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)
Traumatic liver injury09.01.08.010; 12.01.02.008--Not Available
Oropharyngeal pain22.02.05.022; 07.05.05.0040.000208%
Kounis syndrome24.04.04.020; 10.01.03.037; 02.02.02.0200.000139%Not Available
Acute kidney injury20.01.03.016--
Upper-airway cough syndrome22.02.05.0300.000069%
Neuropsychiatric syndrome19.07.03.009; 17.02.10.0140.000139%Not Available
Drug-induced liver injury12.03.01.044; 09.01.07.0230.000417%Not Available
Granulomatosis with polyangiitis24.05.02.013; 22.01.01.015; 20.05.01.013; 10.02.02.0180.000660%Not Available
Platelet dysfunction01.08.03.0030.000104%Not Available
Drug reaction with eosinophilia and systemic symptoms23.03.05.005; 10.01.01.0210.000243%Not Available
Liver function test increased13.03.01.044--Not Available
Frustration tolerance decreased19.04.02.0160.000104%Not Available
Alice in wonderland syndrome19.03.03.0030.000104%Not Available
Appendicitis perforated11.01.07.028; 07.04.06.0110.000069%
Blood immunoglobulin E increased13.06.05.0030.000069%Not Available
Coeliac disease10.04.04.012; 07.17.01.008; 14.02.01.0070.000139%Not Available
Concomitant disease aggravated08.01.03.0630.000069%Not Available
Nikolsky's sign23.03.07.0090.000104%Not Available
Systemic mastocytosis10.02.01.014; 01.05.01.0110.000069%Not Available
Weight loss poor14.03.02.0270.000069%Not Available
Self esteem decreased19.05.02.0040.000208%Not Available
Eosinophilic pneumonia chronic22.01.01.020; 01.02.04.0170.000382%Not Available
Gastric infection11.01.07.008; 07.19.03.0030.000069%Not Available
Post viral fatigue syndrome17.06.09.007; 11.05.04.0280.000208%Not Available
Onychophagia23.02.05.027; 19.18.01.0080.000174%Not Available
Negative thoughts19.15.02.0120.000347%Not Available
Communication disorder19.19.01.0080.000069%Not Available
Disturbance in social behaviour19.05.01.0180.000278%Not Available
Neurodevelopmental disorder19.22.02.003; 17.03.05.0020.000208%Not Available
Conduct disorder19.21.04.0020.000069%Not Available
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