ℹ️ Compiled from public regulatory records · Last regulator revision: May 27, 2026

Montelukast

Leukotriene Receptor Antagonists

Sold as SINGULAIR

GB MHRACA Health CanadaUS FDA

Drug class: Leukotriene Receptor Antagonists
Availability: Prescription only
Routes: Oral
Markets covered: 3
Products on record: 157
FDA reports (12 mo): 9,980

R03DCLeukotriene Receptor Antagonists

Overview

Plain-language summary, compiled from the cited regulatory records

Montelukast is a leukotriene receptor antagonist [1]. It is approved for the prophylaxis and chronic treatment of asthma in patients aged 2 years and older [1]. Montelukast is also indicated for the acute prevention of exercise-induced bronchoconstriction (EIB) in patients aged 6 years and older [1].

Additionally, montelukast provides relief from symptoms of allergic rhinitis (AR), including seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR) in patients aged 2 years and older [1]. It is available under various brand names, including SINGULAIR [1].

In the past 12 months, there were 9,980 adverse event reports for montelukast [2]. The most frequently reported reactions include dyspnoea, asthma, cough, pneumonia, and reports of the drug being ineffective [2].

This is not medical advice. Consult a qualified healthcare professional.

Regulatory status by market

Market	Regulator	Products	Last revision
GB United Kingdom	MHRA	75	May 22, 2026
CA Canada	Health Canada	57	May 25, 2026
US United States	FDA	25	May 27, 2026

GBUnited Kingdom· MHRA

75 products

Uses

GBOfficial regulatory label· revised May 1, 2026[1]

Montelukast 10 mg film-coated tablets is indicated in the treatment of asthma as add-on therapy in those patientswith mild to moderate persistent asthma who are inadequately controlled on inhaled corticosteroids and in whom “as-needed” short acting β-agonists provide inadequate clinical control of asthma.
In those asthmatic patients in whom Montelukast 10 mg film-coated tablets is indicated in asthma, Montelukast 10 mg film-coated tablets can also provide symptomatic relief of seasonal allergic rhinitis. Montelukast 10 mg film-coated tablets is also indicated in the prophylaxis of asthma in which the predominant component is exercise-induced bronchoconstriction.

How to take

CACanada· Health Canada

57 products

Uses

CAOfficial regulatory label· revised April 20, 2026[2]

AND CLINICAL USE....................................................................................... 3 CONTRAINDICATIONS ....................................................................................................... 4 WARNINGS AND PRECAUTIONS ........................................................................................
5 ADVERSE REACTIONS ........................................................................................................ 7 DRUG INTERACTIONS ......................................................................................................
10 DOSAGE AND ADMINISTRATION .................................................................................... 12 OVERDOSAGE ..................................................................................................................
13 ACTION AND CLINICAL PHARMACOLOGY ....................................................................... 13 STORAGE AND STABILITY ................................................................................................ 16 DOSAGE FORMS, COMPOSITION AND PACKAGING ........................................................

USUnited States· FDA

25 products

Uses

USOfficial regulatory label· revised May 27, 2026[3]

1 ). 2 ). Relief of symptoms of allergic rhinitis (AR): seasonal allergic rhinitis (SAR) in patients 15 years of age and older, and perennial allergic rhinitis (PAR) in patients 15 years of age and older. 3 ). 2 ). 1 Asthma Montelukast sodium tablets are indicated for the prophylaxis and chronic treatment of asthma in patients 15 years of age and older.
2 Exercise-Induced Bronchoconstriction (EIB) Montelukast sodium tablets are indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients 15 years of age and older. 3 Allergic Rhinitis Montelukast sodium is indicated for the relief of symptoms of seasonal allergic rhinitis in patients 15 years of age and older and perennial allergic rhinitis in patients 15 years of age and older.
1 )], reserve use for patients who have an inadequate response or intolerance to alternative therapies. 4 Limitations of Use Montelukast sodium is not indicated for the treatment of an acute asthma attack.

Drug interactions

Known interactions involving Montelukast. Select one for details. This list is informational and not a complete interaction checker.

Abametapir Abiraterone Alpelisib Aminoglutethimide Amiodarone Amobarbital Apalutamide Bexarotene Bosentan Butabarbital Butalbital Carbamazepine Cenobamate Dabrafenib Deferasirox Delavirdine Dexamethasone Duvelisib Efavirenz Elagolix Enzalutamide Etravirine Felbamate Fenofibrate Fluconazole Fluvoxamine Fosphenytoin Fostamatinib Gemfibrozil Griseofulvin Imatinib Isoniazid Ivacaftor Ivosidenib Lapatinib Larotrectinib Lefamulin Leflunomide Letermovir Lorlatinib Lumacaftor Mephobarbital Metronidazole Miconazole Mifepristone Mitotane Nafcillin Nateglinide Nevirapine Nitisinone Oxcarbazepine Pentobarbital Pexidartinib Phenobarbital Phenylbutazone Phenytoin Primidone Rifabutin Rifampin Rifapentine Ripretinib Rucaparib Rufinamide Secobarbital Selpercatinib Somapacitan Somatrem Somatropin Sulfadiazine Sulfamethizole Sulfamethoxazole Sulfinpyrazone Tamoxifen Tazemetostat Teriflunomide Toremifene Trimethoprim Troglitazone Tucatinib Valproate Vemurafenib Vilazodone Voriconazole Zafirlukast Abacavir Acarbose Acebutolol Acetaminophen Acetylcysteine Acitretin Acyclovir Adenosine Albuterol Alendronate Alfuzosin Aliskiren Allopurinol Almotriptan Alosetron Alprazolam Amantadine Ambrisentan Amiloride Aminophylline Amitriptyline Amlodipine Amoxicillin Amphetamine Amphotericin B Anastrozole Aripiprazole Aspirin Atazanavir Atenolol Atomoxetine Atorvastatin Atovaquone Azathioprine Azelastine Azithromycin Baclofen Benazepril Bimatoprost Bisoprolol Bortezomib Brimonidine Brinzolamide Budesonide Bumetanide Buprenorphine Bupropion Buspirone Cabergoline Calcitriol Calcium Chloride Capecitabine Captopril Carboplatin Carisoprodol Carvedilol Cefaclor Cefazolin Cefdinir Cefepime Cefotaxime Cefpodoxime Cefprozil Ceftriaxone Cefuroxime Celecoxib Cephalexin Cerivastatin Cetirizine Chlorpromazine Chlorthalidone Ciclesonide Ciclopirox Cimetidine Cinacalcet Ciprofloxacin Cisplatin Citalopram Clarithromycin Clindamycin Clobetasol Clomipramine Clonazepam Clonidine Clopidogrel Clotrimazole Clozapine Cyclobenzaprine Cyclophosphamide Cyclosporine Cytarabine Dapsone Darifenacin Dasatinib Desloratadine Desvenlafaxine Dextromethorphan Diazepam Diclofenac Dicyclomine Didanosine Digoxin Diltiazem Dipyridamole Docetaxel Dofetilide Dolasetron Donepezil Doxazosin Doxepin Doxorubicin Doxycycline Duloxetine Dutasteride Eletriptan Enalapril Epinephrine Eplerenone Epoprostenol Erlotinib Erythromycin Estradiol Etodolac Etomidate Etoposide Exemestane Ezetimibe Famciclovir Famotidine Felodipine Fentanyl Fexofenadine Finasteride Flecainide Fludarabine Fluorouracil Fluoxetine Flurazepam Fluticasone Fluvastatin Folic Acid Formoterol Fosinopril Frovatriptan Furosemide Gabapentin Gadodiamide Galactose Galantamine Gatifloxacin Gefitinib Gemcitabine Gemifloxacin Glimepiride Glipizide Glyburide

Showing 240 of 461. Type above to find a specific drug.

Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.

Sources & citations

[1]MHRA (UK) · PL200750182 · revised May 1, 2026
[2]Health Canada (DPD) · 02399997 · revised April 20, 2026
[3]FDA DailyMed · 52c650cf-3081-7b… · revised May 27, 2026 [PDF]
[4]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.