EVIDENCE-BASEDAWAITING CLINICIAN REVIEW

Montelukast

WHO ATCR03DC03INNMontelukast

Montelukast is an oral leukotriene receptor antagonist used as controller therapy for asthma and for selected allergic-rhinitis patients. Because serious neuropsychiatric events have been reported, the indication and ongoing need should be reviewed rather than treating it as a risk-free allergy tablet.

At a glance

Quick facts

Drug snapshot
Drug class
Leukotriene receptor antagonist
Main uses
Asthma controller therapy; prevention of exercise-induced bronchoconstriction; allergic rhinitis in selected patients when alternatives are inadequate or unsuitable
Route
Oral
WHO ATC
R03DC03
Key safety
Boxed warning for serious neuropsychiatric events; it is not a rescue medicine for acute asthma symptoms.
Monitoring
Asthma control, rescue-inhaler use, mood/behaviour changes and whether the allergic-rhinitis indication still justifies treatment.

Names & terminology

How this medicine may be named or searched

Canonical page name
Montelukast
INN / generic name
Montelukast
Aliases / salts
montelukast · montelukast sodium
Russian support entity
montelukast.ru — entity relationship only, not a clinical source

Structured drug profile

Drug profile

INN data
INNMontelukastInternational nonproprietary / generic name used for this entity.
WHO ATCR03DC03Anatomical Therapeutic Chemical classification; route-specific codes may differ for some medicines.
Drug classLeukotriene receptor antagonistPharmacologic / therapeutic class.
MechanismBlocks cysteinyl leukotriene CysLT1 receptors, reducing leukotriene-mediated airway inflammation and bronchoconstriction.Mechanism summarized at reference level.
RouteOralAvailable routes depend on the specific product.
Main usesAsthma controller therapy; prevention of exercise-induced bronchoconstriction; allergic rhinitis in selected patients when alternatives are inadequate or unsuitableApproved indications can differ by country and formulation.
Key safety contextBoxed warning for serious neuropsychiatric events; it is not a rescue medicine for acute asthma symptoms.Check exact product labeling and patient-specific contraindications.
Monitoring / reviewAsthma control, rescue-inhaler use, mood/behaviour changes and whether the allergic-rhinitis indication still justifies treatment.Monitoring depends on indication, dose, route and patient factors.

What is Montelukast?

Montelukast is an oral leukotriene receptor antagonist used as controller therapy for asthma and for selected allergic-rhinitis patients. Because serious neuropsychiatric events have been reported, the indication and ongoing need should be reviewed rather than treating it as a risk-free allergy tablet.

What is Montelukast used for?

Asthma controller therapy; prevention of exercise-induced bronchoconstriction; allergic rhinitis in selected patients when alternatives are inadequate or unsuitable. The exact approved indication depends on the product, route and country. [1]

How it works

Blocks cysteinyl leukotriene CysLT1 receptors, reducing leukotriene-mediated airway inflammation and bronchoconstriction.

Forms and formulations

Tablets, chewable tablets and oral granules. Different formulations may have different indications, strengths, excipients and instructions and should not be assumed interchangeable.

Country / market layer

Availability and formulations by market

Brand names, strengths, prescription status and approved uses vary by jurisdiction. Check the exact national product record before relying on a formulation.

Market-specific
🇬🇧
United KingdomSearch current eMC product information
Search eMC ↗

Availability depends on the active ingredient, route and formulation; not every medicine in this reference has a current UK product.

This English reference was selected because DiseasesConditions.org also maintains an entity relationship to the project’s Russian-language support site montelukast.ru. The Russian site is not used as a clinical source for this page.

How it is used

Take on the schedule prescribed for the indication. Keep prescribed rescue inhalers available because montelukast does not reverse an acute asthma attack. Do not take extra doses for sudden wheeze unless specifically instructed in a treatment plan.

For prescription treatment, use the patient-specific regimen rather than copying a dose from another person or another formulation.

Side effects

Headache and gastrointestinal symptoms can occur. The most important safety concern is possible serious mood, sleep, behaviour or suicidal symptoms, which can occur during treatment or after discontinuation.

Important warnings and monitoring

Contact the prescriber promptly for new agitation, aggression, depression, abnormal dreams, hallucinations, suicidal thoughts or other marked neuropsychiatric change. Acute severe asthma symptoms require the rescue plan and urgent care when indicated.

Monitoring context: Asthma control, rescue-inhaler use, mood/behaviour changes and whether the allergic-rhinitis indication still justifies treatment.

Interactions

Montelukast has fewer major interactions than many drugs, but medicines that strongly affect hepatic enzymes can alter exposure. Always review the complete medicine list.

Pregnancy and breastfeeding

Asthma control remains important in pregnancy. Decisions about montelukast should consider prior response, alternatives and maternal disease severity rather than stopping controller treatment without advice.

Overdose and accidental extra doses

Large overdoses most often cause gastrointestinal or neurologic symptoms but should be assessed using poison-centre or emergency guidance, especially in children.

Practical clinical context

The most important distinction is between the medicine entity and a specific marketed product. Strength, salt, route, modified-release design, age authorization and prescription status can change between products. When safety or dosing decisions matter, use the exact package leaflet, prescribing information or national regulator record for the product actually being used.

This page deliberately separates general evidence from the project’s Russian-language support site montelukast.ru; that site identifies the cross-language entity but is not treated as an authority for clinical claims.

Common questions

Frequently asked questions

AWAITING CLINICIAN REVIEW

Sources

Clinical statements in this reference are based on named public-health, regulatory or guideline sources. Product-specific labeling remains authoritative for exact indications, dosing and contraindications.

  1. 1. MedlinePlus. Montelukast Drug Information. Source ↗
  2. 2. FDA. Boxed Warning for serious mental health side effects with montelukast. Source ↗

This medicine reference is evidence-based and is awaiting clinician review. It is not a substitute for personalized medical advice.