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)
Cerebrovascular accident24.03.05.001; 17.08.01.007--
Chest discomfort22.02.08.001; 08.01.08.019; 02.02.02.0090.001355%Not Available
Chest pain02.02.02.011; 22.02.08.003; 08.01.08.0020.000868%Not Available
Chills15.05.03.016; 08.01.09.0010.000278%
Choking22.02.05.0010.000069%Not Available
Cholangitis09.02.01.0020.000069%Not Available
Chromaturia20.02.01.0020.000104%
Chronic hepatitis11.07.01.009; 09.01.07.0210.000069%Not Available
Chronic obstructive pulmonary disease22.03.01.0070.000045%Not Available
Clavicle fracture15.08.03.010; 12.04.01.0100.000069%Not Available
Cold sweat23.02.03.002; 08.01.03.0240.000104%Not Available
Colitis ischaemic24.04.08.012; 07.08.01.0040.000139%Not Available
Coma17.02.09.001--Not Available
Completed suicide19.12.01.001; 08.04.01.010--Not Available
Concussion17.11.01.004; 12.01.10.0050.000104%Not Available
Confusional state19.13.01.001; 17.02.03.005--
Conjunctivitis11.01.06.012; 06.04.01.002--
Conjunctivitis allergic10.01.04.002; 06.04.01.0030.000069%Not Available
Constipation07.02.02.001--
Coordination abnormal17.02.02.0040.000243%Not Available
Cough22.02.03.0010.002258%
Crying19.04.02.002; 17.02.05.013; 12.02.11.001; 08.01.03.0050.000973%Not Available
Cushingoid19.07.03.001; 14.11.01.006; 05.01.01.002; 24.08.02.0040.000069%
Cyanosis24.03.01.007; 22.02.02.007; 02.01.02.0020.000069%
Deafness04.02.01.0010.000104%Not Available
Death08.04.01.001--
Decreased activity08.01.01.006; 19.11.01.0020.000069%Not Available
Decreased interest19.15.02.0040.000208%Not Available
Dehydration14.05.05.001--
Delusion19.10.01.0010.000104%
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