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Montelukast

Lanair, Montelukast +pharma, Montelukast Accord, Montelukast Actavis · ATC code R03DC03

Brand names: Lanair, Montelukast +pharma, Montelukast Accord, Montelukast Actavis, Montelukast Aristo, Montelukast Für Kinder Von, Montelukast Für Pädiatrische Patienten Von, Montelukast Krka, Montelukast Ratiopharm, Montelukast Sandoz, Montelukast Stada, Montelukast Unimark, Singulair, Monkasta, Montelair Hexal …

Key facts
Active substance
Montelukast
Drug class
Leukotriene antagonist
ATC code
R03DC03
Authorisation
authorised nationally; no central EU authorisation
Information as of
2026-10-27

Boxed warning

Seriousneuropsychiatric (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 (including suicide). The mechanisms underlying NP events associated with montelukastsodium useare currently not well understood [see Warnings and Precautions (5.1)].
Because ofthe risk of NP events, the benefits of montelukast sodium may not outweigh the risks in some patients, particularly when the symptoms of disease may be mild and adequately treated with alternative therapies. Reserve use of montelukast sodium for patients with allergic rhinitis who have an inadequate response or intolerance to alternativetherapies [see Indications and Usage ( 1.3)]. In patients with asthma or exercise-induced bronchoconstriction, consider the benefits and risks before prescribing montelukast sodium.
Discussthe benefits and risks of montelukast sodium with patients and caregivers when prescribing montelukast sodium. Advise patients and/or caregivers to be alert for changes in behavior or new NP symptoms when taking montelukast sodium. If changes in behavior are observed, or if new NP symptoms or suicidal thoughts and/or behavior occur, advisepatients todiscontinue montelukast sodium and contact a healthcare provider immediately [see Warnings and Precautions (5.1)].

Key facts

Montelukast is a leukotriene receptor antagonist. Per the US prescribing information, the tablets are used from 15 years of age for asthma, exercise-induced bronchoconstriction and allergic rhinitis.

What it is used for

  • Prophylaxis and chronic treatment of asthma from 15 years of age
  • Prevention of exercise-induced bronchoconstriction from 15 years of age
  • Seasonal and perennial allergic rhinitis from 15 years of age, reserved for inadequate response or intolerance to alternative therapies
  • Not for treatment of an acute asthma attack

Dosing

  • Asthma: one 10 mg tablet once daily in the evening, with or without food
  • Exercise-induced bronchoconstriction: one 10 mg tablet at least 2 hours before exercise; no additional dose within 24 hours
  • Allergic rhinitis: one 10 mg tablet once daily, timing individualised
  • Asthma plus rhinitis: only one dose once daily in the evening
  • Missed dose: take the next dose at the regular time; never 2 doses at once

Contraindications

  • Hypersensitivity to any of its components

Important warnings

  • Boxed warning: serious neuropsychiatric events, including agitation, aggression, depression, sleep disturbances, suicidal thoughts and suicide
  • Discontinue and contact a healthcare provider immediately if behaviour changes or suicidal thoughts occur
  • In allergic rhinitis, benefits may not outweigh the risks
  • Events also reported after discontinuation

Side effects

  • Most common: upper respiratory infection, fever, headache, pharyngitis, cough
  • Abdominal pain, diarrhea, otitis, influenza, sinusitis
  • Neuropsychiatric events (e.g., dream abnormalities, insomnia, hallucinations, depression)

Interactions

  • No dose adjustment with theophylline, prednisone, oral contraceptives, digoxin, warfarin, itraconazole, NSAIDs, benzodiazepines or CYP inducers

Pregnancy and breastfeeding

  • Decades of cohort data have not established a drug-associated risk of major birth defects

Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

Common questions – ask Medelix

For patients

Patient information (US)

Patient information (US) →

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

Austria

  • LanairG.L. Pharma Gmbh · 1 register entry
  • Montelukast +pharma+pharma Arzneimittel Gmbh · 1 register entry
  • Montelukast AccordAccord Healthcare B.V. · 2 register entries
  • Montelukast ActavisActavis Group Ptc Ehf. · 1 register entry
  • Montelukast AristoAristo Pharma Gmbh (Art 57) · 1 register entry
  • Montelukast Für Kinder VonTeva B.V · 1 register entry
  • Montelukast Für Pädiatrische Patienten VonAccord Healthcare B.V. · 1 register entry
  • Montelukast KrkaKrka, D.D., Novo Mesto · 1 register entry
  • Montelukast RatiopharmTeva B.V · 2 register entries
  • Montelukast SandozSandoz Gmbh · 2 register entries
  • Montelukast StadaStada Arzneimittel Gmbh · 1 register entry
  • Montelukast UnimarkUnimark Remedies Sro · 1 register entry
Show all 13 brand names
  • SingulairOrganonhealthcare Gmbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Germany

  • MonkastaTad Pharma Gmbh · 1 register entry
  • Montelair HexalHexal Ag · 1 register entry
  • Montelukast1 A Pharma Gmbh, Ratiopharm Gmbh, Puren Pharma Gmbh & Co. Kg, Heumann Pharma Gmbh & Co. Generica Kg, Synthon Bv, Ametas Medical Gmbh, Aristo Pharma Gmbh (Art 57), Indoco Remedies Czech S.R.O., Viatris Germany Gmbh, Stadapharm Gmbh, Denk Pharma Gmbh & Co. Kg, Abz-Pharma Gmbh, Aliud Pharma Gmbh · 20 register entries
  • SingulairOrganonhealthcare Gmbh · 3 register entries

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Turkey

  • AerokastBERKO İLAÇ VE KİMYA SAN. A.Ş. · 1 register entry
  • AirfixNEUTEC İLAÇ SAN. TİC. A.Ş · 10 register entries
  • AirlastBİOFARMA İLAÇ SAN. VE TİC. A.Ş. · 3 register entries
  • AirlineHÜSNÜ ARSAN İLAÇLARI A.Ş. · 6 register entries
  • AirmolCELTİS İLAÇ SAN. VE TİC. A.Ş. · 10 register entries
  • AlecastİLKO İLAÇ SAN.VE TİC. A.Ş. · 4 register entries
  • AlientoGENVEON İLAÇ SAN. VE TİC. A.Ş. · 6 register entries
  • ClastNOBEL İLAÇ SAN. VE TİC. A.Ş. · 6 register entries
  • CulentoWORLD MEDICINE İLAÇ SAN. VE TİC. A.Ş. · 6 register entries
  • LuxatDEVA HOLDİNG A.Ş. · 2 register entries
  • MedlukastEXELTIS İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
  • MeflortASET İLAÇ SAN. VE TİC. A.Ş. · 6 register entries
Show all 21 brand names
  • N-FessRECORDATİ İLAÇ SAN. VE TİC. A.Ş. · 6 register entries
  • NottaSANOVEL İLAÇ SAN. VE TİC. A.Ş. · 8 register entries
  • OnceairABDİ İBRAHİM İLAÇ SAN. VE TİC. A.Ş. · 8 register entries
  • RespairSANTA FARMA İLAÇ SAN. A.Ş. · 6 register entries
  • SinairBERKO İLAÇ VE KİMYA SAN. A.Ş. · 1 register entry
  • SingulairORGANON TURKEY İLAÇLARI LİMİTED ŞİRKETİ · 3 register entries
  • SinmontHUMANİS SAĞLIK A.Ş. · 9 register entries
  • VentilarUMUT İLAÇ TİC. VE SAN. LTD. ŞTİ. · 3 register entries
  • ZespiraBİLİM İLAÇ SAN. VE TİC. A.Ş. · 8 register entries

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

USA

  • SingulairOrganon LLC · 1 register entry

Source: U.S. FDA – Drug labels (openFDA/DailyMed), as of 2026-10-28

Brand names in 27 more European countries
Belgium
Montelukast Ab, Montelukast Eg, Montelukast Eurogenerics, Montelukast Für Kinder Im Alter Von, Montelukast Krka, Montelukast Sandoz, Montelukast Teva, Singulair
Bulgaria
Eфира, Moнтелукаст Акорд, Алвокаст, Ефира, Монкаста, Сингулар
Croatia
Melarth, Monkasta, Monlast, Montelux, Singulair
Cyprus
Modulair, Montelukast Krka, Montol, Singodem, Singulair
Czechia
Castispir, Monkasta, Montelar, Montelukast Farmax, Montelukast Medreg, Montelukast Teva, Montelukast Viatris, Singulair
Denmark
Montelukast "sandoz", Montelukast Accord Healthcare, Montelukast Krka, Montelukast Stada, Montelukast Teva, Montelukast Viatris, Singulair
Estonia
Monkasta, Montelukast Teva
Finland
Montelukast, Singulair
France
Montelukast Accord, Montelukast Almus, Montelukast Arrow, Montelukast Bgr, Montelukast Cristers, Montelukast Eg, Montelukast Evolugen, Montelukast Krka, Montelukast Sandoz, Montelukast Teva, Montelukast Unimark, Montelukast Viatris, Montelukast Zentiva, Montelukast Zydus, Singulair
Greece
Apilone, Ascolin, Atentus, Miralust, Modulair, Mokast, Moncas, Montalis, Montast, Singodem, Singulair, Singument-S, Thordel, Velukast, Yekast, Zakomoxit, Μoνtalis
Hungary
Eonic, Monalux, Mondeo, Montelukast, Singulair Mini
Iceland
Montelukast Alvogen, Singulair
Ireland
Montelair, Montelukast, Singulair
Italy
Aleast Per Bambini Da, Brokast, Elunkast, Leukast, Lukanof, Lukasm, Monast, Monkasta, Montegen, Montelukast Accord, Montelukast Alter, Montelukast Aurobindo, Montelukast Doc, Montelukast Dorom, Montelukast Eg, Montelukast Mylan, Montelukast Pensa, Montelukast Per Bambini Dai, Montelukast Sandoz, Montelukast Sun Pharma Italia Srl, Montelukast Tecnigen, Montelukast Teva, Montelukast Zentiva, Nolus, Saslong, Singulair
Latvia
Monkasta
Lithuania
Monkasta
Luxembourg
Montelukast Eurogenerics, Montelukast Ratiopharm, Montelukast Sandoz, Singulair
Malta
Actamone, Monkasta, Montelair, Montelukast Aurobindo, Montelukast Normon, Montol
Netherlands
Montelukast Accord, Montelukast Amarox, Montelukast Ametas, Montelukast Aurobindo, Montelukast Glenmark, Montelukast Indoco, Montelukast Krka, Montelukast Natrium Aurobindo, Montelukast Opko, Montelukast Sandoz, Montelukast Synthon, Montelukast Teva, Montelukast Viatris, Montelukast Voor Pediatrische Patiënten Van, Mooncast, Singulair
Norway
Montelukast Krka, Montelukast Sandoz, Montelukast Teva, Singulair
Poland
Asmenol, Astmodil, Milukante, Monkasta, Montelukast, Montelukastum Unimark, Orilukast, Promonta, Romilast, Singulair
Portugal
Montelucaste Accord, Montelucaste Alter, Montelucaste Apilif, Montelucaste Aurobindo, Montelucaste Azevedos, Montelucaste Baldacci, Montelucaste Bluefish, Montelucaste Bluepharma, Montelucaste Bluesar, Montelucaste Chesmon, Montelucaste Ciclum, Montelucaste Farmoz, Montelucaste Generis, Montelucaste Krka, Montelucaste Mylan, Montelucaste Omnicals, Montelucaste Pensa, Montelucaste Pharmakern, Montelucaste Ratiopharm, Montelucaste Sandoz, Montelucaste Tecnigen, Montelucaste Tecnilor, Montelucaste Tetrafarma, Montelucaste Teva, Montelucaste Tolife, Montelucaste Vitória, Singulair
Romania
Monkasta, Montelukast Arena, Montelukast Gemax Pharma, Montelukast Teva, Montelukast Unimark, Singulair
Slovakia
Astmasan, Belokast, Monkasta, Montelukast, Spiromon
Slovenia
Monkasta, Singulair
Spain
Monkasta, Montelukast Accord, Montelukast Almus, Montelukast Alter, Montelukast Asthmapharma, Montelukast Aurovitas, Montelukast Cinfa, Montelukast Combix, Montelukast Efg Teva, Montelukast Kern Pharma, Montelukast Mabo, Montelukast Mylan, Montelukast Normon, Montelukast Opko, Montelukast Pensa, Montelukast Qualigen, Montelukast Sandoz, Montelukast Stada, Montelukast Sun, Montelukast Tarbis, Montelukast Tecnigen, Montelukast Teva, Montelukast Ur, Montelukast Viatris, Montelukast Vir, Pluralais, Singulair
Sweden
Montelukast Accord, Montelukast Amarox, Montelukast För Barn Från, Montelukast Krka, Montelukast Sandoz, Montelukast Stada, Montelukast Teva, Montelukast Viatris, Singulair

EMA – Article 57 product data (EU/EEA), 2026-10-28

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Sources

  1. U.S. Food and Drug Administration. MONTELUKAST SODIUM (Camber Pharmaceuticals, Inc.) – Prescribing Information, 2025-03-13. DailyMed (NLM), 2026-10-27. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=97a682c2-7e00-4d07-a5ac-4436c977f842
  2. EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  3. EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  4. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  5. U.S. FDA – Drug labels (openFDA/DailyMed), 2026-10-28. https://dailymed.nlm.nih.gov/dailymed/
  6. Wikidata (CC0): ATC R03DC.

Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error

Source: U.S. Food and Drug Administration (FDA), prescribing information, via DailyMed (NLM); public domain. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.