Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Montelukast sodium
Drug ID BADD_D01497
Description Montelukast was first approved for clinical use by the US FDA in 1998 as Merck's brand name Singulair.[L6301] The medication is a member of the leukotriene receptor antagonist (LTRA) category of drugs.[L6301,L6304,L6307,L6310,L6325,L6328,L6331] Although capable of demonstrating effectiveness, the use of such LTRAs like montelukast is typically in addition to or complementary with the use of inhaled corticosteroids or other agents in asthma step therapy.[A178645] Regardless, in 2008-2009, there were FDA-led investigations into the possibility of montelukast to elicit neuropsychiatric effects like agitation, hallucinations, suicidal behaviour, and others in individuals who used the medication.[A178651] And although these kinds of effects are currently included in the official prescribing information for montelukast,[L6301,L6304,L6307,L6310,L6325,L6328,L6331] the drug still sees extensive use worldwide via millions of prescriptions annually and has since become available as a generic and as a brand name product.
Indications and Usage For the treatment of asthma
Marketing Status Prescription; Discontinued
ATC Code R03DC03
DrugBank ID DB00471
KEGG ID D00529
MeSH ID C093875
PubChem ID 23663996
TTD Drug ID D00QET
NDC Product Code 13668-080; 50090-4919; 68084-875; 71335-0620; 68071-3355; 50268-573; 65862-568; 69367-287; 71335-0374; 53747-079; 51927-0018; 27241-016; 63187-289; 68788-9438; 50090-5774; 63187-896; 42291-621; 66499-0016; 71335-1602; 43063-762; 58657-715; 71335-0033; 50090-4705; 71335-1599; 71335-0301; 63187-550; 72189-223; 31722-728; 65862-574; 68071-1755; 78206-173; 76397-004; 16729-119; 63552-027; 57237-213; 65862-843; 50268-575; 78206-171; 71335-0514; 63187-692; 50473-0002; 50090-2480; 68788-7668; 65862-567; 71335-1326; 63187-216; 53002-4730; 13668-079; 59651-329; 42385-709; 60312-0711; 61919-097; 50090-2176; 55111-593; 52343-035; 52343-037; 43063-381; 50090-5403; 63629-8106; 58657-717; 27241-018; 42708-042; 68788-7771; 70518-2881; 57237-255; 68071-4047; 63629-4978; 62993-0806; 50090-2921; 71205-189; 71335-1995; 62993-0807; 80426-041; 42291-622; 27241-015; 61919-009; 55111-763; 29300-221; 53002-1441; 55111-725; 29300-220; 55111-594; 71610-026; 63187-751; 63187-430; 31722-727; 13668-081; 42291-623; 63187-781; 58657-716; 29300-222; 68071-5141; 33342-110; 62175-210; 52343-036; 65015-823; 50268-574; 78206-172; 68071-2486; 50370-0003; 60312-0275; 33342-111; 62175-205; 0093-7487; 62175-204; 60312-0117; 13668-531; 57237-212; 70518-0172; 78206-170; 68788-7669; 71205-181; 15894-0004
Synonyms montelukast | 1-((((1R)-1-(3-((E)-2-(7-chloro-2-quinolinyl)ethenyl)phenyl)-3-(2-(1-hydroxy-1-methylethyl)phenyl)propyl)thio)methyl)-cyclopropaneacetic acid | MK 0476 | MK-0476 | Singulair | montelukast sodium | sodium 1-(((1-(3-(2-(7-chloro-2-quinolinyl)ethenyl)phenyl)-3-(2-(1-hydroxy-1-methylethyl)phenyl)propyl)thio)methyl)cyclopropylacetate
Chemical Information
Molecular Formula C35H35ClNNaO3S
CAS Registry Number 151767-02-1
SMILES CC(C)(C1=CC=CC=C1CCC(C2=CC=CC(=C2)C=CC3=NC4=C(C=CC(=C4)Cl)C=C3)SCC5(CC5)CC(=O)[O -])O.[Na+]
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal pain07.01.05.002--
Abnormal dreams19.02.03.001; 17.15.02.001--Not Available
Aggression19.05.01.001--Not Available
Alanine aminotransferase increased13.03.01.003--
Anaphylactic reaction24.06.03.006; 10.01.07.001--
Angioedema23.04.01.001; 10.01.05.009--Not Available
Anxiety19.06.02.002--
Arthralgia15.01.02.001--
Aspartate aminotransferase increased13.03.01.006--
Asthenia08.01.01.001--Not Available
Bronchitis22.07.01.001; 11.01.09.001--
Completed suicide19.12.01.001; 08.04.01.010--Not Available
Conjunctivitis11.01.06.012; 06.04.01.002--
Cough22.02.03.001--
Depression19.15.01.001--
Dermatitis23.03.04.002--Not Available
Dermatitis atopic10.01.04.004; 23.03.04.016--Not Available
Diarrhoea07.02.01.001--
Disorientation19.13.01.002; 17.02.05.015--Not Available
Dizziness24.06.02.007; 17.02.05.003; 02.01.02.004--
Dyspepsia07.01.02.001--
Ear infection11.01.05.001; 04.03.01.006--Not Available
Ear pain04.03.01.003--
Eczema23.03.04.006--
Epistaxis24.07.01.005; 22.04.03.001--
Erythema multiforme23.03.01.003; 10.01.03.015--
Erythema nodosum23.07.02.001; 10.02.01.020--Not Available
Fatigue08.01.01.002--
Gastroenteritis11.01.07.004; 07.19.03.001--Not Available
Hallucination19.10.02.002--
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