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)
Asthenia08.01.01.001--Not Available
Asthma22.03.01.002; 10.01.03.0100.002570%Not Available
Ataxia17.02.02.001; 08.01.02.0040.000069%
Atelectasis22.01.02.0010.000069%
Atrial fibrillation02.03.03.002--
Attention deficit/hyperactivity disorder19.21.04.0010.000208%Not Available
Aura17.02.07.0110.000069%Not Available
Back pain15.03.04.0050.000556%
Belligerence19.05.01.0150.000069%Not Available
Blood bilirubin increased13.03.01.008--
Blood cortisol decreased13.10.09.0040.000174%Not Available
Blood creatine phosphokinase increased13.04.01.001--
Blood glucose increased13.02.02.002--Not Available
Blood pressure decreased13.14.03.0020.000174%Not Available
Blood pressure fluctuation24.06.01.0020.000069%Not Available
Blood pressure increased13.14.03.0050.000382%Not Available
Body temperature increased13.15.01.001--Not Available
Bone disorder15.02.04.004--Not Available
Bone pain15.02.01.001--
Bradycardia02.03.02.002--Not Available
Bronchiolitis22.03.02.004; 11.05.04.0080.000069%Not Available
Bronchitis22.07.01.001; 11.01.09.0010.000452%
Bronchospasm22.03.01.004; 10.01.03.0120.000174%
Burning sensation17.02.06.001; 08.01.09.0290.000174%Not Available
Cardiac arrest02.03.04.001--
Cardiac failure02.05.01.001--
Cardiac failure congestive02.05.01.002--Not Available
Cellulitis23.09.01.001; 11.02.01.001--Not Available
Cerebral arteritis24.05.01.002; 17.08.02.0040.000069%Not Available
Cerebral infarction24.04.06.002; 17.08.01.004--Not Available
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