMLS CUI
C0298130
RxNorm CUI
88249
Labeler
Preferred Pharmaceuticals, Inc.

Clinical Data

This intervention maps to 8 entities in the Ltrl knowledge graph.

2
Conditions
3
Biomarkers
2
Specialists
0
Symptoms
69
Clinical Trials

Data is sourced from SNOMED CT, UMLS, and the Ltrl clinical knowledge graph. Content sections marked as pending require physician authorship. Consult a healthcare provider before starting any treatment.