Montelukast
Prescription ·Strong evidence ·Reviewed May 2026
A leukotriene receptor antagonist (LTRA) used for the maintenance treatment of asthma, exercise-induced bronchoconstriction, and allergic rhinitis. Blocks cysteinyl leukotriene receptor CysLT1, reducing inflammation, bronchoconstriction, and mucus secretion. While effective, it is generally less potent than inhaled corticosteroids as monotherapy for asthma. Carries an FDA black box warning for neuropsychiatric events. The decision to prescribe should weigh benefits against the risk of these events.
The bottom line
Evidence rating strong. Most-documented uses: maintenance treatment of persistent asthma, prevention of exercise-induced bronchoconstriction, symptomatic relief of allergic rhinitis (seasonal and perennial). 10 sources indexed (2023–2025), with 0 interaction records on file.
How it works, mechanistically.
Core mechanism
Selectively and competitively binds to the cysteinyl leukotriene type 1 receptor (CysLT1), blocking the actions of leukotrienes C4, D4, and E4. These leukotrienes are potent pro-inflammatory mediators released from mast cells, eosinophils, and other cells via the 5-lipoxygenase pathway of arachidonic acid metabolism. Their effects include bronchoconstriction (1000x more potent than histamine), increased vascular permeability, mucus hypersecretion, and eosinophil recruitment. By blocking CysLT1, montelukast reduces all these downstream effects.7
Dosing & protocol.
Rapidly absorbed with approximately 64% bioavailability (film-coated tablet). Food does not affect the film-coated tablet. Take in the evening for asthma; any time of day for allergic rhinitis. Chewable tablets should not be swallowed whole.
Full safety detail.
Side effects
- Headache
- Abdominal pain
- Thirst
- Upper respiratory infection symptoms
- Neuropsychiatric events (agitation, aggression, anxiousness, depression, disorientation, dream abnormalities, hallucinations, insomnia, irritability, restlessness, suicidal thinking and behavior, tremor, BLACK BOX WARNING)
- Eosinophilic granulomatosis with polyangiitis (Churg-Strauss, rare)
Sources, by evidence tier.
Numbered references. Citations throughout the page link here.
Meta-analyses & systematic reviews
5- 1Intranasal Corticosteroids and Oral Montelukast for Paediatric Obstructive Sleep Apnoea: A Systematic ReviewNeeds reviewPMIDZaffanello M, Pietrobelli A, Nosetti L et al. · Pharmaceutics · 2025
Zaffanello M, Pietrobelli A, Nosetti L et al.. Intranasal Corticosteroids and Oral Montelukast for Paediatric Obstructive Sleep Apnoea: A Systematic Review. Pharmaceutics. 2025
- 2Efficacy of montelukast for adenoid hypertrophy in paediatrics: A systematic review and meta-analysisNeeds reviewPMIDAlanazi F, Alruwaili M, Alanazy S et al. · Clinical otolaryngology : official journal of ENT-UK ; official journal of Netherlands Society for Oto-Rhino-Laryngology & Cervico-Facial Surgery · 2024
Alanazi F, Alruwaili M, Alanazy S et al.. Efficacy of montelukast for adenoid hypertrophy in paediatrics: A systematic review and meta-analysis. Clinical otolaryngology : official journal of ENT-UK ; official journal of Netherlands Society for Oto-Rhino-Laryngology & Cervico-Facial Surgery. 2024
- 3Montelukast use in pregnancy: A systematic review and meta-analysis of maternal and fetal outcomes in asthma treatmentNeeds reviewPMIDFareed A, Siblini D, Vaid R et al. · Congenital anomalies · 2024
Fareed A, Siblini D, Vaid R et al.. Montelukast use in pregnancy: A systematic review and meta-analysis of maternal and fetal outcomes in asthma treatment. Congenital anomalies. 2024
- 4Montelukast in paediatric asthma and allergic rhinitis: a systematic review and meta-analysisNeeds reviewPMIDMayoral K, Lizano-Barrantes C, Zamora V et al. · European respiratory review : an official journal of the European Respiratory Society · 2023
Mayoral K, Lizano-Barrantes C, Zamora V et al.. Montelukast in paediatric asthma and allergic rhinitis: a systematic review and meta-analysis. European respiratory review : an official journal of the European Respiratory Society. 2023
- 5A systematic review and meta-analysis of loratadine combined with montelukast for the treatment of allergic rhinitisNeeds reviewPMIDWang H, Ji Q, Liao C et al. · Frontiers in pharmacology · 2023
Wang H, Ji Q, Liao C et al.. A systematic review and meta-analysis of loratadine combined with montelukast for the treatment of allergic rhinitis. Frontiers in pharmacology. 2023
Reference material
5- 6FDA Drug Safety Communication: FDA requires Boxed Warning about serious mental health side effects for the asthma and allergy drug montelukast (Singulair). FDA. 2020.Source linkedPMID
- 7Chauhan BF, Ducharme FM. Anti-leukotriene agents compared to inhaled corticosteroids in the management of recurrent and/or chronic asthma in adults and children. Cochrane Database Syst Rev. 2012.Source linkedPMID
- 8Philip G et al. Montelukast for treating seasonal allergic rhinitis: a randomized, double-blind, placebo-controlled trial. Ann Allergy Asthma Immunol. 2002.Source linkedPMID
- 9Shao M, Sun J, Zheng Q. Efficacy and safety of montelukast-levocetirizine combination therapy in combined allergic rhinitis and asthma syndrome: a systematic review and meta-analysis. The Journal of asthma : official journal of the Association for the Care of Asthma. 2025Source linkedPMID
- 10Lo CWH, Pathadka S, Qin SX et al.. Neuropsychiatric events associated with montelukast in patients with asthma: a systematic review. European respiratory review : an official journal of the European Respiratory Society. 2023Source linkedPMID
Deep dives & adjacent profiles.
This page is educational. Do not start, stop, or change a supplement or medication based on it without checking with a qualified healthcare professional.
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