Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Montelukast
Drug ID BADD_D01496
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 D08229
MeSH ID C093875
PubChem ID 5281040
TTD Drug ID D00QET
NDC Product Code 68071-4034; 63629-8235; 65162-771; 65977-0040; 68645-560; 71335-1979; 31722-726; 0781-5554; 63629-4886; 70518-3133; 65162-772; 71205-128; 68071-1561; 51128-502; 68788-8099; 68071-2425; 0781-5560; 65162-732; 63187-626; 27241-017; 55154-8075; 51128-503; 0781-5555; 0904-6808; 72865-175; 68001-361; 50268-556; 70518-2603; 51128-501; 71610-563; 33342-102
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 C35H36ClNO3S
CAS Registry Number 158966-92-8
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
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)
Demyelination17.16.02.0010.000069%Not Available
Depressed level of consciousness17.02.04.002--
Depressed mood19.15.02.0010.000973%Not Available
Depression19.15.01.0010.003751%
Depression suicidal19.15.01.0040.000174%Not Available
Derealisation19.10.02.0010.000069%Not Available
Dermatitis23.03.04.0020.000069%Not Available
Dermatitis atopic23.03.04.016; 10.01.04.004--Not Available
Dermatitis exfoliative23.03.07.001; 10.01.01.0040.000139%
Diabetes mellitus inadequate control14.06.01.004; 05.06.01.0040.000069%Not Available
Diarrhoea07.02.01.001--
Diet refusal14.03.01.0110.000069%Not Available
Diplopia17.17.01.005; 06.02.06.0020.000139%Not Available
Discomfort08.01.08.0030.000104%Not Available
Disorientation19.13.01.002; 17.02.05.0150.000313%Not Available
Dissociation19.14.01.0020.000139%Not Available
Disturbance in attention19.21.02.002; 17.03.03.0010.000764%
Dizziness24.06.02.007; 17.02.05.003; 02.01.02.0040.001841%
Drooling17.02.05.0050.000069%Not Available
Drug abuse19.07.02.010--Not Available
Drug eruption23.03.05.001; 10.01.01.005; 08.01.06.0150.000104%Not Available
Drug hypersensitivity10.01.01.001--Not Available
Dry mouth07.06.01.0020.000174%
Dysaesthesia17.02.06.0030.000104%
Dysarthria19.19.03.001; 17.02.08.001--
Dysgeusia17.02.07.003; 07.14.03.0010.000347%
Dyskinesia17.01.02.0060.000278%
Dyspepsia07.01.02.0010.000417%
Dysphagia07.01.06.0030.000452%
Dysphonia22.02.05.005; 19.19.03.002; 17.02.08.0040.000313%
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